Written Description - A Must Or Not?

Originally published December 17, 2004

INTRODUCTION

Recently, the United States Court of Appeals for the Federal Circuit strongly reaffirmed a patentee's obligation to provide a written description in a patent to comply with the written description requirement of 35 U.S.C. §112 ¶1. The Federal Circuit rendered this decision in University of Rochester v. G.D. Searle & Co.^[i] Specifically, the Federal Circuit upheld the Federal District Court for the Western District of New York's decision^[ii] to invalidate the University of Rochester's patent^[iii] based on the patentee's failure to comply with the written description requirement of §112. This decision, as well as the opinions rejecting the appeal to rehear the case en banc, confirms the continuing vitality of a written description requirement in the law, independent of enablement, new matter and priority issues.

While the Federal Court has clearly rejected the proposition that there is no independent requirement for written description in 35 U.S.C. §112, the Court leaves open the question on how fundamental research is to be protected where the inventors have a clear path to the final goal, but lack the resources to achieve the goal before their competitors. Many have suggested the decision in Rochester leads to the undesirable result that a product cannot be claimed until it is "in hand and reduced to practice" even if the product and the means of obtaining the product can be clearly described (enabled). Moreover, the effect of this decision will have repercussions not only with respect to patent claim drafting practice, but also with respect to commercialization of inventions.^[iv]

Generally speaking, a patent disclosure must contain the following three elements: (a) written description, (b) enablement and (c) best mode.[v] The basis for the written description requirement stems from 35. U.S.C. §112 ¶1, which states: 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.^[vi]

Although §112 references a "written description," many believe it is unclear whether this reference is meant to be independent from or in addition to the enablement requirement.^[vii] However, historically, the CCPA made absolutely clear the independent existence of the written description requirement. In In re Barker^[viii], the CCPA reaffirmed the principle that an application could satisfy the written description requirement and not the enablement requirement, or vice versa, citing to the 1967 decision In re Ruschig.^[ix] Oddly, this particular citation may be inapt, as the CCPA in Ruschig^[x] specifically observed that the rejection being affirmed did not spring from 35 U.S.C. §112. Nonetheless, the CCPA in Ruschig did specify that "'[t]he specification shall contain a written description of the invention."^'[xi]

Later, in Vas-Cath Inc. v. Mahurkar^[xii], and numerous subsequent cases, the Federal Circuit applied the written description requirement particularly to questions involving priority claims.^[xiii] Specifically, the Vas-Cath Court used the written description as the baseline to determine whether a patent applicant had "described" his invention with sufficient clarity in a case he had filed prior to the case in which the claims in dispute were first presented.^[xiv] The court continues to police priority claims under the written description rubric today as seen in Chiron Corp. v. Genentech, Inc.^[xv]

The Vas-Cath decision, and its progeny, led some to believe that the Federal Circuit had decided to confine application of the written description requirement to priority contests that is until the Federal Circuit's decision in Regents of the University of California v. Eli Lilly & Co.^[xvi] In Lilly, the Federal Circuit began a series of decisions more broadly applying the written description requirement independent of priority concerns. Specifically, the Federal Circuit applied the written description requirement to reject attempts to claim subject matter, such as genetically recombinant technology and related biotechnology, through use of functional language, where the actual structure or character of the subject matter claimed was not envisioned at the time of filing.^[xvii]

The Federal Circuit received intense criticism for the Lilly decision. Nonetheless, the court has routinely applied the written description requirement, even where claims for benefit of priority cases were not involved. For example, in Enzo Biochem, Inc. v. Gen-Probe Inc., the court held that the mere reference in the specification to a biological deposit in a public depository fulfills the written description requirement and the enablement requirement.^[xviii] In Amgen Inc. v. Hoechst Marion Roussel, the Federal Circuit noted that the written description requirement is "to prevent an applicant from later asserting that he invented that which he did not."^[xix] The court in Amgen did, however, focus on the priority policing role of the written description requirement rather than as an independent, additional requirement for §112 compliance.^[xx] This line of cases seemed to is the basis for petitions for certiorari in a number of cases, including Rochester and Chiron.

