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

 

Filing a Divisional Application in Singapore – Part 10

September 16, 2020

This is the tenth post in our 16-part series examining divisional practice in Argentina, Brazil, Canada, China, Europe, India, Indonesia, Malaysia, Mexico, Pakistan, Russia, Thailand, Saudi Arabia, Singapore, the United States, and Vietnam (in no particular order).  Our first nine posts examining divisional practice in Brazil, Mexico, China, India, Argentina, Canada, Thailand, Pakistan and Malaysia can be found here:  Divisional Practice – Brazil, Divisional Practice – Mexico, Divisional Practice – China, Divisional Practice – India, Divisional Practice – Argentina, Divisional Practice – Canada, Divisional Practice -Thailand,  Divisional Practice – Pakistan, and Divisional Practice – Malaysia.

Time Periods for Filing a Divisional in Singapore

In Singapore, a divisional application can be filed at any time while an application is pending (i.e., before the conditions for grant are met) or before the application has been refused, withdrawn or abandoned.  The divisional application may be filed of the Applicant’s own volition or to address a lack of unity objection under Section 25(5)(d) of the Patents Act.

Requirements for filing a divisional application

When filing a divisional in Singapore, the following must be submitted:

  1. A Request for Grant of a Patent;
  2. A Statement of Inventorship;
  3.  Full description of the invention, claims, abstract and, if applicable, drawings; and
  4. The official fee of SGD $160 (about $120 USD).

The Statement of Inventorship must provide the full details for each inventor (including full name, address, country of permanent residence and nationality) as well as information on how the Applicant derived its rights to the invention from each of the inventors (such as via assignment or employment).

The divisional application will be treated as having, as its date of filing, the date of filing of the earlier application.

A divisional application must not contain any additional matter extending beyond that disclosed in the original application.  Added matter is a ground for revocation under Singapore law.

Double Patenting in Singapore

Double patenting is a ground for revocation in Singapore. The test for double patenting is whether the granted divisional claims are directed to “the same invention” as those of the parent patent. Careful drafting of the divisional claims is therefore required to ensure that they are not identical in scope with any of the parent claims.  For example, claims that use different terminology but are otherwise identical in substance, or dependent claims where the combination of limitations or additional features results in claims having identical scope in the divisional and the parent, should be avoided.

Examination

For a divisional application filed on or after January 1, 2020, a request for substantive examination must be filed within 36 months from the filing or lodgement date of the divisional application. It is no longer possible to rely on the allowed or granted claims of a corresponding application under supplementary examination due to closure of the supplementary examination route for applications having a filing or lodgement date on or after January 1, 2020.

This post was written by Lisa Mueller and Kian Hoe Khoo of Davies Collison Cave Asia Pte. Ltd.

First Gene Therapy Products Approved in Brazil

September 1, 2020

Brazil has become the first among the Latin American countries to approve the marketing of gene therapy products. Specifically, the Brazilian Health Regulatory Agency (ANVISA) recently granted marketing authorization for Novartis’ gene therapy products Luxturna® and Zolgensma®.  As published in the Brazilian Federal Register, Luxturna® received its marketing authorization on August 6th and a few days later, on August 17th, Zolgensma® received its marketing authorization. Prior to ANVISA’s final decision, both products had been approved by the Brazilian Technical Commission of Biosafety (CTNBio), which is responsible for evaluating biosafety of Genetically Modified Organisms (GMOs) in Brazil.

Luxturna®

Luxturna® (voretigene neparvovec) is indicated for the treatment of adult and pediatric (children over 12 months) patients with vision loss caused by bi-allelic retinal pigment epithelium (RPE) mutation-associated hereditary retinal dystrophies.  In Brazil, no other therapeutic option available for the treatment of this rare disease until approval of Novartis’ gene therapy.

It took 232 business days from the submission of the marketing authorization application for ANVISA to provide its decision. As part of the administrative approval procedure, ANVISA and Novartis signed a Term of Commitment to ensure that the company will conduct additional trials with Brazilian patients to continue to monitor the safety and effectiveness of Luxturna®  on a long-term basis.

Zolgensma®

Zolgensma® (onasemnogene abeparvovec) is indicated for the treatment of pediatric patients less than 2 years of age with type 1 spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron (SMN1) gene and with bi-allelic mutations in the SMN1 gene and up to 3 copies of the SMN2 gene.

After 149 business days of analysis, ANVISA concluded that the product’s benefits surpassed its risks and granted the marketing authorization. However, because it is a new gene therapy, the authorization was granted on a exceptional basis, meaning that Novartis is required to send data on Zolgensma’s® ongoing trials as agreed to in the signed Term of Commitment.

