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An intervention by Russia’s IP ombudsman seeks to solve the validity issue over secondary patents, but is it needed, asks Maxim Stobolev of Rouse.
The Russian IP ombudsman Anatoly Semenov has written to the Russian lower house, the State Duma, drawing its attention to the increasing number of patent conflicts among pharmaceutical manufacturers in Russia and urged the Duma to legislate to address the issue.
According to Semenov, there are no clear-cut criteria for assessing the validity of so-called ‘secondary patents’ seeking protection that extends beyond the original active ingredient. As a result, foreign companies try various means to extend patent protection by patenting some new aspects thereof. They often succeed, despite such new patents being of questionable validity.
The Russian Federal Service for IP (Rospatent) approves more than 75% of patent applications, whereas in other countries it is only 50%. Thus, if no measures are taken, foreign companies will be obtaining more and more new patents for known drugs which they can then use to prevent Russian generics companies producing them. This could quickly lead to the bankruptcy of a number of Russian pharmaceutical companies, many of which are generics manufacturers rather than researchers or innovators.
A Rospatent spokesman has acknowledged the problem and said that some amendments to the legislation, such as tightening the conditions for granting patents for certain drugs, are already being prepared.
What prompted Semenov’s letter was a recent dispute between the Russian company Pharmasintez and the Argentinian pharmaceutical company Tuteur relating to the cancer drug, capecitabin.
The original drug, marketed under the brand name Xeloda, was developed by the Swiss company Roche and is now off-patent. Tuteur owns Eurasian patent No. 18867 for a method for producing it. The Pharmasintez analogue of the drug had been developed and passed clinical trials before Tuteur filed its Eurasian patent application. However, in November 2018 Tuteur filed a suit against Pharmasintez (as well as a few other Russian pharmaceutical companies also producing the drug) claiming infringement of the Tuteur patent.
Under the Eurasian patent convention the following acts shall constitute an infringement of the patent owner’s exclusive right:
The making, use, importing, offering for sale, sale or any other form of marketing or storage for that purpose, of a product protected by a Eurasian patent;
The use of a process protected by a Eurasian patent or the offering thereof for such use; and
The use, importing, offering for sale, sale or any other form of marketing or storage for that purpose, of a product directly obtained by a process protected by a Eurasian patent.
The infringement can potentially be established if it is shown that Pharmasintez used the same method as protected by the Tuteur patent. There is prior use defence in Russia. There is also the ‘Bolar exemption’ (although, as recent court practice shows, it may not apply under certain circumstances).
However, for now it appears premature for Pharmasintez to revert to these defences while it has not yet been established that Pharmasintez uses the patented method.
It is for this purpose that the court, having a few drug samples at its disposal, appointed technical expertise. However, Pharmasintez objected, stating that the plaintiff in its suit had initially presented no evidence of infringement; therefore, there was no reason to appoint the expertise.
"The capecitabin case shows that the plaintiff does not even have to submit any proof, since the court may still obtain it by appointing the technical expertise."
The court rejected Pharmasintez’s objection stating that it is up to the court whether or not to appoint the expertise. In particular, the expertise should be appointed in complex technical cases like this. On top of that, the plaintiff, apparently anticipating that the drug samples may not be sufficient to prove the infringement, asked the court to request further documents from the Russian Ministry of Health disclosing the details of the method by which Pharmasintez’s drug is produced.
This was even more alarming for Pharmasintez which objected again, stating that the data is the company’s commercial secret.
The case is currently under consideration at the first instance court. It is also important to note that Pharmasintez has attempted to revoke the patent, but unsuccessfully.
Extending patent protection
On the one hand, Semenov’s concern is understandable. It has to do with the old problem of extension of patent protection of a drug, the main patent for which has expired.
There are different ways of extending such patents. For example, recently it has been usual practice to obtain patents for new forms of known drugs characterised by specific physical-chemical parameters. In order to revoke such patents a special scientific study may be required. Thus, Servier’s patent for the alpha form of perindopril, after a long trial involving a series of scientific experiments, was finally revoked in different jurisdictions.
Obtaining a patent for a new method of producing a drug is another way of extending patent protection. It has always been considered less effective though, since it is much harder for the plaintiff to prove the infringement of a method patent than a product patent.
Yet, the present capecitabin case shows that the plaintiff does not even have to submit any proof, since the court may still obtain it by appointing the technical expertise. This may certainly push pharmaceutical producers intending to extend patent protection of their drugs to more seriously consider patenting new methods for producing them.
On the other hand, it is hard to agree with Semenov that some amendments to the current legislation are needed. It is well known that the patentability of pharmaceutical inventions (particularly the inventive step), may be hard to assess, and this is the reason why some secondary patents preventing diligent manufacturers from producing drugs are subsequently considered invalid.
However, the key criteria of patentability—novelty, inventive step and industrial applicability—should apply to secondary patents in the same way they do to primary ones. If an invention meets these criteria, it should be eligible for patent protection.
Any further conditions would lead to an unjustifiable restriction of inventors’ rights. Ultimately, the key to ensuring the development of a respected patent system that balances the needs of all the stakeholders is to ensure high quality examination.
Maxim Sobolev is a Russian patent and trademark attorney and a Eurasian patent attorney at Rouse. He can be contacted at: email@example.com
Rouse, ombudsman, validity, Russia IP, State Duma, patent protection, Rospatent, innovation, generics manufacturers, brands, exclusive rights, prior use