In an October 17, 2019 update (“2019 Update”) of its current subject matter eligibility guidance (2019 Revised Patent Subject Matter Eligibility Guidance (“2019 PEG”)), the United States Patent and Trademark Office (“USPTO”) gave further instruction on the eligibility of certain
Personalized Medicine Bulletin
The Personalized Medicine Bulletin, published by Foley & Lardner LLP, focuses on legal and regulatory developments related to precision and personalized medicine. It covers topics such as FDA approvals of personalized therapies, gene and cell-based treatments, diagnostic testing systems, and emerging technologies in biomanufacturing and gene editing. The bulletin also addresses government initiatives and funding programs supporting precision medicine research, including NIH and White House efforts. Additionally, it discusses intellectual property issues like patent programs for cancer immunotherapy and regulatory guidance impacting the development and commercialization of personalized medical products.
Latest from Personalized Medicine Bulletin - Page 3
Personalized Cancer Therapy Found Nonobvious
In OSI Pharmaceuticals, LLC v. Aoptex Inc. (Fed. Cir. 2018-1925, Oct. 4, 2019), the Federal Circuit reversed the Patent Trial and Appeal Board’s (Board) decision that certain claims of US Patent No. 6,900,221 were unpatentable as obvious. The court…
Personalized Therapy Patent Falls as Patent-Ineligible
In a non-precedential opinion, the Federal Circuit held as patent-ineligible patent claims to personalized therapy to treat patients who would benefit from inhaled nitric oxide treatment and withhold treatment from patients who might be harmed. INO Therapeutics LLC v. Praxair…
Statements of Efficacy and Safety Material Claim Limitations
In Allergan Sales, LLC v. Sandoz, Inc., (Fed. Cir. 2018-2207, Aug. 29, 2019), the Federal Circuit held that “wherein” clauses in a patent claim were limitations because the “wherein” elements were material to patentability. In doing so, the court…
The Era of Personalized Medicine Has Arrived – PMC’s Annual Progress and Outlook Report
The Personalized Medicine Coalition (PMC) released its annual “Personalized Medicine At FDA: A Progress & Outlook Report” (Report) that monitors current successes and challenges in bringing personalized therapies to market.
Notable Developments for 2018
Several milestones were noted…
Federal Circuit Invalidates Patented Cancer Therapy
In BTG International Limited v. Amneal Pharmaceuticals LLC, (Fed. Cir. Slip Op. 2019-1147, May 14, 2019), the Federal Circuit held that U.S. Patent No. 8,822,438 (“the ‘438 Patent”) was invalid as obvious over the prior art. The ‘438 Patent…
PMC Releases “A Consumers Guide to Genetic Health Testing”
The Personalized Medicine Coalition, or the “PMC” is an organization of over 250 members that seeks to promote the understanding and adoption of personalized or precision medicine concepts, services, and products by health care providers and consumers. Periodically, the PMC…
USPTO Patent Eligibility Training on 2019 Revised Subject Matter Guidance
On February 28, 2019, the USPTO summarized and explained the recently issued 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG) that changes the procedures for determining whether a patent claim is directed to patent eligible subject matter. While a…
New Guidance from Federal Circuit for Computer-Implemented Medical Methods
A patent claiming methods to integrate physiological treatment data remotely using a computer was held invalid under 35 U.S.C. § 101. University of Florida Research Foundation, Inc. v. General Electric Company, et al. (Fed. Cir., Slip Op. 2018-1284, February 26,…
Is 101 Relief in Sight?
Senators Thom Tillis (R-N.C.) and Chris Coons (D-Del.) released a plan to revise Section 101 of Title 35 of the U.S. Code relating to U.S. patent law, reports Alexis Kramer of Bloomberg Law. As reported by Ms. Kramer, the senators…