Patents, Genes and the Future of Biotech
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The decision yesterday rendered by Federal District Court Judge Robert W. Sweet that invalidated the patents issued to Myriad Genetics for the breast cancer marker genes BRCA1 and BRCA2 is analogous to the “shot heard round the world” that kicked off the American Revolution in 1775. While it isn’t clear whether or not the decision will stand (Myriad has appealed the ruling), it does have the potential to change the way in which life sciences companies may operate in the future.
Patents are the lifeblood of the biotechnology industry. Because of this, scientists, university technology transfer offices and many would be entrepreneurs have sought to patent any and all ideas, inventions and potential products that may serve as the basis for a life sciences community. This has resulted in the issuance of a surfeit of composition of matter patents for many human and non-human DNA sequences that encode potential industrial and therapeutic proteins.
Prior to the sequencing of the human genome, many scientists and entrepreneurs had compelling and legitimate arguments to patent newly discovered DNA sequences. While these sequences existed in nature prior to their discovery, their commercial potential could not be fully realized until the genes and their products were isolated and fully characterized which generally required many years of scientific study. In contrast, however, the advent of whole genome sequencing allows scientists, to easily identify genes and their products that are likely to have future commercial potential and value. Because this renders inventions that make use of the genes or proteins themselves obvious, composition of matter patents are no longer feasible or warranted. Also, while composition of matter patents may have been lucrative in the past, it is usually secondary process patents that extend the commercial lifecycle of protein-based drugs. For example, the composition of matter patent for recombinant erythropoietin (held by Amgen) expired in 2004. However, Amgen has recombinant erythropoietin process and production patents that preclude competition in the US until 2017.
While composition of matter patents may be important for therapeutic proteins, the same isn’t true for diagnostic products. In fact, composition of matter patents in this case (like Myriad Genetics patents for BRAC1 and BRACA2) tend to stifle innovation and create monopolies for the companies that own them. The elimination of composition of matter patents for DNA sequences will give scientists the requisite freedom to operate and necessary creativity to develop new tests and uses for novel genes and their products.
To that end, the diagnostic industry would be well served if it adopted the open source business model pioneered by the software industry. This has resulted in the creation and development of new products, commercial applications and business opportunities that have exceeded the expectations of the companies that developed the original code. I see no reason why the same approach couldn’t be used in the diagnostic and personalized medicine industries as they continue to mature. After all, the human genome is the ultimate source code and allowing free and unfettered access to its contents will undoubtedly result in many innovative, useful and previously unimagined commercial scientific and healthcare advances in the future.
Until next time…
Good Luck and Good Job Hunting!!!!!!!!!
As
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Roche 
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Mark Senak, author of the incisive 
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Merck of Germany 