USPTO and IMPI Announce Parallel Patent Grant Initiative

January 4, 2021

On December 7, 2020, the United States Patent and Trademark Office (USPTO) and the Mexican Institute of Industrial Property (IMPI) announced the launch of the Parallel Patent Grant (PPG) initiative.  The PPG initiative is in the form of a work sharing agreement between the two offices, allowing applicants to expedite the grant of a Mexican patent provided that a corresponding patent has already granted in the U.S.

For an application to be eligible under the PPG initiative, both the Mexican and corresponding U.S. applications must share the same priority date.  Applicants who have a granted U.S. patent can utilize the PPG initiative by simply submitting a request to IMPI.   According to IMPI, approximately 11,000 patent applications filed between 2015 and 2018 may benefit from the PPG initiative.

The introduction of the PPG initiative is a result of a Memorandum of Understanding (MoU) on Technical and Strategic Collaboration signed by both offices on January 28, 2020.  Under the terms of the MoU, a parallel patent grant framework was instituted which allowed IMPI to leverage search and examination results from the USPTO when issuing a counterpart Mexican patent.  Since the signing of the MoU, the USPTO and IMPI have tested the PPG on around 200 applications.

The USPTO and IMPI have a long history of work sharing cooperation.  This includes the Patent Prosecution Highway (PPH) program has been implemented since 2011.

This post was written by Lisa Mueller.

A Primer on Patent Term Extension in Russia

December 4, 2020

Background

Since 2003, Article 1362 of the Russian Civil Code has provided patent holders the possibility of extending the term of a Russian patent for a drug, pesticide or agricultural chemical for a period of up to five years.  A patent term extension (PTE) request can be filed six months from: (1) the issuance of the first marketing authorization for a drug, pesticide or agricultural chemical; or (2) patent grant date, whichever expires last.

The following documents are required for filing a PTE request:

  1. A list of claims that are restricted to the approved drug (independent and corresponding dependent claims) which form the basis of the PTE being sought;
  2. Documents which establish that the drug (for which the first marketing authorization has been granted) and the patented product are identical. There is no specific list of documents that will be accepted by the Russian Patent and Trademark Office (Rospatent). Such documents may include: medical pharmacopoeia, extracts from the registration dossier, package insert, extracts from the Medical Guides such as the Merck Index, etc.;
  3. A notarized copy of the first marketing authorization issued by the local Health Authority; and
  4. A copy of the drug label.

Applications for PTE are submitted to Rospatent and are generally reviewed by the same branch department that examined the original application, including the same Examiner.  Technically, the grant of an extension by Rospatent does not prolong the term of the patent for which an extension is sought.  Instead, Rospatent issues a supplementary patent having a restricted scope of protection.  Specifically, the claims in a supplementary patent cannot contain alternative features but are limited to the exact features of the product described in the marketing authorization.  For example, claims directed to a process (e.g., such as a manufacturing process), expression vectors, cells, etc., are not eligible for extension.  Said another way, in Russia, PTE is available for patents claiming a compound corresponding to the active pharmaceutical ingredient (API) of the marketed product and arguably, their use.

As mentioned above, when filing a request for PTE with Rospatent, the Applicant (e.g., patent holder) must submit an amended claim set that recites that same features as the drug, pesticide or agricultural chemical in the granted marketing authorization (Approved Product).  If an Examiner believes that the amended claims do not comply with the Administrative Regulations, an Office Action will be issued.  For example, an Examiner might issue an Office Action if the claims: (1) have not been sufficiently narrowed; or (2) cover alternatives (e.g., such as in a Markush group which might cover more than one compound).  The current trend of Rospatent is to require Applicants to overly narrow the scope of the claims of the supplemental patent. For example, with respect to a biologic product, if an independent claim of an original patent is directed to the complementary determining regions (CDRs) of the antibody, Rospatent will insist on restricting the scope of the supplemental patent to the full length antibody which can potentially lead to the attempts by biosimilars to design around such supplemental patent (e.g., by making minor changes in the constant regions of the antibody).

In order to obtain the broadest scope of protection in a supplementary patent, the Applicant must provide convincing arguments detailing how each feature recited in the amended claim set is related to the Approved Product.  For example, if a claim recites certain isomers, the Applicant should provide copies of technical documents that demonstrate that the composition contains at least trace amounts of such isomers. A patent claim to “a compound and a pharmaceutically acceptable salt thereof” will likely be accepted by an Examiner if the Approved Product is in the form of a salt.   However, claim recitations such as “solvates” or “hydrates” will likely be excluded from the claims if the Approved Product is not in fact a solvate or hydrate. Moreover, if a patent is directed to a composition or formulation comprising certain ingredients that are present within a recited range, the Applicant will be permitted to submit an amended claim set to specify the exact amount of the each ingredient as described in the marketing authorization even if the recited amounts were not specifically disclosed in the specification.

If the original patent contains claims that cover several compounds that are present in multiple commercial products and each product has received its own separate marketing authorization, it may be possible to obtain an additional supplemental patent for each of the compounds.

Once a PTE request is accepted, the Applicant receives the supplemental patent and the new claims are published under the original patent number.  The term of the patent is calculated from the day after the original patent expiry date.

