Healthcare & Pharmaceuticals Blog
- Blog: Waller Law BlogCMS expands disclosure requirements and increases enforcement powers in affiliation rule Posted on September 19, 2019 by Patsy Powers,Justin R. Hickerson
- Blog: Biologics BlogIn Mayo, Federal Circuit Seeks to Head Off Disputes Over When Claims Are “Deemed Allowable” by Counting Continued Examination Time Until Notice of AllowancePosted on September 18, 2019 by Earlier this week, the Federal Circuit declined to further extend the patent term of an antibody patent held by the Mayo Foundation. In Mayo Foundation v. Iancu, the court held that the time spent on a request for continued examination (“RCE”) following a declaration of interference did not count toward the three-year application pendency period [...]
- 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: 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: 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 Joins 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 [...]