By Donald Zuhn —

Last Thursday, authorities on patent law and public policy were brought together to discuss the intersection of cutting-edge genetic research and intellectual property.  The discussion, prompted by the recent ACLU v. USPTO case, took place on The Kojo Nnamdi Show on WAMU, Washington, DC's leading public radio station, and those interested in listening to the full 52-minute program can do so here.  The conversation, guest-hosted by Rebecca Roberts, featured Dr. Hans Sauer, the Associate General Counsel for Intellectual Property for the Biotechnology Industry Organization (BIO); Joshua Sarnoff, Professor of the Practice of Law at American University's Washington College of Law; and Shobita Parthasarathy, Co-Director of the Science, Technology and Public Policy Program at the Ford School of Public Policy at the University of Michigan, and the author of "Building Genetic Medicine: Breast Cancer, Technology, and the Comparative Politics of Health Care."

Ms. Roberts began the discussion by noting that almost 20% of all human genes are patented, and that since 1982, the U.S. Patent and Trademark Office has issued tens of thousands of patents for genes and gene-related products.  She then asked Dr. Sauer to briefly explain the basis upon which human genes are patentable.  Dr. Sauer analogized gene patenting to the patenting of purified vitamin B12 for treatment of megaloblastic anemia.  He noted that more than 80 years ago, prior to the isolation and purification of vitamin B12, the only "treatment" for megaloblastic anemia was for patients to consume a pound of raw liver a day.  While the discovery of this treatment was significant — George Whipple, George Minot, and William Murphy shared the 1934 Nobel Prize in Medicine for this discovery — researchers labored for more than 20 years to identify and purify the component in liver that was responsible for the treatment's efficiacy.  In 1947, Merck succeeded in identifying and isolating that component — vitamin B12 — and secured patent protection for isolated and purified vitamin B12.  Dr. Sauer pointed out that in an infringement suit brought by Merck against E.R. Squibb & Sons, the accused infringer asserted that vitamin B12 was a "natural substance," and therefore, not patentable.  The court disagreed, finding that Merck had claimed an isolated and purified form of vitamin B12 that was not found in nature, and that Merck's isolated vitamin B12 was better than the form found in nature since patients were spared having to consume a pound of liver in order to derive the same benefits.  Dr. Sauer explained that the requirements for patenting genes were no different than the requirements for patenting vitamin B12.  As for whether the isolation and purification of a gene sequence is sufficient to establish patentability, Dr. Sauer acknowledged that this is "a bit of a question," since the issue "hasn't been looked at by the courts for a long time."

Turning to the ACLU case, which concerns BRCA1 and BRCA2 gene sequences patented by Myriad Genetics (see "Association for Molecular Pathology v. U.S. Patent and Trademark Office"), Prof. Sarnoff contended that the case had been filed "precisely to address the question of whether it is enough to isolate and purify and identify some additional, or even some improved use for the natural materials that you extract."  Alluding to the Supreme Court's decision in KSR International Co. v. Teleflex Inc. and the CAFC's recent decision in In re Kubin, Prof. Sarnoff observed that "the Federal Circuit said the Supreme Court 'unambiguously discredited' . . . a doctrine that [the CAFC] had adopted back in the early 90's on which most of these genetic patents had been found to be not obvious and therefore patentable," and thus believed that there were "yet other reasons why even if you think these things are patentable, many of the thousands of [gene] patents should never have been issued because they were not sufficiently creative to warrant granting them."

Prof. Sarnoff opined that the ACLU and the Public Patent Foundation (PUBPAT) had targeted Myriad "because people view [Myriad] as the poster child for patents that have adverse effects in this area."  However, Dr. Sauer argued that the largest holders of gene patents are public institutions, with the University of California holding the top spot and the U.S. government finishing a close second.  Therefore, much of the hostility aimed at biotech companies for the patenting of human genes was probably misplaced.

As for the particular sequences patented by Myriad Genetics, Ms. Parthasarathy indicated that while 5% of all breast cancers are linked to mutations in either the BRCA1 or BRCA2 genes, the possession of a mutated copy of the BRCA1 or BRCA2 gene does not necessarily result in breast or ovarian cancer.  She noted that in the 12 years since the patents has been issued, "a lot of the research that's been done [on the sequences] has actually not been done in this country, which is an interesting part of this question of whether or not these patents actually stimulated or stifled innovation."

