The University of Rochester (“Rochester”) appeals from the decision of the United States District Court for the. Western District of New York granting summary judgment that United States Patent 6,048,850 is invalid.
Univ. of Rochester v. G.D. Searle &
Co.,
BACKGROUND
Traditional non-steroidal anti-inflammatory drugs (“NSAIDs”) such as aspirin, ibuprofen, ketoprofen, and naproxen are believed to function by inhibiting the activity of enzymes called cyclooxygenases. Cyclooxygenases' catalyze the production of a molecule called prostaglandin H2, which is a precursor for other prostaglan-dins that perform various functions in the human body. Id. at 219;
In the early 1990s, scientists discovered the existence and separate functions of two distinct cyclooxygenases, referred to as “COX-1” and “COX-2.” 1 COX-1 is expressed (i.e., produced biologically) in the gastrointestinal tract, where it is involved in the production of prostaglandins that' serve a beneficial role by, for example, providing protection for the stomach lining. Id. COX-2 is expressed in response to inflammatory stimuli, and is thought to be responsible for the inflammation associated with diseases such as arthritis. Id. It is now known that the traditional NSAIDs inhibit both COX-1 and COX-2, and as a result they not only reduce inflammation, *918 but also can cause undesirable side effects such as stomach upset, irritation, ulcers, and bleeding. Id.
After the separate functions of COX-1 and COX-2 were discovered, it was hypothesized that it would be possible to reduce inflammation without gastrointestinal side effects if a method could be found for selectively inhibiting the activity of COX-2 (ie., inhibiting the activity of COX-2 without inhibiting COX-1 activity). Id. To that end, Rochester scientists developed a screening assay for use in determining whether a particular drug displayed such selectivity, and filed a U.S. patent application directed to their developments in 1992. After filing a series of continuation, continuation-in-part, and divisional applications derived from that 1992 application, the scientists eventually received United States Patent 5,837,479 in 1998, covering methods “for identifying a compound that inhibits prostaglandin synthesis catalyzed by mammalian prostaglan-din H synthase-2 (PGHS-2).”
From a division of the application that led to the '479 patent, the scientists also obtained, on April 11, 2000, the '850 patent. The '850 patent contains three independent claims and five dependent claims. The three independent claims read as follows:
1. A method for selectively inhibiting PGHS-2 activity in a human host, comprising administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product to a human host in need of such treatment.
5. A method for selectively inhibiting PGHS-2 activity in a human host, comprising administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product in a human host in need of such treatment, wherein the activity of the non-steroidal compound does not result in significant toxic side effects in the human host. 6. A method for selectively inhibiting PGHS-2 activity in a human host, comprising administering a non-steroidal compound that selectively inhibits activity of the PGHS 2 gene product in a human host in need of such treatment, wherein the ability of the non-steroidal compound to selectively inhibit the activity of the PGHS-2 gene product is determined by:
a) contacting a genetically engineered cell that expresses human PGHS-2, and not human PGHS-1, with the compound for 30 minutes, and exposing the cell to a pre-determined-amount of arachidonic acid;
b) contacting a genetically engineered cell that expresses human PGHS-1, and not human PGHS-2, with the compound for 30 minutes, and exposing the cell to a pre-determined amount of arachidonic acid;
c) measuring the conversion of arachi-donic acid to its prostaglandin metabolite; and
d) comparing the amount of the converted arachidonic acid converted by each cell exposed to the compound to the amount of the arachidonic acid converted by control cells that were not exposed to the compound, so that the compounds that inhibit PGHS-2 and not PGHS-1 activity are identified.
’850 patent, col. 71, 1. 36 — col. 72, 1. 51. Thus, all eight claims are directed to methods “for selectively inhibiting PGHS-2 activity in a human host” by “administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product to [or in] a human host in need of such treatment.”
On the day the '850 patent issued, Rochester sued G.D. Searle & Co., Inc., Mon
*919
santo Co., Pharmacia Corp., and Pfizer Inc. (collectively, “Pfizer”), alleging that Pfizer’s sale of its COX-2 inhibitors Cele-brex® and Bextra® for treatment of inflammation infringed the '850 patent,
2
and seeking injunctive and monetary relief.
