Healthcare & Pharmaceuticals Blog
- Blog: Homeostasis: Dykema's Health Care Law BlogEleventh Circuit Rejects Expert Challenge to Clinical Judgment Decision in Hospice False Claims Act LitigationPosted on September 13, 2019 by Jonathan S. FeldOn September 9, 2019, the U.S. Court of Appeals for the Eleventh Circuit issued an important decision for health care providers, especially those in the hospice industry. In U.S. v. AseraCare, Inc., No.16-13004, Slip. Op. (11th Cir. September 9, 2019), the Court held that a “reasonable disagreement between medical experts” about prognosis for a terminally ill patient, without more, cannot establish falsity. Slip. Op. at 3. The case began in 2008 as a qui tam action when former AseraCare company employees filed a False Claims Act lawsuit alleging that AseraCare submitted documents t...
- Blog: Waller Law BlogProvider Agreements can be sold free and clear of future liabilities, Delaware court rulesPosted on September 12, 2019 by John C. Tishler
- Blog: Haynes and Boone BlogsNo Nonce-nse: MTD Products Inc. v. Iancu Untangles Means-Plus-Function InterpretationPosted on September 11, 2019 by Kelvin VargheseIn MTD Products Inc. v. Iancu, the U.S. Court of Appeals for the Federal Circuit described how to identify a means-plus-function limitation under 35 U.S.C. § 112, ¶ 6. In particular, the court clarified that the question of whether § 112, ¶ 6 applies is distinct from the determination of what structure corresponds […] The post No Nonce-nse: MTD Products Inc. v. Iancu Untangles Means-Plus-Function Interpretation appeared first on Haynes and Boone Blogs.
- Blog: Biologics BlogFederal Circuit Walks Back Its “Exceptional” Stance on the Doctrine of Equivalents in the Latest Amgen v. Sandoz DecisionPosted on September 5, 2019 by In Amgen’s long-running dispute with biosimilar-maker Sandoz over biosimilar versions of Amgen’s filgrastim (Neupogen®) and pegfilgrastim (Neulasta®) biologics, the Federal Circuit earlier this year affirmed summary judgment of no literal infringement and no infringement under the doctrine of equivalents. Amgen Inc. v. Sandoz Inc., 923 F.3d 1023 (Fed. Cir. May 8, 2019). In so holding, [...]
- Blog: Patent 213For the First Time, a Medical Treatment Patent Is Ruled Invalid Under Mayo/MyriadPosted on August 30, 2019 by Nicholas J. Landau, Ph.D. and Stephanie D. ScruggsAs discussed in a previous blog post, since Mayo v. Prometheus, critics of medical treatment patents have advocated that such patents should be banned from patenting. While such arguments seemed futile based on the consistent position taken by the U.S. Court of Appeals for the Federal Circuit (CAFC) that treating a disease or other condition...
- Blog: EndpointsExperienced Health Care and Privacy Partner Join’s Verrill Dana’s Health Care GroupPosted on December 13, 2018 by Academic and Clinical Research GroupWe are pleased to welcome attorney Nadine Peters to our nationally-recognized Health Care Group. Nadine comes to Verrill Dana with more than 15 years of experience as a health care and privacy attorney and focuses on clients within the health care and life sciences industries. Most recently, Nadine served as Deputy General Counsel at the Patient-Centered Outcomes Research Institute (PCORI), an independent non-profit organization authorized under the Affordable Care Act to fund comparative effectiveness research. Prior to PCORI, she was [...]