TLO® INSIGHT: Federal Court Throws Patentability of Genes in Doubt

In a decision that surprised the legal and scientific communities alike, a federal court in the Southern District of New York has held that all of the claims at issue in seven of Myriad Genetics, Inc.’s breast cancer gene patents are invalid, including those directed toward methods of using isolated genes as markers for breast cancer.  The decision, if upheld, would throw into doubt the multitude of patents covering human genes and have enormous implications for the biotech industry.

In the 1990s, Myriad Genetics obtained several patents claiming the isolated genes BRCA1 and BRCA2, and methods of using these genes to identify the presence of certain mutations in a subject’s genetic material.  As a result, testing for the genes, or conducting research on the genes, generally could not be performed without Myriad’s consent.

Last year, the American Civil Liberties Union filed suit on behalf of various professional medical organizations, scientists, cancer survivors and others against the U.S. Patent and Trademark Office and Myriad Genetics, among others, seeking judicial review as to whether human genes could be patented.  In particular, the plaintiffs argued that genes, products of nature, fall outside the realm of things that can be patented.  Further, they argued that the patents stifle research and innovation and limit testing options.

Mryiad asked the court to dismiss the case, claiming that the work of isolating the DNA from the body transforms it and makes it patentable. Such patents, it said, have been granted for decades; the Supreme Court upheld patents on living organisms in 1980 in Diamond v. Chakrabarty.

In a 152 page opinion, Judge Robert Sweet held the claims at issue from the seven patents were invalid for failing to recite patentable subject matter under 35 U.S.C.§ 101.  With respect to the claims directed towards the isolated genes themselves, Judge Sweet opined that both U.S. Supreme Court and lower court precedent have established that products of nature do not constitute patentable subject matter absent a change that results in the creation of a fundamentally new product.  In particular, the court held that “the purified product must possess ‘markedly different characteristics’” than that of naturally existing products.   Thus, turning to the facts of the case, Judge Sweet held the isolated BRCA1 and BRCA2 genes as claimed are not “markedly different” from their native DNA, and therefore are not patentable subject matter.

Myriad argued that the isolated genes should be patentable based on the patentability of other chemical compounds as determined by other courts.  In particular, Myriad argued that the structural and functional differences of isolated DNA (compared to native DNA) render the subject matter patentable just as structural and functional differences render chemical compounds patentable.  In rejecting this argument, Judge Sweet held that genes not only have chemical characteristics, but informational characteristics as well, as genes are physical carriers of genetic information.  The court held that “it would be erroneous to view DNA as ‘no different[]’ than other chemicals previously the subject of other patents.”  Judge Sweet cited to the informational character of DNA to use this uniqueness to distinguish case law supporting patentability of chemical compounds.  As a result, the court held that because the structural and functional differences of synthetic and Native DNA do not affect the fundamental informational quality of the DNA, the isolated genes are not markedly different from what appears in nature, and thus, not patentable.

In finding invalid the method claims, the court found that the claims in the Myriad patents are directed to abstract mental processes of “analyzing” or “comparing” gene sequences, and thus are not “transformational” as required by Federal Circuit precedent in In re Bilski.

It is important to note that the Supreme Court has affirmed Bilski, holding that an abstract idea is unpatentable.  This holding parallels with Judge Sweet’s determination that Myriad’s patent methods are unpatentable because they are directed towards an abstract process.  Though the Supreme Court in Bilski did explain that the machine or transformation test is not the sole test of patentability, the specific question of whether methods of isolating DNA sequences are patentable will need to be decided in the Appeal of Judge Sweet’s decision.  Stay tuned.  As this critical decision to the biotech industry works its way through the Appellate process.