Isolated DNA is patent-eligible because it is a "non-naturally occurring composition of matter," so said an appellate court in determining, once again, the validity of Myriad Genetics Inc.'s claims for its BRACAnalysis breast cancer gene test.
The split decision, handed down Thursday by the U.S. Court of Appeals for the Federal Circuit, should result in a big sigh of relief from biotechs, Mary Webster, a patent attorney with Nixon Peabody, told BioWorld Today. The challenge to Myriad's patents for isolated DNA of the BRCA 1 and BRCA 2 genes was essentially an attack on a whole class of claims that are the bedrock of much of biotech's intellectual property.
The court's second take on the Association for Molecular Pathology v. Myriad Genetics isn't much different from its first split decision, which was appealed to the Supreme Court last year. (See BioWorld Today, Aug. 2, 2011, and Dec. 9, 2011.)
Like it did the first time, the appeals court upheld Myriad's composition claims based on isolated DNA, as well as Claim 20, a method claim for screening potential cancer therapeutics via changes in cell growth rates of transformed cells. And the court again struck down other method claims related to comparing or analyzing DNA sequences, saying "such claims include no transformative steps and cover only patent-ineligible abstract, mental steps." (See BioWorld Today, July 23, 2012.)
Basically, "we're back to where we were," Courtenay Brinckerhoff, a partner at Foley & Lardner, told BioWorld Today, as the ruling restored the status quo, especially for personalized medicine-type claims.
The Supreme Court had sent the case back to the Federal Circuit with orders to reconsider it in light of its decision in Mayo Collective Services v. Prometheus Laboratories Inc., which involved method claims on applying a law of nature. Given Thursday's decision, the case is likely to be appealed to the Supreme Court yet again, Brinckerhoff said. (See BioWorld Today, March 21, 2012, and March 27, 2012.)
No 'Magic Microscope'
While the outcome was a repeat of the Federal Circuit's earlier decision, the court was more explicit this time around and minced few words. For instance, in writing the majority opinion, Judge Alan Lourie pointedly rejected the "magic microscope" the government had offered as the legal patent test for clarifying when genetic material is a product of nature. (See BioWorld Today, April 5, 2011.)
Under that test, a DNA molecule wouldn't be eligible for a patent if the imaginary microscope could zoom in on the molecule within the human body. In effect, the magic microscope differentiated between genomic and synthetic, or complementary, DNA, Webster explained. The Federal Circuit's decision is the "nail in the coffin" for the government's proposed microscope test, she said, because the court refused to draw a patent line between the two types of DNA.
According to the court, "the ability to visualize a DNA molecule through a microscope, or by any other means . . . is worlds apart from possessing an isolated DNA molecule that is in hand and usable. It is the difference between knowledge of nature and reducing a portion of nature to concrete form, the latter activity being what the patent laws seek to encourage and protect."
The appellate court also pointed out that while Myriad's molecules are "prepared from products of nature, so is every other composition of matter. All new chemical or biological molecules, whether made by synthesis or decomposition, are made from natural materials. . . . As such, they are different from natural materials, even if they are ultimately derived from them."
The court continued by chiding the plaintiffs and lower court, which had overturned the patents, for focusing primarily on the genetic function of the isolated DNA instead of its structure. "We recognize that biologists may think of molecules in terms of their uses, but genes are in fact materials having a chemical nature and, as such, are best described in patents by their structures rather than by their functions," it added.
A Matter of Policy
The Federal Circuit also recognized its limitations in Myriad, noting that the plaintiffs and government have basically argued for isolated DNA to be considered a special case that should be excluded from patent eligibility. But that's not the court's prerogative, the appellate court said. That's a policy issue that must be decided by Congress.
While Myriad was making its way through the court system, Congress was working on the America Invents Act (AIA), a comprehensive reform of the nation's patent system. Had it wanted to overturn years of case law and the patent eligibility of isolated DNA, Congress could have done so with that law, Lourie said.
Congress may yet weigh in on the matter. Rep. Debbie Wasserman Schultz (D-Fla.) tried to attach an amendment to the AIA that would have denied patents for DNA. But rather than passing the amendment, Congress instructed the Patent and Trademark Office (PTO) to prepare a report on how exclusive licensing and patents on genetics affect the practice of medicine. (See BioWorld Today, Feb. 17, 2012.)
In that study, the PTO hoped to address how the evolving patent system is keeping pace with delivering patient care and how to balance patients' interest in accessing information about their own health with the interest of patent holders.
In the first of two public hearings the PTO held on the subject, some speakers questioned the fairness of gene-based patents. And the Association for Molecular Pathology called for a moratorium on gene patents, including process claims, while the issue undergoes full legal and legislative consideration.
The Federal Circuit seemed to address some of those sentiments in its ruling Thursday. The question is not whether it is "desirable for one company to hold a patent or license covering a test that may save people's lives, or for other companies to be excluded from the market encompassed by such a patent that is the basic right provided by a patent, i.e., to exclude others from practicing the patented subject matter," the court said.