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The US Supreme Court this week heard oral arguments in Association for Molecular Pathology v Myriad Genetics. The case, which concerns the patentability of human genetic material, could have serious implications for innovators in the biotechnology industry and their ability to secure investment – and patent owners in other sectors should also pay close attention to the outcome.
Back in May 2009 the Public Patent Foundation and the American Civil Liberties Union filed suit against Myriad Genetics, the University of Utah Research Foundation and the USPTO in the Southern District of New York. The lawsuit – brought on behalf of the Association for Molecular Pathology, among a number of other parties including several cancer patients – claimed that Myriad’s patents on human genes associated with increased risk of developing breast and ovarian cancer were invalid. “The case deals with the question of whether Myriad Genetics’ claims to isolated genes that have been derived from humans are eligible for patent protection,” explains Barbara Rudolph, a partner at Finnegan who was counsel of record for the filing of an amicus brief in the case on behalf of the American Intellectual Property Law Association.
The Supreme Court has taken on several cases in recent years relating to patentable subject matter. Mayo v Prometheus and Bilski v Kappos dealt with the patentability of diagnostic methods and business methods respectively. “What makes Myriad different from those recent cases is that it covers compositions of matter – actual chemical compounds – whereas others have focused on methods and claims to method,” Rudolph tells IAM. “The position taken by the plaintiffs is that these claimed DNA molecules are essentially the same as what already exists in nature, and that whatever changes have been made to them are not sufficient enough to merit patent protection.” The plaintiffs further contend that Myriad’s patent rights grant it an effective monopoly over diagnostic testing for mutations and abnormalities in the relevant genes, therefore preventing others from developing alternative diagnostic methods and leading to a market with little competition and high prices for consumers. “The other main prong of the plaintiffs' argument is that patents of this kind chill research in the area, because they allow a company like Myriad to preclude other companies from studying and investigating these types of genes,” she adds.
Rudolph reports that the oral arguments heard by the Supreme Court on Monday focused on whether patents on human genetic material encourage or restrict innovation. “On the one hand, there is the argument that patents play a crucial role in incentivising the research and development that leads to these kinds of breakthrough technologies,” she says. “On the other side of the coin is the worry that patents might pre-empt whole fields of research if what they claim is something that already exists in nature.” Though there is no real indication at this stage as to how the Supreme Court justices may rule in the case, Rudolph highlights an amicus brief filed by the US government which which may suggest a possible framework for a decision. “The government’s brief took the position that certain types of DNA molecule – those that preserve the exact sequence of nucleotides as found in the human genome – should not be patent eligible, but DNA molecules that have certain sequences removed and require more human intervention to create should be patent eligible,” she explains. “That could be a possibility in terms of how the justices may rule – to say that one class is patentable but the other isn’t.”
In addition to the businesses that could be prevented from obtaining patent protection on the products of their R&D by such a decision, the fact that the USPTO has been granting patents on human genetic material for quite some time means that there are plenty of holders of existing patents that could be affected. A 2005 study by the journal Science found that as much as 20% of human genes had been patented in the United States, with 63% of those patents assigned to private sector entities and 28% assigned to universities.
The Supreme Court is expected to hand down its decision within the next couple of months. While she admits it is difficult to predict what effects the Supreme Court’s eventual ruling could have on industry, Rudolph suggests that companies outside of the genetic diagnostic field should be watchful of the outcome. “In the longer term, there may be an impact on the biotech sector,” she says. “And depending on how the court rules and the breadth of the ruling, it may affect companies that are researching and developing other types of products that are derived from natural sources.” If that is the case, then the consequences of the Supreme Court’s ruling could be very far-reaching indeed.
Competition/antitrust, IP politics, IP litigation, Patents, IP finance
One issue that is not widely recognised is the difference between the US and the rest of the world on doing research on a patented subject - "The Research Exemption ". The research exemption in the US is very narrow in scope compared with everywhere else. In the ROW it permissible for. say a university or research charity to undertake research on something that has been patented, provided that it is not for commercial use. In the US case of Madey vs Duke university, the business of the university was held to be research. Wikipedia says "In 2002, the Court of Appeals for the Federal Circuit dramatically limited the scope of the research exemption in Madey v. Duke University, 307 F.3d 1351, 1362 (Fed. Cir. 2002). The court did not reject the defense, but left only a "very narrow and strictly limited experimental use defense" for "amusement, to satisfy idle curiosity, or for strictly philosophical inquiry." The court also precludes the defense where, regardless of profit motive, the research was done "in furtherance of the alleged infringer’s legitimate business." In the case of a research university like Duke University, the court held that the alleged use was in furtherance of its legitimate business, and thus the defense was inapplicable."
Thus "gene patents" are more likely to be restrictive of research into those genes than anywhere else. For the avoidance of doubt i am in favour of Myriad.Ian Harvey, INTIPSA Ltd on 18 Apr 2013 @ 20:29