Ass’n for Molecular Pathology v. U.S. Patent and Trademark Office, No. 2010-1406 (Fed. Cir. August 16, 2012).

On August 16, 2012, a split panel of the U.S. Court of Appeals for the Federal Circuit issued its highly anticipated ruling in Ass’n for Molecular Pathology v. U.S. Patent and Trademark Office (the “Myriad case”), effectively affirming their 2011 ruling. The Supreme Court had sent the case back to the Federal Circuit for further review in light of its recent Prometheus opinion. The Federal Circuit upheld the patent-eligibility of the claims covering isolated DNA sequences, and upheld the claims covering a screening method using a transformed cell. The Court also held that the claims directed to methods of “comparing” and “analyzing” sequences were not patent-eligible subject matter under 35 U.S.C. § 101.

The Federal Circuit Decision

As noted, three types of claims were at issue: (i) composition claims directed to isolated DNA molecules; (ii) method claims directed to “comparing” or “analyzing” DNA sequences; and (iii) method claims for screening potential cancer therapeutics using transformed cells. Upholding its initial decision, the Federal Circuit determined that the isolated DNA claims and the method claims using a transformed cell were patent-eligible, but that the method claims directed to “comparing” or “analyzing” DNA sequences were not.

Patent-Eligibility of Isolated DNA Molecules

According to the majority opinion, “[T]he compositions here are not natural products. They are the products of man, albeit following, as all materials do, laws of nature.” The critical inquiry is whether the claimed DNA has “markedly different characteristics” from naturally occurring DNA.

Although the panel unanimously held that claims directed to complementary DNA (“cDNA”) were patentable because cDNA is synthesized DNA lacking naturally occurring gene sequences present in the human body, the panel split on the patentability of isolated DNA.

Writing for the majority, Judge Lourie emphasized that isolated DNA molecules do not exist in nature. They are a product of human ingenuity because they can only be obtained by chemical manipulation in a laboratory. The fact that their “information content” (i.e., their nucleotide sequences) is similar to that in naturally occurring DNA does not negate their patent eligibility.

Judge Moore’s concurring opinion expanded on Judge Lourie’s analysis. She noted that short strands of isolated DNA molecules are patent-eligible because they have a new utility relative to the naturally occurring sequences. While Judge Moore acknowledged that longer sequences of isolated DNA molecules do not share the expanded utility of the shorter sequences, she argued that such molecules were deemed to be patent-eligible in view of Congress’s authorization of the “expansive scope” of patentable subject matter, as well as established U.S. Patent Office policy.

Judge Bryson dissented-in-part with regard to the patentability of isolated DNA. Citing the Prometheus opinion, Judge Bryson asserted that chemical manipulation is not “enough” to distinguish the isolated DNA molecules from naturally occurring DNA. Judge Bryson also warned against defining patent-eligible subject matter based on Patent Office practice because such a decision “is in effect to give the PTO lawmaking authority that Congress has not accorded it.”

Patent-Eligibility of Methods of Screening Potential Cancer Therapeutics

All three judges held that a claim directed to a method for screening potential cancer therapeutics by growing host cells transformed with an altered gene in the presence or absence of a potential cancer therapeutic constitutes patent-eligible subject matter. Citing Diamond v. Chakrabarty, 447 U.S. 303 (1979), the majority opinion noted that a cell transformed with an altered gene is itself patent-eligible subject matter. Thus, a method or process using such a cell is also patent-eligible.

Patent-Eligibility of “Comparing” and “Analyzing” Methods

All three judges maintained their earlier decision that claims directed to methods of “comparing” or “analyzing” gene sequences are not patent-eligible subject matter under § 101. The court held that these claims are invalid because they require nothing more than “abstract mental processes.” The court noted that the claims do not specify any active steps. Instead, the claims can be accomplished by the pure mental process of comparing two nucleotide sequences.

Next Steps

A request for en banc rehearing at the Federal Circuit or a petition for a writ of certiorari to the Supreme Court could be filed in this case. The petition for a writ of certiorari is likely, and must be filed within ninety days after entry of judgment.

The Federal Circuit’s decision demonstrates the value of presenting different types of claims, as well as claims of varying scope. For example, applications that include claims directed to compositions of matter could also include claims covering various distinct aspects of the technology.

In light of the Court’s decision, applicants and patentees may also wish to evaluate their diagnostic portfolios for risk of potential § 101 challenges by third parties. It may be helpful to include additional steps in diagnostic claims to ensure that the claims contain sufficient transformative steps (e.g., extraction, sequencing, and other processing steps) to satisfy the Prometheus requirements.

It remains to be seen what effect this decision will have on the biotech and pharma industries, but it appears to have positive and negative aspects. It is not the “Armageddon” that some predicted because most of the claims were found to be patent-eligible.