Recently, the Court of Appeals for the Federal Circuit (CAFC) in the Myriad case (The Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, Myriad Genetics, Inc. and Lorris Betz, et al., (No. 2010-1406 (Fed. Cir. July 29, 2011)) held that isolated DNA was patentable subject matter, overturning a highly controversial lower court decision ruling that claims directed to isolated DNA were unpatentable. The CAFC ruling reaffirms the long-standing, decades-old practice by the U.S. Patent and Trademark Office in allowing such claims, which are in thousands of issued patents. Patent owners and applicants, particularly in the biotechnology and genomics fields, should feel a renewed confidence in obtaining, enforcing and investing in patents claiming isolated genes.

The Appeal and Issue

The Association of Molecular Pathology and nineteen other plaintiffs filed a lawsuit in the District Court of the Southern District of New York challenging the patentability of claims directed to isolated DNA, specifically the BRCA1 and BRCA2 genes, and methods of identifying mutations in genetic material obtained from a human for the presence of the BRCA1 and BRCA2 genes. The BRCA1 and BRCA2 genes are associated with a hereditary predisposition to breast cancer. The ability to diagnose susceptibility to breast cancer can have a significant impact on available health care options to a patient. The District Court invalidated the claims at issue, holding that the isolated DNAs were "products of nature" because, despite being isolated by the inventors using laboratory techniques, they were not "markedly different" from the DNA in its natural state as found in a human. The American Civil Liberties Union (ACLU) argued on behalf of the Association of Molecular Pathology and the other parties challenging the patent claims. Among the parties alleging invalidity of the claims were women who's health insurance providers apparently denied them a test provided by Myriad that would have determined their genetic pre-disposition to a hereditary form of breast cancer.

The human genome is composed of DNA, which is a component of human chromosomes found in cells of the human body. DNA is made of building blocks of nucleotides that are held together by chemical bonds, including covalent bonds, to form nucleic acids. Through a process referred to as transcription, DNA forms ribonucleic acid (RNA), which, in turn, is translated into a protein that can alter cellular processes, all of which can occur naturally in a human cell. cDNA can be synthesized in a laboratory from templates of genetic material and does not occur in the human body.

The specific issue in the Myraid case was whether the isolated BRCA1 and BRCA2 DNA, cDNA and claimed methods qualified as subject matter for which an inventor can apply for a patent, or "patentable subject matter."

Qualification as one of the statutorily permissible forms of subject matter is a prerequisite for patentability. Other requirements include novelty and nonobviousness of the claimed invention, enablement by one of ordinary skill in the art to make and use the claimed invention, and an adequate written description of the claimed invention, all of which were not challenged in the current Myriad case.

Isolated Genes are Markedly Different - Rejection of the "Magic Microscope" Test

In Myriad, the CAFC held that the isolated BRCA1 and BRAC2 genes are "markedly different – have a distinctive chemical identity and nature – from molecules that exist in nature." The court's conclusion was largely based on the presence of covalent bonds in genomic (naturally occurring) DNA that were absent in the DNA isolated by the inventors and, thus, the isolated DNA was a "distinct chemical entity" not found in nature. The court rejected the government's argument that if a "magic microscope" were used to visualize DNA in a cell in the human body, it would be the same as isolated DNA claimed in the patents. Rather, visualization by the "magic microscope" does not cleave covalent bonds of the DNA and, therefore, does not isolate the DNA from components of a chromosome, all of which are "act[s] of human invention." Likewise, the court held that cDNA, made from a nucleic acid template, was patentable subject matter because it is not found in the human body.

The court rejected an analogy of isolating DNA to purifying chemical elements found in nature, excising a kidney from the human body or plucking a leaf from a tree. Purification, excision or plucking would result in an entity that was not necessarily "markedly different" from that found in nature, despite being removed from its natural environment, contrary to isolation.

Method Claims Require More Than Abstract, Mental Steps

Certain method claims of the challenged patents were held by the CAFC to not claim a patentable process, consistent with the decision of the District Court in New York. Such claims included steps of "comparing" or "analyzing" DNA sequences, which the Myriad court held were "abstract mental processes and fail the machine-or-transformation test." The machine or transformation test is one test to determine whether the claimed invention is patentable subject matter and requires that the method be tied to a particular machine or apparatus, or transform a particular thing into a different state or thing. In contrast, claims for methods of screening therapies by measuring growth rates of cells were held to be patentable subject matter because "growing" and "manipulating" cell growth are "transformative" steps.

It is Unlikely the Debate Will End

The U.S. Patent and Trademark Office has allowed numerous claims directed to isolated genes, which are now in issued patents. The Myriad court has made clear that such claims are directed to patentable subject matter, which provides some relief to Patentees and inventors in the field of genomic research. However, methods of using isolated genes should include steps that are indicative of a transformation process, such as growing or manipulating, or use of a machine, such as measuring or assaying. Mere steps of "comparing" or "analyzing," without transformation or machine steps, are vulnerable to challenge as nonpatentable subject matter in issued patents and rejections in pending cases.

Most commentators believe the plaintiffs, the losing party, will appeal the decision to a full panel of the Court of Appeals for the Federal Circuit or the U.S. Supreme Court. The U.S. Supreme Court has recently opined on patentable subject matter in Bilski., et al. v. Kappos, 130 S. Ct. 3218, 561 US __, 177 L. Ed. 2d 792 (2010) and is considering the patentability of methods for therapeutics in Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 628 F.3d 1347 (Fed. Cir. 2010). Regardless of the ultimate fate of the Myriad case, the debate of what constitutes patentable subject matter, whether isolated genes or methods of therapeutics, will remain controversial as further decisions from the Court of Appeals for the Federal Circuit and the U.S. Supreme Court on patentable subject matter emerge.

Click here to read the Myriad decision.

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