In a recent opinion, the District Court of New Jersey held that a decision in a parallel proceeding at the Patent and Trademark Appeal Board (PTAB) does not give rise to collateral estoppel in the court proceeding. The case concerns Sanofi Aventis’s (“Sanofi”) LANTUS® injectable insulin drug, indicated for the treatment of diabetes mellitus. After…
U.S. Senator Orrin Hatch, co-author of the Hatch-Waxman Act, recently proposed an amendment to the Act that would prevent generic drug companies from using any AIA post-grant procedure (IPR or PGR) on an Orange Book patent identified in their PIV certifications. The proposed amendment would require that the patent certification required under 21 USC §…
Two recent sets of decisions at the PTAB provide guidance on how to increase the likelihood of a petition being successful at instituting an IPR. The first set of decisions relate to the erectile dysfunction (ED) drug tadalafil (CIALIS®). In IPR2017-00323, Mylan successfully petitioned for an IPR against ICOS’s U.S. Patent No. 6,943,166, which claims,…
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…