The purpose of the United States patent system is "[t]o promote the Progress of Science and useful Arts." (1) Currently, there is a heated emotional debate about whether patents directed to genetic sequences promote or hinder the progress of science, a debate which may soon find its way to the United States Supreme Court. (2) Unfortunately, the debate is too often characterized in terms of policy concerns. In Association for Molecular Pathology v. United States Patent and Trademark Office, Judge Sweet broke with three decades of United States Patent and Trademark Office (USPTO) precedent, (3) declaring the method and system claims to the genetic sequences of BRCA1 and BRCA2 ineligible for patents. (4) Judge Sweet created a blanket exception to 35 U.S.C. [section] 101 by characterizing genes under the "law of nature" exception to patentability. (5) Myriad Genetics Inc. (Myriad) appealed, and the Federal Circuit Court of Appeals ruled on July 29, 2011. (6) The Federal Circuit reversed Judge Sweet's ruling by upholding claims directed to isolated genetic sequences as subject matter eligible for patenting under 35 U.S.C. [section] 101. (7) However, the Federal Circuit invalidated diagnostic method claims that merely compared a genetic sequence to an individual's native genetic sequence as an abstract mental process. (8) Both parties filed a petition for rehearing in the Federal Circuit. (9)
The real issue in Association for Molecular Pathology is patient access to health care, which should not be achieved through a judicially-created exception to the statutory definition of patent eligible subject matter. While the Federal Circuit focuses on the science, the underlying issues largely guide their interpretation. It is unlikely that agreement on the science and how it applies to patent eligible subject matter will ever be achieved. Judge Moore, in his concurring opinion, rightly states that it is the policy that tips the scales towards patentability. (10)
Weakening biotechnology patent law by declaring claims to genetic sequences patent ineligible, as products of nature under 35 U.S.C. [section] 101, would negatively impact patient access to biotechnology advances by decreasing the incentive of investors to enter the market more than it could possibly help promote patient access to BRCA1 and BRCA2 diagnostic technologies. Patient access to second opinions, affordable diagnostic technologies, patient counseling, comprehensive genetic testing, and insurance coverage are not aspects of patent law, and are best addressed through meaningful health care reform.
A. 35 U.S.C. [section] 101 Patentable Subject Matter
Patentable subject matter, the threshold test for patentability, is defined as "any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof." (11) The statute on patentable subject matter, 35 U.S.C. [section] 101, is given broad meaning through the use of the word "any" in describing the type of new and useful processes that are patentable, the legislative history surrounding its enactment, and the interpretation that "anything under the sun that is made by man" is patentable. (12) The proper forum for excluding a specific subject matter from the patent bargain lies with Congress in the legislative body and not the judiciary. (13)
However, courts recognize some subject matter as ineligible for patentability under 35 U.S.C. [section] 101. Exceptions to patentable subject matter include laws of nature, physical phenomena, and abstract ideas. (14) Products of nature should be "free to all men and reserved exclusively to none." (15) Laws of nature, physical phenomena, and abstract ideas are recognized as a type of scientific discovery, rather than a novel invention. This promotes the policy that a discovery is left to the public domain while an invention benefits from intellectual property rights. …