Cases involving PTE in Russia

Gilead Pharmasset LLS – PTE for Sovaldi® (sofosbuvir)

On August 20, 2018, Gilead Pharmasset LLS (Gilead) filed an application for extension of Russian Patent No. 2651892 for its product Sovaldi® (sofosbuvir).  The patent covered an antiviral composition comprising an effective amount of isopropyl propionic acid or its stereoisomer for the treatment of hepatitis C and a method for producing isopropyl propionic acid or its stereoisomer.  In its PTE application, Gilead narrowed its claims to a single active ingredient, sofosbuvir, an S-stereoisomer, as the API.  Rospatent rejected Gilead’s application on two grounds stating that: (1) sofosbuvir was a specific stereoisomer of the species claimed in the patent and not identical to the composition recited in the claims; and (2) the specification failed to describe that the S-stereoisomer was the specific substance that produced and possessed the activity essential to achieve the claimed purpose of treating hepatitis C.

The Intellectual Property (IP) Court held that Rospatent’s refusal was inconsistent with the applicable legal provisions, reversed the decision and directed Rospatent to grant the PTE application.  Specifically, with respect to the first ground, the IP Court reviewed the claims and held that the patent covered any stereoisomer of isopropyl propionic acid, including the S- and R-stereoisomers as alternatives.  According to the IP Court, each stereoisomer alternative had a separate set of features which had to be compared with the Approved Product separately, which had not been done by Rospatent.  With respect to the second ground, the IP Court noted that the S-stereoisomer was recited in the claim without referencing any specific chemical structure or feature.  However, the IP Court found that the general description in the specification to a method of producing the stereoisomer by separation of the distereoisomers to be sufficient.  Additionally, the IP Court held that based on the state of the art, the separation of the diastereoisomers was routine, the obvious of effect of which was the stereoisomer would maintain its features and activity.  Therefore, the description in the specification of a general method without specific examples was sufficient.

However, this was not the end of the proceedings.  Rospatent disagreed with the decision of the IP Court.  Not only did Rospatent refuse to grant the PTE application, it challenged the IP Court’s decision and filed a cassation appeal.  The Presidium of the IP Court rejected the cassation appeal and upheld the first instance (IP Court) decision finding no error of law or procedure.

Genentech Inc. – Ocrevus® (ocrelizumab)

In 2018, Genentech Inc. filed a PTE application for Russian Patent No. 2326127 covering its product Ocrevus® (ocrelizumab) used in the treatment of multiple sclerosis.  Rospatent issued a preliminary rejection of the application.  In response, Genentech filed a response together with amended claims 1 and 2 which read as follows:

  1. A humanized antibody that binds human CD20, the antibody comprising the VH sequence of SEQ ID NO:8 and the VL sequence of SEQ ID NO:2.
  2. A humanized antibody that binds human CD20, the antibody comprising the light and heavy chain amino acid sequence of SEQ ID NO: 21 and 22, respectively.

Despite Genentech’s amendments, Rospatent issued a final rejection of the application.  Genentech appealed the rejection to the IP Court.  Genentech argued that Rospatent examined amended claim 1 for industrial applicability rather than its correspondence to the features of the approved product Ocrevus®.  Additionally, Genentech criticized Rospatent’s decision: (1) prohibiting Genentech from submitting additional data and information to support its application or amended claim 1; and (2) failing to grant PTE for claim 2, which had not been the subject of any rejections.

In support of its position, Rospatent argued that claim 1 did not include the amino acid sequences of the constant regions and was not limited to any specific antibody isotype (the isotype of Ocrevus® was IgG1).  By failing to limit claim 1 to the specific antibody isotype, the claim encompassed all antibody isotypes (e.g., IgA, IgM, IgG, etc.).

The IP Court held that in order to assess compliance with the requirements of part 1 of Article 8 of Russian Ministry of Economic Development by Order No. 809 dated November 3, 2015, Rospatent had to answer the following questions:

  1. Did the patent claim describe the API of the medicinal product under the marketing authorization?
  2. Did the patent claim describe a combination or group of combinations within a single chemical structure?
  3. Did the specification disclose that the chemical composition or group of compositions covered by the patent claim could be used as the API of a medicinal product?
  4. Did the set of features of the product encompassed by the patent claim correspond to the active ingredient of the medicinal product under the marketing authorization?
  5. Did the specification plausibly disclose that the composition or group of compositions with a single chemical structure as recited in the claim present the necessary activity for use in the medicinal product under the marketing authorization?
  6. Did the set of features for the compositions recited in the claim correspond to the set of features of the medicinal product approved in the marketing authorization?

In order to assess the relationship between the amended claims filed by Genentech for PTE and the features of the active ingredient under the marketing authorization, the IP Court requested written opinions by experts.  Moreover, the IP Court requested the presence of the experts at a hearing to answers not only its questions but also those of Genentech and Rospatent.

