Federal Circuit Purges Non-Infringement Verdict for Patented Colon Cleansing Method

This month the Federal Circuit held that Breckenridge’s proposed labeling for a generic colonoscopy prep kit would induce infringement of Braintree’s patent covering SUPREP.  Braintree Labs., Inc. v. Breckenridge Pharm., Inc., No. 16-1731 (Fed. Cir. May 5, 2017).  In doing so, the Federal Circuit clarified when proposed labeling amounts to an affirmative intent to induce […]

Invention Need Not Be Publicly Disclosed to Trigger AIA Version of On-Sale Bar

The Federal Circuit ruled yesterday that public sales of a product do not need to disclose the details of an invention to bar a patent application under post-America Invents Act (“AIA”) 35 U.S.C. § 102.  Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc. et al.  In reaching this decision, the court rejected Helsinn’s argument that […]

A Thin Gray Line: Reading Claims in Light of the Specification Versus Impermissibly Reading Limitations into the Claims

There is a fine and often ambiguous line between improperly importing limitations from the specification into the claims and interpreting claims in light of the specification.  The Federal Circuit recently drew that line in The Medicines Company v. Mylan, Inc., reversing a lower court’s judgment that Plaintiff Mylan’s proposed bivalirudin formulation would infringe U.S. Patent […]

Board Holds that Unexpected Results Overcome Claims that Were Prima Facie Obvious

In Coalition for Affordable Drugs V LLC v. Biogen MA Inc., the PTAB denied an obviousness challenge of a patent covering methods of treating multiple sclerosis using a particular dosage of known fumarate drugs.  The patent at issue—U.S. Patent No. 8,399,514—is listed in the Orange Book for Biogen’s Tecfidera® product. The claims of the ’514 […]

District of Delaware Applies IPR Estoppel Provisions to Bar Party from Pursuing New Prior Art Combinations

Although not a Hatch-Waxman case, the District of Delaware’s recent ruling in Parallel Networks Licensing, LLC. v. IBM, could have a significant impact on ANDA-filers strategic approach to IPRs.  In this case, the patentee (“Parallel”) filed a complaint in 2013 asserting that IBM infringed three patents.  The litigation proceeded in federal district court; however, in […]

Federal Circuit Confines Exception to Closed-Ended Interpretation of “Consisting of” Transition

On Friday, the Federal Circuit weighed in on the exception to the closed nature of the “consisting of” transition in patent claims, holding that the exception is more limited than perhaps previously thought.  In Shire Development, LLC v. Watson Pharmaceuticals, Inc., the Federal Circuit reversed the district court’s infringement finding, holding that a claimed Markush […]

Federal Circuit Reverses Examiner’s Anticipation Rejection Based on Examiner’s Belief that Prior Art Structure Inherently Performed Claimed Function

The Federal Circuit recently reversed and remanded an Examiner’s rejection of a claim that involved an element requiring both structural and functional limitations.  See In re Chudik, No. 2016-1487 (Fed. Cir. Jan. 9, 2017).  Specifically, the Federal Circuit reversed the Examiner’s rejection because the record failed to establish that a single prior art reference contained […]

Private Plaintiff Must Prove Antitrust Injury to Recover for Antitrust Violations Based on Reverse Payment Settlements of ANDA Litigation

Three years ago, the Supreme Court held in Federal Trade Comm’n v. Actavis, Inc. that pay-for-delay settlement agreements may constitute antitrust violations under the rule of reason if their anticompetitive effects are unreasonable when viewed in light of the agreements’ size, scale in relation to future litigation costs, independence from other services that might justify […]

FDA Rejects Vanda Pharmaceuticals Efforts to Force ANDA-Filers to Include Labeling Statements Related to its Three-Year Exclusivity

Last week, the FDA rejected Vanda Pharmaceutical’s Citizen Petition requesting that FDA withhold approval of ANDAs for its schizophrenia drug, Fanapt®, for three years.  (Letter from Janet Woodcock, M.D., Director Center for Drug Evaluation and Research, to Richard L. Gulino, Senior Vice President, General Counsel and Secretary, Vanda Pharmaceuticals Inc., dated Nov. 28, 2016.)  Specifically, […]