Novartis also commited to conduct additional studies with Brazilian patients to enable the evaluation of whether Zolgensma® maintains a positive benefit-risk balance.  Additionally, Novartis also agreed to train (i) healthcare professionals who will perform infusions of the drug; and (ii) Brazilian hospitals in the appropriate storage and handling of  Zolgensma®.

Regulatory framework and next steps

The Brazilian regulatory framework on advanced therapeutic products is very new.  At the end of 2018, ANVISA’s Collegiate Board of Directors approved Rule #260/2018, which defines the technical standards for conducting clinical trials with experimental advanced therapy products.  On February 26, 2020, ANVISA’s Rule #338/2020 was published which provides the requirements for obtaining a marketing authorization for advanced therapy products. The regulation classifies advanced therapy products into three different categories: (i) advanced cell therapy; (ii) gene therapy; and (iii) tissue engineering. Both Luxturna® and Zolgensma® fall into the second category, gene therapy.

The next step for Novartis to introduce Luxturna® and Zolgensma® into the Brazilian market involves receiving price approval from the Brazilian Drugs Market Regulation Chamber (CMED).  This approval is expected by the end of 2020.  There is much anticipation regarding the pricing of these drugs, particularly since Zolgensma® is currently considered to be the world’s most expensive drug (at USD $2.125 million).

The approval of the first gene therapy products in Brazil also brings up the issue of whether these drugs will become available in the Public Healthcare System (SUS). The analysis of whether a drug is incorporated into the SUS is conducted by the National Commission for Incorporation of Health Technologies (CONITEC), which issues a recommendation to the Ministry of Health. While Luxturna® and Zolgensma® are currently not in the SUS, the Brazilian population can obtain free access to these products through a court order.

Although there are still some a few steps to be taken until Luxturna® and Zolgensma® truly get into the hands of patients in Brazil, the approval itself and the consolidation of a regulatory framework on advanced therapeutic products is expected to promote the development of this pharmaceutical in Brazil.

This post was written by Lisa Mueller, Roberto Rodrigues, Ana Calil and Natalia Toledo of Licks Attorneys.

Brazil’s Path for Speeding Up Innovation: A New National Strategy for Intellectual Property

August 28, 2020

On August 10, 2020, a draft of the National Strategy of Intellectual Property (ENPI) was published in the Brazilian Official Gazette Public Consultation #46/2020.  A copy of the ENPI can be found here: Eng_Annex-ii_enpi -public consultation.  Publication of the draft of the ENPI set a 20-day period (which has now been extended) for the public to make comments and suggestions on the draft.  The draft was produced by a working group that includes various public administration entities that are coordinated by the Intellectual Property Interministerial Group (GIPI), which is presided by the Ministry of Economy.

The objective of the ENPI is to set forth the grounds for a balanced and effective National System of Intellectual Property (SNPI), which will be broadly used to foster creativity, investments in innovation and access to knowledge with the aim of promoting competition and the social and economic development of Brazil.  The ENPI is divided into seven structural axes : (i) Intellectual Property (IP) for Competitiveness and Development; (ii) Dissemination, Education, and Training in IP; (iii) Governance and Institutional Strengthening; (iv) Modernization of Legal and Infralegal Marks; (v) Legal Observance and Security; (vi) Intelligence and the Vision of the Future; and (vii) Inclusion of Brazil in the Global IP system.

As alluded to above, public comments and suggestions on the draft can be submitted until September 13, 2020 (extended deadline) and is completely voluntary.  Specifically, any comments or suggestions should be submitted electronically and should use ENPI’s General Glossary of Terms.  Specifically, comments and suggestions should be structured based on each of ENPI’s seven structural axes.

The draft proposes several actions to be implemented and follows the general guideline that intellectual IP is a general tool that is to be used to foster innovation and attract investments.  Additionally, the draft proposes to establish new IP regulatory landmarks to prepare Brazil for a 4.0 Economy that will allow for digital transformation of Brazilian companies.

We would like to highlight several significant actions proposed by the draft:

In the section relating to “Governance and Institutional Strengthening” (Structural Axis 3), the draft proposes the development of an IP policy within the Ministry of Health.  Development of such a policy would help to establish a connection and a continuation of strategic actions or actions that would be implemented (short-term, middle-term or long-term strategies) by stakeholders and public administration entities.