For Ms. Parthasarathy, the question of whether gene patents stimulate or stifle innovation hinges on the answers to two other questions.  First, "[a]t what stage in the development process, in the innovation process, do you need patents in order to really stimulate innovation?"  According to Ms. Parthasarathy, "[w]hat we found from a lot of studies is that in fact patenting genes is not something that a lot of people are thinking about in the innovation process," and that "in some cases [gene patenting] can stifle the innovation process."  Second, "[w]hat level of inventiveness do you need [to justify a patent on a gene]?"  Here, Ms. Parthasarathy suggested that "[i]n contemporary molecular genomics, the process of finding a gene — much of it is routine scientific work."

With respect to Ms. Parthasarathy's characterization of contemporary molecular genomics, Dr. Sauer countered that "[d]iscovering, identifying, characterizing, and patenting a gene is not an easy thing to do."  He also noted that the patentability of gene sequences rested on more than the mere isolation and sequencing of a gene.  Although he acknowledged that maybe this wasn't always the case, developments in the past ten years — particularly with respect to examination of gene sequences for compliance with the utility requirement — meant that applicants needed to describe more than just a gene's sequence in order to secure patent protection.

Ms. Parthasarathy, however, asserted that one thing that might be getting lost in the gene patenting debate was the impact of gene patents on "the culture of science."  She stated that "[t]here have bee
n a number of studies that suggest that perhaps on a day-by-day basis, there isn't necessarily litigation or cease and desist letters, but however, people are now operating in a different kind of environment."  Ms. Parthasarathy contended that this changing environment was altering the way in which researchers study and work with gene sequences.  She argued that "we have to decide — and policy makers have to decide — whether that kind of decision making — decision making about patents out there in the market — is something that we're content with."

Dr. Sauer countered that researchers need not alter the way in which they worked since "[e]nforcing a patent against a fellow scientist or somebody who does pure research — that may or may not be a situation where patent infringement even exists."  Moreover, he argued that it simply wasn't practical for a company to bring suit against a researcher:

For Prof. Sarnoff, Ms. Parthasarathy's question about the impact of gene patenting on innovation also contains an ethical component.  In particular, he speculated about the impact of gene patents on "people's ability to use things that they think should be free for use."  Reading from an American Medical Association brief (from a case other than the ACLU case), Prof. Sarnoff stated that "physicians have an obligation to share their knowledge and skills and to report the results of clinical and laboratory research," and therefore, "[t]he intentional withholding of new medical knowledge, skills, and techniques from colleagues for reasons of personal gain is detrimental to the medical profession and society [and] is to be condemned."  He then asked:

For those who find his ethical argument unpersuasive, Prof. Sarnoff argues that because the federal government funds most of the early stage research that leads to gene patents, there is also a good financial argument against gene patents.  According to Prof. Sarnoff, "the public shouldn't have to pay twice, first by funding the research and then through the patents."

Prof. Sarnoff also noted that an HHS Advisory Committee report recently concluded that "[t]he prospect of receiving a patent was not the major force motivating scientists to search for gene-disease associations that could be used to develop genetic tests, and patents do not serve as powerful incentives for either genetic research in the diagnostic area or the development of genetic tests."  Dr. Sauer, however, pointed out that this same report also concluded that "[p]atents don't seem to pose a huge obstacle with respect to patient access, test utilization, or even have clear impacts on test pricing — so that patented tests in that sense don't seem to be systematically more expensive than unpatented tests, or don't seem to be used more or less often."

Speaking of the Supreme Court's decision to grant certiorari in another case involving patentable subject matter (In re Bilski) — and perhaps also alluding to the issue of gene patenting — Prof. Sarnoff concluded the discussion by asking:  "Will the Supreme Court Justices know enough about patent law to make good decisions, and the converse is, will they not be so captured by the history of patent boosterism, that they'll actually bring more common sense to the decision?"