In a lengthy opinion released yesterday in Assoc. for Molec. Pathology v. USPTO, __F.Supp.2d___(S.D. N.Y.) (PDF below), the court invalidated claims directed to isolated DNA sequences, as well as to cancer screening methods using them, and even to methods of screening potential anti-cancer compounds using them. Although the Judge stated that his opinion was limited to DNA sequences, it is difficult not to extrapolate his reasoning to many heretofore patentable chemical compounds that are obtained by purification from natural sources, including body tissues, fluids, cells and the like. For background on this lawsuit, including representative claims and patents, please refer to my post of May 18, 2009, archived under “Patentable Subject Matter.”
After construing the DNA claims to cover “real and tangible molecules of deoxynucleotides linked by a phosphodiester backbone” that are “substantially separated from cellular components which naturally accompany a gene [including the rest of the chromosomal DNA],” the Judge’s reasoning took an interesting turn. The opinion contains an extensive review of the older case law, such as Funk Bros. Seed Co. v. Kalo, and again and again, the Judge carved off what he viewed as findings of novelty for s. 102 examination and subject matter that might be “new” for s. 101 but was still an unpatentable “product of nature.”
The Judge stated and restated the rationale of the decision: “Considerations of novelty are irrelevant for s. 101 purposes.… Products of nature do not constitute patentable subject matter absent a change that results in creation of a fundamentally new product.” To patent a substance arguably present in “the jungle of nature” – my term, or is it from Bergy? – the claimed composition must be “a product of human ingenuity ‘having a distinctive name, character [and] use.’” [citing Chakrabarty]. Separating absolute novelty from fundamental newness permitted the Judge to distinguish, and ignore, the well-known opinion by Judge Learned Hand in Parke-Davis (189 F.2d 95) which found purified adrenaline to be patentable in view of earlier less-pure adrenal gland extracts that were marginally medically useful. Likewise, In re Bergstrom (PGE3 claim) was ignored as a decision turning on the issue of inherent anticipation, not patentable subject matter. Because he limited his opinion to attempts to claim DNA, the Judge ignored In re Bergy, which permitted applicant to patent cultured pure strain microorganisms useful to make antibiotics.
Simple purification and isolation is not enough, per se. Citing In re Merz, 97 F.Supp. 599 (CCPA 1935), the Judge found that “Purification of known materials does not result in a patentable product” unless “the product obtained in such a case had properties and characteristics which were different in kind from those of the known product rather than in degree.” Turning to the “isolated and purified DNA” claims, the Judge found that alteration in the essential characteristic of the DNA – the sequence of nucleotides – had not taken place, so that the claimed DNA was not “markedly different from DNA as it exists in nature. “ He brushed aside Myriad’s assertions that the isolated DNA molecules were useful for applications that could not be carried out using the natural material, since he found the preservation of the natural DNA sequence of premier importance, rather than the undisputable structural differences between these relatively small molecules and the chromosomal DNA from which they were isolated.
The assay claims and the screening claims were invalidated primarily as made up of mental steps that were not transformative, unlike the administering and determining steps in the Fed. Cir.’s recent Prometheus decision. The Judge dismissed the Constitutional claims against the PTO as not necessary to decide the case.
Of course, this will go to the Federal Circuit for review, and likely to the Supreme Court. Hal Wegner has written that Myriad should have read the older case law more closely, particularly FunK Bros. which was not decided on “product of nature” grounds. Regarding claiming isolated and purified DNA sequences, appellees and their allies should consider that the Federal Circuit has implicitly approved of this type of claiming for at least 20 years. In 1994, I wrote the following for an AIPLA “Roadshow”:
However, anyone attempting to patent a DNA sequence still faces the potential ‘natural product’ rejections such as those discussed above [inter alia Funk Bros.]. Luckily, for the patent attorney and his clients, the Fed. Cir. has issued two rulings which implicitly approved the language which the applicants employed to bring DNA ‘out of the jungle.’ In the Amgen v Chugai decision (18 USPQ2d 1016 (Fed. Cir. 1991)) claim 2 was found to be valid:
‘(2) A purified an isolated DNA sequence consisting essentially of a DNA sequence encoding erythropoietin.’ [Lin, U.S. Pat. No. 4703008].
In Fiers v. Sugano, 25 USPQ2d 1601 (Fed. Cir. 1993), both the Patent Office and the court started with an assumption of the allowability of this ‘count’:
‘A DNA which consists of DNA which codes for a human fibroblast interferon-beta polypeptide.’
Let’s hope that our “luck” in patenting biomolecules has not run out.