Presenting a live 90-minute webinar with interactive Q&A Patents and the Written Description Requirement Navigating Section 112 Disclosure Obligations and Withstanding Invalidity Challenges TUESDAY, NOVEMBER 27, 2012 1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific Today’s faculty features: Thomas L. Irving, Partner, Finnegan Henderson Farabow Garrett & Dunner , Washington, D.C. Annemarie Hassett, Partner, Goodwin Procter , New York The audio portion of the conference may be accessed via the telephone or by using your computer's speakers. Please refer to the instructions emailed to registrants for additional information. If you have any questions, please contact Customer Service at 1-800-926-7926 ext. 10 .
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Patents and the Written Description Requirement Navigating Section 112 Disclosure Obligations and Withstanding Invalidity/Unpatentablity Challenges in Preparation, Prosecution, and Litigation by Annemarie Hassett Tom Irving ahassett@goodwinprocter.com tom.irving@finnegan.com Strafford Webinar, Nov. 27, 2012
Disclaimer These materials are public information and have been prepared solely for educational and entertainment purposes to contribute to the understanding of U.S. intellectual property law and practice. These materials reflect only the personal views of the joint authors and are not individualized legal advice. It is understood that each case is fact-specific, and that the appropriate solution in any case will vary. Therefore, these materials may or may not be relevant to any particular situation. And not all views expressed herein are subscribed to by each joint author. Thus, the joint authors and FINNEGAN and GOODWIN PROCTER cannot be bound either philosophically or as representatives of various present and future clients to the comments expressed in these materials. The presentation of these materials does not establish any form of attorney-client relationship with the joint authors or FINNEGAN or GOODWIN PROCTER. While every attempt was made to insure that these materials are accurate, errors or omissions may be contained therein, for which any liability is disclaimed. 5
Ariad v. Lilly Implications of the decision on patent prosecution for predictable arts for non-predictable arts on patent litigation Best practices to meet the written description requirement 6
Written description requirement: Purpose and Scope General Policy: The requirement of an adequate disclosure assures that the public receives quid pro quo for the limited monopoly which is granted to the inventor. ( Bonito Boats v. Thunder Craft Boats ) 7
Written description requirement: Purpose and Scope 35 U.S.C. § 112, ¶ 1: 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 which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. 8
Written description requirement: Purpose and Scope Purpose: Describe exactly what the grant covers “The specification shall contain a written description of the invention and the manner and process of making and using it , …” Must “convey clearly to those skilled in the art the information that applicant has invented the specific subject matter claimed.” ( Carnegie Melon v. Hoffman La Roche quoting Vas-Cath v. Mahurkar) Requires more than a “hope” or a “plan.” ( Fiers v. Revel ) 9
Written description requirement: Purpose and Scope Purposes of the Written Description Requirement: Before the introduction of a claims requirement (1836), the written description served to define the metes and bounds of the patented invention. This requirement kept the inventor from “pretending that his invention is more than what it really is.” ( Evans v. Eaton, 20 U.S. 434-435 (1835)) 10
Written description requirement: What is Required The written description must describe the invention “in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention.” ( University of California v. Eli Lilly & Co.) An inventor must be able to “describe [the] invention with particularity.” ( Fiers v. Revel) An applicant describes the invention “by such descriptive means as words, structures, figures, diagrams, formulas, etc., that fully set forth the claimed invention.” ( Lockwood v. American Airlines, Inc. ) 11
Written description requirement: What is Required The written description requirement also can be satisfied by: “showing that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics … i.e. , complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics.” (Manual of Patent Examination and Procedure) 12
Written description requirement: What is Required The written description does not require: examples ( Falkner v. Inglis) ; actual reduction to practice ( Falkner v. Inglis); word for word disclosure ( Fujikawa v. Wattanasin ); the same type of written description for every type of invention ( Capon v. Eshhar); or express disclosure of each and every species of a genus ( In re Robins ). 13
Written description requirement: What is Required Applying the Written Description Requirement: Compliance is a question of fact. Would the ordinary skilled artisan have understood that the inventor was in possession of the claimed invention at the time of filing? Compare the patent claims with the patent disclosure. The requirement is not met if the claimed invention lacks sufficient specificity in the disclosure. 14
Written description requirement: What is Required Applying the Written Description Requirement: The requisite level of detail to meet the requirement is based on factors: the nature and scope of the claims; the predictability of the relevant technology; the existing knowledge in the field; the prior art; the maturity of the field. 15
What Is Not Required A few broad principles hold true across all cases. The written description does not require: actual reduction to practice ; any particular form of disclosure; word for word disclosure; the same type of written description for every type of invention; or express disclosure of each and every species of a genus. 16
Is Disclosure of One Species or Embodiment Enough? Some language in Ariad suggests that disclosure of a sufficient embodiment or example would satisfy WD. For example, the opinion describes one of the "few broad principles that hold true across all cases" as follows: We have made clear that the written description requirement does not demand either examples or an actual reduction to practice; a constructive reduction to practice that in a definite way identifies the claimed invention can satisfy the written description requirement. Falko-Gunter Falkner v. Inglis, 448 F.3d 1357, 1366-67 (Fed. Cir. 2006). This passage supports the view that examples are not necessary but that a specific example falling within a claim is sufficient to satisfy WD. 17
When Is More Disclosure of More Than One Species Or Embodiment Required? Other language in Ariad suggests that a single example may not always suffice: Nor do we set out any bright-line rules governing, for example, the number of species that must be disclosed to describe a genus claim, as this number necessarily changes with each invention, and it changes with progress in a field. Compare Eli Lilly , 119 F.3d at 1567 (holding an amino acid sequence did not describe the DNA sequence encoding it), with In re Wallach , 378 F.3d 1330, 1334 (Fed. Cir. 2004) (discussing how it is now a "routine matter" to convert an amino acid sequence into all the DNA sequences that can encode it). 18
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