Last year, several doctors' groups, together with the ACLU and Public Patent Foundation, filed a lawsuit seeking to invalidate patents on two genes related to breast cancer and owned by Utah-based Myriad Genetics. The plaintiffs, who can be viewed as arguing more broadly against all genetic patents, claimed in the suit that such patents are not only illegal under the nation's patent laws, but also unconstitutional.
On Monday afternoon, the plaintiffs won. Ruling on summary judgment motions filed by both sides, New York federal district court Judge Robert Sweet ruled on summary judgment invalidated Myriad's patents on the BRCA1 and BRCA2 genes. In his 152-page opinion [PDF], Sweet wrote that the patents in question cover parts of the natural world and therefore don't conform to section 101 of U.S. patent laws, which those govern what qualifies as patentable subject matter.
Sweet agreed with the ACLU's basic argument that the "isolated" DNA that Myriad claimed to have patented is still a product of nature, and can't be covered by patents. He wrote: "It is concluded that DNA's existence in an 'isolated' form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes. Therefore, the patents at issue directed to 'isolated DNA' containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable subject matter."
The plaintiffs did lose on one point: Sweet agreed with the U.S. Patent and Trademark Office, which was also a named defendant in the case, that it was inappropriate for him to address the constitutional questions raised in the lawsuit. The ACLU had argued that genetic patents violate the First Amendment by preventing research and discussion of the patented subject matter and that they violate the so-called "progress clause" of the U.S. Constitution because patents like Myriad's don't "promote the progress" of science.
Earlier this year, PTO lawyers argued vociferously that even if Myriad's patents were ultimately invalidated, courts were not supposed to address constitutional claims in cases where it's unnecessary. Sweet accepted those arguments, and chose not to rule on the constitutional claims; he dismissed the ACLU's First Amendment and "progress clause" claims without prejudice.
Still, Sweet's opinion could have a profound impact on "composition" gene patents where the isolated DNA itself is claimed as the patented invention. According to the ACLU, about 20 percent of the human genome has been patented.
While the USPTO doesn't need to stop issuing these types of gene patents solely because of this ruling, Sweet makes it clear toward the end of his opinion that if he is upheld in the event of an appeal, the agency will need to make sure its practices conform to his decision, and "avoid issuing patents related to isolated DNA or the comparison or analysis of DNA sequences."
That leaves a big "if," considering that the next level, the U.S. Court of Appeals for the Federal Circuit, is a court that's considered patent-friendly and likely to reject, or at least narrow, such a broad challenge to gene patents.
The ACLU's Chris Hansen told The Am Law Litigation Daily that he believes that Sweet's decision could invalidate other gene patents. Myriad's lawyer at Jones Day declined to comment. We'll have more in this space soon.
The full name of the case is Association for Molecular Pathology et al. v. U.S. Patent and Trademark Office et al.
Read Judge Sweet's opinion [PDF].