Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al., decided March 29, 2010, is a controversial decision that calls into question the patentability of isolated genes. The U.S. District Court for the Southern District of New York ruled that “isolated” or “purified” genes are not patentable subject matter because they are not “markedly different” from a product of nature. An appeal is expected to the U.S. Court of Appeals for the Federal Circuit.
According to patent law, products of nature cannot be patented because they are not “made by man.” The United States Patent and Trademark Office (USPTO) takes the position that an isolated and purified DNA molecule that has the same sequence as a naturally occurring gene is eligible for a patent because that DNA molecule does not occur in that purified or isolated form in nature. Natural substances constitute patentable subject matter, according to the USPTO, provided that they are “isolated and purified,” because they do not occur in that “isolated” or “purified” form in nature.
The USPTO’s policy was called into question in Association for Molecular Pathology, et al. This lawsuit involved two human genes, known as BRCA1 and BRCA2 genes. Mutations in these genes are responsible for about 40% of inherited *** cancers and about 80% of inherited *** and ovarian cancers. The availability of “isolated” or “purified” BRCA1 and BRCA2 genes now makes the diagnosis of inherited *** cancer a reality. Previously, the only available method to diagnose human *** cancer involved *** examination, e.g., mammogram, followed by biopsy in which cells are examined under a microscope. The diagnosis of inherited *** cancer now involves screening the BRCA1 and BRCA2 genes in a cancer test for the mutations responsible for inherited *** cancer.
The lawsuit was filed by the American Civil Liberties Union (ACLU) and other plaintiffs who challenged the validity of several claims in the patents at issue. The principal defendant, Myriad, is a company that developed and commercialized the cancer test. The dispute arose when a *** cancer patient took the Myriad cancer test to see if her genes had the mutations that are responsible for inherited *** cancer. The test came out positive, indicating that her genes have the mutations responsible for inherited *** cancer. The patient wanted a “second opinion.” No second opinion was available, however, because Myriad patented the isolated BRCA1 and BRCA2 genes and associated cancer test. The patient sought the assistance of the ACLU in bringing suit against Myriad and against the USPTO.
The court’s ruling invalidated composition of matter claims directed to isolated BRCA1 and BRCA2 nucleic acid sequences. The court reasoned that the USPTO’s policy was incorrect, and that purification of these genes did not transform a product of nature into patentable subject matter. The court also invalidated claims directed to methods for analyzing a BRCA1 and BRCA2 sequence to assess mutations reflecting cancer risk. Applying the test of In re Bilski, which limits patentability to processes that are tied to a machine or apparatus or that transform a particular article into a different state or thing, the court held that the method claims do not satisfy the Bilski test because they covered only abstract mental processes.
This case is controversial, raises important policy issues, and could have a significant impact on the biotechnology industry.
Patents serve to stimulate innovation by rewarding research and development (R&D) in exchange for a limited right to exclude others from copying the patented invention during the term of the patent. Patentees argue that, without patent protection, companies could not recover the costs of R&D because the invention could be copied by all. The countervailing view is that the risk of infringement claims for gene patents may discourage use of those genes in research and clinical settings. The appeal of the Association for Molecular Pathology et al. decision is sure to be watched closely.
If you have questions about the subject of this IP Law Alert, please contact Nancy W. Vensko or the Fitch Even attorney with whom you regularly consult.