Tag: Doctrine of Equivalents

The Doctrine of Equivalents: Examination of the Law in Italy

October 27, 2020

In many jurisdictions, the scope of protection afforded by a patent is defined by the claims as read either literally or under doctrine of equivalents.  Infringement based on the doctrine of equivalents may be based in part on statutory law, the interpretation of which is generally established via case law (e.g. Court decisions).  The purpose of the doctrine of equivalents is to promote fair patent coverage so that trivial departures (e.g., variants or deviations) from the claim language cannot be used to avoid infringement.

This is the seventh post in our series examining the law governing the doctrine of equivalents in several European countries.  Our first post examined the law governing the doctrine of equivalents in Spain, our second post examined the law in the Netherlands, our third post examined the law in Germany, our fourth post examined the law in Denmark, our fifth post examined the law in the United Kingdom, and out sixth post examined the law in France.  These posts can be viewed here:  Doctrine of Equivalents – Spain, Doctrine of Equivalents – the Netherlands,  Doctrine of Equivalents – Germany,  Doctrine of Equivalents – Denmark,  Doctrine of Equivalents – United Kingdom and Doctrine of Equivalents – France.

Doctrine of Equivalents in Italy

Background

Italy has a population of about 60 million and, as one of the most industrialized countries in the European Union (EU) together with Germany, it is an attractive market for many industries such as pharmaceuticals and telecoms.  As a result, many foreign companies often litigate in Italy, especially when it comes to important patents on which those companies start multinational litigation in the major EU countries.  Thus, for many years now, Italy has had in place a system of specialized intellectual property (IP) courts that have exclusive jurisdiction on patent matters that are staffed with highly experienced judges.

In patent litigation, the Italian IP judges almost always appoint a court expert to advise whether the patent is valid and infringed. The court expert is generally an experienced patent attorney working in private practice, who is free of conflicts, and has a suitable technical background in the field of technology of the litigation.  The expert renders an opinion on the “gist” of the case rather than only on specific technical issues. Specifically, the expert’s opinion is based on briefs filed by the patent attorneys representing the parties, rather than by (non-patent) lawyers. The involvement of an expert, whose opinion is generally fully adopted by the IP judges, contributes to the high quality of the court decisions. Because of the reliance by the IP judges on the findings of the expert, many  times a party wishing to launch a product in Italy before the expiration date of a patent will start an invalidity and non-infringement action on the merits, so as to try and obtain a favorable expert report, as this may significantly decrease the chances of a preliminary injunction (PI) being granted if the launch takes place after the expert report is issued.

Moreover, Italian patent litigation is appealing for three additional reasons. First, there is no requirement for the patentee to start a litigation on the merits once a PI is granted (unlike in other EU countries where, if the patentee does not start the litigation on the merits, the PI is automatically lifted). Second, the patentee is not liable to pay damages to the alleged infringer if, for example, during the course of subsequent litigation on the merits, the PI is lifted. Third, any first instance decision can be appealed by the losing party, without having to first request a leave to appeal.

Although there is no discovery in Italy, a patentee who suspects ongoing infringement and  is unable to find publicly available evidence of the infringement, can request, in ex parte proceedings, the authorization to inspect the premises of an alleged infringer by surprise (e.g., unannounced) so as to collect relevant evidence prior to commencing litigation on the merits or filing a request for a PI. This type of inspection is particularly helpful, such as, for example, in the case of process patents or in connection with patents relating to devices that are used by an alleged infringer in the course of its manufacturing activity. Since the inspection is a fact-finding measure rather than a punitive measure, the threshold for obtaining the authorization to carry out such an inspection from an IP judge is rather low, and these authorizations are frequently granted. The patentee has one month to carry out the inspection and then start the action based on the evidence collected.

First instance proceedings on the merits generally last about 18 to about 24 months. First instance PI proceedings can last as take as little as about 2 weeks to about 1 month.

Direct Infringement

In Italy, direct infringement is governed by Art. 66 of the Italian IP Code (IPC), which recites as follows:

“1. The rights for a patent of invention consist of the exclusive faculty to implement the invention and to gain profit therefrom in the territory of the Italian State, within the limits and under the conditions set out by this Code.

2.  In particular, the patent confers the following exclusive rights on its owner:

a) if the subject matter of the patent is a product, the right to prohibit third parties, unless authorized by the owner, from manufacturing, using, placing on the market, selling or importing for such purposes the product in question;

b) if the subject matter of the patent is a process, the right to prohibit third parties, unless authorized by the owner, from applying the process, as well as from using, placing on the market, selling or importing for such purposes the product directly obtained by the process in question.

2-bis. The patent also confers the exclusive right on the owner to prohibit third parties, except with his or her consent, from supplying or from offering to supply, to persons other than the parties entitled to use the patented invention, a means relating to an essential element of that invention and necessary for its implementation in the territory of a state in which the invention is protected, if the third party is aware of the suitability and intended use of said means to implement the invention or is able to have that awareness based on  ordinary diligence.

2-ter. Paragraph 2-bis does not apply when the means are constituted by products that are currently on the market, unless the third party induces the party to whom the means are supplied to carry out the acts prohibited pursuant to paragraph 2.”

 Claim Construction

Art. 52 IPC contains the provisions forming the legal basis for claim construction in Italian patent litigation:

“1. The claims specifically indicate what the subject matter of the patent is intended to be.

2.  The limits of protection are determined by the claims; however, the description and the drawings serve the purpose of interpreting the claims

3.  The provision in paragraph 2 must be understood so as to simultaneously ensure fair protection to the owner and reasonable legal certainty to third parties.

3-bis. In order to determine the scope of protection conferred by the patent, due account shall be taken of any element which is equivalent to an element specified in the claims.”

 The protocol of interpretation of Art. 69 of the European Patent Convention (EPC), i.e., the article relating to the extent of protection conferred by a patent and whose wording mirrors that of Art. 52 IPC, is also often relied upon for construing the claims in Italian patent litigation. Specifically, Art. 1 of the protocol of interpretation states that:

“Article 69 should not be interpreted as meaning that the extent of the protection conferred by a European patent is to be understood as that defined by the strict, literal meaning of the wording used in the claims, the description and drawings being employed only for the purpose of resolving an ambiguity found in the claims. Nor should it be taken to mean that the claims serve only as a guideline and that the actual protection conferred may extend to what, from a consideration of the description and drawings by a person skilled in the art, the patent proprietor has contemplated. On the contrary, it is to be interpreted as defining a position between these extremes which combines a fair protection for the patent proprietor with a reasonable degree of legal certainty for third parties.”

 Thus, under Italian law, claim construction is partly a mixed question of law and fact and the claims are construed on the basis of the specification, as well as on the basis of the prosecution history (see below) and the prior art.

Prosecution History (Prosecution History Estoppel)

The effect of the prosecution history when assessing the scope of protection of a claim in Italian patent litigation is governed by Italian case law. The presently prevailing case law provides that while any statements contained in the prosecution history are not necessarily binding on the patentee, they nevertheless can carry a significant weight when interpreting the claims of the enforced patent.  For example, recently the IP court of Milan stated that “in infringement proceedings the features intentionally excluded by the patent owner during examination for the purpose of distinguishing his patent from the prior art cannot be considered to be technical equivalents of the claimed elements (this approach has been reiterated multiple times by the present court, in line with the US file history estoppel theory). So as to respect the requirement of certainty of the limits of the exclusive rights with respect to … third parties, the owner has the duty to specify his claims, where his statements made in examination have a preclusive relevance with respect to the scope of protection of the  monopoly.” (Court of Milan, decision published on June 1, 2018).

Italian Supreme Court’s Case Law Regarding the Doctrine of Equivalents

The leading Italian case that established the test to be used when determining infringement by equivalents is the Italian Supreme Court decision dated January 13, 2004. In this decision, the Italian Supreme Court established that “[i]n order to assess …. whether the accused embodiment can be considered to be equivalent to the patented one, so as to represent an infringement thereof, it is necessary to determine whether, in allowing to obtain the same final result, the accused embodiment is inventive, thereby providing a solution that is not obvious with respect to the patented one and is not a repetition of the patented one either: this is the case for the solution that goes beyond the knowledge of the average skilled person facing the same problem. In fact, only in this case it is possible to consider that the [accused] solution falls outside the protected solution.” This test was then repeatedly endorsed by the Italian Supreme Court in several decisions, including decisions issued in 2011, 2012, 2015 and 2016.

Essentially, the test to determine infringement by equivalents involves answering the following two questions:

  1. Does the allegedly infringing solution lead to the same final result as the patented solution?

If the answer is no, then there is no infringement by equivalents. If the answer is yes, proceed to question 2.

  1. Does the allegedly infringing solution represent an invention with respect to the patented solution?

If the answer is yes, then there is no infringement by equivalents.  If the answer is no, then there is infringement by equivalents – unless the allegedly infringing solution forms part of the state of the art, in which case it is excluded from the scope of protection of the patent.

Pemetrexed Decisions

The recent pemetrexed litigation, which caused quite a stir throughout Europe, also reached Italy. In this case, Eli Lilly’s European Patent No. 1313508 (the ‘508 patent) had been granted with a claim directed to the use of pemetrexed disodium (an antifolate) to inhibit tumor growth in combination with vitamin B12. The underlying application had claimed the use of antifolate rather than pemetrexed disodium. During examination at the EPO, Eli Lilly had first amended its claims to pemetrexed in view of certain prior art. The EPO objected to the amendment arguing that the application as filed did not disclose pemetrexed, but rather only a specific salt thereof, namely the disodium salt.  As a result, Eli Lilly limited its claims to pemetrexed disodium.

In Italy, Fresenius argued that its generic product, which contained pemetrexed ditromethamine, did not constitute an infringement by equivalents of the ‘508 patent.  Specifically, Fresenius argued that the ‘508 patent was limited to a specific pemetrexed salt and that the patent could not be interpreted broadly because it had been limited during examination so as to exclude any salts other than the disodium salt. In contrast, Eli Lilly argued that infringement by equivalents existed because the limitation of the claims to the specific disodium salt was only because of formal reasons and a skilled person would understand that the salt form of pemetrexed used was irrelevant for the purpose of achieving the result of the invention. Based on this argument, Eli Lilly requested a PI.

At first instance, the Milan IP court denied the PI request.  Specifically, the Court found that the scope of protection of the patent, even when interpreted so as to take any equivalents into consideration, had to be limited so the objective scope of the patent as amended during examination, regardless of the type of objection that had resulted in the amendment.

