LSIPR 50 2016: Steve Bossone and Stephen Breyer
Name: Steve Bossone
Organisation: Alnylam Pharmaceuticals
Position: Vice president of intellectual property
Steve Bossone has worked at Alnylam Pharmaceuticals since 2010 and is vice president of intellectual property at the company. He achieved his JD in IP from Suffolk University Law School, and since graduating he has had various roles in pharmaceutical companies, including working as a patent counsel at EMD Serono from 2004 to 2007 and Shire Human Genetics Therapies from 2007 to 2010.
Alnylam has developed an extensive patent estate in the field of RNA interference (RNAi) therapeutics, enabling multiple business relationships which have furthered the development of the therapeutics. To add to its capabilities, in 2014 Alnylam paid Merck $175 million for its subsidiary Sirna Therapeutics, a firm specialising in RNAi therapeutics.
John Maraganore, chief executive of Alnylam, said: “We believe that the acquisition of Merck’s RNAi technologies and intellectual property will further our efforts to build a new class of medicines, advancing them to patients in need.”
Bossone is an advocate of protecting IP in the life sciences industry, having spoken before the US Senate Committee on the Judiciary about limiting ‘patent troll’ abuse. He suggested that making sweeping changes to the patenting and licensing system without due consideration to how these changes could affect small businesses and legitimate patent owners would “do serious harm to the life sciences ecosystem”.
Name: Stephen Breyer
Organisation: US Supreme Court
Position: Associate justice
Associate Justice Stephen Breyer has had a long career at the US Supreme Court, where he has presided over many important cases. He achieved his LLB from Harvard Law School and served as a law clerk to Justice Arthur Goldberg in 1964. He worked as a special counsel to the US Senate Judiciary Committee from 1974 to 1975, and as an assistant professor, professor of law and lecturer at Harvard Law School from 1967 to 1994.
Breyer served as a judge and chief judge at the US Court of Appeals for the Federal Circuit from 1980 to 1994. Former US President Bill Clinton nominated him as an associate justice of the Supreme Court and he took his seat in 1994.
He has noted that this approach is down to his six interpretive tools: text, history, tradition, precedent, the purpose of a statute, and the consequences of competing interpretations.
Breyer’s influence in the life sciences industry is centred on his involvement in the Association for Molecular Pathology v Myriad Genetics and Mayo v Prometheus cases, in which he delivered the Supreme Court’s decisions.
"this approach is down to his six interpretive tools: text, history, tradition, precedent, the purpose of a statute, and the consequences of competing interpretations."
In Mayo, the court held that claims to methods of administering drugs to treat gastrointestinal autoimmune diseases did not meet the patent-eligible subject matter standards of 35 USC §101. As part of this decision, the court outlined a two-step inquiry that provided more regimented guidance on patent eligibility.
Under the Mayo test, one must determine whether claims are directed to a patent-ineligible concept, ie, laws of nature, natural phenomena, or abstract ideas. If so, one must then search for the “inventive concept” by determining whether additional elements “transform the nature of the claim” into a patent-eligible application.
This decision, delivered by Breyer, has altered the landscape in biotech and pharma patenting.
