Patent Law | Expert Legal Commentary
May 25, 2010
Ass’n for Molecular Pathology v. USPTO: Isolated Genes Are Not Patentable Subject Matter
Ass’n for Molecular Pathology v. USPTO
Tom Zuber and Josh Lawler of Zuber Lawler & Del Duca
In a controversial decision, the U.S. District Court for the Southern District of New York has held that neither isolated DNA nor methods directed toward identifying mutations in these genes constitute patentable subject matter under 35 U.S.C. section 101. If upheld on appeal, Ass’n for Molecular Pathology v. USPTO, ____ F. Supp. 2d ___, 2010 WL 1233416, No. 09 Civ. 4515 (S.D.N.Y. March 29, 2010), could have far-reaching implications for the biotechnology industry.
Myriad Genetics, a defendant in the case, owns interests in several patents on the human genes BRCA1 and BRCA2, both of which can indicate an increased risk of breast or ovarian cancer. Ownership of these patents gives Myriad the ability to control the availability of genetic testing for BRCA1 and BRCA2 sequences and to restrict research on the sequences by other laboratories.
The plaintiff group, represented in court by the ACLU and the Public Patent Foundation, included researchers, testing laboratories medical societies, advocacy organizations, and cancer patients. The plaintiffs sought to invalidate Myriad’s BRCA-related patents, claiming that: 1) the grant of the patents on human genes breached Article 1 Section 8 and the First and Fourteenth Amendments of the U.S. Constitution because the patents inhibit research on the genes in violation of both the protection of freedom of thought and Congress’ Constitutional mandate to “promote the Progress of Science and useful Arts”; and 2) the patent claims fall within the product-of-nature exception for 35 U.S.C. section 101 and thus do not constitute patentable subject matter.
In earlier proceedings, the District Court had denied defendants’ motion to dismiss the plaintiffs’ claims for jurisdictional issues, lack of standing, and failure to state a claim. The Court had found that the plaintiffs’ constitutional claims provided both subject matter jurisdiction and standing to sue the U.S. Patent and Trademark Office due to a lack of available statutory remedies. Even though the USPTO is generally immune from suit due to the availability of statutory remedies for claims arising from patents, those remedies do not provide for constitutional challenges.
Isolated DNA does not constitute patentable subject matter
The District Court separated the challenged patents into two classes: 1) composition claims directed at “isolated DNA coding” for the BRCA1 and BRCA2 genes; and 2) method claims directed toward identifying specific mutations in the BRCA genes that might indicate an increased cancer risk by analyzing and comparing sequences taken from human samples. The District Court held that both classes of patents were directed toward non-patentable subject matter and were thus invalid.
Regarding the “isolated DNA” composition claims, the plaintiffs argued that the isolated genes fall within the “products of nature” exception to patentability recognized by the U.S. Supreme Court in Diamond v. Chakrabarty, 477 U.S. 303, 309 (1980). The Diamond case held that to be patent eligible, a product should have “markedly different characteristics from any found in nature.”
In Ass’n for Molecular Pathology, the District Court found Myriads’ composition claims invalid because they did not possess “markedly different properties” from native DNA because the “isolated” form of DNA “alters neither [the] fundamental quality of DNA as it exists in the body nor the information it encodes.” 2010 WL 1233416, at *1. The information-bearing characteristics are the key characteristics of a gene, and because both the isolated and native version had those characteristics in common, the two were not “markedly different,” even though there might be slight chemical differences in the genetic material. Id. at 41-43, 46.
Myriad argued that the purification of “naturally occurring compounds” renders them patent-eligible, but the District Court held that without more, purification alone does not render a compound patentable. Id. at *37.
The Diagnostic Method Claims did not satisfy the Bilski machine-or-transformation test
In In re Bilski, 545 F.3d 943 (Fed. Cir. 2008), which is currently under appeal to the U.S. Supreme Court, the Federal Circuit held that method claims must meet a “machine-or-transformation” test in order to be patentable. In other words, either 1) the claimed process or method is tied to a particular machine or apparatus, or 2) the method or process transforms a particular article into a different state or thing. Id. at 954.
The District Court found that Myriad’s diagnostic method claims did not satisfy the Bilski test. No machine or apparatus at issue, and, the District Court reasoned, the claimed acts of “comparing” and “analyzing” DNA sequences are “abstract mental processes,” not physical transformations. 2010 WL 1233416, at *48. The Court further held that the transformative acts of “isolating and sequencing DNA” should not be read into the language of the claims, even though they may be required to perform the claimed methods, because such preparatory acts were merely “data-gathering steps” to the DNA comparison or analysis. Id. at 49.
The District Court distinguished its decision from the Federal Circuit’s recent holding in Prometheus v. Mayo, 581 F.3d 1336, 1347 (2009), which held that method claims for optimizing the therapeutic efficacy of a drug treatment transformed the human body in a way that created physical and chemical changes in the assayed metabolites. See Ass’n for Molecular Pathology, 2010 WL 1233416, at 47-48.
One particular claimed method was directed toward “comparing the growth rate of cells “ in the presence or absence of a cancer therapeutic. The District Court declared that method claim invalid under section 101 because it covers a fundamental scientific principle and is not more than a “preparatory data-gathering step.” Id. at *50.
The Court did not address the plaintiffs’ constitutional claims
The plaintiffs’ attempt to use constitutional claims to invalidate the patent and bring in the USPTO as a defendant was novel. And even though the District Court considered those claims for purposes of denying the defendants’ motion to dismiss, it did not address those claims in its final opinion under the doctrine of constitutional avoidance. The District Court stated that it did not need to reach “unnecessary constitutional questions” in light of its decision to invalidate the patents under section 101. Id.
Myriad has publicly stated that it plans to appeal the District Court decision to the Federal Circuit, and the Supreme Court’s Bilski opinion, if published before the Federal Circuit decides this appeal, may affect the appellate decision in this case. Accordingly, the final impact of the District Court’s opinion in Ass’n for Molecular Pathology is unknown at this time.
However, with prudent drafting, patent practitioners in the biotechnology fields may be able to minimize the impact of this case on their claims. Biopharmaceutical products generally differ from products in nature, so this decision should not significantly impact those patents. However, regardless of the biotechnology field, practitioners should make a special effort to differentiate their claimed products from products of nature in the process of drafting.
Similarly, when drafting diagnostic method claims, practitioners should endeavor to include necessary transformation steps as central to the claimed method.
Ultimately, if Ass’n for Molecular Pathology is upheld on appeal, it may be more difficult for biotechnology companies to obtain patents on DNA claims, and a number of existing DNA-based patents may be called into question and ultimately invalidated. On the other hand, however, the opinion could result in an increased availability for genetic testing for cancer risks, which could in turn open up a significant competitive economic market.
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