On Monday, April 4, 2011 a long line of lawyers and interested parties waited to enter the Federal Circuit to hear the much anticipated oral arguments in The Association of American Pathology v. Myriad.  Amongst them were HDP patent attorneys, who filed an Amicus Brief in the Appeal.

BACKGROUND:

The case is an Appeal from a decision by U.S District Court Judge Robert Sweet of the Southern District of New York (SDNY).  Judge Sweet denied Myriad’s motion to dismiss based on standing and then granted summary judgment for Plaintiffs, holding that patents for isolated DNA containing breast cancer susceptibility genes (BRCA) were invalid, and that patents for methods of analyzing gene sequences were also invalid.

HDP filed an Amicus Brief on November 4, 2010 on behalf of Gilead Sciences, Inc., BioGenerator and Elan Pharmaceuticals in support of Defendants-Appellants (Myriad).  The Amicus Brief focused on the sole issue: Does Myriad U.S. 5,747,282 (U.S.’282) Claim 2, defining a man-made, synthetic, non-natural, new cDNA probe (SEQ ID #1), having commercially-proven useful medical-diagnostic property, qualify as patent-eligible subject matter under 35 U.S.C. §101?  The position of the HDP Amicus Brief is that the SDNY decision should be reversed on statutory and factual grounds upon CAFC review of this single issue.   

ISSUES:

Three main issues were addressed by the Fed. Cir. Panel (Judges A. Lourie, W. Bryson and K. Moore) during the oral argument:  (1) standing, (2) redressability and (3) the merits of the case, whether isolated DNA is a “product of nature” and thus not patentable-eligible subject matter under 35 U.S.C. §101.

1.  STANDING

First, standing appeared to be the largest issue, especially for Judge Moore.  The Court spent considerable time discussing the standing issue.  The questions revolved around whether certain of the Plaintiffs met both prongs required for bringing a declaratory judgment action as found in MedImmune Inc. v. Genentech Inc., 549 U.S. 118 (2007).  Namely, whether there exists a “substantial controversy … of sufficient immediacy and reality” and “meaningful preparation” to conduct the potentially infringing activity.  The Court questioned why the Plaintiffs who had received the most threatening letters had the weakest affidavit statements in that they would have “an earnest desire to consider” practicing the invention.  Most markedly, Judge Moore stated, while speaking to Christopher Hansen of the American Civil Liberties Union (ACLU), “Do you not recognize the profound impact that would have on our patent system if anyone who was ready, willing, and able to compete tomorrow could bring a DJ action against the patentee in any forum of their choosing without any affirmative act directed at all against them by the patentee?”  The ACLU argued that MedImmune doesn’t require directly attacking a particular Plaintiff, but only that they have a reasonable basis that they would be sued.   Thus, it would not be surprising if this case is decided on standing.

2.  REDRESSABILITY

Second, redressability was briefly discussed.  Myriad raised the argument that even if the Plaintiffs were to win on the asserted patent claims, it would not open up BRCA testing because the Plaintiffs failed to challenge all of the Myriad patent claims.  Myriad pointed out that, indeed, only 15 of 179 claims in the 7 patents in suit were challenged by the Plaintiffs.  Myriad questioned what made these 15 claims special and argued that this case was identified just to attack gene patents everywhere.  The ACLU countered that the Plaintiffs would not infringe the unchallenged claims.

 3.  DNA §101-INCLUDABILITY

Third, turning to the highly publicized merits of the case, many analogies were discussed by all Parties and the Judges.  Indeed, commentators on the oral arguments have already deemed them the “Battle of the Analogies.” 

In arguing that isolated DNA is §101-includable, Myriad used the analogy of a tree and a baseball bat.  A baseball bat is made of wood and although the wood existed in a tree, a baseball bat did not exist until the hand of man isolated it from the tree.  Judge Moore countered this with her own analogy of two minerals in a rock.  If you remove or isolate one mineral from the rock, that does not change the fact that the mineral existed in nature in the rock.  Myriad countered that such a mineral should be patent-eligible subject matter if, for example, man had to break chemical bonds to separate the mineral.  Judges Moore and Bryson continued to distinguish the patent eligibility of the process required to isolate material versus the patent eligibility of the material itself.  Judge Bryson said, “Mining can be complex, but mining for diamonds does not render the diamonds eligible under Section 101.”

The ACLU argued “The human gene is a product of nature and no more patentable than a human kidney.”  Essentially that a kidney can be taken out of the body, but it is still a kidney that existed in nature.    Judges Lourie and Bryson countered this by discussing that, unlike removal of a kidney, chemical bonds, such as covalent bonds, had to be broken and chemical structure altered to create the isolated DNA, i.e. that isolated DNA does not exist in nature but exists as a larger chemical structure.  

Lastly, the U.S. Solicitor General from the DOJ, Neal Katyal, also addressed the Panel as a “Friend-of-the-Court” without the support of the USPTO.  This was the first time a Solicitor General has argued at the Federal Circuit.  The DOJ took a more middle-of-the-ground stance.  Using a “magic microscope” analogy, the DOJ argued that claims to isolated DNA, such as Myriad’s U.S. ‘282 Claim 1, is not patentable subject matter because a “magic microscope” can see the DNA in a human body.  However, cDNA, such as Claim 2 in U.S. ‘282, is patentable subject matter.  Myriad and the DOJ both properly argued that BRCA-gene cDNA hybridizing-probe of U.S.’282 Claim 2 is §101-eligible as a new and useful synthetic, non-natural construct (as urged in HDP Amicus Brief).  Nonetheless, the ACLU argued that “none of the claims in the ‘282 patent are limitied to cDNA,” but rather claim “genomic DNA generally” (which is grossly factually incorrect).

The DOJ also responded to Lourie and Bryson’s breaking chemical bonds discussion with a lithium example.  Lithium occurs in nature in salt form.  Lithium is only isolated by breaking covalent bonds with surrounding material.  However, since it is the third element in the periodic table it should not be patentable-eligible subject matter.  During rebutal, Myriad argued that lithium may well be patent-eligible subject matter if it did not exist in nature, but for human intervention to break the chemical bonds from the salt. 

Interestingly, the Panel noted the Executive Branch’s apparent discrepancy between the USPTO, an administrative agency, granting “DNA patents” for the past 30-35 years and the DOJ’s current opinion on DNA as patentable-eligible subject matter.

Very little time was spent discussing the method claims at issue in this case.  Myriad argued that the “comparing” and “analyzing” claims were comparable to the “determining” claims found to be patentable subject matter in Prometheus Laboratories Inc. v. Mayo Collaborative Services, 581 F.3d 1336 (Fed. Cir. 2009) in that a transformation necessarily takes place to compare and analyze materials.  The ACLU argued that Myriad’s method claims at issue don’t involve transformative steps, and that mere comparing sequences on a computer screen could be considered infringement.