Myriad, ACLU Battle Renewed in Fed. Cir. Oral Arguments With DOJ Joining the Fray

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A battle of analogies broke out in April 4 oral arguments at the U.S. Court of Appeals for the Federal Circuit, as attorneys for Myriad Genetics Inc., the American Civil Liberties Union, and the U.S. government attempted to find the best model for determining the patent eligibility of claims on isolated DNA (Association for Molecular Pathology v. U.S. Patent and Trademark Office, Fed. Cir., No. 2010-1406, oral arguments, 4/4/11).

As the flaws of each analogy faced quizzing by the panel, the court struggled with a test for distinguishing exactly how different a composition of matter must be, compared to its counterpart “product of nature,” so as to pass muster under Section 101 of the Patent Act.

ACLU Challenges Patent Eligibility.

In 2009, the American Civil Liberties Union and the Public Patent Foundation at Benjamin N. Cardozo School of Law filed a declaratory judgment complaint (78 PTCJ 64, 5/15/09).

The complaint challenged patent eligibility, under 35 U.S.C. §101, of nine composition of matter and six method claims of patents (5,747,282; 5,837,492; 5,693,473; 5,709,999; 5,170,001, 5,753,441; and 6,033,857) on the BRCA1 and BRCA2 genes associated with hereditary breast and ovarian cancer. The patents are owned or part-owned by the University of Utah Research Foundation. Myriad is the exclusive licensee of the patents and the sole clinical provider of full sequencing of the BRCA1/2 genes in the United States.

The complaint also alleged that the Patent and Trademark Office's policy that allows naturally-recurring genes to be patented if they are “isolated from their natural state and purified” is unconstitutional, in violation of the First Amendment and the intellectual property clause of the Constitution, Art. 1, Sec. 8, Cl. 8.

The ACLU and PUBPAT acted on behalf of the Association of Molecular Pathology and other medical associations, medical researchers, breast cancer counselors, and women diagnosed with or seeking diagnosis.

In November 2009, Judge Robert W. Sweet of the U.S. District Court for the Southern District of New York denied Myriad's motions to dismiss for lack of subject matter and personal jurisdiction and for failure to state a claim (79 PTCJ 4, 11/6/09).

In March 2010, the court ruled in favor of the plaintiffs on the merits, finding both the composition of matter and method claims unpatentable. No. 09 Civ. 4515, 94 USPQ2d 1683 (S.D.N.Y. March 29, 2010) (79 PTCJ 661, 4/2/10). However, the court dismissed the plaintiffs' constitutional claims against the PTO.

Myriad appealed to the Federal Circuit.

Passion on Both Sides in Extensive Briefing.

Briefing in the case has been extensive. The appellant's brief submitted by Myriad in October contested both the jurisdiction and merits decisions (81 PTCJ 10, 11/5/10). Myriad is represented by Gregory A. Castanias of Jones Day, Washington, D.C., who argued the company's case before the Federal Circuit.

Sixteen briefs were submitted by friends of the court within a week of Myriad's brief, with 12 briefs specifically supporting reversal.

Most notably, one of the four briefs supporting neither party was submitted by the U.S. Department of Justice, without PTO support. The DOJ addressed only the isolated DNA claims, supporting affirmance on some and reversal on others by proposing a new distinction for patent eligibility purposes. The government requested and was granted the opportunity to split argument time with Myriad, with Acting Solicitor General Neal Kumar Katyal appearing before the appellate court during the oral arguments.

The plaintiffs-appellees' brief was filed at the end of November (81 PTCJ 210, 12/17/10) by the ACLU's Christopher A. Hansen, New York, who also argued on their behalf before the Federal Circuit.

Eleven briefs filed by friends of the court supported the plaintiffs or affirmance. Myriad's reply brief addressed only arguments made by the parties and the DOJ.

A side issue that developed early in the case, whether Chief Judge Randall R. Rader should recuse himself for comments made at two conferences (80 PTCJ 47, 5/14/10; 80 PTCJ 499, 8/13/10), was rendered moot when the judge did not appear as a member of the panel.

Standing Issues Discussed in Detail.

Judges Alan D. Lourie, William C. Bryson, and Kimberly A. Moore queried the parties.

Moore was most vocal on the issue of standing. She forced both Castanias and Hansen to address whether certain of the plaintiffs met both prongs required for bringing a declaratory judgment action, after the Supreme Court's decision in MedImmune Inc. v. Genentech Inc., 549 U.S. 118, 81 USPQ2d 1225 (2007) (73 PTCJ 242, 1/12/07)--“a substantial controversy … of sufficient immediacy and reality” and “meaningful preparation” to conduct potentially infringing activity.

Moore noted that some plaintiffs were ready, willing, and able to offer BRCA1/2 testing but had not received any threat from Myriad contesting their activities, while plaintiffs who received threatening letters in the past--thus perceiving a substantial controversy--filed declarations saying only that they had “an earnest desire to consider” offering the tests.

