Section VIII Carve-Outs Remain Viable in the Wake of GSK v. Teva

Last week, Judge Andrews from the District of Delaware granted Defendant Hikma’s motion to dismiss Plaintiff Amarin’s induced infringement claims related to the drug Vascepa®. Amarin Pharma, Inc. v. Hikma Pharm. USA Inc. Amarin sells Vascepa® for two indications: severe hypertriglyceridemia (the “SH indication”) and cardiovascular risk reduction (the “CV indication”). Hikma received FDA approval…

Federal Circuit Holds Claim Can Be Obvious Where a Combination of References Would Inherently Meet Claim Element

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…

Federal Circuit Confirms that Blocking-Patents Can Kill Secondary Considerations

The Federal Circuit recently refused to rehear a panel decision that affirmed a district court’s finding that the existence of a blocking patent negated the patent owner’s argument that commercial success, failure of others, and long-felt but unmet need showed the patents-in-suit were non-obvious. Acorda Therapeutics, Inc. et al. v. Roxane Labs., Inc. et al. (original…

Post-Priority-Date Evidence May Be Relevant to 35 U.S.C. § 112 Inquiry

Recently, the Federal Circuit reversed a jury decision upholding the validity of two Amgen patents directed to a large genus of antibodies that reduce LDL cholesterol. Amgen et al. v. Sanofi et al., No. 2017-1480.  Defendants argued that the patents failed to satisfy the written description and enablement requirements under 35 U.S.C. § 112.  The…