375 F.3d 1303
UNIVERSITY OF ROCHESTER, Plaintiff-Appellant,
v.
G.D. SEARLE & CO., INC., Monsanto Company, Pharmacia Corporation, and Pfizer Inc., Defendants-Appellees.
No. 03-1304.
United States Court of Appeals, Federal Circuit.
July 2, 2004.
Gerald P. Dodson, Morrison & Foerster, LLP, of Palo Alto, California, filed a petition for rehearing en banc for plaintiff-appellant. With him on the petition were Emily A. Evans, Erica D. Wilson and Erik J. Olson.
Gerald Sobel, Kaye Scholer LLP, of New York, NY, filed an opposition to the petition for defendants-appellees. With him on the opposition were Richard G. Greco, Sylvia M. Becker and Daniel L. Reisner. Of counsel on the opposition was Robert L. Baechtold, Fitzpatrick, Cella, Harper & Scinto, of New York, NY.
Daniel J. Furniss, Townsend and Townsend and Crew LLP, of Palo Alto, CA, filed an amici curiae brief for the Regents of the University of California, et al. With him on the brief were Susan M. Spaeth and Madison C. Jellins.
ORDER
LARIMER, Judge.
A petition for rehearing en banc was filed by the Appellant, and a response thereto was invited by the court and filed by the Appellees.1
This matter was referred first as a petition for rehearing to the merits panel that heard this appeal. Thereafter, the petition for rehearing en banc, response, and the amici curiae brief were referred to the circuit judges who are authorized to request a poll whether to rehear the appeal en banc. A poll was requested, taken, and failed.
Upon consideration thereof,
IT IS ORDERED THAT: (1) The petition for rehearing is denied.
(2) The petition for rehearing en banc is denied.
NEWMAN, Circuit Judge, dissents in a separate opinion.
LOURIE, Circuit Judge, concurs in a separate opinion.
RADER, Circuit Judge, with whom GAJARSA and LINN, Circuit Judges, join, dissents in a separate opinion.
LINN, Circuit Judge, with whom RADER and GAJARSA, Circuit Judges, join, dissents in a separate opinion.
DYK, Circuit Judge, concurs in a separate opinion.
The mandate of the court will issue on July 9, 2004.
Notes:
The Regents of the University of California, et al. filed an amici curiae brief
NEWMAN, Circuit Judge, dissenting from the denial of rehearing en banc.
I respectfully dissent from the court's decision not to resolve en banc the burgeoning conflict in pronouncements of this court concerning the written description and enablement requirements of the Patent Act. This question has been promoted from simple semantics into a fundamental conflict concerning patent scope and the support needed to claim biological products. The appropriate forum is now the en banc tribunal, not continuing debate in panel opinions applying divergent law.
I fully share Judge Lourie's understanding of the law. The continuing attack on well-established and heretofore unchallenged decisions such as Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed.Cir. 1991) ("we hereby reaffirm, that 35 U.S.C. § 112, first paragraph, requires a `written description of the invention' which is separate and distinct from the enablement requirement") and earlier cases such as In re Ruschig, 54 C.C.P.A. 1551, 379 F.2d 990 (CCPA 1967) (written description is one of three distinct requirements under 35 U.S.C. § 112) is not only unwarranted, but is disruptive of the stability with which this court is charged. If precedent has become obsolete or inapplicable, we should resolve the matter as a court and again speak with one voice.
The new biology has indeed raised new and important questions, with implications for policy as well as law. However, the answer is not the simplistic one espoused by some commentators; it is simply incorrect to say that there is not now and never has been a "written description" requirement in the patent law. It has always been necessary to disclose and describe what is patented. It has never been the law that one can claim what is not made known and set forth in the patent.
Various past decisions have been offered to support the exotic proposition that it is not necessary for the inventor to describe the patented invention, but that enablement alone suffices under the statute. These cases concern traditional issues of generic disclosures and specific examples, and questions of support and predictability for scientific concepts and their embodiments. Such traditional law was applied in Regents of the University of California v. Eli Lilly & Co. 119 F.3d 1559 (Fed.Cir. 1997), a case that is misdescribed in this debate, for Lilly does not depart from precedent in its holding that the written description requirement can be fulfilled by "a precise definition, such as by structure, formula, chemical name, or physical properties." Id. at 1565, quoting Fiers v. Revel, 984 F.2d 1164, 1171 (Fed.Cir.1993).
If the nature of the subject matter is not amenable to precise description, some alternative mode of disclosure is required, such as deposit in a public depository. Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956 (Fed.Cir.2002). However, the public purpose of patents is seriously disserved by eliminating the description requirement entirely. Federal Circuit law of written description has become encumbered with inconsistent pronouncements, leading me to remark that "[c]laims to an invention that is not described in the specification are an anachronism." Housey Pharms., Inc. v. Astrazeneca UK Ltd., 366 F.3d 1348, 1357 (Fed.Cir.2004) (Newman, J., dissenting). If the majority of this court is nonetheless sympathetic to that position, there should be careful consideration of the implications of precedent, for the law is that "Section 112 requires that the application describe, enable, and set forth the best mode of carrying out the invention." Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 724, 122 S.Ct. 1831, 152 L.Ed.2d 944 (2002).
The issue of whether patent law contains a separate written description requirement has percolated through various panels of this court, on a variety of facts. The differences of opinion among the judges of the Federal Circuit, are, in microcosm, the "percolation" that scholars feared would be lost by a national court at the circuit level. Percolation is the great justifier of conflict among the regional circuits. In the words of the Supreme Court:
We have in many instances recognized that when frontier legal problems are presented, periods of "percolation" in, and diverse opinions from, state and federal appellate courts may yield a better informed and more enduring final pronouncement by this Court.
Arizona v. Evans, 514 U.S. 1, 24 n. 1, 115 S.Ct. 1185, 131 L.Ed.2d 34 (1995). This question has percolated enough; it is ripe for en banc resolution.
LOURIE, Circuit Judge, concurring.
I concur in the decision of the court not to rehear this case en banc, just as previously the court also declined to hear a written description case en banc. See Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 970-75 (Fed.Cir.2002). That is because this case was properly decided based on one of the grounds relied on by the district court in invalidating the Rochester patent, see Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916 (Fed.Cir.2004), the analysis of which will not be repeated here.
Contrary to the assertions of the appellant, certain amici, and some of the dissenters, there is and always has been a separate written description requirement in the patent law. The requirement to describe one's invention is basic to the patent law, and every patent draftsman knows that he or she must describe a client's invention independently of the need to enable one skilled in the relevant art to make and use the invention. The specification then must also describe how to make and use the invention (i.e., enable it), but that is a different task.
The requirements of the statute cannot be swept away by claiming that it relates only to priority issues or that the prohibition on introduction of new matter takes care of the need for a written description. The statute does not contain a limitation that it pertains only to priority issues. Moreover, the prohibition on introduction of new matter (35 U.S.C. § 132) is not a substitute for the written description requirement. Section 282 of the Patent Act lists as a defense to an infringement action invalidity arising from a failure to comply with a requirement of section 112 of the Act, which includes written description. In contrast, the new matter provision, section 132, appears in a provision entitled "Notice of rejection; reexamination." Failure to comply with that section is not expressly listed in the statute as an invalidity defense to infringement, although we have held that the unsupported claims are invalid. See, e.g., Quantum Corp. v. Rodime, PLC, 65 F.3d 1577 (Fed.Cir.1995) (invalidating claims that were broadened in scope during reexamination in violation of 35 U.S.C. § 305, which is analogous to section 132).
The separate written description requirement poses no conflict with the role of the claims. It is well established that the specification teaches an invention, whereas the claims define the right to exclude. SRI Int'l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1121 n. 14 (Fed.Cir.1985). While claims must be supported by the written description, the latter contains much material that is not in the claims. The written description contains an elucidation of various aspects of an invention as well as material that is necessary for enablement. Moreover, the written description often contains material that an applicant intended to claim that has been rejected in examination. Thus, the written description and the claims do not duplicate each other.
The fact, if it is a fact, that written description has only been relied upon in recent years as a ground of invalidity does not remove that requirement from the statute. Legal holdings arise when they do because litigants raise them and courts have to decide them. Contrary to what has been asserted, the interpretation of the statute as containing a separate written description requirement did not originate with Lilly. See Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555 (Fed.Cir.1991); In re Ruschig, 54 C.C.P.A. 1551, 379 F.2d 990 (CCPA 1967). It has always been there. And if a particular scope of claim has not been sustained by the courts for failure to comply with the written description requirement, it is because the applicant did not describe, and presumably did not invent, the subject matter of the scope sought.
