Written Description Requirement Did Not Require Patentee To Recite Known Gene Sequences Used In Vaccine
The One Sentence Summary: In an appeal from a decision of the Board of Patent Appeals and Interferences in an interference involving a patent application and an issued patent covering a mutant poxvirus vaccine, the Federal Circuit held that (1) the absence of examples involving poxviruses in the specification did not render the written description inadequate; (2) the written description standard may be met even where actual reduction to practice of an invention is absent; and (3) there is no per se rule that an adequate written description of an invention that involves a biological macromolecule must contain a recitation of known structure.
What They Were Fighting About: Falkner held U.S. Patent No. 5,770,212 ("the Falkner '212 patent"). Inglis filed U.S. patent application no. 08/459,040 ("the Inglis '040 application"). The subject of both the patent and the application was a safer poxvirus vaccine.
An interference proceeding resulted in the Board of Patent Appeals and Interferences invalidating several claims of the Falkner '212 patent, and holding that several claims in the Inglis '040 application were valid. (An interference is a proceeding used to determine priority when an applicant and a patentee are claiming the same patentable subject matter and their filing dates are so close together that there is a reasonable possibility that the first to file is not the first inventor). In the interference, both inventors sought the benefit of earlier-filed applications to establish dates of constructive reduction to practice. (Priority in an interference goes to the first to invent, but a rebuttable presumption exists that the inventors made their inventions in the chronological order of their effective filing dates, namely that the senior party invented first). The Board accorded the Inglis '040 application the benefit of several earlier-filed applications, dating back to September 25, 1990, and the Falkner '212 patent the benefit of earlier filed applications dating back to April 29, 1994, thus resulting in several of the claims in the Falkner patent being invalidated.
On appeal, Falkner argued that the Board's decision invalidating its claims was incorrect because the specifications from Inglis's earlier applications did not adequately describe and enable the poxvirus, and thus Inglis was not entitled to priority. The Federal Circuit rejected Falkner's contentions and affirmed the decision of the Board.
Federal Circuit Holdings:
- Written description is a question of fact, judged from the perspective of one of ordinary skill in the art as of the relevant filing date, and enablement is a questions of law involving underlying factual inquiries.
- The Federal Circuit applies the standards of the Administrative Procedure Act ("APA") in reviewing decisions of the Board. It will set aside actions of the Board if they are arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law, and it sets aside factual findings that are unsupported by substantial evidence (that evidence which a reasonable person might accept as adequate to support a conclusion). The Federal Circuit reviews questions of law de novo.
- The adequacy of the disclosure is judged from the perspective of one of ordinary skill in the art.
- The Board's legal conclusion of enablement, in light of its underlying findings of fact, was not incorrect, despite the fact that the Inglis '040 application provided a detailed example of an embodiment that comprised not a poxvirus, but a herpesvirus, including the identity of the deleted essential gene sequence. There was extensive disclosure of the selction of an essential gene, its deletion or inactivation, and the production of a mutated virus with the deleted or inactivated gene, albeit for herpesvirus. However, the differences between the herpesviruses and poxviruses were well known, and this would have aided the person of ordinary skill in the art in her application of the lessons of the herpesvirus example in the construction of poxvirus vaccines.
- The absence of examples involving poxviruses in the Inglis applications did not render the written description inadequate. A claim will not be invalidated simply because the embodiments of the specification do not contain examples explicitly covering the full scope of the claim language. It is unnecessary to spell out every detail of the invention in the specification; only enough must be included to convince a person of sill in the art that the inventor possessed the invention and to enable such a person to make and use the invention without undue experimentation.
- The fact that Inglis had not actually produced a poxvirus vaccine was not necessary to meet the written description requirement. That requirement implements the principle that a patent must describe the technology that is sought to be patented and serves both to satisfy the inventor's obligation to disclose the technological knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed. However, constructive reduction to practice is an established method of disclosure. Although actual reduction to practice ordinarily provides the best evidence that an invention is complete, it does not follow that proof of reduction to practice is necessary in every case.
- The Inglis specifications adequately described the poxvirus invention, despite not describing the "essential regions" of the poxvirus genome. Existing literature references at the time of the Inglis applications described the DNA sequence of the poxvirus genome and the locations of the essential regions. It is binding precedent of the Federal Circuit that whenever a claim limitation is directed to a macromolecular sequence, the specification need not always recite the gene or sequence. A requirement that patentees recite known DNA structures, if such a requirement existed, would serve no goal of the written description requirement. It would neither enforce the quid pro quo between the patentee and the public by forcing the disclosure of new information, nor would it be necessary to demonstrate to a person of ordinary skill in the art that the patentee was in possession of the claimed invention. Where accessible literature sources clearly provided, as of the relevant date, genes and their nucleotide sequences (here "essential genes"), satisfaction of the written description requirement does not require either the recitation or incorporation by reference of such genes and sequences.
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