Univ. of Rochester,
In evaluating the parties’ motions, the district court found that, although all of the claims require the use of a “non-steroidal compound that selectively inhibits activity of the PGHS-2 gene,” the '850 patent neither discloses any such compound nor provides any suggestion as .to how such a compound could be made or otherwise obtained other than by trial-and-error research. Id. at 224-25, 228-29. Indeed, the court found no evidence in the '850 patent that the inventors themselves knew of any such compound at the time their patent application was filed. Id. at 228. Accordingly, the court concluded that the patent’s claims are invalid for lack of written description. Id. at 224.
The district court also found that practice of the claimed methods would require “a person of ordinary skill’in the art ... to engage in undue experimentation, with no assurance of success,” and on that basis concluded that the claims are also invalid for lack of enablement. Id. at 232. The court considered, but rejected as eoncluso-ry, Rochester’s experts’ opinions that one of skill in the art would have known to start with existing NSAIDs and would have used routine methods to make structural changes to lead compounds to optimize them, citing a general failure to point to any language in the patent supporting those opinions. Id. at 233.
Finding no genuine issue of material fact concerning either written description or enablement, the district court accordingly granted' Pfizer’s motions for summary judgment of invalidity of the '850 patent for failure to meet the written description and enablement requirements, denied Rochester’s cross-motion, and dismissed the complaint. Id. at 235-36.
Rochester now áppeals. We have jurisdiction pursuant to 28 U.S.C. § 1295(a)(1).
DISCUSSION
Rochester asserts three grounds of error on appeal. First, it argues that the district court erred by granting Pfizer’s motion for summary judgment of invalidity for lack of written description. Second, it argues that the court erred by granting Pfizer’s motion for summary judgment of invalidity for lack of enablement. Third, Rochester contends that the court erred by denying its cross-motion for summary judgment with regard to written description. Pfizer refutes each of those asserted grounds of error.
Summary judgment- is appropriate when there are no genuine issues of material fact and the moving party is entitled to judgment as a matter of law. Fed.R.Civ.P. 56(c);
Johns Hopkins Univ. v. Cellpro, Inc.,
An issued patent enjoys a presumption of validity, 35 U.S.C. § 282, that can be overcome only through clear and convincing evidence,
U.S. Surgical Corp. v. Ethicon, Inc.,
In its first argument, Rochester asserts that the district court effectively— but erroneously — held that a patent claiming a method of obtaining a biological effect in a human by administering a compound cannot, as a matter of law, satisfy the written description requirement without disclosing the identity of any such compound. Indeed, Rochester contends that “no written description requirement exists independent of enablement.” In any event, Rochester argues that its patent met the requirements of § 112 and is not invalid. 3
Pfizer responds to Rochester’s argument by pointing out that we have “interpreted § 112 ‘as requiring a “written description” of an invention separate from enablement,’ ” (citing
Enzo Biochem, Inc. v. Gen-Probe Inc.,
We agree with Pfizer that our precedent recognizes a written description requirement and that the '850 patent does not satisfy that requirement. As in any case involving statutory interpretation, we be
*921
gin with the language of the statute itself.
Consumer Prod. Safety Comm’n v. GTE Sylvania, Inc.,
The specification shall contain a written description of the invention, and of the manner and process of making and. using it, in such full, clear, concise, and-exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
35 U.S.C. § 112, ¶ 1 (2000). Three separate requirements are contained in that provision: (1) “[t]he specification shall corn tain a written description of the invention”; (2) “[t]he specification shall contain a written description ... of the manner and process of making and using it [ie., the invention] in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same”; and (3) “[t]he specification ... shall set forth the best mode contemplated by the inventor of carrying out his invention.”
In common parlance, as well as in our and our predecessor court’s case law, those three requirements are referred to as the “written description requirement,” the “enablement requirement,” and the “best mode requirement,” respectively.
See In re Moore,
Although there is often significant overlap between the three requirements, they are nonetheless independent of each other.
