Patent for sofosbuvir extended in Russia

The patent term in Russia is 20 years from the filing date. However, if more than five years have elapsed from the filing date to the receipt of the first permission for using the medicine, the patent term can be extended. It is extended by the period that has elapsed since the filing date to the date of receipt of the permission, less five years, but by a term not exceeding five years.

According to the Rules for extending patents adopted in 2015, there are two requirements for extending a patent relating to a compound. Firstly, the combination of features of the patent claim shall be identical to that of the active component of the medicine indicated in the permission. Secondly, the description of the invention shall contain information that the compound has such an activity that allows to use it in the medicine indicated in the permission.

If a patent is extended, an additional patent is granted. Such a patent shall have claims relating to the compound, the permission for which has been granted.

Gilead filed a request with the Russian patent office (Rospatent) to extend it’s patent for Sofosbuvir for three years.  Rospatent refused on the basis sofosbuvir is not identical to the compound of claim 1 (compound A) since sofosbuvir is the (S)-stereoisomer of compound A, whereas claim 1 recites “stereoisomer” of compound A in general.   In addition, sofosbuvir is not disclosed in the description i.e., there is no information in it that sofosbuvir has, indeed, been obtained and has the activity that would allow to use it for the purpose indicated in the permission, i.e., for treating hepatitis C. Therefore, both above-mentioned requirements for extending patents are not met.

Gilead filed an appeal to the Intellectual Property Rights Court. The Court, in reversing the refusal noted the following:

  • The current patent legislation allows to set out features of a claim as alternatives. Sofosbuvir is one of the two alternatives for the feature of claim 1 “or its stereoisomer”;
  • Despite the (S)-stereoisomer of compound A (sofosbuvir), not being specifically mentioned in the description, one example illustrates a method for obtaining a mixture of (R)- and (S)-stereoisomers, and the other example – a method for separating (R)- and (S)- stereoisomers of some of the claimed compounds having similar structures. Therefore, there is information in the description that sofosbuvir has the activity that allows to use it for treating hepatitis C.

Therefore, both requirements are met. The Court ordered Rospatent to extend the patent for 3 years and grant an additional patent with amended claims relating specifically to (S)-stereoisomer of compound A as was requested, i.e. sofosbuvir.

Despite the Court’s decision in the present case may raise questions from the point of view of formalities, it appears generally fair. That said, it is interesting how the Court would deal with a situation when the permission is granted for a compound falling within a Markush-type claim, which is not specifically mentioned, and the method of producing which is not specifically disclosed in the description. There would apparently be less reason than in the present case to extend the patent and grant an additional patent having claims limited to this specific compound, because it obviously was not within the scope of invention as initially filed.