Little Evidence of Shift in Views as Myriad Isolated DNA Patent Challenge Argued Again

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Summary: A Federal Circuit panel considers once again, now in light of Mayo, whether Myriad's isolated DNA and method claims are eligible for patents under Section 101.

Takeaway: Judge Lourie appears certain to say yes once more; Judge Bryson appears certain to say no once more; and Judge Moore will have the deciding vote once more.

By Tony Dutra  

The majority and dissenting opinion writers the first time around in the case challenging the patent eligibility of isolated DNA claims showed little evidence of changed views as the U.S. Court of Appeals for the Federal Circuit held oral arguments July 20 (Association for Molecular Pathology v. U.S. Patent and Trademark Office, Fed. Cir., No. 2010-1406, oral arguments 7/20/12).

Although largely upholding the Myriad claims as patent-eligible, each member of the three-judge panel submitted an opinion in 2011 (150 PTD, 8/4/11).

The U.S. Supreme Court vacated the court's decision March 26, asking the appeals court to reconsider its views in light its decision on method claims in Mayo v. Prometheus (60 PTD, 3/29/12).

Taking up the case again on remand, Judge Alan D. Lourie appeared unconvinced that Mayo had anything to say about, in his view, patent-eligible claims on isolated DNA as chemical compositions.

Having partially dissented from the majority's original 2011 ruling, this time around Judge William C. Bryson did not even discuss the Mayo ruling as affecting the composition claims. Instead, he continued with his earlier focus on hypotheticals that, in his view, presented clearly patent-ineligible inventions and paralleled the claims in Myriad Genetics Inc.'s patents at issue here.

Judge Kimberly A. Moore's vote clinched the original Federal Circuit decision favoring patent eligibility, but she wrote a concurring opinion with different arguments than the majority had used. During the July 20 remand arguments, Moore asked probing, critical questions of each counsel, and it was unclear whether the parties or Mayo said anything to alter the judge's views, though practitioners told BNA after the session that Moore seemed likely to remain in favor of patent eligibility.

The Challenge in Myriad.

The case arose from a 2009 declaratory judgment challenge against patents for which Myriad is the exclusive licensee (91 PTD, 5/14/09).

The patents (5,747,282; 5,837,492; 5,693,473; 5,709,999; 5,170,001, 5,753,441; and 6,033,857) claim isolated DNA, cDNA, and methods related to the BRCA1 and BRCA2 genes associated with hereditary breast and ovarian cancer.

The American Civil Liberties Union and the Public Patent Foundation filed the lawsuit on behalf of the Association of Molecular Pathology and other medical associations, individuals involved in medical research, breast cancer counselors, and women diagnosed with or seeking diagnosis for cancer. They argued that the claims were ineligible for patenting under Section 101 of the Patent Act, 35 U.S.C. §101.

In its first decision, the Federal Circuit agreed that only one of the method claims--Claim 20 of the '282 patent--and all claims to cDNA are patent eligible, but they were divided as to claims to isolated DNA. 653 F.3d 1329, 99 USPQ2d 1398 (Fed. Cir. 2011).

A week after its surprising unanimous decision rejecting method claim patent eligibility in Mayo Collaborative Services v. Prometheus Laboratories Inc., 132 S. Ct. 1289, 101 USPQ2d 1961 (2012) (55 PTD, 3/22/12), however, the Supreme Court granted the ACLU's petition for writ of certiorari, vacated the Federal Circuit's opinion, and remanded the case for reconsideration (60 PTD, 3/29/12).

The appeals court requested supplemental briefing covering only two points: What is the applicability of the Supreme Court's decision in Mayo to Myriad's isolated DNA claims and to method Claim 20 of the '282 patent?

Briefing by the parties and friends of the court provided few surprises (120 PTD, 6/22/12).

Human Judgment to Create Isolated DNA.

At the start of the July 20 oral arguments, Lourie confined the discussion to the questions presented for supplemental briefing, and he was unconvinced that Mayo said anything about the isolated DNA claims at issue in this case.

His first question to Gregory A. Castanias of Jones Day, Washington, D.C., who represented Mayo, was a softball: “Is it a small move from the law of nature at issue in Mayo and the isolated matter at issue here?”

“It's not a small move at all,” Castanias replied. He described in some detail the “enormous amount of human judgment” that the listed patent inventors had to make to determine the appropriate start and stop points in identifying the BRCA 1/2 sequences. And then he turned his attention to Bryson.

Castanias used an analogy to a baseball bat at oral arguments the first time, and sought to make a parallel again--the bat is created by extraction from a tree but human invention is required to turn it into an article useful for hitting a ball. “Man decided which parts to use and which to throw away,” he said, “and that's what happened here.”