In re Alton,
The “written description” requirement serves a teaching function, as a
“quid pro quo
” in which the public is given “meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time.”
Enzo,
In addition, and most significantly, our precedent clearly recognizes a separate written description requirement. In
In re Ruschig,
The Patent Office Board of Appeals, and subsequently the Court of Customs and Patent Appeals, affirmed that rejection. In reaching its decision, the court observed that the claimed compound was not described in the specification and would not “convey clearly to those skilled in the art, to whom it is addressed, in any way, the information that appellants invented that specific compound.” Id. at 996. It did not teach the specific compound. Although the appellants had argued that the rejection was improper because one skilled in the art would be enabled by the specification to make the specific compound, the court explained that it was “doubt[ful] that the rejection [was] truly based on section 112, at least on the parts relied on by appellants [ie., the ‘language therein about enabling one skilled in the art to make the invention’]. If based on section 112, it is on the requirement thereof that ‘The specification shall contain a written description of the invention.’ ” Id. at 995-96.
While it is- true that this court and its predecessor have repeatedly held that
*923
claimed subject matter “need not be described in haec verba” in the specification to satisfy the written description requirement,
e.g., In re Smith,
[T]he appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement.... A description of an anti-inflammatory steroid, ie., a steroid (a generic structural term) described even in terms of its function of lessening inflammation of tissues fails to distinguish any steroid from others having the same activity or function. A description of what a material does, rather than of what it is, usually does not suffice. [Regents of the Univ. of Cal. v.] Eli Lilly [ & Co., Inc.], 119 F.3d [1559,] 1568 [ (Fed.Cir.1997) (“Lilly”) ].... The disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described. Id.
Enzo,
Rochester is also factually incorrect in its assertion that a written description requirement separate from the enablement requirement was not recognized prior to
Ruschig
in 1967. For example, in
Jepson v. Coleman,
Similarly, in 1962 the court affirmed the Board’s rejection of the original claims in a patent application, based on,
inter alia,
the rejected claims’ “fail[ure] to meet the requirements of 35 U.S.C. § 112 in that they are broader than the invention described in the written description thereof as set forth in the specification.”
In re Sus,
Rochester’s suggestion in its brief that Lilly “compounded Ruschig’s error” by “invoking the written description requirement in a case without priority issues” is similarly deficient. Neither Wm. Moore nor Sus, for example, involved any priority issues. Moreover, even if the court had never had occasion to apply the written description requirement to original claims prior to the 1987 Lilly decision, that requirement was nonetheless always present. As explained in Enzo:
It is said that applying the written description requirement outside of the priority context was novel until several years ago. Maybe so, maybe not; certainly such a holding was not precluded by statute or precedent. New interpretations of old statutes in light of new fact situations occur all the time....
... As for the lack of earlier cases on this issue, it regularly happens in adjudication that issues do not arise until counsel raise them, and, when that occurs, courts are then required to decide them.
Indeed, as early as 1822 the Supreme Court recognized the existence of separate written description and enablement requirements:
[T]he patent act requires ... that the party [ie., the inventor] “shall deliver a written description of his invention, in such full, clear, and exact terms, as to distinguish the same from all other things before know[n], and to enable any person skilled in the art or science, & c. & c. to make, compound, and use the same.” The specification, then has two objects: one is to make known the manner of constructing the machine (if the invention is of a machine) so as to enable artizans [sic] to make and use it, and thus to give the public the full benefit of the discovery after the expiration of the patent.... The other object of the specification is, to put the public in possession of what the party claims as his own invention, so as to ascertain if he claim anything that is in common use, or is already known, and to guard against prejudice or injury from the use of an invention which the party may otherwise innocently suppose not to be patented.
