On August 31, 2011, the Federal Circuit issued its second decision in Classen Immunotherapies, Inc. v. Biogen Idec, which was on remand from the Supreme Court after Bilski v. Kappos. Judge Newman wrote the opinion for the court, which was joined by Chief Judge Rader, and holds that two of the three asserted patents recite patent-eligible subject matter under 35 USC § 101.  The court also finds that the “safe harbor” of 35 USC § 271(e)(1) only applies in the context of obtaining pre-marketing regulatory approval, and so did not prevent some of Classen’s infringement claims relating to studies of already-approved vaccines. While this decision raises some questions as it answers others, the Federal Circuit provides useful guidance for evaluating the patent-eligibility of method claims that involve some type of information gathering.

There is much in the Classen opinions that warrants further analysis and commentary, but for now I provide this synopsis of the main points.

Procedural Background

Classen asserted three patents against Biogen Idec and other defendants who participated in studies evaluating the risks associated with different vaccination schedules. The district court granted motions for summary judgment that the claims were invalid under 35 USC § 101 and not infringed because the allegedly infringing activities were sheltered by the “safe harbor” of 35 USC § 271(e).

The Federal Circuit first decided Classen’s appeal in 2008, when a panel comprised of Circuit Judges Newman and Moore and District Judge Farnan (sitting by designation) held in a one paragraph, non-precedential decision authored by Judge Moore that Classen’s claims do not satisfy 35 USC § 101. Classen sought and was granted certiorari by the Supreme Court, but the Court vacated and remanded to the Federal Circuit shortly after it issued its decision in Bilski v. Kappos.

The Claims At Issue

The three Classen patents at issue (U.S. 6,638,739; U.S. 6,420,139; and U.S. 5,723,283) are based on Dr. Classen’s discovery that the particular schedule of infant immunization for infectious diseases can affect the later occurrence of chronic immune-mediated disorders such as diabetes, asthma, hay fever, cancer, multiple sclerosis, and schizophrenia. The patents collectively include 230 claims, and Classen designated two representative claims for the district court’s analysis.

Claim 1 of the ‘739 patent was designated as representative of the claims of both the ‘739 patent and the ‘139 patent, and 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 . . . .

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.

The Patent Eligibility Issue

The Federal Circuit opinion reviews the language of 35 USC § 101 and Supreme Court decisions leading up to Bilski. The court indicates that §101 is generally regarded as a low hurdle, and emphasizes that other statutory requirements, such as § 102, § 103, and § 112, place more meaningful limits on patentability.

Turning to the district court decision, the Federal Circuit notes that while the district court had invalidated the claims for including mental steps, “the presence of a mental step is not of itself fatal to § 101 eligibility.” Indeed, “the claims must be considered as a whole when determining eligibility.” Citing its 2010 decision in Research Corporation Technologies, Inc. v. Microsoft Corp., the Federal Circuit explains that, when applying § 101, it is important to consider where the claimed methods fall on “the continuum from abstractness to specificity.”

Turning to the claims at issue, the Federal Circuit finds that the ‘139 and ‘739 patents are directed to “a method of lowering the risk of chronic immune-mediated disorder,” and so “are directed to a specific, tangible application.” The court therefore holds that the claims of these patents pass through the “coarse eligibility filter of § 101.” On the other hand, the court is careful to leave the door open for invalidation on other grounds, such as prior art.

The Federal Circuit reaches a different conclusion on the claims of the ‘283 patent, finding that they are not patent-eligible under 35 USC § 101. The court characterizes the ‘283 patent claims as relating to “methods of ‘determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder,’ by reviewing information on whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder.” The Federal Circuit distinguishes these claims from those of the ‘139 and ‘739 patents on the ground that the other claims “include the subsequent step of immunization on an optimum schedule,” i.e., a specific application and practical use of the obtained knowledge.

The court explains

methods that simply collect and compare data, without applying the data in a step of the overall method, may fail the § 101 filter.

Thus, important to the court’s determination that the ‘283 patent does not satisfy § 101 is the fact that the claims do not put the knowledge gained from the “comparing” step into “practical use.”

