On August 31, 2011, the Federal Circuit issued a precedential decision in Classen Immunotherapies, Inc. v. Biogen Idec (App. 2006-1643, -1649), a patent case of significant interest to the personalized medicine industry. As with the Prometheus case, this case addresses patent-eligibility of certain types of method claims. The Federal Circuit decided Classen on remand from the Supreme Court after Bilski v. Kappos (U.S. 2010). The Federal Circuit previously issued a first decision in Classen in 2008. The original panel, comprising Circuit Judges Newman and Moore and District Judge Farnan (sitting by designation), held in a one paragraph, non-precedential decision authored by Judge Moore that Classen’s claims failed to satisfy 35 USC § 101.

This time around, the Federal Circuit takes a closer look at Classen’s claims, and determines that two of the three Classen patents at issue are directed to patent-eligible subject matter under 35 USC § 101.

Judge Newman wrote the opinion for the court, joined by Chief Judge Rader. Chief Judge Rader also wrote a separate opinion to express “additional views,” which was joined by Judge Newman. Judge Moore wrote a dissenting opinion.

In a Foley Legal News Alert, my colleague Courtenay Brinckerhoff and I provide a brief summary and analysis of Classen, including aspects of the decision regarding § 101 and limitations on the infringement safe harbor provision under 35 USC § 271(e)(1).

Rather than reiterate what we say there, I will just follow up briefly by saying that certain aspects of the opinions by Judges Newman and Moore regarding patent-eligibility are quite interesting, as discussed below.

As we note in the Alert, with regard to the three patents at issue (U.S. Pat. No. 6,638,739; U.S. Pat. No. 6,420,139; and U.S. Pat. No 5,723,283) the court discusses two representative claims in its analysis. Claim 1 of the ‘739 patent, which represents claims in the ‘739 and ‘139 patents, recites:

1. A method of immunizing a mammalian subject which comprises:

(I) screening a plurality of immunization schedules . . . , by

(a) identifying [first and second patient populations that were immunized with] . . . infectious disease-causing organism-associated immunogens according to … [first and second immunization schedules] and

(b) comparing the effectiveness of said first and second screened immunization schedules in protecting against or inducing a chronic immune-mediated disorder …

(II) immunizing said subject according to a subject immunization schedule . . . [with] . . . lower risk . . . .

In addition, representative claim 1 of the ‘283 patent recites:

1. A method of determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder . . . which comprises immunizing mammals . . . and comparing the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder, in the treatment group, with that in the control group.

Judge Newman’s Majority Opinion Regarding § 101

Judge Newman, in her majority opinion, determines that claims in the ‘739 and ‘139 patents recite patent-eligible subject matter, but claims in the ‘283 patent do not.

Aspects of her opinion may be somewhat enlightening to those drafting diagnostic method claims. In her opinion, Judge Newman refers to the statutory role of §101 as a “‘coarse eligibility filter,’ not the final arbiter of patentability,” which is determined by other statutory requirements, such as §§ 102, 103, and 112. When considering §101, she notes that the “distinction between a concrete, physical step of a process claim, as compared with data gathering or insignificant extra-solution activity, warrants specific consideration in the context of evolving technologies,” a point relevant to personalized medicine.

Regarding claims of the ’139 and ’739 patents, Judge Newman states that they “are directed to a method of lowering the risk of chronic immune-mediated disorder, including the physical step of immunization on the determined schedule.” She concludes these claims are directed to “a specific, tangible application,” as described in Research Corp. Techs., Inc. v. Microsoft Corp., 627 F.3d 859 (Fed. Cir. 2010).

Regarding claims of the ‘283 patent, on the other hand, she states that these claims stand “in contrast to the ’139 and ’739 patent claims, which include the subsequent step of immunization on an optimum schedule.” She suggests that the ‘283 patent merely “states the idea of collecting and comparing known information.” She also opines that the “representative claim of the ’283 patent is directed to the single step of reviewing the effects of known immunization schedules, as shown in the relevant literature.” I’m not sure I agree with this particular claim construction, namely because claim 1 of the ‘283 patent expressly recites an immunizing step. Judge Moore likewise points out in footnote 1 of her dissenting opinion that she is “perplexed” by Judge Newman’s suggestion in this regard. Judge Newman further says that “‘immunizing’ in the ’283 patent refers to the gathering of published data, while the immunizing of the ’139 and ’739 patent claims is the physical implementation of the mental step claimed in the ’283 patent.” Again, I am I not sure how one can interpret an immunizing step as data gathering in any of the claims.

That said, I believe Judge Newman raises a notable distinction between claims in the ‘283 patent and those in the ’139 and ’739 patents. Namely, claim 1 in the ‘283 patent recites a physical step of immunizing and then the step of “comparing,” i.e., a mental or data gathering step. Thus, this claim does not require any physical action after “comparing.” Nor does it require any data gathering step (or any other step) before the physical action step. Claim 1 of the ’283 patent “claims the idea of comparing known immunization results … but does not require using this information for immunization purposes.”

By contrast, one following the’139 and ’739 patents claims first obtains information (data gathers) and then applies that information when performing a subsequent physical step, i.e., immunizing a subject. As such, one can see a possible rationale for asserting that the ’139 and ’739 patents claims are directed to “a specific, tangible application,” while claim 1 of the ‘283 patent does not apply information obtained in the mental/data gathering step to anything.

In Prometheus, as noted by Judge Newman, the court stated that “methods of treatment . . . are always transformative when one of a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition.” (See June 1 post for a discussion of the court’s previous treatment of diagnostic method claims). In the current decision, Judge Newman distinguished claims in the two cases by saying that “the claims in Prometheus are for a method of controlling individualized dosages of a specific drug by measuring its metabolic products in the blood of individual patients, while the Classen patents operate on published information to determine general immunization schedules.” It mattered to Judge Newman that claim 1 of the ‘283 patent did not include immunizing in light of gathered information, i.e., putting knowledge to practical use.

Judge Moore’s Dissent Regarding § 101

In her dissent as it relates to patent-eligibility, Judge Moore notes that none of the Classen claims are “directed to any specific treatment steps or drugs [or schedules to be used] or even any specific chronic immune disorder.” She sees no distinction between any claims at issue that warrants treating them differently. Citing Bilski, she states that “Classen cannot escape the fundamental abstractness of his claims by limiting them to a single field of use – immunization.” She believes that the majority does not “consider how these staggeringly broad claims will preempt the entire immunization field from considering any two schedules prior to immunizing any patient with any drug – clearly a sweepingly broad principle.” On the whole, she finds that the “single physical immunization step” cannot make “this principle patentable subject matter.”

Classen Decision May Resolve Some Questions, At Least For Now

In short, as discussed in our Alert, the Federal Circuit in Classen may provide some useful guidance when drafting method claims that involve some type of information gathering. It appears that if the claims recite a step of “putting this knowledge to practical use,” such as an active treatment step based on obtained information, they are likely to be patent-eligible under 35 USC § 101. On the other hand, if the claimed methods culminate in obtaining information, and nothing more, they may be vulnerable to challenge under 35 USC § 101.

Keep in mind, however, that the Supreme Court is considering Prometheus right now, and may decide to go in a different direction. At least the Justices will have the benefit of certain Federal Circuit judges’ viewpoints beforehand. Stay tuned.