Just before the New Year, the Federal Circuit affirmed a decision from the District of Delaware finding patent claims related to using Zohydro ER in patients having hepatic impairment (liver disfunction) invalid as obvious. Persion Pharm. LLC v. Alvogen Malta Oper. Ltd. Some of the claims at issue included pharmacokinetic limitations requiring that the serum…
Last week the Patent Trial and Appeal Board invalidated Concert Pharmaceuticals’ patent covering modified ruxolitinib compounds in a final inter partes review decision, despite having initially denied institution of the underlying petition. The Board found all claims of U.S. Patent No. 9,249,149 obvious over the prior art. Ruxolitinib is the active ingredient in Concert’s Jakafi®…
The Federal Circuit recently reversed a district court finding that a Bayer patent covering formulations of the erectile dysfunction (“ED”) drug vardenafil hydrochloride trihydrate (Levitra®) was not obvious. Bayer Pharma AG et al. v. Watson Laboratories, Inc., et al. 2016-2169 (Fed. Cir. Nov. 1, 2017). In reaching this decision, the Court found that the district…
The Federal Circuit recently reversed a PTAB decision in which the Board relied on common sense to invalidate a patent on obviousness grounds. Arendi S.A.R.L. v. Apple Inc., No. 2015-2073 (Fed. Cir. Aug. 10, 2016). Background. Apple, Google, and Motorola filed an IPR petition challenging Arendi’s U.S. Patent No. 7,917,843 (“the ’843 patent”). The ’843…
The PTAB recently rejected Dr. Reddy’s Laboratories’ IPR petitions for Galderma’s patent covering its Oracea® (doxycycline) product for the treatment of rosacea. Galderma’s patent, U.S. Patent No. 8,603,506 (“’506 patent”) is directed to the treatment of rosacea using low dosages of the tetracycline antibiotic doxycycline. Dr. Reddy’s filed three petitions for IPR against the ’506…
Yesterday, the Federal Circuit affirmed a decision from the Southern District of New York that four patents listed in the Orange Book for OxyContin® are invalid as anticipated and obvious in Purdue Pharma, L.P. v. Teva Pharmaceuticals USA, Inc. This decision addressed two groups of patents: three product-by-process patents directed to oxycodone API, and a…
After nearly five years of litigation with Par and Alkermes, TWi can finally launch its generic version of Megace ES® (megestrol acetate). On remand from the Federal Circuit following an initial finding of invalidity, the District of Maryland held that the asserted claims are invalid for obviousness and lack of enablement, and denied the plaintiffs’ motion…
On July 22, 2015, the Patent Trial and Appeal Board rejected Amneal Pharmaceuticals LLC’s America Invents Act (AIA) challenge to Endo Pharmaceuticals’ patent related to Opana ER. The patent at issue (the ‘216 patent) relates to oral controlled-release pharmaceutical formulations comprising oxymorphone and methods of using it for sustained pain relief. In its Final Written…
Last Thursday, in its decision in AstraZeneca LP v Breath Ltd., the Federal Circuit affirmed Breath Ltd.’s Paragraph IV ANDA challenge of AstraZeneca’s Orange Book patent covering sterile budesonide compositions. It was undisputed that those of ordinary skill in the art would have been motivated to pursue a sterile budesonide composition, limiting the obviousness dispute…
Judge Hochberg of the District of New Jersey just issued an opinion finding two patents covering Warner Chilcott’s osteoporosis drug Altevia® (risedronate) invalid for obviousness. Warner Chilcott, LLC v. Teva Pharmaceuticals USA, Inc., 2015 U.S. Dist. LEXIS 26207 (D.N.J. March 4, 2015). This case demonstrates the importance of challenging whether alleged unexpected properties and skepticism…