Eli Lilly and Co.

Eli Lilly and Company (" Lilly ") is pleased to offer the following comments regarding the Patent and Trademark Office's ("PTO's") recently published Revised Interim Guidelines for Examination of Patent Applications Under the 35 U.S.C. Sec. 112, ¶ 1 "Written Description" Requirement (" the Guidelines ") and the accompanying training materials entitled Synopsis of Application of Written Description Guidelines ("the Training Materials"). Having been involved in expensive and prolonged patent litigation that centered in part on the "written description" requirement for patentability, Lilly is particularly sensitive to the costs and burdens to the public of patents that contain claims to subject matter nowhere described in the patent specification. Our threshold comment to the PTO is, therefore, that the Guidelines make completely clear to patent examiners the important public policy objectives that are served by making reasonable and fairly based rejections for lack of written description in every circumstance where the decisions of the Federal Circuit justify such rejections. Where reasonable and fairly based rejections are made, applicants are afforded the opportunity to develop the law on "written description" through the ex parte appeal process. This route is far less expensive and far more satisfactory for both inventors and accused infringers than the painful process of inter partes litigation before a Federal court. If the PTO can encourage such fairly based rejections to be made and if such rejections result in ex parte appeals, it is critical that appeals of this type be accelerated through the PTO so that definitive decisions of the Board of Patent Appeals and Interferences and, where appropriate, the Federal Circuit, can be developed in a timely manner. We urge the PTO to continue its outreach to the bar and trade groups to help identify such situations and accelerate the appeal process. Lilly's review of the Guidelines has centered on the application of this " statutory requirement" to inventions in the chemical arts and life sciences. While we are encouraged that, through judicial decisions such as the Regents of the University of California v. (the Lilly case), the boundaries of the "written description" requirement have come into reasonably clear focus, we are concerned that some of the PTO's speculation on what is and is not a proper "written description" goes beyond any judicial sanction. Thus, instead of encouraging examiners to make reasonable and fairly based rejections, the Guidelines may instead encourage the issuance of U.S. patents that …