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Genericness Banned In Russia – Patent



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The story started back in 2019. At that time, SUGEN, INC. and
PHARMACIA & UPJOHN COMPANY Pharmacia Upjohn sued Nativa, a
Russian company, The Ministry of Health of the Russian Federation
and Oleg Mikhaylov, the third person closely associated with Nativa
against infringement of their patent No 005996 for Pyrrole
substituted 2-indolinone protein kinase inhibitors (case No
А40-166505/17-15-1481).

Earlier, Nativa had sought a license from the plaintiffs but was
refused and sued them claiming a compulsory non-exclusive license
in court. Nativa also asked the court to recognize its patent No
567535 dependent upon plaintiffs’ patent No 005996.

The plaintiffs argued that the respondent produced a generic
named Sunitinib-nativ and sold it infringing their patent. However,
the court opined that the plaintiffs had no base to make their
claims and, on the contrary, the respondent had the right for a
compulsory license because his drug was based on his own
(dependent) patent. The owner of the dependent patent may claim a
compulsory license if his invention is 1) an important technical
achievement and has 2) substantial economic advantages over the
original patent.

The court ordered expert examination which produced
contradictory conclusions. The court nevertheless ruled that the
compulsory license should be granted because it satisfied the above
(1,2) conditions.

The plaintiffs appealed the judgment. They argued that the use
of the patent owned by the respondent does not relieve him from
liability for infringement of their patent. The respondent did not
prove that his invention is an important technical achievement nor
does it have substantial economic advantages. The court of appeal
confirmed however the judgment of the 1st instance court.

The plaintiffs again appealed the judgment with a cassation
complaint. This time at the IP court. They repeated the earlier
arguments and argued that the respondent’s invention had no
advantages in comparison with the original patent. They also
pointed out inconsistencies in the experts’ reports. The
reports do not contain convincing information about the importance
of the technical achievement, nor do they demonstrate any economic
advantages.

Notwithstanding, IP court upheld the previous judgments. This
ended the series of hearings in 2019.

Further, the plaintiffs appealed the judgment at the Supreme
court in February 2020. The judge of the Supreme court examined the
case and found that the case had no grounds for being eligible for
consideration by the judicial collegium for economic disputes of
the Supreme court.

The plaintiffs went back to the Moscow commercial court and
initiated a case on the basis of newly discovered evidence which is
allowed by the procedural rules. The case was initiated in early
2022 and the judgment was handed down on March 10, 2022. The court
meticulously listed the arguments put forth by both parties during
the previous hearings. The new evidence put forward by the
plaintiffs indicated that the respondent’s patent No 2567535
had been invalidated by the patent office on June 25, 2021 because
it did not meet criteria of patentability.

The court relied on the Decree of the Supreme Court No 17 of
2021 and the provisions of the Procedural Code that provides that,
when a case is re-examined because of newly discovered evidence,
there should be important circumstances which could not be known to
the plaintiffs, and if they had known those circumstances that
could have led to a different judgment.

As a result, the court came to the conclusion that its earlier
judgment of 2019 should be cancelled and the case should be
examined again from the beginning.

The new hearing was scheduled for May 18, 2022. The judgment was
announced on June 17, 2022. The court examined all evidence and
concluded that original claims could be satisfied and
Nativa’s counterclaims should be dismissed.

The court found that Rospatent had invalidated patent No 2567535
on June 25, 2021 because it did not satisfy criteria of
patentability. The plaintiffs used that fact as a newly discovered
circumstance and asked the court to reconsider the case. Nativa
appealed the decision of the patent office at the IP court, so
examination in court was suspended pending decision of the IP
court. The IP court dismissed Nativa’s appeal.

This allowed the Moscow commercial court to continue examination
of the case and it satisfied the claims of the plaintiffs, i.e. it
forbade production, offer for sale, sale, other ways of marketing
and storage for those purposes of the drug Sunitinib-nativ until
expiration of the term of the Eurasian patent No 005996.

Originally Published by The Patent Lawyer Magazine
Newsletter

The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.

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