Tuesday, April 12, 2011

A Historical Perspective on the Gene Patent Controversy

"A page of history is worth a volume of logic”
- New York Trust Co. v. Eisner, 256 US 345, 349 (1921) (Holmes, J.).

Critics postulate that gene patents threaten to impede next-generation genetic testing technologies, such as whole genome sequencing and multiplex genetic testing. We see this concern reflected, for example, in the recent arguments before the Federal Circuit in the Myriad case (Association for Molecular Pathology v. US PTO) where the parties speculated as to whether the challenged patent claims would cover whole genome sequencing. It also seems likely that US governments amicus brief arguing that genomic DNA is patent ineligible was motivated, at least in part, by a desire to clear patents perceived to be an impediment to whole genome sequencing. In considering how to respond to these concerns, we might do well to take the advice of Justice Holmes, and look for guidance to a page of history.

This is not the first time that there has been a call for a prohibition against patenting certain subject matter, based on allegations that patents pose a threat to biomedical research and the public health. In the past, these crusades have often been led by prominent members of the scientific and medical community, who raised alarming concerns that in retrospect seem greatly exaggerated, if not wholly unwarranted.

For example, more than 30 years ago numerous concerned parties filed amicus briefs in Diamond v. Chakrabarty warning that a prohibition against the patenting of genetically modified organisms was necessary to prevent a "gruesome parade of horrible." These briefs quoted a number of scientists, including Nobel laureates, for the proposition that patents on living organisms might pose a serious threat to the human race by encouraging genetic research. In retrospect, the Supreme Court's decision not to follow their advice, and to allow the patenting of genetically modified organisms, is seen as an important milestone that facilitated the growth of biotechnology, thereby facilitating numerous benefits to mankind.

In 1995, a debate raged over the patenting of medical procedures, and the arguments that were raised at that time show striking parallels to today's controversy over gene patents. At that time, the patent office had a long-standing practice of issuing medical procedure patents, but they do not appear to have been the source of any controversy. In fact, the practice had been officially sanctioned by the Board of Patent Appeals and Interferences in 1954, in ex parte Scherer. Apparently, however, most of the public, particularly doctors, were unaware of the practice.

That all changed after a lawsuit was filed in 1993 by a surgeon against a group of doctors alleging infringement of a patent claiming a method of performing cataract surgery. Pallin v. Singer, 36 USPQ2d 1050 (D. Vt. 1995). As described in a leading patent law casebook by Professors Merges and Duffy, "[t]he litigation caused a shudder in the medical community, if only because it called attention to the PTO's practice of allowing surgical patents."

After news of the lawsuit became known, major mainstream media outlets such as the Wall Street Journal, New York Times and Los Angeles Times all published high-profile stories calling attention to the lawsuit. It also became the subject of law review articles decrying the negative effect of these patents on the practice of medicine. The American Medical Association and many physicians raised arguments against medical procedure patents that are highly reminiscent of the claims being made about gene patents today. For example, some doctors argued that medical procedure patents are unethical, and that patents are not needed as financial incentives for doctors to develop better methods for improving patient outcomes. They also argued that patents delay information sharing, and increase the costs patients pay for healthcare. The American Medical Association and many physicians argued patents for medical methods should be prohibited, insisting "that it is impossible to "own" a method of treating patients were performing surgery." Concern was expressed that the medical procedure patents could impede research, forcing researchers to license the patent if they wanted to use the patented technique.

Today, no one is wringing their hands over medical procedure patents. The lawsuit which precipitated the outcry ended in 1996 when the parties stipulated to the patent invalidity due to prior art uses of the claimed technique. Congress intervened in 1996 by enacting 35 USC 287(c), which essentially eliminates the availability of remedies for infringement by medical practitioners. Importantly, Congress did not go along with the suggestion of the American Medical Association and ban the patenting of medical procedures, which can still be patented, and these patents play an important role in incentivizing the development of important innovations such as medical devices.

The limitation on remedies did resolve the concerns that doctors could be sued for performing medical procedures. There appears to be no reported decision in which 35 USC 287(c) has been asserted, and in reality there probably was little threat that the practice of medicine would be harmed by these patents - the lawsuit that triggered all this was probably just an aberration, much like the Myriad suit. Nonetheless, this simple statutory fix addressed the concerns, and since then medical procedure patents have generated little controversy.

In fact, concerns about the gene patent thicket have been with us for more than a decade. Initially, much of the concern was that gene patents would prove an insurmountable obstacle to commercialization of DNA microarrays, based on a perception that since the arrays often comprise DNA sequences representing hundreds or even thousands of unique genes, it would be too difficult to obtain the necessary licenses on the gene patents. In fact, this perceived fear has never come to pass. DNA microarray technology has been the subject of numerous patent infringement lawsuits, but never involving a human gene patent. In a recent book chapter, I discuss possible explanations as to why the postulated gene patent thicket has not presented itself, particularly in the context of microarrays and basic biomedical research. The same rationale would also largely apply to the fears that gene patents will impede the commercialization of whole genome sequencing.

The lesson from all this is that we should be very careful about imposing restrictions on patentability based on perceived fears, when history tells us that in many cases these fears turn out to be vastly overstated. To the extent there are real concerns, there are more targeted solutions than a broad-based attack on patent eligibility, such as the statutory solution to the perceived problem of medical procedure patents.