On April 11, 2000, the University of Rochester (the "University") finally obtained U.S. Patent No. 6,048,850 after a series of continuation and divisional applications. The patent included three independent and five dependent claims.^[xxi] Generally speaking, the claims covered a method of producing a COX-2 inhibitor (also known as a PGHS-2 inhibitor), a compound beneficial as an anti-inflammatory drug.

On the day the '850 patent issued, the University sued G.D. Searle & Co., Monsanto Co., Pharmacia Corp. and Pfizer Inc. (collectively, "Searle") in the Federal District Court in the Western District of New York. The University alleged that Searle's sale of the COX-2 inhibitors Celbrex® and Bextra® for the treatment of inflammation infringed the '850 patent.^[xxii] The University sought injunctive and monetary relief. In response, in May 2002, Searle moved for summary judgment, alleging that the '850 patent was invalid because it failed to comply with the written description and enablement requirements of §112.^[xxiii]

In evaluating the parties motions, the district court noted that although all of the claims of '850 patent included the administration of a "non-steroidal compound that selectively inhibits activity of the PGHS-2 gene," the '850 patent specification did not disclose any such compound or any method of how to make the compound. The district court held that the '850 patent failed to meet the written description requirement. The court also held that a person skilled in the art would have had to partake in "undue experimentation, with no assurance of success" to create the necessary compound. Thus, the court determined that the '850 patent failed to satisfy the enablement requirement of §112. From these findings, the district court granted Searle's motion for summary judgment and found the '850 patent invalid.

On appeal to the Federal Circuit, the University asserted three grounds of error. First, the University asserted that the district court erred by granting Searle's motion for summary judgment of invalidity for lack of written description. Second, the University contended that the court also erred by granting Searle's motion with respect to lack of enablement. Finally, the University argued that the court erred by denying the University 's motion for summary judgment with regard to the written description.

The University first argued that no written description requirement existed independent of enablement. However, in this instance, the Federal Circuit responded to the University's argument by resoundingly affirming the applicability of the written description requirement independent of claims ot priority. Specifically, the Federal Circuit rejected the notion that the written description requirement and enablement were not independent of one another. In addition, the court pointed to the Supreme Court's recent Festo decision as additional evidence supporting the written description as a statutory requirement distinct not only from the best mode requirement, but also enablement.^[xxiv]

The court noted that, in previous decisions, it has interpreted §112 as requiring three elements in a patent's specification.^[xxv] These elements are: (a) written description; (b) enablement; and (c) best mode. While the court acknowledged that these requirements may overlap in certain circumstances, the court provided examples where a requirement could be met, but not the others. Specifically, the court indicated that a patentee may have provided an enabling disclosure even though the patentee failed to meet the description requirement. This could occur, for example, when a patentee provides a sufficiently descriptive and enabling disclosure of invention A that also allows the enablement of the closely related invention B. Under this situation, the patent enabled invention B without fully describing it because the inventor has not shown that they possess invention B. Moreover, the court contended that the specification may describe an invention without enabling the practice of the full breadth of its claims. However, the court firmly stated that generalized language likely does not satisfy the requirement if it does not convey the detailed identity of the invention and, in this instance, the patentee failed to include any language, generalized or otherwise, that describes the applicable compounds.

The University next argued that, even if the written description requirement exists, courts should not apply the requirement in cases where priority is not an issue, particularly in cases unrelated to biotechnology or DNA sequences. The University noted that, except with respect to priority issues, the only Federal Circuit cases holding patents invalid for failing to provide a sufficient written description, involved inventions based on DNA structures^[xxvi]. The Federal Circuit disagreed with the University's suggestion. The Fed Circuit emphatically stated that the written description requirement of §112 exists whether a question of priority arises or not and regardless of the technology at issue.^[xxvii]

The University then attempted to distinguish the "written description requirement" cases Enzo and Lilly cases by noting that, unlike the patents at issue in those cases, the '850 patent did not claim a composition of matter, but rather set forth method claims.^[xxviii] The court rejected this distinction. The court stated:

Regardless of whether a compound is claimed per se or a method is claimed that entails the use of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods. As the district court observed "[t]he claimed method depends upon finding a compound that selectively inhibits PGHS-2 activity. Without such a compound, it is impossible to practice the claimed method of treatment."^[xxix]

The court did somewhat limit the extent of its holding since the court did not mandate that a patentee satisfy the written description requirement by providing a description of an actual reduction to practice.[xxx] Instead, the Federal Circuit stated that constructive reduction to practice is an established method of disclosure; however, the Federal Circuit did hold that an application must "describe the claimed subject matter in terms that establish the applicant was in possession of the . . . claimed invention, including all of the elements and limitations."[xxxi] Thus, the court found that the University failed to meet the written description requirement because the compounds used in the '850's method claims were not described in the specification.