On appeal, the appeal court reversed the first instance findings and granted the PI. The appeal court reasoned that  “unlike the limitations resulting from objections based on the prior art, a limitation introduced so as to overcome an added matter objection cannot effectively influence the application of the doctrine of equivalents, given that such objection focuses on  formal aspects relating to the literal wording of the text of the amended claims compared to the original text of the patent application.” Thus, the appeal court drew a distinction between claim amendments made for purposes of distinguishing the invention from the prior art and claim amendments arising as a result of formal objections, holding that in the latter case the limitations introduced during examination could be interpreted broadly so as to take into consideration any equivalents thereof.

This post was written by Lisa Mueller and Micaela Modiano of Modiano & Partners.

The Doctrine of Equivalents:  Examination of the Law in France

September 22, 2020

In many jurisdictions, the scope of protection afforded by a patent is defined by the claims as read either literally or under doctrine of equivalents.  Infringement based on the doctrine of equivalents may be based in part on statutory law, the interpretation of which is generally established via case law (e.g. court decisions).  The purpose of the doctrine of equivalents is to promote fair patent coverage so that trivial departures (e.g., variants or deviations) from the claim language cannot be used to avoid infringement.

This is the sixth post in our series examining the law governing the doctrine of equivalents in several European countries.  Our first post examined the law governing the doctrine of equivalents in Spain, our second post examined the law in the Netherlands, our third post examined the law in Germany, our fourth post examined the law in Denmark, and our fifth post examined the law in the United Kingdom.  These posts can be viewed here:  Doctrine of Equivalents – Spain, Doctrine of Equivalents – the Netherlands,  Doctrine of Equivalents – Germany,  Doctrine of Equivalents – Denmark, and Doctrine of Equivalents – United Kingdom.

Doctrine of Equivalents in France

Background 

In France, the Paris courts have exclusive jurisdiction to hear patent infringement proceedings, and since April 2020, share its jurisdiction on patent validity with the French Intellectual Property Office (Institut National de la Propriété Intellectuelle – INPI).

With regard to the courts specifically, at first instance, patent disputes are within the exclusive jurisdiction of the Paris Court of First Instance (Tribunal Judiciaire de Paris, ex Tribunal de Grande Instance), and on appeal, at the Paris Court of Appeal (Cour d’Appel de Paris).  The third chamber of the Paris Court of First Instance has three panels of three judges that handle only intellectual property matters. Despite these judges being designated to a specialized chamber, judges may have knowledge in different legal matters (e.g., criminal law, divorce, etc.) and usually do not have a technical or scientific background.  Preliminary injunction proceedings are handled by the presiding judge of one of the three panels, or, when an action on the merits is already pending, by the judge of the panel who is in charge of the case preparation (Juge de la Mise en Etat).  The fifth division of the Paris Court of Appeal comprises two chambers of three judges specialized in intellectual property matters who deal with appeals against judgments relating to patent matters. The courts render between forty and sixty patent litigation decisions a year.

Since April 2020, oppositions against French patents became available and can be filed. INPI has exclusive jurisdiction for oppositions and thus, in this context, renders decisions on patent validity. INPI examiners in oppositions are specialized in patents and have technical backgrounds. This new opposition procedure aims to reinforce the value of patents in France since applications are not subject to a rigorous, in-depth examination by INPI.  Thus, oppositions provide a mechanism for a third party to challenge the validity of a patent that is less costly than filing a judicial procedure, such as a nullity action.  Any appeal filed in response to a decision rendered by INPI during an opposition falls within the exclusive jurisdiction of the Paris Appeal Court.

The burden of proof, both in infringement and nullity actions, rests with the claimant.  Before the courts, the claimant’s writ of summons must contain detailed arguments in both law and fact such that the Court can form a judgment by itself.  Infringement can be proven by any means, such as a bailiff’s report or a saisie-contrefaçon.  Unlike litigation in the U.S. or United Kingdom, proceedings in France do not include discovery or disclosure.  The saisie-contrefaçon is a very specific and efficient probative measure which is generally carried out as the first step in infringement proceedings.  This procedure allows any claimant or potential claimant to instruct a bailiff to enter any location and write a detailed description of the alleged infringing product (with or without taking samples) or process.  The bailiff may be assisted by experts (such as patent attorneys) designated by the claimant.  In order to perform a saisie-contrefaçon, the claimant must obtain an order from the President of the Paris Court of First Instance by way of an ex parte request.  In order to obtain such an order, the claimant only needs to prove that s/he is entitled to bring an infringement action (namely, s/he is the patent owner or exclusive licensee) and that the patent is in force (e.g., the annuity fees have been paid).  It is not necessary to prove infringement in order to obtain permission to carry out a saisie-contrefaçon, because the purpose of a saisie-contrefaçon is to determine whether an infringement has occurred, and if so, to what extent.  Nonetheless, the claimant is required to present “reasonably available evidence of infringement” (Paris Court of First Instances, 22 December 2017, 17/14521, Constellium Issoire/Arconic Inc.).  Once a saisie-contrefaçon has been performed, the requesting party must bring an infringement action on the merits within a month.  If the requesting party fails to bring such an action, the saisie-contrefaçon can be annulled, without prejudice to any compensatory damages that the seized party may claim for any losses incurred.  The party subject to the saisie-contrefaçon can challenge or modify the order or request its withdrawal in summary proceedings.  Additionally, it can also obtain a court order protecting the confidentiality of the seized material.

Once an action is filed, a Juge de la Mise en Etat sets the timeline of the proceedings and both sides generally file two or three briefs.  Once the case is ready to be heard, no further briefs or exhibits can be submitted, and a final oral hearing is set.

Given the fact that all evidence and arguments need to be set forth in writing, the hearings last at most one or two hours for each party, depending on the complexity of the case. In 99% of the cases, the hearing is limited to the pleadings of the attorney of each party. Neither the claimant or defendant are heard and there is no witness or expert hearing.

Infringement and nullity are dealt with during the same hearing, and both can be involved as counterclaims. Claims of a patent can be amended during the proceedings, in the context of  parallel specific proceedings before the INPI, and even throughout an appeal.

The average length of time for first instance proceedings is approximately 18 to 24 months.  Appeals generally take a similar length of time.

Direct Infringement

The French Intellectual Property Code (IPC) broadly defines the following as acts of patent infringement:

  • The manufacture, supply, placing on the market, use, importation, exportation and transshipment or holding of, for the aforementioned purposes, of a product that is the subject of a patent;
  • The use of a process subject to a patent or, where a third party knows or where circumstances make it clear that the use of the process is prohibited without the consent of the owner of the patent, offering the use of such a process in France; and
  • The supply, placing on the market, use, importation, exportation, transshipment or possession for the aforementioned purposes of the product obtained directly by a process that is the subject of the patent.

However, in order to decide whether direct infringement is present, it is first necessary to construe whether an allegedly infringing product or process falls within the scope of the claims.  As in other European jurisdictions, patents must be construed in France in accordance with Article 69 of the European Patent Convention (EPC) and the Protocol on the Interpretation of Article 69 of the EPC (Protocol).

Claim Construction

Article 69 of the EPC and Article L.613-2 of the IPC, which are identical, describe the scope of protection provided by a patent and states: “The extent of the protection conferred by a European patent or a European patent application shall be determined by the claims. Nevertheless, the description and drawings shall be used to interpret the claims.”  Further guidance is provided in the Protocol to Article 69 of the EPC.  Article 1 of the Protocol requires that when determining the scope of protection of a patent, a balance be struck between the strict, literal meaning of the words of the claim and using the claims as merely a guideline.  Specifically, Article 1 state:

Article 1 – General principles

Article 69 should not be interpreted as meaning that the extent of the protection conferred by a European patent is to be understood as that defined by the strict, literal meaning of the wording used in the claims, the description and drawings being employed only for the purpose of resolving an ambiguity found in the claims. Nor should it be taken to mean that the claims serve only as a guideline and that the actual protection conferred may extend to what, from a consideration of the description and drawings by a person skilled in the art, the patent proprietor has contemplated. On the contrary, it is to be interpreted as defining a position between these extremes, which combines a fair protection for the patent proprietor with a reasonable degree of legal certainty for third parties.

Article 2 of the Protocol also makes it clear that equivalents must be considered when determining the scope of protection:

Article 2 – Equivalents

For the purpose of determining the extent of protection conferred by a European patent, due account shall be taken of any element which is equivalent to an element specified in the claims.

The approach in France with respect to claim construction is defined by a decision by the Court of Appeal of Paris in Dolle v Emsens on October 11, 1990, where the Court stated:

Article 69, as completed by its protocol, has chosen a middle way between a literal construction of the claim, in which the description and the drawings should be used only to dissipate ambiguities, and a road map, in which the claim would be used just as a guideline and in which the protection would extend to what, according to the skilled person, the patentee intended to protect.

 This compromise must ensure a fair protection for the patentee against the skill of the infringer to disguise infringement, and enable third parties to know with certainty what is protected.

 In view of Article 69, the judge must construe the claims by reference to the description and drawings.

 He must give the claim its full meaning, so that this condensed text is understood.

 The construction leads to a definition of the substance of the claimed invention, without adding any element which the claim did not include and did not suggest. (emphasis added)

The reference to the full meaning of the claim and the substance of the claimed invention demonstrates that in France, judges seek a fair balance to ensure both reasonable protection for the patentee as well as a reasonable degree of legal certainty for third parties.  Specifically, when construing claims, judges seek to understand, through the eyes of a skilled person, the technical problem solved by the patent and the means taught to solve the problem, including their function.  However, the construction of a claim cannot result in (i) adding a feature which is not clearly part of the invention (e.g., the interpretation must not involve adding a feature); or (ii) omitting a feature which is clearly part of the invention.