During the proceedings, the experts testified that the active ingredient of Ocrevus® was not identical to the composition described in claim 1.  Specifically focusing on the breadth of claim 1, the experts stated that claim failed to include the amino acid sequences of the constant region or antibody isotype. Thus, claim 1 encompassed any constant region and antibodies of all isotypes, while Ocrevus® had a specific constant region and IgG1 isotype.   Regarding narrower claim 2, the experts agreed that the amino acid sequences recited in this claim were identical to the active ingredient of Ocrevus® as the sequences recited in this claim encoded the heavy and light chains of IgG1.

Therefore, based on the evidence provided by the experts, the IP Court in its decision of February 4, 2020, which was later upheld by the IP Court Presidium decision on July 9, 2020, concluded that:  (1) claim 1 was not identical to, and was in fact broader, than the composition of the active ingredient of the medicinal product under the marketing authorization (claim 1 was broader because the claim did not include the amino acid sequences of the constant regions and was not limited to the antibody  isotype; and (2) it had no obligation to grant PTE for claim 2 because Genentech had expressed its desire to have PTE applied to the entire claim set as filed, but not to certain claims.

Please continue to watch BRICS & Beyond for updates on patent term extension in Russia.

This post was written by Lisa Mueller and Vladislav Ugryumov of Gowlings.

 

 

Filing a Divisional Application in Saudi Arabia – Part 12

November 27, 2020

This is the twelfth 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 eleven posts examining divisional practice in Brazil, Mexico, China, India, Argentina, Canada, Thailand, Pakistan, Malaysia, Singapore and Russia 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, Divisional Practice – Malaysia, Divisional Practice – Singapore and Divisional Practice in Russia.

Divisional Practice in Saudi Arabia

In Saudi Arabia, divisional practice is fairly flexible.  Specifically, one or more divisional applications can be filed: (1) in response to a lack of unity rejection; and/or (2) at any time for any reason (e.g., voluntary divisionals are permitted).

Time Period for Filing a Divisional Application

A divisional application can be filed any time before a receipt of a decision to grant or reject an original (e.g., parent) application.  A divisional application cannot be filed from another divisional application (e.g., no cascading divisionals are permitted).

Requirements for Filing a Divisional Application

Under Saudi Arabian patent law, the requirements for filing a divisional application are as follows:

  1. Submission of a copy of the specification (including the abstract), claims and drawings of the divisional application as well as an entry form indicating the name and address of the Applicant and the inventor(s);
  2. The divisional application cannot include any subject matter not disclosed in the parent and priority application(s); and
  3. The parent application and the divisional application cannot claim identical subject matter.

The priority and filing dates of each divisional application will be identical to the priority and filing dates of the (original) parent application.

Claims of a Divisional Application

A divisional application may be filed with the claims as originally filed in the parent application or PCT application.  However, the claims of a divisional application filed with the same claims as a parent or PCT application must be amended during examination to ensure that neither the parent or divisional application claim identical subject matter.  In other words, there can be no overlap of claimed subject matter in the parent or the divisional applications and an Examiner will reject the claims of a divisional application in the event of such overlap.  Nonetheless, the claims of the divisional application may encompass broader subject matter than a parent application (subject to examination and opinion of an Examiner).

Double Patenting

Any patent issuing from a parent and a divisional application cannot claim the identical subject matter as this would present a double patenting problem.  In order to determine whether or not double patenting exists, the claims as allowed are examined to determine whether or not identical subject matter is being claimed.  Specifically, claimed subject matter will be recognized as being identical if:

  1. The independent claims in the parent and divisional application are completely (100%) identical with one another; or
  2. One or more independent claims in the parent or divisional application recite one or more alternatives and the one or more alternatives are identical with one or more alternatives claimed in the parent or (another) divisional application.

Examination of Divisional Applications

A divisional application is accorded the same filing date as the parent application but is treated as a new patent filing.  As such, the divisional application:

  1. Is allotted its own (new) application number;
  2. Requires payment of its own filing fees (separate from the filing fees paid in the parent application) and all back annuities;
  3. Requires the filing of a request for examination (separate from the filing of a request for examination in the parent application);
  4. Is prosecuted separately from the parent application; and
  5. Results in a patent that is independent from the parent application.

The fees for a divisional patent application are the same as for any parent application.    Examination fees must be paid within 18-24 months from the actual filing date of the divisional application. If the fees are not paid within a three-month notice period, the application will be considered to be withdrawn.

Pursuant to standard regulations, the Applicant or his legal representative will be notified of the publication.

The term of a patent issuing off of a divisional application is twenty years from the filing date of the parent application.

This post was written by Lisa Mueller and Namir Sioufi of Saba IP.

Important Amendments made to Indonesia’s Patent Law

November 13, 2020

On November 2, 2020, the Omnibus Law on Job Creation through Law No. 11 of 2020 (Job Creation Law) was passed and became effective immediately.  Chapter VI on the Ease of doing Business, Article 107 of the Job Creation Law amends certain provisions of the Patent Law No. 13 of 2016 (Patent Law).  The main amendments to the Patent Law are directed to: (i) the working requirements; (ii) compulsory licensing; and (iii) simple patents.

