Brinks Hofer Gilson & Lione: Federal Circuit Upholds Claims to Isolated DNA Molecules

Brinks Hofer Gilson & Lione: Federal Circuit Upholds Claims to Isolated DNA Molecules

On July 29, 2011, a divided panel of the United States Court of Appeals for the Federal Circuit, in an appeal from the United States District Court for the Southern District of New York, issued its highly-anticipated decision in Association for Molecular Pathology v. U.S. Patent & Trademark Office, No. 2010-1406, slip opinion (Fed. Cir. July 29, 2011) ("Myriad") [enhanced version available to lexis.com subscribers / unenhanced version available from lexisONE Free Case Law]. Each of the three panelists authored a separate opinion, with the three opinions consuming a total of 105 pages. The majority held that composition of matter claims directed to "isolated" DNA molecules recite patent-eligible subject matter under 35 U.S.C. § 101. The majority also held that a method of screening cancer therapeutic candidates satisfies § 101 where the method includes the steps of "growing" transformed cells in the presence and absence of a therapeutic candidate and "determining" the cells' relative growth rates. On the other hand, the majority held that methods comprising a step of "comparing" two gene sequences or "analyzing" a gene sequence do not satisfy § 101 absent an additional transformative step.

Background
Myriad Genetics is a molecular diagnostic company offering tests that detect mutations in a patient's BRCA genes. This is deemed useful because such mutations have been correlated with a greatly increased risk of breast and ovarian cancer.

In May 2009, a group of medical organizations, researchers, genetic counselors, and patients ("Plaintiffs") filed suit against the University of Utah Research Foundation, Myriad Genetics and the U.S. Patent & Trademark Office (PTO) seeking a declaratory judgment that fifteen claims related to aspects of BRCA diagnostic tests from seven patents assigned to Myriad were drawn to patent-ineligible subject matter under 35 U.S.C. § 101. The challenged claims included (1) composition of matter claims directed to "isolated" DNA corresponding to the human BRCA genes, (2) method claims directed to methods of detecting cancer-predisposing mutations in a patient's BRCA genes (the "diagnostic method claims") and (3) a method claim directed to a method of screening potential cancer therapeutics (the "screening method claim").

Myriad moved for summary judgment, arguing that the Plaintiffs lacked standing to bring a declaratory judgment suit challenging the validity of its patents. The district court denied Myriad's motion, holding that the Plaintiffs had established standing under "all the circumstances" of the case. The district court then granted summary judgment of invalidity to the Plaintiffs on all 15 claims, holding that the challenged claims were all drawn to patent-ineligible subject matter under § 101.

Federal Circuit Decision
The Federal Circuit affirmed in part and reversed in part. At the outset, the Court unanimously affirmed declaratory judgment standing, although on much narrower grounds than the district court. In particular, the Federal Circuit found that only one of the Plaintiffs, Dr. Ostrer, had alleged a sufficiently real and imminent injury for declaratory judgment jurisdiction because he intended to immediately engage in allegedly infringing BRCA-related activities.

As to patent eligibility, the majority noted that § 101 encompasses a broad scope of patent-eligible subject matter, subject to certain judicially created exceptions, including "products of nature," "mental processes" and "laws of nature."

The Federal Circuit majority held that the composition of matter claims recited patent-eligible subject matter because the claimed "isolated" DNA molecules "are markedly different-have a distinctive chemical identity and nature-from molecules that exist in nature." Specifically, whereas native DNA exists as part of a large, contiguous DNA molecule, isolated DNA has been cleaved or synthesized to consist of only a fraction of a naturally occurring DNA molecule. In other words, isolated DNA molecules are not the same as the DNA molecules existing in nature and have "a distinctive chemical identity from that possessed by native DNA." Thus, the majority found that isolated DNA is not a "product of nature" and held that all of the composition claims recited patent-eligible subject matter.

In his dissenting opinion, Judge Bryson stated that isolated genes are patent-ineligible "products of nature," arguing that the structural differences between an isolated gene and the corresponding native gene are irrelevant to the function and utility of the isolated gene.

Turning to the diagnostic method claims, the Federal Circuit panel unanimously affirmed the district court's holding that these claims were patent-ineligible. The Court reasoned that the single step recited in each method-either "analyzing" a nucleotide sequence or "comparing" two nucleotide sequences-was an abstract mental step.

The Federal Circuit panel unanimously held that the screening method claim recited patent-eligible subject matter. Using the machine-or-transformation test as an "important clue" to the patent-eligibility of the claimed method, the court reasoned that the claimed method involved two transformative steps: "growing" cells and "determining" growth rate-both of which were central to the purpose of the claimed method. Finally, the Court found that the claimed method was not so abstract as to claim a scientific principle because it was tied to host cells transformed with specific genes (BRCA) and to a specific method of measuring therapeutic effect (measuring growth rate).

Impact of the Decision
In upholding the patent eligibility of isolated DNA molecules, the Myriad decision affirmed the PTO's established practice of granting patent protection for such molecules. It is unlikely, however, that the court's divided decision will be the last word on the patent eligibility of isolated DNA molecules. Reconsideration by the Federal Circuit en banc, or review by the Supreme Court, is likely.

The panel's unanimous opinion on the diagnostic method claims provides some guidance to patentees and litigants. The decision reinforces the importance of including transformative steps in diagnostic method claims. Patent applicants should ensure that all diagnostic method claims recite more than simply "analyzing" or "comparing" steps. Claims should explicitly include transformative steps, such as "administering," "isolating," and "determining." Conversely, litigants accused of infringing diagnostic method claims that lack transformative steps should consider invalidity defenses based on § 101.

If you have any questions or wish to discuss how this decision may impact your company, please contact your attorney at Brinks Hofer Gilson & Lione.

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This Client Alert is intended to provide information of general interest to the public and is not intended to offer legal advice about specific situations or problems. Brinks Hofer Gilson & Lione does not intend to create an attorney-client relationship by offering this information and review of the information shall not be deemed to create such a relationship. You should consult a lawyer if you have a legal matter requiring attention. For further information, please contact a Brinks Hofer Gilson & Lione lawyer.

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