DIAGNOSTIC METHOD CLAIMS AND PRIMER TOOLS LACK PATENT-ELIGIBILITY

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 and the use of polynucleotides as therapeutics. Continue reading this entry

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.

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All of Us Research Program Opens May 6th

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. Continue reading this entry

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 (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 date of enactment. Continue reading this entry

Over 30% of New Drug Approvals in 2017 were Personalized Medicines

The Personalized Medicine Coalition (PMC) recently published its “Personalized Medicine at FDA: 2017 Progress Report” (Report) that highlights drug approval developments and milestones achieved in 2017. Last year was notable for a record number of personalized medicine approvals by the FDA, and 5 “firsts” for the industry:

  1. Three gene therapies were approved;
  2. A tissue agnostic indication for cancer therapy was approved;
  3. 23andMe received approval of its direct to consumer genetic test;
  4. A personalized medicine biosimilar was approved; and
  5. A test using next-generation sequencing technology was jointly approved by FDA and CMS.

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