Working Requirements

Up until the passage of the Job Creation Law, under Article 20 of the Patent Law, patent holders were required to manufacture a patented product or use a patented process or method in Indonesia within three years from the date of grant or face the possibility of a compulsory license and/or cancellation of a patent.  Now, amended Article 20 provides several ways in which a patent can be worked in Indonesia.  These include:

  1. Product patents: Making, importing or licensing a patented product
  2. Process patents:  Making, licensing, or importing products resulting from a patented process
  3. Method patents: Making, importing or licensing products resulting from the patented method, system and use.

Note:  According to Article 19 of the Patent Law, a “product” patent includes an apparatus, a machine, a composition, a formula, a product produced by a process, a system, etc.  A “process” patent includes a process, a method, or a use.  Although “method” patents were originally included in the definition of “process” patents, “method” patents have now been grouped separately according to the Job Creation Law and are intended to cover a method, a system, and a use.  We expected the Indonesian Government will soon draft and pass a regulation to clarify the definition of “method” to provide a clear understanding of the differences between a “process” and a “method”.

Additionally, patent holders will be able to submit a written request to postpone fulfilment of the working requirement. If approved, compliance with the working requirement may be postponed for a maximum of five years.  It may be possible for patent owners to obtain further postponement beyond the maximum five-year period citing valid reason(s) for the delay.  A request for postponement must be filed within three years from grant of the patent.  Article 45 provide transitional provisions for requesting such postponement. Specifically, any pending request for postponement filed before October 31, 2019 but for which no decision has yet been issued, will be processed according to the previous regulation (Regulation No. 15/2018).  For patents granted under the previous regulation but before the new regulation (Regulation 30) became effective and require a postponement for working, patent holders must file a request for postponement within three years from October 31, 2019, namely, by October 30, 2022.

Compulsory License

Article 82 of the Patent Law has been amended to be consistent with the amendments to Article 20.  Specifically, if an invention is not worked, a third party can file an application for a compulsory license thirty-six months after the date of grant.  Prior to this amendment, a third party could file an application for a compulsory license if the patent owner did not manufacture the product or use a process or method covered by the patent within thirty-six months after grant. As a result of this amendment, patent holders can avoid compulsory licensing by importing a product or licensing a product, process or method.

Simple Patents

In many jurisdictions, simple patents are commonly known as a utility model, petty patent or innovation patents.  Due to an increase in the number of simple patent applications being filed in Indonesia, the Patent Office sought to clarify the scope and distinguish simple patents from patents.  Previously, a simple patent could be granted for a new invention or development of an existing product, process or method that was industrially applicable.  As a result of the Job Creation Law, Article 3 of the Patent Law has been amended to recite that a simple patent can be granted for any invention which is a novel development from an existing product or process having practical uses that can be applied in industry and is “a simple product, a simple process, or a simple method”.  Currently, it is unclear how this additional further definition will affect prosecution of simple patents.

Additional amendments have also been made to accelerate the examination of simple patents.  As a result of these amendments:

  1. A request for substantive examination must be submitted simultaneously at the time of filing of a simple patent.
  2. A simple patent will be published within 14 days of filing. Once published, the application will proceed to substantive examination.
  3. Any opposition during the 14-day publication period will not be considered during substantive examination (suggesting that an opposition will constitute a separate proceeding so as not to delay the start of substantive examination).
  4. A decision to approve or reject a simple patent application is shortened from 12 months to 6 months from the filing date of the application.

Please continue to watch BRICS & Beyond for updates on Indonesia’s patent law.

This post was written by Lisa Mueller and Indah Handayani from Tilleke & Gibbins.

Filing a Divisional Application in Russia – Part 11

November 6, 2020

This is the eleventh 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 ten posts examining divisional practice in Brazil, Mexico, China, India, Argentina, Canada, Thailand, Pakistan, Malaysia and Singapore 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, Divisional Practice – Malaysia and Divisional Practice – Singapore.

Divisional Practice in Russia

In Russia, divisional practice is very flexible.  Specifically, one or more divisional applications can be filed: (1) in response to a lack of unity rejection; and/or (2) at any time for any reason (e.g., voluntary divisionals are permitted).

Time Period for Filing a Divisional Application

A divisional application can be filed at any time:

  1. Up until the date of registering a patent in a parent application. However, as this typically occurs within 2-3 weeks following payment of the grant fee, it is recommendable to file a divisional application before or at the time of paying the grant fee; or
  2. Within 7 months from the date of receipt of a final rejection in a parent application.

Requirements for Filing a Divisional Application

According to Articles 1374 and 1375 of the Russian Civil Code Part IV (“Code”), the requirements for filing a divisional application are as follows:

  1. Submission of a copy of the specification (including the abstract), claims and drawings of the divisional application as well as an entry form indicating the name and address of the Applicant and the inventor(s);
  2. The divisional application cannot include any subject matter not disclosed in the parent application; and
  3. The parent application and the divisional application cannot claim identical subject matter.

More than one divisional application can be filed from a parent application.

Additionally, in accordance with current patent practice in Russia, a divisional application can be filed from a divisional application (i.e., “cascading” divisionals are permitted).  The priority and filing dates of each cascading divisional application will be identical to the priority and filing dates of the very first (original) parent application.