In the “Modernization of Legal and Infralegal Marks” (Structural Axis 4) section, several proposals are made which may impact the pharmaceutical area.  For example, one proposal supports measures to adjust the patents granted on drugs that are considered strategic to the Brazilian Health System (SUS).  Specifically, the proposal in the draft aims at (i) enabling changes to the minimum medication price, established by Law #10,742/2003, based on the remaining term of a patent; (ii) reviewing  Resolution #02/2004 of the Drug Market Regulation Chamber – CMED – (Brazilian FDA Department) to include patent evaluation before allowing the commercialization of a first generic medicine; and (iii) reviewing Ordinance #2/GM/MS/2017, Chapter III, Annex XXVII, that institutes the National Policy of Medicine.

Also proposed is the creation of a technical group at GIPI to evaluate and (eventually) propose adjustments in several intellectual property legal “landmarks” that affect public health and innovation policy in the health sector.  These adjustments will be directed at:  (i) the sole paragraph of article 40 of Law #9.279/96, which states that a patent will  have at least a ten year term from the date of grant; (ii) article 229C of #9.279/96 establishing ANVISA’s (the Brazilian FDA) prior consent for the granting of patents on pharmaceutical products and processes ; (iii) data protection for tests submitted to ANVISA for obtaining marketing authorization for drugs; and (iv) evaluating the repurposing/repositioning of medical uses (second medical use patents.)

“Brazil’s inclusion in the Global System of IP” (Structural Axis 7) is intended to empower its participation in IP international forums, stimulate the presence of Brazilian companies abroad and promote a local business environment beneficial for foreign investments. This section also seeks to set the groundwork for promoting Brazil’s inclusion in the Global Patent Prosecution Highway´s (GPPH) pilot program. Accordingly, this section intends to assess and stimulate Brazil’s participation in international agreements, such as: The Geneva Act of the Hague Agreement Concerning the International Registration of Industrial Designs; 1991 Act of the International Convention for the Protection of New Varieties of Plants); Patent Law Treaty – PLT; Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure; Singapore Treaty on the Law of Trademarks; WIPO Copyright Treaty – WCT; WIPO Performances and Phonograms Treaty – WPPT; Beijing Treaty on Audiovisual Performances; and Lisbon Agreement on Appellations of Origin and Geographical Indications.

After receiving comments and suggestions by September 13, 2020, the National Strategy of Intellectual Property will be finalized and implemented. The implementation should last about 10 years. Specifically, its execution will be divided into separate Action Plans having their own 2-year schedule which will be aligned with the government’s future actions for the IP sector. GIPI will be responsible for ENPI’s governance and implementation.

Please continue to watch BRICS & Beyond for updates on the National Strategy of Intellectual Property in Brazil.

This post was written by Lisa Mueller and Roberto Rodrigues Pinho and Ana Calil of Licks Attorneys.

 

Implementation of a new patent linkage system is imminent in Mexico – are you ready?

August 21, 2020

It is expected that on November 5, 2020, Mexico’s new Federal Law on Protection of Intellectual Property (LFPPI) will take effect.  Pursuant to the LFPPI, the Mexican Institute of Industrial Property (IMPI) and the Federal Commission for the Protection against Sanitary Risks (namely, the regulatory agency known as COFEPRIS), will participate jointly in the design and implementation of a new patent linkage system for allopathic medicines.

It is expected that by approximately December 17, 2020: (i) a regulation will be issued by the Executive branch of the Mexican Government; and/or (ii) General guidelines will be issued by COFEPRIS and IMPI, that will provide the rules regarding this new patent linkage system.

The current patent linkage system requires: (1) bi-annual publication in the IMPI Gazette of a list of allopathic medicine patents; and (2) that intra-governmental communications between COFEPRIS and IMPI occur prior to the granting of any sanitary registrations for allopathic medicines.  The current linkage system is regulated by regulations under the current Industrial Property Law and the Health Supplies Regulation.

Under the new LFPPI, support of the patent linkage system will be elevated to that of Federal law instead of merely legislation (under the Mexican legal system, laws, such as Federal laws, have a higher hierarchy than regulations).  Thus, the new patent linkage system will require,  somewhat similarly to the current linkage system, the following:  (1) bi-annual publication in the IMPI gazette of the list of allopathic medicine patents; and (2) that such publication occur as a result of a coordinated effort between IMPI and COFEPRIS in the operation of the linkage system.

The LFPPI also establishes that publication of the list be carried out in accordance with the current Health regulations, which may trigger different interpretations from those already made in the past by the Mexican courts.

It is expected that the scope of the linkage system will be modified based on the new regulations to be issued.  For example, it is anticipated that the linkage system will include new requirements or obligations, such as a requirement that notice be provided to the patent owner, or that the patent owner be permitted to conduct a hearing, as established by the U.S.-Mexico-Canada Trade Agreement (USMCA)/El Tratado entre México, Estados Unidos y Canadá (TMEC).

