Isolated DNA Molecules used for Cancer Screening Are Patent Eligible

The Federal Circuit on July 29, 2011, held in a 2-1 decision that isolated BRCA1/2 DNA molecules used for diagnosing increased breast and ovarian cancer risk are eligible for patent protection under 35 U.S.C. §101. Association for Molecular Pathology v. USPTO, Fed. Cir., No. 2010-1406, 7/29/2011.

In addition, the panel unanimously agreed that claims on methods of using the DNA to screen for cancer risks were patent eligible, but held that method claims directed to “analyzing” and “comparing” DNA sequences are not. The panel also unanimously agreed that the district court had declaratory judgment jurisdiction to decide the case, although only with respect to one plaintiff who was a research doctor directly corresponding with the patentee.

Composition Claims

Addressing the plaintiff’s argument that the DNA molecules were naturally occuring material, Judge Alan Lourie noted that the test under Supreme Court law is whether human intervention has given the claimed material “markedly different” characteristics. The Court was persuaded that the claimed molecules are markedly different from molecules that exist in nature in that they have “a distinctive chemical identity and nature.”

The Court rejected the plaintiff’s argument that, because the claimed isolated DNAs retain the same nucleotide sequence as the native DNAs, the claimed and native DNAs are not “markedly different.” This approach, according to Judge Lourie, does not look at whether there are marked differences, i.e., having distinctive characteristics, but at the similarity in the information content of the isolated and native sequences that are important to their genetic function. “Uses of chemical substances may be relevant to the non-obviousness of these substances or to method claims embodying those uses, but the patent eligibility of an isolated DNA is not negated because it has similar informational properties to a different, more complex natural material that embodies it,” he wrote.

The Court also rejected the government’s position, which considered only man-made DNA molecules (such as cDNA) to be patent eligible. According to the government, if the claimed DNA molecule could be seen in the human body through an imaginary “magic microscope,” the claim covers unpatentable subject matter. The test misunderstands the difference between science and invention. “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,” according to the Court.

The Court further noted that the PTO has been issuing patents on DNA molecules for almost 30 years, and that it reaffirmed this longstanding practice in its 2001 Utility Examination Guidelines, 66 Fed. Reg. 1092, Jan. 1, 2001. “If the law is to be changed, and DNA inventions excluded from the broad scope of §101 contrary to the settled expectation of the inventing community, the decision must come not from the courts, but from Congress,” Judge Lourie wrote.

Method Claims

Considering the method claims in this case in light of the Supreme Court’s decision in Bilski v. Kappos, 130 S. Ct. 3218 (2010), the unanimous panel found the methods of “comparing” or “analyzing” sequences to be patent-ineligible as directed to abstract ideas.

The claims reciting a method of screening by “comparing” a sequence from a tumor sample to a sequence from a non-tumor sample were not saved by limiting the comparison to BRCA genes, Judge Lourie noted. The patenting of abstract ideas cannot be circumvented by limiting the method to a particular technological environment, he explained. While the application of an abstract idea may describe patentable subject matter, the Myriad claims do not “apply” the step of comparing to nucleotide sequences in a process; instead, the step of comparing “is the entire process claimed,” the court pointed out. Nor would the Court consider steps taken in connection with the claimed process, such as extracting or sequencing, because those steps were not part of the claims themselves.

The Court distinguished the “comparing” and “analyzing” claims in this case from the “administering” and “determining” claims in Prometheus Labs., Inc. v. Mayo Collaborative Servs., 628 F.3d 1347, 1350 (Fed. Cir. 2010). In Prometheus, the steps of administering and determining were transformative because those steps in the claim acted upon particular objects identified in the claim, i.e., administering a drug to a subject or determining the drug’s metabolite levels. By contrast, the “comparison” between the two sequences, as expressed in the claims of this case, can be accomplished by mere inspection alone.

On the other hand, the claim to a method of “screening” potential cancer therapeutics via changes in cell grown rates is transformative because it includes steps of “growing” host cells transformed with an altered BRCA1 gene. “The claim includes the steps of ‘growing’ transformed cells in the presence or absence of a potential cancer therapeutic, an inherently transformative step involving the manipulation of the cells and their growth medium,” Judge Lourie wrote. As it is tied to measuring a therapeutic effect on the sells, it presents “functional and palpable applications,” the Court concluded.

Standing

Applying the Supreme Court’s test in Medimmune Inc. v. Centoco Inc., 409 U.S. 1376 (2005), the Court was persuaded that, with respect to one doctor, this case alleged sufficient affirmative acts by the patentee and meaningful preparation to infringe by the doctor to support declaratory judgment jurisdiction in this case.
The Court acknowledged that the patentee’s assertion of its rights occurred more than 10 years ago, but concluded the relevant circumstances of the dispute remain the same even if the controversy may have dissipated over time. The patentee’s enforcement actions brought the research of the doctor and others to a halt, the testing technology still requires the use of the claimed processes and materials, and the doctor still has and directly expressed the same desire and ability to engage in that testing. The Court did not find such circumstances to support standing for the other plaintiffs, but held that standing for one plaintiff was sufficient to consider the merits of the case.
Not addressed in the Court’s opinion is a July 27, 2011 letter from Myriad’s lawyers stating that the doctor is no longer associated with the NYU Medical Center where he conducted his research.

Concurring and Dissenting Opinions

In her concurring opinion, Judge Kimberly Moore generally agreed with Judge Lourie’s opinion, but with respect to the composition claims said that it may not be sufficient to focus on the “markedly different chemical structure” of isolated DNAs. It is also important to consider whether these differences impart a new utility which makes the molecules markedly different from nature, she observed. The ability to use isolated DNA molecules as the basis for diagnostic genetic testing is clearly an enlargement of the range of utility as compared to nature, Judge Moore concluded. She also noted the extensive historical background of this technology and cautioned against expanding patent ineligibility where both settled expectations and extensive property rights are involved.

Judge William Bryson agreed with majority except as to the composition claims. In his dissenting opinion on that subject, he wrote that the process of isolating genetic material from a human DNA molecule does not make the isolated genetic material a patentable invention. He concluded that the isolated genes are not materially different from the native genes, making an analogy to new minerals discovered in the earth or new plants found in the wild. The difficulty of extracting or finding such materials does not make them patent eligible, he concluded.