Under French law, claim construction is partly a mixed question of law and fact and the claims and specification are construed as of the date of the filing or priority date (where applicable) of the application. When construing the claims, judges may take into account definitions of terms that are contained in dictionaries, handbooks or other documents that are submitted by the parties; however, these definitions will not supersede the meaning of term that is provided in the patent itself.  Documents can be submitted to help clarify the knowledge of a skilled person and how s/he would read and understand a patent. Additionally, a written opinion from an expert can also be provided to further clarify the documentary evidence and substantiate the knowledge of a skilled person.  All of this information can be used to help judges distinguish between features which should be considered to be:

  1. “essential” (e.g., those features without which (i) the claim could not be considered to be novel and inventive; or (ii) the claimed means would not perform the function of the invention); and
  2. “non-essential” or “minor” (e.g., those features that are not necessary for the claim to be considered novel and inventive or are not indispensable for the claimed means to perform the function of the invention)

Prosecution History Estoppel

There is no prosecution history estoppel under the IPC; therefore, judges are under no obligation to consider or refer the prosecution history during an infringement proceeding. Whether or not the prosecution history is taken into account is considered by the judges on a case-by-case basis like any other fact in the case. Essentially, it is up to the judges to assess the potential relevance and impact of the statements and amendments made by the Patentee during prosecution and/or litigation. Nonetheless, French case law comprises a number of decisions in which the prosecution history has been used to clarify issues involving the construction of the claims of a patent. For example, in Institut Pasteur v Siemens Healthcare Diagnostics, the Tribunal de Grande Instance de Paris, 3rd chamber, 2nd section, on May 28, 2010 stated:

Institut Pasteur rightly argues that only these provisions [Article 69 and its Protocol] govern the interpretation of the claims‘ wording and that the ‘file wrapper estoppel’ theory, which consists in also taking into account, to interpret a patent, the statements made by the applicant during the grant or opposition proceedings, cannot be applied […]  However, they in no way exclude the possibility for the court, which has to rule on the extent of the protection conferred by the patent, of referring to the wording of the claims as initially filed and of appraising the scope thereof, in particular, in light of the amendments made during the grant or opposition proceedings before the European Patent Office.

Determination of Infringement Under French Law

French law provides a three-part test for determining infringement.  The test involves asking the following questions:

  1. Is there literal infringement, namely, does the allegedly infringing (or contested) means reproduce the claimed invention (or means) in both its form (or structure) and function to achieve the same result? If the answer is yes, there is literal infringement, if the answer is no, go to question 2.
  2. Is there infringement by reproduction of the essential means of the claimed invention, namely, are the differences between the claimed means and the allegedly infringing or contested means only with respect to details which are not part of the essential means (e.g., directed to a minor feature) of the claim? If the answer is yes, there is infringement; if the answer is no, go to question 3.
  3. Is there infringement by equivalence, namely, does the allegedly infringing or contested means performs the same function to provide the same result as the claimed means? If the answer is yes, there is infringement by equivalence; if the answer is no, there is no infringement.

With respect to each of these questions, the claimed means and the allegedly infringing or contested means should be considered not only in terms of their form (or structure) but also in terms of their function (meaning, its primary technical effect) and results (meaning the advantages provided by the claimed means).

Furthermore, under question 2, over time, French case law has articulated various questions which should be examined to determine whether a feature is merely a detail (e.g., a minor feature) or an essential feature of the claim:

  1. Is the feature presented as essential in the patent or during the pre-grant prosecution phase (e.g., does the patent mention alternatives)?
  2. Is the feature one of those without which the claim would not have been found to be novel and inventive?
  3. Is the feature indispensable for fulfilling the function of the claimed means and solving the technical problem underlying the invention?

If a claimed feature or means which is not literally reproduced is found to be a minor feature (e.g., detail), then there will be a finding of infringement.

With respect to finding infringement by equivalence under question 3, such infringement occurs when the allegedly infringing or contested means performs the same function to achieve the same result.  However, the doctrine of equivalence only applies if it has been established that the function of the claimed invention or means is novel.  Therefore, the test for infringement by equivalence involves analyzing three questions:

  1. Do the essential means of the patent whose form is not reproduced (e.g., the “means at issue”) perform a novel function? If the answer is yes, go to question 2.  If the answer is no, there is no infringement by equivalence.
  2. Do the contested means perform the same function? If the answer is yes, go to question 3.  If the answer is no, there is no infringement by equivalence.
  3. Do the contested means provide the same result? If the answer is yes, there is infringement by equivalence. If no, there is no infringement by equivalence.

Under question 1, the doctrine of equivalence only applies if the claimed means at issue performs a novel function.  Specifically, infringement by equivalence only exists if the claimed means at issue differs from the prior art not only by its form (or structure) but also by the function it performs.  More specifically, if the function of a claimed means at issue is known in the prior art, then the scope of the claim is limited to the claimed structure (and minor variants thereof). In this case, the claims cover specific means and the doctrine of equivalence does not apply.  In contrast, if the function of the claimed means at issue is novel, the scope of the claim extends to structures performing the same function to achieve the same result.  Under this scenario, the claim is considered to cover “general” means and the doctrine of equivalence applies. Therefore, when assessing infringement under the doctrine of equivalence, the key question is the contribution of the invention to the art.

With respect to question 2, two means are considered to perform the same function if they result or produce the same primary technical effect.  The “primary technical effect” is defined as the effect that is directly and immediately produced by the implementation of the means (which is not to be confused with the result, which is the advantage provided by the means).

Under question 3, the result obtained the allegedly infringing means must be “of the same nature and identical quality and efficacy“.

Because an analysis of infringement can be very complex due to the doctrine of equivalents, French judges, who, as mentioned previously herein, do not have a technical background, can designate an expert to assist them during the hearing.

Life Science Cases Involving the Doctrine of Equivalents

The doctrine of equivalents is rarely applied by French judges in the life sciences field.

Recently, the doctrine of equivalents was explained in the decision Eli Lilly v Fresenius, Tribunal Judiciaire de Paris, 3rd chamber, 3rd section, on September 11, 2020 were the Court stated:

The amendment for addition of matter is not such as to prohibit the patentee from invoking infringement by equivalents, since it is a condition of form, relating to the substance of the inventive contribution and the literal content of the specification, which prohibits the patentee from adding an element that could not be directly and unambiguously deduced from the patent, it does not alter the basis on which the interpretation must be made and it has no impact on the scope of protection conferred. On the contrary, with regard to the assessment of the scope of the patent, Article 69 of the EPC requires that equivalents be considered. It infers that an addition of material under the issuance, does not prohibit the invoking of infringement by equivalence, provided that the particular means or combination of means claimed […] have a function new […], except to render the doctrine of equivalents completely ineffective.

This decision clarifies the application of the doctrine of equivalents with regard to patent scope and infringement. The case provides that the addition of a new means to the claims at the time of issuance does not preclude invoking infringement by equivalence if the means has a new function. It is important to note that in this case, Fresenius was considered to be a literal infringer and hence the Court avoided examining infringement by equivalents for the product.

Also, in the previously mentioned decision, Institut Pasteur v Siemens Healthcare Diagnostics, the Tribunal de Grande Instance de Paris, 3rd chamber, 2nd section, on May 28, 2010 stated:

That it follows that in the patented means, the use of probes consisting of DNA fragments, is only new in its form, the function of hybridization with viral RNA for the detection of the disease being known;

That infringement by equivalence, which in the present case cannot therefore result based on the identity of functions, can therefore only result if the very form of the patented means is reproduced, in an equivalent form, and in view of what characterizes its patentability, namely, probes consisting of fragments of cloned DNA defined by their restriction sites and corresponding to the retroviral genome contained in the clone λJI9…

Another example is the decision in Mundipharma Laboratories and others v Sandoz and others where the Tribunal de Grande Instance de Paris, 3rd chamber, 3rd section, on July 2, 2010 stated:

In the present case, in order to prevail under the theory of equivalents, the function of the cellulose ether in claim 1 had to be new, but this function, which was recognized as delaying the release of the active ingredient, was already known in prior art. Thus, the UK patent 2 196 848 filed on October 22, 1987 with a priority date of October 31, 1986, relating to a composition of controlled release hydromorphone, guaranteed an analgesic action of at least twelve hours, with a dissolution profile falling within the rate values claimed in the contested patent and specified that the substances in the patent were not a controlled release matrix are hydrophilic or hydrophobic polymers, as gum, cellulose ether…

Under these conditions, infringement by equivalence cannot be retained.

We note that in the two above cases, the claimed means did not perform a novel function, thus there was no infringement under the doctrine of equivalents.

This post was written by Lisa Mueller of Casimir Jones, and Francine Le Péchon-Joubert and Carlyne Sevestre of De Gaulle Fleurance & Associes

 

The Doctrine of Equivalents: Examination of the Law in Australia

February 17, 2020

Background

Australia bats above its average in terms of the number of high-profile litigious patent disputes conducted before its courts. Despite its relatively small population, the large consumer appetite and rigorous court process make Australia a popular testing ground before commencing litigation in other major jurisdictions, such as the United States (U.S.) and Europe.

Infringement proceedings are heard in the first instance by a single judge of the Federal Court, often in conjunction with revocation proceedings. There is an automatic right of appeal from a decision of a single judge of the Federal Court in infringement/revocation proceedings, which will be heard by a full bench of the Federal Court (usually 3, but sometimes 5 judges). However, leave must be sought to appeal a decision of the Full Federal Court to the High Court of Australia (Australia’s highest appellate court).

Relief for infringement can be in the form of an injunction and, at the option of the plaintiff, either damages or an account of profits. There is no cap on the amount of damages that can be awarded, and additional damages may be awarded by the court having regard to such matters as the flagrancy of the infringement, the need to deter similar infringements, the conduct of the infringer and any benefits accrued by the infringer.

In contrast to its U.S. and many of its European counterparts, in assessing infringement the Australian courts have ostensibly rejected the doctrine of equivalents. Nonetheless, a purposive approach to claim construction affords some degree of flexibility for Patentees seeking to enforce their patents in Australia

Infringement

Under section 13 of the Patents Act 1990 (Cth) (Patents Act), a Patentee has the exclusive right to exploit a patented invention and to authorize another person to exploit the invention. Therefore, a patent is infringed if a person exploits the patented invention without the Patentee’s authorization, by:

  1. making, hiring, selling or otherwise disposing of a patented product;
  2. offering to make, hire, sell or otherwise dispose of a patented product;
  3. using or importing a patented product;
  4. keeping a patented product for the purpose of doing an act described in 1, 2 or 3;
  5. using a patented method or process; and/or
  6. doing an act described in 1, 2, 3 or 4 with a product resulting from the use of a patented method or process.

Section 117 of the Patents Act also provides that supply of a product may also constitute an infringement if the use of that product would infringe a patent. In this context, contributory infringement is said to have occurred if:

  1. the product is capable of only one reasonable use; or
  2. the product is not a staple commercial product and the supplier has reason to believe that the person would put it to an infringing use; or
  3. supply of the product includes any instructions or inducement to put it to an infringing use.

There are, however, a number of statutory exemptions to infringement, including certain prior use, acts for obtaining regulatory approval and experimental use.

