The Patent Trial and Appeal Board recently denied petitions from generic drug companies Amneal, Par, and Roxane Laboratories challenging the validity of Jazz Pharmaceuticals’ four Orange-Book-listed patents covering the narcolepsy drug Xyrem® under the America Invents Act’s (AIA) covered business method (CBM) review program. Par Pharm., Inc. et al. v. Jazz Pharm., Inc., CBM2014-00149, CBM2014-00150,…
The Federal Circuit has long reviewed all claim construction orders “de novo” – without any deference to factual issues underlying the district court’s decision. Today, the Supreme Court overturned that longstanding precedent, ruling that findings of fact made as part of a claim construction order should be reviewed for clear error. Teva Pharmaceuticals USA Inc., et…
In November, we wrote about Mylan’s attempt to dismiss an infringement action for lack of personal jurisdiction. U.S. District of Delaware Judge Gregory M. Sleet denied that motion, finding specific jurisdiction because Mylan sent its paragraph IV certification to the NDA holder who was located in Delaware. AstraZeneca AB v. Mylan Pharms., Inc., 2014 U.S.…
In the antitrust case of Mylan v. Celgene, pending in the District of New Jersey (Civil Action No. 14-2094), Judge Esther Salas issued an oral order, finding that Mylan had stated a claim under the Sherman Antitrust Act based on Celgene’s refusal to sell samples of certain pharmaceutical products to Mylan. In particular, Judge Salas…
A valid reissue patent must satisfy 35 U.S.C. § 251, which requires that there be an “error” in the original patent. On December 24, 2014, the Federal Circuit clarified this “error” requirement with its decision in Fleming v. Escort Inc., 2014 U.S. App. LEXIS 24419 (Fed. Cir. 2014). In Fleming, the patentee alleged that he…