In addition, the Federal Circuit stated that although the written description requirement is a question of fact, a court can determine whether the whether a patent fails to meet the written description requirement based on the language of the patent specification.^[xxxii] In this instance, the court noted that even one skilled in the art could not practice the claimed methods since the ‘850 patent does not disclose any compounds that can be used in its claimed methods.[xxxiii] The Federal Circuit noted that the "patentee is . . . required to provide sufficient description to show one skilled in the art that the inventor possessed the claimed invention at the time of filing."[xxxiv] The Federal Circuit thereby affirmed the district court's ruling, granting Searle's motion for summary judgment.

The Federal Circuit has declined to rehear the University appeal en banc.[xxxv] The nature of the split in the Federal Circuit on the written description issue can be gleaned from the separate opinions on the decision not to rehear. Specifically, none of the judges has taken the position that the law does not countenance a separate written description requirement. Indeed, Judges Lourie and Dyk, concurring, and dissenting judges Judge Newman (separately) and Judges Rader, Linn and Gasarja (dissenting together) uniformly stated their belief that there is a separate written description requirement.[xxxvi] Instead, the dissenting judges seem to contend that that the Federal Circuit’s position and interpretation has been inconsistent in its application.[xxxvii] Judge Lourie’s strong concurrence notes that, independent of priority claims, the application of the written description requirement has not been confined to chemistry or biotechnology, but diverse technologies including dental floss, hip replacements, lounge chairs and automated sales kiosks.[xxxviii]

THE FUTURE

There is a general expectation that in the wake of the Rochester and Chiron decisions, the Federal Circuit will shortly issue an opinion attempting to unify the case law, if the Supreme court does not first take up the issue. The Rochester decision, and other recent precedent, is sending a message that the Federal Circuit does not intend to limit the written description requirement solely to cases involving issues of priority or DNA structure. Rather, Rochester holds that the written description requirement applies when a patentee seeks to claim an aspect of an invention in terms of functionality rather than structure. Basic patent law provides that a patentee is entitled to a genus of a species without identifying every species within the genus. Now the question becomes: How many species must the patentee identify? The tension lies in the number and method of identifying the species.

Many arts that involve fundamental, as opposed to applied, research raise a question of function vs. structure. In many instances, investigators know well in advance of the creation of the physical element being sought what it needs to do and how to obtain it. In contrast, in many developed arts, functional claiming likely meets the written description requirement as long as the function corresponds to a known structure. Where inventors often first discover the function of a target protein or compound or the requirement of a new electric synapse or superconductor, etc., without first determining the structure, this continuing tension is likely to persist regardless of a unifying decision from the Federal Circuit. The question then becomes: How can the assignee of the fundamental research, many times a University or similar institution, protect the fruits of its intellectual exercise, while those with greater resources race down the pathway to identification, realization and commercialization of the end product?

Unfortunately, potential patentees who have only a functional discovery may be less willing to devote time, energy and resources to patent protection. Specifically, the current law could deter inventors from publicly disclosing their inventions via the patent system if they do not yet know the structure and/or cannot invest a large amount of time and money on research to discover it. Even if such patentees proceed with patent applications, the value and marketability of the patent likely will be reduced substantially.

While there is an abundance of suggestions in the literature that solutions for this dilemma may be for applicable patentees to seek license revenues based on the research and functions already identified, they are not generally welcomed. The concept of reach through royalties on licenses of this type is generally discredited. Moreover, while reliance on trade secret protection has been recently encouraged, its applicability to institutions, as opposed to private corporations, is sharply limited.

