Site Navigation Page Content

Debate over the legality of human gene patents set for Oct. 21

The Wake Forest University School of Law’s Law and Medicine Society and the Wake Intellectual Property Student Association are hosting “The Gene Patent Debate” at noon on Thursday, Oct. 21, in Room 1302 of the Worrell Professional Center.

The event is free and open to the public.

The debate will feature Dr. Cynthia Rothschild (’99) and Dean Stell discussing the controversial holding of Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al., which came down this summer and will have an immense impact on the practice of patent law if upheld. The law school’s Professor Mark Hall will moderate

Rothschild is a partner at Kilpatrick Stockton LLP, who specializes in patent law and chair of the Intellectual Property Section of the North Carolina Bar Association. Dean is the associate director of Wake Forest Baptist Medical Center’s Office of Technology Asset Management. He is responsible for applying for patents on behalf of the school faculty.

The panel will address the potentially ground-breaking litigation, which is currently on appeal at the U.S. Court of Appeals for the Federal Circuit.

Last March, the District Court for the Southern District of New York ostensibly rocked the biotechnology industry when it invalidated the process of patenting human genes.

Gene patenting is a process which a company gains exclusive rights to a gene, meaning that it may prohibit any other organization from conducting research involving the genes.  In the case at issue, Myriad Genetics won a fierce race to identify two genes which are highly predictive as to the onset of breast and ovarian cancer due to inheritance.  Myriad obtained patents on these genes even though the company did not actually invent anything, because under existing case law, the act of isolating and purifying the gene was transformative enough to justify a patent.

The ACLU and the Public Patent Foundation (a not-for-profit) led the recent lawsuit against Myriad, joined by many professional health care organizations.  Due to the patents, Myriad
is the only laboratory in the United States where patients can be tested for breast or ovarian cancer genetic indicators.  A positive test often leads patients to seek serious preventative options, such as mastectomy.  The patents prevent any other researcher from testing these genes or developing alternative tests, which makes it practically impossible for women to use other tests or get an outside second opinion about test results.

In Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al., 702 F.Supp.2d 181 (S.D.N.Y. 2010), most often referred to as the Myriad Genetics case, the District Court ruled against the company owning the patent — putting the thousands of other gene patents that have been issued in the U.S. at risk — by finding that purification of a natural product (i.e., human genes), without more, could not transform it into patentable subject matter.

“If you are feeling ambitious, you may find the full opinion at the citation above — which the judge took no less than 156 pages to reason through. . .

Alternatively, you can come and hear this controversial issue debated by two professionals in the field, and come out feeling adequately informed in 50 minutes,” said Liz Arnold (’11).

“Does patenting encourage big companies to take on expensive research, or does it inhibit scientific advances that could save lives by giving one company a monopoly?   Will the appellate court overturn this new case law?  Please come and hear much more detailed discussion of the legal issues and public policy questions.”