Judge wipes out Biogen's Tecfidera patent protections in suit against Mylan

Fiercepharma | June 18, 2020

Judge wipes out Biogen's Tecfidera patent protections in suit against Mylan
In the high-stakes patent fight between Biogen and Mylan over Tecfidera’s main remaining patent, Mylan has scored a major win in federal court. U.S. District Judge Irene Keeley said Mylan “demonstrated by clear and convincing evidence” that certain claims of Biogen’s '514 patent are invalid for “lack of written description.” The decision threatens Biogen’s bestselling medicine with early generics; Tecfidera, a multiple sclerosis drug, generated $3.3 billion in the U.S. last year. The company's '514 patent is set to expire in 2028, meaning the decision, if upheld, could wipe out years of monopoly sales. Biogen’s shares were down about 6% on Thursday morning on the news. A spokesman said the company is disappointed with the decision and will appeal.

Spotlight

Orphan drugs (ODs) for rare diseases (RDs) present pharma companies with the opportunity to address a substantial unmet medical need, with approximately 7,000 RDs, and only about 5% having effective treatments. A large number of patients in the US are affected with these RDs (around 25-30 million people). The majority of RDs affect children. Also, RDs often translate into chronic and deteriorating conditions for patients, the majority being affected and starting in childhood, and often resulting in early death. Significant economic and social burdens exist for patients, caregivers, and the healthcare system to treat RDs.

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Spotlight

Orphan drugs (ODs) for rare diseases (RDs) present pharma companies with the opportunity to address a substantial unmet medical need, with approximately 7,000 RDs, and only about 5% having effective treatments. A large number of patients in the US are affected with these RDs (around 25-30 million people). The majority of RDs affect children. Also, RDs often translate into chronic and deteriorating conditions for patients, the majority being affected and starting in childhood, and often resulting in early death. Significant economic and social burdens exist for patients, caregivers, and the healthcare system to treat RDs.