In reversing the summary judgment of the Southern District of New York, the Court of Appeals for the Federal Circuit held today in an opinion by Judge Lourie that claims to isolated DNA and claims for methods of screening potential cancer therapeutics were directed to patentable subject matter.  However, the Federal Circuit affirmed the lower court’s decision that method claims directed to “comparing” or “analyzing” DNA sequences are patent ineligible.  The ruling came in the “Myraid” case, The Association for Molecular Pathology v. The United States Patent and Trademark Office, et al., 2010-1406 (July 29, 2011).  The summary judgment by the trial court held that various medical researchers, patients and others had standing to challenge Myriad Genetics’ patents and that patent claims to isolated DNA, method claims to “comparing” and “analyzing” and claims to the screening of cancer therapeutics described subject matter that is not patentable.  Id.  For a discussion of the background of the case and the lower court's decision, see our Legal Alert dated March 30, 2010.

The Federal Circuit first addressed the issue of “standing,” whether any of the plaintiffs had the right to file the suit.  Relying on the Supreme Court’s decision in MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007), the Court held that at least one of the medical researchers, Dr. Ostrer, had standing to sue for declaratory judgment.  Dr. Ostrer established a sufficiently real and imminent injury because he intended to actually and immediately engage in allegedly infringing BRCA-related activities and Myriad had a history of enforcing its patents against others.  Assoc. for Molecular Pathology, slip op., at 24-35.

The Court then turned to whether Myriad Genetics’ claims to isolated DNA, methods directed to “comparing” or “analyzing” DNA sequences, and methods directed to screening for cancer therapeutics described patentable subject matter. 

Isolated DNA Molecules Are Patentable Subject Matter

Relying on the Supreme Court’s decisions in Diamond v. Chakrabarty, 447 U.S. 303 (1980), and Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948), the Court held that claims to both cDNA and isolated DNA represented patentable subject matter.  With respect to cDNA, the Court reasoned (and both concurring opinions agreed) that cDNA is not a composition that ever exists in nature in that particular form and thus is patentable subject matter.  Using similar reasoning, the majority held that isolated DNA is a free-standing portion of a native DNA molecule and is not found in nature in the claimed form.  The majority held that the isolated BRCA1 or BRCA2 genes must be isolated from the chromosomes they are on in nature and manipulated chemically, noting that “isolated DNA is not purified DNA.”  Id. (slip op., at 41-42).  As such, isolated DNA is not the same molecules of DNA that exist in the body, and likewise have a distinctive chemical identity from that possessed by native DNA.  Id.  In addition, both Judge Lourie’s majority opinion and Judge Moore’s concurring opinion placed great emphasis on deference to the U.S. Patent and Trademark Office’s (USPTO) longstanding practice that isolated DNA molecules are patentable subject matter.  Id. (slip op., at 47-48) and concurring opinion by Moore (slip op., at 18-19). 

Methods of Comparing or Analyzing DNA Sequence Are Not Patentable Subject Matter

The Court held that Myriad's method claims for “comparing” or “analyzing” sequences are not patentable because they describe only abstract mental processes.  Id. (slip op., at 49-50).  These invalidated claims recite, for example, a “method for screening a tumor sample,” by “comparing” a first BRCA1 sequence from a tumor sample and a second BRCA1 sequence from a non-tumor sample, “wherein a difference in the sequence indicates an alteration in the tumor sample.”  U.S. Patent No. 5,710,001, claim 1.  Applying the machine-or-transformation test [from the Bilski v. Kappos, 130 S. Ct. 3218 (2010) case], the Court held that these types of claims recite nothing more than the abstract mental steps necessary to compare two different nucleotide sequences.  Id. (slip op., at 50).  The Court noted that these claims do not specify any action prior to the step of “comparing” or analyzing,” and that the plain meaning of the terms “comparing” and analyzing” neither is nor implies “extracting” or “sequencing” DNA, or otherwise “processing” a human sample, as argued by Myriad.  The Court distinguished Myriad Genetics’ claims from those held to be patentable in Prometheus Labs., Inc. v. Mayo Collaborative Servs., 628 F.3d 1347 (Fed. Cir. 2010).  The Court held that the Myriad claims failed to specify any action or processing steps (e.g., “determining” the sequence of BRCA genes”), and that the comparison between the two sequences could be accomplished by “mere inspection alone.”  Id. (slip op., at 51-52).

Methods of Screening Therapeutics Are Patentable Subject Matter

Finally, the Court held that Myriad Genetics’ claim for a method for screening potential cancer therapeutics by monitoring changes in cell growth rates satisfied the machine-or-transformation test, and thus was patentable subject matter.  Id. (slip op., at 53).  The Court noted that the challenged claim recited a method that included the steps of “growing” host cells transformed with an altered BRCA1 gene in the presence or absence of a potential cancer therapeutic, “determining” the growth rate of the host cells with or without the potential therapeutic, and “comparing” the growth rate of the host cells.  Id.  The Court found that “growing” the transformed cells was an inherently transformative step involving the manipulation of the cells and that “determining” the cells’ growth rates also necessarily involved physical manipulation of the cells.  Id.  Further, these steps were recognized to be central to the purpose of the claimed process because growing the cells and determining their growth rate achieves the goal of the claimed method (i.e., assessing a compound’s potential as a cancer therapeutic).  Id. 

Judge Bryson’s Concurrence

Judge Bryson concurred with respect to standing and the patentability of the cDNA claims the method claims.  However, he dissented from the Court’s holding that the BRCA gene claims and claims to gene fragments are patent-eligible.  Judge Bryson reasoned that claims to the isolated BRCA genes clearly fell on the “unpatentable” side of the line drawn by the Supreme Court drew in Diamond v. Chakrabarty because the only material change made between the claimed genes and their natural state was the change that was incidental to the extraction of the genes from the environment in which they are found in nature.  Judge Bryson further disagreed with the emphasis that the majority placed on the USPTO’s practice of allowing patents on human genes.

The Bottom Line

Claims to isolated DNA molecules, whether directed to cDNA or native DNA sequences, remain patent-eligible subject matter as do claims directed to methods of screening cancer therapeutics.  However, method claims directed to “comparing” or “analyzing” DNA sequences to correlate to a condition or disease state must include some additional active processing steps in order to satisfy the machine-or-transformation test and be patentable.

Thus, the Federal Circuit has solidified its application of the machine-or-transformation test to biotechnological methods, which will stand at least until the Supreme Court rules in the Prometheus case (cert granted June 20, 2011).  In the interim, patent applicants will do well to consider the Federal Circuit’s emphasis on active steps in methods relating to biological phenomenon.

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