Category: Russia

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 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.

 

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.

USTR 2018 Special 301 Report: Pharmaceutical and Medical Device Innovation and Market Access

May 11, 2018

Last month, the Office of the United States Trade Representative (USTR) released its 2018 Special 301 Report (the Report), identifying trading partners that do not adequately or effectively protect and enforce intellectual property (IP) rights or otherwise deny market access to U.S. innovators and creators that rely on protection of their IP rights.  The Report calls on U.S. trading partners to address IP-related challenges with a special focus on the countries identified on the Watch List and Priority Watch List.

Countries identified on the Watch List are:

  • Barbados
  • Bolivia
  • Brazil
  • Costa Rica
  • Dominican Republic
  • Ecuador
  • Egypt
  • Greece
  • Guatemala
  • Jamaica
  • Lebanon
  • Mexico
  • Pakistan
  • Peru
  • Romania
  • Saudi Arabia
  • Switzerland
  • Tajikistan
  • Thailand
  • Turkey
  • Turkmenistan
  • United Arab Emirates
  • Uzbekistan
  • Vietnam

Countries identified on the Priority Watch List are:

  • Algeria
  • Argentina
  • Canada
  • Chile
  • China
  • Colombia
  • India
  • Indonesia
  • Kuwait
  • Russia
  • Ukraine
  • Venezuela

With respect to pharmaceutical and medical device innovation and market access, the Report details the efforts of the USTR over the last year to engage with trading partners to ensure that U.S. IP owners have a full and fair opportunity to use and profit from their IP, including by the promotion of transparent and fair pricing and reimbursement systems.  In addition to ensuring that trading partners have robust IP systems, the USTR has sought to reduce market access barriers to pharmaceutical products and medical devices, including measures that discriminated against U.S. companies, were not adequately transparent or did not offer sufficient opportunity for meaningful stakeholder engagement.  Additionally, the USTR pressed trading partners to appropriately recognize the value of innovative medicines and medical devices so that these partners can fairly contribute their share to the research and development of new treatments and cures.  USTR activities with respect to specific countries are described in more detail below:

  • Canada and Mexico: Sought strong IP provisions during the renegotiation and modernization of the North American Free Trade Agreement (NAFTA) including seeking provisions that ensure the national-level government processes for the listing and reimbursement of pharmaceutical products and medical devices are transparent, provide procedural fairness, are nondiscriminatory and provide full market access for U.S. products.
  • South Korea: Sought to obtain, through negotiations, improvement and better implementation by South Korea of the U.S.-Korea Tree Trade Agreement (KORUS FTA).  Specifically, the USTR sought to obtain Korea’s commitment to better implement its KORUS FTA commitments to provide fair and non-discriminatory treatment of pharmaceutical products, including imported products, under certain medical pricing and reimbursement programs.
  • Japan: Engaged with Japan in the context of the U.S.-Japan Economic Dialogue to ensure transparency and fairness and address other concerns with respect to pharmaceutical and medical devices pricing and reimbursement policies.
  • China: Pressed China on a range of issues that impact and affect the pharmaceutical sector.  These included: providing for effective protection against unfair commercial use, unauthorized disclosure of test and other data generated to obtain marketing approval for pharmaceutical products, as well as expediting the implementation of an effective mechanism for the early resolution of potential patent disputes.
  • India: Engaged with India to secure meaningful IP reforms on a number of longstanding issues. These issues included:  criteria for patentability and compulsory licensing as well as protection against unfair commercial use, as well as unauthorized disclosure of test or other data generated to obtain marketing approval for pharmaceutical products.
  • Indonesia: Engaged Indonesia to resolve a number of concerns regarding revisions to Indonesia’s patent law. These revisions included:  criteria for patentability, local manufacturing and use requirements and the grounds and procedures for issuing compulsory licenses.
  • Argentina: Engaged Argentina with respect to concerns regarding the scope of patentable subject matter and effective protection against unfair commercial use, as well as unauthorized disclosure of undisclosed test or other data generated to obtain marketing approval for pharmaceutical and agricultural chemical products.
  • Saudi Arabia: Engaged Saudi Arabia regarding its protection and enforcement of patents and effective protection against commercial use as well as the unauthorized disclosure of undisclosed test or other data generated to obtain marketing approval for pharmaceutical products.
  • United Arab Emirates: Sought confirmation that the United Arab Emirates will continue to protect pharmaceuticals through local procedures and the Gulf Cooperation Council (GCC) patent system.

The Report also highlights concerns regarding IP protection and enforcement and market access barriers affecting U.S. entities that rely on IP protection, including those in the pharmaceutical and medical device industries.  Examples of such barriers by trading partners include:

  • Unfair issuance, threat of issuance, or the encouragement of others to issue compulsory licenses. Trading partners being monitored with respect to such activities include Chile, Colombia, El Salvador, India and Malaysia.
  • Employment of measures that are discriminatory, nontransparent, or otherwise trade-restrictive that have the potential to hinder market access in the pharmaceutical and medical device sectors and which might potentially result in higher product costs. Examples include unreasonable regulatory approval delays and non-transparent reimbursement policies (such as pricing and reimbursement systems which are non-market-based or that do not otherwise appropriately recognize the value of innovative medicines and medical devices).  Trading partners being monitored with respect to such activities include Algeria, Australia, Canada, Japan, Korea, Turkey and New Zealand.

In our next few posts, we will examine in detail the USTR’s findings with the countries on the Priority Watch List.

This post was written by Lisa Mueller.