Claim construction

To determine whether infringement has occurred, the claims must first be construed by the court through the eyes of a skilled person. The rules of claim construction are well established in Australia and were summarized in Jupiters Ltd v Neurizon Pty Ltd [2005] FCAFC 90; (2005) 222 ALR 155 at [67] as follows:

  • the proper construction of a specification is a matter of law;
  • a patent specification should be given a purposive, not a purely literal, construction;
  • the words used in a specification are to be given the meaning which the normal person skilled in the art would attach to them, having regard to his or her own general knowledge and to what is disclosed in the body of the specification;
  • it is not legitimate to narrow or expand the boundaries of monopoly as fixed by the words of a claim by adding to those words glosses drawn from other parts of the specification, although terms in the claim which are unclear may be defined by reference to the body of the specification;
  • experts can give evidence on the meaning which those skilled in the art would give to technical or scientific terms and phrases and on unusual or special meanings to be given by skilled addressees to words which might otherwise bear their ordinary meaning; and
  • it is for the Court, not for any witness however expert, to construe the specification.

Doctrine of Equivalents

The doctrine of equivalents was considered obliquely by the Full Federal Court on appeal in H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70 (Lundbeck). In this case, Lundbeck asserted that Alphapharm infringed a claim of its LEXAPRO (escitalopram) patent directed to a method of manufacturing escitalopram via a cyano-substituted diol intermediate, by manufacturing and importing into Australia goods containing escitalopram. Alphapharm argued that it had not infringed Lundbeck’s method claim because it used a bromo-diol intermediate in place of the claimed cyano-diol intermediate.

At first instance, the trial Judge considered the use of the bromo- instead of the cyano-substituent to be ‘evanescent’ and immaterial to the process because the bromo-substituent was replaced by a cyano-substituent in a subsequent step. Thus, the trial judge held – in an apparent nod to the doctrine of equivalents – that the Alphapharm process did not infringe Lundbeck’s method claim. However, this finding was overturned on appeal, with the Full Court stating at [93]:

The author of [the method claim] clearly had in mind the existence of a convention whereby a substitutable element could be represented by the symbol “R”. The failure to use that symbol instead of the symbol “NC” signified that the cyano-diol was an essential integer of the method disclosed by [the process claim]. It follows that a method that involves substitution of the bromo-diol for the cyano-diol does not infringe the method disclosed by [the method claim]. (emphasis added)

This statement was a strong indication by the Full Court that it rejects the doctrine of equivalents approach, and that an essential feature of a claim cannot be substituted for an alternative that achieves the same result in the same way.

Purposive Construction

While claim construction in Australia is based on a plain reading of the claims through the eyes of a skilled person, a practical, common-sense approach must be applied (as opposed to a purely literal one). In doing so, the Australian courts have adopted a purposive approach to construction, following the seminal UK House of Lords decision in Catnic Components Limited & Anor v Hill & Smith Limited [1982] RPC 183 (HL) (Catnic).

In Catnic, the claims at issue concerned a galvanized steel lintel having a rear support member ‘extending vertically’ from the base plate. The alleged infringing lintel contained a support member that extended upwardly at an angle of 84°. While not extending precisely vertical (i.e., 90°) as required by a purely literal reading of the claims, the House of Lords held that infringement had nonetheless occurred because a skilled person would recognise that a precisely vertical support member was not essential to performing the invention.

The relevant question when applying a purposive construction is ‘what the person skilled in the art would have understood the Patentee to be using the language of the claim to mean’ (Lord Hoffmann in Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2004] UKPC 6; (2004) 64 IPR 444 at [34]).

Substitution of terms in a claim

In 2018, the Full Federal Court made it abundantly clear in GlaxoSmithKline Consumer Healthcare Investments (Ireland) (No 2) Limited v Generic Partners Pty Limited [2018] FCAFC 71 (GSK) that a purposive construction does not extend to the substitution of one term in the claims with another. In this case the Full Court considered whether claim 1 should be construed to correct a mistake, where the Patentee had used the term ‘basket’ when it had intended to use the term ‘cylinder’. This was relevant to the question of infringement because the alleged infringing product contained a cylinder, not a basket.

The Full Court held that the claims were not infringed because a skilled person would not have understood the Patentee to be using the term ‘basket’ to mean ‘cylinder’ (even if this could be deduced by the skilled person to be an obvious error based on the specification). The Full Court distinguished circumstances in which the court is required to re-write the claims to give effect to the Patentee’s intentions from those in which a skilled person would understand there to be some leeway in the parameters of the language used. For example, in Catnic, in the context of the invention a skilled person would understand ‘vertical’ to mean ‘substantially vertical’.

In cases such as Catnic, the Full Court in GSK acknowledged at [110]:

These are situations in which the court endeavours to give effect to the skilled addressee’s understanding of the claim language in preference to a purely literal or grammatical construction, not because the skilled addressee understands that the claim contains a mistake that requires correction, but because, when read in the context of the document as a whole and the common general knowledge, the words used would convey that meaning to the skilled addressee.

Where a Patentee has made a mistake in the claim language, the only possible recourse is to seek an amendment to the specification, which presents its own challenges and limitations once a patent has been accepted (allowed). Furthermore, the Patentee’s right to recover damages or an account of profits in respect of any infringement of the patent before the date of such an amendment is limited to circumstances in which the court is satisfied that the specification without the amendment was framed in good faith and with reasonable skill and knowledge.

Otherwise, the Patentee is taken to have drafted the claims in words of its own choosing and the purpose of the court is to interpret those words through the eyes of the skilled addressee, not to re-write the claims as the Patentee intended. Thus, while not expressly rejecting the doctrine equivalents, the approach of the Australian courts to date signifies that the substitution of alternatives in a claim will not be considered favourably.

This post was written by Lisa Mueller and Claire Gregg of Davies Collison Cave Pty Ltd.

The Doctrine of Equivalents: Examination of the Law in the United Kingdom

January 23, 2020

In many jurisdictions, the scope of protection afforded by a patent is defined by the claims as read either literally or under doctrine of equivalents.  Infringement based on the doctrine of equivalents may be based in part on statutory law, the interpretation of which is generally established via case law (e.g. Court decisions).  The purpose of the doctrine of equivalents is to promote fair patent coverage so that trivial departures (e.g., variants or deviations) from the claim language cannot be used to avoid infringement. 

This is the fifth post in our series examining the law governing the doctrine of equivalents in several European countries.  Our first post examined the law governing the doctrine of equivalents in Spain, our second post examined the law in the Netherlands, our third post examined the law in Germany, and our fourth post examined the law in Denmark.  These posts can be viewed here:  Doctrine of Equivalents – Spain, Doctrine of Equivalents – the Netherlands,  Doctrine of Equivalents – Germany and Doctrine of Equivalents – Denmark.

Doctrine of Equivalents in the United Kingdom

Background

The United Kingdom (UK) is one of the top jurisdictions in the world for patent enforcement.  Most patent cases are brought in the Patents Court, a specialized court based in London that is part of the High Court of Justice.  Also available is the Intellectual Property Enterprise Court (IPEC) which handles smaller, less complex disputes.  Regardless, there are no jury trials available in either court.  Patent cases in the High Court tend to move relatively quickly, normally taking between nine to 12 months to go to trial, although in more complex lawsuits, the time to trial can take 18 months to two years.  Both the High Court and IPEC can grant injunctions and award damages.  Although the awarding of an injunction is discretionary, there is a high likelihood that a permanent injunction will be granted if the patentee is successful in proving its case. 

Although damages in the IPEC are capped at about 500,000 British pounds, there is no limit on damages in the High Court, however, awards are generally not as high as those typically seen in U.S. litigation.  While there is some discovery in the UK, it is nowhere near the level permitted in the U.S.  For example, there are no depositions in the UK.  However, courts have “disclosure”, a type of document discovery, which the courts require remain focused. 

Patent cases in the UK are heavily expert-driven.  Additionally, there is a bifurcated representation process. Barristers make arguments in court and solicitors collect information, draft briefs and interface with the client.  Moreover, the UK also has a “loser pay” system, where the winning side is able to recover a portion of its legal costs.  In the IPEC, recovery is limited to about 50,000 British pounds.  Although there is no cap for costs in the High Court, generally, the winning side recovers about 60-70 percent of its costs.

A party may appeal from either the Patents Court or the IPEC to the Court of Appeal. There is no automatic right of appeal and the losing party must seek permission to appeal from either the first instance court or the Court of Appeal. An appeal will typically be allowed on questions of law, rather than findings of fact or evidence-based issues.  After the Court of Appeal, a party may appeal to the Supreme Court. Permission is rarely granted and usually only on a point of law or for important public policy reasons.

Direct Infringement

Under section 60(1) of the Patents Act 1977 (Patents Act), a patent is infringed if any of the following acts are carried out in the UK:

  • Where the invention is a product, a person (or company) makes, disposes of, offers to dispose of, uses or imports the product or keeps it, whether for disposal or otherwise;
  • Where the invention is a process, a person (or company) uses the process or offers it for use in the United Kingdom when it is known, or it is obvious to a reasonable person in the circumstances, that its use there without the consent of the proprietor would be an infringement of the patent; or
  • Where the invention is a process, a person (or company) disposes of, offers to dispose of, uses or imports any product obtained directly by means of that process or keeps any such product, whether for disposal or otherwise.

However, in order to decide whether direct infringement is present, it is first necessary to construe whether an allegedly infringing product or process falls within the scope of the claims.  As in other European jurisdictions, patents must be construed in the UK in accordance with Article 69 of the European Patent Convention and the Protocol on the Interpretation of Article 69 of the EPC.

Claim construction

Article 69 European Patent Convention (EPC) describes the scope of protection provided by a patent and states: “The extent of the protection conferred by a European patent or a European patent application shall be determined by the claims. Nevertheless, the description and drawings shall be used to interpret the claims.”  Further guidance is provided in the Protocol to Article 69 (Protocol) of the EPC.  Article 1 of the Protocol requires that when determining the scope of protection of a patent, a balance be struck between the strict, literal meaning of the words of the claim and using the claims as merely a guideline.  Specifically, Article 1 states:

Article 1 – General principles

Article 69 should not be interpreted as meaning that the extent of the protection conferred by a European patent is to be understood as that defined by the strict, literal meaning of the wording used in the claims, the description and drawings being employed only for the purpose of resolving an ambiguity found in the claims. Nor should it be taken to mean that the claims serve only as a guideline and that the actual protection conferred may extend to what, from a consideration of the description and drawings by a person skilled in the art, the patent proprietor has contemplated. On the contrary, it is to be interpreted as defining a position between these extremes, which combines a fair protection for the patent proprietor with a reasonable degree of legal certainty for third parties.

