On August 25, 2011, on behalf of Plaintiffs, the ACLU filed a Petition for Panel Rehearing with the Federal Circuit in Assn. Molec. Path. et al. v. USPTO et al., known as the Myriad “gene patenting” case. Four days later, on August 29, 2011, Myriad likewise filed its own Petition for Panel Rehearing. Both parties filed their Petitions in response to a precedential decision by the Federal Circuit a month earlier. In that decision, a three-judge panel held, among other things, that all “isolated DNA” claims at issue are patent-eligible, contrary to Plaintiffs’ position. All three judges wrote detailed opinions, with Judge Lourie writing the majority opinion, Judge Moore concurring-in-part, and Judge Bryson concurring-in-part but dissenting-in-part regarding claims encompassing isolated genomic DNA. For background details of the case, see August 9 post, July 31 post and July 29 post. (Many thanks to Kevin Noonan at Patent Docs for first providing the Petitions.)

ACLU/Plaintiffs Petition for Panel Rehearing

In their recent petition, Plaintiffs ask the same three judges rehear the case again. Notably, they do not ask for a rehearing en banc, which would entail reconsideration by all active Federal Circuit judges.

Considering the density and depth of the opinions written by all three judges, requesting a rehearing by the same panel appears to be an odd move by Plaintiffs. To the extent the ACLU and Plaintiffs would like the Federal Circuit to take another stab at the case, one would think they would wish to involve different judges who might agree with Judge Bryson or a least disagree with Judges Lourie and Moore. Judge Dyk, for example, previously indicated support for the idea that isolated DNA products are not patent-eligible, as seen in his separate opinion in Intervet Inc. v. Merial Ltd. There, Judge Dyk expressed his doubt that an “‘isolated’ DNA sequence is qualitatively different from the product occurring in nature,” and opined that “[t]he mere fact that such a DNA molecule does not occur in isolated form in nature does not, by itself, answer the question.” For more discussion, see Courtenay Brinckerhoff’s August 12, 2010 post on PharmaPatents.

Perhaps the point is that Plaintiffs are not actually interested in having the Federal Circuit take a bite at this apple again. Plaintiffs may be only interested in making a show of an effort at a rehearing, but without risking the court actually granting it.

ACLU Rehashes the Merits Regarding Isolated DNA

In their Petition, Plaintiffs assert that the “majority” erred in focusing on the chemical structure of the isolated DNA sequences “without considering (1) that the language of the patents defines the function, not the structure of the patented genes and gene fragments; and (2) that gene fragments with the altered chemical structure identified by the Court exists in nature.” Plaintiffs further contend that the dispositive legal question is not whether an isolated DNA is different chemically “from a full chromosome of DNA,” but whether such molecules are products of nature.

Regarding (1), Plaintiffs stress that the isolated DNA claims “are not defined by chemical structure” but “are defined by function.” Plaintiffs assert that claim 1 of U.S. Pat. No. 5,747,282, for example, encompasses any chemical that “codes for a BRCA1 polypeptide.” What Plaintiffs fail to acknowledge, however, is what claim 1 recites in full: “An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.” Looking at this language, it is unclear how one can argue that the claim recites “function.” Rather, it recites a genus of specific isolated DNA products, i.e., chemical molecules, that encode a specific amino acid sequence (SEQ ID NO:2).

Later, the Petition argues that when isolating a gene, a “scientist [] does not decide or control the size or composition of the fragments/chemicals” and “does not decide where the covalent bonds should be broken or what the terminations should look like at the ‘3 or ‘5 ends.” Plaintiffs also state that “scientists performing isolation generally do not stitch the fragments back together to form longer segments, such as an entire gene.” In these passages, presumably Plaintiffs refer to scientists isolating a gene or DNA fragment for the first time, not what scientists do with isolated DNA molecules once relevant sequences are known. Regardless, it is not clear how Plaintiffs statements here relate to patent-eligibility. Claims at issue are directed to specific DNA molecules (even if encompassing a large genus), regardless of what a scientist decides, controls or performs when isolating and sequencing the DNA in the first instance. Thus, at best, Plaintiffs may raise written description and/or enablement considerations, but 35 U.S.C. §112 is not relevant here.

Regarding (2), Plaintiffs assert that fragments of the BRCA genes “as short as 15 nucleotides can be found throughout the human genome.” This point appears to be either irrelevant (yes, sequences of non-isolated fragments and genes are found in a human genome) or scientifically incorrect (15-nucleotide fragments do not exist in an isolated form in the genome).

Plaintiffs go on to say that “a scientist isolating an entirely different chromosome, in order to sequence an entirely different gene, is likely to create a 15-nucleotide fragment from BRCA-1,” and that “the scientists could not avoid this result.” Even assuming hypothetically such statements are scientifically accurate (a dubious proposition, unsupported in the Petition), once again, it is not clear how such points are relevant to patent-eligibility. At most, such arguments may be relevant to anticipation or obviousness—legal questions not at issue in the case.

