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Patent war over generic drug treatments

Source: Patent news by Grill-IP

The confrontation between the Russian government and Western pharmaceutical firms is escalating, even making it to the top of the news of the BBC Russian website. At the heart of the dispute is a medication called Revlimid, which is used to treat myeloma – a relatively rare form of cancer that affects the bone marrow and the body’s white blood cells of elderly people.

Russia has licensed a generic version of the drug from an Argentine company, which calls it Metiblastan and sells it 20% cheaper than the original. US company Celgene, the maker of Revlimid, is protesting strongly against the decision, not least as the medication accounts for around 63% of its revenues. Patents covering Revlimid in the United States expire in April 2027, and the drug is one of the world’s most expensive treatments. In the United States, an annual course of Revlimid costs around $128,666 per patient per year. In Russia, treating a patient with Revlimid would cost around $90,000 a year (or more than 500,000 rubles a month). Not long ago, the Russian government had flagged plans that it would license generic versions of any expensive drug regardless of the patent situation, in a bid to drive down the cost of treating certain medical conditions.

As the Moscow government pushes for cheaper drug supplies, it rejects Celegene’s claims of patent infringement, pointing out that US patents are not valid on Russian territory.

Originally called lenalidomide, and marketed by Celgene as Revlimid, the drug is a derivative of Thalidomide, a powerful medication used to treat leprosy, certain skin conditions and cancers. Thalidomide gained notoriety in the 1950s and 60s when it was prescribed to pregnant women as a treatment for morning sickness, but in reality caused thousands of babies to be born with horrible birth defects.

In 1999, Thalidomide was discovered to be effective in treating myeloma. Celgene then developed a molecular derivative called lenalidomide, which it brought to market five years later; the derivative is considered to be more powerful than its parent drug, and has fewer side effects. In Great Britain, Revlimid was licensed as a myeloma treatment as recently as August 2014.

However Celgene is not a company without controversy. The company has just settled a patent suit with Indian rival Natco Pharma and its US partner Arrow International Limited, a subsidiary of UK drugs giant Allergan, which will allow these companies to sell lenalidomide a year before Celgene’s patent expires in 2027.

The company is also embroiled in a long-running lawsuit with a former employee, Beverly Brown, who is a whistleblower alleging dubious marketing practices for Revlimid, including the encouragement of so-called “off-label prescriptions” (prescribing the drug for uses other than those advised, and charging US healthcare systems Medicare and Medicaid for the cost) and the payment of bribes to doctors prescribing the drug.

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Author: grill-ip

Grill IP is a non-profit project for educational and entertaining purposes only. Our aim is to provide quick and easy access to aggregated and original patent news, IP analysis, interesting business cases in IP, basic legal updates and a list of patent transactions.

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