Lead Opinion
Opinion for the court filed by Circuit Judge NEWMAN. Additional views filed by Chief Judge RADER, in which Circuit Judge NEWMAN joins. Dissenting opinion filed by Circuit Judge MOORE.
This appeal reaches us on remand from the Supreme Court,
The Court’s remand concerns the question of patent-eligibility, 35 U.S.C. § 101, of the subject matter claimed in the Classen patents in suit. The question arises on the district court’s application of the common-law exclusions from § 101 of “laws of nature, natural phenomena, and abstract ideas.” Diamond v. Diehr,
We conclude that the claimed subject matter of two of the three Classen patents is eligible under § 101 to be considered for patenting, although we recognize that the claims may not meet the substantive criteria of patentability as set forth in § 102, § 103, and § 112 of Title 35. However, questions of patent validity are not before us on this appeal, for the only motion for summary judgment under these substantive provisions was based on prior use asserted by defendant Merck, and was denied by the district court because facts were in dispute. Denials of summary judgment are not appealable.
The district court granted summary judgment that the claims are not infringed, based on Classen’s failure to allege facts sufficient to establish infringement by Merck, and based on the safe-harbor provision of 35 U.S.C. § 271(e)(1) as to other defendants. We affirm the judgment as to
We now consider the issues on appeal and cross-appeal.
I
Subject MatteR Eligibility— 35 U.S.C. § 101
In suit are three related patents, each entitled “Method and Composition for an Early Vaccine to Protect Against Both Common Infectious Diseases and Chronic Immune Mediated Disorders or.their Sequelae”: United States Patents No. 6,638,-739 (“the '739 patent”), No. 6,420,139 (“the '139 patent”), and No. 5,723,283 (“the '283 patent”). The inventor is Dr. John Barthelow Classen, and the patents are assigned to Classen Immunotherapies, Inc. (“Classen”). The patents state Dr. Classen’s thesis that the 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, and that immunization should be conducted on the schedule that presents the lowest risk with respect to such disorders. The three patents state that Dr. Classen has discovered that
when one or more immunogens ... is first administered at an early age (typically prior to 42 days of age), it can substantially decrease the incidence, frequency, prevalence or severity of, or prevent, at least one chronic immune mediated disorder, and/or a surrogate marker thereof.
283 patent col.7 11.35-41; '739 patent col.7 11.39-45; '139 patent col.711.35-41.
The three patents contain a total of 230 claims. The summary judgment proceedings were directed to the “representative claims” selected by Classen. The claims of the '139 and '739 patents state the method whereby information on immunization schedules and the occurrence of chronic disease is “screened” and “compared,” the lower risk schedule is “identified,” and the vaccine is “administered” on that schedule. Classen states that “The patented method of the '139 and '739 patents is exemplified by Claim 1 of the '739 patent.” Classen Br. 11. Claim 1 states:
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.
Classen states that the '139 and '739 patents are 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:
[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.
Classen Br. 22. Classen states that the patents are infringed by the act of reviewing the published information, whether or not any change in the immunization schedule is made upon such review. Classen Br. 41 (“maintenance of the current schedule is step (II) of the Classen method”).
The '283 patent claims the first step of the above method, by reviewing and comparing published information on the effects of immunization schedules in treated and control groups of mammals, with respect to the occurrence of immune-mediated disorders. Claim 1 was designated as representative of the '283 patent:
1. 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.
Classen states that the '283 patent is infringed when a person reviews relevant information, whether the person is a producer of vaccines, a health care provider, or a concerned parent. Classen Br. 41 (“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”). The '283 patent claims do not include performing immunizations in accordance with the information learned by the claimed method.
The three patents list over four hundred references related to immunization schedules, the occurrence of immune-mediated disordérs, and various studies and reports in this field. For example, the patents cite a publication entitled “The Swedish Childhood Diabétes Study: Vaccinations and Infections as Risk Determinants for Diabetes in Childhood,” L. Blom et al., Diabetologia, 34(3):176 — 81 (1991); this publication states that: “The possible association between viral diseases and diabetes has also prompted an interest in vaccinations as possible risk factors for diabetes,” id. at 176, and describes “a nationwide incident case referent study [where] we have evaluated vaccinations, early and recent infections and the use of medicines as possible risk determinants for Type 1 (insulin-dependent) diabetes mellitus in childhood.” Id. The study concludes:
When vaccinations were considered as possible risk factors for diabetes, a significant decrease in relative risk estimated as odds ratio (OR) was noted for measles vaccination.... In conclusion, a protective effect of measles vaccination for Type 1 diabetes in childhood is indicated as well as a possible causal relationship between the onset of the disease and the total load of recent infections.
Id. The Classen patents acknowledge that this study “suggested that vaccination against measles may influence a reduction in the incidence of diabetes,” but criticize the study for the asserted absence of controls.