Currently, there are several legislative initiatives currently being studied and under discussion in advance of the LFPPI coming into effect.  These legislative initiatives seek to provide limitations on the scope of the new linkage system.  These efforts demonstrate that there are lobbing efforts underway by various stakeholders and associations to define certain inclusions or limitations into the final version of the new linkage system.  In fact, on August 19, 2020, an announcement was made that COFEPRIS: (i) is no longer considered to be an autonomous government entity (up until August 19, 2020, COFEPRIS was a decentralized agency of the Ministry of Health and in charge of the control and surveillance of all aspects related to sanitary regulations (i.e., drugs, medical devices, health services, food supplements, food and beverage, cosmetics, pesticides, clinical studies, etc.), with administrative, technical and operational autonomy), but instead is now dependent on the Undersecretary for Prevention and Promotion of Health); and (ii) issued new rules “announcing” that “use” patents will no longer be considered under the patent linkage system.  The formal rules for items (i) and (ii) have not yet been published, thus, we are unable to know the basis or rational behind this announcement; however, this is an example of the trend of the Mexican government to limit the patent linkage system to compound patents only.

Please continue to watch BRICS & Beyond for updates on the new patent linkage system in Mexico.

This post was written by Lisa Mueller and José Alejandro Luna Fandiño of Olivares.

 

Filing a Divisional Application in Malaysia – Part 9

August 10, 2020

This is the ninth post in our 16-part series examining divisional practice in Argentina, Brazil, Canada, China, Europe, India, Indonesia, Malaysia, Mexico, Pakistan, Russia, Thailand, Saudi Arabia, Singapore, the United States, and Vietnam (in no particular order).  Our first eight posts examining divisional practice in Brazil, Mexico, China, India, Argentina, Canada, Thailand, and Pakistan can be found here:  Divisional Practice – Brazil, Divisional Practice – Mexico, Divisional Practice – China, Divisional Practice – India, Divisional Practice – Argentina, Divisional Practice – Canada, Divisional Practice -Thailand, and Divisional Practice – Pakistan.

Time Periods for Filing a Divisional in Malaysia

Pursuant to the Malaysia Patents Act of 1983 (Patents Act), a divisional application can be filed (1) in response to an objection under Section 26 of the Patents Act, for a lack of unity of invention; or (2) in response to any objection raised in an Examiner’s first examination report. Additionally, the Patents Act also permits the filing of one or more voluntary divisional applications at the Applicant’s discretion.  Finally, one or more divisional applications can be filed off of an original (e.g., parent application) and nested divisional applications are also permitted.

While a divisional application can be filed at any time after an original (e.g., parent) application is filed but prior to issuance, according to Regulation 19A of the Malaysian Patents Regulations of 1986 (Regulations), a divisional application must be filed no later than 3 months from the mailing date of an Examiner’s first examination report.  Therefore, it is recommended that an Applicant file any divisional applications at the same time when filing amendment and/or response to the first examination report.  In situations where the Examiner’s first report indicates that the claims are allowable and the application is proceeding to grant (e.g., usually, within 1 month from mailing of the clear examination report), Applicant can file one or more divisional applications while the application remains pending.

Requirements for filing a divisional application

When filing a divisional in Malaysia, the following must be submitted:

(a) Patents Form 17 for appointment of patent agent;

(b) Patents Form 1 (application form);

(c) full description, claims, abstract and, if applicable, drawings;

(d) Patents Form 5 (request for substantive examination) or Patents Form 5A (request for modified substantive examination); and

(e) the appropriate filing fees.

A request for substantive or modified substantive examination must be filed when filing a divisional application.

The subject matter of a divisional application cannot go beyond the disclosure in the initial application as filed.  If additional subject matter is added in one or more divisional application, the Applicant will be requested to remove the additional subject matter.  Failure to do so will result in the divisional application being refused.

The date a divisional application is filed will become the filing date of a divisional application; however, the divisional application will be accorded the benefit of any right of priority to its original (e.g., parent) application for any subject matter contained therein. 

The examination of a divisional application is carried out in the same manner as for any other application. 

Double Patenting

The claims of one or more divisional applications cannot be identical to those of any prior parent application, otherwise the claims in the divisional application will be rejected for double patenting.