Evans v. Eaton,
Rochester also argues that
Fiers v. Revel,
We agree with Rochester that
Fiers, Lilly,
and
Enzo
differ from this case in that they all related to genetic material whereas this case does not, but we find that distinction to be unhelpful to Rochester’s position. It is irrelevant; the statute applies to all types of inventions. We see no reason for the rule to be any different when non-genetic materials are at issue; in fact, where there might be some basis for finding a written description requirement to be satisfied in a genetics case based on the complementariness of a nucleic acid and, for example, a protein, that correspondence might be less clear in a non-genetic situation. In
Enzo,
we explained that functional descriptions of genetic material can, in some cases, meet the written description requirement if those functional characteristics are “coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics.”
The same is not necessarily true in the chemical arts more generally. Even with the three-dimensional structures of enzymes such as COX-1 and COX-2 in hand, it may even now not be within the ordinary skill in the art to predict what compounds might bind to and inhibit them, let alone have been within the purview of one of ordinary skill in the art in the 1993-1995 period in which the applications that led to the '850 patent were filed. Rochester and its experts do not offer any persuasive evidence to the contrary. As the district court pointed out:
Tellingly, ... what plaintiffs experts’ [sic] do not say is that one of skill in the art would, from reading the patent, understand what compound or compounds — which, as the patent makes clear, are necessary to practice the claimed method — would be suitable, nor would one know how to find such a compound except through trial and error .... Plaintiffs experts opine that a person of ordinary skill in the art would understand from reading the '850 patent *926 what method is claimed, but it is clear from reading the patent that one critical aspect of the method — a compound that selectively inhibits PGHS-2 activity— was hypothetical, for it is clear that the inventors had neither possession nor knowledge of such a compound.
Univ. of Rochester,
Rochester also attempts to distinguish
Fiers, Lilly,
and
Enzo
by suggesting that the holdings in those cases were limited to composition of matter claims, whereas the '850 patent is directed to a method. We agree with the district court that that is “á semantic distinction without a difference.”
Univ. of Rochester,
We of course do not mean to suggest that the written description requirement can be satisfied only by providing a description of an actual reduction to practice. Constructive reduction to practice is an established method of disclosure, but the application must nonetheless “describe the claimed subject matter in terms that establish that [the applicant] was in possession of the ... claimed invention, including all of the elements and limitations.”
Hyatt v. Boone,
Rochester also contends that “[t]he patent-in-suit cannot be per se invalid,” because written description is a question of fact. Rochester further argues that:
[Consistent with written description’s fact-intensive nature, this Court has recognized diverse forms of description, including description primarily (if not entirely) based on functional characteristics. In Union Oil [Co. v. Atlantic Richfield Co.,208 F.3d 989 (Fed.Cir.2000) (“Unocal”) ], for example, the Court rejected the argument that the patent-in-suit was invalid because it described claimed gasoline mixtures by their “desired characteristics,” rather than by their “exact chemical compo-nentes].”
In response, Pfizer argues that the district court did not apply a per se rule, and that written description of a method of selectively inhibiting the activity of an enzyme by administering a chemical compound is insufficient unless a skilled artisan can recognize the identity of the compound, and the description must convey what the compound is, not just what it does. Pfizer points out that the district court found that the '850 patent does not disclose the structure or physical properties of any of the compounds required to practice the claimed methods, and that the structure of such compounds cannot be deduced from any known structure-function correlation. Pfizer agrees with the district court that the '850 patent discloses nothing more than a hoped-for function for an as-yet-to- *927 be-discovered compound, and a research plan for trying to find it.
We agree with Pfizer that the '850 patent is deficient in failing to adequately describe the claimed invention. First, although compliance with the written description requirement is a question of fact,
Vas-Cath,
Second, it is undisputed that the '850 patent does not disclose any compounds that can be used in its claimed methods. The claimed methods thus cannot be practiced based on the patent’s specification, even considering the knowledge of one skilled in the art. No compounds that will perform the claimed method are disclosed, nor has any evidence been shown that such a compound was known. The '850 patent does contain substantial description of the cyclooxygenases, including the nucleotide sequences of coding and promoter regions of the genes that encode human COX-1 and COX-2 and a comparison of those sequences.
See, e.g.,
'850 patent, figs. 6A-6B, 10A-10D, and 11A-11C. The patent also describes in detail how to make cells that express either COX-1 or COX-2, but not both,
id.