The Classen patents list several publications of Huang et al., including “The Effect of Pertussis Vaccine on the Insulin-Dependent Diabetes Induced by Streptozotocin in Mice,” Pediatric Research, vol. 18, No. 2, pp. 221-226 (1984). This reference was cited by the patent examiner under § 102 (anticipation) during prosecution of Classen’s parent application, but the rejection was withdrawn on Classen’s argument that the claims require vaccination before 42 days from birth, as distinguished from the schedule used by Huang. Classen wrote to the examiner:
Claims 2, 3, 6, 7, 9-14, 16 and 33 are rejected as anticipated by Huang et al. (1984), which allegedly] discloses both immunization against pertussis by administering a pertussis immunogen at 45, 55, 59 and 85 days of life (see p. 221), and reduction in the incidence of diabetes.
Huang et al. (1984) cannot anticipate claims 2, 3, 6, 7, 9-14 and 16 because his first administration was to mice which were 45 days old, and claim 3 (the independent claim) requires a first administration before 42 days from birth.
Appl. Ser. No. 08/104,529, Attorney Letter, Nov. 21, 1996, at 21-22.
The district court was not asked, in the summary judgment phase, to consider the effects of these and other references on the substantive conditions of patentability. The Classen patents state that “prior to the present invention, chronic immune mediated diseases, such as diabetes mellitus, were not considered vaccine complications.” '283 patent col.3 11.54-56; '139 patent col.3 11.54-56; '739 patent col.3 11.54-56. However, issues of validity based on prior publications were not presented for summary judgment. The only patentability issue was raised in Merck’s motion for anticipation based on prior use, as we discuss in Part II, post.
The defendants’ motions for summary judgment included the ground that the subject matter did not meet the threshold eligibility requirements of 35 U.S.C. § 101. In granting this motion, the district court accepted Classen’s theory that there is a relation between childhood immunization schedules and the occurrence of chronic immune-mediated disorders. The defendants challenged the correctness of Dr. Classen’s theory, citing a study by Dr. Frank DeStefano for the Centers for Disease Control, published as “Childhood Vaccinations, Vaccination Timing and Risk of Type I Diabetes Mellitus,” Pediatrics, Dec. 2001. The district court did not hold a Daubert hearing — about which Classen now complains — but accepted Classen’s premise for the purpose of deciding eligibility of the subject matter under § 101.
The district court stated that the claims “describe little more than an inquiry of the extent of the proposed correlation between vaccines and chronic disorders.” Classen,
The defendants argue that the Classen methods are directed to no more than the steps of reading published information, that the “determining” and “comparing” steps of the claims are performed in the mind, and that any immunizing step is simply conventional activity, citing the Court’s negation of the “notion that post-solution activity, no matter how conventional or obvious in itself, can transform an unpatentable principle into a patentable process,” Parker v. Flook,
Classen disputes this characterization, and argues that Dr. Classen discovered a method of immunizing that lowers the risk of chronic immune-mediated disease. Classen states that this method is not an abstract idea, but a new and useful application of a newly discovered scientific fact. Thus Classen argues that the method is within the statutory classes of patent-eligible subject matter. Classen also points to the subordinate claims that were not considered by the district court, that are directed to specific immunogens, specific immunization schedules, and specific immune-mediated disorders. Classen states that even if the representative claims are deemed to be unduly broad, other claims are more specific and cannot be characterized as “abstract.” Classen states that these other claims were not considered by the district court, and were improperly invalidated on summary judgment.
A. The § 101 Threshold
The statement of patent-eligible subject matter has been substantially unchanged since the first Patent Act in 1790. As now codified:
§ 101. Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Interpretation of this -provision early reached the courts in the context of charges of infringement, where the parties disputed the scope available to the patent. In 1839 Justice Story referred to patents as “securing to the whole community great advantages from the free communication of secrets, and processes, and machinery, which may be most important to all the great interests of society, to agriculture, to commerce and to manufactures, as well as to the cause of science and art,” Blanchard v. Sprague,
These principles, based on the statute and elaborated in the common law of patents, continue to be reinforced. In Diamond v. Chakrabarty,
The subject-matter provisions of the patent law have been cast' in broad terms to fulfill the constitutional and statutory goal of promoting “the Progress of Science and the useful Arts” with all that means for the social and economic benefits envisioned by Jefferson. Broad general language is not necessarily ambiguous when congressional objectives require broad terms.
Id. at 315,
These principles have steadfastly guided the patent law, and in Bilski v. Kappos the Court reiterated its concern for “barr[ing] at the threshold,” id., and encouraged preservation of the legal and practical distinctions between the threshold inquiry of patent-eligibility, and the substantive conditions of patentability. The Court explained:
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 Court in Diehr also discussed the statutory meaning of “new” in § 101 as compared with “new” in § 102; the former being a general statement governing the threshold of entry into the patent system for further consideration, the latter setting the conditions and limitations of patentable novelty:
It has been urged that novelty is an appropriate consideration under § 101.... Section 101, however, is a general statement of the type of subject matter that is eligible for patent protection “subject to the conditions and requirements of this title.” Specific conditions for patentability follow and § 102 covers in detail the conditions relating to novelty. The question therefore of whether a particular invention is novel is “wholly apart from whether the invention falls into a category of statutory subject matter.”