Article 2 of the Protocol also makes it clear that equivalents must be considered when determining the scope of protection:

Article 2 – Equivalents

For the purpose of determining the extent of protection conferred by a European patent, due account shall be taken of any element which is equivalent to an element specified in the claims.

As will be discussed in more detail herein, the UK Supreme Court in Actavis v Eli Lilly ([2017] UKSC 48 (12 July 2017)), established a doctrine of equivalents consistent with Article 2 of the Protocol by introducing a new two-part test for determining infringement in the UK.  Specifically, the test asks the following questions:

  1. Does the variant infringe any of the claims as a matter of normal interpretation; or
  2. Does the variant, nonetheless infringe because it varies from the invention in a way or ways which is or are immaterial?

If the answer to either question is “yes”, then infringement exists.

With respect to question 1, claims are construed according to their “normal interpretation”.  Specifically, a “purposive approach” (described in cases such as Catnic [1982] RPC 183, Improver [1990] FSR 181 and Kirin-Amgen [2005] RPC 9) is used.  Under the purposive approach, the scope of a claim is defined by giving effect to “what the skilled person in the art would have understood the patentee to be claiming”. This is an objective interpretation of the language of the claim, through the eyes of the skilled addressee (who brought with them their common general knowledge) in light of the description and drawings of the patent. 


If infringement is not established under a normal interpretation (question 1), a court will consider whether there is infringement under the doctrine of equivalents using question 2.  Question 2 requires determining whether a variant is “immaterial”.  Determining whether a variant is immaterial involves performing a three-part test which asks the questions:

  1. Notwithstanding that it is not within the literal meaning of the relevant claims of the patent, does the variant achieve substantially the same result in substantially the same way as the invention, i.e., the inventive concept revealed by the patent?
  2. Would it be obvious to the person skilled in the art, reading the patent at the priority date, but knowing that the variant achieves substantially the same result as the invention, that it does so in substantially the same way as the invention?
  3. Would such a reader of the patent have concluded that the patentee nonetheless intended that strict compliance with the literal meaning of the relevant claim(s) of the patent was an essential requirement of the invention?

In order to establish infringement using the above three-part test, a patentee has to establish that the answer to the first two questions is ”yes“ and the answer to the third question is “no“.  In decisions subsequent to Actavis, such as, for example, Icescape v Ice-World ([2018] EWCA Civ 2219), the correct identification of the inventive concept appears to be the key when assessing a question of infringement under the doctrine of equivalents.  In fact, what the post-Actavis cases seem to suggest is that under the doctrine of equivalents what matters more is the core of the inventive concept that the claim seeks to protect and less the actual meaning of the words in a claim. 

Reliance on the Prosecution History (Prosecution History Estoppel)

Reliance on the prosecution file when considering whether a variant infringes a patent is only appopriate in certain or limited circumstances.  Specifically, consideration of the prosecution file is warranted (1) when the point at issue truly cannot be resolved by study of the claims or description, and the contents of the file unambiguously resolves the point,  or (2) where it would be contrary to the public interest for the contents of the file to be ignored.  An example of the latter would be where a patentee made it clear during prosecution that he did not regard a variant as falling within the scope of protection, but then subsequently asserted that that variant infringed the claim at issue. 

Supreme Court’s decision in Actavis v. Eli Lilly

Actavis involved Eli Lilly’s (Lilly) European Patent No. 1,303,508 (the ’508  patent).  The ’508 patent claims the use of the compound pemetrexed disodium in combination with vitamin B12 to inhibit tumor growth.  The combination reduces the known toxic effects of anti-folates, like pemetrexed disodium, in the treatment of cancer and has been marketed by Lilly under the brand name Alimta since 2004.  The relevant claims of the ’508  patent were claims 1 and 12.  However, the Court’s reasoning focused on claim 1 (in Swiss form) which recites:

  1. Use of pemetrexed disodium in the manufacture of a medicament for use in combination therapy for inhibiting tumour growth in mammals wherein said medicament is to be administered in combination with vitamin B12 or a pharmaceutical derivative thereof [which it then specifies].”

Actavis’s proposed generic products involved pemetrexed compounds used together with vitamin B12 for cancer treatment.  However, instead of pemetrexed disodium, the active ingredient in Actavis‘s products were (a) pemetrexed diacid, (b) pemetrexed ditromethamine, or (c) pemetrexed dipotassium. 

Lilly brought an infringement claim against Actavis in the High Court.  The High Court granted Actavis a declaration of non-infringement.  The Court of Appeal agreed that there was no direct infringement but concluded that Actavis’s products indirectly infringed the patent.  The Supreme Court concluded that Actavis directly infringed the patent and also dismissed Actavis’s cross-appeal on the basis that even if the products did not directly infringe, they would indirectly infringe as held by the Court of Appeal.

With respect to question 1, the Supreme Court found that Actavis‘ products did not infringe on the basis of a normal interpretation of claim 1.  However, with respect to question 2, the Court concluded that all of Actavis‘s products involved a medicament containing the pemetrexed anion and vitamin B12, and thus achieved substantially the same result in substantially the same way as the invention.  Once one knew Actavis‘s products achieved substantially the same result as the invention, the notional addressee of the patent would have thought it obvious that this was so, particularly as s/he would have regarded investigating whether pemetrexed free acid, pemetrexed ditromethamine or pemetrexed dipotassium worked as a routine exercise.  With respect to the third question, the Supreme Court felt that the Court of Appeal placed too much weight on the words of the claim.  The Supreme Court felt that it was very unlikely that the notional addressee would have concluded that the patentee could have intended to exclude any pemetrexed salts other than pemetrexed disodium from the scope of protection.  Therefore, the Supreme Court provisionally concluded that Actavis’s products directly infringed claim.

With respect to the prosecution history, the Examiner rejected the claims for use of the term ”anti-folate“ for reasons of disclosure and clarity under Articles 83 and 84 EPC.  In response, Lilly proposed amending the claims to the word ”pemetrexed“.  The Examiner objected on the basis of added matter under Article 123(2) stating that there was no basis for such terminology because pemetrexed was a distinct compound from pemetrexed disodium.  Lilly filed new claims reciting ”pemetrexed disodium“ and the application proceeded to grant.  The Supreme Court stated that the Examiner was wrong to take the view that the patentee should be limited to pemetrexed disodium because the teaching of the patent did not expressly extend to any other anti-folates.  Nonetheless, the Court stated that even if the Examiner was right or at least justified in taking the stance that he did, this did not have any bearing on the question of whether any pemetrexed salts other than pemetrexed disodium should be within the scope of the patent pursuant to the doctrine of equivalents.  According to the Court, ”The whole point of the doctrine is that it entitles a patentee to contend that the scope of protection afforded by the patent extends beyond the ambit of the claims as construed according to normal principles of interpretation.“  Thus, the Supreme Court felt that the contents of the prosecution file did not justify departing from the prelimary conclusion that the Actavis products directly infringed claim 1.

This post was written by Lisa Mueller of Casimir Jones, and Anne Marie Carr of Murgitroyd, UK/Ireland.          

The Doctrine of Equivalents: Examination of the Law in Denmark

November 20, 2019

In many jurisdictions, the scope of protection afforded by a patent is defined by the claims as read either literally or under doctrine of equivalents.  Infringement based on the doctrine of equivalents is generally not based on any statutory law but rather has been established via case law (e.g. Court decisions).  The purpose of the doctrine of equivalents is to promote fair patent coverage so that trivial departures (e.g., variants or deviations) from the claim language cannot be used to avoid infringement. 

This is the fourth post in our series examining the law governing the doctrine of equivalents in several European countries.  Our first post examined the law governing the doctrine of equivalents in Spain, our second post examined the law in the Netherlands, and our third post examined the law in Germany.  These posts can be viewed here:  Doctrine of Equivalents – Spain, Doctrine of Equivalents – the Netherlands, and Doctrine of Equivalents – Germany.

Doctrine of Equivalents in Denmark

Background

Despite its somewhat small size, Denmark is a fairly litigious country when it comes to patent litigation.  Some reasons for this are:  the cost of litigation is not extremely high and Denmark is a highly technically developed country with many specialized industries (such as, for example, pharmaceuticals).  In Denmark, courts are organized in a three-tier system comprising: (a) city courts; (b) two high courts (the Eastern and Western High Courts) and the Maritime and Commercial High Court; and (c) the Supreme Court.  Most patent proceedings, including proceedings for preliminary injunctions, are decided by the Maritime and Commercial High Court in Copenhagen (Maritime Court), as the court of first instance.  Appeals from the Maritime Court are to the Eastern High Court, and in some instances, the Supreme Court. 

As the main venue for patent cases, the Maritime Court can be considered to be a specialized patent court that having significant expertise in patent matters. Generally, cases before the Maritime Court are heard by a permanent law judge with a law degree and two technically qualified judges (who each may have a law degree) who are individuals with relevant commercial and/or technical backgrounds and/or experience.  The proceedings are generally conducted in Danish and infringement and validity claims are heard simultaneously (i.e., there is no bifurcation).  In addition to patent cases, the Maritime Court hears other commercial cases such as trademarks, designs, contracts, labor rights, bankruptcy, maritime law, etc., but no criminal cases.

Claim Construction

According to Article 69 European Patent Convention (EPC) the extent (“the scope”) of the protection conferred by a European patent or application is determined by the claims.  Nonetheless, the description (i.e., specification) and drawings are also considered when interpreting the claims.  Specifically, in Denmark, the claims are construed to determine the “essential” or “significant” features or parts of the invention.  Language in the claims that is not relevant to the “essential” or “significant” parts of the invention (e.g., namely, non-essential features) may be given less or very little weight when assessing the scope of protection. 

Statements made by the patentee during examination (i.e., prosecution) can be relevant to claim construction, particularly if made for purposes of avoiding prior art (e.g., novelty and/or inventive step).  Thus, as will be discussed in further detail herein, prosecution history estoppel may apply in Denmark both in the context of construing the claims as well as in the application of equivalency under the doctrine of equivalents.   

Patent Infringement

The protocol for interpreting Article 69 EPC, which is an integral part of the EPC according to Article 164(1) EPC, states:

Article 1 – General principles

Article 69 should not be interpreted as meaning that the extent of the protection conferred by a European patent is to be understood as that defined by the strict, literal meaning of the wording used in the claims, the description and drawings being employed only for the purpose of resolving an ambiguity found in the claims. Nor should it be taken to mean that the claims serve only as a guideline and that the actual protection conferred may extend to what, from a consideration of the description and drawings by a person skilled in the art, the patent proprietor has contemplated. On the contrary, it is to be interpreted as defining a position between these extremes, which combines a fair protection for the patent proprietor with a reasonable degree of legal certainty for third parties.

