Why Myriad Still Matters

Originally posted Feb 2011

The bellwether case in genetic rights will set the tone for the foreseeable future of biotech.

Filed in May 2009, Association for Molecular Pathology v. U.S. Patent and Trademark Office, often called the Myriad case, pits Myriad Genetics and the Patent Office against an assortment of professional associations and individual plaintiffs. The case is to determine whether BRCA1 and BRCA2, genes associated with breast and ovarian cancers, can be patented. Myriad, the University of Utah, and National Institute of Environmental Health Sciences were granted patents on the two genes in the late 1990s.

District Court Judge Robert W. Sweet ruled against the defendants in March of last year, saying that “patents ... directed to 'isolated DNA' containing sequences found in nature are unsustainable as a matter of law”. This is a serious ruling for biotech firms, people at risk for cancer, and civil rights activists in general. Beyond that, however, it also invalidated the rest of the essentially immeasurable pool of patents on genes. (And I mean “immeasurable”: sources list the number anywhere between 2,000 and 500,000.)

The ruling is, of course, being appealed. Considering the effects this change in operating procedures would have on the entire genetic world, the Myriad case will almost certainly reach the Supreme Court of the United States. What the highest court in the land will do is anyone’s guess—while the justices have a tendency to break toward the interests of corporations, Mr. Sweet’s opinion appears to be well-founded. The Department of Justice filed an amicus brief in support of the plaintiffs in the most recent appeal.

Well, sort of. What they did was to file a brief that supported the concept that an unmodified human gene is unpatentable. They did not comment on the patenting of cDNA (complimentary DNA, a type of DNA created in the lab) that contains identical information. Judge Sweet’s ruling made all isolated DNA encoding sequences found in nature ineligible for patent. Essentially, the DoJ disagreed that the genetic information was protected from patent by virtue of being found in nature; only the DNA itself was out of reach.

This is much different from precedent set on other information licensing. If, for example, a work is in the public domain, it remains in the public domain, no matter where it resides. You cannot patent the concept of having the complete works of William Shakespeare on a USB drive. You can patent the USB drive, but you cannot patent the work that is already free for public use. However, apparently, you can patent the expression of BRCA1 in cDNA without having to patent either BRCA1 or cDNA.

It appears (if only to me) that, in the end, the Supreme Court decision will at the very least invalidate the patents held by the defendants on genetic information already expressed on existing non-synthesized human DNA. This will likely open the way for most of the rest of the patented genome to be released.

To this reporter, that sounds like a good thing. What could possibly be wrong with an open genome?