In March 2010, when a New York Federal Court declared invalid 15 claims in seven patents covering human genes, a legal beachhead against the patenting of human genes was established (Assoc for Molecular Pathology v USPTO).
The Court concluded that the human BRCA1 and BRCA2 breast cancer susceptibility genes are products of nature and thus not patentable. While many inventive steps may be necessary to allow scientists to extract and read a gene sequence, the court held that the ordering of the DNA sequence itself cannot be patented because the sequence was determined by nature, not by man.
According to the New York court, the clear line of US Supreme Court precedent establishes that isolation of a product of nature, without more, does not render the isolated product patentable. The US Supreme Court has long-recognised that scientific principles and laws of nature are not patentable because they have always existed, define the relationship of man to his environment and, as a consequence, ought not to be the subject of exclusive rights in any one person. Molecular Pathology is the first case where a court has applied these principles to the discovery of human gene sequences.
The proliferation of patent rights directed to genetic material has been postulated to contribute to a phenomenon where competing patent rights, held by independent parties, prevent any one party from engaging in productive innovation. Plaintiffs cited studies to the court to demonstrate the chilling effect of gene patents on the advancement of genetic research and clinical testing.
On the other side, the patentee argued, unsuccessfully, that a determination that genes are not patentable could have a broad, negative effect on medical research and that absent the promise of a period of market exclusivity, innovation in the biochemical arena may be hindered.
All eyes will be on the patentee's appeal and the impact of the appellate decision on the fast-growing and lucrative field of genetic engineering.
Martin B Pavane, partner (mpavane@cplplaw.com), and Darren S Mogil, associate (dmogil@cplplaw.com)
Cohen Pontani Lieberman & Pavane LLP
551 Fifth Avenue
New York, NY 10176
United States
Tel: +1 212 687 2770
Fax: +1 212 972 5487
www.cplplaw.com