Moreover, it is not correct, as has been asserted, that our decisions, particularly Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559 (Fed.Cir.1997), have created a "heightened" written description requirement for biotechnology inventions. We have applied the written description requirement to cases that are not in the fields of chemistry or biotechnology. See, e.g., In re Curtis 354 F.3d 1347 (Fed.Cir. 2004) (dental floss); Tronzo v. Biomet, Inc., 156 F.3d 1154 (Fed.Cir.1998) (artificial hip sockets); Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473 (Fed.Cir. 1998) (sectional sofas); Lockwood v. Am. Airlines, Inc., 107 F.3d 1565 (Fed.Cir. 1997) (automated sales terminals); Vas-Cath (double lumen catheters). The statute is the same for all types of inventions, although it may be applied differently, based on the technology and what is known by one of ordinary skill in the art at the time an invention was made. Indeed, Rochester's claimed invention at issue in the present case is not biotechnological. Although the inventors apparently contemplated that the tools of biotechnology would be used to determine whether a given drug is a COX-2 inhibitor insofar as the specification of the '850 patent describes how to make cell lines that express one or the other of COX-1 and COX-2, that method is claimed in another patent. The claims of this patent are all directed to pharmaceutical methods for selectively inhibiting a natural process in the human body. That is not what one commonly refers to as biotechnology.
It has been noted that genes can be described by their informational function, not just by structure or physical or chemical properties, and that a lesser written description may be adequate than is required for other types of inventions. Maybe so. Technology progresses, and what one skilled in the art would read from a particular disclosure may change. The PTO has now provided guidelines that help to guide applicants in preparing their patent applications.
It is obviously correct that genes convey information (e.g., to make other nucleic acids or to encode particular proteins). That fact does not serve to deny the existence of a written description requirement in the law. It only goes to whether, under the facts of a particular case, the written description requirement has been met. A fact-finder may have to decide whether claiming a material solely by its information-conveying character results in a "single means claim" purporting to claim everything that works, a dubious fulfillment of the requirement to "distinctly claim the subject matter" of the invention. 35 U.S.C. § 112. In any event, it is fact-intensive. But, once again, these matters go to whether the written description requirement has been met, not whether it exists.
As for the proposition that an original claim is part of the written description, that is clear. See In re Gardner, 475 F.2d 1389, 1391 (CCPA 1973). However, the issue may still remain in a given case, especially with regard to generic claims, whether an original claim conveys that one has possession of and thus has invented species sufficient to constitute the genus. Thus, the fact that a statement of an invention is in an original claim does not necessarily end all inquiry as to the satisfaction of the written description requirement. See Enzo, 323 F.3d at 968-69 ("[R]egardless whether the claim appears in the original specification and is thus supported by the specification as of the filing date, § 112, ¶ 1 is not necessarily met.... If a purported description of an invention does not meet the requirements of the statute, the fact that it appears as an original claim or in the specification does not save it. A claim does not become more descriptive by its repetition, or its longevity.").
In sum, I concur in the decision of the court not to rehear this case en banc. Our precedent is clear and consistent and necessitates no revision of written description law.
RADER, Circuit Judge, dissenting from the court's decision not to hear the case en banc, with whom Circuit Judges GAJARSA and LINN, join.
By a narrow margin,1 this court has declined to take this case en banc. Thus, this court avoids the opportunity to clarify and correct its confusing jurisprudence on the new written description invalidity doctrine.
In 1997, this court for the first time applied the written description language of 35 U.S.C. § 112, ¶ 1 as a general disclosure requirement in place of enablement, rather than in its traditional role as a doctrine to prevent applicants from adding new inventions to an older disclosure. Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559 (Fed.Cir.1997). In simple terms, contrary to logic and the statute itself, Eli Lilly requires one part of the specification (the written description) to provide "adequate support" for another part of the specification (the claims).2 Neither Eli Lilly nor this case has explained either the legal basis for this new validity requirement or the standard for "adequate support." Because this new judge-made doctrine has created enormous confusion which this court declines to resolve, I respectfully dissent.
Confusion in This New Validity Doctrine
A recent case illustrates well the confusion engendered by this new doctrine. In Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956 (Fed.Cir.2002), this court struggled over the scope of the written description invalidity doctrine first created in 1997. Eli Lilly, 119 F.3d at 1559. In its original Enzo opinion, 285 F.3d 1013 (Fed.Cir.2002), this court invalidated claims to polypeptides that detect the gonorrhea bacteria. The inventor of these DNA probes specifically disclosed them and deposited three polypeptides at the American Type Culture Collection. Even for claims limited in scope to the deposited material, this court invalidated the patent for insufficient disclosure of the invention. Id. at 1022 (concluding that "a deposit is not a substitute for a written description of the claimed invention" (quotation omitted)). This decision correctly applied the 1997 Eli Lilly doctrine which requires a nucleotide-by-nucleotide recitation of the structure of a biotechnological invention. Eli Lilly, 119 F.3d at 1567. Accordingly, the mere deposit of material did not satisfy that reading of 35 U.S.C. § 112, ¶ 1. Enzo, 285 F.3d at 1022.
That Enzo opinion caused an immediate firestorm. See, e.g., Brief of Amicus Curiae United States at 1, Enzo Biochem, Inc. v. Gen Probe, Inc., 323 F.3d 956 (Fed.Cir. 2002). Within a few months, this court vacated its original opinion and reversed the result. See Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956 (Fed.Cir. 2002). This flip-flop shows the problem. The Director of the Intellectual Property program at the George Washington University Law School stated it concisely: "[S]ince the first panel opinion faithfully followed Eli Lilly, and the result is obviously wrong, the Eli Lilly description doctrine is itself misguided." Martin J. Adelman, If Eli Lilly Is Good Law, Didn't the Withdrawn Panel Opinion in Enzo Biochem Have It Right?, at 2 (2003) (unpublished paper prepared for the 11th Annual Conference on International Intellectual Property Law and Policy at Fordham University, April 24-25, 2003).
Following issuance, withdrawal, and reissuance of Enzo, this court engaged in lengthy debate over the new disclosure validity doctrine. Enzo Biochem, 323 F.3d at 971-75 (Lourie, J., concurring in decision to not hear the case en banc); id. at 975 (Newman, J., concurring); id. at 975-76 (Dyk, J., concurring); id. at 976-87 (Rader, J., dissenting)3; id. at 987-89 (Linn, J., dissenting). That debate continued in this court's subsequent cases. See, e.g., Moba B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1323 (Fed.Cir.2003) (Rader, J., concurring) (explaining that juries face the "cumbersome task" of deciding that "the patent's disclosure can enable a skilled artisan to make and practice the entire invention, but still not inform that same artisan that the inventor was in possession of the invention").
Indeed a brief survey of the literature on this topic, an astounding amount in a few short years, shows 31 articles criticizing the Eli Lilly doctrine, 7 articles defending the doctrine, and 16 neutrally commenting on the state of this evolving case law.4 In its brief requesting en banc reconsideration in Enzo Biochem, the United States issued a call for clarity, which this court has yet to address:
Although this Court has addressed the "written description" requirement of section 112 on a number of occasions, its decisions have not taken a clear and uniform position regarding the purpose and meaning of the requirement.... A review of the plain text of section 112, and the case law of this Court, reveals at least three different possible tests for an adequate "written description." ... En banc consideration of the written description provision is appropriate so that the court can provide inventors, the public, and the USPTO with an authoritative interpretation of the provision.
Brief of Amicus Curiae United States at 4-5, 9.
In sum, by any measure, the Eli Lilly doctrine has engendered confusion. After all, Eli Lilly created a new validity doctrine under 35 U.S.C. § 112, ¶ 1 separate from enablement and yet described it as "analogous to enablement." 119 F.3d at 1569. Unfortunately, this court has passed up another opportunity to resolve the confusion.
Supreme Court's Role in the Eli Lilly Doctrine
In an effort to supply some coherent basis for its new validity doctrine, this court in Rochester refers to an 1822 Supreme Court case that discusses the written description language of the Patent Act. Univ. of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 924 (Fed.Cir.2004). An examination of Rochester's references to the Supreme Court in their proper historical context impeaches, rather than supports, the modern written description validity doctrine.
In 1793, the Patent Act, 1 Stat. 318, required an inventor to describe the scope of the invention in the body of the specification; the Act did not require any claims. Instead the Act required the inventor to provide "a written description of his invention, and of the manner of using, or process of compounding the same, in such full, clear, and exact terms, as to distinguish the same from all other things before known, and to enable any person skilled in the art or science ... to make, compound, and use the same...." In re Barker, 559 F.2d 588, 592 (CCPA 1977) (ellipses in original). Without citing this statutory language, Rochester recounts the Supreme Court's explanation that this provision contained two requirements:
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 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, 7 Wheat. 356, 20 U.S. 356, 433-34, 5 L.Ed. 472 (1822). For obvious reasons, Rochester undertakes no further explanation of the Supreme Court's language. In simple terms, the Supreme Court could not have meant that the written description portion of the specification must provide adequate support for the claims as this court's law presently requires. Patents did not even contain claims in 1822.
