AMP v. Myriad – Oral Argument

The Federal Circuit heard oral argument in Association of Molecular Pathology v. USPTO on Monday, April 4. The case comes to the Federal Circuit on appeal from the U.S. District Court for the Southern District of New York. There, a number of plaintiffs represented by the American Civil Liberties Union (ACLU) and the Public Patent Foundation brought suit against the USPTO and Myriad Genetics, asserting that Myriad’s patent claims to certain isolated, purified breast cancer DNA sequences and related methods were invalid as unpatentable under 35 U.S.C. § 101 as natural products, natural phenomena, or abstract ideas. The plaintiffs prevailed against Myriad at this district court, and Myriad appealed the decision to the Federal Circuit, where a panel of Judges Bryson, Lourie, and Moore heard arguments.

Arguments on behalf of Myriad first focused on jurisdictional issues, then on substantive matters of patentability of the claimed products and methods. Counsel for Myriad argued that the defendants did not engage in meaningful preparation to practice the asserted claims. Judge Moore questioned whether operating under the threat of a cease and desist letter, though several years old, might be enough for declaratory judgment, and whether a burden may in some instances shift to a patentee to show that there is no threat of continued litigation. Myriad argued in response that the threat of litigation had here been removed. When argument turned to the issues of patentability, Judge Bryson asked for clarification of the scope of the isolated, purified nucleic acid claims. In response, counsel for Myriad referred to the USPTO utility guidelines, which refer to the patentability of isolated genes. All three judges on the panel asked questions drawing analogies to mining, purifying, and patenting purified elements such as gold and lithium. Myriad acknowledged that it believed such minerals to be patentable under § 101, but placed greater emphasis on an analogy to extracting wood from a tree to make a baseball bat. Myriad then presented arguments that its method claims to analyzing and comparing were analogous to other claims recently ruled to be patentable subject matter.

At the outset of the ACLU arguments, Judge Moore steered the focus to jurisdictional issues. The arguments addressed whether any one plaintiff would be “ready, willing, and able” to practice the asserted patent claims, with the ACLU arguing that several researchers satisfied this requirement because sequencing the patent-protected isolated genes would be a trivial matter. On the merits, the panel again invoked analogies to patentability of purified natural substances, biological and inorganic, in questioning the ACLU. The ACLU drew another analogy between removing genomic DNA and removing a kidney from the body; both, the ACLU argued, involved procedures to remove a part of the body that remained the same once extracted. The court turned its attention to the functions of nucleic acids in the cell as compared to the functions of nucleic acids in isolated and purified form, and the ACLU characterized the functions of both as bonding to opposing strands. The ACLU concluded arguing that the method claims at issue brought about no transformation, but merely mental processes that one could infringe by looking at two sets of nucleotide sequences on a computer screen.

As we previously reported, the Department of Justice (DOJ) filed an amicus brief in this case. Acting Solicitor General Neal Katyal represented the U.S. government’s positions from that brief. The Solicitor General did not address the jurisdictional issues, but instead went directly to the substantive patentability issues. The importance of human ingenuity and the unimportance of any living-nonliving distinction formed the basis for much of the government’s argument. The Solicitor General repeatedly proposed a “magic microscope” view of isolated, purified nucleic acid sequences, saying that if one could examine a segment of a nucleic acid molecule in the body with a magic microscope, one would see the same matter as if one could examine isolated, purified nucleic acid. Judge Lourie questioned the Solicitor General from several angles on the issue, including the mined elements analogy, the ACLU’s focus on genes as abstract information, and the significance of purification with respect to the product claims. Judge Moore further questioned the Solicitor General as to the effect of Congress’s silence in the face of long-standing USPTO practice regarding isolated, purified nucleic acid as patentable. Because this is a question of law, the Solicitor General stated that Congressional acquiescence alone should not be determinative.

Myriad’s rebuttal arguments dealt again with both jurisdictional and substantive patentability issues. Judge Moore asked why mere extraction should render a product patentable, to which counsel for Myriad replied that the extraction was no trivial matter. Judge Bryson asked for further clarification as to whether Myriad would argue that isolating naturally-occurring chemical elements, like isolating segments of human nucleic acids, could produce a patentable product if the isolation process involved breaking covalent bonds. Myriad conceded that such a product could be patentable under its views of § 101.

If Myriad ultimately prevails in this case, then isolated, purified segments of naturally-occurring human nucleic acid will continue to be patentable subject matter under § 101, consistent with current USPTO practice. Because for-profit endeavors have greater incentive to engage in research that may yield patent-protectable discoveries, a ruling in Myriad’s favor would encourage privately-funded genetic research. To the extent that courts disagree with Myriad and current USPTO practice, whether to the extent of the DOJ or to the further extent of the ACLU, various formulations composed of or comprising nucleic acids may then fall outside of the scope of patentable subject matter under § 101. A ruling in favor of the DOJ or the ACLU may allow a researchers and medical professionals to more-easily build upon or practice previously-discovered knowledge of genetics, at the expense of some incentive for private research to pursue new genetic discoveries.