Secondary patents: Moscow mewl

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.

Drug dispute

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:

1. a)
   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;
2. b)
   The use of a process protected by a Eurasian patent or the offering thereof for such use; and
3. c)
   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.