In fact, even the Supreme Court's allusion to "two objects," the reason for the Rochester cite, takes on a different meaning under careful legal analysis. The Supreme Court clearly linked its "other object" of the specification disclosure to the portion of the statute requiring the inventor "to distinguish the same from all things before known." Evans, 20 U.S. at 430. Significantly, that language no longer appears in 35 U.S.C. § 112. Later in 1870, the Patent Act first articulated the requirement that applicants define their exclusive right in a distinctly drafted claim. Act of July 8, 1870, Ch. 230, 16 Stat. 198. Only one logical conclusion flows from this history. When the Patent Act assigned the notice function to claims rather than the written description, enablement became the sole 35 U.S.C. § 112, ¶ 1 standard for adequate disclosure of an invention.5 See Enzo Biochem, 323 F.3d at 977. This observation about the meaning of 35 U.S.C. § 112, ¶ 1 has been axiomatic patent law for decades. In a decision of the Court of Customs and Patent Appeals that is binding on this court, Judge Rich interpreted 35 U.S.C. § 112, ¶ 1 to have only two requirements — not enablement and the Eli Lilly written description doctrine, but enablement and best mode! In re Gay, 50 C.C.P.A. 725, 309 F.2d 769, 772 (CCPA 1962). In sum, the Eli Lilly written description doctrine has no basis in this court's legal precedent. Thus, Rochester cannot explain the missing 1793 statutory language, the advent of the claim requirement that replaced the 1822 description doctrine, the inapplicability of the Evans quote to a new 1997 invalidity doctrine, or the apparent conflict with binding CCPA interpretations of 35 U.S.C. § 112, ¶ 1.
The Rochester reference to the 1822 Supreme Court language does, however, reveal some insights into the reasons that the Eli Lilly doctrine engenders confusion. As the 1822 Supreme Court reference explains, the original statute required a written description to warn "an innocent purchaser or other person using a machine, of his infringement." Evans, 20 U.S. at 434. In other words, the statute incorporated a written description requirement to define the scope of the invention for infringement and for distinguishing the invention from prior art. Eli Lilly and its progeny convert that original infringement doctrine into a new challenge to validity. Suddenly, all the difficulty and imprecision of defining an invention in legal language, see Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 731, 122 S.Ct. 1831, 152 L.Ed.2d 944 (2002), becomes a validity doctrine.
In sum, a careful legal analysis of the language and history of 35 U.S.C. § 112, ¶ 1 shows that the Eli Lilly doctrine has no basis in the written description language of the original Patent Act. Moreover, as this court's binding CCPA precedent shows, the statutory language of 35 U.S.C. § 112, ¶ 1 has not changed in any way that justifies "discovery" of a vast new validity doctrine over two hundred years after the 1793 Act. To the contrary, the changes in the statutory language of § 112, ¶ 1 since 1793 impeach the reasoning of Rochester and Eli Lilly.
Rochester also refers to the Supreme Court's listing of patent requirements in Festo. Rochester, 358 F.3d at 921 (quoting Festo, 535 U.S. at 736, 122 S.Ct. 1831). In the first place, the Festo listing is just that, a passing reference to some of the requirements of the Patent Act. The passing reference, for instance, does not even mention some binding requirements, e.g., subject matter eligibility and claim definiteness. In fact, in another post-Eli Lilly listing of Patent Act requirements, the Supreme Court acknowledged only enablement as the disclosure quid pro quo of the statute: "In addition [to novelty, utility, and nonobviousness], to obtain a utility patent, a breeder must describe the plant with sufficient specificity to enable others to `make and use' the invention after the patent term expires." J.E.M. AG Supply, Inc. v. Pioneer Hi-Bred Int'l, Inc., 534 U.S. 124, 142, 122 S.Ct. 593, 151 L.Ed.2d 508 (2001). A careful analysis of the Supreme Court's passing recitations of patent requirements does not support the Eli Lilly doctrine.
Rochester's invocation of the Festo listing of a "disclosure" requirement, however, betrays a telling incompleteness in its reasoning. The Supreme Court is entirely correct to acknowledge the requirement of full "disclosure" at the time of invention that prevents updating the patent document with later inventions. Beginning in 1967, this court and its predecessor applied the written description language to achieve this vital purpose of the Patent Act — tying disclosure to the time of invention. In re Ruschig, 54 C.C.P.A. 1551, 379 F.2d 990 (CCPA 1967); Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555 (Fed.Cir.1991). In the words of Judge Rich, the first judge to use the description requirement to police priority, "The function of the description requirement is to ensure that the inventor had possession, as of the filing date of the application relied on, of the specific subject matter later claimed by him." In re Wertheim, 541 F.2d 257, 262 (CCPA 1976) (emphasis added). In fact, every application of the written description doctrine before Eli Lilly in 1997 applied the written description doctrine for this important purpose and only for this important purpose. Enzo, 323 F.3d at 984-87 (listing every written description case in the CCPA and Federal Circuit). Thus, the Festo listing does not endorse the Eli Lilly innovation, but properly invokes the necessity of tying disclosure to the time of invention. In its attempt to support the 1997 doctrine, however, Rochester invokes Vas-Cath and other Federal Circuit decisions without noting the proper context of those decisions.
In sum, the Supreme Court offers no comfort to the Eli Lilly doctrine. Rather, in proper historical and legal context, the Supreme Court's allusions to the description requirement impeach both Rochester and Eli Lilly.6
The Hypothetical Policy Analysis
Rochester refers to a situation where a patent can enable an invention that is not described by the specification. In the words of the opinion, "[s]uch can occur when enablement of a closely related invention A that is both described and enabled would similarly enable an invention B if B were described." Rochester, 358 F.3d at 921 (emphasis original). This hypothetical seems to suggest that the 1997 doctrinal creation closes a major gap in patent law. To the contrary, this court only created the Eli Lilly requirement in 1997; the patent system had succeeded quite well for over two hundred years without it. Moreover no other patent system in the world has the Eli Lilly requirement to this day. The world's patent systems work quite well without it.
The hypothetical actually facilitates a policy analysis that explains the reasons that the new 1997 requirement is both superfluous and dangerous. In the first place, the hypothetical rarely, if ever, happens. No actual case presents the hypothetical. In both Eli Lilly and Rochester, for instance, the invention A (rat insulin in Eli Lilly; an assay for Cox 1 and 2 in Rochester) was enabled and described, but the invention B (human insulin in Eli Lilly; a Cox 2 inhibitor in Rochester) was not enabled.
In understandable terms, the hypothetical says that an inventor invents the radio, but his invention solves a problem that enables those of ordinary skill in the art to know how to make and use both a radio and a TV. His patent disclosure only describes a radio but he claims broadly an "electrical receiver." Thus, his claims seem to encompass the TV which his specification does not describe but would enable if it were described. In that context, the reason the hypothetical does not occur becomes obvious. If everyone of ordinary skill in the art knows from the disclosure how to make and use the TV, the exceptionally talented inventor will also. To avoid any risk of losing the TV invention, the inventor will fully disclose it and claim it, probably in a separate application. For this very practical reason, no case has ever presented the hypothetical. Inventors know when they have made an invention and realize that they must properly disclose it or risk losing it entirely.
Carrying the genuinely "hypothetical" hypothetical forward, however, what happens if the radio inventor for some unfathomable reason does not grasp that he has enabled a TV and later asserts the radio patent against a TV maker? In simple terms, a court would properly interpret the claim as limited to the radio. The TV maker would not infringe a claim that covers only the radio. On the other hand, the Eli Lilly doctrine would instead invalidate the radio patent. Is that the best result? After all, the inventor did invent the radio. Should he lose everything because he did not disclose the TV?
The facts of Eli Lilly itself illustrate the real problems in this area of patent interpretation and enforcement. In simple terms, the inventor in that case invented and disclosed rat insulin but not human insulin. In fact, at the dawn of the biotechnological age in 1977, the inventor could not make human insulin. Biotechnology was in its infancy; it would have taken months, if not years, of experimentation to make human insulin. Nonetheless the inventor claimed the rat insulin invention broadly and later asserted it against human insulin. In this setting, U.S. patent law (and world patent law in general) has two complementary ways to prevent any injustice — enablement and traditional (not Eli Lilly) written description (enforcing the actual time of invention). If the inventor has not enabled human insulin in the specification, the inventor has not enabled the full scope of the claim. By the way, as noted earlier, if the rat insulin inventor had invented human insulin as well, he surely would have disclosed it. In other words, a lack of disclosure is a dead give-away for enablement problems. Alternatively, or likely in conjunction, the traditional written description requirement as applied by this court and its predecessor beginning in 1967 will prohibit any addition of new matter to the patent document to "update" the claims to cover human insulin. See, e.g., Chiron Corp. v. Genentech, Inc., 363 F.3d 1247 (Fed.Cir.2004).
In sum, our patent law (and the world's patent law) has worked well for 200 years because the law already possesses ample remedies for the Rochester hypothetical, which, as a practical matter, never occurs. Neither Eli Lilly nor Rochester explains the legal policy that supports the new doctrine.
The Practical Problems
By its terms, the Eli Lilly doctrine stated: "An adequate written description of a DNA ... `requires a precise definition, such as by structure, formula, chemical name, or physical properties.'" 119 F.3d at 1566 (quoting Fiers v. Revel, 984 F.2d 1164, 1171 (Fed.Cir.1993)). In sum, Eli Lilly asserts a new free-standing validity requirement. Based on the absence of a nucleotide-by-nucleotide recitation in the specification of the human insulin cDNA, the court determined that the applicant had not adequately described the invention. Thus, the failure to actually sequence the nucleotides prevents an applicant from claiming a new and useful polypeptide.
