Myriad Responds: ACLU Asks the Wrong Question

14 November 2012 Personalized Medicine Bulletin Blog

On October 31, 2012, Myriad Genetics, Inc. et al. (“Respondent” or “Myriad”) filed its brief in opposition to Petitioners’ (The Association for Molecular Pathology et al., represented by the American Civil Liberties Union or ”ACLU”) quest for U.S. Supreme Court review in the ongoing legal battle over whether isolated DNA is patent-eligible subject matter. Myriad argued that U.S. Supreme Court review is not warranted, and that if it is, the question for the Supreme Court is not whether human genes are patentable, but whether isolated DNA molecules that were identified and defined by human inventors are patent-eligible subject matter in the United States.

Myriad’s Issues for Review

Three questions were presented for review, briefly summarized as follows:

  1. Did the Federal Circuit correctly apply Diamond v. Chakrabarty, 447 U.S. 303 (1980) (“Chakrabarty“), in light of Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012) (“Mayo“), to conclude that isolated DNA molecules, defined and isolated by human inventors, are products of human ingenuity and therefore patent-eligible? 
  2. Did the Federal Circuit correctly apply Mayo, when it held that one of the challenged method claims (claim 20) was patent-eligible under 35 U.S.C. Section 101 because, unlike the method claims held invalid in Mayo, claim 20 is based not on a law of nature but on a man-made, non-naturally-occurring transformed cell that is the product of human intervention?
  3. Did the Federal Circuit correctly conclude that 19 of the 20 plaintiffs recruited to join this lawsuit lacked standing because they had no injury traceable to Myriad, or failed to show any controversy between the parties?

In contrast, the ACLU differently positioned the issues for review. In sum, the ACLU presented the issues as:

  1. Are human genes patentable?
  2. Did the Federal Circuit err in upholding method claim 20 patent-eligible?
  3. Did the Federal Circuit err in adopting a rule, contrary to normal standing rules, that Petitioners who have been indisputable deterred by Myriad’s “active enforcement” of its patent rights nonetheless lack standing to challenge those patents absent evidence that they have been personally threatened with an infringement action?

Framing the Issue Frames Public Discourse

Petitioner and Respondent each offered three issues for review but this post will focus on the gene patenting debate. Everyone – from licensed patent attorneys, to scientists, to the public in general – appears to have an opinion on the issue of gene patenting, especially as framed by the ACLU – “are human genes patentable?” However, as Myriad noted in its brief and the Federal Circuit indicated in its decision, Myriad’s patent claims are not an attempt to patent “human genes” but rather isolated DNA molecules not found in nature. The Federal Circuit based its decision in part on the fact that the isolated DNA molecules are obtained in the laboratory and man-made – the product of human ingenuity. The court also noted that while isolated DNA molecules are prepared from products of nature, so is every other composition of matter. All new chemical or biological molecules, whether made by synthesis or decompositions, are made from natural materials.

Myriad also responded to the ACLU’s contention that standard isolation results in random DNA fragments that are identical to those that exist in the body. By definition, Myriad noted, isolated DNA is a molecule that has been removed from the body. It cannot simultaneously be removed from the body and be in the human body. With respect to the ACLU’s claim that covalent bonds of DNA molecules may be broken in the body, this fact, Myriad argued, is irrelevant because this assertion omits critical elements of the definition of isolated DNA. Isolated DNA is more than just DNA with bonds broken, Myriad explained, the DNA must also be separated from the body and other DNA not of interest.

Myriad further argued that not only has the ACLU incorrectly framed the question for review, but also that the U.S. Patent Office (“PTO”), after public discourse and review, has been issuing patents on “isolated DNA” for over 30-some years. This patented technology has fueled significant advancement in human, agricultural, and industrial products. Myriad also pointed out that its technology, obtained after great effort and investment, has improved individualized patient care.

Myriad’s Patents Do Not Impede Research and Improvements 

In my post of November 9, 2012, I reviewed the article The Next Controversy in Genetic Testing: Clinical Data as Trade Secrets? which opined in part that Myriad’s patents have inhibited others in the field from developing and improving upon its technologies. Myriad’s brief noted that to the contrary, its patents have not inhibited additional research and development. For example, gene expression profiles, inspired by Myriad’s inventions but outside the scope of Myriad’s patents, have been devised to test breast and ovarian cancer risk, noting PCT Publ. No. PCT/US2008/080358 and PCT Publication No. WO 2009/052417. Other technologies that do not involve isolating a DNA molecule, such as whole genome sequencing, is not covered by Myriad’s patent claims.

The Questions for Patent Attorneys and the Industry

Apart from the public discourse regarding whether or not “human genes are patentable” is the issue of interest to patent attorneys and the industry – whether the Federal Circuit correctly applied the Supreme Court’s prior case law when it held that isolated DNA molecules are patent-eligible subject matter. Myriad argued that the Federal Circuit, and in particular Judge Lourie who wrote the lead opinion, correctly noted that the correct inquiry for composition claims remains the Chakrabarty test, viewed, in light of the fundamental principles reiterated in Mayo. Judge Lourie, Mayo noted, applied the Mayo test and cataloged a variety of differences between the claimed compositions and native DNA caused by human intervention, including for example that 1) isolated DNA is free-standing, 2) is synthesized or have chemically severed backbones, and 3) has significantly fewer nucleotides than native DNA. Judge Moore agreed with Judge Lourie in part for distinct policy reasons. Even Judge Bryson, Mayo stated, looked to the Chakrabarty test and determined that most of the isolated DNA claims are patent-eligible. Only the claims to the patent-eligibility of longer isolated DNA molecules did he disagree with Judges Lourie and Moore. Judge Bryson, Myriad stated, noted that such were not patent-eligible based on his own evaluation of the similarities between isolated DNA molecules and native DNA.

Supreme Court Review?

Earlier today, the law blog Patent Docs, reported that the Supreme Court updated its docket for this case indicating that it has now been distributed for conference on November 30. Seven amicus curiae briefs have been filed, two of which are available on this post.

Whether or not the Supreme Court decides to entertain an appeal, let’s hope the right question is asked and addressed – are artificially isolated DNA molecules that are structurally and functionally distinguishable from native DNA, patent-eligible?

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