A Myriad of Options in the Spirit of the Law

by Adriana Lee Benedict

In a couple days, petitioners in AMP v. USPTO will be filing their brief on the merits following the Supreme Court’s grant of certiorari in late November.  For many, the Supreme Court’s ruling in this case will provide a long-awaited answer to the question of whether or not isolated DNA is patentable subject matter under §101.  In August, the Federal Circuit ruled on the case for a second time following a remand from the Supreme Court, in which the Federal Circuit was asked to reconsider its ruling in light of the Supreme Court’s recent ruling in Mayo v. PrometheusThe majority, written by Judge Lourie, found that Mayo did “not control the question of patent-eligibility of such claims. They are claims to compositions of matter” and that while “Plaintiffs and certain amici state, that the composition claims are mere reflections of a law of nature.  Respectfully, they are not, any more than any product of man reflects and is consistent with a law of nature.”  Judge Bryson’s dissent, on the other hand, explained that, “In cases such as this one, in which the applicant claims a composition of matter that is nearly identical to a product of nature, it is appropriate to ask whether the applicant has done ‘enough’ to distinguish his alleged invention from the similar product of nature,” concluding that Myriad had not made a “substantial ‘inventive’ contribution” or claimed anything more than a combination of “well-understood, routine, conventional” elements.”

It seems likely that the Supreme Court will agree with Judge Lourie that the gene patents in question in Myriad, whether or not they are products of nature, are not laws of nature, as some of the patents in question in Mayo were.  Yet I would be surprised if they took this to mean that Mayo therefore does not control the question of patent-eligibility in Myriad.  In Mayo, Justice Breyer’s majority opinion was incredibly clear that the metabolic correlation at issue was not patentable under §101 because it tied up a law of nature and therefore preempted its use for further research.  Isn’t that exactly what Myriad is about?  Certainly all parties would agree that Myriad’s patents, whether natural products (physical phenomena) or not, serve to preempt breast cancer research on the BRCA1 and BRCA2 genes.

When the Supreme Court articulated the §101 exception for laws of nature, physical phenomena and abstract ideas in Gottschalk v. Benson, it explained that these kinds of claims were not patentable because they consist of the “basic tools of scientific and technological work.”  It is difficult to dispute that Myriad’s isolated genes are basic scientific tools. But according to Myriad, under this rule, their patents would only be invalid if they claimed real human DNA, and that it is not dispositive that their isolated DNA is nearly identical to real human DNA, because it is not naturally occurring.

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Twitter Round-Up (1/13-1/19)

By Casey Thomson
The flu, gun control, and legal action against the FDA – all amongst our Twitter feeds this past week. Read on for more:
  • Frank Pasquale (@FrankPasquale) retweeted a link to the FDA’s current legal trouble concerning their failure to disclose antibiotic resistance data. The Government Accountability Project (GAP) is accusing the FDA of violating the freedom of information law, failing to release data on antibiotic drug usage within the meat industry in order to, as they claim, protect industry secrets. This failure takes special significance when considering that, according to GAP, “80% of all antibiotics sold in the US are utilized by the meat industry.” (1/14)
  • Michelle Meyer (@MichelleNMeyer) retweeted an article in the Health Affairs Blog concerning how to improve the Learning Healthcare System (LHS), which adapts data into knowledge that directs evidence-based practice and health system change. Specifically, the U.S. Department of Veterans Affairs is developing two approaches, namely Point-of-Care Research (“a method of performing clinical trials within the daily practicalities of the [health-care system] (with the intent of advancing these systems to LHS)”), and the Collaborative Research to Enhance and Advance Transformation and Excellence (strengthening health services research, which analyzes the factors regarding the obtainment of care). (1/14)
  • Arthur Caplan (@ArthurCaplan) reported on the American College of Physicians’ new recommendation that all healthcare providers receive the influenza vaccine for this particularly harsh flu season, in addition to other listed immunizations. (1/15)
  • Frank Pasquale (@FrankPasquale) additionally added a post on the inequality of the 2012-2013 flu outbreak – namely, the disproportionate number of lower-income individuals who are contracting the illness. The article noted the results of a study which found that while the majority of efforts for vaccinations occur in more wealthy neighborhoods, covering poorer neighborhoods with vaccine care early benefits the wealthier neighborhoods more so than if such vaccinations were delayed. (1/16)
  • Arthur Caplan (@ArthurCaplan) also shared a link to an examination into New York’s newly passed major gun control law, which addressed gun control ownership of those with mental illness. Caplan dissolved claims that the new measures were “draconian,” noting that such practices of reporting individuals that may pose concern for the safety of others have already been in practice but that these new policies make the process of reporting a legal imperative, and simpler.
  • Daniel Goldberg (@prof_goldberg) shared an article on SAGE Journals about the experience of gender within the healthcare science environment, specifically looking at the subtle practices of masculinist actions taking place that may remain unnoticed or unchallenged. The report is based on the discussed experiences of healthcare scientists with men in healthcare science laboratories. (1/16)
  • Alex Smith (@AlexSmithMD) linked to an article on an intervention for “post-hospital syndrome”, commonly known as the Acute Care for Elders (ACE) Unit. The intervention, while evidence-based and already in place in many hospital locations, may be overlooked by practitioners or healthcare authors. This unit works to reduce the effects that often derive largely from the “allostatic and psychological stress” accumulated during a hospital stay. (1/18)
  • Frank Pasquale (@FrankPasquale) posted a report on bias in reporting on breast cancer clinical trials. The study found that “nearly one-third of reports on large, randomized studies over-emphasize some benefits of therapy,” in addition to providing “insufficient attention or discussion of treatment side effects.” Considering that such reports factor prominently in how doctors decide to pursue treatment and therapy for patients, this misreporting leaves many doctors unaware of the true consequences of tested treatments – and may cause them to decide plans for treatment that they would not otherwise pursue. (1/19)

Note: As mentioned in previous posts, retweeting should not be considered as an endorsement of or agreement with the content of the original tweet.

Worth Reading This Week

By Nicolas Terry