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May the Force Be With You, BIOCAD

2 November 2015

BIOCAD has won a lawsuit against Roche in an unusually high-profile for Russian pharma industry litigation.

The argument concerned rituximab. This is the most expensive medical product, bought in Russia as a part of a 7 nosologies Programme, for those suffering from blood cancer – non-Hodgkin’s lymphoma and chronic lymphocytic leukemia. The average purchase volume is approximately 7-8 billion roubles. (the equivalent of 100-114.2 mil euros as of 2 November, 2015) a year.

For years, Russian hospitals had received Roche medical products. Last year the tender was won by a Russian company for the first time, it was BIOCAD, who had created a Russian biosimilar based on monoclonal anti-bodies – rituximab. A patent for the original product had run out and other manufacturers got an opportunity to produce a high-technology product at an available price.

Genentech Corporation, Roche’s American daughter, has additionally patented the original rituximab’s method of administration. At the beginning of the year, the American pharmaceutical company has demanded to ban the manufacturing, offer for sale, sale and other commercialization of the biosimilar of this medical product. Aside from this, Genentech was trying to have the batch, which was already on sale, withdrawn and destroyed.

The legal claim was filed at the Arbitration Court of Moscow on 25 February 2015. Despite Genentech’s expectations, the court refused to sustain the claim. Nonetheless, the first instant judgment at a set date was not appealed by Genentech, and became final.

For the same reason, BIOCAD filed a petition for a pre-term cessation of patent for rituximab’s method of administration, which belongs to Genentech. Interestingly, Genentech annulled their patent, not having waited for the case hearing in the Chamber for Patent Disputes.

BIOCAD’s victory in court undoubtedly is a significant event for Russian pharmaceuticals industry and medicine in general.

RPhG Comment about BIOCAD

The total value of BIOCAD’s export contracts for the last year and a half exceeds 700 mil dollars. The company’s main blockbusters are medicines for cancer therapy. These are biosimilars based on monoclonal anti-bodies: rituximab (31%), trastuzumab (24%) and bevacizumab (21%).

In 2016 BIOCAD is planning to sell the amount of rituximab, cepeginterferon Alfa-2b and filgrastim in the Russian Commonwealth, Cuba, Jordan, Algeria, Morocco, Vietnam, Paraguay and Sri Lanka, worth 62.5 mil dollars. The biggest and most varied range of medical products went on sale in Vietnam, Republic of South Africa and Latin American countries: Paraguay, Peru, Columbia, Chile, and Ecuador. The company tied up many contracts for medical product delivery to the markets of developing countries, where the top customers are Brazil and India. In 2014, BIOCAD made good deals for product delivery to Turkey, Belarus, Argentina and Republic of South Africa.

Related news: Roche in Russia: A Living Dog is Better Than a Dead Lion


Source: Pharmvestnik newspaper   back to headlines