This new 1997 rule changes the established rules of claiming and disclosing inventions. Many biotechnological inventions predate Eli Lilly. Before the 1997 change, no inventor could have foreseen that the Federal Circuit would make a new disclosure rule. Without any way to redraft issued patents to accommodate the new rule, many patents in the field of biotechnology face serious and unavoidable validity challenges simply because the patent drafter may not have included the lengthy nucleotide sequences. After all, the sequences are often routinely available (albeit at some cost) to those of ordinary skill in this art.
The Eli Lilly doctrine also seems to impose some illogical requirements on patent drafters today. Must a software patent disclose every potential coding variation that performs a claimed function? Must a biotechnological invention list every amino acid variation for a particular protein or protein function — a task conceivably as impractical as the software disclosure requirement? Must a university or small biotech company expend scarce resources to produce every potential nucleotide sequence that exhibits their inventive functions? Perhaps more important for overall patent policy, must inventors spend their valuable time and resources fleshing out all the obvious variants of their last invention instead of pursuing their next significant advance in the useful arts? Again Eli Lilly and Rochester appear to have given little thought to these unintended consequences.
This court, however, is not even the only judicial institution that must deal with the unintended consequences of the 1997 doctrine. Under this new disclosure test, every case where the written description does not specifically disclose some feature of the claimed invention will give rise to a validity challenge. Thus, trial courts will have to empanel juries to inquire whether one of skill in the art would have known that the inventor "possessed" the full invention. In a sense, the Eli Lilly doctrine converts this courts confusing case law about the role of the specification in defining the invention into a validity question. Thus, trial courts as well must struggle to discern the standard for sufficient disclosure of an invention.
Rochester emphasizes that this new disclosure doctrine is different from enablement. Rochester, 358 F.3d at 921. Thus, a trial court, as in this case, must first ask its jury whether the specification provides sufficient information to enable one of ordinary skill in the art to make and use the invention. Then the trial court must ask the jury again to look at the same specification for information that an inventor of extraordinary skill "possessed" the invention. Under this courts law, a patent disclosure could apparently enable one of ordinary skill to make and practice the entire invention, but still not inform that same artisan that the inventor was in possession of the invention. Moreover, the trial court must give separate instructions and entertain separate witnesses on these inseparable patent rules to ensure adequate disclosure. Viewed in the practical terms of trial procedure and jury understanding, this 1997 doctrine unnecessarily complicates and prolongs patent enforcement. In sum, Rochester does not resolve any of the confusion or provide a sound legal basis for the Eli Lilly doctrine. For these reasons, this court should have reviewed this case en banc.
Appendix
Defending Eli Lilly Written Description
---------------------------------------------------------------------------------------------------------
Citation Quotation
---------------------------------------------------------------------------------------------------------
Paula K. Davis, Questioning the Requirement By strictly requiring written description of
for Written Description: Enzo Biochem the invention, the public is guaranteed that
v. Gen-Probe and Overly Broad the inventor was in possession of the invention
Patent Cases, 37 Ind. L.Rev. 467, 500 (2004) when the patent application was filed.
In effect, the written description defines the
scope of the invention — the metes and
bounds that will be given exclusivity.
---------------------------------------------------------------------------------------------------------
F. Scott Kieff, The Case for Registering The U.S. Court of Appeals for the Federal
Patents and the Law and Economics of Circuit's strong reading of the written description
Present Patent-Obtaining Rules, 45 B.C. requirement to put the public on
L.Rev. 55, 99 (2003) clear notice of what will infringe and what
will not makes sense because the patentee,
as the drafter, is the least-cost avoider of
such ambiguities. This legal development
was controversial to be sure; yet it marks
an important weapon in the system's arsenal
for fighting social cost.
---------------------------------------------------------------------------------------------------------
Cynthia M. Lambert, Note: Gentry Gallery Although there may be negative effects resulting
and the Written Description Requirement, from a stricter written description
7 B.U. J. Sci. & Tech. L. 109, 139 (2001) standard, including narrowed patent scope
and a potential tragedy of the anticommons,
the stricter standard is the better choice in
terms of fairness to the public because it
prevents inventors from overreaching.
---------------------------------------------------------------------------------------------------------
Daniel P. Chisholm, Note: The Effect of the Absent this heightened interpretation,
USPTO's Written Description Guidelines broadly construed claims would allow applicants
on Gene Patent Applications, 35 Suffolk to obtain exclusive rights to products
U.L.Rev. 543, 570 (2001) in which they do not actually possess.
Granting such broad claims would stifle the
very purpose of the United States patent
system: preserving incentives for continued
innovations.
---------------------------------------------------------------------------------------------------------
Margaret Sampson, Comment: The The use of a heightened written description
Evolution of the Enablement and Written requirement by the Federal Circuit to
Description Requirements Under 35 U.S.C. define and limit the scope of claimed inventions
112 in the Area of Biotechnology, 15 preserves incentives for continued
Berkeley Tech. L.J. 1233, 1273 (2000) innovation.
---------------------------------------------------------------------------------------------------------
Mark J. Stewart, Note: The Written Description Through application of the written description
Requirement of 35 U.S.C. 112(1): requirement, courts can distinguish
The Standard After Regents of the University between claims to technologies that are too
of California v. Eli Lilly Co., 32 Ind. broad or basic to justify patent protection,
L.Rev. 537, 563 (1999) and those dealing with other types of technologies
that are more predictable and may
justify broader protection.
---------------------------------------------------------------------------------------------------------
Emanuel Vacchiano, Comment: It's a Wonderful Fortunately, the CAFC narrowly construes
Genome: The Written-Description patent rights based on disclosures of DNA
Requirement Protects the Human Genome sequences, and as a result, will likely invalidate
from Overly-Broad Patents, 32 J. Marshall patent claims based on EST disclosures
L.Rev. 805, 832 (1999) that contain a broad scope of protection
encompassing a gene or even an entire
protein-coding segment of a cDNA.
---------------------------------------------------------------------------------------------------------
Criticizing Eli Lilly Written Description
---------------------------------------------------------------------------------------------------------
Citation Quotation
---------------------------------------------------------------------------------------------------------
Stephen J. Burdick, Note: Moba v. Diamond Moba illustrates the problems associated
Automation, Inc.: Questioning the with the separate written description requirement.
Separate Written Description Requirement, The judge-made doctrine does
19 Berkeley Tech. L.J. 133, 151 (2004) not contribute any additional value to the
other patentability requirements. Its
effects are redundant with the enablement
and new matter requirements of patent law.
Additionally, the written description requirement
creates confusion and discourages
patenting and innovation. The Federal
Circuit should dispose of the separate written
description requirement entirely.
---------------------------------------------------------------------------------------------------------
Martin J. Adelman, 3-2 Patent Law [T]he original panel opinion in Enzo Biochem
Perspectives § 2.9 (2004) is correct if we assume that Eli Lilly
is sound law, since Eli Lilly holds that the
failure to actually detail the sequence of
nucleotides of a polypeptide prevents an
applicant from claiming it. Obviously merely
depositing a polypeptide does not disclose
its sequence without a sequencing operation.
Thus a disclosure that effectively puts the
polypeptide in possession of the public by
virtue of providing a set of directions for
obtaining it should not be treated differently
than an inventor who puts the polypeptide
in a depository without sequencing it. Since
this is a result that is difficult do defend, it
proves that the Eli Lilly doctrine is itself
misguided. It is thus time to formally overrule
it along with In re Deuel another case
that holds that the act of sequencing is the
key to patentability.
---------------------------------------------------------------------------------------------------------
Harold C. Wegner, The Disclosure Requirements The first problem here is the judicial activism
of the 1952 Patent Act: Looking from several panel opinions that created
Back and a New Statute for the Next Fifty a "written description" requirement apart
Years, 37 Akron L.Rev. 243, 244 (2004) from the original "new matter" proscription.
---------------------------------------------------------------------------------------------------------
Jennifer L. Davis, Comment: The Test of The court has not issued clear and consistent
Primary Cloning: A New Approach to the standards. In fact, the court itself
Written Description Requirement in Biotechnological appears confused over the proper standards
Patents, 20 Santa Clara by which to judge the adequacy of a written
Computer & High Tech. L.J. 469, 487-88 description as reflected by the recent decision
(2004) in Enzo I followed by a reversal upon
rehearing in Enzo II ....
---------------------------------------------------------------------------------------------------------
Martin J. Adelman, If Eli Lilly Is Good [S]ince the first panel opinion [in Enzo]
Law, Didn't the Withdrawn Panel Opinion faithfully followed Eli Lilly, and the result
in Enzo Biochem Have It Right?, at 2 reached is obviously wrong, the Eli Lilly
(2003) (unpublished paper prepared for the description doctrine is itself misguided.
11th Annual Conference on International
Intellectual Property Law and Policy at
Fordham University, April 24-25, 2003).