Claims of a Divisional Application

A divisional application may be filed with the claims as originally filed in the parent application or PCT application.  However, the claims of a divisional application filed with the same claims as a parent or PCT application must be amended prior to issuance to ensure that neither the parent or divisional application claim identical subject matter.  In other words, there can be no overlap of claimed subject matter in either the parent and the divisional application.

Double Patenting

Any patent issuing from a parent and a divisional application cannot claim the identical subject matter as this would present a double patenting problem.  In order to determine whether or not double patenting exists, the claims as allowed are examined to determine whether or not identical subject matter is being claimed.  Specifically, claimed subject matter will be recognized as being identical if:

  1.  The independent claims in the parent and divisional application are completely (100%) identical with one another; or
  2. One or more independent claims in the parent or divisional application recite one or more alternatives and the one or more alternatives are identical with one or more alternatives claimed in the parent or (another) divisional application.

If two applications claim identical subject matter, an Examiner will likely to reject the claims for double patenting during the first stage of prosecution in both applications.  In the situation where two applications claiming identical subject matter have the same priority date and are filed by the same Applicant, an Examiner will issue an Office Action setting a period of 12 months for the Applicant to decide which of the two applications should be allowed to proceed to grant (assuming there are no other rejections).  If the Applicant does not respond to the Office Action, both applications will become abandoned.

If two applications claiming identical subject matter are owned by different Applicants, a patent may be issued with respect to only one of these applications provided that the Applicants agree to such an arrangement and execute an agreement to that effect.  The agreement must be concluded within 12 months from issuance of an Office Action raising the issue of the identity of the subject matter being claimed in the two applications.  The term for executing the agreement and submitting it to the Patent Office can be extended for an additional 10 months.  In the absence of an agreement between the Applicants, both applications will be abandoned.

There are no specific regulations that address the situation where identical subject matter is claimed in an issued patent and a pending divisional application owned by different Applicants.  However, the Code contains regulations that address a situation where identical subject matter is claimed in an issued patent and pending divisional application owned by the same Applicant.  In this situation, no Decision of Grant will be issued for the divisional application until the time the issued patent is revoked by the Applicant (owner).

Unfortunately, Examiners do not always check to see whether or not identical subject matter is being claimed in a pending parent and divisional application or an issued patent and pending divisional application, especially if the identical subject matter is being claimed as one or more alternatives.  Therefore, it is possible that multiple patents may issue to the same Applicant (or different Applicants) claiming identical subject matter.  Therefore, it is important for Applicants to be diligent when prosecuting divisional applications in Russia to ensure that the claims being pursued in any divisional application are not identical to any parent or other divisional application owned by the Applicant (or others).

The issuance of two patents claiming identical subject matter can be challenged in the revocation tribunal known as the “Chamber for Patent Disputes”.  A revocation action can be filed by a third party at any time during the term of the patent.  We are not aware of any revocation actions that have been filed on the ground that two patents claim identical subject matter.  In the absence of such case law, we cannot predict the approach the tribunal might take to resolve such an action.

Examination of Divisional Applications

A divisional application is accorded the same filing date as the first parent application but is treated as a new patent filing.  As such, the divisional application:

  1. Is allotted its own (new) application number;
  2. Requires payment of its own filing fees (separate from the filing fees paid in the parent application);
  3. Requires the filing of a request for examination (separate from the filing of a request for examination in the parent application);
  4. Is prosecuted separately from the parent application; and
  5. Results in a patent that is independent from the parent application.

The fees for a divisional patent application are the same as for any parent application.  Additionally, the term of a patent issuing off of a divisional application is twenty years from the filing date of the first (original) parent application.

A divisional application is examined only when a Request for Examination (“Request”) is filed within the prescribed period (namely, thirty six months from the date of filing of the application). If a Request is not filed within time, the application will be considered withdrawn.

This post was written by Lisa Mueller and Vladislav Ugryumov from Gowlings.

 

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.

Europe: Use of “Veggie Burger” is Okay but “Vegan Cheese” is Not

October 25, 2020

Background

In Europe, Regulation (EU) No. 1308/2018 (Regulation) establishes a common organization of markets for agricultural products.  Article 78 of the Regulation states that the terminology and naming conventions (such as definitions, designations, and sales descriptions) for various sectors and products, such as meat and milk and milk products intended for human consumption are provided in Annex VII.  Part III of Annex VII specifically reserves the use of the terms “milk”, “cheese”, “yoghurt”, “butter” or “whey” exclusively to products that contain dairy “milk” (which is defined as “…the normal mammary secretion obtained from one or more milkings without either addition thereto or extraction therefrom”).  However, the Regulation does not contain any provision that reserves the use of the terms “steak”, “sausage”, “escalope”, “burger” or “hamburger” exclusively for products that contain meat.

Amendment 165 and 171

Late in the day on Friday of last week, members of the European Parliament (MEP) cast their final votes on two amendments relating to the use of dairy-like and “meaty” terminology for plant-based products that would have amended certain portions of Parts I and III of Annex VII of the Regulation.  Interestingly, the MEPs took different positions on the two somewhat similar proposals.  Specifically, the MEPs voted against Amendment 165, which would have amended Part I to prohibit terms like “steak”, “sausage”, “escalope”, “burger” or “hamburger” from use with plant-based (vegetarian and vegan) products.  However, the MEPs voted for Amendment 171, which amends Part III to ban terms like “vegan cheese” as well as “butter-style”, “yogurt-style” and “cheese-style” for dairy-free products.  Thus, as a result, plant-based alternatives will not be able to carry any dairy-related terms.