Plaintiffs also contend that Myriad’s own briefs never referred to “covalent bonds” or “hydroxyl” termination points, suggesting that Plaintiffs would have responded in the record earlier if given the chance. Emphasis on this terminology misses the point of the majority opinion, however. In his opinion, Judge Lourie indicates that one should consider whether “human intervention has given ‘markedly different,’ or ‘distinctive,’ characteristics” to the claimed subject matter, i.e., the claimed molecule has “a markedly different chemical structure” or “a distinctive chemical identity and nature” from a molecule that exists in nature. The emphasis on whether the product is “markedly different” comes right out of Chakrabarty, a Supreme Court case discussed at length by all parties. To the extent that terms like “covalent bonds” or “hydroxyl” termination points are relevant in Judge Lourie’s opinion, they underscore that an isolated DNA molecule is different in chemical structure from DNA as it exists in a chromosome. Such scientific facts go to the heart of the case.

Standing Considerations

Lastly, Plaintiffs assert that the Federal Circuit erred by failing to find standing for two additional plaintiffs. When I first heard that Plaintiffs filed a Petition for Rehearing, I assumed Plaintiffs would address, and attempt to dispel, any misinformation regarding standing of Dr. Ostrer. In a letter to the court dated July 27, 2011, just two days before the Federal Circuit issued its decision, Myriad alleged that Dr. Ostrer recently changed jobs and was no longer capable of conducting infringing tests, which affected his standing. In a letter dated the same day as the July 29th decision, the ACLU asserted that “Dr. Ostrer continues to wish to engage in the sequencing….” This language (in contrast with language stating he “will immediately engage” at his new job) caused some commentators to support Myriad’s attack of Dr. Ostrer’s standing.

My initial thinking had been that the ACLU would surely use this Petition to dispel any negative notions regarding Dr. Ostrer’s standing, once and for all. When concluding that he (and only this Plaintiff) had standing, the Federal Circuit found it noteworthy that Dr. Ostrer received a letter from Myriad demanding royalty payments, and Dr. Ostrer stated in the record “unequivocally that he will immediately begin such testing” in the absence of relevant patents.  It seems an easy thing to confirm that these facts remain true regardless of Dr. Ostrer’s new employment. Instead, however, the Petition merely states that “Dr. Ostrer is a member of the organizational plaintiff American College of Medical Genetics (ACMG)” and that “gene patenting is germane to ACMG’s purpose.” Considering the narrow grounds on which the judges found standing for Dr. Ostrer, it is strange that Plaintiffs chose not to reiterate their position in line with the Judges’ thinking.

Lastly, Plaintiffs assert that one other plaintiff has standing (not two, as indicated in the Petition’s heading). According to the Petition, plaintiff Dr. Ellen Matloff “was told by Myriad that she and geneticists at Yale would violate Myriad’s patents if they performed the tests that she wanted to perform.” This assertion misses the mark, however, in that it fails to address whether Dr. Matloff stated in the record that she “will immediately begin” BRCA testing. As agreed upon by all three Federal Circuit judges, “‘some day’ intentions” are insufficient to support an “actual or imminent” injury for standing “without . . . any specification of when the some day will be,” as stated in Lujan, 504 U.S. 555, 564 (1992).

Myriad Petition for Panel Rehearing

Like Plaintiffs, Myriad filed a Petition for a rehearing by the same panel, not en banc. Not requesting en banc review is less surprising here, because Myriad essentially won its case, especially from a commercial standpoint. In its Petition, Myriad focuses solely on the standing question, and specifically on Dr. Ostrer’s professional move from New York University Medical Center (NYU) to Montefiore’s laboratories. Myriad asserts that it offered a license to NYU as in institution in 1998, and addressed its letter to Dr. Ostrer only in his capacity as an NYU employee. Thus, according to Myriad, Dr. Ostrer’s departure from NYU destroys any controversy between NYU and Myriad. Myriad also contends that it has never communicated with Montefiore about its patents. Myriad also focuses on the language in ACLU’s July 29th letter, stating that “Dr. Ostrer continues to wish to engage in the sequencing…,” pointing out, as discussed above, that ACLU did not say he “will immediately engage” in relevant testing at Montefiore.

Interestingly, Myriad also requests that the Federal Circuit dismiss the appeal as moot for the reasons discussed above, but not vacate the July 29th decision and opinions themselves. Citing U.S. Bancorp Mortgage v. Bonner Mall Partnership, 513 U.S. 18, 25 (1994), Myriad argues that an appellant judgment should only be vacated where mootness arises through no fault of any party—otherwise a party presented with an adverse ruling has an incentive to manufacture mootness during an appeal process. According to Myriad, Dr. Ostrer’s “unilateral action” of changing jobs, rendering the present case moot, bars Plaintiffs from obtaining vacatur of the judgment against them.

What’s Next?

It seems likely that the Federal Circuit will deny Plaintiff’s Petition for Panel Rehearing, perhaps as intended by the ACLU and Plaintiffs all along. In any event, I imagine that the ACLU is chomping at the bit to get this case before the Supreme Court. It is less clear what the Federal Circuit might do with Myriad’s Petition. As discussed above, Myriad informed the court of Dr. Ostrer employment change for the first time less than two days before Federal Circuit issued its decision. It may be that the court would not consider such information at the last minute, and would only consider its impact on standing in a rehearing. Myriad also proposes a legal avenue to keep the July 29th opinions in place, while reducing the chance that the Supreme Court will hear the case. Stay tuned for more exciting updates in this never-boring case.