By Kevin E. Noonan --
Today, the Federal Circuit revisited the patent-eligibility of claims directed to methods for optimizing childhood immunization, in Classen Immunotherapies, Inc. v. Biogen IDEC. The Federal Circuit's original opinion, handed down in December 2008, was vacated by the Supreme Court in view of that Court's decision in Bilski v. Kappos, and remanded to the Federal Circuit for reconsideration in view of the Supreme Court's instructions on the proper standard to be applied to determine patent-eligibility for method claims.
Today's decision could not be more different from the Federal Circuit's earlier decision. That decision, in its entirety, was as follows:
In light of our decision in In re Bilski, 545 F.3d 943 (Fed. Cir. 2008) (en banc), we affirm the district court's grant of summary judgment that these claims are invalid under 35 U.S.C. § 101. Dr. Classen's claims are neither "tied to a particular machine or apparatus" nor do they "transform a particular article into a different state or thing." Bilski, 545 F.3d at 954. Therefore we affirm.
That decision was written by Judge Moore, joined by Judge Newman (who dissented in the Court's en banc In re Bilski decision) and District Court Judge Joseph Farnan, sitting by designation. Today's opinion was written by Judge Newman, joined by Chief Judge Rader, and Judge Moore penned a furious dissent. In addition, Judge Rader wrote an opinion containing "additional views" regarding challenges to patent validity sounding in § 101. The Court in its opinion also addressed not only the § 101 issues raised by the parties but also the denial of summary judgment of invalidity for anticipation and the District Court's determination that the activities of several co-defendants were within the "safe harbor" provisions of 35 U.S.C. § 271(e)(1). In view of the complexities of these opinions, this post is limited to the majority opinion; future posts will consider Judge Moore's dissent and Chief Judge Rader's "additional views," which are directed to policy implications of § 101 challenges to patent eligibility.
There are three patents in suit: U.S. Patent Nos. 5,723,283, 6,420,139, and 6,638,739; these patents contain a total of 230 claims asserted in the lawsuit. Plaintiff designated certain claims as "representative claims," and the panel opinion made its determination on these claims. The majority opinion draws a distinction between the claims of the '283 patent (which it found were not patent-eligible under § 101) and the claims of the '139 and '739 patents (which the majority found to be patent-eligible). Claim 1 of the '283 patent can be compared to claim 1 of the '739 patent to illustrate the differences in the claims:
The '283 patent claim:
A method of determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder in a treatment group of mammals, relative to a control group of mammals, which comprises immunizing mammals in the treatment group of mammals with one or more doses of one or more immunogens, according to said immunization schedule, 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 '739 patent claim:
1. A method of immunizing a mammalian subject which comprises:
(I) screening a plurality of immunization schedules, by
(a) identifying a first group of mammals and at least a second group of mammals, said mammals being of the same species, the first group of mammals having been immunized with one or more doses of one or more infectious disease-causing organism-associated immunogens according to a first screened immunization schedule, and the second group of mammals having been immunized with one or more doses of one or more infectious disease-causing organism-associated immunogens according to a second screened immunization schedule, each group of mammals having been immunized according to a different immunization schedule, and
(b) comparing the effectiveness of said first and second screened immunization schedules in protecting against or inducing a chronic immune-mediated disorder in said first and second groups, as a result of which one of said screened immunization schedules may be identified as a lower risk screened immunization schedule and the other of said screened schedules as a higher risk screened immunization schedule with regard to the risk of developing said chronic immune mediated disorder(s),
(II) immunizing said subject according to a subject immunization schedule, according to which at least one of said infectious disease-causing organism-associated immunogens of said lower risk schedule is administered in accordance with said lower risk screened immunization schedule, which administration is associated with a lower risk of development of said chronic immune-mediated disorder(s) than when said immunogen was administered according to said higher risk screened immunization schedule.
Plaintiff espoused a broad scope for these claims. According to the majority opinion, plaintiff argued that the claims of the '739 patent were infringed "when a health care provider reads the relevant literature and selects and uses an immunization schedule that is of lower risk for development of a chronic immune-mediated disorder:" specifically:
[T]he '139 and '739 patents in suit are directly infringed when a physician, hospital or other health care provider reads the relevant literature and selects an immunization schedule and immunizes a patient in accordance with the schedule which appears to have minimal risk.
On the other hand, plaintiffs contended that the claims of the '238 patent were infringed "when a person reviews relevant information, whether the person is a producer of vaccines, a health care provider, or a concerned parent," specifically, "the infringer need only assess risk, it is not necessary for the infringer to conduct its own clinical trials or prove the cause of any adverse effects."