§ 5.2, at cols. 8-20, as well as “assays for screening compounds, including peptides, polynucleotides, and small organic molecules to identify those that inhibit the expression or activity of the PGHS-2 gene product; and methods of treating diseases characterized by aberrant PGHS-2 activity . using such compounds,”
id.
at col..8, 11. 2-7;
see also id.
§ 5.6, at cols. 24-25. Such assay methods are in fact claimed in the '479 patent,
i.e.,
Rochester’s
other
patent based on the same disclosure. The '850 patent specification also describes what can be done with any compounds that may potentially be identified through those assays, including formulation into pharmaceuticals, routes of administration, estimation of effective dosage, and . suitable dosage forms.
Id.
§ 5.8, at cols. 27-34. As pointed out by the district court, however, the '850 patent does not disclose just
“which
‘peptides, polynucleotides, and small organic molecules’ have the desired characteristic of selectively inhibiting PGHS-2.”
Univ. of Rochester,
Third, Rochester’s reliance on
Unocal
is unavailing. Although we held in that case that a “description] of the exact chemical component of each combination that falls within the range claims of the '... patent” is not necessary to comply with § 112, we explained that the patentee is nonetheless required to provide sufficient description
*928
to show one of skill in the art that the inventor possessed the claimed invention at the time of filing.
Unocal,
Rochester also cites
In re Edwards,
Although cases such as Unocal, Enzo, Edwards, and Herschler demonstrate that patent applicants have some flexibility in the “mode selected for compliance” with the written description requirement, neither those cases nor any other cases cited by Rochester eliminate the requirement that the patent specification set forth enough detail to allow a person of ordinary skill in the art to understand what is claimed and to recognize that the inventor invented what is claimed. The only claims that appear to be supported by the specification are claims to assay methods, but those claims were already issued in the '479 patent.
*929 Rochester argues that “[t]he appealed decision vitiates universities’ ability to bring pioneering innovations to the public,” and that:
Congress has determined that licensing of academia’s inventions to industry is the best way to bring groundbreaking inventions to the public. See 35 U.S.C. § 200. By vesting in universities the patent rights to their federally funded research, the Bayh-Dole Act of 1980 encouraged “private industry to utilize government funded inventions through the commitment of the risk capital necessary to develop such inventions to the point of commercial application.” H.R.Rep. No. 96-1307, pt. 1, at 3 (1980).
Further, amici the University of California and the University of Texas assert that “[t]his Court’s decision will have a significant impact on the continuing viability of technology transfer programs at universities and on the equitable allocation of intellectual property rights between universities and the private sector.”
That argument is unsound. The Bayh-Dole Act was intended to enable universities to profit from their federally-funded research. It was not intended to relax the statutory requirements for patentability. As pointed out by amicus Eli Lilly, “no connection exists between the Bayh-Dole Act and the legal standards that courts employ to assess patentability. Furthermore, none of the eight policy objectives of the Bayh-Dole Act encourages or condones less stringent application of the patent laws to universities than to other entities. See 35 U.S.C. § 200.” 8
In sum, because the '850 patent does not provide any guidance that would steer the skilled practitioner toward compounds that can be used to carry out the claimed methods — an essential element of every claim of that patent — -and has not provided evidence that any such compounds were otherwise within the knowledge of a person of ordinary skill in the art 9 at the relevant time, Rochester has failed to raise any question of material fact whether the named inventors disclosed the claimed invention. Accordingly, we affirm the district court’s grant of Pfizer’s motion for summary judgment.
In view of our affirmance of the district court’s decision on the written description *930 ground, we consider the enablement issue to be moot and will not discuss it further.
With respect to the third asserted error, relating to the denial of Rochester’s cross-motion for summary judgment, Rochester argues that because Pfizer adduced no evidence, other than the patent in suit, to support its written description defense, Rochester was entitled to summary judgment on that issue. Rochester contends that, because all issued patents are presumed to be valid, the district court was wrong to conclude that the '850 patent constitutes clear and convincing proof of its own invalidity.
