Protecting biopharmaceutical inventions in Russia and Eurasia

As in most European countries – where the respective national patent system coexists with a wider European system – the national patent system in Russia coexists with the Eurasian patent system, which comprises eight contracting states. The legislative basis of the Russian patent system is the Civil Code. The Eurasian patent system is based on the Eurasian Patent Convention (1994), which includes (in addition to Russia) seven members of the Commonwealth of Independent States: Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Tajikistan and Turkmenistan.

Under the Eurasian patent system, a single application is filed with the Eurasian Patent Organisation (EAPO), which grants a patent that is automatically valid in all contracting states, as long as the maintenance fees in each state are paid. The Eurasian patent system applies only to inventions and its official language is Russian. Both patent systems have a wide range of features, including:

• substantive examination of the patent application (in which industrial applicability, novelty and inventive step are evaluated);
• appeal and invalidation procedures;
• the possibility of enforcing patents in court;
• participation in the Patent Prosecution Highway;
• patent term extension; and
• divisional application filing.

When seeking to protect inventions in Russia, the choice between the two patent systems should be informed by a number of factors, including business and marketing interests and costs.

Patentable biopharmaceutical inventions

Both the Russian and Eurasian patent systems provide protection for biopharmaceutical subject matter, including:

• products, such as compounds, nucleic acids, proteins, cells, cell lines, strains, pharmaceutical compositions, transgenic plants and animals; and
• use and method claims, such as treatment methods.

The two systems both stipulate that the following are unpatentable:

• inventions that contravene public interests or principles of humanity and morality;
• plant varieties; and
• animal breeds.

In addition, the Russian legislation states that the following are unpatentable:

• methods of cloning humans and human clones;
• methods of modifying the genetic integrity of human germline cells; and
• uses of human embryos for industrial and commercial purposes.

Recent amendments to Russian legislation

A number of amendments to the Russian patent legislation have been adopted in recent years, two of which are particularly relevant to the protection of biopharmaceutical inventions.

Sufficiency of disclosure

Although the Russian patent legislation previously included a requirement that the specification of an application disclose the invention to a degree sufficient for implementing the invention, the ‘sufficiency of disclosure’ requirement – as a matter to assess during substantive examination and a legal reason to reject a patent application or invalidate a patent – was introduced into the Civil Code only in 2014. In the context of protecting biopharmaceutical inventions, the Russian Patent Office (Rospatent) has traditionally given great importance to matters concerning the amount of disclosure and support in the specification for inventions claimed. Before this amendment entered into force, evaluation of such matters fell under the evaluation of industrial applicability. Since the amendments are relatively new, there is still little guidance from Rospatent as to how it interprets and enforces the new legislation – in particular, how it distinguishes between matters relating to sufficiency of disclosure and those relating to industrial applicability. In any case, questions concerning the necessary extent of disclosure and support in an application will not diminish in importance any time soon, regardless of the part of the legislation to which they are subject.

Similar sufficiency of disclosure requirements were recently introduced to the Eurasian patent legislation.

Supplementary patents in patent term extension procedure

Pursuant to the Russian legislation, with regard to patents for medicaments, pesticides and agrochemicals that require marketing authorisation, if the term between the filing date and the date of obtaining first marketing authorisation is more than five years, the patent term (20 years) may be extended by that term minus five years on the patent owner’s request. The patent term extension cannot exceed five years. Previously, extensions were granted in the form of an enclosure to the actual patent, indicating the independent claims of the patent that concerned the product subject to the first marketing authorisation; said independent claims were extended in full. In accordance with the recent Civil Code amendments, a patent term extension is granted in the form of a supplementary patent with its own set of claims characterising the product that is subject to the marketing authorisation. In order to enforce the new legislation, the Administrative Regulations for Patent Term Extension for Inventions and the Procedure for Issuance and Operation of Supplementary Patents for Inventions and Extension of the Validity Term of Patents for Inventions entered into force in 2016.

Under the Eurasian patent system, the validity term of a Eurasian patent (20 years) may be extended in all contracting states except Tajikistan and Kyrgyzstan. An extension application must be filed with the EAPO within the term stipulated by the legislation of the corresponding state. The patent term extension procedure, terms and necessary documents are stipulated in the legislation of each contracting state. Thus, the validity term of a Eurasian patent may be extended by different terms in different states, or extended in some states but not in others.

