In a memorandum distributed last week to the U.S. Patent and Trademark Office patent examining corps, Robert Bahr, the Deputy Commissioner for Patent Examination Policy, sought to clarify the Office's guidance regarding the written description requirement of 35 U.S.C. § 112(a), and in particular, the examination of claims directed to antibodies for compliance with the written description requirement. The memorandum, entitled "Clarification of Written Description Guidance For Claims Drawn to Antibodies and Status of 2008 Training Materials," is divided into three sections, which address the Federal Circuit's recent decision in Amgen Inc. v. Sanofi, the Written Description Training Materials released by the Office in 2008, and the Office's current guidance on the written description requirement.
In the first section of the memorandum, Deputy Commissioner Bahr discusses the Federal Circuit's clarification in Amgen Inc. v. Sanofi of the written description requirement as applied to antibodies. In that case, the Federal Circuit clarified how the Court (and U.S. Patent and Trademark Office) should apply the written description requirement in 35 U.S.C. § 112(a) to properly circumscribe the scope of claims to monoclonal antibodies. Perhaps the most significant portion of the opinion involved the jury instructions, which relied on Noelle v. Lederman for the proposition that characterizing a new antigen was sufficient to satisfy the statute for claims encompassing a broad genus of antibodies that could bind to the new antigen. The Federal Circuit determined that this instruction "is not legally sound and . . . not based on any binding precedent," finding the instruction to be improper because it effectively eliminated the written description requirement from the statute in favor of enablement, contrary to the Court's en banc Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co. decision, stating that "[b]y permitting a finding of adequate written description merely from a finding of ability to make and use, the challenged sentence of the jury instruction in this case ran afoul of what is perhaps the core ruling of Ariad." In setting forth its abrogation of the "fully characterized antigen" test more directly, the Federal Circuit declared that:
[T]he "newly characterized antigen" test flouts basic legal principles of the written description requirement. Section 112 requires a "written description of the invention." But this test allows patentees to claim antibodies by describing something that is not the invention, i.e., the antigen. The test thus contradicts the statutory "quid pro quo" of the patent system where "one describes an invention, and, if the law's other requirements are met, one obtains a patent." Indeed, we have generally eschewed judicial exceptions to the written description requirement based on the subject matter of the claims [citations omitted].
The Office's memorandum explains that "[t]he Amgen court expressly stated that the so-called 'newly characterized antigen' test, which had been based on an example in USPTO-issued training materials and was noted in dicta in several earlier Federal Circuit decisions, should not be used in determining whether there is adequate written description under 35 U.S.C. § 112(a) for a claim drawn to an antibody." The memorandum states that "[i]n view of the Amgen decision, adequate written description of a newly characterized antigen alone should not be considered adequate written description of a claimed antibody to that newly characterized antigen." The memorandum also notes that the Manual of Patent Examining Procedure (MPEP) will be updated to incorporate the Amgen decision in due course.
The second section of the memorandum indicates that Written Description Training Materials that were made available by the Office in March of 2008 are now considered by the Office to be outdated. In a series of articles published in 2008 and 2009, we reported on the Training Materials (albeit not on Examples 13 and 14, which concern antibodies to a single protein and antibodies to a genus of proteins, respectively). According to the Office's memorandum, the Written Description Training Materials "are outdated and should not be relied upon as reflecting the current state of the law regarding 35 U.S.C. §§ 101 and 112." The memorandum also notes that the Office is currently preparing written description training materials containing examples that will reflect recent developments in the law regarding 35 U.S.C. §§ 101 and 112.
The memorandum concludes by providing the examining corps with a list of currently available guidance on the examination of claims for compliance with the written description requirement. According to the memorandum, "USPTO personnel should continue to follow the guidance in the MPEP regarding written description (see, e.g., MPEP 2161.01 and 2163), except insofar as MPEP 2163 indicates that disclosure of a fully characterized antigen may provide written descriptive support of an antibody to that antigen." The memorandum notes that the following materials "remain applicable and should be followed by USPTO personnel":
• The 2015 training module entitled "Examining Claims for Compliance with 35 USC 112(a) : Overview & Part I - Written Description";
• The 2015 Written Description Workshop materials; and
• The 2015-16 training slide set entitled "Antibody Decisions and Their Compliance with the Written Description Requirement."
