California’s Bet on Precision Medicine


California sees opportunities in personalized medicine. Earlier this month, Governor Brown announced the creation of a two year initiative – California Initiative to Advance Precision Medicine to “begin building infrastructure and assembling resources necessary to advance precision medicine-orientated data, tools and applications.” See California Launches Initiative to Advance Precision Medicine. Continue reading this entry

Perspectives on the President’s Precision Medicine Initiative


President Obama’s “precision medicine initiative” earmarked over $200 million from his proposed 2016 budget to “bring us closer to curing diseases like cancer and diabetes – and to give all of us access to the personalized information we need to keep ourselves and our families healthier.”[1] The National Institutes of Health (“NIH”) and the National Cancer Institute (“NCI”) will be the major benefactors if the proposed budget for this initiative is approved. A recent article co-authored by Drs. Francis S. Collins and Harold Varmus, directors of the NIH and NCI, respectively, identifies precision medicine’s critical needs and discusses how the President’s initiative will help “accelerate progress toward a new era of precision medicine.”[2] Continue reading this entry

Direct-to-Consumer Genetic Test Authorized by FDA


23andMe is not a traditional diagnostics company. Rather than seeking to directly sell its services to health care professionals, 23andMe went straight to the consumer, offering genetic screening and analysis in a mail-order fashion. For ninety-nine dollars, customers only needed to send in a saliva sample and the company would analyze the customer’s genetic information, interpret and report the results directly to the consumer, bypassing the physician or genetic counselor. Continue reading this entry

Patenting Stem Cells in View of the USPTO’s New Interim Guidance


Late last year, the USPTO issued its modified and revised 2014 Interim Guidance on Patent Subject Matter Eligibility (Interim Guidance) to assist patent examiners and the public in determining if a claim presented for examination is patent-eligible in view of recent U.S. Supreme Court decisions, namely Alice Corp., Myriad, and Mayo. In addition to streamlining the analysis of patent claims directed to any one of the judicial exceptions to patent-eligibility (abstract ideas, laws of nature and physical phenomena), the USPTO provided illustrative examples to be used in combination with the Interim Guidance. One such example discussed the patent-eligibility of claims directed to stem cells or regenerative medicine. Fortunately for these industries, application of the Interim Guidance as discussed in the example finds that many stem cell technologies are patent-eligible. Continue reading this entry

Details Emerge for President’s Precision Medicine Initiative


Personalized medicine has a friend in high places. President Obama recently announced an initiative to support “precision” or personalized medicine. In very general terms, the President stated during his 2015 State of the Union address that he wanted the United States to lead a new era of medicine – an era that delivers the right treatment at the right time. Continue reading this entry