Celgene Being Sued By Cancer Patient Over Generic Access

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In a move that is sure to be studied by generic pharma attorneys, a man suffering from multiple myeloma and taking Celgene’s Revlimid drug has sued the company. David Mitchell is a public policy specialist who has had the disease since 2010 and has been taking Revlimid for at least six years. Mitchell claims that since he’s started taking the drug, his co-pay has risen from $42 per week to $250. He decided to sue Celgene, alleging that the company has prevented generic competition from entering the market. In 2014, Mylan sued Celgene for refusing to supply the samples needed to produce a generic version of the drug. Celgene could not get the case thrown out of court and is currently looking for a summary judgment.

Mitchell is actually part of a class action lawsuit that claims that Celgene has refused to provide Revlimid samples to generic manufacturers. Mitchell claims that Celgene “abused our system,” and said that their actions prevented a generic option from reaching the market. Thus far, Celgene has declined to comment, citing the pending litigation.

Mitchell’s case is prominent in part because he has worked for most of his career as a public policy communications professional in Washington DC. But analysts and legal observers believe that if his class action suit is successful, other similar suits will arise with patients alleging drug companies blocked generic competition and access to the market.

President Trump campaigned on lowering drug prices for American citizens but has yet to address the issue in government. If the President quickens the pace of generic drug approvals, greater competition could lead to lower prices. However, any action taken is unlikely to affect the case between Mitchell and Celgene.

Celgene is unlikely to see generic competition for Revlimid until at least 2022. Several of the drug’s patents extend further than that, with some reaching until 2027, but Celgene and Natco Pharma came to an agreement which allows Natco to produce a generic version of the drug five years earlier.

 

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In today’s fast-growing, highly regulated generic pharmaceutical market, companies increasingly require specialized legal guidance as their products are developed, launched, and litigated. Wilson Sonsini Goodrich & Rosati’s attorneys address this need by providing expert counsel to companies in the global generics industry, offering sophisticated representation far beyond the scope of general corporate and securities counsel. We have assembled a highly experienced team of experts from a cross-section of the firm’s key practice areas, including intellectual property, litigation, antitrust, FDA/regulatory, technology transactions, exports and FCPA, trade secret, and trademark and copyrights. Led by the former chief legal officer of Mylan Pharmaceuticals, one of the world’s leading generic and specialty pharmaceutical companies, our attorneys work closely with our generic pharmaceutical clients’ legal and scientific personnel and senior management to understand and meet their specific needs both in the U.S. and abroad.

We have assembled a highly experienced team of experts from a cross-section of the firm’s key practice areas, including intellectual property, litigation, antitrust, FDA/regulatory, technology transactions, exports and FCPA, trade secret, and trademark and copyrights. Led by the former chief legal officer of Mylan Pharmaceuticals, one of the world’s leading generic and specialty pharmaceutical companies, our attorneys work closely with our generic pharmaceutical clients’ legal and scientific personnel and senior management to understand and meet their specific needs both in the U.S. and abroad.

 

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