The vote on Amendment 171 follows a 2017 ruling from the European Court of Justice that banned the use of dairy terms like “milk”, “butter”, “cheese” and “yogurt” for purely plant based products (e.g., tofu) with the exception of coconut milk, peanut butter, almond milk and ice cream.  Not surprisingly, the European Dairy Association lauded the vote stating that “Non-dairy products cannot hijack our dairy terms and well-deserved reputation of excellence in milk and dairy.”  Opponents to Amendment 171 point out that the ban appears to contradict the European Green Deal objectives and the Farm-to-Fork Strategy which both aim to create healthier and more sustainable food systems.

It will be fascinating to watch the implementation of Amendment 171 in the EU.  Although the purpose of Amendment 171 is to prevent customer confusion, by voting against Amendment 165, it seems likely that some customer confusion will result.  Only time will tell.

This post was written by Lisa Mueller

Change in Data Exclusivity for Pharmaceutical Products in the United Arab Emirates

October 19, 2020

On September 21, 2020, the United Arab Emirates (UAE) Ministry of Health & Prevention (MOHAP) issued Ministerial Decree 321 of 2020 (Decree 321) relating to the use of clinical and preclinical data and information regarding innovative pharmaceutical products registered in the UAE.

Decree 321 sets a data exclusivity period of 8 years from the date of marketing approval (Data Exclusivity Period) for innovative pharmaceutical products which contain an active pharmaceutical ingredient for which no other pharmaceutical product has obtained a marketing license in the UAE.  According to Decree 321, generic and biosimilar companies can apply for marketing approval within the last 2 years of the end of the Data Exclusivity Period if evidence is provided that the innovative pharmaceutical product is not protected by any patent in the UAE.  However, there is an exception to the 8-year Data Exclusivity Period.  Specifically, for the purposes of protecting public health or other reasons to be decided on a case-by-case basis, a generic or biosimilar company can obtain a marketing license during the Data Exclusivity Period.

Decree 321 will apply to innovator pharmaceutical products that obtain a marketing license from the MOHAP after its publication.  Publication is expected within the next 6 months.  Innovator pharmaceutical products which have obtained a marketing license prior to the publication of Decree 321 will be subject to Ministerial Decree 404 of 2000 (Decree 404).  Under Decree 404, the MOHAP will deny marketing approval for a product that infringes a patent that exists either in the UAE or in the country of origin from which the product has been imported.  It is important to note that under Decree 321, the requirement for a generic or biosimilar company to provide evidence that the innovative pharmaceutical product is not protected by any patent is limited solely to the UAE and not the country of origin.

Decree 321 seeks to provide a balance for innovator and generic/biosimilar pharmaceutical companies by providing a strong intellectual property system for innovators and increased transparency of the rules for obtaining approval for follow-on products for generic and biosimilar companies.  Given this change in the law, it will be important for innovator pharmaceutical companies to obtain patent protection for their products in the UAE since reliance on the country of origin will no longer be possible once Degree 321 comes into effect.

Please continue to watch BRICS & Beyond for updates on patenting life science inventions in the UAE.

This post was written by Lisa Mueller and Namir Sioufi of Saba IP.

Are You Ready for China’s Patent Linkage System?

October 16, 2020

On September 11, 2020, the National Medical Products Administration (NMPA) and the China National Intellectual Property Administration (CNIPA) issued the “Implementing Measures for Drug Patent Dispute Early Resolution Mechanism (Trial for Implementation)” (Draft Measures).  The Draft Measures establish a framework for a patent linkage system in China.  The NMPA and CNIPA have invited public comment on the Draft Measures until October 25, 2020.  Once finalized, this new patent linkage system will present challenges and opportunities for both innovator and generic drug companies doing business in China.

Establishment of a Chinese “Orange Book”

Similar to the Orange Book in the U.S., the Draft Measures propose to establish an information disclosure platform for marketing authorization holders (MAH) to list drug-related patent information.  This platform will be known as the Approval Drug Patent Registration Platform (Platform).  Patents eligible for listing on the Platform include active pharmaceutical ingredients (APIs), compositions containing APIs, methods of use, biologics (patents containing specific sequence information can be listed (e.g., SEQ ID NOS. covering the variable heavy and/or light chain and/or complementary determining regions (CDRs)) and Traditional Chinese Medicine (patents related to compositions, extracts and methods of use of Traditional Chinese Medicine).

The Draft Measures provide time limits and procedures for submitting and updating patent listing information in the Platform.  These time limits are:  (1) if a patent has already been granted, patent listing information may be submitted with a new drug application (NDA); (b) if the patent is newly granted and a NDA is pending, the patent listing information may be submitted within 30 days of receiving notice of patent grant; (c) if a NDA has already been approved, the Draft Measures do not specify a deadline for submitting patent information; and (d) for any patents already listed, any updates should be submitted within 30 days of any changes to the patent listing information.  Patents are not eligible for listing if an NDA has not been filed or if a drug has not yet received marketing authorization (in China).  If a patent is not listed on the Platform, it will not be eligible for patent linkage protection.

