United States: Rochester Decision Exacerbates Tension Between the Written Description Requirement and Biotechnology Inventions

Tension has been steadily increasing between biotechnology interests and the requirements imposed by patent laws that protect biotechnology discoveries. Many important scientific discoveries are characterized by the function or activity of a molecule rather than its structure, and biotechnology companies often seek early protection on their commercial interests largely based on activity. In contrast, patent law requires an inventor to provide an adequate written description of the structure of the claimed molecule. This statutory requirement has been a source of continued frustration to those pursuing biotechnology patents. The latest U.S. Court of Appeals for the Federal Circuit decision on the issue of written description exacerbates the inherent tension between scientific discoveries in the area of biotechnology and the rules governing patent rights.

Patent claims define the limits of an invention and constitute a source of economic power for patent holders. However, the exclusionary power conferred by a patent can only be as strong as the supporting disclosure’s compliance with the requirements of 35 U.S.C. § 112. In return for the period of exclusivity provided by a patent, the first paragraph of 35 U.S.C. § 112 requires an inventor to provide a written description of the claimed invention in such full, clear, concise and exact terms as to enable any person skilled in the art to which the invention pertains to make and use the invention.

The purpose of the written description is to convey with reasonable clarity to those skilled in the art possession of the presently claimed invention at the time the patent application was filed. The Federal Circuit has warned that each case involving the issue of written description must be decided on its own facts and conceded that the precedential value of cases in the area of written description is extremely limited. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555 (Fed. Cir. 1991).

In 1993, the Federal Circuit held that adequate description of a genus requires precise definition of the genus, and this definition must distinguish the claimed subject matter from other material of the same type. Fiers v. Revel, 984 F.2d 1164, 1171 (Fed. Cir. 1993).

Defining written description in the context of biotechnology and pharmaceuticals, Regents of University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997) held that a description of genetic material "‘requires a precise definition, such as by structure, formula, chemical name, or physical properties,’ not a mere wish or plan for obtaining the claimed chemical invention."

Over the last two years, the Federal Circuit has rendered several decisions that appeared to signal a move away from the Lilly rule. After initially holding that a reference to specified biological material in a public depository was not a sufficient written description, the court on rehearing indicated that Lilly did not hold that all functional descriptions of genetic material necessarily fail as a matter of law to meet the written description requirement and held the written description requirement may be satisfied if, in the knowledge of the art, the disclosed function is sufficiently correlated to a particular, known structure. Enzo Biochem, Inc., v. Gen-Probe, Inc., 296 F.3d 1316 (Fed. Cir. 2002).

The Federal Circuit again distinguished Lilly in a biotechnology context in Amgen Inc. v. Hoechst Marion Roussel, Inc.,314 F. 3d 1313 (Fed. Cir. 2003). Amgen’s patent was found to comply with the written description requirement because it sufficiently described vertebrate and mammalian host cells used in the invention. In contrast to Lilly and Enzo Biochem, the claim terms in Amgen were not new or unknown biological materials that ordinarily skilled artisans would easily miscomprehend but, instead, were deemed to readily convey distinguishing information concerning the identity of the host cells.

Moba, B.V. v. Diamond Automation, Inc., No. 01-1063 (Fed. Cir. 2003), constitutes a third decision in which the Federal Circuit distinguished Lilly by finding that the patent-at-issue encompassed a claimed element that the specification did not describe. After considering its recent decisions regarding written description involving biotechnology inventions as well as the more predictable mechanical arts, the court found that, on the facts of the Moba case, the Lilly rule did not require a particular form of disclosure. The court emphasized that an original disclosure showing the inventor possessed the invention at the time the application was filed satisfies the written description requirement. In his concurring opinion in Moba, Judge Rader suggested "the viability of the Lilly rule is on the decline."

Accordingly, by the time of the Moba decision, a number of indicators appeared to signal the Federal Circuit’s willingness to limit the Lilly disclosure rule to certain fact scenarios and to find that a functional description of genetic material meets the written description requirement where that function is sufficiently correlated to a particular, known structure. It is against this backdrop that the Federal Circuit rendered the decision in University of Rochester v. G.D. Searle & Co., Case No. 03-1304 (Fed. Cir., Feb. 13, 2004).

University of Rochester v. G.D. Searle & Co.

In a decision that has been anxiously awaited by the pharmaceutical and biotechnology communities, the Federal Circuit affirmed summary judgment of invalidity for failure to comply with the written description requirement because a compound recited in the claimed methods was defined purely by functional characteristics. The court concluded that, as a matter of law, the patent at issue clearly and convincingly proved its own invalidity where the required compound was not disclosed and where there was no pre-existing awareness in the art of a compound exhibiting the claimed activity. University of Rochester v. G.D. Searle & Co., Case No. 03-1304 (Fed. Cir., Feb. 13, 2004).

Non-steroidal anti-inflammatory drugs such as aspirin, ibuprofen, ketoprofen and naproxen function to inhibit a class of enzymes termed cyclooxygenases. The University of Rochester (Rochester) patent relates to the discovery of the existence and function of two distinct cyclooxygenases. COX-1 performs a beneficial function in the gastrointestinal tract, whereas COX-2 exacerbates undesirable inflammation associated with diseases such as arthritis. Non-steroidal anti-inflammatory drugs inhibit both species of cyclooxygenases and can result in both a beneficial reduction in inflammation as well as undesirable gastrointestinal side effects. Rochester was issued U.S. Patent No. 6,048,850 (the `850 patent), which is directed to a method of selectively inhibiting the COX-2 form of the enzyme by administering a non-steroidal compound that selectively inhibits activity of the COX-2 gene product.