B. Mental Steps
The district court held that none of the Classen claims meets the threshold under § 101 of eligibility for patenting, reasoning that the method claimed in all three patents includes the mental step of reviewing the relevant literature to determine the lower-risk immunization schedule. The district court did not discuss whether the claims were anticipated or obvious in view of the prior art, and it appears that this aspect was not raised, in the district court, in the context of § 101. However, precedent has recognized that the presence of a mental step is not of itself fatal to § 101 eligibility, and that the “infinite variety” of mental and physical activity negates application of a rigid rule of ineligibility. See Application of Prater,
In Prater the court explained the inappropriateness of attempting to establish a universal rule for all situations that include mental activity:
Between the purely mental and purely physical end of the spectrum there lies an infinite variety of steps that may be either machine-implemented or performed in, or with the aid of, the human mind (e.g., “comparing” and “determining”). In ascertaining whether a particular step is “mental” or “physical,” each case must be decided on its own facts, considering all of the surrounding circumstances, to determine which end of the spectrum that step is nearer. It may well be that the step of “comparing” may be “mental” in one process, yet “physical” in another.
Id. Classen states that its claims include physical steps of immunization, and are not entire “[s]ets of steps occurring only in the mind,” In re Sarkar,
The Court in Bilski v. Kappos did not define “abstract,” and Justice Stevens observed in concurrence that “[t]he Court, in sum, never provides a satisfying account of what constitutes an unpatentable abstract idea,”
this court also will not presume to define “abstract” beyond the recognition that this disqualifying characteristic should exhibit itself so manifestly as to override the broad statutory categories of eligible subject matter and the statutory context that directs primary attention on the patentability criteria of the rest of the Patent Act.
The court in Research Corporation, explaining that the claims must be considered as a whole when determining eligibility to seek patentability, described the statutory role of § 101 as a “coarse eligibility filter,” not the final arbiter of patentability. The court explained that the substantive conditions of Title 35 must be applied, and remarked that “section 112 [is a] powerful tool[] to weed out claims that may present a vague or indefinite disclosure of the invention,” and observed that “a patent that presents a process sufficient to pass the coarse eligibility filter may nonetheless be invalid as indefinite.”
The Research Corporation court also explained that the “subject matter might also be so conceptual that the written description does not enable a person of ordinary skill in the art to replicate the process,” and that this too is a matter of patentability under § 112, not eligibility under § 101.
The court in Research Corporation observed that the commercial application of the technology is relevant to deciding whether an invention is so abstract as to negate § 101 subject matter. Id. at 869 (“Indeed, this court notes that inventions with specific applications or improvements to technologies in the marketplace are not likely to be so abstract that they override the statutory language and framework of the Patent Act.”); see Diehr,
The claims of the '139 and '739 patents are directed to ■ a method of lowering the risk of chronic immune-mediated disorder, including the physical step of immunization on the determined schedule. These claims are directed to a specific, tangible application, as in Research Corporation, and in accordance with the guidance of Bilski v. Kappos that “[rjather than adopting categorical rules that might have wide-ranging and unforeseen impacts,” exclusions from patent-eligibility should be applied “narrowly,”
Claim 1 of the '283 patent states the method 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. This stands in contrast to the '139 and '739 patent claims, which include the subsequent step of immunization on an optimum schedule. Claim 1 of the '283 patent claims the idea of comparing known immunization results that are, according to the patent, found in the scientific literature, but does not require using this information for immunization purposes. Classen states, for example, that Merck induces direct infringement by parents when Merck provides and physicians distribute the book “What Every Parent Should Know About Vaccines,” because the book advises parents to understand vaccines and vaccination schedules. Classen Br. 18.
Claim 1 of the '283 patent states the idea of collecting and comparing known information. As discussed in Association for Molecular Pathology, supra, 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.
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, for “Congress took [a] permissive approach to patent eligibility to ensure that ‘ingenuity should receive a liberal encouragement.’ ” Bilski,
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. Although recourse to existing knowledge is the first step of the scientific method, the method claimed in the '283 patent simply invites the reader to determine the content of that knowledge. The '283 claims do not include putting this knowledge to practical use, but are directed to the abstract principle that variation in immunization schedules may have consequences for certain diseases. In contrast, the claims of the '139 and
Classen also argues that the claims of all three patents meet the machine-or-transformation test of this court’s vacated In re Bilski opinion, citing Prometheus Laboratories, supra, where this court held that “claims to 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.”
Viewing the representative claims of the Classen patents in accordance with their purported scope, we conclude that the claims of the '139 and '739 patents reasonably meet the threshold of § 101 eligibility, and that analysis of the subject matter of these claims, and other claims in these patents, should proceed by way of the statutory criteria of patentability.
