Last week, an unconventional new player launched its first drug patent attack. The hedge fund Hayman Credes Master Fund, L.P., under the name Coalition For Affordable Drugs (ADROCA) LLC, filed an IPR petition against U.S. Pat. No. 8,663,685. (IPR2015-00720.) The patent, which covers the drug AMPYRA (dalfampridine), is owned by Acorda Therapeutics, Inc. This is…
In the first Federal Circuit ruling of an appeal from an inter partes review (“IPR”) decision, the Court held that the Patent Trial and Appeal Board (“the PTAB”) correctly applied the broadest reasonable interpretation standard to construct patent claims, held that it lacked jurisdiction to review the PTAB’s decision to institute an IPR, affirmed the…
In In re Modafinil Litigation, the Eastern District of Pennsylvania recently held that a plaintiff challenging a reverse payment as anti-competitive need not prove as a threshold matter that the reverse payment was both large and unjustified. Rather, this analysis should be part of the traditional “rule of reason” test. The Court also held that…
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…
The complex interactions between an Inter Partes Review (“IPR”) before the patent office and a patent infringement action in Federal District Court require a patent challenger to think strategically about the approach they take to challenge a patent. Judge James Donato’s recent holding in IpLearn-Focus, LLC v. Microsoft Corp. highlighted the effect that District Court…
Last week the Patent Trial and Appeal Board found Supernus Pharmaceuticals Inc.’s three patents covering the drug Oracea® (doxycycline, USP 30 mg immediate release & 10 mg delayed release beads) valid in the first ever defense of pharmaceutical patents before the Patent Trial and Appeal Board. Amneal Pharmaceuticals, LLC v. Supernus Pharmaceuticals, Inc., IPR2013-00368, -00371,…