Wednesday, September 7, 2011

The Rule Against Abstract Claims in the Federal Circuit post-Bilski

Classen Immunotherapies, Inc. v. Biogen Idec (Fed. Cir. 31 Aug 2011)

As the Federal Courts have been quiet recently, I thought I’d take the opportunity to comment on the decision of the US Federal Circuit in Classen Immunotherapies, remanded to the CAFC by the USSC for reconsideration in light of Bilski. Classen is very interesting for two reasons: it is a rare instance of the correct application of the rule against abstract claims to hold a claim invalid; and it provides contrasting interpretations of Bilski in the majority dissenting opinions.

The three patents at issue where based on the purported discovery that early immunization reduces the risk of immune-mediated diseases, including eg diabetes. The district court had granted summary judgment that all of the claims in the patents were invalid as being directed to an abstract idea. Two of the patents claimed a method of comparing two immunization schedules, choosing the one with lower risk, and immunizing according to the lower risk schedule: see claim 1 of the ‘739 patent. The third ‘283 patent claimed a method of determining whether an immunization schedule affects the risk of immune-mediated disease by comparing the incidence of such diseases in two groups of mammals treated with different immunization schedules. Thus both types of claim were based on the discovery that the immunization schedule affects the risk of immune-mediated disease, but the first type of claim included the step of actually immunizing a patient according to the preferred schedule.

On remand, the majority in the Federal Circuit, Newman J for herself and Rader CJ, held the claims ofthe '739 patent, which including the immunization step, to be patentable subject matter, while the claims of the ‘283 patent were invalid as claiming an abstract principle. The classic Canadian statement of the rule against claiming an abstract principle is found in Shell Oil [1982] 2 SCR 536: “A disembodied idea is not per se patentable. But it will be patentable if it has a method of practical application” In my recently published article on “The Rule Against Abstract Claims: History and Principles” 26(2) CIPR 205 (not yet available on the IPIC website, pre-publication draft here), I note that while the rule has been established for over 200 years, it is quite difficult to find a case that actually applies this rule to invalidate a claim. The leading cases – Hornblower v Boulton (1799), 101 ER 1285, Hickton’s Patent (1909), 26 RPC 339 (CA), NRDC [1959] HCA 67 and Shell Oil – all uphold the validity of the patent, applying the positive aspect of the rule, that a idea is patentable if it has a method of practical application, rather than the negative corollary that an abstract idea per se is unpatentbale. Classen is interesting because, in my view, the majority decision is consistent with Canadian law in both the holding that the ‘739 claims are patentable – "it will be patentable if it has a method of practical application" –  and the holding that the ‘283 claims are not – "[a] disembodied idea is not per se patentable."

The point made by the majority in holding the ‘239 claims invalid is that there is a distinction between using the information disclosed by the patent, and practising the method of the patent. By claiming a “method” of determining which schedule is lower risk, the patentee would have monopolized the use of the information itself, not just its application:

Classen’s position in the district court appears to have been that the Classen claims are infringed if the subject thereof is the subject of study, analysis, verification, or other scientific inquiry. As the district court remarked, Classen’s view of its claims appears to have been that they covered “thinking” about their subject matter. That is, of course, incorrect. The information in patents is added to the store of knowledge with the publication/issuance of the patent. An important purpose of the system of patents is to negate secrecy, and to provide otherwise unknown knowledge to the interested public. . . In turn, the subject matter of patents may be investigated and verified and elaborated; the technological/scientific contribution to knowledge is not insulated from analysis, study, and experimentation for the twenty years until patent expiration. (slip op at 30)

It is important to recognize that this is not equivalent to the preemption argument often invoked by the US Supreme Court in subject matter cases: see Bilski 130 S Ct 3218 at 3270, quoting Benson 409 US 63 at 70-71. The preemption argument invoked by the USSC complains that the effect of the patent is a practical monopoly on the idea disclosed in the patent. The majority in Classen did not object to claims which monopolize all practical applications of the information: “A pioneering invention, that meets the substantive criteria of patentability, may indeed warrant broad scope. Breadth does not negative patent eligibility, although it may not meet the conditions of patentability” (slip op at 31). It is monopolization of the information itself that is objectionable. This is consistent with the standard Canadian position, that a patent may preempt all practical applications of an idea, so long as the patentee’s inventive contribution lies in the idea itself: see Fox 4th ed at 29.

In my article on the principles of the rule against abstract claims, I suggested that there are three rationales that might support the negative aspect of the rule, though it is difficult to determine which rationale is best supported by the case-law, simply because there is so little case-law actually applying the negative corollary. I must admit that while I find the majority conclusion in Classen to be compelling, it is not clear to me which, if any, of my proposed rationales explains that result. This makes the case all the more thought-provoking.

The other interesting aspect of Classen is the CAFC’s treatment of Bilski. In a forthcoming article in the CIPR, “The Rule Against Abstract Claims: A Critical Perspective on US Jurisprudence” (draft here), I argue that the USSC has systematically mis-interpreted the rule against abstract claims, wrongly using it in an attempt to impose field-specific restrictions. The CAFC has traditionally responded by selectively interpreting the ambiguous aspects of the USSC decisions in order to return to an orthodox position consistent with that expressed by the SCC in Shell Oil. This is particularly evident in the CAFC response to the trilogy of USSC decisions on computer-related inventions (see my paper for a more detailed discussion). The majority in Classen is adopting the same strategy with respect to Bilski. While Bilski’s scattered reasoning generally affirmed a variety of what I would call mis-understandings of the rule against abstract claims that were set out in prior USSC decisions, the very incoherence of the decision allowed the Classen majority to interpret the decision according to a more orthodox view of that rule. The decision of Moore J in dissent is more consistent with the spirit of the Bilski decision, in expressing a general dismay at the breadth of the claims (slip op 6-7), and relying both on preemption (8-9), in the typical USSC mode, as referring to practical preemption, not merely preemption of information, to hold the claims invalid.

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