But Bryson still believed there was a dividing line somewhere in the process, saying you could not simply cut the trunk of a tree and claim you invented the trunk.

As Castanias continued with detail on the decisions in isolating the DNA claimed by Myriad, Lourie again fed him what he wanted. “You're saying it's a product of human ingenuity,” Lourie said. Of course, Castanias agreed.

Did Inventor Give Material Its Utility?

References to analogies continued with Moore's questioning, particularly in a colloquy with Melissa N. Patterson of the appellate staff of the Civil Division, U.S. Department of Justice, representing the views submitted by the solicitor general on behalf of the government, arguing against isolated DNA patent-eligibility.

Moore claimed that Myriad's isolated DNA had utility as probes and primers in detecting BRCA 1/2 mutations, but Patterson countered that the inventors did not give the DNA sequences that utility. She said the question of patent eligibility should turn on whether the inventor “bestowed utility” on the material it purportedly invented.

When Castanias returned for rebuttal, he faced Moore's questioning that echoed Patterson's point on utility. Moore brought up an analogy to coal, saying that extracting it from the ground and discovering that it could burn gives it a utility, but not one that an inventor could claim.

Castanias rejected the parallel to the instant case, though, giving other examples of utility, such as protein replacement therapy, associated with Myriad's DNA strands. Moore tried to minimize that utility as simply “making more of the protein,” but Castanias--assisted by Lourie once again--identified other uses.

Human Ingenuity, Human Judgment.

Nevertheless, Moore persisted and attacked Castanias's point that human ingenuity was involved in the start and stop points of the genetic sequence. Moore characterized that as merely “knowing where to clip it,” and Bryson joined the conversation again.

Bryson turned to another analogy that was discussed in oral arguments the first time around--a kidney. “If I understand where you have to cut a kidney to maximize its effectiveness in transplant operations,” he asked somewhat incredulously, “I have a right to claim the kidney? I invented an isolated kidney?”

Castanias said no, again trying to distinguish the instant claims as “much more involved.” Again pointing to the record, he relied in part on what the inventors decided to leave out in finding the patented sequences.

But Moore continued, questioning why Myriad's isolated DNA sequences should be considered “man made,”--referring to an often quoted patent eligibility requirement described in Diamond v. Chakrabarty, 447 U.S. 303, 206 USPQ 193 (1980)--simply because the inventor decided what to eliminate.

Castanias closed saying only that Chakrabarty drew a line, at least for Section 101 purposes, and that the panel in its original ruling “applied the line. Nothing in Mayo changes that line.”

Broad Policy Underpinning Mayo?

Christopher A. Hansen, staff attorney with the ACLU Speech, Privacy and Technology Project, argued for the declaratory judgment plaintiffs in the case and tried to invoke Mayo immediately.

Both Hansen and Patterson were effectively making arguments for a broader policy underpinning in Mayo that would capture both laws of nature--at issue in that case--and “products of nature,” as claimed here.

Hansen concentrated on a preemption argument, citing the breadth of the DNA claims in that they covered a wide spectrum of isolated and manipulated DNA forms.

Moore would have none of it, though, pointing to the Mayo court's holding that preemption is a relative concern and not specifically related to the breadth of the claim. “Your preemption argument is a waste of time and space,” she said, cutting Hansen off quickly.

Patterson had more luck by citing the high court's related concern in Mayo that, as the Supreme Court said, “even a narrow law of nature (such as the one before us) can inhibit future research.”

Patterson said that the underlying concern of the court in making that statement was whether the patentee is trying to claim “stuff that's supposed to be free to all mankind,” which--she said in countering Lourie's immediate objection--would equally cover laws of nature and products of nature. “The problem here is that these claims preclude public access to a product of nature.”

Moore was skeptical, if slightly less so. In fact, she pointed to Myriad's brief in the case, pages 16-17 for examples of other means by which researchers could determine BRCA 1/2 cancer predisposition without infringing the claims.

But What About Settled Expectations?

In the Federal Circuit's original opinion, Moore relied to some extent on the issue of utility, in fact distinguishing the utility of DNA sequences by their length. She also relied on the “settled expectations” of the patent community, given the thousands of patents on isolated DNA granted by the Patent and Trademark Office over the last 30 years.

As to the latter point, none of the parties addressed it, and Moore herself had to bring it up, asking, “To what extent should we consider the settled property right?”

Patterson argued that the Supreme Court was clear in both Mayo and in its earlier Section 101 decision, Bilski v. Kappos, 130 S. Ct. 3218, 95 USPQ2d 1001 (2010) (124 PTD, 6/30/10), that the patent eligibility query does not involve consideration of settled expectations.

