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The year 2003 was a very active year at the US Court of Appeals for the Federal Circuit in the area of chemical, pharmaceutical, and biotech inventions. On the patentability side, the year 2003 signaled a significant change of direction in two areas of great interest to pharmaceutical and biotech patentees--the areas of written description and inherency.
In the written description area, 2003 represented the first year in which the court signaled a reversal of the trend it established in 1997, requiring provision of specific sequences for applicants claiming biological molecules. The Federal Circuit is not quite ready to reverse its "written-description-plus" requirement for biotech inventions. However, the Federal Circuit has shown an increasing willingness to permit an applicant to rely on deposits or other inherent characteristics, such as physical or chemical properties, to satisfy the written description requirement.
In the inherency area, the court resolved a conflicting line of cases and made it clear that inherency does not require recognition of the inherent features in the prior art. Furthermore, the court clarified that it is proper to rely on the doctrine of inherency to demonstrate anticipation of the totality of a claim, not just one or two elements of the claim. This is already having a significant impact on patent holders seeking second-and third-generation patents based on trivial changes as compared to first-generation patents.
Cases Relating to Patentability
The year 2003 proved to be a turning point on two key patentability issues that have affected patentability of biotech and pharmaceutical inventions, namely, written description and inherency.
In the area of written description, the court continues to address the unintended consequences resulting from its 1997 holding in Regents of the University of California v. Eli Lilly & Co. (1) At the risk of oversimplifying, the Lilly case established the rule that it is not enough for written description purposes to merely name a DNA by the properties of the protein encoded by it, in that particular case the species "human insulin-encoding cDNA" and the genus "mammalian insulin cDNA," even when the specification enables one skilled in the art to make and use the DNA. (2) The University had actually obtained the rat cDNA but merely proposed a method by which the corresponding human cDNA could be obtained. The Federal Circuit held that, regardless of whether the application enabled the human cDNA, the name cDNA is not itself a written description of that DNA because "it conveys no distinguishing information concerning its identity." (3) Accordingly, an example providing a process for obtaining human insulin-encoding cDNA does not satisfy the written description requirement in the absence of further information in the patent pertaining to that cDNA's relevant structural or physical characteristics. (4)
To its proponents, the Lilly case has represented an important safeguard preventing the discoverer of a single biological molecule with a desirable property from monopolizing all as yet unidentified molecules having such property. In other words, it prohibits one from obtaining a patent covering "anything that works." The proponents cite Amgen Inc. v. Chugai Pharmaceutical Co. Ltd. (5) for the propositions that (1) there is no invention without conception and (2) there is no conception until the inventor can "describe his invention with particularity." (6) Accordingly, without the sequence or at the very least some meaningful distinguishing physical or chemical properties, the written description requirement is not met. With any other approach, the proponents argue, "one could obtain a patent claiming of goal or the results of a research plan." (7)
To its opponents, the Lilly case has established a new requirement for patentability of biological inventions above and beyond the requirements for any other area of technology. For example, under the proponents' reading of Lilly, even an actual reduction to practice, as evidenced by a working example or a deposit, is not a sufficient description of a biological molecule. (8) This ignores several longstanding doctrines of patents law: (1) a structural formula is not itself the invention; rather, it is merely a convention developed in the art for representing that invention; (9) (2) an actual reduction to practice of an invention is a safe haven as a written description; (10) and (3) the context in which the court in Amgen required a distinguishing description is when there was no reduction to practice. (11) The opponents argue further that a tool already exists for preventing the unscrupulous patentee from obtaining overly broad patents. That tool is the enablement requirement. (12)
Ironically, the issue of written description for biological inventions was brought to the forefront this year at the Federal Circuit in a case involving, of all things, an egg-sorting machine. More particularly, in Moba, B. V v. Diamond Automation, Inc., 13 the issue was whether a claim encompassing the step of lifting eggs from a moving conveyor was adequately described given that the patent specification disclosed no such conveyor mechanism. The Federal Circuit concluded that functional descriptions are not necessarily deficient under the written description requirement, citing to its earlier case of Enzo Biochem Inc. v. Gen-Probe Inc.: (14)
More recently, in Enzo Biochem we clarified that Eli Lilly did not hold that all functional descriptions of genetic material necessarily fail as a matter of law to meet the written description requirement; rather, the requirement may be satisfied if in the knowledge of the art the disclosed function is sufficiently correlated to a particular, known structure. (15)
Moba was particularly interesting for two reasons. First, it acknowledged that Eli Lilly had indeed expanded the court's application of the written description requirement, noting that from 1967 to 1997 the court applied the written description requirement solely "to prevent the addition of new matter to claims." (16) Thus, for the first time, Eli Lilly invoked the written description requirement in a case without priority issues by requiring a precise definition of a DNA sequence in the patent specification.
Second, Moba shows that the Federal Circuit, while not going so far as to overrule Eli Lilly, is going to be construing it more narrowly. In particular, the court made reference to its recent decision in Enzo, noting that on reconsideration it reversed its initial holding that neither the specification nor the deposited biological material recited the precise "structure, formula, chemical name, or physical properties" required by Lilly. (17) The Federal Circuit cited to the fact that in Enzo it remanded the case to the district court to "determine whether a person of skill in the art would glean from the written description, including information obtainable from the deposits of the claimed sequences, subsequences, mutated variants and mixtures sufficient to demonstrate possession of the generic scope of the claims." (18) The most colorful part of the opinion was Judge Rader's concurrence, in which he advocated that Eli Lilly be overruled. Judge Rader noted that:
1. The language of [section] 112, [paragraph] 1 indicates that a patent will contain an adequate description if it provides enough information to enable a person skilled in the art to make and use the invention.
2. Any disclosure that enables one to make and use the invention also, by definition, shows that the inventor was in possession of that full invention.
3. The erroneous written description requirement of Lilly lacks both a statutory and a logical foundation.
4. For more than 30 years, this court and its predecessor understood this basic principle of patent law and confined the written description doctrine to its purpose--policing priority of invention.
5. In 1997, this court inexplicably wrote a new disclosure requirement, found nowhere in title 35, and attributed that new requirement to the written description doctrine.
6. This new disclosure doctrine, applied so far only to biotechnology cases, requires a nucleotide-by-nucleotide recitation of the structure of a biotechnological invention.
7. It complicates biotechnology patent drafting to the point of …