Article 2 – Equivalents

For the purpose of determining the extent of protection conferred by a European patent, due account shall be taken of any element which is equivalent to an element specified in the claims.

The protocol for interpreting Article 69 EPC is applicable to granted European patents validated in Denmark. However, according Article 64(3) EPC, the question of infringement of a European patent is dealt with under national, namely, Danish law.

Similar to Article 69 EPC, Section 39 of the Danish Patent Act (DPA) stipulates that:

The extent of the protection conferred by the patent and the patent application shall be determined by the patent claims. For the interpretation of the claims the description may serve as a guide.

Article 3 of the DPA defines what acts are not to be performed by third parties, i.e., what acts can potentially constitute infringement.  Specifically, according to this article:

…without permission of the patent owner, no one may exploit the invention by making, offering, putting on the market or using a product that is the subject matter of the patent, by importing or possessing a product for these purposes, by using a process that is the subject matter of the patent or by offering the process for use in Denmark, if the person offering the process knows or it is obvious in the circumstances that the use of the process is prohibited without the permission of the patent owner, or by offering, putting on the market or using a product obtained by a process that is the subject matter of the patent, or by importing or possessing the products for these purposes. 

There are two major types of patent infringement in Denmark: 1) literal infringement; and 2) infringement under the doctrine of equivalents. In order to assess whether infringement has occurred it is first necessary to interpret the terms used in the claims as discussed previously herein.  Once the meaning of the claims has been construed, a determination is made whether the claims have been literally infringed, before moving on to determine whether the claims have been infringed by equivalence.  Of course, an assessment of infringement under the doctrine of equivalents is only made when literal infringement has not been found.

Literal infringement

In Denmark, literal infringement requires an analysis of whether each and every essential or significant part of the invention can be found in the alleged infringing product or process.  If each and every essential or significant feature or part of the invention cannot be found in the alleged infringing product or process, namely, if deviations exist between the essential or significant features or parts of the invention and the alleged infringing product or process, then there can be no finding of literal infringement and the analysis moves to whether or not infringement exists under the doctrine of equivalents.

Infringement under the Doctrine of Equivalents and Prosecution History Estoppel

Under the doctrine of equivalents, if deviations exist between the essential or significant features or parts of the invention and the alleged infringing product or process, a determination must be made whether the deviations would be an obvious alternative recognized by one skilled in the art to be useful for the same purpose as the essential or significant feature or part recited in the claims. It is a fundamental premise that the protection afforded under the doctrine of equivalents reflect a balance between clarity and fairness. Specifically, the analysis involves determining whether the deviation (1) performs the same function in the same way as the essential or significant feature or part recited in the claim in order to solve the same problem as the claimed invention; (2) would be recognized by one skilled in the art as being an obvious alternative to the essential or significant feature or part recited in the claim; and (3) was not specifically excluded during examination (namely, the allegedly infringing product or process  must not belong to the prior art). 

As mentioned above, one limitation on equivalency in Denmark is the doctrine of prosecution history estoppel.  Generally, the Maritime Court will review statements and/or amendments made by the patentee during examination.  Statements made by the patentee to the effect that a certain embodiment is not covered by the scope of the claims will usually be binding.  Likewise, arguments and/or amendments made to claims to overcome novelty and/or inventive step rejections will preclude a finding of infringement under the doctrine of equivalents. 

The High Court decision U 2009/1523 (Guldager) set the direction for a more international approach toward applying Article 69 EPC which has been followed in several recent cases. An examples of a case in the life science area involving the doctrine of equivalents are:  Maritime Court decision A-19-17 (Eli Lilly and Company and Eli Lilly Danmark A/S v. Fresenius Kabi AB v/Fresenius Kabi and Fresenius Kabi Oncology Plc.), concerning Eli Lilly’s DK/EP 1 313 508 relating to the use of pemetrexed in combination with vitamin B12 and optionally, folic acid (covering the product Alimta®). 

This post was written by Lisa Mueller of Casimir Jones, and Lars Pallisgaard Olsen and Verena Simpson of Guardian IP Consulting.

The Doctrine of Equivalents: Examination of the Law in Germany

August 29, 2019

In many jurisdictions, the scope of protection afforded by a patent is defined by the claims of the patent as read either literally or under doctrine of equivalents.  Infringement based on the doctrine of equivalents is generally not based on any statutory law but rather has been established via case law (e.g. Court decisions).  The purpose of the doctrine of equivalents is to promote fair patent coverage so that trivial departures (e.g., variants) from the claim language cannot be used to avoid infringement. 

This is the third post in our series examining the law governing the doctrine of equivalents in several European countries.  Our first post examined the law governing the doctrine of equivalents in Spain and our second post examined the law in the Netherlands.  These posts can be viewed here:  Doctrine of Equivalents – Spain and Doctrine of Equivalents – the Netherlands.

Doctrine of Equivalents in Germany

Background

Almost two-thirds of patent infringement cases brought in Europe are filed in Germany. In fact, Germany handles about 1,200 patent infringement year, the most of any European country, putting it third in the world (behind the U.S. and China) in terms of the number of patent cases handled per year (See, https://www.mintz.com/sites/default/files/media/documents/2018-07-30/Law360%20-%20Renaud%20-%207-27-18.pdf).

Germany has a bifurcated patent litigation system wherein patent infringement and invalidity (i.e., revocation) actions are tried in different courts.  Twelve District Courts (Landgerichte) have exclusive jurisdiction over patent infringement actions whereas the German Federal Patent Court has exclusive jurisdiction over invalidity actions.  A large number of the patent litigation cases filed in Germany are filed in the court in Düsseldorf.

German procedural law does not provide for jury trial.  Cases are decided by judges, who tend to be very sophisticated.  Also, unlike most jurisdictions, injunctions are generally awarded as a matter of right in Germany.  Finally, the losing party is required to cover the winning party’s costs and fees (up to a statutory defined limit).

Claim Construction

According to Article 69 European Patent Convention (EPC) the extent (“the scope”) of the protection conferred by a European patent or application is determined by the claims.  Nonetheless, the description (i.e., specification) and drawings are also considered when interpreting the claims.  Specifically, the claims are construed as a notional (i.e., ordinary) person skilled in the art would understand them. The applicable standard is the technical meaning associated with the recited features, bearing in mind the problem and solution achieved by the invention. Furthermore, if a patent provides or requires a specific definition for a claim term, such definition will control over the standard or traditional definition. In fact, the Bundesgerichtshof (German Federal Court of Justice, FCJ (or “BGH” in German)), has made it clear that patentees are entitled to act as their own “lexicographer” (FCJ “Spannschraube”, X ZR 85/96, GRUR 1999, 909). As a result, this can affect the breadth of the technical interpretation of a claim.

Statements made by the patentee during examination (i.e., prosecution) are generally not relevant to claim construction. The content of the description of the patent itself remains the essential guide for determining the meaning of the claims. Although statements made by the patentee (or, by the examiner) during prosecution can have some relevance as an indication of what a skilled person would have considered encompassed by the scope of the technical teaching (FCJ X ZR 29/15 “Pemetrexed”), there is essentially no doctrine of file or prosecution history estoppel in Germany.

Patent Infringement

The protocol on the interpretation of Article 69 EPC, which is an integral part of the EPC according to Article 164(1) EPC states:

Article 1 – General principles

Article 69 should not be interpreted as meaning that the extent of the protection conferred by a European patent is to be understood as that defined by the strict, literal meaning of the wording used in the claims, the description and drawings being employed only for the purpose of resolving an ambiguity found in the claims. Nor should it be taken to mean that the claims serve only as a guideline and that the actual protection conferred may extend to what, from a consideration of the description and drawings by a person skilled in the art, the patent proprietor has contemplated. On the contrary, it is to be interpreted as defining a position between these extremes, which combines a fair protection for the patent proprietor with a reasonable degree of legal certainty for third parties.

Article 2 – Equivalents

For the purpose of determining the extent of protection conferred by a European patent, due account shall be taken of any element which is equivalent to an element specified in the claims.

The protocol on the interpretation of Article 69 EPC is applicable to granted European patents validated in Germany. However, according Article 64(3) EPC, the question of infringement of a European patent is dealt with under national, e.g. German, law. The same is true for other EPC member states.

Similar to Article 69 EPC, section 14 of the German Patent Act (GPA) stipulates that:

The extent of the protection conferred by the patent and the patent application shall be determined by the patent claims. Nevertheless, the description and the drawings shall be used to interpret the patent claims.

Section 9 of the GPA defines what acts are not to be performed by third parties, i.e., what acts can potentially constitute infringement:

The patent shall have the effect that the proprietor of the patent alone shall be entitled to use the patented invention within the scope of the law in force. In the absence of the consent of the proprietor of the patent, any third party shall be prohibited from

1. producing, offering, putting on the market or using a product which is the subject-matter of the patent, or from either importing or possessing such a product for the purposes referred to;

2. using a process which is the subject-matter of the patent or, if the third party knows or if it is obvious from the circumstances that use of the process is prohibited in the absence of the consent of the proprietor of the patent, from offering the process for use within the territorial scope of this Act;

3. offering, placing on the market or using a product which is produced directly by a process which is the subject-matter of the patent, or from either importing or possessing such a product for the purposes referred to.

There are two major types of patent infringement in Germany: 1) literal infringement; and 2) infringement under the doctrine of equivalents. In order to assess whether infringement has occurred it is first necessary to interpret the terms used in the claims as discussed previously herein.  Once the meaning of the claims has been construed, a determination is made whether the claims have been literally infringed, before moving on to determine whether the claims have been infringed by equivalence.  Of course, an assessment of infringement under the doctrine of equivalents is only made when literal infringement has not been found.

Literal infringement

In Germany, literal infringement (“wortsinngemäße Verletzung”) requires that each and every feature of a claim also be present in the embodiment being analyzed. Specifically, one must analyze whether an embodiment realizes all of the features recited in a claim in light of its technical meaning.  As apparent from the use of the term “literal” infringement, mere philological congruence of the embodiment with the features of a claim is not the appropriate standard but rather the technical meaning associated with the recited features (as discussed above in connection with claim construction).