Pfizer responds by arguing that there is no issue of material fact in dispute and that the '850 patent is invalid as a matter of law. Pfizer argues further that the district court properly found that Rochester’s experts’ declarations did not raise any issue of material fact, because they focused only on the use and function of the screening assay, rather than on the disclosure in the specification of a suitable compound. According to Pfizer, common sense dictates that one has not described a method of treating a disease with a drug if he has not disclosed any such drug or even if one exists, and there is accordingly no need for any evidence of invalidity beyond the '850 patent itself.
Although section 282 of the Patent Act places the burden of proof on the party seeking to invalidate a patent, it does not foreclose the possibility of that party demonstrating that the patent in suit proves its own invalidity,
see, e.g., PIN/NIP,
CONCLUSION
Because the court did not err in holding the '850 patent to be invalid for failing to comply with the written description requirement of 35 U.S.C. § 112, ¶ 1, and in granting summary judgment in favor of Pfizer on that ground, the decision of the district court is
AFFIRMED.
Notes
. COX-l and COX-2 are alternatively referred to as "PGHS-1” and “PGHS-2,” respectively, where "PGHS” is an abbreviation for “pros-taglandin H synthase.”
. Celebrex® and Bextra®, generically known as celecoxib and valdecoxib, respectively, were both developed by Searle, which was purchased by Monsanto in 1985. In 2000, Monsanto merged with Pharmacia & Upjohn, Inc. to form Pharmacia Corp. In 2002, Monsanto, sans Searle, was spun off from Phar-macia, and Pharmacia merged with.Pfizer in 2003. The combined company has retained the name Pfizer Inc.
. Rochester is supported by amici curiae the Regents of the University of California, the University of Texas Southwestern Medical Center at Dallas, and the University of Texas M.D. Anderson Cancer Center, which make essentially the same points.
. Pfizer is supported by amicus curiae Eli Lilly & Co., which makes similar arguments.
. We and the Supreme Court have frequently used the term “public notice” in connection with claims and discussion of the doctrine of equivalents, the point being that the public is entitled to notice of what the inventor has claimed and the Patent and Trademark Office has agreed should be the subject of a patent's limited right to exclude. However, while the role of the claims is to give public notice of the subject matter that is protected, the role of the specification is to teach, both what the invention is (written description) and how to make and use it (enablement).
. In
Sus,
the claims at issue were rejected by the patent examiner under 35 U.S.C. § 112, ¶ 2. However, the Court of Customs and Patent Appeals pointed out in subsequent cases that that rejection was "more properly considered under the first paragraph of that section.”
In re Robins,
. Indeed, if compounds that selectively inhibit activity of the PGHS-2 gene product had been known in the art, it is difficult to see how the claims of the '850 patent would have satisfied the novelty requirement of 35 U.S.C. § 102. After all, the novelty of those claims, if any, would appear to reside in the fact that COX-2 selective inhibitors were previously unknown. The issue of patentability under § 102, however, was not decided by the district court, and we do not address it further.
. Section 200, entitled “Policy and objective,” provides that:
It is the policy and objective of the Congress to use the patent system to promote the utilization of inventions arising from federally supported research or development; to encourage maximum participation of small business firms in federally supported research and development efforts; to promote collaboration between commercial concerns and nonprofit organizations, including universities; to ensure that inventions made by nonprofit organizations and small business firms are used in a manner to promote free competition and enterprise without unduly encumbering future research and discovery; to promote the commercialization and public availability of inventions made in the United States by United States industry and labor; to ensure that the Government obtains suffi-cienl rights in federally supported inventions to meet the needs of the Government and protect the public against nonuse or unreasonable use of inventions; and to minimize the costs of administering policies in this area.
35 U.S.C. § 200 (2000).
. In
O’Reilly v. Morse,
. Although we have treated the issue in this case as one of written description, as it was argued and decided below, underlying that question is the fundamental issue whether Rochester actually invented the subject matter it claimed in the '850 patent as required by 35 U.S.C. § 102(1). As the Supreme Court has cautioned, "a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.”
Brenner
v.
Manson,