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. U.S. Patent & Trademark Office, No. 09-Civ-4515, i.e., the ACLU/Myriad “gene patenting” case. On appeal is the March 29, 2010 summary judgment decision of the U.S. District Court for the Southern District of New York (Sweet, J.) that invalidated the challenged claims in seven Myriad patents as patent-ineligible under 35 U.S.C. § 101. The panel was interested in both the standing/jurisdiction issue and the substantive patent-eligibility issue, so the parties divided their time between both issues. The U.S. Department of Justice (DOJ) also was given time to present the government's views on patent-eligibility. While the Federal Circuit's decision is likely to provide guidance, further resolution of the patent-eligibility issue is likely to come from the Supreme Court. The ultimate decision may not only have far-reaching impact on existing intellectual property rights, but also may affect current and future patent strategies, particularly in biotechnology-related fields.

Myriad owns or is the exclusive licensee of a series of patents claiming isolated DNA compositions, as well as methods for testing for the presence of genetic mutations that are correlated with an increased risk of certain breast and ovarian cancers. 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 challenged two decisions by the lower court: the district court's grant of summary judgment in the ACLU's favor on invalidity under § 101 as to certain claims relating to the underlying DNA sequences; and the district court's denial of Myriad's motion to dismiss for lack of standing and subject matter jurisdiction. For a more complete procedural history of the case, see below or the March 30, 2010 edition of Foley's Legal News Alert: Life Sciences, “District Court Rules That Genes and Genetic Tests Are Not Patentable” (http://tinyurl.com/3rko9lq).

The Oral Hearing

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. However, Judge Moore was not completely satisfied with that argument 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 decision in MedImmune v. Genentech, 549 U.S. 118 (2007) eliminated any requirement for “immediacy” as a prerequisite to declaratory judgment jurisdiction. Judge Moore probed this issue further, referring to the Supreme Court's decision in Lujan v. Defenders of Wildlife, 504 U.S.555 (1992), where the Court held that “‘some day' intentions” without “concrete plans” are 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 argued 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 whether the methods were merely directed to thought processes. In response, Myriad stated that, like the claims at issue in Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 581 F.3d 1336 (Fed. Cir. 2009), the method claims at issue involved transformative steps. The ACLU disagreed, arguing that the claims encompass mere comparisons of sequence data per se.

The DOJ's Arguments

Solicitor General Neal Katyal argued separately to present the government's position. He urged the Court to adopt a “magic microscope” test (referred to later by Judge Moore 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.

Solicitor General Katyal then 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 that the USPTO is “wrong.”

Judge Moore also raised the issue of stare decisis, and asked Solicitor General Katyal whether the issue is one that Congress should decide. In response, he 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

The Federal Circuit's opinion is not expected for a few months. While predicting results from oral argument is always a risky (and often fruitless) undertaking, it seems likely that the Court will find standing and jurisdiction, albeit likely on narrow grounds. Resolving the case on the merits will be more difficult, but at least Judge Lourie appeared willing to formulate a test that would uphold the patent-eligibility of Myriad's isolated DNA claims.

The Case to Date: Stage I — District Court Proceedings

As noted above, Myriad owns or is the exclusive licensee of a series of patents claiming isolated DNA compositions, as well as methods for testing for the presence of genetic mutations that are correlated with an increased risk of certain breast and ovarian cancers. A coalition of plaintiffs, led by the ACLU, challenged the claims as encompassing patent ineligible subject matter, e.g., products of nature. In particular, plaintiffs argued that certain Myriad patent claims recite subject matter that is not patentable under 35 U.S.C. § 101, and that the USPTO exceeded its constitutional authority in granting the patents.

Exemplary claims at issue relate to two different types of subject matter: (1) compositions of matter consisting of isolated DNA encoding all or part of the BRCA1 or BRCA2 genes, and (2) methods of using the isolated DNA to detect mutations in BRCA1 and BRCA2 by analyzing a gene sequence in a patient sample, or by comparing such a sequence to a normally occurring gene. The district court determined that all claims at issue were invalid because they encompassed non-statutory subject matter under 35 U.S.C. § 101.

Regarding the composition claims, the district court stated that “purification of a product of nature, without more, cannot transform it into patentable subject matter. Rather, the purified product must possess‘markedly different characteristics'” (emphasis added). The court determined that the isolated DNA recited in Myriad's claims were not “markedly different” from native DNA. The court emphasized the role of DNA as an information carrier and stated that “[t]he preservation of this defining characteristic of DNA in its native and isolated forms mandates the conclusion that the challenged composition claims are directed to unpatentable products of nature.”

