By Kevin E. Noonan -- In its recent decision in Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc. the Federal Circuit reminds us that most verities in patent law are not eternal and frequently subject to case-by-case interpretation, in this case the purported verity being that reciting the indefinite article ("a") in a patent claim is construed to mean "one or more." Besides showing that "it ain't necessary so" the case is beneficial for motivating a review of when and under what circumstances "a" means "one or more" and when it means "one," but it is also illustrates how this ..read more

By Kevin E. Noonan -- A preliminary injunction is one of the most potent weapons in a patent plaintiff's arsenal, being capable of shutting down an accused infringer's continued infringement, prohibiting the infringing product from the stream of commerce, and forcing (or at least strongly motivating) a defendant to settlement. Being so powerful, such injunctions are not easily obtained and are cabined by several requirements, the most potent being the need to show a likelihood of success on the merits at trial. In Biomedical Device Consultants and Laboratories of Colorado, LLC v. Vivitro Labs ..read more

The American Conference Institute will be holding its 4th Annual Summit for Women Leaders in IP Law on June 25-26, 2024 at the National Union Building in Washington D.C. The Summit will enable women in Intellectual Property roles to come together to explore industry trends and important factors impacting today's women IP leaders and practitioners. This year's co-chairs are Vanessa Bailey, Head of Patent Policy at Amazon and Adrianna S. Luedke, Director and Associate General Counsel at Lockheed Martin Corp. In past conferences, attendees have been able to learn to advance and thrive in the inte ..read more

American Conference Institute (ACI) will be holding is 15th Annual Summit on Biosimilars & Innovator Biologics: Legal, Regulatory, and Commercial Strategies for the Innovator and Biosimilars Marketplace on June 20-21, 2024 at the New York City Bar Association. Conference Co-Chairs are Deidre Parsons, Senior Director, Public Policy & Governmental Relations, Alnylam Therapeutics; Harshika Sarbajna, Vice President Commercial and Head Global, Alvotech; and Paki Banky, Director, Senior IP Counsel, IP Lead Cell and Gene at Novartis. Conference attendees will hear from Administrative Patent J ..read more

American Conference Institute (ACI) will be holding its 22nd Advanced Summit on Life Sciences May 29-30, 2024 at the Fairfield Inn & Suites Manhattan Times Square South, New York, NY. This year's conference co-chairs include MJ Edwards (Senior Associate General Counsel, Patent Prosecution Team Lead, Gilead Sciences Inc.), Nicole Woods (Vice President, Assistant General Patent Counsel, Eli Lilly and Company), and Mercedes Meyer (Partner, Banner Witcoff LLP). This year's event highlights deep dives into the best regulatory and IP strategies for protecting digital health therapies and inventi ..read more

The American Conference Institute (ACI) will be presenting its 20th Annual Paragraph IV Disputes Conference on April 25-26, 2024 in New York City. As in the past, this curated program will not only address "hot" topics but also will put the issues within the context of pre-suit considerations, case filings, final adjudication, and every step in between. This year's conference co-chairs include Andrei Iancu (Partner, Sullivan & Cromwell LLP and former Director of the USPTO), Brian Malkin (Associate General Counsel, Teva Pharmaceuticals), and Mira Mulvaney (Assistant General Patent Counsel ..read more

By Kevin E. Noonan -- A fractured affirmance of a district court decision to dismiss an infringement action under 35 U.S.C. § 271(e)(1) was the occasion for the Federal Circuit to illustrate the continued debate over the scope of the safe harbor enacted as part of the Hatch-Waxman Act in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. The case arose over a brief (one week) importation of two transcatheter heart valve systems (Class III medical devices, subject to regulatory approval by FDA) by Meril in conjunction with attendance by their representatives at a medical conference. These r ..read more

By Joshua Rich -- In a Federal Register notice dated March 29, 2024, the U.S. Patent and Trademark Office is updating the required method for serving it with a notice of appeal to the U.S. Court of Appeals for the Federal Circuit, a notice of election to proceed by civil action in district court, or a request for extension of time to file a notice of appeal or commence a civil action. Previously, all such notices or requests had to be served by mail. Under the new rule, the notices and requests are to be served by email (with Priority...      Related Stories USPTO Pub ..read more

By Kevin E. Noonan -- Last week, the Federal Circuit handed down a pair of non-precedential decisions affirming the Patent Trial and Appeal Board (PTAB) in inter partes review (IPR) proceedings. This post concerns the decision in Cardiovalve Ltd. v. Edwards Lifesciences Corp., which has as its most significant aspect an unnecessary untethering of obviousness with evidence regarding the skill and inventiveness of the person of ordinary skill in the art under KSR International Co. v. Teleflex Inc. The case arose with Edwards's challenge of claims 1-3, 5, 6, and 8-11 of Cardiovalve's U.S. Patent ..read more

By Kevin E. Noonan -- Last week the Federal Circuit handed down a pair of non-precedential decisions affirming the Patent Trial and Appeal Board (PTAB) in inter partes review (IPR) proceedings. This post concerns the decision in Medtronic, Inc. v. Teleflex Life Sciences Ltd. The case arose in two IPR proceedings involving U.S. Patent No. 8,142,413, owned by Teleflex and related to methods for using a coaxial guide catheter in interventional cardiology procedures. Claims 1, 2, 4, 5, and 7-14 were challenged by Medtronic for being unpatentable for anticipation* or obviousness; claim 1 was consid ..read more