Federal Circuit Limits the Power of Credibility Assessments, Lack of Commercial Availability, and Preference for Alternative Designs in Obviousness Analysis

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 […]

Federal Circuit Dislikes “Common Sense”

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 […]

PTAB Analyzes Section 112 Support in Declining to Institute IPR on Galderma’s Rosacea Patent

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 […]

Federal Circuit Affirms Invalidity of OxyContin® Patents[1]: The Low ABUK Patents

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 […]

District Court Relies on Inherency to Find Megace Patent Invalid as Obvious

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 […]

PTAB Rejects ANDA-Filer’s IPR Challenge to Endo’s Opana ER Patent, Finds Limitations Not Inherently Disclosed in Prior Art

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 […]

Federal Circuit Discounts Commercial Success Evidence Even Though Alleged Invention Helped Secure Regulatory Approval

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 […]

District of New Jersey Finds Altevia® Patents Obvious

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 […]

PTAB’s First Inter Partes Review Of Pharma Patents Is Against Generic Challenger

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, […]

Federal Circuit limits application of inherency doctrine in obviousness cases

This week the Federal Circuit vacated and remanded a district court judgment of invalidity because the district court had incorrectly applied the inherency doctrine in the obviousness analysis. The case, between Par and Twi, involved methods of use of nanosized formulations of the drug megestrol acetate. Par Pharm., Inc. v. TWi Pharms., Inc., No. 1:11-cv-02466 […]