This post was written by Lisa Mueller and Ng Kim Poh of Christopher & Lee Ong

Changes in Ukrainian Patent Law Strongly Favor Generic Manufacturers

July 23, 2020

On July 21, 2020, the Parliament of Ukraine introduced several major amendments to Ukrainian patent law.  Although the amendments still need to be approved by the President in order to become effective, this is considered a mere formality and is expected to be completed within the next several weeks.  

The amendments are particularly relevant for the pharmaceutical industry, and even more so for local generic manufacturers, for which the amendments are very favorable.  The amendments are as follows:

Significant limitation in the scope of patent protection

According to the amendments, methods of treatment claims are no longer patentable.  Additionally, patent protection for new forms of known substances, such as salts, esters, ethers, complexes, combinations and other derivatives, polymorphs, metabolites, pure form, particle size, isomers, will be difficult to obtain unless the Applicant can demonstrate that the new form of the known substances differs significantly from the original substances with respect to efficacy.  This change is very similar to the wording of Section 3(d) of the Indian Patent Act of 1970 (http://ipindia.nic.in/writereaddata/Portal/ev/sections/ps3.html), and is contradictory to Ukraine’s international obligations of harmonizing its law with the European Union’s (EU) legislation.

New rules regarding supplementary protection certificates (SPC)

The amendments also require that a valid Ukrainian marketing authorization (MA) exist when a Patent Owner applies for a SPC. Additionally, there are new timing requirements with respect to the filing for an SPC.  Specifically, a Patent Owner can only obtain an SPC in Ukraine if a Ukrainian MA is filed within one year after the filing of the very first MA application for the product in another country.  For example, if the very first MA is filed in the United States on May 1, 2018, and a second MA is filed in Russia on June 15, 2019, in order to obtain an SPC for any patent filed in the Ukraine covering the product, the MA in Ukraine would have to be filed before May 1, 2019.  Additionally, a request for a SPC must be filed within 6 months after the initial Ukrainian MA is obtained or after a patent (that covers the product encompassed by the MA) is granted, whichever occurs first. 

Another change relates to the limits on protection provided by a granted SPC.  Specifically, a SPC in Ukraine will not cover the use of a patented product that is solely exported out of the country.  Moreover, a SPC will not be deemed to be infringed if a patented drug is used within 6 months prior to the expiration of a SPC for purposes of creating a stockpile of product for sale after patent expiry.

New options with respect to oppositions

The amendments also introduce an opposition procedure into Ukrainian patent law.  This is good news as the availability of an opposition procedure provides an alternative to the lengthy and costly litigation previously required to invalidate a patent.  The amendments provide two opportunities for an opposition:  a pre-grant opposition, which can be filed within 6 months after the patent application publishes, and a post-grant opposition that can filed within 9 months after publication of the grant of the patent.  Both oppositions will be conducted by the Ukrainian Patent Office.  The grounds for a pre-grant and post-grant opposition will be different. Specifically, the grounds available for a pre-grant opposition will include novelty, inventive step, lack of industrial applicability, lack of subject matter eligibility (i.e., the invention is directed to a method of treatment or plant variety), or that the invention is contrary to moral principles.  In contrast, a post-grant opposition will be limited to just novelty, inventive step and lack of industrial applicability.    

In summary, the new amendments to Ukrainian patent law will make life more challenging for larger pharmaceutical companies and will require greater expenditure of resources and time in order to obtain, maintain, and enforce patents against generic companies in the country.

Please continue to watch BRICS & Beyond for updates on patent law changes in Ukraine.

This post was written by Lisa Mueller and Taras Kyslyy of Arzinger.

Zombie Patents? USPTO Issuing Notices of Abandonment in U.S. National Stage PCT Applications After Filing of an RCE where no Inventor Oath or Declaration or Substitute Statement has been Filed

July 22, 2020

Back on April 2, 2015, the U.S. Patent and Trademark Office (USPTO) published final rules for implementing the Geneva Act of the Hague Agreement Concerning the International Registration of Industrial Designs July 2, 1999 (Final Rules).  Implementation of the Hague Agreement was significant because it allowed Applicants to (1) file a single international design application with the USPTO as the “office of indirect filing”; (2) designate multiple Hague Agreement member countries and pay filing fees for each designated country; and (3) benefit from the resulting registration becoming effective and enforceable in each of the designed countries. 

