The American Medical Association et al. File Amici Brief Arguing for Affirmance of AMP v. PTO

An amici brief was filed yesterday by Professors Lori Andrews and Joshua Sarnoff on behalf of the American Medical Association, American Society of Human Genetics, American College of Obstetricians and Gynecologists, American College of Embryology, and the Medical Society of the State of New York, arguing for affirmance of the district court's decision in AMP v. PTO. Professor Andrews has for years been one of the most outspoken critics of gene patents, and was involved with a bill introduced in Congress in 2007 that if enacted would have broadly prohibited the patenting of DNA-based inventions.

Their brief is more alarmist than the brief submitted by the ACLU/PubPat, arguing that gene patents have cost patient's their lives, and the healthcare system billions of dollars. For example, allege that gene patents are being asserted against physicians across the country, and that physicians have to worry about infringing patents based on nothing more than mere "conscious thoughts." They also contend that gene patents are killing patients. For example, they state that drug companies have used these patents to prevent use of genetic testing to determine whether a drug will help or harm patients, to block the availability of genetic testing (which they allege resulted in the of a 10-year-old patient), and to force patients to use poor quality diagnostic tests rather than improved alternatives (which they allege resulted in a patient undergoing unnecessary removal of ovaries based on erroneous BRC genetic test result).

The AMA et al. adopt a very broad definition of the diagnostic method claims, under which they would be infringed by anyone merely "reading and thinking about the sequence data disclosed in the patent." As discussed in a previous post, this is a much broader interpretation of the claims than Myriad has proffered.

They also argue that patents are not necessary to incentivize the discovery of genetic mutations correlated with disease or the commercialization of diagnostic testing based on these discoveries, citing to the Sec.'s Advisory Committee on Genetics, Health and Society (SACGHS) Report.

In the amici brief submitted by me and Robert Cook-Deegan, we argued that regardless of whether patents are necessary to incentivize the development of genetic diagnostic testing for Mendelian traits, in which mutations in a single gene are highly correlated with a specific disease, they quite likely will be necessary for the optimal development of next-generation genetic diagnostic testing involving much more complex relationships and multiple genes, or if FDA imposes heightened regulation on diagnostic testing. We also argued that a decision broadly rendering gene patents patent ineligible could have serious unintended negative consequences for biotechnology, particularly outside the realm of Mendelian genetic diagnostic testing, and that there are other more focused approaches for dealing with problematic gene patents or gene patent enforcement activities. The AMA brief does not address these points, but rather seems to assume that the only available mechanisms for dealing with problems associated with gene patents is a broad prohibition extending far beyond Myriad and BRCA testing.