On the day the `850 patent issued, Rochester sued G.D. Searle & Co., Inc., Monsanto Co., Pharmacia Corp. and Pfizer, Inc. (collectively, Pfizer) alleging that sale of Pfizer’s COX-2 inhibitors Celebrex® and Bextra® infringed the `850 patent. The district court found that the `850 patent neither disclosed a non-steroidal compound that selectively inhibits COX-2 nor provided a suggestion how it could be made and held that the patent’s claims were invalid for failure to comply with the written description requirement of 35 U.S.C. § 112, first paragraph.

Although multifaceted, the substantive focus of Rochester’s argument on appeal was two-fold. First, Rochester alleged no written description requirement exists independent of enablement. Second, Rochester attempted to distinguish the Federal Circuit’s precedent by limiting the precedential decisions involving biotechnology inventions to genetic material and to composition of matter claims.

The Federal Circuit commenced its analysis by addressing the relative independence of the three separate provisions within § 112, first paragraph, and pointed out that the separate written description requirement found support in the statute itself as well as in Supreme Court decisions rendered as early as Evans v. Eaton, 20 U.S. (7 Wheat.) 356, 433-34 (1822) and as recent as Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 736 (2002), and also in a range of precedential decisions by the Federal Circuit. In a comprehensive analysis, the court acknowledged the often significant overlap between the written description, enablement and best mode requirements set forth in § 112, first paragraph. In this context, the court also pointed out that the written description requirement applies to original claims and rejected Rochester’s attempt to limit the written description requirement to the priority context. Rochester also was reminded that the written description requirement continues to serve a teaching function, as a quid pro quo in which the public is given meaningful disclosure in exchange for being excluded from practicing the invention for the term of the patent.

The court also noted that even in cases involving inherent written description, the requirement must still be met in some way so as to describe the invention sufficient for one skilled in the art to recognize what is claimed. Here, the Federal Circuit cited Enzo Biochem for the proposition that a sufficient disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described rather than merely describing the subject matter in functional terms. The court concluded that the `850 patent contained no language, generalized or otherwise, that describes compounds that achieve the claimed effect.

The court was equally strong in its rejection of Rochester’s argument that precedent should be limited to inventions claiming genetic material or to composition of matter claims with biotechnology inventions. The court made clear that its decisions in Fiers, Lilly and Enzo Biochem differed only with respect to the subject matter of the claims and not the rule for compliance with the written description requirement. While Enzo Biochem stated genetic material may satisfy the requirement for written description if the functional characteristics of the material are coupled with a disclosed correlation to a structure, the same is not necessarily true for other chemical arts. For example, it may not be within the ordinary skill in the art to predict the structure of a COX-2 selective inhibitor similar to the complement of a DNA molecule even if the COX-2 structure is known. The claims in issue require a COX-2 selective inhibitor in order to practice the claimed method. However, the patent specification makes clear that a critical aspect of the method - a compound that inhibits COX-2 - was hypothetical and that the inventors had neither possession nor knowledge of such a compound.

The Federal Circuit pointed to Rochester’s argument that a patent may not be held invalid on its face as contrary to precedent and cited to several recent decisions where patents had been held invalid for failure to meet the written description or enablement requirement, based solely on the language of the patent specification. The Federal Circuit found that, without disclosure of any compounds that have the desired characteristic of selectively inhibiting COX-2, the claimed methods cannot be said to have been described.

Finally, Rochester asserted that Federal Circuit precedent in Union Oil Co. v. Atlantic Richfield Co., 208 F.3d 989 (Fed. Cir. 2000), had recognized diverse forms of description, including description primarily, if not entirely, based on functional characteristics. Acknowledging that patent applicants have some flexibility in the mode selected for compliance with the written description requirement, the court stated that the written description requirement had been satisfied by specifying ranges of properties of the claimed gasolines, reflecting the way oil refiners actually formulate gasoline and allowing one skilled in the art to recognize what was being claimed. The Federal Circuit pointed to the common denominator of a patent specification that sets forth enough detail to allow a person of ordinary skill to understand what is claimed and that the inventor invented what is claimed. This common denominator was not shared by Rochester, which did not present any evidence that the ordinarily skilled artisan would be able to identify any compound based on its vague functional description.

Impact of Rochester on Patent Rights

University of Rochester v. G.D. Searle & Co. will likely impact patent prosecution and litigation for years because it calls into question the validity of patents that rely either solely or in part on function rather than structure to claim a biotechnology or biopharmaceutical invention. The resulting uncertainty introduced with regard to the ability to obtain and enforce biotechnology patents will impact the value of patent licensing transactions and risk allocation to the parties engaged in these transactions. The holders of patent rights in biotechnology inventions as well as potential infringers will require greater scrutiny of their positions prior to initiating enforcement or commercialization activity, respectively. As to the University of Rochester, this ruling effectively translates into a loss of billions of dollars in projected royalty payments.