Also included in the Final Rules, however, was a change that impacted U.S. utility patent practice, specifically, the filing of a Request for Continued Examination (RCE).  Most importantly, the Final Rules clarified that the filing of an RCE under 37 CFR. § 1.114 was not applicable in international design applications and excluded U.S. National Stage Patent Cooperation Treaty (PCT) applications that did not comply with 35 U.S.C. § 371.  On page 17930 of its summary of the Final Rules, the USPTO explained that this change to Section § 1.114 was made to “clarify that the request for continued examination practice set forth in § 1.114 added in section 4403 of the AIPA [American Inventors Protection Act of 1999] does not apply to an international application until the international application complies with 35 U.S.C. § 371 (which requires the filing of an inventor’s oath or declaration (or substitute statement) in the international application, as well, as for example, the basic national fee and an English language translation of the international application if filed in another language)”.  As a result, the USPTO amended § 1.114 by revising paragraphs (e)(3)-(5) and adding paragraph (e)(6) to currently read as shown below:

§  1.114    REQUEST FOR CONTINUED EXAMINATION.
(a) If prosecution in an application is closed, an applicant may request continued examination of the application by filing a submission and the fee set forth in § 1.17(e) ….
*****
(e) The provisions of this section do not apply to:
(1) A provisional application
(2) An application for a utility or plant patent filed under 35 U.S.C. § 111(a) before June 8, 1995;
(3) An international application filed under 35 U.S.C. 363 before June 8, 1995 or an international application that does not comply with 35 U.S.C. § 371;
(4) An application for a design patent;
(5) An international design application; or
(6) A patent under reexamination.

The Final Rules became effective on May 13, 2015.  Thus, beginning on this date, a U.S. National Stage PCT application for which an inventor’s oath or declaration (or substitute statement) had not been filed was not eligible for an RCE filing.

Last week, Applicants who filed an RCE in a U.S. National Stage PCT application in which an inventor oath or declaration had not been filed began receiving Notices of Abandonment which stated:

“The Office acknowledges the filing off the Request for Continued Examination (RCE) on January 1, XXXX.  However, the RCE provisions of 37 CFR 1.114 do not apply to an international application that does not comply with 35 U.S.C. 371.  See 37 CFR 1.114(e)(3).  An inventor’s oath or declaration for each named inventor is required for an international application to comply with 35 U.S.C. 371, notwithstanding the changes permitting applicants to postpone filing the inventor’s oath or declaration until the date on which the issue fee is paid.  See 37 CFR 1.495(c)(3)(ii).  See also Changes To Implement the Hague Agreement Concerning International Registration of Industrial Designs, Final Rule, 80 Fed. Reg. 17918, 17930 (April 2, 2015).  The present application, which is a national stage entry of an international application, has not met the requirement of 35 U.S.C. 371(c)(4) in that a compliant inventor’s oath or declaration has not been filed for each named inventor.  Accordingly, as a proper reply to the Office Action mailed on June 1, XXXX, has not been timely filed, the application is abandoned.”

The receipt of these Notices of Abandonment came as a complete surprise to many Applicants and has led to the question as to “What do you do if you find yourself in this predicament?” 

For abandoned applications:

  1.  Obtain executed inventor oaths or declarations or substitute statements as quickly as possible;
  2. File an RCE form along with the executed inventor oaths or declarations or substitute statements; and
  3. File a Petition for Revival of an Application for Patent Abandoned Unintentionally under 37 CFR § 1.137(a) and the petition fee as soon as possible.

For pending U.S. National Stage PCT applications:

  1. Conduct an audit of your currently pending application and obtain executed inventor oaths or declarations or substitute statements and file them in the USPTO as soon as possible; or
  2. If the application is under final rejection and executed inventor oaths or declarations cannot be readily obtained or the conditions for filing a substitute statement have not been met, file a continuation application.

Patents issued from U.S. National Stage PCT applications in which an RCE was filed without an inventor oath or declaration:

Consider filing an RCE form with the executed inventor oaths or declarations or substitute statements and a Petition for Revival of an Application for Patent Abandoned Unintentionally under 37 CFR § 1.137(a) (Petition to Revive) and petition fee as soon as possible. 

Although it may appear odd to be filing a Petition to Revive on an issued patent, the USPTO has previously granted such petitions.  For example, a Petition to Revive was granted in U.S. Patent No. 6,872,198 (the ‘198 patent).  U.S. Application No. 10/231,748 (Application), which issued as the ‘198 patent, was filed with a nonpublication request under 35 U.S.C. § 122(b)(2)(B)(i).  A PCT application was later filed claiming priority to the Application.  During litigation, it was alleged that the Application should have been abandoned under 35 U.S.C. § 122(b)(2)(B)(iii) for failure to notify the U.S. Patent Office of the PCT filing.  The Patent Owner filed a Rescission of Previous Nonpublication Request and a Petition to Revive on March 23, 2006.  The USPTO granted the petition on August 17, 2006.  In its Decision Granting Petition Under 37 CFR § 1.137(b) (Decision), the USPTO noted that “[T]his application matured into Patent No. 6,872,198 on March 29, 2005.  Therefore, no further action being required, this patented file is being referred to Files Repository.”  Copies of the Petition to Revive and Decision are provided here:  

petition_to_revive_6872198-2Download
decisiononpetition-1Download

The ‘198 patent was the subject of litigation in Arrow Intern. v. Spire Biomedical, Inc., 443 F.Supp.2d 182 (D. Mass. 2006) and Arrow Intern. v. Spire Biomedical, Inc., 635 F.Supp.2d 46 (D. Mass. 2009).

