US BIOTECH
Te US Supreme Court, on March 20, unanimously invalidated a broad medical diagnostic patent owned by the Prometheus Laboratories Inc unit of Nestle SA and asserted in a patent infringement lawsuit against Mayo Collaborative Services (doing business as Mayo Medical laboratories), thereby giving a significant victory to the medical profession (Mayo v Prometheus, 566 US [2012]). Te Prometheus patents—US patent numbers 6,355,623 and 6,680,302—include claims which cover a method for determining the proper dose of a drug used to treat autoimmune disorders. By invalidating these patents, medical providers have potentially been saved from a host of broad newly issued patents covering medical diagnostic tests. Nervous physicians in the US have been at risk of infringing such patents merely by using scientific research in arriving at patient treatment options. Te court cited the provisions of the US Patent Act, which dictates that discoveries based upon the “laws of nature” cannot be patented. Te court held that a process which recites a law of nature, likewise, cannot be patented, and it reversed the Federal Circuit’s judgment favouring Prometheus.
Amicus curiae briefs urging the court toward its final determination were filed by a relatively broad coalition of groups including the American Association of Retired Persons (AARP), the American Civil Liberties Union (ACLU), the American Medical Association (AMA), and the Cato Institute. Amicus briefs supporting Mayo included associations of physicians, researchers, medical educators, healthcare service providers, several public interest groups, two clinical laboratories, and two high-tech non-life sciences companies. Amicus briefs supporting Prometheus included life sciences biotech companies, Pharmaceutical Research Manufacturers of America (PhRMA), the Association of University Technology Managers, and Myriad Genetics (itself at the centre of a Supreme Court decision discussed below). Te Obama administration supported Prometheus and the biotech industry’s position.
Vocal opponents of the expansion of patent law into the medical profession include Timothy B.
www.worldipreview.com
Lee in his Law & Disorder article: “Oblivious Supreme Court poised to legalize medical patents”, published within a week of oral arguments in the case. Lee quotes from the AMA’s amicus brief: “If claims to exclusive rights over the body’s natural responses to illness and medical treatment are permitted to stand, the result will be a vast thicket of exclusive rights over the use of critical scientific data that must remain widely available if physicians are to provide sound medical care.” Te AMA doctors went on to argue: “Conscientious physicians will be unwilling and unable to avoid considering all relevant scientific information when reviewing test results. Tus, as medical knowledge accumulates, patent licenses increasingly will be required for physicians to conduct even well established diagnostic tests.” Justice Stephen Breyer, writing the court’s main opinion, obviously agreed with the doctors.
Te number of patent cases accepted by the Supreme Court is relatively small and, for this reason, the patent bar takes great interest in its decisions. Te court’s decisions have enormous impact upon the day-to-day practice of patent attorneys. Tose involved with patent prosecution are guided by the court’s dictates as to what type of patent claims stand a better chance of resisting an invalidity challenge. Tose whose practice includes patent litigation defences will be armed with invalidity arguments which may be bolstered by the court’s decisions.
Te Mayo v Prometheus decision surprised and disappointed the biotech industry and directly impacts on the delivery of personalised medicine, which tailors medical treatment to the genetic makeup and characteristics of individual patients. Biotech observers seemed encouraged by the oral argument in this case. Companies, have in recent years, increasingly sought to patent medical diagnostic procedures and methods which are arrived at aſter obtaining favourable outcomes from experimenting with the efficacy of drugs.
Drug efficacy is not the only concern. Some drugs are somewhat toxic, such that monitoring the levels of toxins in patients’ bloodstream will ensure that dosage levels will not adversely
World Intellectual Property Review Annual 2012 29
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