On April 4, 2011, Judges Lourie, Bryson and Moore at the U.S. Court of Appeals for the Federal Circuit heard oral arguments in Association for Molecular Pathology v. USPTO, also known as the ACLU/Myriad “gene patenting” case. This case has garnered extraordinary attention from the biotech, pharmaceutical, and health care industries, from academic and government researchers, from breast cancer patients and their families, and from the U.S. Department of Justice (DOJ) itself.

These groups disagree on the fundamental legal question of whether isolated DNA should be eligible for a patent, and also disagree on the fundamentally political question of whether the patenting of genes promotes or stifles innovation and development of new diagnostics and therapies. While the Federal Circuit’s decision in this case will be important, further resolution of the issues is likely to come from the Supreme Court. The ultimate decision could have a profound effect on existing intellectual property rights, and could impact current and future patent strategies, particularly in biotechnology-related fields.

Case Synopsis

Myriad owns or is the exclusive licensee of a series of patents claiming isolated DNA compositions and methods for testing for the presence of genetic mutations that are correlated with an increased risk of certain breast and ovarian cancers (the BRCA1 and BRCA2 genes). A coalition of plaintiffs, led by the ACLU, challenged the claims as encompassing patent-ineligible subject matter, e.g., products of nature.

On appeal, Myriad challenges two decisions by the district court: the denial of Myriad’s motion to dismiss for lack of standing and subject matter jurisdiction, and the grant of summary judgment in ACLU’s favor on invalidity under § 101.

The Oral Hearing

The judges were interested in both the standing/jurisdiction issue and the patent-eligibility issue, and so the parties divided their time between those issues. The DOJ also was given time to present the government’s views on the patent-eligibility issue.

Standing/Jurisdiction

For Myriad, Greg Castanias argued that there is no standing or declaratory judgment jurisdiction because there is no real or immediate controversy between the parties. He pointed out that the only affirmative actions by Myriad were letters sent in 1998, long before the ACLU brought this suit. Judge Moore was not completely satisfied with that argument, however, and pointed out that the recipients could have been operating under the continuing influence of those “cease and desist” letters. On the other hand, Judge Moore herself pointed out that Judge Sweet’s rationale in support of standing was so broad that any customer wanting access to any cheaper product would have standing to challenge a patent.

For the ACLU, Chris Hansen argued that the Supreme Court’s 2007 decision in MedImmune v. Genentech eliminated any requirement for “immediacy” as a prerequisite to declaratory judgment jurisdiction. Judge Moore probed this issue further, referring to the Supreme Court’s 1992 decision in Lujan v. Defenders of Wildlife, where the Court held that “‘some day’ intentions” without “concrete plans” is not sufficient to confer jurisdiction. Judge Moore and Judge Bryson seemed to agree that the affidavits of the plaintiffs who had received the strongest “cease and desist” letters from Myriad were the weakest on alleging injury, because they attested only that they would consider performing BRCA testing if the Myriad patents were invalidated, not that they actually would do so.

Patent-Eligibility Under 35 U.S.C. § 101.

On the merits, Judge Bryson asked both parties if the act of sequencing a person’s entire genome would infringe the isolated DNA claims. Myriad said no, because of the “isolated” requirement. The ACLU said yes, because the BRCA genes are present in the genome. The judges also asked the parties how they would decide the patent-eligibility of a mineral isolated from a rock or of elemental lithium, which does not exist in nature in elemental form.

Judge Lourie seemed willing to adopt a test centering on whether covalent bonds are broken. Interestingly, he drew a line between “purification” which he might not view as conferring patent-eligibility, and “isolation,” which he might view as sufficient if the isolation process involves breaking covalent bonds. The ACLU urged that isolated DNA is identical to DNA, and argued that all Myriad did was “snip the gene.” Judge Lourie reined in that argument, pointing out that isolating DNA was “not research by tweezers.”

With regard to the method claims, Judge Lourie asked Myriad if the methods weren’t just directed to thought processes. In response, Myriad stated that, like the claims at issue in Prometheus, the method claims here inherently involve transformative steps. The ACLU disagreed, arguing that the claims encompass mere comparisons of sequence data per se.

The DOJ’s Arguments

Solicitor General Katyal argued separately to present the government’s position. He urged the court to adopt a “magic microscope” test (which Judge Moore later referred to as a “kitschy test”) for patent-eligibility. That is, if a “magic microscope” could “see” the claimed nucleotide sequence in nature, it should not be patent-eligible under 35 U.S.C. § 101. He explained that the “magic microscope” could see both full-length DNA sequences and partial DNA sequences, but not sequences that do not occur naturally, such as cDNA sequences.

The Solicitor General stated that the government has looked into the issue, and believes that the majority of DNA patents would survive this test, because most have claims that recite cDNA or other non-naturally occurring DNA sequences, or have method claims.

Judge Moore pointed out the apparent disagreement between the DOJ and the USPTO, given that the USPTO has been granting patents on “isolated DNA” for 35 years, and has not withdrawn the Utility Guidelines that support the patent-eligibility of such claims. Solicitor General Katyal responded frankly, the USPTO is “wrong.”

Judge Moore also raised the issue of stare decisis, and asked the Solicitor General whether the issue is one that Congress should decide. In response, the Solicitor General argued that patent-eligibility is a fundamentally legal question, and that 35 years of USPTO practice cannot blur the line that 35 U.S.C. § 101 draws against products of nature.

The Court’s Opinion

It probably will be several months before the Federal circuit issues its opinion in this case. We can expect a carefully written and well-reasoned opinion, regardless of the outcome. While predicting results from oral argument is always a risky (and often fruitless) undertaking, it seems more likely than not that the court will find standing and jurisdiction, although it probably will do so on narrow grounds. The resolution on the merits may be more difficult, but at least Judge Lourie appears to be formulating a test that would uphold the patent-eligibility of Myriad’s isolated DNA claims.