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Russian Court provides first compulsory license for production of a US drug

A Russian pharmaceutical company for the first time has received a license for the production an analogue of a drug in Russia, the rights for which are owned by a global drugmaker, reports The Pharma Letter local correspondent,

The Moscow Arbitration Court granted a compulsory license for infamous Russian drugmaker Nativa to use the patent of US biotech major Celgene (Nasdaq: CELG) for the production of its Revlimid (lenalidomide) within Russia. The drug, an antitumor immunomodulator which is used to treat leprosy, tuberculosis and multiple myeloma, generated full-year 2017 sales of $8.19 billion for Celgene.

In March 2017 Celgene filed a lawsuit against Nativa with the requirement to ban the production and sales of lenalidomide to the Arbitration Court of the Moscow region. After this a counter claim was filed by Nativa, which asked the court to permit a compulsory licensing of this drug in the Russian market. According to Nativa, Russian-made lenalidomide will be "significantly cheaper than the American original."

In the meantime, the latest decision of the Moscow Arbitration Court means Nativa will pay royalties to Celgene for the sales of it analogue of the drug in Russia.

According to Nativa’s deputy director Julia Gerasimova, this is the first decision of Russian court to issue a license on the production of an analogue of a Western drug in Russia, despite the fact that the relevant rules on the procedure for granting such licenses have long been introduced in the Civil Code of Russia.

Russia has long been developing legislation that should expand the possibilities for issuing compulsory licenses for the production of analogues of Western drugs in Russia. In 2016, the Russia Federal Antimonopoly Service threatened to deprive foreign pharmaceutical companies of their right to exclusively produce and sell patented drugs if they for economic or political reasons refused to supply these drugs to Russia.

Analysts believe such a decision may contribute to the filling of further lawsuits by Russian drugmakers on the issuance of compulsory licenses for the production of drugs of foreign origin, which may result in serious losses of global drugmakers, operating in Russia.

Nativa is the record holder in the number of lawsuits filed against it regarding patent infringement. Currently the company is involved in six such proceedings in Russian courts. In addition to Celgene, AstraZeneca, the company had legal proceedings with AstraZeneca, Orion Corp, Bayer, Bristol-Myers Squibb, Boehringer Ingelheim and Pfizer.


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