Gene Patents: Association for Molecular Pathology v. USPTO
A federal court case in New York might be one of the biggest landmark cases in modern legal history. The ACLU is challenging Myriad Genetics’ patents on the BRCA genes, which are related to breast and ovarian cancer. In recent years, major biotechnology companies have sequenced and patented about 20% of the human genome. Each patent gives that company the exclusive right to license testing procedures that involve that gene. Myriad charges approximately $3,000 for each test involving the BRCA genes.
Many commentators have been shocked that these companies have been able to patent human genes, which can be seen as products of nature instead of technological developments. Gene patents hamper fair competition because the company with the original sequencing patent is able to control all future sequences.
On the other hand, if companies have no legal protections at all for their genetic sequencing research, they will be less likely to push forward, investing millions in this technology.
The case, Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al, was filed early this year. The entire docket up through September is available from Justiia.com, but it is soul-crushingly large; the only substantive item so far is the original complaint. All the other documents are affidavits, notices, memos, and briefs. The defendants have not defended on the merits of the case yet because their preliminary challenges were just rejected this week.
The court, as it rejected the combined motion to dismiss, not only rejected the technical jurisdictional and procedural arguments raised by the defendants, but also emphasized the importance of this case:
The challenges to the patents-in-suit raise questions of difficult legal dimensions concerning constitutional protections over the information that serves as our genetic identities and the need to adopt policies that promote scientific innovation in biomedical research. The widespread use of gene sequence information as the foundation for biomedical research means that resolution of these issues will have far-reaching implications, not only for gene-based health care and the health of millions of women facing the specter of breast cancer, but also for the future course of biomedical research.
It must be emphasized that this case is in very early stages. The defendants will likely answer the complaint and defend on the merits of the case in a few months, and then a long stage of discovery and depositions will occur. It may be several months or even years before the court rules on this case and then it will almost certainly be appealed. This case may very well be argued in the Supreme Court in several years.
If the challengers are ultimately successful, thousands of other patents could be challenged and revoked. If Myriad successfully defends its patents, biotechnology companies will continue to patent increasing amounts of the human genome.
Hear is an interesting aspect that speaks to the fears that overly protective genetic patents; 1) stifle innovation 2) holdup medical testing 3) reduce competition .
Patent Stacking & Injunctive Threats:
“Royalty stacking refers to situations in which a single product
potentially infringes on many patents, and thus may bear multiple royalty burdens. The term “royalty stacking” reflects the fact that, from the perspective of the firm making the product in question, all of the different claims for royalties must be added or “stacked” together to determine the total royalty burden borne by the product if the firm is to sell that product free of patent litigation. As a matter of simple arithmetic, royalty stacking magnifies the
problems associated with injunction threats and holdup, and greatly so if many patents read on the same product. In this key sense, the problems of injunction threats and royalty stacking are intertwined.”
http://faculty.haas.berkeley.edu/SHAPIRO/stacking.pdf
keep in mind, though, that the term of a patent is only 20 years, at which point it enters into the public domain.
i don’t think 20 years is too much to ask when you consider the enormous amount of money and resources spent on research and development.
It all really depends on the industry. Technology and science is quickly progressing. We have to keep the interests of society in mind while balancing that with the need for profit.
The resources invested in R&D are certainly an understandable interest. I’d be curious to see more specific numbers on it, though. I assume they spend somewhere in the couple million dollar range developing each one, and charge $3k for each testing. So after a few hundred tests, their costs are probably paid for.
But I don’t really know what goes into this kind of development. It seems like a really really good deal for the companies, though, and maybe it should be modified.
Whatever the result of this case, it will be extremely important.