Intema Files Petition for Grant of Certification

Following the Fed. Cir. holding that the claims in Intema’s patent (U.S. Pat. No. 6,573,103) on an improved method for determining the risk of a Down’s syndrome pregnancy were patent-ineligible as directed to a law of nature and a mental step, Intema petitioned the Supreme Court to grant cert. on May 16, 2013 (2013 U.S. S. Ct. Briefs LEXIS 2395). Intema urged the Court to consider that the Intema panel holding that Mayo (“Prometheus”) compelled the ruling, was a “miscarriage of justice” and would “eviscerate” claims to diagnostic and screening tests and personalized medicine.

The heart of Intema’s thorough analysis of Mayo, and about every other major decision involving patentable subject matter in the life sciences area, is its argument that the Fed. Cir. has imposed a “rigid rule” (a popular term to get the S. Ct. interested in reviewing a Fed. Cir. decision) that (a) data gathering steps, even if they include novel and non-obvious combinations of known steps, may not be considered all or even part of the “inventive concept” required by Mayo, that ensures that the patent is significantly more that the natural law itself, and (b) that a claimed method that provides test results (Intema studiously avoids the term “diagnosis” for some reason) that determine a (potential) course of action must include a final step that involves physical activity (as opposed to mental activity, such as arriving at a diagnosis).

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Teresa Stanek Rea Announces Her Departure From the PTO

Acting USPTO Director Teresa “Terry” Rea has announced that she will leave the PTO after a new Director is selected. She will probably complete two years in the position, which has been affected by the sequestration of funding, a backlog of applications that is still daunting, and the need for even more Examiners capable of applying ever-changing standards of patentability to evolving technologies. Terry has served the IP community capably for years, particularly in her various roles in the AIPLA, where she became the first woman with a background in life sciences patent law to serve as President. Apart from wondering who would want her current job, I certainly wish her well, and am curious to see what the future will bring her way.

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Bayh-Dole Has Stood the Test of Time

Recently, the Bayh-Dole Act has come under attack as inhibiting the spread of technological innovation. One thing the writers seem to have in common is the absence of any ability to recall what the situation was pre-Bayh-Dole when private companies tried to license inventions from “universities” that were made with Government funding. Title to such inventions rested with the U.S. Government agency that had financed the research, and Government agencies in the 70’s and early 80’s did not have anything like the modern technology transfer offices that many universities and other non-profit institutions have today. When I arrived in Minneapolis in 1984, my employer, Merchant & Gould represented both the University of Minnesota and the Mayo Clinic, and had filed fewer than 20 patent applications for each of them—although Merchant & Gould had been in business for more than 80 years.

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Dr. Watson, Genomics and the Law

Since the legal tsunami of court decisions affecting many aspects of life sciences – from patents on Round-UpTM Ready soybeans to “companion diagnostics” – has rolled back out to the sea of summer break, I have found time to reflect on the progression of the life sciences – particularly genomics. My musings were prompted by two recent New York Times’ articles – one by Edward Rothstein on an exhibit, “Genomics – Unlocking Life’s Code”, (Aug. 30, 2013) now at the Smithsonian Institute and another by Amy Harmon,  entitled “Golden Rice: Lifesaver?” (Aug. 25, 2013).

My reflections were also triggered by an opportunity that was offered to me a few weeks ago – and that I leapt to take – to go birding with Dr. James Watson, the co-discoverer of the structure of DNA in 1953. Although he is well into his 80’s, he had little trouble getting in and out of my SUV and “getting on” the birds with his binoculars. A further coincidence was that, earlier in the year, I had presented a paper on patenting DNA at the Cold Spring Harbor Laboratories, where he is the Emeritus Director. I told him this with some trepidation, since he came out against patenting DNA many years ago.

The point of this story is not to point out the wonders of geriatric medicine, but that it reminded me that all the progress that has been made in genomics-based biotechnology has occurred in the blink of an eye, insofar as human scientific advances go. When Drs. Watson and Crick published on the structure of DNA in 1953, I was unwrapping my first chemistry set. Ten years ago, a human genome was sequenced. If the service was widely available, most people could carry the DNA sequence around with them on a flash drive. All this progress in only about 50 years! If any of you youngsters think that this is a long time, consider that it took 500 years or so from the discovery that the planets revolve around the sun until we could put a man on (just) our moon.

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