On July 29, 2011, in one of the most controversial and publicized biotech patent cases in many years, the Federal Circuit decided the “ACLU/Myriad” gene patenting case, formally known as Assn. Mole. Path. et al. v. USPTO et al. In a majority opinion by Judge Lourie, the Court addressed the case on the merits, after finding standing. The Court held all “isolated DNA” claims at issue patent-eligible, but held as patent-ineligible diagnostic method claims that in effect recite only “comparing” or “analyzing” DNA sequences. While it is anticipated that this ruling may be the subject of en banc review before the Federal Circuit and/or will ultimately find its way to the Supreme Court, today's decision and its impact will undoubtedly be of great interest to everyone working in the biotechnology and diagnostic medicine fields.  

Background

After hearing oral arguments on April 4, 2011, Judges Lourie, Bryson, and Moore issued opinions relating to the appeal of 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. (See Foley's April 4, 2011 Legal News Alert: The Federal Circuit Hears Oral Arguments in Myriad Isolated DNA Case http://tinyurl.com/3eltcsq.)

Standing Found for One Plaintiff

In the majority opinion issued on June 29, 2011, Judge Lourie first addressed the issue of standing. The finding of standing here is particularly interesting because the Court could have dodged the ball and declined to address the merits. Instead, the Court affirmed the district court finding of declaratory judgment jurisdiction, finding that at least one plaintiff, Dr. Harry Ostrer, had standing to challenge the validity of Myriad's patents. Applying the Supreme Court's test in MedImmune v. Genentech, the Federal Circuit determined that at least Dr. Ostrer alleged an intention to actually and immediately engage in allegedly infringing activity. Unlike other plaintiffs who merely alleged that they would “consider” engaging in relevant testing, Dr. Ostrer “not only has the resources and expertise to immediately undertake clinical BRCA testing, but also states unequivocally that he will immediately begin such testing.”

Isolated DNA Composition Claims Are Patent-Eligible

On the merits, the Court held that Myriad's composition claims directed to “isolated” DNA molecules refer to patent-eligible subject matter under 35 U.S.C. §101. In reversing the district court, the Federal Circuit refused to find “isolated DNA” patent-ineligible products of nature, because such molecules as claimed do not exist in nature.

Citing the Supreme Court's decisions in Chakrabarty and Funk Brothers as “set[ting] out the framework for deciding the patent eligibility of isolated DNA molecules,” the Court noted that the distinction “between a product of nature and a human-made invention for purposes of §101 turns on a change in the claimed composition's identity compared with what exists in nature.” Specifically, one must consider whether “human intervention has given ‘markedly different,' or ‘distinctive,' characteristics.” Applying this test, the Court concluded that isolated DNA claims relate to molecules that “are markedly different — have a distinctive chemical identity and nature — from molecules that exist in nature.” In this analysis, the Court discounted the plaintiffs' approach of only considering the “information content,” i.e., sequence information, contained in isolated and native DNA, or the fact that DNA molecules genetic function is to transmit information.

The Court discussed how isolated DNAs exist in a distinctive chemical form, i.e., as distinctive chemical molecules, as compared to DNA in the body. Noting that “isolated DNA is not purified DNA,” the Court explained:

Purification makes pure what was the same material, but was previously impure. Although isolated DNA must be removed from its native cellular and chromosomal environment, it has also been manipulated chemically so as to produce a molecule that is markedly different from that which exists in the body. It has not been purified by being isolated.

The Court further stated:

In this case, the claimed isolated DNA molecules do not exist as in nature within a physical mixture to be purified. They have to be chemically cleaved from their chemical combination with other genetic materials. In other words, in nature, isolated DNAs are covalently bonded to such other materials. Thus, when cleaved, an isolated DNA molecule is not a purified form of a natural material, but a distinct chemical entity. In fact, some forms of isolated DNA require no purification at all, because DNAs can be chemically synthesized directly as isolated molecules.

Interestingly, this passage relates to Judge Lourie's proposed “breaking of covalent bond” test that he raised during oral argument.

In addition, the Court also rejected the U.S. Department of Justice's (DOJ) proposed “magic microscope” test. Under this test, the DOJ would find isolated DNA claims reciting cDNA and other non-native sequences patent-eligible, but isolated DNA claims reciting native genomic sequences patent-ineligible. The majority opinion stated that this proposed test “misunderstands the difference between science and invention and fails to take into account the existence of molecules as separate chemical entities.” As the Court explained, the “ability to visualize a DNA molecule through a microscope, or by any other means, when it is bonded to other genetic material, is worlds apart from possessing an isolated DNA molecule that is in hand and usable… Visualization does not cleave and isolate the particular DNA; that is the act of human invention.”

“Growing” and “Determining” Method Claim Held Patent-Eligible

The Court also reversed the district court's decision regarding Myriad's method claim directed to screening potential cancer therapeutics comprising at least the steps of “growing a transformed eukaryotic host cell” and “determining the rate of growth of said host cell.” See claim 20 of U.S. Pat. No. 5,747,282. Unlike other method claims at issue, the Court found this method claim patent-eligible under §101. As relating to the “growing” and “determining” steps, the Court found that the claim “includes transformative steps, an ‘important clue' that it is drawn to a patent-eligible process,” citing the Supreme Court's decision in Bilski v. Kappos.

“Comparing” or “Analyzing” Diagnostic Method Claims Held Patent-Ineligible

In a move to be noticed by the personalized medicine community, the Court affirmed the district court's finding of patent ineligibility regarding certain method diagnostic claims.

Method claims found ineligible here recite, for example, (1) a method for detecting a mutation in a gene comprising the step of “analyzing a sequence” of a gene from a human sample, or (2) a “method for screening germline of a human subject for an alteration” in a specific gene comprising the step of “comparing germline sequence” of a particular gene from a tissue sample. According to the Court, such claims were patent-ineligible because, “they claim only abstract mental processes.”

The Court rejected Myriad's argument that the methods necessarily embodied transformative steps, similar to the claims recently upheld in Prometheus. Noting that while the Prometheus claims recited a “determining” step that embodied a transformation, the Myriad claims at issue here did not.

Judge Moore's and Judge Bryson's Additional Opinions

While agreeing with Judge Lourie's opinion regarding standing and the holdings pertaining to method and isolated cDNA claims, both Judge Moore and Judge Bryson authored separate opinions regarding the patent eligibility of isolated genomic DNA composition claims, with Judge Moore concurring on additional grounds and Judge Bryson dissenting.

While agreeing that all isolated DNA claims recited patent-eligible subject matter, Judge Moore wrote separately to express her views that “Funk Brothers and Chakrabarty do not stake out the exact bounds of patentable subject matter. Instead, each applies a flexible test…” She also suggested that the fact that a claimed DNA is not a product of nature by itself does not make it so “markedly different” as to satisfy §101. Rather, one should consider whether chemical differences impart a new utility. In addition, Judge Moore also was persuaded by Congress' and the USPTO's long-standing authorization of an expansive scope of patentable subject matter, as well as the fact that Congress has remained silent on this issue.

In his opinion concurring-in-part and dissenting-in-part, Judge Bryson opined that relevant composition claims directed to native genomic DNA, including those reciting gene fragments, were ineligible for patent protection. Judge Bryson would find claims directed to cDNA patent-eligible, however, in line with the DOJ's position.

Looking Ahead

This decision will be of great interest to the biotech community and to those generally following patent jurisprudence on the subject matter eligible for patent protection under §101. It is expected that at least the ACLU/plaintiffs will consider a request for a rehearing en banc at the Federal Circuit and/or petition for certiorari at the Supreme Court, which is currently considering the Prometheus case