In a lawsuit filed April 3, U.S. generics giant Mylan is suing Celgene Corp, accusing Celgene of maintaining unlawful monopolies over drugs Revlimid and Thalomid, by blocking generic versions from the market.
According to the lawsuit filed in the U.S. District Court, Mylan is accusing Celgene of "using federal limits on the distribution of Revlimid and Thalomid, which were designed to promote the drugs' safety, as a pretext to keep generic drug makers from obtaining their own samples." Because the drugs are derivatives of thalidomide, the drug tragically prescribed to pregnant women in the 1950's, leading to egregious birth defects, risk evaluation and mitigation strategy programs are mandatory for Celgene products.
Mylan's lawsuit seeks to force Celgene to sell enough Revlimid and Thalomid at market prices to allow for the bioequivalence testing that is mandatory before the generic versions can be launched. Mylan also seeks compensation and damages.
This is not the first lawsuit Celgene has faced over Thalomid bioequivalence, and Mylan's litigation reignites a debate on generic drug availability for products that, are approved and marketed under a restricted distribution system or Risk Evaluation and Mitigation Strategy.
Revlimid is covered by 12 patents, including a patent covering the composition that expires in 2019 and a polymorph patent, covering another form of the compound, that expires in 2026. The distribution plan for Thalomid, is covered by numerous patents, six of which are part of the Revlimid patent portfolio and expire in 2018 and 2020.
Read the Reuters press release