---------------------------------------------------------------------------------------------------------
Duane M. Linstrom, Spontaneous Mutation: In sum, the latest Enzo decision has shifted
A Sudden Change in the Evolution of the direction of the development of the written
the Written Description Requirement as It description requirement for DNA patents,
Applies to Genetic Patents, 40 San Diego but it has also left us with even more
L.Rev. 947, 970 (2003) uncertainty in the law than before the
ruling.
---------------------------------------------------------------------------------------------------------
Jennifer Gordon, Ph.D., Preparing and Until the dissenters can persuade the Court
Prosecuting a Patent That Holds Up in to review the Lilly written description rule
Litigation, 766 PLI/Pat 873, 907-08 (2003) en banc, the Federal Circuit can continue to
apply the Lilly standard to invalidate any
patent, regardless of whether priority is an
issue, where the written description does
not show possession of the invention at the
time of filing.
---------------------------------------------------------------------------------------------------------
Rachel Krevans and Cathleen Ellis, Preparing The Federal Circuit doctrine that makes
for Biotech Patent Litigation, 760 PLI/ enablement a separate requirement from
Pat 529, 555-56 (2003) the written description requirement contradicts
the plain language of the statute.
---------------------------------------------------------------------------------------------------------
John C. Stolpa, Case Comment: Toward The Federal Circuit should take the next
Aligning the Law with Biology? The Federal available opportunity to overrule the Eli
Circuit's About Face in Enzo Biochem, Lilly decision through an en banc hearing
Inc. v. Gen-Probe, Inc., 4 Minn. Intell. and return enablement as the sole substantive
Prop. Rev. 339, 366 (2003) disclosure requirement of 35 U.S.C. 112,
paragraph 1. The heightened written description
standard applied to biotechnology
inventions after Eli Lilly ignores fundamental
biological principles and focuses too
much attention on the structure of a DNA
or protein. In addition, the standard is
inflexible to technological changes and requires
constant updating that leads to uncertainty
over patent validity. Finally, the
heightened requirement fails to meet the
constitutional purpose behind the patent
laws by discouraging full disclosure of biological
inventions. Simply returning to the
enablement disclosure standard that was in
effect prior to Eli Lilly would solve the bulk
of these problems.
---------------------------------------------------------------------------------------------------------
Laurence H. Pretty, Patent Litigation The term "written description" appears
§ 1:3.3, Defenses Against Patent Validity, grammatically as the subject for the verb
1-44 (2003) "enable" in the enablement section of 35
U.S.C. § 112. However, the written-description
requirement has been judicially
construed to have a separate and additional
purpose.
---------------------------------------------------------------------------------------------------------
Stephen R. Albainy-Jenei and Karlyn A. While Rochester is on appeal to the U.S.
Schnapp, Early-Stage Companies Face Court of Appeals for the Federal Circuit, it
New Challenges Rochester Case Limited the is likely that such reach-through claims will
Patentability Of Reach-Through Claims, remain severely restricted, possibly hurting
12/8/03 Nat'l L.J. S3, col. 1, S3, col. 1+ the value of intellectual property for many
(2003) earlystage biotechnology companies.
* * *
In addition, the overall cost in legal fees for
drafting and prosecuting more carefully
crafted, fully detailed biotechnology
applications will only increase for complex
inventions.
While big pharmaceutical companies will
have the money to spend in such endeavors,
it will be the universities and the small
biotech start-ups that will most certainly be
affected since these institutions historically
do not have the resources, both financial
and in personnel, to overcome this new set
of obstacles in trying to obtain patent protection
for their scientific contributions in an
ever-changing landscape.
---------------------------------------------------------------------------------------------------------
Dan L. Burk and Mark A. Lemley, Policy In biotechnology, however, the doctrine
Levers in Patent Law, 89 Va. L.Rev. 1575, has been applied as a sort of "super-enablement"
1652-54 (2003) requirement, forcing biotech
patentees to list particular gene sequences
in order to obtain a patent covering those
sequences. The written description doctrine
as currently applied is a macro policy
lever. The Federal Circuit has applied the
doctrine to biotechnology cases in a way
that would be inconceivable in other industries,
such as software. The effect is to
narrow the scope of biotechnology patents—
or at least DNA patents—rather dramatically.
---------------------------------------------------------------------------------------------------------
Warren D. Woessner, "Do-Over!"—The It is time for the court to deliver Lilly and
Federal Circuit Takes a Second Look at Enzo (I) to the doctrinal scrap heap where
Enzo v. Gen-Probe, 85 J. Pat. Trademark holdings like Durden and Druey ended up,
Off. Soc'y 275, 285 (2003) and let the evolution of biotechnology patent
law continue in a productive direction.
---------------------------------------------------------------------------------------------------------
Robert L. Harmon, Must a Patent Describe In the meantime, however, we are confronted
an Accused Infringement?, 85 J. Pat. with a welter of confused and confusing
Trademark Off. Soc'y 153, 154 (2003) precedent that not only defies restatement,
but renders analysis and synthesis distinctly
unmanageable. The only approach the author
has found to making some sense of the
situation is to ask what the motivation of the
Federal Circuit is in its efforts to restrict
this once well-recognized tenet of patent
law.
---------------------------------------------------------------------------------------------------------
Sven J.R. Bostyn, Written Description After The third way is to limit the application of
Enzo Biochem: Can the Real Requirement the written description requirement to cases
Step Forward Please?, 85 J. Pat. Trademark where priority issues are involved, and limiting
Off. Soc'y 131, 151 (2003) it to these issues, leaving the bulk of
the disclosure evaluation to the enablement
requirement, the key feature of the quid pro
quo of the patent system. In the author's
view, that ought to be the optimal solution,
leading to a coherent and stable patent
system, both for patent applicants and for
patent offices and courts. In this light, it
would have been a good opportunity to hear
the Enzo case en banc.
---------------------------------------------------------------------------------------------------------
David Kelly, Comment: The Federal Circuit The Federal Circuit's decision in Lilly, however,
Transforms the Written Description has fashioned the description requirement
Requirement into a Biotech-Specific into a barrier to scientific progress in
Hurdle to Obtaining Patent Protection for the field of biotechnology. This heightened
Biotechnology Patents, 13 Alb. L.J. Sci. & standard, applied exclusively to biotechnology
Tech. 249, 270 (2002) patents, will likely have an adverse effect
on the progress of biotechnological innovations.
Rather than awarding patent protection to
the discoverers of new and useful genes,
Lilly rewards those who first sequence the
gene accurately. The result will be patent
protection to those who can sequence DNA
the fastest, not to those who invested their
life's work locating the gene.
---------------------------------------------------------------------------------------------------------
Eli A. Loots, The 2001 USPTO Written Some conflict between patent prosecution
Guidelines and Gene Claims, 17 Berkeley and patent litigation is inevitable. However,
Tech. L.J. 117, 134 (2002) the current conflict has been recognized
as a widening gulf between the norms of the
scientific community and those of the legal
system.
---------------------------------------------------------------------------------------------------------
Limin Zheng, Purdue Pharma L.P. v. The court's continuing use of an inconsistent
Faulding Inc., 17 Berkeley Tech. L.J. 95, and often overly-stringent written description
103 (2002) requirement leaves inventors, especially
those in the pharmaceutical industry, with
little incentive to disclose, and is likely to
discourage inventors from seeking patent
protection.
---------------------------------------------------------------------------------------------------------
Jeffie A. Kopczynski, Note: A New Era for Recent Federal Circuit patent cases have
112? Exploring Recent Developments in held biotechnology inventions to a higher
the Written Description Requirement as written description standard than inventions
Applied to Biotechnology Inventions, 16 in other areas, such as the mechanical
Harv. J. Law & Tech. 229, 230 (2002) arts.... This perception of unpredictability
has caused the Federal Circuit to
apply a heightened written description requirement
to biotechnology patents. This
paper argues that the written description
requirement for patents should not be applied
differently to inventions in different
disciplines.
---------------------------------------------------------------------------------------------------------
Shraddha A. Upadhyaya, The Postmodern The postmodern trilogy unjustifiably departs
Written Description Requirement: An from precedent in order to meet
Analysis of the Application of the Heightened the increasing intellectual difficulties of
Written Description Requirement to biotechnology patents. The sophisticated
Original Claims, 4 Minn. Intell. Prop. Rev. obviousness function simply will not bar biotechnology
65, 120-21 (2002) patents, but a simple written
description requirement will. This anomaly
is troublesome. The written description requirement
cannot and should not serve any
function other than to guarantee that subsequently
filed claims are entitled to the benefit
of the original application.
---------------------------------------------------------------------------------------------------------
Sheila R. Arriola, Biotechnology Patents The problem created by the Federal Circuit
After Festo: Rethinking The Heightened could be remedied by overruling the prior
Enablement and Written Description biotechnology enablement and written
Requirements, 11 Fed. Circuit B.J. 919, 951 description case law that heightened these
(2002) requirements on the basis of the state of
technology at the time of those decisions.
The USPTO could then relax the enablement
and written description requirements
with respect to proteins and their analogs.
