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U.S. Patents on Biotechnical Subject Matter: Challenges of the Written Description Requirement
By Linda B. Truong and Seth D. Levy
[June 2006]
In pursuing U.S. patent protection, applicants must not only overcome any relevant prior art, but must also be mindful of several requirements under 35 U.S.C. §112; particularly, the “enablement” requirement, the “best mode” requirement, and the “written description” requirement. In the areas of biotechnology and the life sciences, these requirements can be problematic for patent applicants. It can be especially challenging for those conducting basic or early stage research in these fields.
Recently, in Falkner v. Inglis, the Court of Appeals for the Federal Circuit summarized and clarified the “written description” requirement in the biotechnical context.1 The Federal Circuit upheld a U.S. Patent and Trademark Office (USPTO) decision in a patent interference proceeding that Inglis was the earlier inventor of the subject technology—vaccines made from a poxvirus vector having a deleted or inactivated essential gene that reduces the risk of infection by the virus because it can not replicate in an inoculee. The court held that the USPTO did not err in finding that Inglis’s patent specification properly enabled the claims and met the written description requirement. However, the court found that the USPTO had mischaracterized the written description standard.
The written description requirement is set forth in 35 U.S.C. §112, first paragraph, which provides, in pertinent part, that “[t]he 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 make and use the [invention].” Courts have held that to satisfy the written description requirement, “the applicant must...convey to those skilled in the art that, as of the filing date…he or she was in possession of the invention.”2
In clarifying the written description standard in Falkner, the Federal Circuit held that for purposes of the written description requirement, “(1) examples are not necessary to support the adequacy of a written description; (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.” An underlying rationale for this holding is that the specification is written for a person of skill in the art, and it is thus unnecessary to spell out every detail when one of skill in the art would readily be convinced that the applicant possessed the invention. The court also reasoned that when accessible literature sources clearly provide the structure of a biological macromolecule, a re-description of what is already known is not necessary.
While this Federal Circuit decision reinforces an applicant’s ability to meet the written description requirement by providing a specification that is interpreted in light of the level of skill in the art, the decision speaks fundamentally to what is not required for fulfilling the requirement. An applicant must bear in mind, however, that the amount of information necessary to satisfy the written description requirement varies with the nature and scope of an invention and with the state of the art in any particular field of technology.
These challenges can be compounded when a patent application that does not satisfy the requirements of 35 U.S.C. §112 is published by the USPTO. The application may thus become prior art as to subsequently-filed applications, regardless of whether it itself meets the §112 requirements necessary for a grant of patent protection. In fact, the publication may be prior art with respect to a subsequent patent application filed by the same inventor, in which the §112 requirements have been satisfied. The earlier-filed application may have been insufficient to result in a grant of patent protection, but, even so, its publication may effectively preclude patent protection from later being obtained for an invention described in an application that meets the §112 requirements.
It is important to consider the sufficiency of information available with respect to the requirements of 35 U.S.C. §112 before a patent application is filed. If an applicant’s disclosure does not meet the §112 requirements but an application is nonetheless filed, it may trigger a chain of events that forever precludes the possibility of pursuing patent protection for the invention, even if the §112 requirements can be satisfied in a later-filed application.
Footnotes
1 Falkner v. Inglis, No. 05-1324 (Fed. Cir. May 26, 2006), (full opinion may be found at
http://www.fedcir.gov/opinions/05-1324.pdf).
2 See Falkner v. Inglis (Fed. Cir. 2006), (citing Vas-Cath, Inc. v. Mahurkar, 935 F. 2d 1555, 1563-64 (Fed. Cir 1991).
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This Life Sciences Advisory Bulletin is a publication of the
Life Sciences Group of Davis Wright Tremaine LLP. Our purpose
in publishing this Advisory Bulletin is to inform our clients
and friends of developments in life sciences law. It is not
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Copyright © 2006,
Davis Wright Tremaine LLP.
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