II
Anticipation by Prior Use— 35 U.S.C. § 102
The district court declined to decide Merck’s motion for summary judgment based on Merck’s asserted prior use. Merck’s motion was premised on the ground that an activity for which Classen charges Merck with infringement is the same activity that was known and used and recommended by Merck more than a year before Classen’s earliest filing date. Merck states that Classen’s claims are anticipated by the prior use of that schedule, for “that which infringes if later anticipates if earlier,” Polaroid Corp. v. Eastman Kodak Co.,
On appeal, Merck asks this court to decide this anticipation question ab initio, despite the general rule that the denial of a summary judgment motion is not appeal-able. Kendall v. City of Chesapeake, Va.,
Ill
Infringement
A. Merck’s Motion for Summary Judgment
The district court granted Merck’s motion for summary judgment of non-infringement, on the ground that “[t]he only specific act of infringement alleged in Classen’s amended complaint was Merck’s participation in or facilitation of the 2001 study conducted by Dr. Frank DeStefano” for the Centers for Disease Control, and that “Merck offered uncontroverted evidence that it had no involvement in the DeStefano study.” Classen,
Classen appeals, arguing that even if Merck did not “participate in or facilitate” the DeStefano study, Merck infringed the Classen patents when Merck “reviewed” the study and “evaluated the correlation” therein. Classen states that Merck’s “screening of the trials, papers, etc.” of the DeStefano study of itself was an act of infringement. Classen Br. 40. Classen also argues that Merck infringed the representative claims based on its funding of studies of the relationship between the hepatitis B vaccine and the occurrence of multiple sclerosis. Classen also complains
The district court observed that it was undisputed that Merck did not participate in the DeStefano study, and that Classen had not “offered any evidence linking Merck to any other study or evaluation of the correlation between vaccination schedules and inciden[ce] of immune mediated disorders.” Classen Immunotherapies, Inc. v. Biogen IDEC, No. WDQ-04-2607, slip op. at 5 (D.Md. Dec. 14, 2005). The district court stated that “Classen’s claims rely on Merck’s participation in or inducement of an examination of the correlation between vaccine schedules and immune mediated disorders,” and that no evidence supported this charge. Id. We do not disturb the grant of summary judgment on the ground that no evidence of Merck’s involvement in this study was presented by Classen. The district court did not abuse its discretion in declining to consider Classen’s subsequent proffer of evidence, after summary judgment was granted.
The district court also acted within its discretion in declining to accept GlaxoSmithKline and Biogen’s untimely motion for summary judgment on the same grounds.
B. The “Safe-harbor” Provision, 35 U.S.C. § 271(e)(1)
Classen charged Biogen and GlaxoSmithKline with direct infringement on the ground,that both companies participated 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.” Classen,
§ 271(e)(1). It shall not be an act of infringement to make, use, offer to sell, or sell within the United States ... a patented invention ... 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 argues that the district court erred in its application of § 271(e)(1). Classen states that this statute, as enacted and intended, and as judicially interpreted, is limited to activities conducted to obtain pre-marketing approval of generic counterparts of patented inventions, before patent expiration. GlaxoSmithKline and Biogen respond that their reporting of vaccine relationships, or recommendations in view of the relevant literature, or other activity in conformity with FDA regulations, are within the infringement safe-harbor of § 271(e)(1). Classen states that the district court extended § 271(e)(1) beyond its statutory and legislative purpose, for there is no issue in this case of submissions for regulatory approval of generic products, or like policy considerations. Classen is correct, for § 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.
This purpose was emphasized throughout the legislative process: “The purpose of sections 271(e)(1) and (2) is to establish that experimentation with a patented drug product, when the purpose is to prepare for commercial activity which will begin after a valid patent expires, is not a patent infringement.” Id. Again in Part 2 of H.R.Rep. No. 98-857, at 8, 1984 U.S.C.C.A.N. 2686, 2692 (1984), the Report is explicit that “the only activity which will be permitted by the bill is a limited amount of testing so that generic manufacturers can establish the bioequivalency of a generic substitute.” The Report states that “the generic manufacturer is not permitted to market the patented drug during the life of the patent; all that the generic can do is test the drug for purposes of submitting data to the FDA for approval.” Id. at 30, 1984 U.S.C.C.A.N. at 2714. The activities of which Biogen and GlaxoSmithKline are accused by Classen cannot be stretched into this role.
Every decision examining the statute has appreciated that § 271(e)(1) is directed to premarketing approval of generic counterparts. before patent expiration. The Court applied this limitation to medical devices in Eli Lilly & Co. v. Medtronic, Inc.,
In Merck KGaA v. Integra Lifesciences I, Ltd.,
Extensive precedent recites the purpose of § 271(e)(1) to facilitate market entry upon patent expiration. See, e.g., Warner-Lambert Co. v. Apotex Corp.,
The court erred in its application of § 271(e)(1) to the activities of Biogen and GlaxoSmithKline in providing vaccines, in advising on immunization schedules, and in reporting any adverse vaccine effects to the FDA. The judgment of noninfringement based on the safe-harbor of § 271(e)(1) is vacated.
C. Study of the Classen Information 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. As the Court stated in J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc.,
This quid pro quo is fundamental to patent systems. The statutory requirements of description, enablement, and best mode, implement this policy, for these requirements facilitate understanding and elaboration of the inventor’s contribution. Were such information prohibited from study until patent expiration, not only would the advance of science be slowed, but the design-around of patented subject matter would be inhibited, if not excluded,
Our colleague in dissent argues that the Classen claims “preempt[] the field of study and prevents any investigation into any immunogen, known or unknown, and to any disease.” Diss. Op. at 1079. Study of the information in patents is not preempted, whether that information is broadly claimed, as in Classen’s “representative” claims, or more narrowly claimed, as in other Classen claims. 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. Nor does breadth preclude investigation by others. To the contrary, a fundamental purpose of patenting is to provide knowledge, to achieve further advance. The dissent’s “absurd” examples are indeed absurd.