Practical considerations during substantive examination

Industrial applicability

Applicants are frequently surprised by Rospatent’s approach to evaluating compliance with the industrial applicability requirement for patent grant. Under this approach, the possibility of using the invention in any field is assessed on the basis of the scope of the available experimental data; the examiner considers the possibility of using the invention in any field by seeing whether and to what extent the claimed invention is ‘confirmed’ by the experimental data. That is, the application materials must confirm implementation of the claimed invention through realisation of the invention’s purpose. Evaluation of this matter is part of the evaluation of industrial applicability. Since in most cases the implementation of a claimed invention can be confirmed only by corresponding experimental data, in practice, compliance with this requirement is confirmed by looking at whether the scope of the invention as claimed in each claim is justifiable by the available experimental data plus knowledge of the prior art (which may allow for the scope of the claim to be broadened beyond that of the experimental data). Usually, the examiner raises an industrial applicability objection based on a broadly worded claim feature whose scope goes beyond that which seems justifiable by the available experimental data. This explains why claim breadth has traditionally been linked to the industrial applicability requirement: an ‘illegitimately’ broad claim or feature is seen as casting doubt on the possibility of implementing the invention for each combination of features within the scope of the claim. For example, the scope of the claim may encompass doubtful or unrealistic combinations of parameters, in which case the invention may not work. This makes the invention inapplicable in industry. In response to an industrial applicability objection, the applicant is expected to justify the chosen scope of the claims or amend them accordingly. Submission of post-priority or post-filing experimental data to confirm the original or desirable scope of the claims is allowed. Thus, contrary to the hopes of some applicants, simple indication of the passage in the specification that forms the language basis for the feature in question is insufficient to address the industrial applicability objection to a broadly worded claim. The takeaway is that it is always better if the claims are reasonably based on the experimental data.

In contrast, the EAPO is largely indifferent to the industrial applicability matter per se. However, objections to an inconsistency between the narrow scope of the available experimental data and the broad scope of the claims are not unusual.

Indication of purpose

Under the Russian legislation, a patent claim directed to virtually any biopharmaceutical product (except for chemical compounds characterised by full structure) must recite a specific purpose of the subject matter claimed. This includes macromolecules, kits, cells, devices, compositions and transgenic organisms. In particular, in cases where oligonucleotides and polypeptides (proteins) are claimed, a biological function (a type of activity, biological property) – which must be indicated for such subject matter – is considered sufficient indication of a purpose (eg, “An antibody against X, comprising…” or “A polynucleotide encoding the protein of claim 1…”). Claims such as “A composition comprising…” or “A method comprising…” will be rejected for lack of purpose. A lack of purpose recited in the claim is interpreted as the possibility of using the claimed subject matter for any possible purpose, which is formally rejected as not completely supported by the specification. Arguing against the requirement to recite a purpose is futile. Naturally, the scope of purpose recited in a claim may be a matter of dispute. For example, the preamble “A pharmaceutical composition comprising…” does contain a mandatory purpose, which is “pharmaceutical” (ie, for medical treatment); however, wording the purpose in such a broad manner may be conceivable only if the composition is useful in the treatment of many different kinds of disease or condition. Since this is never the case, the Russian examiner will require further specification of the purpose – for example, “A pharmaceutical composition for the treatment of colon cancer…” or “A pharmaceutical composition for inhibiting enzyme X…”. The purpose of a pharmaceutical composition may be recited in the claim in the form of not only a therapeutic application, but also a biological activity. The same applies to therapeutic method claims, which may be “a method of treatment” or “a method of exerting some biological activity”. Claims such as “Use of… in medicine” or “A diagnostic method comprising…” will also be rejected as reciting too broad a purpose.

Antibody subject matter

This is perhaps the most popular kind of protein to claim as an invention. Regarding characterisation of a subject matter directed to a polypeptide (or nucleic acid), the Russian legislation is not very specific, simply requiring recitation of appropriate nucleotide/amino acid sequences (if they are established) or physicochemical and other characteristics that allow for distinguishing the claimed polypeptide from others. If the claimed protein is an antibody (immunoglobulin), the minimal sequence-wise characterisation expected by Rospatent corresponds to recitation of the six complementarity-determining region (CDR) sequences (three light chain and three heavy chain CDR sequences) plus a purpose of the antibody, which may be specific binding to the antigen in question. If no sequences of the antibody are established, in accordance with the aforementioned requirement, the antibody should be characterised with at least one physicochemical feature (eg, a binding constant) and at least one other feature (eg, a method of production). Therefore, contrary to the expectations of some applicants, characterisation of an antibody simply through the epitope that it recognises, another antibody with which it competes for binding to the same antigen or one, two, three, four or five CDR sequences will not be accepted as sufficient. This approach is also used by the EAPO.

Human embryos

Russian legislation does not allow for the patenting of inventions that involve use of human embryos. An absolute taboo is inventions involving the destruction of human embryos. The examiner may also request removal from the specification and claims of any embodiments and experimental data corresponding to use of human embryos. Sometimes, if it is not sufficiently clear from the application materials that the cells used in the invention cannot be human embryonic cells, the applicant may be requested to add to the claim a disclaimer such as “wherein the cell is not a human embryonic cell”.