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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 (the chairman and a ranking member respectively of the Senate Judiciary Subcommittee on Intellectual Property) have been meeting with industry representatives since December of 2018 to discuss how to redefine patent-eligible subject matter under U.S.…
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, 2019). The Federal Circuit affirmed the district court’s invalidity decision on a motion to dismiss and provided a reasoned analysis of § 101 jurisprudence for computer-implemented methods. The decision provides useful guidance to innovators who…
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 majority of the changes directly impact computer-implemented inventions, the 2019 PEG does change how claims to personalized therapies are examined for patent eligibility. The 2019 PEG slide deck is available here (PEG Slide deck).…
On January 4, 2019, the US Patent and Trademark Office (USPTO) announced revised guidance for determining subject matter eligibility under 35 U.S.C. § 101 for computer-implemented inventions (Guidance). The Guidance takes effect Monday, January 7, 2019. The Guidance is important for medical patents that use algorithms for diagnosis and treatment decisions in personalized medicine. Two Primary Changes to Improve Clarity Two primary changes on how patent examiners should apply the first part of…
This year marks the 15th anniversary of the completion of the Human Genome Project. In the decade and a half that has passed since, the genomic revolution has spurred an immeasurable level of excitement and support surrounding the promise of personalized medicine, setting high expectations for a new era of health care and rapidly transforming the field into a multi-billion dollar industry. While realizing that promise has turned out to be neither quick nor easy,…
In Roche Molecular Systems, Inc. v Cepheid, (Slip Op. 2017-1690, October 9, 2018), the Federal Circuit held that patent claims directed to primers and methods of detecting pathogenic bacteria using the primers are invalid for failing to claim patent-eligible subject matter. The decision summarizes this panel’s current thinking on the patent-eligibility of unmodified polynucleotides and methods to detect “natural phenomena” using “conventional” tools. Also, the panel deferred opining on the patent-eligibility of modified polynucleotides…
The National Institutes of Health (NIH) opened national enrollment today, May 6th, for the All of Us research program. Initially branded as the “Precision Medicine Initiative Cohort Program,” All of Us is the largest health and medical research program on precision medicine, aiming to enroll 1 million or more diverse volunteers. Any adult age 18 or older may enroll.…
On February 15, 2018, representatives Eric Swalwell (CA-15), John Shimkus (IL-15), Scott Peters (CA-52), Erik Paulson (MN-03), and Juan Vargas (CA-51), introduced the Advancing Access to Precision Medicine Act (H.R. 5062)(“Bill”) to “provide a study by the National Academy of Medicine on the use of genetic and genomic testing to improve health care, and for other purposes.” (Bill, page 1).  The National Academy of Medicine’s report on its study is due within 3 years from the…