Not only would this shift the determination
of patent scope from judges back to the
USPTO's biotechnology examiners, but it
would force patentees to protect their inventions
proactively through continuations and
CIPs, rather than reactively through the
doctrine of equivalents. On balance, the
long-term costs of this proposed approach
are far less than those that Festo and the
heightened enablement and written description
requirements will have on patent protection,
and ultimately, on the biotechnology
industry as we know it.
---------------------------------------------------------------------------------------------------------
Robert A. Hodges, Note: Black Box Biotech The Federal Circuit's imposition of a heightened
Inventions: When a "Mere Wish Or standard for the written description of
Plan" Should Be Considered an Adequate DNA inventions in Eli Lilly increases the
Description of the Invention, 17 Ga. St. gap between the written description
U.L.Rev. 831, 860 (2001) requirement for biotech inventions and the
realities of how such inventions are
produced.
---------------------------------------------------------------------------------------------------------
Alison E. Cantor, Using the Written If courts are strengthening the written
Description and Enablement Requirements description and enablement requirements in
to Limit Biotechnology Patents, 14 Harv. J. order to limit biotechnology patents, this
Law & Tech. 267, 313 (2000) fact raises concerns about creating special
standards for particular areas of technology.
If it is the courts that impose these standards,
pioneering scientists in a new field
will be unable to determine, when applying
for patents, to what standard their patents
will eventually be held when they are
litigated.
---------------------------------------------------------------------------------------------------------
Mark D. Janis, On Courts Herding Cats: As a first step, the Federal Circuit might
Contending with the "Written Description" simply admit that the written description
Requirement (and Other Unruly Patent requirement is redundant of enablement.
Disclosure Doctrines), 2 Wash. U. J.L. & This would at least allow for a more forthright
Pol'y 55, 107 (2000) exploration of the question whether
redundancy in patent disclosure requirement
remains tolerable. The Federal
Circuit could reach the conclusion, perhaps,
that the written description requirement
simply provides a fail-safe mechanism that
judges (or examiners) may use in their
discretion in hard cases.
---------------------------------------------------------------------------------------------------------
Salima Merani, Hyatt v. Boone, 14 Berkeley Admittedly, the Federal Circuit has used
Tech. L.J. 137, 146 (1999) different expressions in describing a sufficient
written description. Judge Newman,
however, "[did] not view these various expressions
as setting divergent standards for
compliance with [section] 112." She emphasized
that, in all cases, the purpose of the
written description requirement was to ensure
that the inventor had possession of the
claimed invention at the time of the application
filing date. Analysis of historical and
policy rationale of section 112 supports
Judge Newman's view of the written description
requirement.
---------------------------------------------------------------------------------------------------------
Zhibin Ren, Note: Confusing Reasoning, In Lilly, the Federal Circuit deviated
Right Result: The Written Description from the well-established traditional written
Requirement and Regents of the University description standard and adopted an ad hoc
Of California v. Eli Lilly Company, 1999 approach to conduct a written description
Wis. L.Rev. 1297, 1324 (1999) analysis for DNA claims. This approach
allows the court to use whatever is handy to
justify the result it wants to reach.
---------------------------------------------------------------------------------------------------------
Arti K. Rai, Intellectual Property Rights in In essence, the Lilly court used the written
Biotechnology: Addressing New Technology, description requirement as a type of elevated
34 Wake Forest L.Rev. 827, 835 (1999) enablement requirement. An ordinary
enablement challenge to the University of
California's claim was not raised (and, if
raised, probably would have failed) because
it would have been relatively easy for a
person of ordinary skill in the art to use the
rat insulin cDNA that Lilly had already
sequenced to "fish out" the human cDNA
from a cDNA library.
---------------------------------------------------------------------------------------------------------
Janice M. Mueller, The Evolving Application The Lilly decision may profoundly limit the
of the Written Description Requirement scope of protection available for new gene
to Biotechnological Inventions, 13 inventions; ... Lilly aptly illustrates the
Berkeley Tech. L.J. 615, 615-16 (1998) increased widening of the gulf between the
norms of the business and scientific communities
and the U.S. patent system, as users
of the latter come to understand that the
patent system no longer reflects the realities
of scientific contribution.
---------------------------------------------------------------------------------------------------------
Michael Delmas Plimier, Genentech, Inc. v. The written description requirement only
Novo Nordisk University of California v. allows very narrow patents, so narrow and
Eli Lilly and Co., 13 Berkeley Tech. L.J. easily dodged as to be almost worthless.
149, 161 (1998)
---------------------------------------------------------------------------------------------------------
Harris A. Pitlick, The Mutation on the The recent decision in Regents of the University
Description Requirement Gene, 80 J. Pat. of California v. Eli Lilly and Co., on
Trademark Off. Soc'y 209, 209-10 (1998) top of Fiers v. Revel, decided only a few
years before, are such extreme departures
from conventional description requirement
jurisprudence that the need for new thinking
about the issue is now even more manifest.
One problem may be nomenclature.
As demonstrated later in the text, the term
"description requirement" is a misnomer.
---------------------------------------------------------------------------------------------------------
Kevin S. Rhoades, The Section 112 [T]here is in fact no justification for carving
"Description Requirement" — A Misbegotten out a separate "description" requirement
Provision Confirmed, 74 J. Pat. & Trademark from the "enablement" requirement in Section
Soc'y 869, 869-70 (1992) 112, first paragraph, that the specification
contain an enabling disclosure of how to
make and use the invention. In brief, the
language and history of the statute support
no such separate requirement, which fulfills
no function or purpose not already served
by the traditional enabling disclosure
standard.
---------------------------------------------------------------------------------------------------------
Neutrally Commenting on Eli Lilly Written Description
---------------------------------------------------------------------------------------------------------
Citation Quotation
---------------------------------------------------------------------------------------------------------
Robert Greene Sterne et al., The Written It is clear that the written description
Description Requirement, 37 Akron L.Rev. requirement applies to all technologies covered
231, 241 (2004) by patent applications and is not limited
to the unpredictable or "complex" arts.
The impact of this principle is that the cost
and difficulty of drafting patent applications
in any art has risen significantly in recent
years to adequately protect all variations
and permutations of the invention.
---------------------------------------------------------------------------------------------------------
Sean A. Passino et al., Written Description To avoid a 112, first paragraph rejection
Traps For Antibody Claims, 86 J. Pat. & under the holding of Noelle, an applicant for
Trademark Off. Soc'y 317, 318-19 (2004) a U.S. patent may want to disclose a fully
characterized antigen if the applicant wants
written description support for a claim to an
antibody defined by its binding affinity to
the antigen. Broader antibody coverage
may be obtained by demonstrating the
claimed antibody's ability to recognize
isoforms of the antigen from one or more
different species or by mapping the epitope
recognized by the antibody.
Furthermore, Noelle has implications wider
than 112, first paragraph rejections. The
doctrine may be used against the USPTO,
infringers alleging invalidity, and parties of
a contested case. Under 35 U.S.C. 102, a
patent or printed publication will not anticipate
a claim unless it "describes" the
claimed invention. If the courts take the
position that a patent or printed publication
fails to describe an embodiment for the
purposes of 112, first paragraph, then it is
difficult to believe that the same patent or
printed publication describes the same
embodiment for the purposes of 102.
... Clearly, this area of the law is evolving.
---------------------------------------------------------------------------------------------------------
Robert M. Schulman, A Review of Significant In the written description area, 2003 represented
2003 Federal Circuit Decisions Affecting the first year in which the court
Chemical, Pharmaceutical, and Biotech signaled a reversal of the trend it established
Inventions, 16 No. 3 J. Proprietary Rts. 1, 1 in 1997, requiring provision of specific
(2004) sequences for applicants claiming biological
molecules. The Federal Circuit is not quite
ready to reverse its "written-description-plus"
requirement for biotech inventions.
---------------------------------------------------------------------------------------------------------
Lewis R. Clayton, Inadequate Descriptions, Though the Rochester inventors made, as
4/5/04 Nat'l L.J. 12, col. 1, 12, col. 1 + the district court noted, "significant discoveries
(2004) in this field," they did not take the
"last critical step" of isolating the necessary
compound, or "developing a process through
which one skilled in the art would be directly
led" to it. Absent a reversal en banc,
those efforts will not be compensated under
the patent laws.
---------------------------------------------------------------------------------------------------------
Chandra Garry, Enzo Biochem, Inc. v. The Federal Circuit in Enzo decided for the
Gen-Probe, Inc., 18 Berkeley Tech. L.J. first time that the written description requirement
195, 208 (2003) may be satisfied by a biological
deposit. At first glance, it appears that
Enzo lowers the written description standard
applied by the court in Lilly, as deposit
seems an easy way to satisfy the written
description requirement. Any such lowering
of the written description standard,
however, is by and large illusory. The decision
in Enzo will likely be strictly limited to
its facts. If not limited to its facts, the
court's redefined written description is not
sufficiently explained by the court so as to
provide an easily workable standard for
future decisions.
