This guest post is from the BiotechBlog Intern, Fintan Burke. Fintan is a student at the School of Biotechnology at Dublin City University. Do you have a response to Fintan’s post? Respond in the comments section below.
While the dust has settled on the oral hearings of Association for Molecular Pathology (AMP) v Myriad (read our report here), the Supreme Court has yet to deliver its verdict in light of those hearings on April 15th. AMP’s argument against Myriad’s claim on the BRCA gene for its cancer diagnostic test was heavily reported, with amicus briefs by James Watson and the US Solicitor General emphasising the gravity given by the US government and scientific communities alike. The case is notable by many in regards to both the fundamental question posed (“Are genes patentable?”) and its implications for the commercial future of personalised medicine.
The case comes in light of two previous cases that addressed diagnostic claims head on. In re Bilski was a US Federal Circuit Court of Appeals decision backed by the US Supreme Court which reiterated that if you need a machine to do some process, or doing that process changes one thing into another, then the process is patentable under Section 101 of the Patent Act (the “Machine or Transformation Test”). The second case, Mayo v Prometheus, gave the controversial decision that a newly discovered law of nature is unpatentable, with its application in a process also unpatentable if there is nothing new introduced into the art.
Dr Eli Loots, a partner in the San Francisco IP law firm Knobbe Martens, does not consider the Prometheus case beneficial to this one.
The court had a variety of reasons for disliking those claims. The claims defined a method but it didn’t require, necessarily, the invention itself in that particular scenario. You could definitely see many people struggling with the fairness of that issue. That can happen any time you have a litigation where one side is being very aggressive on their claim interpretation. This follow-on case is in my mind – and I think in many more practitioners’ minds – are much more telling of the future; of diagnostics in particular and biotech generally.
One source of difficulty for this case, says Loots, is the idea of defining invention in the science world.
At some level you just can’t see a lot of these inventions. You need years of training to understand what these building blocks are made out of. Are they actually there? You can get an expert up there and say ‘well these electrons are distributed on a probability function’ and everybody’s going to fall asleep! Because of that, what biotech has done in the past is to define things functionally… what ends up happening is it appears from the functional language that you have a new, non-obvious invention, but it also appears that you have some really broad claims that may encompass more than people originally envisioned.
From a legal point of view, the biggest cause of concern is the attack on the patent under Section 101, which sets out what is and is not patentable subject matter. During the oral hearing itself, Chief Justice Roberts was heard to ask whether the whole case would not be better off examined under the ‘previously non-obvious’ clause that makes up Section 103. One attorney of a high profile Californian firm (who did not wish to be named) agreed with this suggestion. “They were really just saying ‘you isolated the gene out of the body and you did some things to it but all those steps you did were not novel. They were obvious. They’ve been done before, so you shouldn’t get a patent.’ And a lot of the commentators said ‘well that’s a 103 argument, that’s not a 101 argument.’”
He also explains lifting the patent could damage investment and innovation in the field, though could also lower the price for consumers and offer second opinions. Friend-of-the-court briefs from both sides of the argument echo the ramifications of ruling whether or not genes are patentable. The Biotechnology Industry Organisation stated that “The PTO has been granting patents on isolated DNA molecules for thirty years” and that “modern biotechnology industry has developed and flourished under this regime of consistent protection.” A lift in genetic IP protection may see generic gene diagnostics flooding the market, making the field undesirable for investors. Meanwhile an amicus filed by The Nation Woman’s Health Network et al states “Because Myriad’s patents give them a monopoly on genetic testing for breast and ovarian cancer in the United States … physicians in our country cannot give second opinions regarding a diagnosis for the disease.”
The attorney also considers the previous Mayo v Prometheus case, which got several mentions in this case’s oral hearings, to have underperformed in clearing up patentability matters. “A lot of us in the field think that the Supreme Court sort of muddled the Prometheus opinion. If you read it you’ll see there’s an awful lot of references to obviousness and 103 and that’s probably how they really decided it. Under the guise of ‘you can’t patent mental operations’ is what Prometheus essentially said. But really they were saying ‘and everything else that was part of that was obvious.’”
“Every disinterested observer I talked to thought the Prometheus patent was really, really crappy—outrageous, and a huge mistake by the USPTO” says John Conley, Kenan Professor of law at the University of North Carolina when contacted. “In Myriad, I suppose it’s possible that the court will say, let obviousness handle it, but I think they’ll make a decision under 101.” Continuing his comment on his blog at genomicslawreport.com he notes “What difference will it make? If the Supreme Court invalidates genomic DNA patents, it will be seen as a win by the growing personalized medicine industry. Companies using isolated genomic DNA to screen patients at multiple gene loci will no longer have to worry about whether the genes they are testing are patented—though the industry hasn’t seemed terribly worried about that problem thus far.”
The court is expected to give its decision within the next month.
About the author:
Fintan Burke is a student at the School of Biotechnology at Dublin City University. His main fields of interest include biomedical therapies and recombinant organisms. Fintan may be contacted at [email protected] .