Additionally from a policy perspective, perhaps a technical correction to the statute should be considered that (1) would be retroactive; and (2) would make RCEs in these applications proper provided that all the requirements under 35 U.S.C. § 371 were satisfied by the time the issue fee is paid.  Such a revision of the statute would be consistent with 35 U.S.C. 115(f), which requires the oath or declaration to be filed no later than the date on which the issue fee for the patent is paid.

Considerations for future U.S. National Stage PCT Application filings

One option when filing a U.S. National Stage PCT application is to file the application as a 35 U.S.C. § 120 continuation application, which is also known as a “pass through” or “bypass” continuation.  Filing a bypass continuation avoids the need to submit an oath or declaration before the filing of an RCE.    Another option is to include inventor signatures as part of the PCT Request (Form PCT/RO/101) by utilizing Box VIII(iv).  Alternatively, signatures of the inventors can be included on Form PTO/AIA/01 using the PCT international application number to identify the application to which the declaration is directed and submit the form upon entering the national phase.

We will continue to monitor this situation and provide further updates as they become available.

This post was written by Lisa Mueller and Jeff Childers.

Patentability of Diagnostic Inventions in the United States, Europe and Canada – Part 3

July 22, 2020

Patentability of Diagnostic Inventions in the United States, Europe and Canada – Part 3

This 3-part series will provide an overview of the patentability of diagnostic inventions in the United States (U.S.), Europe and Canada.  Part 1 examined the patentability of diagnostic inventions in the U.S. and can be found here.  Part 2 examined the patentability of diagnostic inventions in Europe and can be found here.   Part 3 will examine the patentability of diagnostic inventions in Canada.

Canada

In Canada, the patentability of medical diagnostic methods is currently in a state of flux.  The issues began with the decision in Amazon.com v. Attorney General (Amazon.com) 97 C.P.R. (4th) 171 (F.C.A).  In Amazon.com, the Federal Court of Appeal identified three important elements for patentability subject matter:  (i) it must not be a disembodied idea but have a method of practical application; (ii) it must be a new and inventive method of applying skill and knowledge; and (iii) it must have a commercially useful result.  Additionally, the Court also ruled that “purposive construction” of patent claims must be performed prior to making a determination of subject matter eligibility, which involves identifying and assessing the essential and non-essential elements of the claims. 

Moreover, in 2015, the Canadian Intellectual Property Office (CIPO) released patentability Examination Guidelines specific to diagnostic methods (Guidelines).  These Guidelines have now been incorporated into the CIPO Manual of Patent Office Practice (MOPOP) and contain the following instructions for Examiners when approaching a claim directed to diagnostic methods:

(a) Identify the problem the inventors set out to solve and the solution provided by the invention, guided by the description and the Examiner’s understanding of the common general knowledge in the relevant art.

(b) Consider that for diagnostic methods, an inventor is generally looking to solve a data acquisition problem and/or a data analysis problem.

(c) Factors that may indicate a data acquisition problem include novel analytes or biomarkers and novel means of identifying or quantifying an analyte (regardless of whether the analyte is new).

(d) Factors that may indicate a data analysis problem include a new correlation between a condition and an analyte that is common general knowledge.

(e) Determine whether elements in the claims are essential (provide a solution to the identified problem) or non-essential (do not provide a solution to the identified problem).

(f) If the essential elements are required solely to solve a “data analysis problem” as opposed to a “data acquisition problem”, the claim will be refused as directed to non-statutory subject matter.

Practically, the Guidelines direct Examiners to reject patent claims where the subject matter of the claim is based only on the identification of new and non-obvious correlation, for example, between a disease state and a known biomarker. While some claims directed to diagnostic inventions have issued since the Guidelines were established, there has been a fair amount inconsistency at CIPO with respect to the application of the Guidelines.  Canadian patent practitioners still determining types of claims which are currently allowable in Canada under CIPO policy, drawing on claim wording strategies similar to those used in the U.S.

