Leave it to the Patent Docs blog to keep us updated on the AMP v USPTO (Myriad) case. In the latest installment, the amicus brief of two academic professors - Christopher Holman, Ph.D. Associate Professor of Law, University of Missouri, KC School of Law and Robert Cook-Deegan, research Professor and Director, Center for Public Genomics at Duke University - argues the wisdom of retaining patent eligibility status for human genes. The brief was not filed to specifically support either side - rather it was filed to support maintenance of "a sensible patent system that accomplishes the constitutional goal of promoting the Progress of Science and useful Arts."
Basically, the Professors point is the there should be no outright ban on gene patents. Gene patents are useful in protecting an innovator and provide impetus for funding of genetic diagnostic testing, personalized medicine, and biotechnology in general (including biological drug development). They argue that there are more targetted regulatory paths one could take that would be more appropriate, or application of other areasof patent law - short of a ban on gene patents - would also help.
They note that gene patents have been issued for more than 30 years without the widespread restrictions of access to the market. In fact, patents have created incentive critical in attracting the substantial investment needed to fuel discovery and development for market introduction. Patent protection has been used to block direct competition among innovator companies, but there is scant evidence that this has had a negative impact on noncommercial, academic research. They note that most concerns about negative consequences of gene patents are based on the assumption that patents are always enforced - which has proven not to be the case.
The authors also note that observers need to differentiate between restrictions stemming from gene patents - namely restrictions between competitive commercial labs and restrictions on patient access to the specific gene test in question. For example, Myriad can use patents to restrict commercial competitors but there is little evidence that patients couldn't gain access to the tests or that fewer were tested as a result in the US.
If you think Myriad's claims are too broad, maybe they are say the authors. But don't invalidate gene patents to resolve. Use less blunt force tools to achieve the same end. Myriad's patents have been variously characterized by critics as:
- BRCA genes were "well known"
- Isolation of the genes was "inevitable"
- BRCA testing would be available without Myriad's contribution
- Myriad was not the first to identify BRCA
All of these are matters of substantive patent law and do not require an attack on patent eligibility. Proper claim construction is the appropriate tool for preventing the claims from being successfully asserted against activites outside their scope.
Moreover, if you don't like Myriad's business practices, then regulate them. Basically, they argue the FDA and other regulators should wake up in the US (as their counterparts in Europe have on this issue), or lawmakers can step in. For example, limitations can be placed on infringement liability for individuals using patented genetic technologies for research or genetic testing uses. This would be analogous to similar restrictions that exist now for ssurgical procedures and other "medical activities". Other possibilities that could be tried include compulsory licensing, march in rights under Bayh-Dole, and practice by state affiliated institutions with sovereign immunity. All less drastic than a general gene patent ban.
I encourage you to read the entire summary argument, and if really motivated go find the brief in its entire glory. Just remember, at present, gene patents are necessary to provide intellectual property protections to fuel investment - a position supported by BayBio, Genetic Alliance, and BIO.
Posted by Bruce Lehr December 8th 2010.