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 […]
Yesterday in Sandoz Inc. v. Amgen Inc., et al., the Supreme Court ruled that biosimilar makers may give 180-day notice of sales before product approval, and that the failure of a biosimilar maker to provide its application and manufacturing information to the RLD drug maker under the Biologics Price Competition and Innovation Act (“BPCIA”) is […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
Last week, the Federal Circuit held in Phigenix, Inc. v. Immunogen, Inc. that a party must be able to prove injury in fact in order to challenge an inter partes review decision in Federal Court. (Fed. Cir. Jan. 9, 2017). Specifically, while any party may challenge a patent via IPR regardless of Article III standing, […]