By Kevin E. Noonan --
On Thursday, counsel for plaintiffs/appellees in Association for Molecular Pathology v. U.S. Patent and Trademark Office (who may be simply Dr. Harry Ostrer, the only plaintiff with standing in the case after the panel decision) filed a petition for panel rehearing before the Federal Circuit. As grounds for rehearing, Plaintiffs list two points of law and fact that they allege were overlooked or misapprehended by the Court. First, the petition contends that the Court "failed to consider whether the DNA fragments claimed in these patents are products of nature." Second, the Court is alleged to have erred by not finding that two other named plaintiffs, the American College of Medical Genetics and specifically named plaintiff Ellen Matloff, satisfied the standards for standing enunciated by the Court.
Regarding the first asserted point of error, plaintiffs allege that "DNA fragments" (presumably, genomic DNA) exist in nature and thus are patent-ineligible. This determination, according to the petition, ignores the "language of the claims" and "the scientific fact that DNA fragments with identical chemical structures are found in nature." The claims do not define the claimed DNA by structure, plaintiffs contend, but by function: encoding BRCA 1 or BRCA 2 polypeptides. The claims thus include "[m]ultiple chemicals with different structures and covalent bonds broken in different places," including "allelic variations," "chemically or biochemically modified" polynucleotides, and nucleotides that are 60% identical to the claimed sequence. According to the petition, "the many different chemicals described in each claim of the patent have nothing in common . . . except that they serve a particular function, i.e. they encode a particular protein" or protein fragment. The petition alleges that this is the function the sequences have in nature, and therefore that the failure of the panel majority to declare the claims patent-ineligible on this basis was "an error in claim construction."
The petition further alleges that "DNA fragments identical to those claimed in the patents appear in the body," citing meiosis, double-strand DNA breaks, and the occurrence of fetal and maternal DNA fragments in maternal blood plasma in support of its conclusion that "all of the fragments that make up the BRCA1/2 genes can be found in natural maternal blood" (having the same characteristics -- broken covalent bonds and free 3' hydroxyl groups -- that the majority cites as a sufficient basis for finding the claimed isolated DNA to be "markedly different"). Also cited are instances where DNA fragments are found in blood plasma from cancer patients. In plaintiffs' view, the purported existence of these DNA "fragments" from these natural sources renders the claimed DNA to be "products of nature" and thus unpatentable.
Finally, the petition cites the methods by which genes have been isolated from genomic DNA -- random fragmentation into vectors and identification of clones encompassing the gene -- as evidence that the claimed DNA fragments are sufficiently identical to what occurs randomly in nature for these fragments to qualify as patent-ineligible "products of nature." The petition also cites the evidence that the oligonucleotide fragments can be found in other genes and are not specific to DNA (see "Caught in a Time Warp: The (In)validity of BRCA1 Oligonucleotide Claims"). According to the petition, "if the claims cover, even in part, any product of nature, they must be found invalid."
The petition also asserts that the majority erred by basing its decision on evidence regarding the chemical nature of DNA that was "not supported by the record," specifically the fact that covalent bonds are broken in isolating BRCA DNA from the chromosome. And the petition notes that plaintiffs would be "happy" to provide declarations containing "responsive facts" to explain to the Court what it "simply got wrong." One has to admire their cheek.
One thing that these arguments reinforce is that what this case needs as a predicate to any further argument is for the Court to construe the claims (see "Is Claim Construction the Key to Patent-eligibility of Isolated DNA?"). While many of the arguments contained in the petition seem fantastical to anyone who has worked in this area of patent law for any time, unless the parties can set forth the evidence and arguments for construing the claims, and the Court has an opportunity to rule on the scope and meaning of disputed claim terms, there can be no basis for the Federal Circuit, or the Supreme Court, to rule affirmatively on the question of whether the subject matter of the composition of matter claims is patent-eligible.
This portion of the petition also seems to indicate that plaintiffs have acquiesced to the majority's decision that cDNA claims are patent-eligible, despite those claims having the same "informational" content as the isolated genomic DNA claims that the petition argues were improperly determined by the majority to be patent-eligible.
With regard to the standing issue, plaintiffs argue that the finding that Dr. Ostrer (at right) has standing confers "organizational standing" on the American College of Medical Genetics, citing "well-established Supreme Court law," specifically Warth v. Selden. For those who have not reviewed the Warth case, it involved a lawsuit against the town of Penfield, N.Y. by an organization, Metro-Act of Rochester, that alleged housing discrimination. The Supreme Court found that the plaintiffs did not have standing to sue because none of the plaintiffs could demonstrate any injury in fact. The relevant "Supreme Court law" recited in Warth is that for an organization to have standing, it must allege that "all or any one" of its members has suffered or been threatened with an immediate injury.
In addition, the petition argues that Ellen Matloff alleged that she "was told by Myriad that she and geneticists at Yale would violate Myriad's patents if they performed the test she wanted to perform." The petition does not, however, point to any evidence that Ms. Matloff "would immediately begin to perform BRCA1/2-related genetic testing upon invalidation of the Myriad patents," which was the basis for the Court deciding that Dr. Ostrer has standing. These assertions of standing for other plaintiffs arise in the wake of allegations by defendants that Dr. Ostrer no longer has the capacity for "immediately begin[ning] to perform BRCA 1/2-related genetic testing upon invalidation of the Myriad patents," an allegation denied by plaintiffs.
The one certain consequence of the filing of plaintiffs' petition is that any petition for certiorari will be delayed, making it likely that the Supreme Court will decide the Mayo Collaborative Svcs. v. Prometheus Labs., Inc. case before ruling on the invalidated method claims in the Myriad case.