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On the Patentability of Genetic Subject Matter: Molecular Pathology v. USPTO

On March 29, 2010, in a controversial decision which, if upheld on appeal, could have far-reaching implications for the biotechnology industry in the United States, the District Court for the Southern District of New York held that isolated genes do not constitute patent eligible subject matter. Judge Sweet in making this ruling in the case of Association for Molecular Pathology v. United States Patent and Trademark Office, also held that claims to analyzing and comparing genes failed to meet the statutory criteria.

The case is one brought by the Association for Molecular Pathology, the American Civil Liberties Union Foundation and the Public Patent Foundation seeking a declaration of invalidity of claims relating to the BRCA1 and BRCA2 genes and their use in predicting susceptibility to breast and ovarian cancers contained in patents held Myriad Genetics and the University of Utah Research Foundation.

In prior proceedings, it had been held that the plaintiffs had standing to bring the suit on the basis that the defendants’ acts were directed to the State of New York and the pleadings raised constitutional claims against the USPTO. It was alleged that the grant of the patents breached Article 1 Section 8 and the First and Fourteenth Amendments to the Constitution as well as the Patent Act (35 USC 101) because the patent claims covered products of nature, laws of nature and/or natural phenomena and abstract ideas or basic human knowledge or thought.

In the March 29 decision, the court found that the claims in question were in conflict with 35 USC 101 and so it did not need to decide the constitutional issues.

The reasons were as follows:

On claims to isolated genes:

Isolated genes are just as much products of nature as unisolated genes and so fall within the “products of nature” exception to patentability recognized by the Supreme Court in 1980 in Diamond v. Chakrabarty. In 1931 the Supreme Court had held in American Fruit Growers v. Brodex that to be patent eligible a product had to be “markedly different” from a product of nature. In the case before him, Judge Sweet concluded that isolation of a gene was analogous to purification of other natural products and so did not result in something “markedly different” from the natural form.

Judge Sweet dismissed the patent owner’s argument that purification of naturally occurring compounds that do not exist in nature in pure form is patent eligible. Such an argument lacked Supreme Court authority to support it. The Court noted that in its 1911 decision in Parke Davis v. Mulford Judge Learned Hand had found that pure adrenaline was a different product from adrenaline mixed with associated gland tissue and so was patentable. However, Judge Sweet viewed this holding as being one dealing with novelty rather than statutory subject matter and, in any case, prior to the American Fruit Growers decision.

The Court found that its conclusion that there was a lack of marked difference between the isolated gene and the gene located in a genome was confirmed by the fact that even though there may be chemical differences between isolated genes and genes present in a genome, the information-bearing characteristics of the gene was the same in both cases. Information-bearing is a key characteristic of genes. Thus, differences in the presence or absence of introns in the genetic material did not make two pieces of DNA “markedly different”.

On claims to comparing and analyzing gene sequences to identify the presence of mutations correlating with a predisposition to breast or ovarian cancer:

The court applied the Bilski transformation test and held that there was no transformation of something into a different state or thing involved in making the comparison. It distinguished the Federal Circuit’s more recent decision in Prometheus v. Mayo which had held that claims relating to analyzing body fluids for metabolites of a drug and adjusting dosage in accordance with that analysis constituted patent eligible subject matter on the basis that in that case the requirement to determine metabolite levels had been construed as involving a transformation whereas in the present case, there was no such “determining step” only “analyzing” and “comparing” steps.

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