Gene therapy Archives

The Cohen-Boyer patents were now issued 35 years ago at Stanford University… so what were they and how did they shape the Modern Biotechnology Field? Recombinant DNA (rDNA) products provided a new technology platform for a range of industries, resulting in over US$35 billion in sales for an estimated 2,442 new products. After Genentech was founded and the industry was starting to establish itself, the monetization of biotech discovery and technology really started with the Cohen-Boyer patents... These are really what made the industry take of - by making research lucrative. So during a collaboration between two US based scientists, enzymes were used to introduce specific DNA segments to plasmids, and then use the result as vehicles for cloning precise, previously targeted strands of DNA. Within four months they had succeeded in cloning genetically engineered molecules in foreign cells – i.e. rDNA was born, and published in the Proceedings of the National Academy of Sciences in 1973. The 17 years during which the Cohen-Boyer patents were licensed, Stanford consulted widely across various stakeholders before settling on the licensing terms. For Stanford, the logic was that recombinant DNA was a platform technology and it was not possible for any one company to exploit all the possible applications. Non-exclusive licensing allowed a large number of companies to push the technology forward in diverse ways, simultaneously. As the US Supreme Court on June 1th 1980 said: Anything under the sun that is made by man is patentable”. What? However, the real difference in this story was that instead of simply publishing this discovery, they decided to commercialise this opportunity through patenting the rDNA techniques – which was generally unheard of in the Biotech field. The original patent application was divided into a process patent application and two divisional product patent applications: one for recombinant DNA products produced in prokaryotic cells and the other for products produced in eukaryotic cells. Advances that have since been developed using this patented technology include drugs for heart disease, anaemia, cancer, HIV-AIDS, diabetes… Over the duration of the life of the patents (1980-97), the technology was licensed to 468 companies, many of them biotech companies who used the licenses to establish themselves. Over the 25 years of the licensing program, Stanford and the University of California system amassed a €241M fortune in licensing revenues (up until 2001). In many ways, Stanford’s management of the Cohen-Boyer patents has become the gold standard for university technology licensing. Who? In 1972, Stanley Cohen, then an associate professor of medicine at Stanford University, met Herbert Boyer (a biochemist and genetic engineer at the University of California) at a conference on bacterial plasmids in Hawaii and got interested in each other’s work. Boyer’s team had isolated an enzyme that could cut DNA strings precisely into segments that carried the code for a predetermined protein and such segments could also be attached to other DNA strands. Cohen, on his part, had developed a method for introducing antibiotic-carrying plasmids into certain bacteria, as well as method of isolating and cloning genes carried by the plasmids. Niels Reimers, founding director of the Stanford Office of Technology Licensing, recognized the huge potential of the gene splicing method in industry applications. He contacted Cohen about filing a patent application and persuaded him about the merits of seeking a patent. Indeed, the licensees list has not only included big names as Amgen, Lilly, Genentech and Merck, but also a many fledgling biotech companies, which used the license to establish their legitimacy. When? The patent application was filed on 4th November 1974, with Cohen and Boyer as inventors. If a patent was issued it was to be assigned to Stanford University. In 1976, Boyer co-founded Genentech with Robert Swanson, a venture capitalist. Six years after the 1974 patent application was filed, the first patent titled “Process for producing biologically functional molecular chimeras” (US Patent No. 4,237,224) was granted on 2nd December 1980. The second titled “Biologically functional molecular chimeras” was granted on 28 August 1984, and the third was granted on 26 April 1988, all three of which would expire in 1997 and assigned to Stanford University. So...? What Stanford has shown is that by initiating the creation of the Silicon Valley, it not only created employment opportunities for its graduates, but was able to opportunistically use the Valley as a platform to help create a thriving biotechnology industry using the Cohen-Boyer patents as a vehicle, without compromising its core academic values. Hence, the Cohen-Boyer Patents were really a game changer for the Biotech Industry when it was realised that research and genetics really was a long-term financial strategy too. Read more on the History of the Cohen-Boyer Patents here.