On January 28, 2016, the White House issued a Memorandum establishing the Moonshot Task Force “to double the rate of progress in the fight against cancer – and put ourselves on a path to achieve in just 5 years research and treatment gains that otherwise might take a decade or more.” (A copy can be found at the end of this post.) The Task force, chaired by the VP, is to focus on “making the most of Federal Investments, targeted incentives, private sector efforts from industry and philanthropy, patient engagement initiatives, and other mechanisms to support cancer research and enable progress in treatment and care.” No mention of the importance of patent protection so far.
The membership will consist of the heads of 13 executive branch departments, agencies, and offices, including NIH, DOE, FDA, and NSF, among other. The head of the Department of Commerce is included, but the USPTO is not mentioned once. However, I have been informed by the PTO Press Secretary that the USPTO, including Director Lee and Chief of Staff Aiyer attended the February 4th Task Force Meeting. The Task Force is to provide a report before the end of the year that includes seven recommendations, including to “identify and address any unnecessary regulatory barriers and consider ways to expedite administrative reforms.”
Again, no mention of the role of patent protection to encourage development of new chemotherapies. But the Task Force could do a lot to address unnecessary regulatory barriers and to expedite administrative reforms by recommending that the PTO tear up its examination guidelines for natural phenomena that are not specifically dealt with by legislation (no patenting of humans) or by Supreme Court decisions (Myriad and Mayo should be read narrowly, so as to permit patenting of nature-derived products, diagnostic methods and methods of medical treatment with known compounds).
Consider that in a paper published by David Newman of the NCI with George Cragg, J Nat. Product. 75(3) 311 (2012), the authors did a rigorous survey from 1940’s to the present and conclude: “Thus, in the area of cancer research, of the 175 [approved anti-cancer] small molecules, 131 or 74.8% are other than synthetic, with 85 or 48.6% actually being natural products or directly derived therefrom.” (A copy of the paper is also available at the end of this post.)
Remember, the holding that isolated genomic DNA is not patent-eligible in Myriad was called a narrow decision by the Supreme Court. It was the PTO that took it upon itself to require Examiners to reject claims to any nature derived compound that is not markedly different in its structure (or function?) than in its natural state. And it was the PTO that issued guidelines stating that diagnostic claims that involved correlation of a biomarker with a pathology or a preferred treatment were not patent-eligible period. This adoption of the “Metabolite Labs. dissent” by Justice Breyer has nothing to do with the Mayo v. Prometheus decision. These two Examination Guidelines have cost applicants millions of dollars in legal fees as they struggle for PTO or judicial clarification. I know from first-hand experience that the Guidelines have delayed, or blocked, the development of new cancer diagnostic methods.
While most of my colleagues have little hope for a legislative “fix” of s. 101, perhaps we can find at least one member of the Task Force that will tackle the need for “administrative reforms” in the war against cancer, that will reach into the PTO. The Memorandum states that a member of the Task Force can designate any Government Employee in his/her agency to help address an issue within its purview. One problem is that the PTO has been circling the wagons for almost two years, to protect these anti-patent Guidelines. How can practitioners and the biotech/pharma industry use the Task Force to get a pro-patent “fox” into this closely guarded “hen house?”