In the United States District Court for the Eastern District of Virginia: Alexandria Division- BRIEF OF AMICUS CURIAE BIOTECHNOLOGY INDUSTRY ORGANIZATION IN SUPPORT OF PLAINTIFFS' MOTIONS FOR SUMMARY JUDGMENT

摘要

The Biotechnology Industry Organization ("BIO") respectfully submits this brief in support of the plaintiffs' motions for summary judgment in the above-captioned consolidated cases. The final rules published by the Patent and Trademark Office ("PTO")on August 21, 2007, significantly alter patent applicants' ability to claim and protect their inventions. Changes to Practice for Continued Examination Filings, Patent Applications Containing Patentably Indistinct Claims, and Examination of Claims in Patent Applications, 72 Fed. Reg. 46,716 (Aug. 21, 2007) ["Final Rules"] (to be codified at 37 CFR pt. 1). The adverse effects of the Final Rules will nowhere be felt more strongly than in the biotechnology industry. This industry relies heavily on patent law and the current, established PTO rules of practice to obtain adequate protection for its inventions and to attract financing for products that often take more than a decade to reach the market. BIO is deeply concerned about the irreversible loss of patent rights and the disincentives to innovation that the Final Rules will cause. Like the plaintiffs, BIO believes that the Final Rules violate the patent laws and the Administrative Procedure Act. 5 USC para.706. Instead of repeating the arguments the plaintiffs have ably made on these points, BIO's brief will address the significant harm that the provisions of the Final Rules that place severe limitations on continuations and on the number of patent claims an applicant can make will cause to the biotechnology industry and the public at large if those Rules are allowed to go into effect.