Myriad: A Look Into the Future of Genetic Patentable Subject Matter.

• Author: Cromer, Nathan Edward

Introduction I. Myriad and Patentable Subject Matter A. District Courts' Interpretation of Patentable Subject Matter in Light of the Myriad Decision 1. Arisoa Dignostics, Inc. v. Sequenom, Inc. (Northern District of California) 2. In re BRCA1-, BRCA2-Based Hereditary Cancer Test Patent Litigation (District Court of Utah) 3. Genetic Technologies Ltd v. Bristol-Myers Squibb Company (District Court of Delaware) 4. Genetic Technologies Limited v. Agilent Technologies (Northern District of California) B. Federal Circuits' Application of the Myriad Interpretation 1. In re Roslin Institute 2. In re BRCA1, BRCA2 II. Conclusion Introduction

In June 2013, the Supreme Court of the United States decided the Association for Molecular Pathology v. Myriad Genetics case. (1) That decision will change the future of patent eligible subject matter. The decision was one of the first cases the Supreme Court determined after the adoption of the America Invents Act of 2013 ("AIA"). (2) Specifically, the Myriad decision deals with 35 U.S.C. [section]101 and patent eligible subject matter related to gene patents. (3) The circuit court initially held that both isolated DNA and synthetically created complimentary DNA (cDNA) were patent eligible subject matter under section 101 of the AIA. (4) The Supreme Court reversed in part finding that isolated DNA, comprised of naturally occurring segments of DNA, is not patent eligible subject matter. (5) However, the Supreme Court found that synthetically created cDNA was not naturally occurring because cDNA has been stripped of its noncoding intron component and contains only the coding exon portion of the DNA. (6) Therefore, cDNA does not occur in nature and falls within the scope of patent eligible subject matter. (7) There have been several district court cases (8) and two circuit court cases (9) that have analyzed subject matter eligibility in light of the Myriad decision.

This Comment is divided into two sections. The first section interprets and analyzes how district courts and circuit courts determine patentable subject matter under the guidance of the Myriad decision. The second section of the Comment approaches the issue from the perspective of a law student with a background in molecular and cellular biology. The second section attempts to understand and predict the future of patentable subject matter eligibility in light of the Myriad Supreme Court decision and its progeny.

1. Myriad and Patentable Subject Matter

   The Myriad decision is the leading authority on gene patents subject matter eligibility. (10) The Court in Myriad addressed the issue of patenting isolated genes and cDNA sequences. (11) Section 101 of the Patent Act (12) permits patents to be issued to "[w]hoever invents or discovers any new and useful...composition of matter," "but laws of nature, natural phenomena, and abstract ideas are basic tools of scientific and technological work that lie beyond the domain of patent protection." (13) The Myriad subject matter analysis relies heavily on the Supreme Court's analysis in Mayo Collaborative Services. (14)

   The holding in Myriad is that isolated genes do not fall within the category of patentable subject matter because they are naturally occurring. (15) However, the Court made the distinction that cDNA, which is synthetically created in a laboratory and is not naturally occurring, is patent eligible. (16) Since the decision in June of 2013, several district courts have engaged in an analysis of patent eligible subject matter. (17) Two federal circuit cases use the Myriad decision in the courts' holdings. (18) In order to understand where the future of gene patents is going, we must first look to how the cases since the Myriad decision are interpreted and applied, both at the district and federal level.

   1. District Courts' Interpretation of Patentable Subject Matter in Light of the Myriad Decision

      Several district court decisions have been decided since the outcome of the Myriad decision in June 2013, which cite to and interpret the analysis performed by the Supreme Court. (19) The Myriad decision relies heavily on the analysis performed by the Supreme Court in Mayo Collaborative. (20) The question presented by the Supreme Court in Mayo is, "do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws?" (21) The Court in Myriad took up this analysis in its statement that isolated DNA was simply DNA that was isolated from a cell, which was naturally occurring and not patent eligible subject matter, but that cDNA was synthetically created in a laboratory and not occurring in nature therefore cDNA did fall within patentable subject matter. (22)

      1. Arisoa Dignostics, Inc. v. Sequenom, Inc. (Northern District of California)

         The district court case Arisoa Diagnostics v. Sequenom, Inc. involves claims that are similar to the isolated DNA claims of the Myriad patent. (23) The court stated that "he who discovers a hitherto unknown phenomenon of nature has no claim to a monopoly of it...[t]his is true even if the discovery...[is] considered groundbreaking, innovative, or brilliant." (24) "A process or method is not unpatentable simply because it contains a law of nature, a natural phenomenon, or an abstract idea." (25) It is well settled in case law that "to be patentable, a process that focuses upon the use of a natural law, a natural phenomenon, or an abstract idea must contain other elements or a combination of elements, referred to as an 'inventive concept.'" (26) In Myriad, the Court went even further in its analysis of what is considered naturally occurring stating that "[s]imply appending conventional steps, specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patentable." (27) "The [Ariosa] Court's conclusion conforms [to] the relevant Supreme Court case law, in particular Flook and Myriad, " "even though Myriad involved composition claims rather than method claims." (28)

         The fact that Myriad involves composition claims and Ariosa involves method claims does not change the analysis performed by the court. (29) "Although the Supreme Court [in Myriad] was not presented with method claims, the Court explained 'had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent.'" (30) Had Myriad sought protection for a method for DNA isolation of the BRCA1 and BRCA2 genes, the method would likely still be found to be ineligible subject matter. The method patent for Myriad's isolated DNA would be found to be ineligible subject matter because "the processes used by Myriad to isolate DNA were well understood by geneticists at the time of Myriad's patents." (31) Had...