Anticipating a decision from the Federal Circuit that continues to emphasize the requirement for either structure, or a known equivalence between structure and function, we generally recommend patent applications that may be targets for this kind of dilemma be augmented by a little "guesswork." There does not appear to be a requirement in the Federal Circuit panoply of written description cases that requires the "structures" to be correct or completely anticipatory of commercial embodiments. Rather, the inventors must provide a sufficient basis for relating structure to function and demonstrate that the inventors, correctly or incorrectly, perceived representative examples of the future embodiments. Where ultimate embodiments are unknown, whether they be COX-2 inhibitors, the shape of a prosthetic joint cup or an online ticket dispenser, the patent attorneys and the inventors should work together to come up with a "picture" of the future, based on the best available information. The attorney should describe a structure, spatial relationship, color or other physical character, based on your best available information. The law actually encourages this, provided it is made clear that these are prophetic or predicted embodiments, not actual ones. Even if wrong, guesses may well be close enough to put the patentee "in possession" of the embodiments realized and commercialized down the road by capturing such embodiments within a fairly represented generic claim. Will this make patent applications more difficult to write, and more expensive? Probably. Will it make the application and the rights that attach more valuable? Undoubtedly. Given a choice between a high price for a useless patent and a slightly higher price for a potentially enforceable one, most clients choose the latter. At a minimum, the choice should be offered wherever it may be appropriate.

Footnotes

^{[i] University of Rochester v. G.D. Searle & Co., 69 USPQ2d 1886 (Fed. Cir. 2004)}

^{[ii] University of Rochester v. G.D. Searle & Co., 68 USPQ2d 1424 (W.D.N.Y. 2003)}

^{[iii] United States Patent No. 6,048,850 ("'850")}

^{[iv] See Rochester, 69 USPQ2d at 1896 (noting that the district court decision "vitiates" universities’ ability to bring pioneering innovations to the public and citing an amicus brief from the Universities of California and Texas indicating that the Federal Circuit’s decision will have an impact on the continuing viability of tech transfer programs with respect to the equitable allocation of rights between universities and the private sector).}

^{[v] Id. at 1890}

^{[vi] 35 U.S.C. §112 ¶1}

^{[vii] See Moba v. Diamond Automation, Inc., 325 F.3d 1306, 1323 (Fed. Cir. 2003) (Rader, J., concurring) (stating that a patent contains an adequate description if it enables a person skilled in the art to make and use the invention)}

^{[viii] 194 USPQ 470 (CCPA 1977)}

^{[ix].Id. at 472-473}

^{[x] 379 F.2d 990, 996 (C.C.P.A. 1967).}

^{[xi] Id. at 995}

^{[xii] 19 USPQ2d 1111 (Fed. Cir. 1991)}

^{[xiii] Id. at 1113-1117}

^{[xiv] Id. at 1118-1120}

^{[xv] 363 F. 3d 1247 (Fed. Cir. 2004)}

^{[xvi] 119 F.3d 1559 (Fed. Cir. 1997)}

^{[xvii] See generally Lilly, 119 F.3rd at 1559-1568}

^{[xix] Amgen, 314 F.3d at 1330}

^{[xx] Id.}

^{[xxi] Rochester, 69 USPQ2d at 1888}

^{[xxii] Id. at 1889}

^{[xxiii] Id.}

^{[xxiv] See Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 736 (2002)}

^{[xxv] Id. at 1890}

^{[xxvi] Rochester cited Fiers v. Revel}, 984 F.2d 1164 (Fed. Cir. 1993)^{, Eli Lilly & Co. v. Barr Laboratories, Inc.}, 251 F.3d 955 ^{(Fed. Cir. 2001) and Enzo}, 323 F.3d 956 (Fed. Cir. 2002)

^{[xxvii] Rochester, 69 USPQ2d at 1891-92}

^{[xxxv] University of Rochester v. G.D. Searle & Co., 71 U.S.P.Q2d 1545 (Fed. Cir. 2004) (Newman and Radar providing lengthy dissents with respect to the Federal Circuit’s refusal to hear the case en banc.)}

^{[xxxvi] See generally Id.}

^{[xxxvii] Id.}

^{[xxxviii] Id.}

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