Podcast: Direct Access Laboratory Testing - Physician Orders and Specimen Collection - Diagnosing Health Care
Podcast: Direct Access Laboratory Testing: Reimbursement & Compliance – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 126: Josh Arant, COO, Mako Medical
The Federal Circuit reviewed the latest decision from the Patent Trial and Appeal Board (PTAB) in an inter partes review that claims 3-6 and 10 of U.S. Patent No. 6,548,019 are obvious, in Rembrandt Diagnostics LP v. Alere,...more
By Memorandum Opinion entered by the Honorable Leonard P. Stark in Natera, Inc. v. Inivata, Inc. et al., Civil Action No. 21-56-LPS (D.Del. March 14, 2022), the Court denied defendants’ motion to dismiss plaintiff’s first...more
Hear from the FDA and the leaders of the biosimilars and innovator biologics industries about the impact of the pandemic on the global IP market and gain practical guidance for what is coming down the pipeline. The novel...more
Talk about bad timing. On Friday, March 6, 2020, non-practicing patent holding company Labrador Diagnostics formed in Delaware and obtained a patent portfolio directed to testing patients for the presences of coronavirus—when...more
The cloud of uncertainty over patent eligibility of patents for medical diagnostic methods remains. On Monday, the Supreme Court declined the opportunity to revisit patent eligibility under its two-step Mayo test when it...more
On August 9, 2019, the Federal Circuit issued a public opinion in Genetic Veterinary Sciences, Inc. v. LABOKLIN GmbH & Co. KG, finding claims directed to methods for detecting a genetic marker for a canine hereditary disease...more
Recently, the U.S Court of Appeals for the Federal Circuit issued a split panel decision in Athena.Athena, which examined the patent subject matter eligibility of four claims in one issued patent, upheld a district court's...more
In 2012, the U.S. Supreme Court decided the landmark case of Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), which was hailed by some as banning patents on methods of medical diagnosis. It...more
At a symposium and webinar presented by Fenwick & West and Mewburn Ellis, we asked U.S. Patent and Trademark Office and European Patent Office examiners to provide perspective on the preparation and prosecution of patent...more
On August 4, 2017, the U.S. District Court in the District of Massachusetts found U.S. patent 7267820 (the ‘820 patent), owned by Athena Diagnostics, Inc., to be directed to non-patentable subject matter, and therefore...more
On August 4, 2017, a pair of decisions reaffirmed that claimed methods which apply routine and conventional techniques to a law of nature are invalid and do not satisfy the “inventive concept” step of the patent eligibility...more
The “prognosis” for patentability of medical diagnostic claims remains uncertain after an order of the Federal Circuit Court of Appeals (“Court”) denying a petition for an en banc rehearing of its decision in Ariosa...more
On December 2, 2015, an almost unanimous Federal Circuit decision was issued denying the en banc rehearing of Ariosa v. Sequenom, a case having significant consequences for diagnostic patents and Section 101 case law in...more
Laboratory developed test (LDT) providers, previously exempt from U.S. Food and Drug Administration (FDA) oversight, under a new FDA proposal, must now consider if their LDTs constitute moderate-risk (Class II) or high-risk...more
Diagnostic medicine is experiencing new challenges at the USPTO and the U.S. Food and Drug Administration (FDA). Under a new FDA proposal, laboratory developed test providers, previously exempt from FDA oversight, must now...more
In Akamai Techs. Inc. v. Limelight Networks, Inc., (August 13, 2015 Fed. Cir.) an en banc Federal Circuit unanimously held that direct infringement under Section 271(a) can occur...more
The U.S. Supreme Court’s recent trilogy of patent-eligibility decisions (Prometheus, Myriad and Alice) have called into question the validity of many U.S. patents on diagnostic medical methods. Nevertheless, legal battles...more
Double-digit growth is predicted for the molecular diagnostic market in the next several years, driven in part by an increased demand for personalized medicine—medical decisions and therapeutic products tailored to address...more