As reported by Kevin Noonan on Patent Docs, plaintiffs-appellees (e.g., the ACLU) have filed a Petition for Panel Rehearing in Association for Molecular Pathology v. USPTO, also known as the ACLU/Myriad "gene patenting" case. The Petition alleges factual and legal errors in the court's July 29, 2011 decision on both the standing issue and the patent-eligibility issue, but is not likely to be granted. While the petition may foreshadow the arguments being formulated for Supreme Court review, its most likely effect will be to delay that review, further extending the period of uncertainty that is hanging over isolated DNA claims.
The Petition alleges that the Federal Circuit erred in finding that only Dr. Ostrer had standing. The Petition asserts that Ellen Matloff also has standing based on "conversations with Myriad" in which she was told that "she and geneticists at Yale would violate Myriad's patents if they performed the tests that she wanted to perform."
In reaching its decision on standing, the Federal Circuit referenced the two-part test for declaratory judgment jurisdiction in patent cases outlined in its 2005 decision in MedImmune, Inc. v. Centocor, Inc.:
a declaratory judgment plaintiff must allege both (1) an affirmative act by the patentee related to the enforcement of his patent rights . . . and (2) meaningful preparation to conduct potentially infringing activity.
The argument in the Petition focuses on the first prong of this test, but does not address the second prong, e.g., Ellen Matloff's actual and immediate intent to perform BRCA1 testing if the Myriad claims are invalidated.
The inclusion of this argument in the Petition for rehearing may fuel speculation as to the continued standing of Dr. Ostrer in view of his recent change in employment. The Petition touches on this issue, noting that "Dr. Ostrer is a member of the organizational plaintiff American College of Medical Genetics (ACMG)," and alleging that "gene patenting is germane to ACMG's purpose," but this hardly seems to satisfy the court's test for standing.
The main focus of the Petition is the court's decision on the patent-eligibility of isolated DNA.
The Petition alleges that the court went astray when it focused on the structure of isolated DNA molecules instead of considering the language of the claims at issue, which define the claimed DNA "by function" in that they recite DNA that "codes for a BRCA1 polypeptide."
The Petition emphasizes the breadth of the claims, pointing out that they encompass more than just the full-length BRCAI and BRCA2 genes, and alleging that they encompass "all fragments (and variations) of those genes."
The Petition also alleges that the court relied on "facts not in the evidentiary record" to reach the erroneous conclusion that the claimed isolated DNA "fragments" do not exist in nature. The Petition alleges several conditions under which fragments exist in nature:
- when gametes are produced during the normal process of meiotic recombination and during the cellular process by which cells make copies of themselves.
- when DNA experiences a double strand break (which then is often repaired).
- in maternal plasma, where the entire fetal and maternal genome can be found in short fragments.
- in the blood of those suffering from cancer, which includes DNA fragments, including fragments of the BRCA1/2 genes.
The Petition also focuses on the "random" processes involved in isolating genes, asserting that the scientist does not decide which covalent bonds to break, or how many:
In short, the chromosomal fragments/chemicals in the bottom of Myriad's test tubes are no more the result of human decision-making than the fragments/chemicals created when there is a naturally-occurring double strand break or in the blood of pregnant women or cancer patients. And, the fragments in all of those situations will be identical to the sequences claimed by Myriad's patents at least some of the time.
(Is the Petition implying that random processes do not reflect the intervention of man? Don't the scientists set these random processes into motion?)
The Petition concludes:
Because the majority premised its conclusions on the chemical alterations caused during the isolation process and either did not consider (or simply got wrong) the question of whether the altered chemicals are "markedly different" from chemicals found in nature, the majority erred.Even if the chemical alterations deemed significant by the majority are significant, they result in chemicals that are not markedly different from and are at times identical to those found in nature. They are thus not patentable subject matter.
Did The Federal Circuit Get It Wrong?
The Petition raises some interesting questions about the Federal Circuit decision, and highlights some problems with the rationale behind Judge Lourie's decision for the court on this issue.
Before Myriad, conventional thinking of both the USPTO and those practicing in this field was that isolating a product from nature sufficiently distinguished that product from a "product of nature" to satisfy 35 USC § 101. This is because, for example, isolation requires the intervention of man, and the product never will be found in nature in an isolated state. Departing from this rationale and relying instead on the "breaking covalent bonds test" opens isolated DNA claims up to challenge both on the § 101 grounds raised in the Petition (e.g., DNA fragments are not patent eligible because they can be found in nature), and on corresponding prior art grounds (e.g., DNA fragments are not novel because they can be found in prior art compositions, such as blood samples).
The Federal Circuit rarely grants petitions for rehearing, so it is not likely that the panel will agree to rehear this case. Nevertheless, it will be interesting to see how Myriad responds, and how the Supreme Court ultimately decides this issue. Given the questions raised by this Petition and other flaws in the Federal Circuit's Myriad decision raised by commentators, it might be best for all of us who innovate, patent, and practice in this field if the standing issue prevents further review, and we can go back to the drawing board with a (relatively) clean slate.