Although the majority opinion suggests that there was sufficient knowledge in the prior art that the patentability of these claims is in question, the opinion draws a strict line between such concerns and the question of patent-eligibility. And the opinion expressly relies on the intervening precedent of Research Corp. Technologies, Inc. v. Microsoft Corp., 627 F.3d 859 (Fed. Cir. 2010); Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 628 F.3d 1347 (Fed. Cir. 2010), cert. granted, _ S. Ct. _ , 2011 WL 973139 (June 20, 2011); and Association for Molecular Pathology v. U.S. Patent & Trademark Office, _ F.3d _, 2011 WL 3211513 (Fed. Cir. July 29, 2011), in reaching its determination on patent-eligiblity. In reciting the conflicting positions of the parties, the majority opinion appears to be setting forth the basis for its decision: whether the claims recite merely a mental step or a fundamental scientific principle, or an application of a principle that properly falls within the scope of § 101.
The majority opinion begins its analysis of the patent-eligibility question by reciting the broad scope of the statutory language, citing ancient precedent as well as Diamond v. Chakrabarty for the principle. According to Judge Newman and Chief Judge Rader, the Supreme Court's decision in Chakrabarty arose at a time when the courts were also considering the patent-eligibility of inventions in "the evolving fields of computer science and technology," including especially Diamond v. Diehr. In making determinations on patent-eligibility, the majority states that the Supreme Court has directed that "the boundary between abstract principle and practical application may vary with the subject matter." These principles remain the standard as evidenced by the Supreme Court's decision in Bilski v. Kappos, which the majority opinion cites for the proposition that:
The §101 patent-eligibility inquiry is only a threshold test. Even if an invention qualifies as a process, machine, manufacture, or composition of matter, in order to receive the Patent Act's protection the claimed invention must also satisfy "the conditions and requirements of this title." §101. Those requirements include that the invention be novel, see §102, nonobvious, see §103, and fully and particularly described, see §112.
The majority "appli[ed] this distinction [between patent-eligibility and the substantive requirements of patentability] to the Classen patents" in arriving at its decision that the claims of the '139 and '739 patents satisfy the test and the claims of the '238 patent do not.
Turning to the District Court's decision on summary judgment that the claims of all the patents-in-suit did not recite patent-eligible subject matter, the majority states that the lower court's reasoning was based on its determination that "the method claimed in all three patents includes the mental step of reviewing the relevant literature to determine the lower-risk immunization schedule" and that the lower court did not consider whether the claims satisfied the other provisions of the Patent Act. Citing Application of Prater, 415 F.2d 1393, 1402 n. 22 (CCPA 1969), the opinion states that "the presence of a mental step is not of itself fatal to §101 eligibility" and that there was no "universal rule" governing "all situations that include mental activity."
Classen argued, and the majority appear to agree, that an important distinction between the claims here and the claims in Bilski is that the presence of "immunization" steps in Classen's claims distinguish them from the commodity hedging method claimed by Bilski. Recognizing the deficiencies in the Supreme Court's Bilski opinion (through the voice of former Justice Stevens, who "observed" that the majority "never provide[d] a satisfying account of what constitutes an unpatentable abstract idea"), the majority turn to the Federal Circuit's own Research Corp. precedent, for the principle that a claim should be disqualified from patent-eligibility only if the characteristic of "abstractness" "should exhibit itself so manifestly as to override the broad statutory categories of eligibile subject matter." Although this "standard" appears subjective at best, the majority illustrates its application in Research Corp., where the claimed method was "functional and palpable" and thus patent-eligible.
Again turning to its Research Corp. precedent, the majority recites the statements in that case that subject matter eligibility is a "course eligibility filter" that is not the "final arbiter" of patentability (rather, the substantive provisions of §§ 102, 103 and 112 fulfill that role). "The preferable procedure" is to "apply the substantive conditions and requirements of patentability" if the claims recite one of the statutory classes of invention and are not "manifestly abstract." Also relevant to the question is whether there is a "commercial application of the technology," which the opinion contends is an indication that the subject matter is not "so abstract as to negate" patent eligibility under § 101.
Using these guidelines, the majority states that the '139 and '739 patent claims are patent-eligible, inter alia, because they recite methods that include "the physical step of immunization on [a] determined schedule" and thus are "directed to a specific, tangible application." Although again raising the possibility that the claims do not satisfy the substantive provisions of the Patent Act, the majority concludes that finding these claims to be patent-eligible is consistent with Supreme Court precedent that subject matter eligibility should be construed broadly, and that "categorical rules" should not be adopted due to the possibility that such rules might have "wide-ranging and unforeseen impacts" on innovation.
