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:
- 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;
- 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.;
- A notarized copy of the first marketing authorization issued by the local Health Authority; and
- 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:
- 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.
- 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:
- Did the patent claim describe the API of the medicinal product under the marketing authorization?
- Did the patent claim describe a combination or group of combinations within a single chemical structure?
- 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?
- 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?
- 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?
- 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.