Information that will be included in a patent listing includes:  the drug name, patent number, patent type, patent status, patentee, MAH, patent expiry date, and contact information.

According to the Draft Measures, if an NDA has already been approved, the MAH can list and update the patent information directly on the Platform without NMPA review.  Nonetheless, an NDA applicant or the MAH is responsible for the truthfulness, accuracy, and completeness of the patent listing information.  Penalties will be imposed for intentionally listing unrelated patents, including prohibiting the applicant from filing application for the same drug again for one year.

Generic Patent Certifications

A generic drug applicant filing for marketing authorization will be required to provide one or more certifications with respect to any patent listed on the Platform and provide supporting evidence for its such certification(s).  Similar to the U.S. Hatch-Waxman framework, the certifications fall into four categories.  These categories are:

Certification Categories

Drug Patent Information

I

 No innovator drug patent information is listed on the Platform.

II

 The innovator drug patent information listed on the Platform has expired or has been invalidated.

III

 Innovator drug patent information is listed on the Platform; however, the generic drug applicant certifies that the generic drug will not be marketed before the expiration date of the patent.

IV

 Innovator drug patent information is listed on the Platform, but the generic drug applicant believes that the patent is invalid or is not infringed

A generic drug applicant and its requisite patent certification will be publicly disclosed on the information platform of the Center for Drug Evaluation (CDE).  However, unlike the U.S. Hatch-Waxman system, a generic drug applicant has no obligation to notify an innovator drug MAH of its application filing and patent certification(s).  Since the Draft Measures do not provide or require any notice be provided to the innovator, innovator drug MAHs should closely monitor the CDE information disclosure in order to avoid missing the deadline for filing an opposition (discussed in more detail below).

Generic drug applications containing a category I and/or II certifications can be approved immediately.  Generic drug applications containing a category III certification, can also be approved immediately, provided that the generic drug applicant includes a notation that the product will launch only after patent expiry.

Generic drug applications containing a category IV certification are subject to an opposition period. Specifically, an innovator drug MAH/patentee can oppose an application containing a category IV certification within 45 days from the date of the CDE public disclosure.  Such an opposition can be filed with a People’s Court or with the CNIPA.  If the generic drug application is for a small molecule, the NMPA will set a 9-month waiting period before approving the generic drug application, beginning from the date the case is accepted by the People’s Court or the CNIPA.  Although the NMPA will wait to approve the generic drug application, the CDE will not stop its technical review during this waiting period.  If the innovator drug MAH/patentee cannot obtain a favorable court judgment or decision from the CNIPA within this 9-month period, the NMPA can grant marketing authorization to the generic application upon expiration of the 9-month period.  Once this occurs, the marketing authorization will be irrevocable.  Nonetheless, a patentee may still sue a generic manufacturer for patent infringement; however, as mentioned, the marketing authorization will not be withdrawn.

Biosimilar applications will not be subject to the patent linkage system.  The NMPA can proceed with the technical review and marketing authorization upon receiving biosimilar applications. In order to delay the entry of a biosimilar, the innovator drug MAH/patentee will need to file an infringement action with the court of CNIPA within 45 days after the CDE’s publication of the biosimilar application, and obtain a favorable decision before the NMPA’s issuance of the marketing authorization.  The NMPA will then convert the marketing authorization into a conditional approval effective only after the relevant patents expire.

Marketing Exclusivity for First Generic Applicants

The first generic applicant filing a category IV certification and receiving the marketing authorization will be granted a marketing exclusivity period for 12 months from the date of marketing authorization.  Additionally, this exclusivity will not exceed the originator’s patent term.  During this exclusivity period, the NMPA will not approve any other generic applications for the same drug; however, the agency can accept and review generic applications.

Patent Term Extension

On July 3, 2020, amendments were proposed to China’s patent law to add patent term extension to compensate for the time that the NMPA and CDE spend in reviewing and approving a marketing authorization for a new drug.  Under the proposal, the maximum extension will not exceed five years, and the total patent term, after adding the extension, will not exceed 14 years at the time marketing authorization is received.

Data and Marketing Exclusivity

Practically speaking, data or market exclusivity is not available for an innovator or improved drug that is manufactured (outside of China) and imported into China.  In other words, a generic drug application can be filed and approved in China as soon as a foreign innovative or improved drug is approved in or outside of China and the generic drug can be commercially manufactured and launched provided there are no patents protecting the drug in China.

However, market exclusivity is available in China for innovator or improved drugs that are manufactured in China.  When such a drug is approved in China, it will be placed under a “New Drug Monitoring Period” which provides a period of up to 5 years during which the NMPA will not grant approval of a generic version of the drug prior to the expiration of the New Drug monitoring Period.