The claims of the '238 patent, on the other hand, are not patent-eligible according to the majority, because they do not recite affirmative immunization steps. The distinction appears to be that the patent-eligible claims of the '139 and '739 patents recite immunization steps after the appropriate schedule has been arrived at by operation of the other steps of the claim, whereas the claims of the '238 patent do not require any immunization step (except the steps that produce the pattern of immunization-related diseases and disorders recited in the claim). This distinction is supported by arguments plaintiff made regarding acts constituting infringement, such as alleging that defendant Merck "induced direct infringement by parents when Merck provides and physicians distribute . . . [a] book that advises parents to understand vaccines and vaccination schedules." Citing AMP v. USPTO, the majority states that "methods that simply collect and compare data, without applying the data in a step of the overall method, may fail to traverse the §101 filter." That is the case here for the '238 patent claims.
The opinion also makes a distinction, termed "special consideration," when courts make patent-eligibility determinations for "evolving technologies" in order to provide the "liberal encouragement" for innovation resulting from the "permissive approach" to patent-eligibility taken by Congress in implementing the Patent Act and recognized by courts since (including the recent Bilski opinion by the Supreme Court). Even under this expansive approach, however, the majority found that the '238 patent claim "is directed to the single step of reviewing the effects of known immunization schedules, as shown in the relevant literature" which, while a "first step in the scientific method" is not sufficient to recite patent-eligible subject matter. The majority found that the method claimed in the '238 patent "do[es] not include putting this knowledge to practical use" and is merely "directed to the abstract principle that variation in immunization schedules may have consequences for certain diseases." This "abstraction" is not patent-eligible because it "is unrelieved by any movement from principle to application."
In making this distinction between the '238 patent claims and the '139 and '739 patent claims, the majority states that "[p]ragmatic thoroughness is thereby achieved, for extensive precedent guides the continuum from abstractness to specificity, in the context of a vast breadth of subject matter. Aided by this experience, courts may more readily resolve close questions such as are here presented."
With regard to the other questions presented for review the majority declined to consider whether the claims were invalid for anticipation, on the grounds that denial of summary judgment was not generally appealable, citing Kendall v. City of Chesapeake, Va., 174 F.3d 437, 443-44 (4th Cir. 1999), as well as the pragmatic consideration that "there is no record, no factual findings or representations on which such findings might be made, indeed no basis for factual inferences, even on the premises of summary adjudication." The Court did consider the question of infringement and whether certain of the defendants' (Biogen and GlaxoSmithKline) accused activities fell within the "safe harbor" provisions of 35 U.S.C. § 271(e)(1). These activities constituted post-approval studies to determine whether immunizations with hepatitis B and Haemophilus influenza vaccines increase the incidence of type 1 diabetes, as well as an allegation that Biogen induced infringement by GSK by "providing instructions and/or recommendations on a proper immunization schedule for vaccines." Classen argued that the § 271(e)(1) safe harbor is limited to pre-approval activities, and the majority agreed. Assaying the legislative history and the purported purposes of the Hatch-Waxman Act, the opinion states that the safe harbor only applies to pre-approval activities (which the Biogen and GSK actions clearly were not):
§271(e)(1) provides an exception to the law of infringement in order to expedite development of information for regulatory approval of generic counterparts of patented products. The statute does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained.
The majority opinion also finds no change in this analysis based on the Supreme Court's decision in Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 207 (2005), which was directed towards "preclinical research" that was, by definition, "pre-approval." The Supreme Court's Merck decision was directed towards (and limited to) "preclinical research, whether or not ultimately included in a submission to the Food and Drug Administration, [that] is exempted from infringement by §271(e)(1) 'as long as there is a reasonable basis for believing that the experiments will produce "the types of information that are relevant to an IND [investigational new drug application] or NDA [new drug application].'" Since the accused actions by Biogen and GSK were "not related to producing information for an IND or NDA," the majority concludes that § 271(e)(1) does not provide a safe harbor under the Merck precedent.
Finally, the majority directed that, on remand, the District Court should determine whether allegations of infringement for performing "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'" is properly within the bounds of the right to exclude granted to Classen or whether it is "impermissible under patent principles," i.e., as "preempting the field of study and prevent[ing] any investigation into any immunogen, known or unknown, and to any disease."
Classen Immunotherapies, Inc. v. Biogen IDEC (Fed. Cir. 2011)
Panel: Chief Judge Rader and Circuit Judges Newman and Moore
Opinion for the court by Circuit Judge Newman; additional views by Chief Judge Rader; dissenting opinion by Circuit Judge Moore