The district court reported that Classen charges the defendants with infringement based on their participation 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.” Classen,
Summary
The district court’s holding of ineligibility for patenting under § 101 is reversed as to the claims of the '139 and '739 patents, and affirmed as to the '283 patent. The judgment of non-infringement is affirmed as to Merck, and is vacated as to Biogen and GlaxoSmithKline insofar as based on § 271(e)(1). Other claims, counterclaims, and defenses raised by complaint and answer were not decided by summary judgment, and are not before us on this appeal. We remand for appropriate further proceedings.
AFFIRMED IN PART, REVERSED IN PART, VACATED IN PART, AND REMANDED
In the last several years, this court has confronted a rising number of challenges under 35 U.S.C. § 101. The language of § 101 is very broad. Nevertheless, litigants continue to urge this court to impose limitations not present in the statute. Subject matter eligibility under section 101 has become the “substantive due process” of patent law — except that reading non-procedural requirements into the constitutional word “process” has more historical and contextual support than reading ab
The patent eligibility doctrine has always had significant unintended implications because patent eligibility is a “coarse filter” that excludes entire areas of human inventiveness from the patent system on the basis of judge-created standards. For instance, eligibility restrictions usually engender a healthy dose of claim-drafting ingenuity. In almost every instance, patent claim drafters devise new claim forms and language that evade the subject matter exclusions. These evasions, however, add to the cost and complexity of the patent system and may cause technology research to shift to countries where protection is not so difficult or expensive.
The first unintended consequence, claim drafting evasion, has occurred several times in the past. After all, patents require a translation of technology into text, i.e., patent claims. Inevitably the subject matter exclusions of eligibility doctrines depend on the way that claims are drafted. Thus, careful claim drafting or new claim forms can often avoid eligibility restrictions. Eligibility then becomes a game where lawyers learn ingenious ways to recast technology in terms that satisfy eligibility concerns.
Two well-known examples of claim drafting to circumvent eligibility restrictions are the Beauregard claim and the Swiss claim. The Beauregard claim was devised to draft around restrictions on software imposed in Gottschalk v. Benson,
The Swiss claim was devised to draft around restrictions on medical treatment methods imposed by the European Patent Convention (“EPC”). EPC, art. 52(4) prohibited patents on the use of a compound X for the treatment of disease Y. The Swiss claim form, however, was for the use of a compound X/or the manufacture of a medicament for the treatment of disease Y. Claims were redrafted so that the focus became the manufacture of a product instead of the direct treatment using that product. The theory was that the claimed use was restricted to the patentable (initial) industrial use instead of the ineligible (ultimate) therapeutic use. See Eisai/Second Medical Indication, G05/83 O.J. (EPO Enlarged Bd. of Appeals 1984) (allowing Swiss claims); Preparatory Documents to Revision of EPC art. 54(5), CA/PL 4/00 (EPO Jan. 24, 2000) (revising the EPC to make clear that such subject matter is patent eligible so that Swiss claims are not needed).
When careful claim drafting or new claim formats avoid eligibility restrictions, the doctrine becomes very hollow. Ex-
In addition to gamesmanship, eligibility restrictions increase the expense and difficulty in obtaining a patent. By creating obstacles to patent protection, the real-world impact is to frustrate innovation and drive research funding to more hospitable locations. To be direct, if one nation makes patent protection difficult, it will drive research to another, more accommodating, nation.
Once again, this unintended consequence is not theory but history. In the past, this cause-effect relationship of eligibility restrictions and stifling innovation favored our country in, for example, biotechnology. While Europe imposed eligibility restrictions, the United States embraced strong patent protection. Compare Diamond v. Chakrabarty,
Europe became known for subjecting such inventions to delays in the patent office, challenges in litigation, increases in cost, and uncertainties in the legal landscape. With those difficulties as a primary contributing factor, investors, corporations, and clinics shifted their research from Europe to the United States. See Opinion of European Union Economic and Social Committee, COM (1995) 661 final (July 11, 1996), (recognizing that “Europe is lagging further and further behind the USA,” as evidenced by the stark contrast in number of biotech patents, firms, and products; proposing strong patent protection as in the United States to solve “Europe’s backwardness”); Council Directive 98/44, 1998 O.J. (L 213) (EC) (finally providing some protection for biotech inventions to counter the trend of companies preferring to patent in the United States). Thus, with some considerable blame on its eligibility doctrines, Europe lost innovation investment to the United States. Our country became the world leader in biotechnology innovation. Nevertheless, the tide can turn against us, too. The effect of eligibility restrictions can send innovation investment elsewhere. Maybe an accommodating clinic in another country would be happy to take the additional funding and opportunity. In sum, judges should tread carefully when imposing new limits on the protection for categories of human innovation.