Paraphrasing the last page of the high court's Mayo opinion, Patterson said, “We are not here to create rules about specific fields, but to determine general rules and general principles.”

Method Claim Discussed as Well.

Lourie's insistence that Mayo was relevant to method claims led him to return to Claim 20 of the '282 patent application repeatedly. Indeed, possibly as much as half the discussion was devoted to that claim, eliciting surprise from observers such as Hans Sauer, associate general counsel for intellectual property for the Biotechnology Industry Organization.

After the session, Sauer told BNA that the focus appeared to surprise the parties as well, who, he said, didn't seem prepared for the level of interest.

Hansen turned to the method claim only after being rebuffed in his preemption argument on the isolated DNA issue.

Castanias was forced to spend some time--unsuccessfully--defending his argument that the claim was not even properly before the court, as the ACLU's cert petition was not directed to the method claims.

But he could not give an answer to Bryson's contention that the Supreme Court vacated the panel's earlier decision, thus putting the entire matter, including issues that the ACLU did not contest at the high court, back before the Federal Circuit.

The relevance of the Mayo ruling to method claims was important because Claim 20 has some parallels to the claims found patent ineligible in Mayo--taking non-patented matter, conducting a test known in the prior art, and determining the result of the test, wherein the result has some meaning.

The difference, Castanias noted, was that the Supreme Court was rejecting in Mayo that the “inventive concept”--the term the Mayo court used--was the law of nature, whereas here previously unknown host cells were being transformed.

Hansen disagreed, contending that the host cells were previously invented and Myriad bought them “off the shelf,” which Castanias contested. In any case, Hansen said, the Myriad method claim ends with a step of “seeing what happens,” which maps to the step the Mayo court held to be objectionable. “The rule has to be that administering [something] and then seeing [the result] is not enough,” he said.

Lourie brought up patents for uses of penicillin and stated, disapprovingly, that Hansen's argument ultimately led to the conclusion that “an invention of that magnitude could not have been patent eligible.”

It was now Bryson's turn to save Hansen. “Your position, I thought, was that regardless [of whether penicillin could be patented], [it's not patent eligible] if all you do is put it next to a bacterium and observe that it is better than [if you used] water.”

“Exactly,” Hansen said.

Practitioners Comment.

Few of the stakeholders were sure of the eventual outcome, and most had some complaint about the discussion.

Sauer was clearly disappointed that the court did not confront more directly Patterson's argument that the claims usurped public access. “The public can't use [Myriad's invention]?,” he asked. “Tell us how that is.”

James Crowne, director of legal affairs for the American Intellectual Property Association, agreed, saying that the lack of evidentiary support for such preemption charges should be “the Achilles heel” of challengers relying on Section 101, but that the court did not adequately address it.

Courtenay C. Brinckerhoff of Foley & Lardner, Washington, D.C., was disappointed that the conversation turned to a debate about whether human judgment or human ingenuity--later changed to “human invention” by Castanias--was involved in isolating this particular DNA sequence. She would have preferred a focus on “the other physical differences in isolated DNA,” and was not sure that the court was adequately mindful of those differences.

Sarah A. Kagan of Banner & Witcoff, Washington, D.C., agreed with Brinckerhoff. She criticized the analogies used by the judges, which, she said, did not get at the point that there are chemical differences in the isolated DNA compared to the product of nature, something that “distinguishes it from a baseball bat or a sculpture.”

Again, Kagan and Brinckerhoff were of a similar mind. BNA asked Brinckerhoff if Patterson had convinced anyone that Mayo's underlying principle would apply to products of nature, and Brinckerhoff said, “It almost doesn't matter whether Prometheus applies. If Prometheus doesn't matter, you only have to show that there is a [chemical] difference. If Prometheus matters, you have to show that there is enough of a difference.” And she contended there was enough of a difference here.

Kagan was probably the most optimistic of Myriad's chances for a repeat win. She saw no signs that Moore had changed her mind, characterizing Moore's approach as, “This has been going on for 30 years and I don't see anything [in Mayo] saying we should have a sea change.”

Indeed, Kagan saw some signs that even Bryson was not steadfast in his earlier dissenting view, though she ultimately predicted, “I think they're going to come out the same way.”

She also agreed with Sauer that the parties “had to play catch-up” after Bryson's comments that the method claim at issue was undoubtedly still before the court. “Still, the judges are all on board with that claim,” she told BNA. “Nobody was asking probing questions on whether that claim would pass muster.”

By Tony Dutra  


Brinckerhoff and Crowne are members of this journal's advisory board.