Defending the standing of the second group of plaintiffs, whom Moore described as “too tentative” to show “meaningful preparation,” Hansen argued that they all do genetic testing every day and would want to add BRCA1/2 tests to their practices, but remain “skittish” given Myriad's threats of infringement litigation.

But the predicate of the question the declarants responded to was that the threat of such a lawsuit was eliminated, Bryson said, and Moore questioned whether the ACLU was aware of “the profound effect” on declaratory judgment filings should the court decide that all that was required under the second prong of the declaratory judgment test was to be “ready, willing, and able” to compete.

A second “redressability” argument as to standing was posed by Myriad. The patent owner argued that, because the plaintiffs did not contest every claim in every one of Myriad's BRCA1/2-related patents, they would not be able to get the relief sought, since they would infringe the non-challenged claims.

Hansen responded that the plaintiffs believe their testing would not infringe any of the remaining claims, and that Myriad has never identified specific claims that would be infringed. Castanias countered that it is not Myriad's burden as to the standing issue to make an infringement argument for uncontested claims.

In any case, though, all three judges made comments at times also supporting granting standing in the case, and it seemed unlikely that the court will reject the case on those grounds.

Moore had no difficulty with the idea that certain plaintiffs would be “still laboring under the threat” of a lawsuit from Myriad, posed in a letter six years earlier. Bryson pointed specifically to Myriad's threats against clinical use that might infringe the patents, versus research use that would also infringe but that the company chose not to enforce. Lourie, it appeared, accepted at face value the ACLU's argument that there were thousands of doctors who would offer the test tomorrow if there were not threat of enforcement.

Battle on DNA Claim Analogies.

The attorneys and judges conducted a battle of analogies to try to get their points across as to the claims on isolated DNA. As Castanias said, “This is a case made for hypotheticals.”

Castanias likened the DNA claims to a baseball bat, composed of nothing more than and having the same “particular qualities inherent in wood,” which he assumed all would agree would have been eligible for patenting by the first inventor.

Lourie and Bryson asked whether the court should make the distinction of patent eligibility for substances created only by chemically breaking bonds, versus the patent ineligibility for substances resulting only from extraction or otherwise treating the surrounding materials with a solvent to make the separation. Lourie also said materials that are compressed in their natural form but not joined to the surrounding materials would not be patent eligible.

Katyal, representing the Justice Department, responded with the example of lithium, isolated only by breaking covalent bonds with surrounding material, but--since it is the third element in the periodic table--no one would claim should be patent-eligible, he said. When Castanias returned for rebuttal, Bryson took up Katyal's argument.

But Castanias would not back down, suggesting that lithium may well be patent-eligible if it “adds new utilities not present” when combined with the other materials.

Moore posed an example of a new mineral embedded in rock, requiring extensive excavation to break from the surrounding materials. Castanias argued that such a mineral should be patent-eligible, pointing to the human interaction required to separate the mineral. He was forced to defend that position, though, as Moore and Bryson both distinguished the patent eligibility of the process required to isolate material versus the patent eligibility of the material itself. Bryson said, “Mining can be complex, but mining for diamonds does not render the diamonds eligible under Section 101.”

On the other hand, after Hansen proposed that the entire effort Myriad accomplished was simply to “pull [the isolated DNA] out” of the genetic material, Lourie said skeptically, “You say that as if [the DNA] is just sitting there.”

Hansen's preferred analogy was to a kidney in his body, with the only difference was that it was removed with a scalpel rather than through a chemical treatment. Bryson contested that analogy. “There are lots of complex molecules that can be created by lopping off” other materials, and those molecules may be functionally very different.

But for analyzing the claims in the instant case, Hansen fell back on the Supreme Court's “markedly different characteristics” standard stated in Diamond v. Chakrabarty, 447 U.S. 303, 206 USPQ 193 (1980)(484 PTCJ A-1, 6/19/80). He said the isolated DNA Myriad uses cannot be markedly different from that in the human body, because it is the company's business model to tell patients, not what is going on in the isolated DNA, but what is going on with the DNA in their bodies.

Government's 'Magic Microscope' Considered.

The panel also returned often to the difference between patent eligibility issues under Section 101 and prior art issues that would impact the analysis of anticipation or obviousness under Sections 102 and 103. Castanias admitted that the mineral embedded in the rock would suffer the same fate--rejection under Section 103--as was the case in Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 76 USPQ 280 (1948). However, that is no reason to use “the coarse filter of Section 101” to deny patentability, he said. Notably, the plaintiffs complaint was on Section 101 grounds only.

The court also asked the counsel to distinguish “isolated” and “purified” substances, since the conjunction of the two is often used as the test for Section 101 patent eligibility. Lourie, in fact, contended that “purify” only means “not contaminated” and does not confer patent eligibility.

Bryson asked Castanias if a person identifying the entire gene sequence of an individual would infringe Myriad's claims and the thousands of other claims to isolated DNA. Castanias contended that, to the extent the BRCA1/2 genetic information was isolated from the entire sequence, yes, it would infringe.

