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 […]

Blocking Patents May Minimize Probative Value of Blockbuster Sales in Obviousness Analysis

Last week, Federal Circuit Judge William Bryson, sitting by designation in the Eastern District of Texas, held that the claims of four of the six Orange Book-listed patents for Restasis® were invalid.  In reaching this decision, Judge Bryson discounted the extensive sales revenues of Restasis® offered by Allergan to demonstrate commercial success.  Allergan, et al. […]

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 […]

Antitrust: Settlement of unrelated claim may be an unlawful reverse payment

The Supreme Court in FTC v Actavis created a new species of antitrust liability when it held that reverse payments from a branded company to an ANDA filer, as part of a Hatch-Waxman settlement agreement, may be unlawful where the “basic reason is a desire to maintain and to share patent-generated monopoly profits.” 133 S. Ct. […]

PTAB Denies Joinder Where Petitioner Relied on Different Experts

A recent PTAB  order refused joinder of IPR petitions challenging the same formulation patent at issue in a previously instituted IPR proceeding despite almost complete overlap between the challenged claims and reliance on the exact same prior art.  Famy Care Ltd. v. Allergan, Inc., IPR2017-00566, Paper 12, (PTAB July 12, 2017).  The patent at issue […]

ANDA Litigants May Use “Post Art” to Support or Challenge Patent Validity

Last week, in Novartis, et al., v. West-Ward Pharmaceuticals International Limited, the District of Delaware denied Defendant’s motion in limine seeking to exclude “post art” evidence, i.e. references published after the critical date, as irrelevant and prejudicial.  In its order, the court remarked that though there are some limitations, post art can be offered for […]

Federal Circuit Clarifies Doctrine of Equivalents As Applied to Chemical Compounds

In Mylan Institutional LLC v. Aurobindo Pharma Ltd., the Federal Circuit offered some clarity to the “sparse and confusing case law” concerning the doctrine of equivalents in the chemical context.  In reviewing a preliminary injunction where the district court found a reasonable likelihood of infringement under the doctrine of equivalents, the Court suggested that the […]