In a move that surprised almost everyone in the patent community, The U.S. Department of Justice has weighed in on the side of those seeking to obliterate “gene patents.” The DOJ’s amicus brief was filed on Friday October 29, 2010 in the case of Associated Molecular Pathologists v. Myriad Genetics currently before a three judge panel of the U.S. Court of Appeals for the Federal Circuit.
The Justice Department’s brief acknowledges that “this conclusion is contrary to the longstanding practice of the Patent and Trademark Office” in issuing such patents as well as to practice of other government agencies like the NIH in seeking and obtaining gene patents.
The issue arose because of an appeal filed by Myriad Genetics seeking to overturn a federal district court decision last April in a case brought by the Association for Molecular Pathology (AMP) and other plaintiffs, including several medical societies, physicians and individual cancer patients. The district court decision invalidated several so-called “gene patents” held by Myriad Genetics and the University of Utah.
The inventors had discovered that certain mutations in two gene sequences, BRCA1 and BRCA2, in some individuals were correlated with a heightened susceptibility to breast cancer. Once these sequences were identified, they could be used to construct screening assays for the mutations and therapeutics. The inventors filed for patents on their discoveries.
The attorneys representing AMP and the other the plaintiffs, the ACLU Foundation and the Public Patent Foundation, challenged seven of the patents for claiming subject matter not eligible for patent protection. The challenged patents cover both isolated DNA derived from the BRCA1 and BRCA2 gene sequences as well as diagnostic methods for determining a patient's predisposition to breast cancer based on identification of certain mutations in BRCA genes extracted from patients and screening tests for new therapeutics.
The plaintiffs got all that they asked for -- and more. The summary judgment decision by federal judge Robert Sweet essentially concluded that all gene patents are invalid because they attempt to monopolize a natural product. According to Judge Sweet, isolated DNA is not eligible for patenting because it is not fundamentally different from native DNA, the “handiwork of nature.” To support his decision, the judge relied on an obscure Supreme Court decision from 1931, American Fruit Growers, Inc. v Brodgex Co., in which the Court struck down a patent that covered oranges having rinds that had been soaked in borax to prevent mold decay. Judge Sweet concluded that the American Fruit Growers case stands for the proposition that a product of nature must be “transformed” in a meaningful way to make it patentable.
In essence, Judge Sweet adopted the argument advanced by ACLU Attorney Hensen: “Genes isolated from the human body are no more patentable than gold extracted from a mountain.” However, this legal reasoning runs contrary to a large body of case law that biological materials, such as proteins, hormones and even stem cells can be patented in their isolated form.
Judge Sweet also invalidated the method claims of the patents based on another test recently laid out in a federal appeals court decision, In re Bilski. The Federal Circuit’s Bilski decision applied this transformation test in the context of a so-called “business method” patent. Judge Sweet extended the transformation test to screening assays and concluded that the discovery of a correlation between a marker and an illness was merely a verification of a natural phenomenon without effecting any transformation that would be sufficient for patent eligibility.
As for the screening method claims, the Myriad decision cannot be squared with other post-Bilski cases that have found transformations in assay steps. Analyzing or comparing DNA from a patient certainly involves several transformative steps, including biopsying blood or tissue, removal of DNA from biopsied cells, separating the particular sequences of interest and preparing the isolated sequences for analysis to detect mutations. Judge Sweet dismisses these transformations as mere “data-gathering.”
Moreover, since Judge Sweet’s decision, the Supreme Court has reviewed the Bilski decision and rejected the “machine or transformation” test as the sole test for the patentability of process or method claims.
Interestingly, the DOJ’s amicus brief doesn’t take a stand one way or the other on the process claims. The brief is essentially limited to the question of whether isolated DNA is patentable. The brief distinguishes engineered DNA molecules – which the brief argues are patentable—from genomic DNA that has merely been isolated from the human genome – unpatentable subject matter in the DOJ’s eyes.
Lurking between the lines of DOJ’s amicus brief is the problem of the cost of Myriad’s assays. According to the plaintiffs, the $3,000 price tag charged by Myriad for the full assay, effectively put the test out of the reach for most Americans whose health plans would not fully cover the test. The Justice Department’s position thus may have been driven by factors far removed from patent practice -- the looming costs of personalized medicine.
However, the ability to charge monopoly prices is at the core of the patent system, which is designed to reward for a limited period of time those who add to mankind’s knowledge. The monopoly price also provides an incentive for others to find alternatives to the patented invention. In fact, Myriad’s revenues are a far cry from the billions of dollars that many drug patents reap annually for their owners in the pharmaceutical industry.
- Tom Engellenner
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