In a Reuters story posted yesterday, Francis Collins, one of the directors of the Human Genome Project, was asked if the Project had lived up to the hype that accompanied the sequencing of the entire human genome ten years ago. Sensibly, he pointed to the value of simply having such an immense amount of data about the biocircuits that run our homeostasis (or disrupt it) to mine, and predicted the rise of personalized medicine in the next ten to twenty years. That may sound like a long time in the 21st century which has already brought us 3D TV, the iPhone and satellite radio. However, this year also marked the 30th anniversary of the Supreme Court’s decision in Diamond v. Chakrabarty, 447 U.S. 303 (1980), holding that man-made, or “genetically-engineered” microorganisms were patentable subject matter. (Chakrabarty got his patent in 1981, ironically directed to a bacterium modified to digest petroleum.) This decision founded the biotechnology industry, and led to the success of companies like Genentech, Biogen, and Genzyme. So those impatient with the pace of the development of customized biomarkers and personalized medicine should take a deep breath and consider what the last thirty years have wrought. Human growth hormone, insulin, recombinant vaccines, recombinant enzymes, and cytokines that can treat truly horrible genetic diseases and, like it or not, corn, cotton, and soybeans that can resist pests or can tolerate relatively user-friendly pesticides. Dr. Collins’ guesstimate for the gestation period of the next plateau of progress in biomedicine may well prove to be prescient. That is, if the courts, and Congress and “public interest groups” don’t succeed in convincing society that the patent system needs to be reigned in before you have to get a license to breathe.
The fragility of the relatively thin framework of case law and regulations that permitted and fostered the growth of this new way of thinking about our physiological destinies was brought home the other day when a reporter wanted to talk to me about a Biogen patent (Fiers, U.S. Pat. No. 7588755). This patent surfaced like a WWII submarine, in 2009, from a series of applications first filed in 1980, the same year that Chakrabarty was decided. The patent claims a method of treating various conditions, including “cancers” by administering to a patient a recombinant polypeptide [human fibroblast interferon] produced by a “non-human host” transformed with certain recombinant DNA sequences. Of course, it is now in litigation, since interferons can treat a wide variety of pathologies, including MS.
For an biotech patent attorney who began to practice in 1981, as did I, reading this patent would be like finding a mint 1966 Mustang in your grandfather’s garage, but the reporter did not want to talk about sequence listings, hybridization or pBR322. She wanted to talk about whether or not the claims were valid in view of all the attacks on “gene patents” she had been reading about. I wanted to ask her to mentally step back to 1980 and imagine how exciting it must have been to be able to produce a human protein, or cytokine, in a bioreactor, without having to extract it from human tissues. But if she took that step back, she would probably find herself in pre-school, so I didn’t bother to try, and instead rambled on for a while about how claims to methods of medical treatment were found to meet the Bilski M or T test, and said good-by.