The panel seemed most amused and intrigued, though, by Katyal's differentiation of ineligible DNA that replicates what is in the human body and other “human-made” forms of DNA.

Katyal proposed thinking in terms of a “magic microscope” that could zero in on one gene and determine if one was looking at the same thing that one could see in the isolated DNA. As in the government's unsolicited brief, he argued that cDNA, for example, would not look the same and thus claims to cDNA--which the government argued are among those at issue in the case--would be patent eligible.

Moore expressed concern that the government's test would invalidate patents on vitamin B12 and antibodies that courts have found patent eligible in the past. Katyal said that “overwhelmingly, the early cases [on patent eligibility] went the other way,” though.

Though he split time with Katyal in the argument, Hansen was unwilling to accept the government's help in this instance. Sweet never construed the claims, but Hansen argued that “none of the claims in the '282 patent are limited to cDNA,” but rather claim “genomic DNA” generally.

Moore was most skeptical of the government's approach, mostly on policy grounds. She noted the split in the government on this issue in that no one from the PTO signed the government's brief. She also pointed to the inaction of Congress on the issue of gene patenting over the 35 years of biotechnology industry development, and she asked whether “stare decisis” requires the court to leave it to Congress to change the law on gene patent eligibility.

Katyal addressed each issue in turn. Saying that “the PTO has been wrong” in issuing patents on isolated DNA, he insisted that the government's opposition to such patents would not threaten the biotechnology issue to any great extent. He claimed that the Department of Justice did an extensive review of the patents at issue and found that the vast majority of patent claims issued by the PTO have not been drawn to the isolated DNA, but rather to the human-made variations on it.

Method Claims an Afterthought.

Compared to the isolated DNA claims, the method claims at issue received scant attention.

Hansen and Castanias both referred to the Federal Circuit's decision that diagnostic method tests were patent eligible in their transformative effects, in Prometheus Laboratories Inc. v. Mayo Collaborative Services, 581 F.3d 1336, 92 USPQ2d 1075 (Fed. Cir. 2009) (78 PTCJ 635, 9/25/09).

However, while Hansen contended that the “comparing” and “analyzing” steps in Myriad's claims were not parallel to the Prometheus claims, Castanias argued that the steps necessarily compare and analyze materials that had to have undergone a transformation.

Lourie, who wrote the court's opinion in Prometheus, asked the parties to compare the claims at issue to a “determining” step found to be patent-eligible in Prometheus.

Hansen argued that the claims would be infringed by simply looking at a computer screen at the genetic sequences side-by-side. Castanias again read limitations into the claims based on what was being determined.

Stakeholders' Comments.

In a conversation with BNA after the oral arguments, Courtenay C. Brinckerhoff of Foley & Lardner, Washington, D.C., said she was impressed by the attention given to both the standing and Section 101 issues, Brinckerhoff said that she expects a reasoned opinion on both standing and subject matter patentability, and she hopes for a narrow opinion on standing, tied specifically to the threatening letters Myriad sent. “Even if they decide on narrower grounds,” she said, “it's going to be an important standing decision.”

Sarah A. Kagan of Banner & Witcoff, Washington, D.C., felt that each of the panelists had reservations about standing, and she was not convinced that the court would get to the merits.

Brinckerhoff was pleased with Castanias's response to the lithium analogy, disagreeing with Katyal that an element is barred from patent eligibility. “If it did not exist in nature as lithium and it takes the intervention of man to get lithium, I don't have a problem with saying it could be patented,” she said.

On the other hand, she was not convinced by Castanias's baseball bat analogy, either, since the sap and gum from the wood must be removed by an air-drying process to make a bat.

Kagan, though, thought the baseball bat analogy was the most apt. “It starts out as a product of nature, but the hand of man changes that to a baseball bat,” she said, citing a change in structure and in function. She criticized Katyal's magic microscope and other “futuristic tools” to investigate DNA comparisons. “The fact that they don't exist almost suggests to the contrary that things are patent eligible,” she said.

BNA also asked about the impact on the industry if either Sweet's opinion is upheld or if the government's magic microscope view is considered an acceptable “middle ground”--in Moore's words.

“If Judge Sweet is right, it is a big problem for biotechnology, but also for health care and the economy generally,” Brinckerhoff said. “It's a utopian view to think that government and universities will pick up these type of discoveries if companies don't fund the research,” she said. “If all DNA is unpatentable, we will suffer for not having these diagnostic tests, or at best they will only provide advantages to overseas jurisdictions.”

“If the court adopts the 'magic microscope test,' ” instead, Brinckerhoff said, “the largest impact will be on existing patents. There will probably be enough guidance to craft future claims. I may be optimistic in saying this, but it probably wouldn't be totally devastating.”

By Tony Dutra  


District court opinion at http://pub.bna.com/ptcj/094515Mar29.pdf

Oral argument recording available citing “Appeal Number” 2010-1406 at http://www.cafc.uscourts.gov/oral-argument-recordings/search/audio.html

Brinckerhoff is a member of this journal's advisory board.