The Beginning of the End? A Federal District Court Holds Gene Patents Invalid

Nearly two months after the close of oral arguments, a New York District Court has issued its ruling in the widely publicized gene patenting case against Myriad Genetics. The case concerns patents of the BRCA1 and BRCA2 genes held by Myriad Genetics. Mutations of these genes are linked with significantly increased risk of breast and ovarian cancer. For additional background on the case, see my prior post: Can Someone Else Own Your Genes? In what is sure to become a watershed case on the issue of gene patents, U.S. District Court Judge Robert Sweet held that Myriad’s patents are invalid.

The plaintiffs argued that the patented genes at issue in the lawsuit are products of nature and therefore, ineligible for patent protection. Supreme Court precedent has long held that “products of nature” are outside the scope of patentable subject matter under 35 U.S.C. §101. In response, the defendants attempted to make a distinction between DNA as it exists in the body (“native DNA”) and isolated DNA fragments (“isolated DNA”) which are the subject of Myriad’s patents. In his opinion, Judge Sweet stated that to be considered patentable, the item claimed must be “markedly different” from a product of nature. Furthermore, purification of a naturally occurring substance is insufficient to render a product of nature patentable.

In holding that isolated DNA is not markedly different from a product of nature, Judge Sweet emphasized the unique characteristic of DNA as a carrier of information about the construction of the human body – a characteristic which inheres in both native DNA and isolated DNA. Judge Sweet reasoned that this fundamental similarity between native DNA and isolated DNA led to the conclusion that isolated DNA is not “markedly different” from a product of nature and is therefore ineligible for patent protection.

The impact of Myriad’s patents on the accessibility BRCA testing and on the advancement of medical research and treatment was hotly contested, both in oral argument and in the media,. The court devoted 16 pages of its 152 page opinion to the discussion of these issues; however, Judge Sweet ultimately stated that these sensitive factual issues could not be resolved at the summary judgment stage. Regardless, it seems naïve to think that these policy questions did not influence the court’s ultimate decision on the patentability issue.

The decision is viewed by medical researchers and patient advocates as a victory that will remove a major impediment to the advancement of genetic research and allow for greater accessibility and more competitive pricing of genetic testing. Myriad’s attorney, Brian Poissant, stated that disallowing gene patents would wreck the foundation of the biotechnology industry. However, Poissant also downplayed the effect of this litigation – pointing out that this case affects only 7 of Myriad’s 23 patents related to the BRCA genes. The decision issued by Judge Sweet is by no means final; Myriad has already expressed its intention to appeal the decision to the Second Circuit Court of Appeals and the case could make it all the way up to the Supreme Court. If the decision is upheld on appeal, it could be the beginning of the end for gene patents.