By Dennis Crouch
I asked a number of colleagues for their thoughts on the Supreme Court's recent Myriad Decision. However, I only allowed a 40 word statement from each.
Most patent law specialists look at Supreme Court review with some trepidation. For many, the split decision comes with a sigh of relief. Gregory Dolin (U Baltimore) writes that "the decision could have been much worse. The decision could have been much worse. After all, the petitioners argued that neither isolated DNA nor cDNA should be patent eligible. So the fact that the Supreme Court concluded that cDNA is patent eligible is a victory for Myriad." Jorge Contreras (American) calls the decision a "common sense" application focused on "the fundamental purposes of the patent system." Professor John Duffy (UVA) sees the decisions as "a half-loss to inventors, a half-loss to advocates for a broader public domain but, unfortunately, a full victory for patent lawyers, who will have lots of business opining on, and litigating, the complexities of this decision." Barbara Rudolph (Finnegan) notes that the decision "could have an immediate [negative] effect on existing patent portfolios of some biotech companies, particularly those in the fields of diagnostics and personalized medicine. . . . It is, however, a positive development for companies that rely on [non-patented] cDNA for the development and manufacture of novel therapeutic proteins."
The decision is in some tension with the Court's most recent prior section 101 case of Mayo. Jeffrey Lefstin (UC Hastings) queries "is Mayo's 'inventive concept' still required for patent-eligibility? The Court's endorsement of cDNA relies on cDNA being 'new' within the meaning of § 101, not whether creation of cDNA involved anything beyond the 'routine and conventional' activity disparaged in Mayo." David Berry (Cooley Law) praised this aspect of the decision because the Court "didn't concoct a new, off-the-cuff standard; punt on fashioning a useful test, confuse 'eligibility' with 'patentability;' use the word 'obvious' to mean something else again; disparage the art of claim drafting; or leave a whole industry up in the air about the limits of patent protection." Along these lines but in a lamenting tone, Timothy Holbrook (Emory) that "sadly the Court provided very little guidance as to future issues relevant to biotech, such as isolated/purified proteins or other organic chemicals. The Court took pains to make the decision narrow, but for the first time since JEM, it did find something to be patent eligible." Mark Lemley (Stanford) argues that Mayo still holds weight: "if I were a biotech patent owner I wouldn't be celebrating just yet. cDNA patents are easier to design around, and under Prometheus v. Mayo they are probably obvious once we assume knowledge of the naturally-occurring gene sequence."
Moving forward, we have a question of whether the reduced coverage of patent law will still provide sufficient incentive to invest in biotech focused research. Jonathan Masur, professor at The University of Chicago School of Law says yes: "This is the rare case in which the Court's reflexive tendency to split the baby worked well. Biotech companies should have sufficient research incentives going forward, without firms like Myriad exerting too much control over consumers and future R&D."
One problem with Supreme Court review of Section 101 cases is the risk of alienating entire market areas from patent protection. That is why many of us support a broader fair-use regime that could be used as a lever for protecting public interest uses of inventions without eliminating the market value of innovation. Along this line Thomas Cotter (Minnesota) writes: "Ultimately the merits depend on whether the benefits of access outweigh the costs to incentives. The ideal policy solution would be for DNA to be patent-eligible, coupled with an experimental use defense and a guarantee of universal health care." Andrew Chin (UNC) agrees here that the scientific and medical progress are not served by this decision. Chin writes: "Patents on DNA probes are problematic for § 101 doctrine and for DNA research regardless of whether the probes are produced by isolation or synthesis. The distinction will distort scientific and medical progress and ultimately prove to be doctrinally unstable." Former Lead House Staffer in the IP area, Christal Sheppard (U Nebraska) agrees that "Naturally occurring versus synthetic is a ridiculous outdated distinction." Her approach, however, would not be to create a fair-use but instead to fall back on the old rules of novelty. Sheppard writes "The proper distinction should be new-ness (novelty) irrespective of origin."
For innovative companies the first question is how they can take advantage of the Opinion. Eileen Kane (Penn State) offers a clue in the distinction as between genetics and chemistry. Kane writes that "the decision recognizes the complexity of DNA for a patent eligibility analysis and finds that genetics trumps chemistry in establishing the isolated gene as an unpatentable natural product." Dan Burk (UC Irvine) nails this further by noting that the "opinion seems to say that had the gDNA claims been drafted in terms of the chemical structure rather than genetic information, Judge Lourie's view from the opinion below might prevail. Perhaps future claim drafters should think like biochemists and not like geneticists." Professor Kane also notes that the decision reaffirms the non-statutory principle that "discovery does not equal invention."
For the past several years, Myriad (and many others) have been relying on trade secrets as part of their intellectual property scheme. Thus, although Myriad disclosed the BRCA1/BRCA2 gene sequences in their patent applications, the company holds a vast amount of information (such as the genetic code of all of its customers) as trade secrets. Brenda Simon (Thomas Jefferson School of Law) notes that Myriad "does not impact one of the most valuable aspects made possible through Myriad's patent protection: a private biobank of patient data containing information about additional mutations that Myriad can maintain as a trade secret." Barbara Rudolph (Finnegan) agrees that the decision "may presage a shift towards more reliance on trade secret protection for DNA-based inventions."
Looking at the trend over the past decade, Andrew Torrance (Kansas) writes: "For better or worse, the Supreme Court's AMP v. Myriad decision caps a decade-long trend away from the patentability of the human body, human embryonic stem cells, human physiology, diagnosis of human disease, human thoughts, and, now, human genes."
Coming Soon: What does Myriad Say about Software Patents? And, in the words of Professor Holbrook "Will they take CLS?" Professor Srividhya Ragavan (Oklahoma) writes that "Too much of anything – even patents - is good for nothing. Charkabarty exemplified patent law's ability to spur invention while Myriad represents the end of an out-of-control patenting phenomenon which became increasingly disconnected with the system's objectives. Time for software patent-holders to take notice."
Finally, Megan Labelle (Catholic University) highlights the value that Dan Ravicher and PubPat have brought to the table. Professor Labelle writes: "The patent community will rightfully spend much time debating the merits of Myriad. While that debate is important, let's remember that there would be nothing to debate if the ACLU and PubPat hadn't filed this suit in the first place. Myriad has, and should continue to, inform the discussion about the role public interest organizations ought to play in our patent system."