Human Gene Patent Rejected by NY Court

A New York court has struck the patents held by Myriad Genetics Inc. for BRCA1 and BRCA2 which have been linked to breast and ovarian cancer in Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al.

Parties including The American Civil Liberties Union, Public Patent Foundation, and Benjamin N. Cardozo School of Law argued that the patents were unconstitutional. The decision challenges the famous quote about patentable subject matter from Diamond v. Chakrabarty, 447 U.S. 303 (1980),

…a person may have invented a machine or a manufacture, which may include anything under the sun that is made by man.

The e-Commerce Times summarizes the complaint which said,

4. The patenting of human genes, the concept of looking at or comparing human genes, and correlations found in nature between certain genes and an increased risk of breast and/or ovarian cancer violates long established legal principles that prohibit the patenting of laws of nature, products of nature, and abstract ideas. These patents also violate the First Amendment and Article I, section 8, clause 8 of the United States Constitution.

In response to the motion to dismiss on Nov. 2, 2009 (669 F. Supp. 2d 365 (S.D.N.Y. 2009)), the court stated,

The challenges to the patents-in-suit raise questions of difficult legal dimensions concerning constitutional protections over the information that serves as our genetic identities and the need to adopt policies that promote scientific innovation in biomedical research. The widespread use of gene sequence information as the foundation for biomedical research means that resolution of these issues will have far-reaching implications, not only far-reaching implications, not only for gene-based health care and the health of millions of women facing the specter of breast cancer, but also for the future course of biomedical research for gene-based health care and the health of millions of women facing the specter of breast cancer, but also for the future course of biomedical research.

U.S. District Judge Robert Sweet ruled in the decision released today,

The claims-in-suit directed to “isolated DNA” containing human BRCA1/2 gene sequences reflect the USPTO’s practice of granting patents on DNA sequences so long as those sequences are claimed in the form of “isolated DNA.”

This practice is premised on the view that DNA should be treated no differently from any other chemical compound, and that its purification from the body, using well-known techniques, renders it patentable by transforming it into something distinctly different in character. Many, however, including scientists in the fields of molecular biology and genomics, have considered this practice a “lawyer’s trick” that circumvents the prohibitions on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result. The resolution of these motions is based upon long recognized principles of molecular biology and genetics: DNA represents the physical embodiment of biological information, distinct in its essential characteristics from any other chemical found in nature.

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 under 35 U.S.C. § 101.

Similarly, because the claimed comparisons of DNA sequences are abstract mental processes, they also constitute unpatentable subject matter under § 101.

Although the decision is expected to potentially invalidate thousands of patents if upheld, Myriad CEO has stated the decision will not create a material adverse effect in the company’s position.