---------------------------------------------------------------------------------------------------------
Jeffery M. Duncan et al., Practitioners BeWary: In the last six years, several patents to
The Dangers of Functional Descriptions biotech inventions that were otherwise valid
in Biotech Inventions, 15 No. 10 have been struck down because the description
Andrews Ent. Indus. Litig. Rep. 21 (2003) of the invention, often by functional
terms, was found wanting. One difficulty
for biotech patent practitioners is that there
are no bright line rules prescribing what is
or is not an adequate written description.
Instead, as the U.S. Court of Appeals for
the Federal Circuit has repeatedly stated,
the satisfaction of the written description
requirement is a fact-specific inquiry,
decided on a case-by-case basis.
---------------------------------------------------------------------------------------------------------
After Determining That a Seller of a Egg This case [Moba] highlights the state of flux
Processing Machine May Have Induced Infringement at the Federal Circuit concerning the
of Patent Claiming a Method written description requirement.
Directed High-Speed Egg Processing, the
Federal Circuit Address the Written Description
Requirement and the Lilly Case
Again, 13 Fed. Circuit B.J. 179, 182 (2003)
---------------------------------------------------------------------------------------------------------
Andrea G. Reister, Enablement & Written Enzo/Gen-Probe exemplifies the difficulty in
Description: Friend or Foe in Litigation?, annunciating the Federal Circuit's standard
766 PLI/Pat 383, 405-6, 409 (2003) for written description, and the dispute
within the court over the purpose of the
written description requirement and how it
relates to the enablement requirement.
* * *
It remains to be seen whether the Lilly/
Enzo/Gen-Probe requirements for written
description will survive, and supplant the
cases that have dealt with written description
in the context of disputes relating to
priority.
---------------------------------------------------------------------------------------------------------
Janet E. Reed et al., Written Description: In its most recent treatments of the first
A Looser Requirement? The Federal paragraph of 35 U.S.C. 112, the U.S. Court
Circuit Has Been Edging Away from the of Appeals for the Federal Circuit has
Heightened Standard That It Set Out in the edged away from the heightened written
1997 "Lilly' Case, 6/16/03 Nat'l L.J. S1, col. description requirement for biotechnology
1, S1, col. 1 + (2003) patents articulated in Regents of the Univ.
of Calif. v. Eli Lilly Co., 119 F.3d 1559
(Fed.Cir.1997). This process has revealed
dissenting opinions among the Federal
Circuit judges, which may only be resolved
by en banc review of the written description
requirement as a whole. As a result, the
standard for satisfying the written description
requirement remains elusive, leaving
practitioners struggling to determine the
level of written description that will be
deemed "adequate" to support biotechnology
patent claims.
* * *
Though en banc review of the written description
requirement seems timely, the disparate
perspectives of the Federal Circuit
judges make the outcome difficult to predict.
It is uncertain whether a major overhaul
of statutory interpretation is in the
works, or whether the current interpretation
will remain substantially intact. The
patent bar and the biotechnology industry
will no doubt eagerly await resolution of the
current ambiguity, accompanied, it is to be
hoped, by pronouncement of a clear standard
for written description to be applied by
the PTO during patent prosecution and by
the courts in patent litigation.
---------------------------------------------------------------------------------------------------------
Mary S. Consalvi, The Enablement and With this decision [Enzo Biochem] and the
Written Description Requirements, 766 decision in Amgen Inc. v. Hoeschst Marion
PLI/Pat 349, 377, 381 (2003) Roussel, 314 F.3d 1313 (Fed.Cir.2003), it is
clear that written description is still in a
state of uncertainty and ambiguity.
* * *
The law of enablement and written description
under 35 U.S.C. 112, first paragraph is
constantly evolving and emerging. At the
present time, there is still a lot of uncertainty
in the area.
---------------------------------------------------------------------------------------------------------
Anne Y. Brody, Ph.D., Rochester v. Searle: This case touches on many uncharted areas
Complying with the Written Description of biotechnology patent law. With the
and Enablement Requirements in Early-Stage emerging fields of genomics and proteomics,
Drug Discovery, 22 Biotechnology L. the law has to keep up with biotechnological
Rep. 472, 474 (2003) advances. In the University of Rochester's
pending appeal to the CAFC, the real issue
for the written description requirement may
depend on where in the time line of research
and development a discovery turns
into an invention. Is such a method of
treatment claim valid only when a selected
group of compounds is identified? Or are
the solutions (e.g., the drug compounds and
their screening methods) obvious once the
source of the problem is determined? The
determinative factor in the enablement requirement
may be contingent on the definition
of "undue experimentation" in the field
of drug development. The amount of guidance
and what is undue experimentation
change as technologies progress to standardize
many laboratory techniques. For
example, in recent years, high-throughput
screening technologies have reduced time
and effort scientists expend to conduct numerous
parallel experiments simultaneously.
Selecting a starting material and creating a
pool of its variants for screening are now
conventional procedures among the
researchers in biotechnology.
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Todd M. Oberdick, Section 112, Paragraph In light of Gentry Gallery and Johnson
6 — Means Claim and Limitation to Specific Worldwide, a patent practitioner may be
Algorithm — Is This a Stricter Standard tempted to omit a precise description of a
Than Gentry Gallery and Related Mechanical preferred embodiment of the invention for
Cases?, 22 Pace L.Rev. 385, 390 (2002) fear of making "crystal clear" that a narrow
claim interpretation was intended.
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Lisa A. Karczewski, Comment: Biotechnological The Federal Circuit's trilogy of landmark
Gene Patent Applications: The biotech decisions in the past decade have
Implications of the USPTO Written Description made an obvious mark with respect to the
Requirement Guidelines on the future of obtaining patent protection for
Biotechnology Industry, 31 McGeorge genetically engineered products and the
L.Rev. 1043, 1086 (2000) specificity required for satisfying the written
description requirement. Having incorporated
the reasoning from these decisions
into the methodology of its guidelines, only
time will tell whether the USPTO's efforts
will impede the patent application process
for the biotechnology industry.
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Scott A. Chambers, "Written Description" While some practitioners and the Patent
and Patent Examination Under the U.S. and Trademark Office (PTO) cannot ignore
Patent and Trademark Office Guidelines., the law as interpreted by the Court of Appeals
IP Litigator 9, 9 (Sept./Oct.2000) for the Federal Circuit and must respond
in a manner that continues to protect
the intellectual property interests of their
clients. Moreover, the Federal Circuit's
clarification of the written description requirement
suggests that some broadly
drawn patents may be vulnerable to attack
for lack of written description.
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Cindy I. Liu, Gentry Gallery, Inc. v. In Gentry Gallery, Inc. v. Berkline Corp.,
Berkline Corp., 14 Berkeley Tech. L.J. 123, the Federal Circuit narrowed the scope of
123 (1999) patents through the written description
requirement of section 112 by announcing
an omitted element test.
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Laurence H. Pretty, The Recline and Fall It remains to be seen whether Gentry
of Mechanical Genus Claim Scope Under Gallery will become a more influential precedent
"Written Description" in the Sofa Case, 80 than Utter v. Hiraga in permitting
J. Pat. Trademark Off. Soc'y 469, 479-80 attack upon a genus claim in the predictable
(1998) arts by limiting patent protection to the
species disclosed.... It may also be advisable
to include a claim of extreme breadth as
the first filed original claim even at the risk
of presenting a claim that is highly likely to
be rejected, in order to negate any inference
that "written description" will bar any
broader claim later.
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Notes:
Circuit Judges Newman, Rader, Bryson, Gajarsa, and Linn voted in favor ofen banc reconsideration. Chief Judge Mayer and Circuit Judges Michel, Lourie, Clevenger, Schall, Dyk, and Prost voted against en banc reconsideration.
This new validity requirement conflicts with binding precedent because the CCPA made clear that original claims are part of the original disclosure of an invention and thus have no "description" problemsIn re Koller, 613 F.2d 819, 823 (CCPA 1980) ("[O]riginal claims constitute their own description."); In re Smith, 481 F.2d 910, 914 (CCPA 1973) ("Where the claim is an original claim, the underlying concept of insuring disclosure as of the filing date is satisfied, and the description requirement has likewise been held to be satisfied."); In re Gardner, 475 F.2d 1389, 1391 (CCPA 1973) ("Claim 2, which apparently was an original claim, in itself constituted a description in the original disclosure.... Nothing more is necessary for compliance with the description requirement.")
This opinion will not repeat the points made earlier about the legal sufficiency of theEli Lilly doctrine. Some of those points include: First, the statutory language and legal precedents make enablement the only substantive test (other than best mode) in the first paragraph of § 112. Enzo Biochem, 323 F.3d at 977. Second, this court's predecessor first separated written description from enablement in 1967, but only to police priority. Id. Third, this court and its predecessor consistently limited the written description requirement to priority cases, expressly equating the proscription on new matter with written description. Id. at 977-79. Lastly, the vague and ill-defined written description requirement threatens to supplant the well-established enablement requirement, which disproportionately affects biotech inventions. Id. at 981-83.
