Written description after Ariad v. Eli Lilly: 35 USC (section) 112's third wheel.

• Author: Stone, Krista

Cite as 11 J. High Tech. L. 191 (2010)

1. Introduction

   The United States Constitution provides for the establishment of a patent system in order to promote scientific progress and development. (1) A patent grants the patent owner the right to exclude others from making, using, or selling his or her invention for a limited time in exchange for full disclosure of the invention to the public. (2) When the patent expires, the public can then use, develop, and profit from the information without infringing the rights of the inventor. (3)

   The United States patent system reflects an effort to strike a balance between the societal interest in encouraging innovation and the rapid disclosure of this information, and an inventor's reasonable desire to profit from his or her work without having to compete with imitators who did not invest resources to develop the idea. (4) Disclosure to the public is viewed as key to promoting rapid advancement of science and innovation, but because it is often cheaper and easier to be an imitator rather than an inventor, a limited monopoly in the form of a patent is the reward an inventor gets for making, and then disclosing, his or her invention. (5) Inventors naturally want to obtain the broadest possible patent protection, but granting broad patent protection can create monopolies on large swaths of information. (6) Broad patent rights granted to one party can limit the number of inventors who can profit by making improvements or new discoveries in an area covered by a broad patent, in turn stifling innovation. (7)

   Conversely, exceedingly narrow patent rights can lack economic value because in some cases a competitor can easily design around a narrow patent without infringing it. (8) This is precisely the concern in the biotechnology industry where inventions can be difficult to describe fully, even when enabled, and are easily designed around. (9) Thus, patent protection that is too narrow to be meaningful can also stifle innovation. (10) Innovators in the biotechnology field believe that the current strict interpretation of the written description requirement of 35 U.S.C [section] 112 will leave them with just that: narrow patents that offer little real protection for their intellectual property because the patents are easily designed around or simply ignored. (11)

   Despite the dangers associated with a mass of narrow patents, concerns also exist about granting overly broad patents rights. (12) Advocates for a strict written description requirement are concerned that the drawbacks of overly broad patents outweigh the negative aspects of narrow patents. (13) With the rapid advancements in biotechnology, patents on these inventions have proliferated and some companies have sought broad patent protection via functional descriptions. (14) Inventors are coaxed to broaden their claims to cover DNA sequences in other species via a functional description of what the protein does because DNA sequences--the proteins they encode and the protein functions--are similar across species. (15) These broad claims may not be warranted if the DNA sequences are highly variable across species. (16)

   The first paragraph of 35 U.S.C. [section]112 dictates what a patent specification must contain, (17) and its interpretation is the subject of debate. (18) The current interpretation of 35 U.S.C. [section]112 is that the specification must meet three distinct requirements: describing the invention in sufficient detail to enable the public to make and use the invention, describing the best mode for making or using the invention, and providing a written description of the invention. (19) Before the creation of the Federal Circuit, precedent about whether the written description was a third requirement for the specification, separate and distinct from the best mode and enablement requirements, was inconsistent. (20) Many argued it was not a separate requirement at all. (21) The written description requirement was primarily applied to amended claims to insure that an inventor was in actual possession of the invention described in the amendment at the time of the original filing date. (22) The Federal Circuit reviewed its decision in Ariad v. Eli Lilly (23) en banc in order to settle the debate that was swirling around the interpretation of the written description requirement. (24)

   This paper describes how the written description requirement has evolved over time. It shows that the Federal Circuit regarded the written description requirement as a third requirement under 35 U.S.C [section]112, but that written description was mainly applied to show that the inventor was in possession of the invention at the time of filing the patent application, and in a few other limited contexts. The development of today's strict written description requirement is traced. Ariad v. Lilly (25) is summarized along with the Federal Circuit's current interpretation of written description as a third requirement, distinct from enablement, to be applied in a rigorous manner in all contexts. This paper concludes that the written description requirement, as it is currently applied, is a superfluous third wheel. Judging the adequacy of the written description by whether a disclosure is enabling is a better standard to evaluate whether a disclosure meets the requirements of 35 U.S.C [section]112.

2. A Brief History of the Written Description Requirement Prior to Lilly

   The history of the written description requirement can be traced through the five United States Patent Acts and the cases that interpreted these statutes. (26) The Patent Act of 1790 required that the specification "distinguish the invention or discovery from other things before known and used," and also required that the specification enable one skilled in the art to make and use the invention. (27) The Patent Act of 1790 did not require claims, but the requirement to "distinguish the invention" served the same purpose: establishing the scope of what the inventor was claiming. (28) When the Patent Act of 1793 was enacted, the requirements for the specification essentially remained the same. (29)

   In Evans v. Eaton, (30) the Supreme Court interpreted the Patent Act of 1793 to decide whether Evans's patent on an improvement to flour mill machinery was valid. (31) In this case, it was clear that Evans's patent was to an improvement upon the original machinery, but the specification did not expressly point out the nature of the improvement and distinguish it from the original invention. (32) The Court held that Evans could not obtain a patent on the entire machine because he did not invent the entire machine. (33) The Court stated that the written description has two functions: to enable an artisan to make and use the invention and to put the public on notice about the scope of the invention so that they can avoid inadvertent infringement. (34) In 1793, written description was serving the function that claims do today, putting the public on notice of the scope of the invention; once claims began to be required as part of the specification, the function of the written description requirement changed. (35)

   The Patent Act of 1836 eliminated the requirement that the specification distinguish the invention from "other things known before," and added the requirement that claims specify exactly what the inventor was claiming. (36) The claims, not the language in the rest of the specification, now delineated the scope of the rights being claimed by the inventor. (37) The Patent Acts of 1870 and 1952 continued in the vein of the 1793 Act, requiring that the specification enable one skilled in the art to practice the invention, and requiring claims to define the scope of what was being claimed by "particularly point[ing] out" and "distinctly claim[ing]" the invention. (38)

   In re Ruschig marks a shift in the role of the written description requirement from delineating the scope of what was claimed to insuring that the inventor was in possession of the invention at the time of the application for a patent. (39) The only issue in the case was whether the specification had a written description adequate to support a claim to the compound N-(p-chlorobenzenesulfonyl)-N-propylurea. (40) The claim was rejected because the specification only contained a general description of the compound, not a precise chemical formula. (41) The court held that the written description was inadequate without more direction to specific compounds than what was contained in the specification. (42) The court emphasized that the salient question was whether the "specification convey[s] clearly to those skilled in the art, to whom it is addressed, in any way, the information that appellants invented that specific compound." (43) In other words, the applicant must show he or she possessed the invention at the time of filing. (44)

   In Vas-Cath Inc. v. Mahurkar, the Court of Appeals for the Federal Circuit reviewed the development of the written description requirement in response to the district court's comment that "[u]nfortunately, it is not so easy to tell what the law of the Federal Circuit is [with regard to written description]." (45) The Court of Appeals for the Federal Circuit responded by summarizing the relevant case law, stating that written description has been "frequently addressed" in the Federal Circuit and that a "fairly uniform standard for determining compliance with the 'written description' requirement has been maintained throughout." (46) The court in Vas-Cath concluded that written description is "separate and distinct from the enablement requirement" and that the written description must convey that the inventor was in possession of the invention at the time of filing. (47) The court explained that the function of the enablement requirement is to teach "how to make and use an invention without undue experimentation" but that showing possession of the invention at the time of filing would...