Tim McBride Discusses Gene Patents Lawsuit

The American Civil Liberties Union (ACLU) and other organizations have filed suit against the U.S. Patent and Trademark Office (USPTO), Myriad Genetics, and the University of Utah over patents on two human genes. The case, Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al., was filed in the United States District Court for the Southern District of New York.

The defendants hold patents on two human genes, BRCA1 and BRCA2, that are associated with breast and ovarian cancer. The plaintiffs allege that ownership of the patents is illegal and invalid because genes are the products of nature, that ownership of the patents stifles medical research and limits women's options for medical care, and that gene patents are unconstitutional under the First Amendment.

In his analysis of the lawsuit, attorney McBride observes that patents directed to genes have been issued by the USPTO for years. Such patents are presumed valid and directed to patentable subject matter, so long as the claimed genes are stated to be isolated, purified, or modified so as to prevent the claims from encompassing the genes as they occur in nature. In this respect, he says, "Myriad has history on its side and would seem to be on very solid ground." McBride says that the ACLU's strongest argument in the case would likely be the theory that "genes are products of nature that are not patentable under the provisions of the constitution that provide for the protection of inventions."

Less likely to be success if the ACLU's First Amendment argument that the patenting of genes is a prohibition of freedom of speech. McBride says, "The idea behind the patent laws and the issuance of patents is that an inventor and those to whom the rights to an invention are assigned should be rewarded for the investment of time and money in pursuing the discovery with a time-limited monopoly. This allows the inventor to recoup the costs and to benefit from the endeavors in exchange for the full disclosure of the invention to advance the useful arts. This disclosure of the invention does not limit free speech in a traditional sense; to the contrary, the disclosure enables the discussion of the same by other researchers, and encourages the exchange of ideas surrounding the patented technology and ways to improve upon it.”

"Regardless of how this suit proceeds," McBride says, "it should continue to garner substantial public attention as the patents deal with two very well known and commonly publicized diseases--namely breast and ovarian cancers." He adds that this lawsuit serves as an illustration of the give and take that underlies the patent system--namely the reward provided to the patent holder for his effort and often great expense in pursuing research of the patented technology versus the need of the public to be able to utilize that same technology.

Some of Mr. McBride's comments appear in the article "ACLU sues Myriad Genetics over Gene Patents," in the July/August 2009 issue of IVD Technology.