Russian court approves first compulsory licence

Home/Policies & Legislation | Posted 20/07/2018 post-comment0 Post your comment

A court in Moscow has made history by granting a compulsory licence to Russian drugmaker Ukrenergo to make a generic version of Celgene Corporation’s (Celgene) flagship blood cancer drug Revlimid (lenalidomide).

Immunology Serology V18D06

Lenalidomide is used to treat people with myeloma (a type of cancer that affects the plasma cells inside bone marrow) and myelodysplastic syndromes (MDS; a group of conditions that affect the bone marrow). The drug is also undergoing clinical trials as a treatment for Hodgkin’s lymphoma, as well as non-Hodgkin's lymphoma, chronic lymphocytic leukaemia and solid tumour cancers such as carcinoma of the pancreas.

The originator product, Celgene Corporation’s (Celgene) flagship blood cancer drug Revlimid (lenalidomide), had global sales of US$8.2 billion in 2017 and made up the majority of Celgene’s total revenue of US$13 billion in 2017.

Ukrenergo’s generic version, Lenalidomide-Nativ, was registered in the Russian state register in August 2016.

Russia approved the draft Federal Law on Adopting the Protocol amending the Agreement on Trade-Related Aspects of Intellectual Property Rights in April 2017. The adopted of the law allows Russian drugmakers to produce generics using a foreign patent of an originator drug in order to help other countries.

Celgene has vigorously defended its intellectual property rights for Revlimid in the past [1] and also filed a lawsuit trying to forbid the production and marketing of Lenalidomide-Nativ.

This is just one of a number of moves by Russia to stimulate the local drug market. For example, to stimulate local production of active pharmaceutical ingredients (APIs) in Russia, the state plans to provide preferences to domestic producers of the full cycle. Presently, 90% of Russian drugs are made from foreign APIs, commonly originating from China, France and India.

Related article
Celgene settles Revlimid patent litigation with Natco Pharma

Reference
1. GaBI Online - Generics and Biosimilars Initiative. Celgene and Natco in generic lenalidomide battle [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jul 20]. Available from: www.gabionline.net/Generics/News/Celgene-and-Natco-in-generic-lenalidomide-battle

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Source: Donttradeourlivesaway, Pharmstandard, PRNewswire

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