Infringement under the Doctrine of Equivalents

Embodiments that do not make literal use of the teaching of a patent may nevertheless fall within the scope of protection based on equivalence. In Germany, three requirements must be examined to determine whether a “deviating embodiment” infringes a patent under the doctrine of equivalents:

1) Same effect (“Gleichwirkung”);

2) Obviousness (“Naheliegen”); and

3) Whether a skilled person interpreting the claim would recognize the deviating means as an equally valid way of achieving the technical effect (“Gleichwertigkeit”).

Equivalent infringement is only possible in Germany if a deviating embodiment cumulatively satisfies each of the above three requirements. These three requirements have their basis in German case law as the three “Schneidmesser” questions that were developed in five FCJ decisions in 2002 (see, FCJ X ZR 43/01 “Kunststoffrohrteil”; FCJ X ZR 168/00 “Schneidmesser I”; FCJ X ZR 135/01 “Schneidmesser II”; FCJ X ZR 12/00 “Custodiol I”; FCJ X ZR 73/01 “Custodiol II”). More specifically, these three requirements may be phrased as three questions:

Question 1: Has the problem underlying the invention been solved with a deviating means that objectively has the same effect as the claim according to its literal meaning?

Question 2: Would it have been possible for the skilled person as of the priority date of the claimed invention to arrive at the deviating means without having to apply any inventive activity?

Question 3: Are the considerations to be made by the skilled person in order to arrive at the deviating means still orientated to the patent claim, so that the deviating means can be recognized as an equally valid way of achieving the technical effect?

Only if the answer to all three of these questions is “yes” is there a likelihood that a German court will find equivalent infringement.

Same effect (“Gleichwirkung”)

Question 1 – In order for this first requirement to be satisfied, the allegedly infringing embodiment comprising the modified means (or “deviating means”) must objectively be able to achieve the same effect as the technical teaching of the patent.

In order to answer the question of whether the embodiment comprising the deviating means achieves the same effect, one cannot exclusively compare the deviating means to the replaced feature.  Instead, one must consider the entire deviating embodiment as a whole. Thus, the important consideration as far as the corresponding effect is concerned is not what effect(s) the feature in question is supposed to achieve when examined in isolation, but rather, what effect(s) the feature is supposed to achieve within the overall context of the invention.  Therefore, it is essential that (1) despite the modification or deviation from the literal meaning of the claim that the overall effect sought by the teaching of the patent still be achieved; and (2) the advantages of the invention still be achieved despite the replacement of the literal means for obtaining those advantages.

Obviousness (“Naheliegen”)

Question 2 – In order for the second requirement to be fulfilled, it must be shown that it would have been possible for the skilled person to have arrived at the “deviating means” as of the priority date of the application without any inventive considerations based on his/her expert knowledge. Under this requirement, it is necessary to distinguish whether the deviating means was obvious to the skilled person or whether its discovery itself involved an inventive step.  It is essential when assessing obviousness under this requirement that reference be made to a skilled person as of the priority date (the level of expert knowledge at the priority date of the application must be used as a basis for making this assessment).  Any inadmissible “ex post” assessment must be avoided. Not only is the state of the art recited in the patent itself relevant for the assessment of obviousness, but also all other prior art known as of the priority date (i.e., the entire state of the art). This second requirement, and any infringement under the doctrine of equivalents, cannot be satisfied if inventive step must be applied when transitioning from the literal feature recited in the claim to the deviating means in the deviating embodiment.

Skilled person interpreting the claim would recognize the deviating means as an equally valid way of achieving the technical effect (“Gleichwertigkeit”, “Anspruchsorientierung“)

Question 3 – In order for the third requirement to be satisfied, the skilled person must consider the deviating means of the deviating embodiment as an equally valid way of achieving the technical effect of the invention.  This requirement is assessed based on the overall teaching of the patent.  In other words, a deviating means is considered to provide an equally valid way of achieving the technical effect if a skilled person, after reading the entire patent, would understand the deviating embodiment to have equivalent utility (meaning is “as good”) in providing the solution(s) suggested in the patent.  Again, this determination cannot be made by considering the deviating embodiment in isolation, but rather, in its entirety. 

The deviating means does not provide an equally valid way to achieve the technical effect:

  • if the “deviating means” of a deviating embodiment is a technical means that the invention expressly states that it wishes to avoid; or
  • in the event of a disclaimer.

The patentee is deemed to have “disclaimed” a specific embodiment when that embodiment is disclosed as one of several options or alternatives in the description, but not recited in the claims. In such cases, the FCJ (see, FCJ X ZR 16/01 “Okklusionsvorrichtung”, FCJ X ZR 69/10 “Diglycidverbindung”) has held that the patentee intentionally made a “selection decision” specifically excluding everything which did not make its way from the description into the claims. Hence, the patentee was deemed to have disclaimed those specific embodiments.

The FCJ relied on the disclaimer case law in three decisions in 2016 (see FCJ XZR 114/13 “Wärmetauscher”, FCJ X ZR 29/15 “Pemetrexed”, FCJ X ZR 76/14 “V-förmige Führungsanordnung”), of which the decision “Pemetrexed” of June 2016 is the most recent decision and a good example of a case in the life science area involving equivalence in Germany (the corresponding case to “Pemetrexed” in Great Britain is Eli Lilly v. Actavis of July 2017).

However, the situation is different when a “deviating means” is not disclosed in the description and the claimed embodiment is a special implementation (e.g., “pemetrexed disodium”) of an overall principle, which enables a skilled person to arrive at a further (deviating) embodiment that also implements the overall principle (e.g., “pemetrexed dipotassium”) of the invention.  Thus, in Pemetrexed, the FCJ found the third requirement to be met, and denied a disclaimer”, because “pemetrexed dipotassium” was not disclosed in the description as a valid alternative and, as a result, could not have been consciously waived by the patentee from the scope of the claims. Therefore, the FCJ found equivalent infringement.

This post was written by Lisa Mueller of Casimir Jones and Ralf D. Kirsch, Steven M. Zeman and Sebastian Ochs of Grünecker Patent- und Rechtsanwälte PartG mbB, Munich, Germany.

The Doctrine of Equivalents: Examination of the Law in the Netherlands

August 13, 2019

In many jurisdictions, the scope of protection afforded by a patent is defined by the claims of the patent as read either literally or under doctrine of equivalents.  Infringement based on the doctrine of equivalents is generally not based on any statutory law but rather has been established via case law (e.g. Court decisions).  The purpose of the doctrine of equivalents is to promote fair patent coverage so that trivial departures (e.g., variants) from the claim language cannot be used to avoid infringement. 

This is the second post in our series examining the law governing the doctrine of equivalents in several European countries.  Our first post examined the law governing the doctrine of equivalents in Spain and can be found here:  Doctrine of Equivalents – Spain.

Doctrine of Equivalents in the Netherlands

Background

Although the Netherlands is small country with a population of around 17 million, it is a popular venue for patent litigation.  In particular, the Dutch market is important for many multinationals as an entry gate to Europe through which products are often distributed to other countries.  Under the appropriate circumstances, obtaining an injunction in the Netherlands can effectively block distribution of infringing products in Europe.

The Netherlands is also a good venue for patent litigation because it has a specialized patent court in The Hague, which has exclusive jurisdiction to decide patent infringement and validity actions.  Additionally, Dutch judges tend to be highly experienced, with the majority having started their careers in private practice as intellectual property litigators / attorneys.  Several have technical backgrounds or were experienced patent litigators or attorneys before joining the bench.

Claim Construction

The scope of protection of a patent in the Netherlands is determined in accordance with Article 69 of the European Patent Convention (EPC) and the Interpretation Protocol.  Specifically, Article 69(1) of the EPC states that “[T]he extent of the protection conferred by a European patent or a European patent application shall be determined by the claims. Nevertheless, the description and drawings shall be used to interpret the claims.” Thus, the scope of the claims is assessed by determining how a person killed in the art, using his/her general knowledge, would interpret the claims as of the priority/filing date of the application. 

Despite the wording of Article 69(1), Dutch courts have been reluctant to move away from the standard articulated by the Supreme Court in Philips v. Tasseron (1930/1217 (20 June 1930)) which held that the scope of protection of a patent must be based on the “essence of the invention”.  This standard changed slightly in a decision by the Supreme Court in Ciba-Geigy v. Ole Optics NJ (1995/391 (13 January 1995)), which stated that the following four factors must be assessed when assessing the scope of protection of a patent:

  1. When interpreting the terms in the claims, the court must determine the essence of the invention, namely, it must consider the “inventive concept” behind the wording of the claims;
  2. The interpretation of the claims must be adjusted to give a reasonable degree of certainty to third parties (but in certain instances, such interpretation may justify a restricted, literal interpretation of the wording of the claims);
  3. A skilled person may, with restraint, use the prosecution history of the patent at issue for the purpose of interpreting the claims; and
  4. All other circumstances of the case must be taken into account, such as, for example: (a) the possible breakthrough nature of the invention (thus justifying a broader interpretation of the scope of the claims); and (b) the poor drafting of the patent (such as when considering factors 2 and 3), which shall be construed to the disadvantage of the patentee.

Furthermore, in 2014, the Supreme Court clarified that the “essence of the invention” is a “viewpoint” rather than the “starting point” by which the scope of the claims is determined (See, Medinol v. Abbott, 13/00522 (4 April 2014)).  Essentially, what this means is that Dutch courts are able to take the essence of the invention into consideration; however, it is not the decisive factor when it comes to claim construction and determining the scope of protection.

With respect to the prosecution history, according to Dutch case law, consideration of the prosecution history is permitted when such history contains information that is unfavorable to the patentee.  The prosecution history is particularly relevant if it contains information demonstrating that the patentee argued a narrow interpretation of its claims in order to obtain allowance, and/or if the patentee limited its claims during prosecution in view of patentability objections (e.g., novelty and/or inventive step).  However, if the prosecution history contains information that can be used to support a broader interpretation of the scope of the claims then that justified by reading the claims in view of the description and drawings, courts will generally exercise restraint when using such the prosecution history.

Finally, Dutch courts apply the rule that what is “disclosed but not claimed is disclaimed”, which in practice means that if an application discloses a particular product or feature as a possible variant, it should also be claimed.

Doctrine of Equivalents

In the Netherlands, the doctrine of equivalents has been applied in two ways.

  1. Using the function-way-result test.  This test involves determining whether the non-literal variant fulfils the same function as the patented element, by using similar means, leading to a similar result.
  2. Using the insubstantial differences test.  This test, often used in connection with chemical and biotech inventions, involves determining whether the alleged infringing product or process is substantially different or material from what is patented. 

