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Tuesday, 4 September 2012

Patentability of Isolated DNA: A Myriad of Analogies

Odile Crick's
original illustration
of the double helix
It appears that the highly contentious issue of the patentability of human DNA can be the subject of many analogies. Last month's Federal Circuit judgment in Association for Molecular Pathology et al v PTO and Myriad Genetics contained no fewer than five comparisons: leaves on trees, magic microscopes, kidney removal, baseball bats and marble sculpture. Only one resulted in judicial consensus, and it wasn't on the grounds that there is no such thing as enchanted optical instruments.

The judgment is an important one, not only because it found that isolated DNA did not fall under the laws of nature exception, despite the United States Supreme Court's remand that the case be reconsidered in light of the enlarged scope of the exception in Mayo Collaborative Services v Prometheus Laboratories (see the IPKat here and here), but also due to its discussion of the incentives behind innovation and the reasons given for its strict adherence to the existing legal framework.

In An Isolated Gene Shell

Myriad is the exclusive licensee of patents regarding the genetic basis of BRCA related breast and ovarian cancers and provides BRCA diagnostic testing services to women. It is currently the only provider of commercial BRCA testing. The one plaintiff held to have standing, Dr. Ostrer, used to send patient samples to a rival clinical BRCA testing service provider but stopped following vigorous enforcement by Myriad of its intellectual property rights. The legal challenge related to the eligibility of Myriad's patent claims regarding isolated BRCA gene sequences, the diagnostic methods of identifying mutations in these sequences and the method of screening potential cancer therapeutics.

Very broadly, on a 2-1 majority the court decided that under 35 U.S.C section 101 (an unfortunately numbered provision in light of the contention) isolated human DNA molecules are patent eligible, while the methods for comparing gene sequences are not; the claimed molecules represent a non-naturally occurring composition of matter but the comparison and analysis of those molecules included only abstract mental processes and not transformative steps. If there was to be a change to the law, that was a matter for the legislature, and there was no need to alter the relevant principles in light of Prometheus, which had no bearing on the narrow issues on point.

Patent Eligibility, Not Patentability

The critical assessment was whether and to what degree the patent claims fell within the judicially created exceptions (laws of nature, natural phenomena and abstract ideas) to patent-eligible subject matter applicable to the expansively termed section 101. It was not about access to treatment, the desirability of exclusivity or whether the patent claims were novel, non-obvious or too broad. The question was whether isolated DNA molecules as compositions of matter, expressly authorised suitable patent eligible matter in section 101, were patent ineligible products of nature, as prohibited by case law. 'Patent eligibility, not patentability' as Circuit Judge Lourie put it at p. 37 of his opinion.

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

The rather strict adherence and technical approach taken by the majority to the legal framework in coming to its decision on the isolated DNA claims appeared to be justified on three policy grounds. First, the moral and ethical justifications for providing protective intellectual property status to matter which is a chemical entity conveying genetic information was not an issue to be decided by the courts. It was for the legislature to change the law and the established practise of the USPTO (United States Patent and Trademark Office) if it wished to treat isolated DNA differently from other compositions of matter to account for its perceived special function.

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).

Originally dubious as to the outcome of the case, this Kat was reminded not to judge a decision by its issues and finds herself rather disappointingly sitting on the fence. However what seems clear, albeit not explicit, is that a balancing exercise between the technical structure and substantive function within the context of policy considerations took place, with the majority falling on the side of a technical structure test. 

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.


Suleman said...

In response to point (ii) of the Kat's questions: information, use or function is not patentable per se, and so a product claim must relate to matter, and that is best described structurally in the case of patents.

The Court found a convincing way of justifying the 'patent eligibility' of claims to isolated DNA based on them being different from what is found in nature, but they must have also realised if they had decided isolated genes were not patentable due to their similarity to nature, then it would have been very difficult to then define how different something must be from nature for it to be patentable. A structure based novelty test over nature gives a lot of certainty, and I cannot see what other test could be used in this situation. Surely a workable information/use/function based test is not possible?

Tim Roberts said...

The USA seems to be the only country that has a specific rule that you can't patent a 'natural law'. Why is it necessary? Patents are for new processes or things. The exclusion is 19th century judge-made law, from the early days of the development of the jurisprudence. US patent law was codified by statute in the middle of the last century (35 USC). Why the Supreme Court assumed that this early dictum added something to the words of the current statute is a mystery. It is equally difficult to understand what they have decided it does add.

Kate Manning said...

I agree that the Court was convincing in its reasoning and the warning against deciding the issue on a 'gut feeling' resonated strongly. The determination of the genes function and exploitation certainly amounted to a technical contribution.

But perhaps the technical structure based novelty test isn't enough? Rather than attempting a workable function based test, perhaps the law of nature exception could be given more explicit technical elements?

Tim Roberts said...

'Respice finem'! What is the point of a 'law of Nature' exception? The Supreme Court (in Prometheus) don't seem to have given this much thought - they merely noted that there was one, and looked for some way of using it. They offered two justifications - it would not be sufficient simply to say - "Here is this law of Nature - apply it" (true, but 35USC stops this) ; and concerns that claims to 'laws of Nature' would unreasonably inhibit future research. Really this demonstrates the sad results that can follow when you have an appellate Court completely lacking in understanding of the system it is adjudicating on. Their lack of understanding is confirmed by their remand of 'Myriad'.

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