NIH Funded Research Centers Support Precision Medicine Research
Somatic mosaicisms are post-conception changes to cellular DNA that lead to genetic variation among cells in an organism.
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PMC Releases "A Consumers Guide to Genetic Health Testing"
Recently, the PMC released a user-friendly guide for consumers, “A Consumer’s Guide to Genetic Health Testing.”
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. <EM>University of Florida Research Foundation, Inc. v. General Electric Company, et al.</EM>
Medical Treatment Patent Claims Held Patentable Subject Matter Under the Alice/Mayo Section 101 Test
In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int’l Ltd, Slip Op. (Nos. 2016-2707, 2016-2708, April 13, 2018) the U.S. Court of Appeals for the Federal Circuit provided useful guidance for patentees seeking to survive a patent-eligibility challenge under Section 101.
Advancing Access to Precision Medicine Act - A Bipartisan Bill
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 to “provide a study by the National Academy of Medicine on the use of genetic and genomic testing to improve health care.
Why The Federal Circuit Revisited Written Description
In <EM>Stanford University v. The Chinese University of Hong Kong</EM> (Fed Cir. No 2015-2011, June 27, 2017), the Federal Circuit vacated and remanded interference decisions on the ground the Patent Trial and Appeal Board (“Board”) applied the incorrect standard in determining whether a patent specification satisfies the written description requirement.
HHS and Medicare Asked to Expand Coverage for Genetic Tests
15 members of Congress have asked the Department of Health and Human Services (HHS) to examine how the government can help improve access to genetic testing.
One is Not Enough – Infringement Liability under § 271(f)(1)
The Supreme Court’s decision in Life Technologies Corp. v. Promega Corp. is important for manufacturers of kit components.
FDA Hits “Pause” on Regulation of LDTs
On January 13, 2017, the U.S. Food and Drug Administration (FDA) issued a Discussion Paper on Laboratory Developed Tests (LDTs) (Discussion Paper).