Thursday, August 5, 2010

Intervet v. Merial Limited: Judge Dyk Offers His Views on Patent Eligibilty of Isolated DNA Sequences

A dissenting opinion by Judge Dyk in Intervet v. Merial Limited, decided by the Federal Circuit on August 4, contains interesting ruminations on the patent eligibility of patent claims broadly reciting an isolated, naturally occurring genetic sequence, indicating that at least this Federal Circuit judge is not at all convinced that isolation of a naturally occurring DNA sequence is sufficient to render it patent eligible. The patent eligibility of isolated naturally occurring DNA sequences is one of the key issues at stake in AMP v. USPTO, the ACLU/PubPat challenge to Myriad’s BRCA gene patents, discussed in earlier posts. In AMP, the district court agreed with the ACLU that a product of nature, such as a gene, can only be patent eligible if it has been transformed by human intervention to an extent that confers upon the product "markedly different characteristics from any found in nature,” and that the mere isolation of a gene does not result in the requisite qualitative difference in characteristics. Based on this determination, the court ruled that Myriad’s claims to isolated DNA corresponding in sequence to naturally occurring BRCA sequences were patent ineligible and thus invalid.

Significantly, the question of patent eligibility was not before the court in Intervet. The only issues on appeal to the Federal Circuit related to the district court's interpretation of the claim language and judgment of noninfringement. Judge Dyk, however, in his opinion concurring-in-part and dissenting-in-part with the majority, goes out of his way to point out that the validity of the claims was not before the court on appeal, and to make clear that the court’s decision to construe the claims should not be inferred as implying that the claims are patent eligible.

Judge Dyk acknowledges that the Federal Circuit has upheld the validity of gene patents on a number of occasions, but correctly points out that none of these cases directly address the question of whether the claims satisfy the patent eligibility requirements of section 101. Implicitly, he is suggesting that if the issue of patent eligibility had been raised with respect to gene patent, the Federal Circuit might have ruled that isolation of a naturally occurring DNA sequence does not render it patent eligible.

He goes on to note that "it appears that in order for a product of nature to satisfy section 101, it must be qualitatively different from the product occurring in nature, with "markedly different characteristics from any found in nature," based on his reading of relevant Supreme Court precedent such as Chakrabarty and Funk Brothers. He then concludes that

It is far from clear that an ‘isolated’ DNA sequence is qualitatively different from the product occurring in nature such that it would pass the test laid out in Funk Brothers and Chakrabarty. The mere fact that such a DNA molecule does not occur in isolated form in nature does not, by itself, answer the question. It would be difficult to argue, for instance, that one could patent the leaves of the plant merely because the leaves do not occur in nature in the isolated form.

Clearly the Judge's discussion of the patent eligibility of isolated DNA was prompted by the ACLU gene patent challenge. The validity of the claims at issue in Intervet was never addressed by the district court, and was not at issue in the appeal, let alone patent eligibility. The Federal Circuit has decided numerous cases involving isolated DNA sequences, and to my knowledge has never directly addressed the issue of patent eligibility for isolated, naturally occurring DNA sequences.

However, in 1991 a panel of the Federal Circuit did address the highly pertinent question of whether an isolated naturally occurring protein is patent eligible, and seemed to acquiesce. The case, Scripp’s Clinic v. Genentech, involved the alleged infringement of a Scripps patent claiming isolated Factor VIII:C protein. The defendant, Genentech, never challenged the patent eligibility of isolated naturally occurring protein, not surprising since this position would be entirely inconsistent with its own patenting of isolated proteins and DNA sequences. However, the district court decision included a footnote 6 explicitly concluding that a purified protein is patent eligible under section 101, citing Funk Brothers and In re Bergstrom:

There is no dispute over the patentability of a Factor VIII:C preparation. Although Factor VIII:C molecules occur in nature, a purified and concentrated preparation of Factor VIII:C as claimed in the patent constitutes a new form or combination not existing in nature, and hence is patentable under 35 U.S.C. § 101. See Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 68 S.Ct. 440, 92 L.Ed. 588 (1948); In re Bergstrom, 427 F.2d 1394, 1401 (C.C.P.A.1970).” Scripp’s Clinic v. Genentech, 666 F.Supp. 1379 (1987).