The Federal Circuit also addresses Classen’s arguments that all claims satisfy the machine-or-transformation test, because they are akin to methods of treatment that the Federal Circuit held “are always transformative” in its decisions in Prometheus Laboratories, Inc. v. Mayo Collaborative Services. The Federal Circuit distances itself from this broad language, citing the “materially different facts in Prometheus,” where the claims were directed to “a method of controlling individualized dosages of a specific drug by measuring its metabolic products in the blood of individual patients.” The Federal Circuit again draws a line between “the Classen claims that include such transformative steps” and those “that require no more than referring to known information.”

The Safe Harbor Issue

Classen had alleged that Biogen Idec and GlaxoSmithKline directly infringed the patents by participating in studies “to evaluate suggested associations between childhood vaccinations, particularly against hepatitis B and Haemophilus influenza . . . and risk of developing type 1 diabetes; and to determine whether timing of vaccination influences risk.” The district court granted summary judgment of non-infringement on the ground that these activities were sheltered by the safe harbor of 35 USC § 271(e)(1), which excludes from infringement activities that are “solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.”

Classen argued that the statute “is limited to activities conducted to obtain pre-marketing approval of generic counterparts of patented inventions,” and so does not apply to the accused post-approval activities relating to vaccines that already had been approved. GlaxoSmithKline and Biogen Idec argued that their studies were in conformity with FDA regulations, and so fell under the safe-harbor.

The Federal Circuit considers the legislative history and judicial treatment of § 271(e)(1), and finds that both support the proposition that

§ 271(e)(1) is directed to premarketing approval of generic counterparts before patent expiration.

The court therefore concludes that the district court had erred when it determined that § 271(e)(1) sheltered the post-approval activities of Biogen Idec and GlaxoSmithKline “in providing vaccines, in advising on immunization schedules, and in reporting any adverse vaccine effects to the FDA.”

The Federal Circuit therefore reversed the district court’s judgment of patent-ineligibility of the claims of the ’139 and ’739 patents, affirmed the district court’s judgment of patent-ineligibility of the claims of the ’283 patent, affirmed the district court’s judgment of non-infringement by Merck, and vacated the district court’s judgment of non-infringement by Biogen and GlaxoSmithKline under § 271(e)(1). The court remanded the case to the district court “for appropriate further proceedings.”

Chief Judge Rader’s Additional Views

Chief Judge Rader joined Judge Newman’s opinion for the court, but also wrote separately to provide “additional views” highlighting public policy considerations and the real world impact of the “rising number of challenges” under 35 USC § 101 in recent years. Chief Judge Rader argues that “eligibility restrictions” usually are subject to “evasion” by “a healthy dose of claim-drafting ingenuity” and so do little more than drive up the “cost and complexity of the patent system,” which “may cause technology research to shift to countries where protection is not so difficult or expensive.” Overall, he cautions judges (and presumably Supreme Court Justices) to “tread carefully” when imposing new limits on patent-eligibility.

Judge Moore’s Dissent

Judge Moore dissented from the court’s opinion on all issues. She would have affirmed the district court’s judgment that none of the Classen claims satisfy 35 USC § 101, and agreed with the district court’s interpretation of the scope of the safe harbor statute.

Regarding 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.”

Regarding the safe harbor, Judge Moore believes that the panel opinion “is contrary to the plain language of the statute,” which does not limit its reach to “pre-approval uses.” Judge Moore is not convinced that the context of earlier cases addressing the safe harbor support restricting its scope, where those same case acknowledge the breadth of the statutory language.

Federal Circuit Provides Useful Guidance

This decision resolves some of the questions that have been hanging over the patent-eligibility of personalize medicine method claims since the Federal Circuit issued its first Classen decision in 2008. It has been difficult to reconcile the court’s short decision finding the Classen claims invalid under § 101 with the rationale that the court developed and applied when it upheld the claims in Prometheus.

Here, the Federal Circuit has provided useful guidance for 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 the 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. The trick will be to draft patent-eligible “information gathering”-plus-treatment claims that have a single infringer.

Patent holders who are concerned about the continued validity of granted claims in view of this decision can consider filing a reissue application. This strategy may be particularly attractive in view of the recent Federal Circuit decision in In Re Tanaka, which held that a reissue application can be filed for the sole purpose of adding a dependent claim, and the USPTO’s recent adaptation of its practices to that decision.