Old and new possibilities for revocation of evergreen patents

Originally published in Patent Lawyer Magazine

An evergreen patent can otherwise be called a constantly renewable patent, that means “obtained by artificial extension of exclusive rights”. The pharmaceutical industry is most often interested in obtaining such patents which associated with lengthy and expensive research. Since the patent protection provided by such patents lasts 20-25 years, large pharmaceutical companies often do not have time to recoup their investments, and are forced to obtain secondary patents for crystalline forms of a known active drug, substances that are the basis of a medicinal product, pharmaceutical compositions, new finished dosage forms, more effective dosages and modes of administration of pharmaceutical compositions, the use of known compounds or pharmaceutical compositions for a new purpose, etc.

In this regard, companies specializing in the production of generics cannot begin to release cheaper and more accessible drugs on the market. Since the monopoly of the originating companies lasts “forever”, they are forced to challenge the legality of the issuance of such patents in the Chamber of Patent Disputes or in the court.

Let's consider the grounds for recognizing a patent for an invention as invalid in whole or in part, according to Art. 1398 of Civil Code of the Russian Federation.

A patent for an invention, utility model or industrial design may be declared invalid in whole or in part in Rospatent:

• the invention does not comply with the conditions of patentability;
• non-compliance of the application documents for an invention with the requirement of disclosing the essence of the invention, with completeness sufficient for the implementation of the invention;
• the presence in the claims of the invention of features that were absent on the date of filing the application in the description of the invention and in the claims, if it was presented on the date of filing the application;
• the presence of several applications for identical inventions having the same priority date, in violation of the conditions: if during the examination it is established that different applicants have filed applications for identical inventions, and these applications have the same priority date, the patent for the invention may be issued only according to one of such applications to a person determined by agreement between the applicants.

Also in the Intellectual Rights Court:

• if the indicated author or patent holder is not as such.

Based on the first reason, for the possibility of revocation of a patent, an international patent information search is necessary to identify sources that disclose the claimed solution before its priority date. The analysis of the identified documents allows to draw conclusions on the non-compliance with which condition of patentability (“novelty” or “inventive step”) these sources can be opposed. To assess compliance with “industrial applicability”, the presence of a technical result, as well as means and methods confirming the possibility of its implementation, is checked. In addition, the content of the application and the revoked patent is analyzed in detail, the availability of examples and experimental data confirming the achievement of the declared technical result is assessed.

The features of the claim are compared with the features disclosed in the description for challenge on the third ground. Moreover, in the case of “evergreen patents”, when one protects a slightly “narrower” solution compared to the previously patented one, prior applications of the same authors and applicants are analyzed for challenge, subject to non-compliance with the “author’s benefit” (6 months from the date of disclosure).

The most important thing is to establish the connection between the chain of “evergreen patents” and make sure that a narrower solution has not been fully explored by the developer, which is where “gaps” in the sufficiency of disclosure often arise. In general, the Eurasian patent legislation, which is generally harmonized with the legislation of the Russian Federation, proceeds from the same approach.

Therefore, the task was to limit the issuance of “evergreen patents”, leaving them only for those drugs whose properties were previously unknown, which would make it possible to take advantage of the experience of other states to achieve technological sovereignty in the pharmaceutical industry.

In April 2020, amendments were made to the Rules for the Consideration and Resolution of Administrative Disputes, which allow the presentation of additional arguments and additional supporting documents and materials as part of the consideration of objections, including the declaration of new grounds for annulment that were not initially stated when filing objections. These changes have made it possible to reconsider approaches to the revocation of evergreen patents; now the proceedings can last quite a long time until the person who filed the objection runs out of arguments and grounds. This new approach increases the chances of success, since by presenting additional arguments and documents, the objector has the opportunity to correct mistakes made in his original strategy.

Amendments to the Invention Rules dated March 31, 2021 allowed new strategies to be applied to the revocation of evergreen patents.

Now, any solution that is illegal to grant a patent for non-compliance with the condition of patentability "inventive step" falls under suspicion of unlawful grant of a patent for non-compliance with the condition of patentability "inventive step". These solutions may be:

• the form of a known chemical compound (isomer, stereoisomer, enantiomer, amorphous or crystalline form);
• its derivative (salt, solvate, hydrate, complex compound or ether);
• a compound that does not exhibit new properties in comparison with a known compound in qualitative or quantitative terms that are not obvious to a specialist from the prior art.

If a certain form or derivative of a known chemical compound exhibits biological activity useful for the prevention and/or treatment of certain diseases in humans or animals, the following information should be provided:

• indicating the influence of this form or derivative on the etiopathogenesis of the disease or on the condition of the body;
• about the connection with them of the diagnostic factor;
• about reliable data confirming the suitability of a certain form or derivative of a known chemical compound, obtained, in particular, in an experiment on adequate models.

It is worth noting that changes to the Rules were introduced in 2021, and today there are many “evergreen patents” obtained in an earlier period to which these rules do not apply. In practice of 2021-2022, when considering objections in the Chamber of Patent Disputes, it was noticed that the panel willingly takes into account arguments regarding the absence in the application description of: reliable experimental data obtained on adequate models confirming the suitability of a certain form or derivative of a known chemical compound for prevention, diagnosis and/or treatment of the specified disease or condition, including if the compound is a salt, ester, enantiomeric or crystalline form of a previously patented compound, etc.

Rospatent is skeptical about solutions aimed at protecting compounds that do not exhibit new properties in comparison with a known compound in qualitative or quantitative terms, which have not been specifically obtained and studied.

Therefore, when filing objections to invalidate patents for isomers, stereoisomers, enantiomers, amorphous or crystalline forms, salts, solvates, hydrates, esters of previously patented biologically active compounds, first of all, you need to focus on a comparative analysis of how different the description of the new application is from the description of the previous one (earlier in the chain of “evergreen patents”), check all the patents received by the same authors on this topic, including international applications, assess whether this derivative or a new form of the compound was really specially studied and investigated, whether the results were obtained research data on adequate models provide specific indicators confirming improved properties, and if not, then there is every chance to prove that this patent was issued illegally.

Thus, tightening the requirements for patent applications will not only prevent the creation of unwarranted evergreen patents in the future, but also provide a clear picture of which patents do not have the right to evergreen in the past.