Judge Lourie Questions Patentability of Product Claims Having Limitations Directed to Results and Not Structure

Indefiniteness, Intended result

Carlson Caspers successfully defended an indefiniteness verdict at the Federal Circuit in Forest Laboratories, Inc. v. Teva Pharmaceuticals USA, Inc.  The asserted claims were directed to extended-release formulations of memantine, and were listed in the Orange Book for Forest’s Namenda XR® product.  The applicants chose to define their formulation based on pharmacokinetic principles rather than…

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

Credibility assessments, Motion to combine, Obviousness, Teaching away

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

Blocking patents, Commercial Success

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

Enablement, Post-priority date evidence, Written description

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…

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

expert reports, InvalidityLeave a comment

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…