These public policy reasons are consistent with the broad language of § 101. As discussed in the majority opinion, section 101 is a general statement of subject matter eligibility. It is a threshold statement that explicitly directs attention to the “conditions and requirements of this title” to qualify for a patent. Thus, patentability, as opposed to subject matter eligibility, depends on the substantive conditions in the rest of the title. See 35 U.S.C. §§ 102, 103, 112. Many litigation-spawned applications of section 101 do not focus on categories of subject matter that deserve no patent protection but on the particularities of claim language, a question of patentability depending on prior art and adequate disclosure.
Notes
. Classen Immunotherapies, Inc. v. Biogen IDEC, 561 U.S. -,
. The dissent argues that there is "no distinction" between the claims of the '283 patent and the claims of the '139 and '739 patents. The patents, which were separately filed after the patent examiner required restriction because "the inventions are distinct,” distinguish the '283 method where, according to Classen, a person simply reviews known knowledge on immunization effects, from the '139/'739 methods that require physical immunization based on that review. Even if the question as to the '139 and '739 patents were deemed to be close, the '139/'739 method of immunizing on the low-risk schedule determined by the '283 method of reading the literature, may be generously viewed as traversing the boundary into eligibility for substantive review.
. The dissent, in its description of the claimed subject matter, states, for example, that "The Classen claims are not directed to any specific treatment steps or drugs or even any specific chronic immune disorder," Diss. Op. at 1076. That is incorrect. Observe, for example, the claimed immunization schedule of administration of hepatitis B immunogen in two doses, first before 42 days after birth and second between 41-180 days after birth; identifying specific immunogens, with diabetes as the chronic immune-mediated disorder:
'139 patent cl. 32. The method of claim 30 [including diabetes as the chronic disorder] where the hepatitis B immunogen is a killed immunogen administered prior to 42 days after birth, and at least one further immunogen is administered after 41 and before 180 days after birth in a screened schedule, and said further immunogen is selected from the group consisting of BCG, measles, mumps, rubella, diphtheria, pertussis, Hemophilus influenza, tetanus, hepatitis B, polio, anthrax, plague, encephalitis, meningococcal, meningitis, pneumococcus, typhus, typhoid fever, streptococcus, staphylococcus, neisseria, lyme, cytomegalovirus (CMV), respiratory syncytial virus, Epstein Barr virus, herpes, influenza, parainfluenza, rotavirus, adenovirus, human immunodeficiency virus (HIV), hepatitis A, NonA NonB hepatitis, varicella, rabies, yellow fever, rabies, Japanese encephalitis, flavivirus, dengue, toxoplasmosis, cocidiomycosis, schistosomiasis, and malaria immunogens.
All three Classen patents contain claims whose breadth is not of “staggering” character. Our holding is not that any claim is “patentable,” whatever its breadth, but that the claims are eligible at the threshold for review for substantive patentability.
. Our colleague in dissent strays from statute and precedent, in arguing that any activity by any entity concerning any adversely patented product or method is exempted from infringement by § 271(e)(1), provided only that the information obtained is "reasonably related to submitting any information under the FDCA,” Diss. Op. at 1083 (emphasis in dissent), "including information regarding post-approval uses.” Id. Such a massive enlargement of the statutory exemption is incorrect.
. "Natural philosophy” was the term for "science” in the usage of that era.
Dissenting Opinion
dissenting.
Respectfully, I must dissent from the majority opinion on several grounds. I
I. Invalidity under 35 U.S.C. § 101
In Prometheus Laboratories, Inc. v. Mayo Collaborative Services,
The Classen claims are not directed to any specific treatment steps or drugs or even any specific chronic immune disorder. The majority concludes that the '283 patent claims are not directed to patentable subject matter, but that the claims of the '139 and '739 patents are directed to patentable subject matter. With all due respect to the majority, I see no distinction between the '283 claims and '139 and '739 claims which warrants differing treatment. Moreover, I am troubled by the majority’s conclusion that the '139 and '739 patent claims are directed to patentable subject matter without any analysis of the staggering breadth of the claims and the preemption issues inherent in claims directed to such fundamental principles.
Claim 1 of the '283 patent was designated as representative:
1. 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 comparingthe 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.
This claim requires two steps: (1) immunizing a group of mammals according to a schedule and then (2) comparing the incidence of chronic immune mediated disorder in the group to a control group.
Claim 1 of the '739 patent (which is being treated as representative of the '139 and '739 patents) states:
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 disorders) than when said immunogen was administered according to said higher risk screened immunization schedule.