To learn more on the patenting of diagnostic inventions in the U.S., Europe and Canada, please join Lisa Mueller of Casimir Jones, Phillip Price of Dehns, and Noel Courage of Bereskin & Parr LLP for a webinar on July 23, 2020 that will explore in more detail the patentability of diagnostic inventions and provide practical tips on how to overcome objections commonly raised with respect to these inventions in each of these jurisdictions.  You can register for the webinar at the following link:  Link to webinar.

This post was written by Lisa Mueller, Phillip Price of Dehns, and Noel Courage and Ainslie Parsons of Bereskin & Parr LLP.

Patentability of Diagnostic Inventions in the United States, Europe and Canada – Part 2

July 21, 2020

This 3-part series will provide an overview of the patentability of diagnostic inventions in the United States (U.S.), Europe and Canada.  Part 1 examined the patentability of diagnostic inventions in the U.S. and can be found here.  Part 2 will examine the patentability of diagnostic inventions in Europe.

Europe

Despite the challenges of obtaining patent protection for diagnostic inventions in the U.S., patent protection for diagnostic inventions is available in a number of jurisdictions outside of the U.S.  Europe remains a pro-patentee jurisdiction as far as diagnostic inventions are concerned.  At the European Patent Office (EPO), Article 53(c) of the European Patent Convention (EPC) does state that:  “European patents shall not be granted in respect of … methods of treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body…” (emphasis added).  However, the EPO applies this exclusion narrowly.  To be excluded, the method must be both diagnostic in nature and practiced on the human or animal body. 

In G 1/04, the Enlarged Board stated that because neither the EPC nor the preparatory documents to the EPC provided a definition for the term “diagnostic methods”, according to established jurisprudence of the EPO, a diagnostic method must include at least the following steps: 

(i)   the examination phase involving the collection of data;

(ii)  the comparison of these data with standard values;

(iii) the finding of any significant deviation, i.e., a symptom, during the comparison; and

(iv) the decision phase (attribution of the deviation to a particular clinical picture).

Thus, presenting claims lacking some of steps (i) to (iv) may avoid the exclusion.

Additionally, in G 1/04, the Enlarged Board further stated that for a claimed method to be considered a diagnostic method excluded from patentability under Article 53(c) EPC, the claim must contain the following features:

(a) the diagnosis for curative purposes stricto sensu representing the deductive medical or veterinary decision phase as purely intellectual exercise (i.e., decision step (iv), above);

(b) the preceding steps which are constitutive for making that diagnosis (i.e., examination, comparison and finding of significant deviation steps (i) to (iii) above); and

(c) the specific interactions with the human or animal body which occur when carrying those out among these preceding steps which are of a technical nature.

What is meant by feature c) above is that when determining whether or not the method is “practiced on the human or animal body”, only the recited steps that are a) preceding steps necessary for making a diagnosis, and, b) technical in nature, should be considered.   The EPO has a consistent but very broad interpretation of what is meant by the term “practiced on the human or animal body”.  If the performance of the respective step implies any interaction with the human or animal body, then the requirement is met.  The interaction does not need to be invasive, involve any risk to patient safety or require a medical professional to be considered a step “practiced on” the body. Furthermore, a direct physical interaction on the body is not required; it is sufficient that the body is present and an interaction occurs.  Moreover, a diagnostic method claim may be objected to as encompassing steps practiced on the human or animal body even if the practice is not positively recited.  For example, EPO Examiners will consider the content of the description and dependent claims and, if it is considered that a step practiced on the human or animal body is encompassed by the claim, then an objection will likely be raised. 

It is important to note that the exclusion of Article 53(c) EPC does not apply to in vitro diagnostic methods, such as for the testing or processing of samples derived from a subject.  Even simple in vitro diagnostic method claims, straightforwardly based on the discovery of a correlation between a biomarker/ analyte and a disease state/clinical picture, are patent patentable at the EPO.  In this regard, the subject-matter eligibility situation for diagnostics is much more positive at the EPO than at the U.S. Patent and Trademark Office.

To learn more on the patenting of diagnostic inventions in the U.S., Europe and Canada, please join Lisa Mueller of Casimir Jones, Phillip Price of Dehns, and Noel Courage of Bereskin & Parr LLP for a webinar on July 23, 2020 that will explore in more detail the patentability of diagnostic inventions and provide practical tips on how to overcome objections commonly raised with respect to these inventions in each of these jurisdictions.  You can register for the webinar at the following link:  Link to webinar.

This post was written by Lisa Mueller, Phillip Price of Dehns, and Noel Courage and Ainslie Parsons of Bereskin & Parr LLP.