Regarding the method claims, the district court determined that the claims failed to meet the “machine-or-transformation” test as presented in In re Bilski, 545 F.3d 943 (Fed. Cir. 2008). The court noted that the claims did not include a “transformation” step, such as was found to support patent-eligibility in Prometheus Laboratories., Inc. v. Mayo Collective Services. Instead, the court concluded that Myriad's method claims were closely analogous to those found non-patentable in In re Grams, 888 F.2d 835 (Fed. Cir. 1989).

In a decision denying Myriad's motion to dismiss, the district court considered but rejected Myriad's arguments that plaintiffs lacked standing to challenge the patents and that the court lacked subject matter jurisdiction over the case.

The Case to Date: Stage II — Federal Circuit Appeal

Myriad's appeal to the Federal Circuit challenged the district court decision on both the procedural standing/jurisdiction issue and on the substantive patent-eligibility issue.

Relying on the Supreme Court's decision in MedImmune v. Genentech, 549 U.S. 118 (2007), Myriad argued that the district court lacked declaratory judgment jurisdiction because the parties did not have “adverse legal interests,” and plaintiffs failed to demonstrate a controversy of “sufficient immediacy and reality.”

On the merits, Myriad argued that the isolated DNA composition claims met the criteria of 35 U.S.C. § 101. Myriad urged that the district court was wrong to broadly invoke the “products of nature” exclusion and incorrectly adopted and applied a “markedly different characteristics” test. With regard to the method claims, Myriad argued that the claimed methods necessarily included “transformations” of human samples, which required extracting, processing, and analyzing human tissue or blood.

More than 15 parties, including BIO, AIPLA, IPO, Rosetta Genomics, George Mason University, and Alnylam Pharmaceuticals, filed amicus briefs arguing that the district court erred, at least in determining that the isolated DNA composition claims did not qualify as patent-eligible subject matter.

The ACLU and Public Patent Foundation (Benjamin Cardozo School of Law) filed a brief on behalf of plaintiffs-appellees (collectively, “ACLU”). ACLU asserted that plaintiffs have standing, and pointed out that if even one plaintiff has standing, that would be sufficient to confer jurisdiction. On the merits, ACLU argued that the district court decision was supported by Supreme Court decisions and other precedent and also asserted again that the patent claims are unconstitutional under the First Amendment.

At least 12 parties, including the American Medical Association, American Society of Human Genetics, American College of Obstetricians and Gynecologists, American College of Embryology, and the Medical Society of the State of New York, filed amicus briefs supporting affirmance of the district court decision.

Surprisingly, while the USPTO had argued in support of patent-eligibility at the district court, the DOJ filed an amicus brief arguing that claims directed to isolated genomic DNA should not qualify as patent-eligible subject matter under § 101. As stated by the DOJ, § 101 “requires something more than identifying and isolating what has always existed in nature.” Unlike the district court, the DOJ drew a line between naturally occurring DNA sequences and DNA sequences that do not exist in nature, stating that “nearly any man-made transformation or manipulation of raw materials of the genome” is patent-eligible, including cDNAs and other engineered DNA molecules, vectors and recombinant plasmids, chimeric proteins, and “countless industrial products,” such as vaccines and genetically modified crops. (The DOJ brief did not address Myriad's method claims.)

Notably, after the case was fully briefed and awaiting oral argument scheduling, acting U.S. Solicitor General Katyal informed the Federal Circuit that he would “personally” argue the government's position at oral argument. It is unprecedented for a solicitor general to argue a case at the Federal Circuit, especially a patent case, and especially in a case where the government is no longer a party. (For more information on Solicitor General Katyal's letter to the court, see Foley's PharmaPatents Blog at http://tinyurl.com/42tkv93.)

Prometheus: Another Personalized Medicine Case in the Spotlight

As noted above, Myriad brought up the Prometheus case in support of its method claims. The claims at issue in Prometheus Laboratories, Inc. v. Mayo Collaborative Services, are directed to methods of optimizing the dosing of specific drugs used to treat gastrointestinal autoimmune diseases. The Federal Circuit twice has upheld their patent-eligibility under § 101, in decisions rendered both before and after the Supreme Court's decision in Bilski v. Kappos, 130 S.Ct. 3218 (2010). (For more information on Prometheus, see the December 17, 2010 edition of Foley's Legal News Alert: Chemical, Biotechnology & Pharmaceutical available online at http://tinyurl.com/3c6nsm4 and the firm's PharmaPatent Blog at http://tinyurl.com/3lsl2bc.)

Just recently, on March 17, 2011, Mayo filed a petition for certiorari to the Supreme Court, challenging the Federal Circuit's December 2010 decision. (For more information on the certiorari petition, see Foley's PharmaPatent Blog at http://tinyurl.com/3gqdonp.) Thus, Myriad likely will join Prometheus as another personalized medicine case making its way to the Supreme Court.