On appeal, the Federal Circuit in Scripp's did not affirmatively state that a purified protein is patent eligible, but merely noted that "judicial attention has on occasion focused on the patentability of claims in this context, see, e.g., In re Bergstrom, 427 F.2d 1394, 166 USPQ 256 (CCPA 1970)," and that Genentech had conceded that the claims were patent eligible. Scripp’s Clinic v. Genentech, 927 F.2d 1565, 1580-81 (Fed. Cir. 1991).

Significantly, the pre-Federal Circuit cases cited in support of the proposition that an isolated naturally occurring biomolecule is patent eligible do not specifically address the issue of patent eligibility under section 101, but are instead based on arguments based on alleged lack of novelty or obviousness, as discussed in a previous post.

In essence, the district court in Scripp’s inferred that because earlier decisions had upheld the patentability of claims to isolated biological molecules, they must be patent eligible. On appeal, the Federal Circuit in Scripp’s simply accepted the patent eligibility of the isolated protein, arguably implicitly accepting the patent eligibility of this sort of invention. I think Judge Dyk raise the issue in Intervet in order to go on record that the Federal Circuit addressed questions of claim construction and infringement should not be taken as tacit endorsement of patent eligibility for isolated biomolecules, an issue that the court will likely address head-on in the appeal of the ACLU lawsuit.

With so many gene patents, and patents claiming naturally occurring proteins and other biomolecules, and so much litigation involving these patents, why has the issue of patent eligibility never been directly addressed before? One explanation is that until the ACLU got involved, the parties to patent litigation have never had an interest in having these sorts of claims found to be patent eligible. Normally, the party arguing that a gene or protein patent claim is invalid is either a biotechnology company, like Genentech, or the patent office in cases like Bell or Deuel , where in a patent applicant is appealing the rejection of a gene patent claim. Biotechnology companies rely heavily on these patents themselves, and the patent office has concluded that isolated DNA and other molecules is patent eligible.

Gene chip company Affymetrix has argued in amicus briefs that isolated genes are patent ineligible, but they have never been sued for infringement of a gene patent, so have never had the opportunity to raise the issue as a party to litigation. The ACLU case is unique in that you have plaintiffs who do not own gene patents, but to the contrary would like to eliminate them.

The fact that Judge Dyk chose to express his thoughts in this manner is somewhat ironic in view of the recent controversy over statements made by Judge Rader at conferences relating to gene patents. The ACLU has moved to have Judge Rader recuse himself from sitting on a panel to decide the ACLU case, based on the ACLU’s assertion that Judge Rader's statements indicate that he believes that isolated DNA sequences appear to be patentable. (Discussed here, for example) Arguably, Judge Dyk has expressed the opposite view, albeit in the form of a formal opinion rather than as a conference speaker.

Judge Dyk speculates that "it is far from clear" that isolated DNA is qualitatively different from the corresponding DNA as it occurs in nature, i.e., having markedly different characteristics from naturally occurring DNA. However, I would point out that the biotechnology revolution has been based in large part on the ability to isolate and manipulate DNA. Biologic drugs such as recombinant human erythropoietin, for example, were only made possible because scientists succeeded in isolating the erythropoietin gene.

Biotechnology is fundamentally based on the ability to do amazing things with isolated genes that cannot be accomplished with the corresponding gene as it exists in the human body. In my view, even if the Federal Circuit decides that an isolated biomolecule is only patent eligible if it has markedly different characteristics from naturally occurring counterpart, isolated DNA sequences (along with isolated forms of proteins and other biomolecules) should clearly satisfy the test.