This claim requires two steps: (1) compare the incidence of chronic immune mediated disease in two groups of mammals who
While I confess the precise line to be drawn between patentable subject matter and abstract idea is quite elusive, at least for me, this case is not even close. In the '283 patent, Classen claims the scientific method as applied to the field of immunization. No limitations exist on the type of drug to immunize with, the schedules that should be used for the immunization, the type of chronic immune disorder to look for, or any limitation on the control group. It is hard to imagine broader claims. It is harder to imagine a more conceptually abstract claim in the immunization area. Classen’s claims are directed to a thought apart from any concrete realities, specific objects or actual instances. This is very much like patenting E=mc
To determine whether a claim is directed to patentable subject matter, we must look to the whole claim. Diamond v. Diehr,
Although “[t]he line between a patentable ‘process’ and an unpatentable ‘principle’ is not always clear,” Parker v. Flook,
Having discovered a principle — that changing the timing of immunization may change the incidence of chronic immune mediated disorders — Classen now seeks to keep it for himself. In the '283 patent, he accomplishes this goal by claiming the use of the scientific method to study the incidence of chronic immune mediated disorders. This preempts the field of study, and prevents any investigation into any immunogen, known or unknown, and to any disease, known or unknown, over any period of time. Where, as here, a patent preempts an idea, a basic building block of science, within a field of study, the patent in practical effect is a patent on the idea itself. Gottschalk,
The intent and effect of the Classen claims is clear: to keep others from exploring the same principle. “Patent law seeks to avoid the dangers of overprotection just as surely as it seeks to avoid the diminished incentive to invent that under-protection can threaten.” Lab. Corp. of Am. Holdings v. Metabolite Labs., Inc.,
Classen did not invent the immunological response measured in his claim, and the discovery of this phenomenon alone “cannot support a patent unless there is some other inventive concept in its application.” Flook,
The notion that post-solution activity, no matter how conventional or obvious in itself, can transform an unpatentable principle into a patentable process exalts form over substance. A competent draftsman could attach some form of post-solution activity to almost any mathematical formula; the Pythagorean theorem would not have been patentable, or partially patentable, because a patent application contained a final step indicating that the formula, when solved could be usefully applied to existing survey techniques.
Id. at 590,
The claims in this case certainly illustrate the challenge our patent system faces “in striking the balance between protecting inventors and not granting monopolies over procedures that others would discover by independent, creative application of general principles.” Bilski,
In the end, Mr. Classen’s claims seek to monopolize the process of discovery itself, albeit limited to a single field. Our patent system, however, does not award a monopoly that precludes others from using the basic procedures of scientific investigation to study the same phenomenon. See Bilski,
I do not understand the distinction that the majority draws between claim 1 of the '283 patent and claim 1 of the '739 patent. Nor do I understand the test the majority proposes for determining patentability un
Tying an abstract idea to a tangible result or a specific field of endeavor does not make the idea any less abstract. Bilski,
I dissent from the majority’s refusal to réach Merck’s argument on appeal that it was entitled to summary judgment that the claims were invalid for anticipation. I agree that, in general, a denial of summary judgment standing alone is not immediately appealable. But here Merck properly presented us with an alternative grounds for affirming the district court’s summary judgment of invalidity, and this issue was thoroughly briefed below and decided by the district court. There is no basis upon which we could or should simply turn our back and refuse to decide an issue that is squarely before us.
In its motion for summary judgment of invalidity, Merck asserted that Classen’s claims were anticipated because a vaccination schedule for the Recombivax HB hepatitis vaccine was already in use before Classen filed his patents. The district court denied Merck’s motion for summary judgment of anticipation because Merck proffered no evidence that the correlation between immune-mediate disorders and the vaccine were evaluated as required by the representative claims. As the district court correctly noted, the '283 patent requires “immunizing a treatment group and comparing incidence of a chronic immune-mediated disorder to that of a control group.” Classen Immunotherapies v. Biogen Idec, No. WDQ-04-2607, slip op. at 8 (D.Md. Aug. 16, 2006). As the district court held, Merck did not present any evidence that there was a comparison to a control group to determine the incidence of chronic immune-mediated disorders. All Merck demonstrated was that it was using its Recombivax HB hepatitis vaccination on its 0, 1, 6 schedule prior to the Classen patents. Even if the court accepted this proposition, Merck does not demonstrate that the rest of the method was performed — there is no evidence of comparison to a control group as required by the claims. Both the '139 and '739 patents similarly “require comparing the incidence of immune-mediated disorders in treatment groups with different vaccination schedules and immunizing patients of a schedule identified as low risk.” Classen, No. WDQ-04-2607, slip op. at 9. Again, the district court correctly held that Merck offered no evidence that any comparison with different schedules or evaluation of incidence of immune-mediated disorders occurred. Merck’s proof was limited to the fact that it was immunizing on the 0, 1, 6 schedule prior to the Classen patents. This does not prove that it performed the rest of the method — the comparisons which Classen claimed. Accordingly, the district court correctly denied summary judgment. On this record, Merck failed to prove that it had performed all the steps of the method claims and therefore its prior use could not anticipate as a matter of law.
These claims are extremely broad, and Merck may well be able to offer proof of anticipation, but it failed to do so at the summary judgment stage — therefore I would affirm the district court’s denial of Merck’s summary judgment.
III. Infringement
In this case, the district court dismissed Classen’s claims against GlaxoSmithKline (GSK) and Biogen under Rule 12(b)(6), finding that the alleged uses fall into the safe harbor described by 35 U.S.C.
The Supreme Court explored the boundaries of this safe harbor in Merck KGaA v. Integra Lifesciences I, Ltd.,
the statutory text makes clear that it provides a wide berth for the use of patented drugs in activities related to the federal regulatory process. As an initial matter, we think it is apparent from the statutory text that § 271(e)(l)’s exemption from infringement extends to all uses of patented inventions that are reasonably related to the development and submission of any information under the FDCA.
