Ryan Chirnomas, Partner in the Biotechnology group at Westerman, Hattori, Daniels and Adrian, sent in this article discussing the latest developments in the AMP v. USPTO case and what the Plaintiffs next move may be.
After the CAFC issued a decision in AMP v. USPTO on July 29, 2011, there was much speculation as to what would be the next move in this compelling case. A petition for an en banc rehearing or a petition to the Supreme Court to grant a writ of certiorari seemed likely, but instead each party petitioned for a rehearing by the same three-judge panel. Last week, the CAFC denied both of these without providing any further comments. However, these petitions provide some insights as to how the parties’ positions on standing as well as the merits are evolving, and are summarized below.
Plaintiffs’ Petition for Panel Rehearing
On August 25, 2011, the Plaintiffs, represented by the ACLU and PubPat, filed a petition for a panel rehearing on both substantive issues and issues of standing. As to the substantive issues, the Plaintiffs took issue with the majority’s reasoning that isolated DNA does not occur in nature.
The CAFC decision focused largely on the point that isolated DNA has broken covalent bonds where naturally occurring DNA does not. In the petition, the Plaintiffs first argued that the CAFC relies on facts not in the record to reach this decision. Further, the Plaintiffs argued that isolated DNA fragments with broken covalent bonds do in fact occur in nature. For example, the Plaintiffs pointed to transitory situations such as meiotic recombination and mitosis, as well as double stranded breaks of DNA which may be later repaired. Furthermore, the Plaintiffs stated that the entire fetal and maternal genome can be found in short fragments in maternal plasma, and that fragments of the BRCA1/2 genes can be found in the blood of those suffering from cancer.
Furthermore, the Plaintiffs argued that the CAFC focused on structural features of the claimed isolated DNA which is not recited in the claims. The Plaintiffs argued that the isolated DNA is defined by function as reciting DNA that “codes for a BRCA1 polypeptide.” The petition also argued that due to open language in the claims, the claims are broad enough to encompass various fragments of DNA, not just full length BRCA1/2 genes. In sum, the Plaintiffs argued that the CAFC erred in holding that the claimed isolated DNA is markedly different from DNA found in nature. The Plaintiffs provided no comments about other substantive issues in the CAFC decision, such as the patent eligibility of cDNA.
Next, the Plaintiffs discussed standing. In the CAFC decision, only Dr. Ostrer of New York University was regarded as having standing, due to direct contact with Myriad and his explicit statements that he would immediately begin to provide the genetic tests if the claims were invalidated. However, at the end of August 2011, Dr. Ostrer moved from NYU to the Einstein and Montefiore Medical Center of Yeshiva University. In the petition, the Plaintiffs shifted the focus of Dr. Ostrer’s actions from those relating to his affiliation with NYU to those relating to his membership in the American College of Medical Genetics (ACMG), which is another plaintiff in this case (found to lack standing). The Plaintiffs alleged that because gene patenting is germane to the purpose of the ACMG, the ACMG therefore has standing as an organization.
Additionally, in the CAFC decision, it was stated that Myriad only directed communication to three doctors. However, the Plaintiffs argued that the CAFC erred in failing to recognize that Myriad also had contact with Ellen Matloff of Yale University. The Plaintiffs stated that Ms. Matloff personally had conversations with Myriad, in which she was informed that she would violate Myriad’s patents if she performed the tests that she wished to perform. Thus, the Plaintiffs argued that Ms. Matloff also has standing. This petition was denied on September 13, 2011.
Defendants’ Petition for Panel Rehearing
On August 29, 2011, Myriad filed a petition for a panel rehearing only on issues of standing. As noted above, the CAFC previously held that only Dr. Ostrer had standing. However, after the CAFC decision was issued, Dr. Ostrer moved to a new employer, which apparently lacks to ability to carry out genetic testing.
Myriad argued that the dispute in the pending case was between Myriad Genetics and New York University, rather than between Myriad Genetics and Dr. Ostrer. This is at least because the license sought by Myriad was an institutional license for NYU, not a personal license for Dr. Ostrer. Thus, Myriad argued that Dr. Ostrer’s standing relied entirely on his employment at NYU. Since Dr. Ostrer is no longer employed by NYU, Myriad argued that the controversy is moot.
Furthermore, Myriad argued that there is no controversy with Dr. Ostrer’s new employer, the Einstein and Montefiore Medical Center. Myriad stated that they have never had any communications with Montefiore, and even if Montefiore has the same immediate capabilities as NYU, this is insufficient to create a controversy between the parties. Since the case is allegedly moot due to the Plaintiff’s actions, Myriad requested the CAFC not to vacate its previous substantive decision regarding the patents. Instead, Myriad requested that the CAFC merely hold that the dispute is now moot. This petition was denied on September 16, 2011.
In view of the above, the next course of action is for the Plaintiffs to either petition the CAFC for an en banc rehearing or petition the Supreme Court for writ of certiorari. Time will tell which strategy the Plaintiffs choose.
Ryan Chirnomas is a Partner in the Biotechnology group at Westerman, Hattori, Daniels and Adrian LLP. Any questions or comments may be directed to rchirnomas@whda.com. This article is for informational purposes only. The comments herein are the views of the author only and do not necessarily represent the views of Westerman, Hattori, Daniels and Adrian LLP or its clients.
Tags: ACLU, American College of Medical Genetics, AMP v. USPTO, CAFC, gene patenting, Patent eligibility
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