|Odile Crick's |
of the double helix
The effect of the Prometheus ruling on the decision relating to isolated DNA patents was therefore limited. Although it was found as instructive regarding the scope of the law of nature exception and not limited to method claims, it was distinguished on the facts as relating to the patentability of subject matter directed to the correlation between mutation and cancer which would prevent the use by others of a law of nature. Unlike Prometheus, the claims to short isolated strands of DNA were at a lower level of abstraction. They were not directed to the correlation between the mutation and cancer but were a new tool that could be used to determine if that relationship exists. Further, the judgment did not overturn the directly analogous Funk Brothers or Chakrabarty. The Supreme Court in Chakrabarty was found to have drawn a line between unpatentable compositions that were similar to natural phenomenon even if arranged in useful combinations or used to exploit new properties and patentable compositions that had markedly different or distinctive characteristics due to human intervention. As such, even if the invention was based on nature, and resulted in a living organism, it may fall within the scope of section 101 if it was found to have a sufficiently different character or utility. The applicable principles were therefore interpreted as i) laws of nature/manifestations of nature are not patentable; ii) a composition of matter with markedly different characteristics from that found in nature with the potential for significant utility is directed to patentable subject matter.
Applying that flexible test and the wide scope of section 101 to the isolated DNAs, the challenged claims were drawn to patent-eligible subject matter because once cleaved from native chromosomal DNA, an isolated DNA was not a purified form of a natural material but a distinct chemical entity, isolated from its cellular and chromosomal environment. These were not found in nature but in labratories, where they are man-made, the product of human ingenuity (Circuit Judge Lourie at p. 39). Further, the ability to use isolated DNA molecules as the basis for diagnostic genetic testing was clearly an enlargement of the range of utility as compared to nature. The isolated DNAs of the present patents were therefore 'different from the natural products in “name, character and use.” Chakrabarty 447 U.S. at 309-10.11'.
Although concurring in part, Circuit Judge Bryson could not agree that the isolated DNA claims were patent-eligible. In light of Prometheus the proper approach required that the critical aspect of the molecules, the informational content, be given greater weight than the structural differences. In his opinion, the only change made to the genes from their natural state was incidental to the extraction and was not therefore material and worthy of patent protection. Just because the extraction was difficult did not justify the finding that the matter was a product of invention. Further, 'to argue that the isolated BRCA gene is patentable because in its native environment it is part of a much larger structure is no more persuasive than arguing that although an atom may not be patentable, a subatomic particle is patentable because it was previously part of a larger structure' (Circuit Judge Bryson's opinion at p. 11). He considered that if the majority's decision was sustained it was likely to have broad adverse effects on research and treatment.
However, Prometheus was more decisive in relation to the challenged method claims of i) comparing and analysing gene sequences and ii) screening potential cancer therapeutics via changes in cell growth rates of transformed cells. Such methods were indistinguishable from those considered by the Supreme Court. The first of comparing and analysing two gene sequences fell outside the scope of section 101 because they claimed only abstract mental processes, as in Prometheus. Limiting the comparison to just the BRCA genes or to the identification of particular alterations was not sufficient to render the claimed process patent-eligible. Nor could the extraction of DNA from a human sample and sequencing of the BRCA DNA molecule be read into the method claim as providing a transformative step of what was otherwise a claim to a natural law. Yet the second method of screening potential cancer therapeutics was found patent-eligible on the ground that the underlying transformed man-made nature of the subject matter made the method patent-eligible. The specific transformed cells were tied to to specific genes that were grown in the presence or absence of a specific type of therapeutic. As such, applying known types of procedures to it was not merely applying conventional steps to a law of nature.
Innovation and Settled Expectations
|Cat geneticist innovating the kitsch gene|
Secondly, the settled expectations of the biotechnology industry and the scientific community at large were not to be taken lightly. Crucial and valuable property rights related to DNA sequences founded on the longstanding and consistent policy of the legislature and PTO of authorising an expansive scope of patentable subject matter could not be destroyed because of the expansion of the judicial exception to patentable subject matter in Prometheus or because of the government's interpretation of the law (the government suggested that a magic microscope ('an invention in and of itself, although probably not patent-eligible', Circuit Judge Lourie at p. 41) metaphor guide section 101 analysis, which the court did not accept on the grounds that such an analysis fundamentally misunderstood the difference between science and invention);
'Holding isolated DNA not patentable would destroy long settled industry expectations for no reason other than a gut feeling that DNA is too close to nature to be patentable, an arbitrary decision based on a judge-made exception.' (Circuit Judge Moore's opinion at p. 22)Thirdly, the policy of protecting isolated DNA molecules supported innovation;
'Human DNA is, for better or worse, one of the old elements bequeathed to men to use in their work. The patents in this case revealed a new molecular understanding about ourselves...We cannot, after decades of patents and judicial precedent, now call human DNA fruit from the poisonous tree, and punish those inquisitive enough to investigate, isolate, and patent it.' (Circuit Judge Moore's opinion at p. 22-23)However, Circuit Judge Bryson interpreted the justifications from another perspective. 'Broad claims to genetic material present a significant obstacle to the next generation of innovation in genetic medicine — multiplex tests and whole-genome sequencing. New technologies are being developed to sequence many genes or even an entire human genome rapidly, but firms developing those technologies are encountering a thicket of patents' (Circuit Judge Bryson's opinion at p. 19). Further, and importantly in this Kat's opinion, the weight attached to the PTO's guidance and the underlying rationale relating to the expectations of the biotechnology industry were given too much weight:
'There is no collective right of adverse possession to intellectual property, and we should not create one.' (Circuit Judge Bryson's opinion at p. 21).
However, knowing so little about US patent law and genetics / chemistry/chemical genetics / chemogenomics / biochemical genetics, she wonders if any of the IPKat readers could (i) mews as to whether the case may have been decided differently if it had been brought on grounds of obviousness or (ii) provide an opinion as to whether the court was correct in stating 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'.
The IPKat hosts Suleman Ali's post on personalised medicine here.