An appendix to this opinion summarizes this academic commentary
Indeed the United States notes that the current statute requires "a written description of the invention, andof the manner and process of making and using it, in such full clear, concise, and exact terms as to enable [the invention]." 35 U.S.C. § 112, ¶ 1 (emphasis added). As the United States noted, "A straightforward reading of the text of section 112 suggests that the test for an adequate written description is whether it provides enough written information for others to make and use the invention." Brief of Amicus Curiae United States at 5, Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956 (Fed.Cir. 2002).
Moreover, the pre-1967 CCPA cases mentioned inRochester also shed little light on the modern written description requirement. For instance, Jepson does not evince support for Eli Lilly. Rather, Jepson, which does not expressly mention written description at all, decided an interference — a priority dispute — between an application with an earlier filing date and an issued patent with a later filing date. The CCPA held that because the earlier application did not support the claims that were copied from the later patent, the patent was entitled to priority. Jepson v. Coleman, 50 C.C.P.A. 1051, 314 F.2d 533 (CCPA 1963). Thus, Jepson, if at all relevant to written description, was a priority case in the traditional mode of written description jurisprudence. The CCPA decided the Moore case on obviousness grounds; the description commentary in that case is dicta. In re Moore, 33 C.C.P.A. 1083, 155 F.2d 379, 381 (CCPA 1946) (noting that the claims were "properly rejected on the prior art"). The CCPA decided the Sus case under paragraph 2 of § 112, not paragraph 1. In re Sus, 49 C.C.P.A. 1301, 306 F.2d 494, 496 (CCPA 1962). The reason Sus and Moore do not appear on the "written description" landscape is because subsequent case law made it clear that, outside the priority context, the substantive test for compliance with the first paragraph of § 112 is enablement. In re Borkowski, 57 C.C.P.A. 946, 422 F.2d 904, 909 (CCPA 1970). Indeed, Rochester seems to do a disservice to the CCPA's own acknowledgement that Judge Rich inaugurated the written description requirement to police priority in 1967. In re Rasmussen, 650 F.2d 1212, 1214 (CCPA 1981).
LINN, Circuit Judge, with whom RADER and GAJARSA, Circuit Judges, join, dissenting from the court's decision not to hear the case en banc.
The panel opinion in this case perpetuates the confusion our precedent in Lilly and Enzo has engendered in establishing "written description" as a separate requirement of 35 U.S.C. § 112, paragraph 1, on which a patent may be held invalid. That precedent should be overturned. Accordingly, I respectfully dissent from the court's decision not to hear this case en banc.
Section 112 of Title 35 of the United States Code requires a written description of the invention, but the measure of the sufficiency of that written description in meeting the conditions of patentability in paragraph 1 of that statute depends solely on whether it enables any person skilled in the art to which the invention pertains to make and use the claimed invention and sets forth the best mode of carrying out the invention. The question presented by 35 U.S.C. § 112, paragraph 1, is not, "Does the written description disclose what the invention is?" The question is, "Does the written description describe the invention recited in the claims — themselves part of the specification — in terms that are sufficient to enable one of skill in the art to make and use the claimed invention and practice the best mode contemplated by the inventor?" That is the mandate of the statute and is all our precedent demanded prior to Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed.Cir.1997).
Reading into paragraph 1 of section 112 an independent written description requirement, divorced from enablement, sets up an inevitable clash between the claims and the written description as the focus of the scope of coverage. This is ill-advised. Surely there is no principle more firmly established in patent law than the primacy of the claims in establishing the bounds of the right to exclude. See, e.g., Aro Mfg. Co. v. Convertible Top Replacement Co., 365 U.S. 336, 339, 81 S.Ct. 599, 5 L.Ed.2d 592 (1961) ("[T]he claims made in the patent are the sole measure of the grant."); McClain v. Ortmayer, 141 U.S. 419, 424, 12 S.Ct. 76, 35 L.Ed. 800 (1891) ("`The rights of the plaintiff depend upon the claim in his patent, according to its proper construction.'" (quoting Masury v. Anderson, 16 F. Cas. 1087, 1088 (C.C.S.D.N.Y.1873))); White v. Dunbar, 119 U.S. 47, 52, 7 S.Ct. 72, 30 L.Ed. 303 (1886) ("The claim is a statutory requirement, prescribed for the very purpose of making the patentee define precisely what his invention is; and it is unjust to the public, as well as an evasion of the law, to construe it in a manner different from the plain import of its terms."); Burns v. Meyer, 100 U.S. 671, 672, 25 L.Ed. 733 (1879) ("[T]he terms of the claim in letters-patent ... define[] what the office, after a full examination of previous inventions and the state of the art, determines the applicant is entitled to."); Merrill v. Yeomans, 94 U.S. 568, 570, 24 L.Ed. 235 (1876) ("This distinct and formal claim is, therefore, of primary importance, in the effort to ascertain precisely what it is that is patented."); Johnson & Johnston Assocs. Inc. v. R.E. Serv. Co., 285 F.3d 1046, 1052 (Fed.Cir. 2002) (en banc) ("Consistent with its scope definition and notice functions, the claim requirement presupposes that a patent applicant defines his invention in the claims, not in the specification. After all, the claims, not the specification, provide the measure of the patentee's right to exclude."); SRI Int'l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1121 n. 14 (Fed.Cir.1985) ("Specifications teach. Claims claim."). The statute itself makes clear that Congress intended the claims to define the scope of coverage. 35 U.S.C. § 112, ¶ 2 (2000) ("The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.").
The primary role of the written description is to support the claims, assuring that persons skilled in the art can make and use the claimed invention. Id. ¶ 1 ("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."); see also Kennecott Corp. v. Kyocera Int'l, Inc., 835 F.2d 1419, 1421 (Fed. Cir.1987) ("The purpose of the [written] description requirement ... is to state what is needed to fulfil the enablement criteria."); cf. In re Barker, 559 F.2d 588, 594 (CCPA 1977) (Markey, C.J., dissenting) ("The attempt to create historical and current statutory support for a separate description requirement, which was solely a judicial (and unnecessary) response to chemical cases in which appellants were arguing that those skilled in the art might make and use a claimed invention, is mistaken.").
Construing section 112 to contain a separate written description requirement beyond enablement and best mode creates confusion as to where the public and the courts should look to determine the scope of the patentee's right to exclude. Under the panel's analysis, a court looks to the written description to determine the parameters of the patentee's invention — under guidelines yet to be articulated — and then determines if the claims, as properly construed, exceed those parameters. See Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 922-23 (Fed.Cir.2004) ("While it is true that this court and its predecessor have repeatedly held that claimed subject matter `need not be described in haec verba' in the specification to satisfy the written description requirement, it is also true that the requirement must still be met in some way so as to `describe the claimed invention so that one skilled in the art can recognize what is claimed.'" (citations omitted)). There is simply no reason to interpret section 112 to require applicants for patent to set forth the metes and bounds of the claimed invention in two separate places in the application. That is the exclusive function of the claims.
The burden of Lilly and Enzo has fallen on the biotech industry disproportionately, but, as this decision makes clear, the new-found written description requirement will affect all fields of emerging technology. Univ. of Rochester, 358 F.3d at 925 (rejecting a limitation of the Lilly written description doctrine to genetic inventions on the ground that "the statute applies to all types of inventions"). When patent attorneys set out to write patent applications, they do so for an educated audience — those skilled in the art — and attempt to describe the invention in a way that enables those of ordinary skill to make and use the invention as claimed. Before the decision in Lilly, the practicing bar had accepted and found workable the notion elucidated in our precedent that § 112 requires a written description sufficient to enable one of ordinary skill in the art to make and use the claimed invention — i.e., enablement. Lilly changed the landscape and set in motion the debate the panel opinion in this case perpetuates.
As I commented in my dissent from the court's decision not to hear the Enzo case en banc, "Some have praised Lilly for maintaining the integrity of patent disclosures and for curbing patent filings for inventions that have not yet been made but are just nascent ideas. Others have been sharply critical of Lilly." Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 989 (Fed.Cir.2002) (Linn, J., dissenting). That debate continues to leave uncertain how inventions are protected, how the United States Patent and Trademark Office discharges its responsibilities, and how business is conducted in emerging fields of law. These uncertainties will remain unless resolved by this court en banc or by the Supreme Court. The issue is important, is ripe for consideration, and deserves to be clarified, one way or the other. For these reasons, I respectfully dissent from the court's refusal to consider this case en banc.
DYK, Circuit Judge, concurring in the court's decision not to hear the case en banc.
In my view the question of whether 35 U.S.C. § 112 contains a written description requirement (separate from the enablement requirement) does not merit en banc review. For the reasons set forth in the panel opinion and in Judge Lourie's opinion concurring in the denial of en banc review, I think it is clear that the statute contains such a requirement — applicable both in the context of priority and validity disputes. In this particular case the failure to satisfy that requirement was not even a close case. The appellant simply did not invent, much less describe, what was claimed.
My vote to deny en banc review, however, should not be taken as an endorsement of our existing written description jurisprudence. In my view we have yet to articulate satisfactory standards that can be applied to all technologies. Future panel opinions may provide the necessary clarity. If not, there may be a time when en banc consideration of the proper written description standards will be appropriate. But this is neither the right time, nor the right case, in which to consider those difficult questions.