However, in 2019, the “Implementation Regulations of the Drug Administration Law (2019)” (the 2019 Regulations) were released which provide that a drug with novel API will be granted a 6-year data exclusivity period. However, such data exclusivity has not yet become available for drugs with novel APIs because no legislation was enacted to implement the 2019 Regulations.  Moreover, the newly revised “Administrative Measures for Drug Registration (2020)” do not contain any provisions relating to the data exclusivity period, and the 2019 Regulations are now pending further amendment. In view of this, the future of the data exclusivity system remains unclear and needs to be clarified by future legislation.

Timing and Next Steps

In terms of timing, it is likely that the Draft Measures will come into full force and effect next year, although the exact timing is unclear.  The fourth amendment to Chinese Patent Law (Patent Law), which will provide the patent term extension and patent linkage system, is currently under final review and is likely to be promulgated by the end of the month and formally take effect in early 2021.  Also, the “Implementing Rules of the Patent Law” (Patent Implementation Rules) are pending and are expected to come into force later.  Because the Patent Law typically only sets out a high-level framework, a detailed implementing guidance will be provided under the corresponding Patent Implementation Rules. Therefore, the patent term extension system will only be implemented after the Patent Implementation Rules becomes effective.  It is uncertain how long this might take.

Finally, the Supreme People’s Court plans to issue a judicial interpretation on patent linkage system by the end of 2020. As such, we do not expect significant changes to the Draft Measures before its formal release, though some details are still under discussions, such as the period of marketing exclusivity.

Please continue to watch BRICS & Beyond for updates on China’s proposed patent linkage system, patent term extension and data and marketing exclusivity provisions.

This post was written by Lisa Mueller and Helen Cheng and Samuel Zhang of Zhong Lun Law Firm.

Data and Marketing Exclusivity in Russia

October 2, 2020

Article 13 of the Law “On Circulation of Medicines” (the Law) in Russia provides a list of medicines that are subject to state registration (namely, the grant of marketing authorization (MA)) by the Ministry of Health (MoH)), namely:

  1. Medicines that have not (previously) been introduced into circulation in Russia;
  2. Previously approved medicines produced in other (e.g., new) medical forms (in accordance with a list of names of such medical forms (e.g., a new dosage form that justifies its clinical relevance and efficacy)); and
  3. New combinations of previously approved medicines.

The Law also specifically defines the terms “reference medicine”, “generic medicine” and “biosimilar medicine”. Thus, under 1) above, medicines that are subject to state registration include medicines having the following definitions:

Reference medicine:  A medicine:  (i) which has first been approved in Russia; (ii) whose quality, efficacy and safety have been confirmed by the results of pre-clinical and clinical trials; and (iii) which is used for assessment of bioequivalent or therapeutic equivalency, quality, efficacy and safety of a generic or biosimilar medicine;

Generic medicine: A medicine (i) which contains the identical composition (either in terms of quality or quantity) of active ingredients in the same dosage form as the reference medicine; and (ii) the bioequivalent or therapeutic equivalency of which has been confirmed by relevant studies; and

Biosimilar medicine: A biological medicine having similar quality, quantity and safety parameters as a reference biological medicine having the same dosage form and mode of administration.

The Law provides data exclusivity in Articles 18.20 and 18.21 and market exclusivity in Article 18.18.  More specifically, these Articles recite:

Article 18.20: “Application for state registration of a generic medicine for medical use can be filed with an authorized federal executive body in charge of medicines state registration upon expiry of the four-year term from the date of the state registration of the reference medicine in the Russian Federation.”

Article 18.21: “Application on the state registration of biosimilar medicine can be filed with an authorized federal executive body in charge of medicines state registration upon expiry of the three-year term from the date of the state registration of the reference medicine in the Russian Federation.”

 Article 18.18: “Use for commercial purposes of the information on the results of medicine preclinical and clinical studies provided by an applicant for registration of the medicine is not permitted without the applicant’s agreement during 6 years from the date of the medicine state registration of the reference medicine.”

As recited in the Articles 18.20 and 18.21, the data exclusivity period is four years from the date of marketing authorization of the reference medicine for small molecules and three  years for large molecules (e.g., biologics). During the four (for small molecules) and three (for large molecule) data exclusivity period, the MoH will not accept a generic or biosimilar application.  A reference medicine automatically receives data exclusivity as a result of it being the first MA approved by the MoH.  As such, there is no requirement for registering for data exclusivity rights in Russia.   In fact, based on our experience, data exclusivity for reference medicines appears to be working well in Russia.

Furthermore, Article 18.18 establishes an additional marketing exclusivity period of two years for small molecules and three years for large molecules thus providing for a total data and marketing exclusivity period of six years for both small and large molecules.  However, because Article 18.18 is vague and somewhat confusing, there is nothing in this Article that prevents or prohibits the MoH from approving a generic or biosimilar application within the 2 or 3-year marketing exclusivity period.  Therefore, a generic or biosimilar could launch a product at risk prior to the end of the 6-year data and marketing exclusivity period.  If a generic or biosimilar did in fact launch before the end of the 6-year period, the reference product holder (e.g., innovator) would be able to sue the generic/biosimilar for launching before the end of the 6-year period.  To date, this scenario has not yet occurred in Russia, but is a possibility.

Please continue to watch BRICS & Beyond for updates on data and marketing exclusivity in Russia.

This post was written by Lisa Mueller and Vladislav Ugryumov of Gowlings.