Swine Still Soaring: Federal Circuit Judge Expresses Sympathy for Myriad Analysis

Back in March, we headlined our discussion of the district court judgment in the Myriad case “Pigs Fly.” Guess what?—they’re still aloft. On August 4, in a highly technical patent case that, appropriately enough, involved “porcine virus DNA,” one Federal Circuit judge—dissenting Judge Timothy B. Dyk—suggested that he might agree with the basic principle of the Myriad holding: that isolated DNA sequences are not necessarily patentable.

Judge Dyk’s comments were a bolt out of the blue, as he raised an issue that had not been addressed by the parties or the lower court. Because he is a member of the court that will decide Myriad in the next year or so, Judge Dyk’s comments might be more significant than the district court opinion itself. (The case is Intervet Inc. v. Merial Ltd., Fed. Cir. 8/4/2010.)

Porcine Patents. Merial had a patent (U.S. Patent No. 6,368,601, also known as the ‘601 patent) covering DNA molecules derived from a new type of porcine circovirus (PCV-2), the apparent culprit in a disease affecting livestock pigs called Postweaning Multisystemic Wasting Syndrome. Intervet makes a PCV-2 vaccine. Fearing that it would be sued for infringing Merial’s patent, Intervet brought its own preemptive suit for a declaratory judgment (a kind of advance ruling) that its vaccine doesn’t infringe.

Claims 9 and 32 of the ‘601 patent represent the two groups of DNA claims at issue in the case:

9. A vector comprising an isolated DNA molecule comprising a sequence selected from the group consisting of ORFs [open reading frames—sequences that may be translated into proteins] 1 to 13 of porcine circovirus type II.

32. An isolated DNA molecule comprising a nucleotide sequence encoding an epitope which is specific to PCV-2 and not specific to PCV-1 [a related but benign porcine circovirus].

An epitope, as defined in the opinion, is “an immunodominant region of a protein, meaning it is part of an antigen that is recognized by antibodies of the immune system.” (Dyk, p. 2) This makes a segment of viral DNA that encodes an epitope useful in diagnosing and vaccinating against the pathogen, because the epitope can be introduced to the host animal’s immune system in a controlled fashion (e.g., as part of a vaccine) to stimulate production of antibodies. The idea is that the animal’s immune system will later recognize the epitope (and thus the virus) in the event of exposure.

The Federal Circuit’s majority opinion addressed the district court’s construction of claims 9 and 32. The five PCV-2 strains in the patent share 96% nucleotide sequence homology with each other but only 76% homology with PCV-1. The potentially infringing Intervet PCV-2 vaccine contained a nucleotide sequence that was 99.7% homologous to one of the ‘601 patent’s PCV-2 sequences, but the district court construed the claims to cover only the exact sequences disclosed in the patent and ruled that Intervet’s vaccine was therefore noninfringing.

The Federal Circuit found the district court’s claim construction to be too narrow because the “representative” sequences that Merial disclosed “do not constitute the entire scope of the invention.” Under Federal Circuit case law, a claim to a genus (a group of inventions) may be supported if “a sufficient number of species [i.e., individual examples] is disclosed so as to properly identify the scope of the genus.” (Prost, p. 9) Here, the five newly disclosed PCV-2 strains share the defining properties of pathogenicity and 96% sequence homology, in contrast with the “counterexample” of PCV-1, which has only 76% sequence homology and no pathogenicity. The majority remanded the case for further proceedings based on the revised claim construction.

Dyk’s Unexpected Dissent. Judge Dyk dissented from the majority’s construction of claim 9, and agreed with their handling of claim 32. (Dyk, p. 2) So far, just routine patent law inside baseball. But then came the shocker: “At least claim 32 of the ‘601 patent raises substantial issues of patentable subject matter.” In other words, “an isolated DNA comprising a nucleotide sequence encoding” a specified epitope might not be within the very broad scope of the things that the patent law was intended to cover. This is almost exactly what the District Judge Sweet held in Myriad.

Judge Dyk framed the essential question this way:

…whether the isolated DNA molecule, separate from any applications associated with the isolated nucleotide sequence (for example, the production of a vaccine) is patentable subject matter. (Dyk, p. 3, our emphasis)

He then made a point that patent lawyers won’t like to hear but which is absolutely true: “Neither the Supreme Court nor this court has directly decided the issue of the patentability of isolated DNA molecules.” (Dyk, p. 3) He cited a series of cases going back to the early 1990s in which the patentability of isolated DNA sequences had been assumed, but never framed as an issue for decision. So, in his view—an accurate view—while patent practice may support the proposition that isolated genes are patentable subject matter, no appellate court has ever so held.

Judge Dyk then discussed three Supreme Court cases that have reaffirmed the proposition that “‘laws of nature, physical phenomena, and abstract ideas’ are not patentable.” The most recent—the June 28 decision in Bislki v. Kappos—was a business method case concerned with laws of nature and abstract ideas. But the other two—Chakrabarty, from 1980, and Funk Bros. Seed, from 1948—represented claims on either side of the product of nature line. Chakrabarty held, famously, that a genetically engineered bacterium was a human-made invention and thus patentable subject matter. The long-forgotten invention in Funk Bros., a mixture of nitrogen-fixing bacteria that worked together without mutual inhibition, was merely the discovery of a product of nature and thus not patentable.

The standard that emerges from these cases, Judge Dyk concluded, is that “in order for a product of nature to satisfy section 101 [which determines patentable subject matter], it must be qualitatively different from the product occurring in nature, with ‘markedly different characteristics from any found in nature.’” (Dyk, p. 6, citing Charkabarty.) Turning—ominously, perhaps, for gene patent holders—to the issue at hand, he observed that “it is far from clear that an ‘isolated’ DNA sequence is qualitatively different from the product occurring in nature.” (Dyk, p. 6)

Anticipating Myriad. Judge Sweet, the Myriad district judge, expressed exactly the same doubt, and was unable to resolve it. He noted that patent lawyers had always—successfully, until now—contended that isolated genes were “markedly different” from their natural counterparts as chemicals. He held, however, that the proper focus was on genes as information, and from this perspective found no difference at all.

Judge Dyk did not get around to the chemical-information controversy, so we can only guess about his views. We now do know, however, that one member of the court that will decide the fate of gene patents is sympathetic to the general structure of Judge Sweet’s argument, and dubious about gene patents in general. Moreover, he went out of his way to say all this when he had no need to do so. To be fair, appellate courts have long taken the position that they can raise the issue of patentable subject matter on their own. But they rarely do so, which makes it an attention-getting strategy. And Judge Dyk has certainly gotten everyone’s attention.

A final point concerns the relationship between Judge Dyk’s opinion and the ACLU’s curious motion to force Federal Circuit Chief Judge Randall Rader to recuse himself from (refrain from participating in) the Myriad appeal because of some general comments he made at a patent law symposium. (We say “curious” because it has almost no chance of success and has the potential to irritate Judge Rader’s colleagues, if not Judge Rader himself.) While Judge Rader’s comments can hardly be construed as suggesting that he’s made up his mind on any issues relevant to the Myriad appeal, Judge Dyk’s gratuitous comments go pretty far in that direction. Will another recusal motion be forthcoming?

Allison Williams Dobson

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