Merck, 545 U.S at 202,
While it is true that the Supreme Court decided Integra in the context of pre-approval activities, the Court repeatedly underscored the breadth of the statute’s text. Accordingly, I conclude that the safe harbor extends to all uses that are reasonably related to submitting any information under the FDCA, including information regarding post-approval uses.
The majority cites extensively from the legislative history in an attempt to justify its construction. But these citations miss the point entirely. There is no dispute that § 271(e)(1) covers pre-approval studies, as the legislative history indicates. None of the legislative history cited by the majority, nor the cases it references, speak to the question at issue here — whether the statute as enacted also covers post-approval activities. The question is not whether Congress intended to protect pre-approval activity — but whether the enacted legislation covers more than just preapproval activity. The language Congress chose to enact and that was signed into law by the President is plain on its face. There is no “pre-approval” limitation. The statute includes within the safe harbor activity “solely for uses reasonably related to the development and submission of information under a Federal law.” 35 U.S.C. § 271(e)(1). This statute could have been written to indicate solely for uses seeking federal approval or solely for pre-approval uses. It was not. The plain language of this statutory text is broader. Any activity solely for uses reasonably related to the development and submission of informa
I agree with the district court’s plain language construction of the statute, and I agree that, in this case, the alleged participation by GSK and Biogen in studies evaluating risks associated with different vaccination schedules is reasonably related to their requirement to review and report adverse information to the FDA. See, e.g., 21 C.F.R. § 601.70 (requiring annual progress reports of post-approval studies); 21 C.F.R. § 600.80 (requiring the reporting of post-approval adverse reactions). This conclusion, however, disposes of only some of the allegations against GSK and Biogen. Classen also alleges that GSK and Biogen vaccinated patients according to the patented methods, which I believe is not anchored within the statutory safe harbor.
Specifically, in Counts I, II, and IV, Classen accuses GSK of infringing through “the administration of vaccines according to the patented method[s].” Am. Compl. ¶¶ 27, 35, 51. Thus, in Counts I and II, Classen accuses GSK of screening schedules and then immunizing subjects in accordance with a lower risk schedule. In Count IV, Classen accuses GSK of determining the risk of an immunization schedule by immunizing subjects and then comparing the incidence of a disorder (i.e., an adverse event) to that in a control group. Biogen is similarly accused of “administering] the vaccines according to a [risk-reducing] protocol.” Am. Compl. ¶ 6. Although GSK and Biogen might be required to report adverse events that occur as a result of their vaccines, they are not required by law or regulation to perform such post-approval vaccinations in order to generate data. Accordingly, I conclude that these activities are not reasonably related to the development and submission of data to the FDA and therefore do not fall within § 271(e)(l)’s safe harbor exception.
The general administration of drugs or vaccines is not reasonably related to post-approval reporting requirements. For example, while the FDA requires the reporting of post-approval adverse reactions, this does not mean that all commercial uses of the vaccine are “solely for uses reasonably related to the development and submission of information under a Federal law.” The fact that GSK or Biogen would have to report to the FDA any adverse reaction after administering a vaccine does not mean the administration itself is noninfringing.
For these reasons, I would vacate the district court’s dismissal of counts I, II, and IV against GSK and Biogen because some of the alleged activities do not fall within the safe harbor of § 271(e)(1), and I would remand for further proceedings as to those parties. With respect to the district court’s grant of summary judgment of noninfringement to Merck, I agree with the majority’s affirmance because Classen failed to provide any record evidence sufficient to create a genuine issue of material fact.
. I am perplexed by the majority’s suggestion that this claim "is directed to the single step of reviewing the effects of known immunization schedules,” Maj. Op. at 1067, as the claim clearly requires immunizing mammals and then comparing the results to the known group. Moreover, the majority unfairly mischaracterizes Classen's arguments regarding the '283 patent. While Classen says "the claims of the patents in suit,” it is clear from the context that Classen is referring only to the comparison step of the '139 and '739 patents not requiring clinical trials. As that paragraph explains, the claims being discussed [the '139 and '739 claims] contain the two steps of "Step (I) screening” and "step (II)” immunizing. Moreover, the preceding paragraph clearly demonstrates his claim is that "neither the '139 nor the '739 patents require actual participation in conducting a study.” Classen Br. 40. When Classen actually references the '283 patent, he correctly describes the '283 claims as requiring "two method steps: (I) immunization and (II) comparison.” Classen Br. 7. The '283 patent claim clearly and unequivocally requires the physical act of immunization and it is unfair of the majority to analyze the claim for § 101 purposes as though it did not have that step.
. The majority explains the difference between the '283 claim (which it holds is not directed to patentable subject matter) and the '139 and '739 patent claims (which it holds are directed to patentable subject matter) as follows: "[Claim 1 of the '283 patent] stands in contrast to the '139 and '739 patent claims, which include the subsequent step of immunization on an optimal schedule." Maj. Op. at 1066.
. With all due respect to my colleagues, I do not agree with the additional views. First, the additional views improperly criticizes litigants for arguing that abstract ideas are exempt from patent protection. We are bound to follow Supreme Court precedent which clearly and explicitly holds that abstract ideas are not eligible for patent protection. Diamond,