When determining whether protection should be granted based on the doctrine of equivalents, a distinction must be made between “foreseeable” and “unforeseeable” equivalents.  Specifically, Article 2 of the Interpretation Protocol for Article 69 states that “[F]or the purpose of determining the extent of protection conferred by a European patent, due account shall be taken of any element which is equivalent to an element specified in the claims.”  Thus, because Article 2 of the Interpretation Protocol specifies that when determining the extent of protection of an European patent that consideration must be given to equivalents, Dutch courts must first determine whether a person skilled in the art would find that the claims, in view of the description and drawings, should be construed in such a way that any equivalents that were foreseeable on the filing (priority) date, are considered to fall within the scope of protection.  The answer to this question is determined based on what a person skilled in the art, using his/her general knowledge, knew on the filing (priority) date of the application as well as what the patent contributed to the state of the art.  Other relevant factors also taken into consideration include the contents of the description, the essence of the invention, the state of the art, the purpose of the patented product or method, the advantages of the invention, knowledge about the existing product or method, the relation among existing products/methods and the degree to which existing products/methods may also lead to the intended result. 

What about protection for equivalents that were not foreseeable at the filing (priority) date, such as new variants which did not exist at the timing of filing?  Such new variants can only be protected under the doctrine of equivalents if such new elements were not obvious to a person skilled in the art as of the priority/filing date of the application.  Additionally, when determining whether an unforeseeable equivalent also constitutes an equivalent element, a skilled person’s knowledge on the date of the alleged infringement may also be taken into consideration.

Examples of some cases in the life science area involving the doctrine of equivalents are:   Bayer/Sandoz, 5 NJ 2016/496 (February 2016) involving two patents for the method of preparing drospirenone and Eli Lilly/Fresenius involving the use of pemetrexed disodium in combination with vitamin B12 for inhibiting tumor growth

This post was written by Lisa Mueller and Judith Krens of Taylor Wessing.

The Doctrine of Equivalents: Examination of the Law in Spain

August 8, 2019

In many jurisdictions, the scope of protection afforded by a patent is defined by the claims of the patent as read either literally or under doctrine of equivalents.  Infringement based on the doctrine of equivalents is generally not based on any statutory law but rather has been established via case law (e.g., Court decisions).  The purpose of the doctrine of equivalents is to promote fair patent coverage so that trivial departures (e.g., variants) from the claim language cannot be used to avoid infringement.  In this series, we will examine the law governing the doctrine of equivalents in Denmark, France, Germany, Great Britain, Italy, the Netherlands, and Spain. 

Doctrine of Equivalents in Spain

In 1986, Spain joined the European Union and modernized its patent law, which was further updated in 2005.  Today, Spain’s patent laws are fully in line with that of other European Countries and the European Patent Convention (EPC). This, together with Spain’s specialized Intellectual Property (IP) courts, which are mainly in Madrid and Barcelona, and its streamlined litigation procedures, makes Spain a reliable jurisdiction for the enforcement of patent rights.

In determining the scope of patent claims, Spanish Courts consistently apply Article 69 EPC and its protocol of interpretation, which has an equivalent under the Spanish patent law in Law 24/2015. While the extent of the protection conferred by a patent is determined by the claims, the description and drawings are also used.  The claims are construed through the eyes of the person skilled in the art.  Additionally, the new Spanish law specifies that elements equivalent to those specified in the claims must be considered (Article 68(3) Law 24/2015), a provision that mirrors Article 2 of the protocol of interpretation of Article 69 EPC.

Over the years, Spanish courts have developed and refined their own version of the doctrine of equivalents, often with an eye on the approaches taken by U.S., Great Britain and German courts.

In Spain, the doctrine of equivalents is applied in three different ways.

1.  Using the double/triple identity test (based on the U.S. doctrine of equivalents approach).  Under the double identity test, a variant is considered to be equivalent if it performs the same function that leads to be the same result.  However, because this test may result in extending patent protection to new inventions that achieve the same result, the Spanish Courts often apply the “triple identity test” which requires the element have the same function, the same way of working and achieve the same result.  The triple identity test was first applied in Spain in 1967 in a Supreme Court decision interpreting the Intellectual Property Act of 1929 (STS 1967), which includes a selection of decisions from the Courts of Appeals of Barcelona, Madrid, Zaragoza (which no longer decides patent cases) and Valencia.  The double/triple identity tests are normal applied by the Spanish courts when analyzing the doctrine of equivalents in connection with non-complex mechanical patents.

2.  Using the obviousness test.  A modification in the way the triple identity test was applied by Spanish Courts beginning in 2005 (SAPB 2005, Annex II, SAPB 30_11_2005).  Since this time, subsequent decisions by the Barcelona Provincial Court have applied this test in combination with the criterion of equivalency by obviousness (see SAPB 16-3-2011, SAPB 13_11_2009, SAPB 18_9_2006, amp SAPB 30_11_2005).  This combination of using equivalency by obviousness in combination with the triple identity test is often referred to as the “obviousness test”.  An example of how this test was applied in combination with obviousness was described by the Court of Appeals of Madrid (a specialized Court handling IP-related disputes) in a decision of September 27, 2013:

“In order to apply the doctrine of equivalents in an action for patent infringement, equivalence must not be analyzed in abstract.  It is necessary to assess, on the basis of an element-by-element comparison, in case that the contested device does not reproduce any of the patented inventions’ elements, whether an insubstantial variant of that element has been used, the use of which would have been obvious for a person skilled in the art, as long as both elements performed the same function, in the same way and obtained the same result, taking into consideration the technical problem that the patent intends to resolve (hence the importance in these cases of the description); should this be the case, it is also essential that it would be obvious to the person skilled in the art that the variant with respect to some element observed on the contested device would fall within the scope of protection of the patent upon consideration of the context of the patent, that is to say, taking into consideration of the description and the drawings.”

The obviousness test has typically been considered by the Spanish Courts to be more appropriate when dealing with chemical and pharmaceutical patents. 

3. Using the Catnic-Improver test.  An improvement in the obviousness test which has also been applied by the Spanish Courts since 2005 is a variant of the Catnic-Improver test, which has been taken from the courts in Great Britain.  The Catnic-Improver test applies the following three questions, consecutively:

i.  Does the variant have a material effect upon the way the invention described in the patent works?  If yes, the variant is outside of the claim.  If no, go to ii.

ii. Would this (i.e., the fact that the variant had no material effect) have been obvious at the date of publication of the patent to a reader skilled in the art?  If no, the variant is outside the claim.  If yes, go to iii.

iii. Would the reader skilled in the art nevertheless have understood from the description and the claims that the patentee intended that strict compliance with the primary meaning of terms of the claims was an essential requirement of the invention?  If yes, the variant is outside the claim.

With respect to the interpretation of the second question of the Catnic-Improver test, the Spanish Supreme Court has outlined, through a key judgment dated April 29, 2015 (STS 223/2015), that this question is to be assessed as whether a skilled person would have believed that there was a “very high probability” that the variant would work, and not just a “reasonable expectation of success (and likewise, not a 100% chance of success).  In this judgment, the Supreme Court upheld the decision rendered by the Barcelona Appeal Court where it was decided that, in order to find the variant equivalent, the substitution had to be “predictable”, namely, “easy to see and understand”.  The Supreme Court agreed with this approach.

After this 2015 Supreme Court decision, the Catnic-Improver test has been consistently applied by the lower Spanish courts that are competent to hear patent cases, such as the IP courts of Madrid and Barcelona, (which handle specialized appeals involving IP-related disputes), and the 15th Appeals Section of Barcelona.

Date by which Equivalence is assessed.  When assessing the doctrine of equivalents in Spain, one question which often arises is what is the date by which equivalence is assessed?  Is it the date of infringement?  The priority date of the application?  Date of publication of the patent?  Unfortunately, the answer to this question is still unsettled in Spain.  Some decisions implicitly refer to the date when the infringement occurs (especially those decisions which apply the double/triple identity test (but not the obviousness or Catnic-Improver tests).  In contrast, other decisions (typically, those applying the Catnic-Improver or obviousness tests), refer to the filing/priority date of the patent application.  Finally, other decisions refer to the date of publication of the patent.

Other principles to be applied under the doctrine of equivalents.  In addition to the legal tests on equivalence discussed above, Spanish case law has established that the following principles must be followed when applying the doctrine of equivalents:

i. The analysis must be objective.  The behavior/intention of the defendant is irrelevant.

ii. The all-elements rule applies.  The patent and the alternative embodiment cannot be compared globally as a whole (as under an inventive step analysis), but rather, each element/technical feature must be individually compared against its allegedly equivalent alternative, infringement will only exist if all the features are present either literally or by equivalence.

iii. Prosecution history estoppel may apply, particularly in the context of the doctrine of equivalents.  The patentee cannot claim as equivalent those elements which it explicitly and clearly excluded from the scope of protection during prosecution of the patent (Such behavior by the patentee would be inconsistent with its past position regarding the breath of protection, which is not acceptable in accordance with the principle of law “venire contra factum proprium non valet”, or “to come against one’s own fact is not acceptable”, based in the principle of good faith and the trust which has been placed in the patentee’s conduct.).  However, in order for prosecution history estoppel to apply in Spain, the courts have emphasized that this waiver must be explicit and unequivocal, citing the Supreme Court judgment No. 366/12. Decisions, such as the landmark Olanzapine judgment of January 17, 2008 or the more recent decision from the Barcelona Court of Appeal (Section 15) dated May 13, 2019  have interpreted estoppel restrictively. Thus, the application of the prosecution history estoppel will very much depend on the facts and the context in which the patentee made his assertions regarding the scope of the claims.

Examples of some cases in the life science area involving the doctrine of equivalents are:  Supreme court decisions STS 223/2015 (Lundbeck vs several generics companies), concerning a process  to obtain escitalopram; STS 4270/2011 (CINFA et al. vs Eli Lilly), concerning an EP patent on olanzapine and processes for making it; or STS 4845/214 (Wyeth vs Germed) concerning patent litigation involving a sustained release formulation of venlafaxine.  Some of the first decisions involving the application of the doctrine of equivalents in Spain in the area of pharmacy were rendered by the Barcelona Court of Appeal (Section 15), such as the decision of May 2, 2005 (Merck vs Liconsa) or June 7, 2005 (Merck vs Synthon), both concern a process to produce simvastatin.

This post was written by Lisa Mueller, José-Miguel Lissén Arbeloa and Francisco Bernardo of ABG Intellectual Property.