described next provides a means of obtaining expert participation after a patent issues. With respect to gene-sequence-related inventions, a low standard of non-obviousness results from Federal Circuit decisions making it difficult to make a case of obviousness against a genetic invention (for example, gene sequences). In this context the court should return to a stricter standard, which would also be more consistent with other countries’ practices in biotechnology patenting.

  • Open Review procedure. Congress should seriously consider legislation creating a procedure for third parties to challenge patents for a limited period after their issuance in an administrative proceeding before administrative patent judges of the USPTO. The speed, cost, and design details of this proceeding should make it an attractive alternative to litigation to determine patent validity and be fair to all parties.

  • USPTO capabilities. To improve its performance the USPTO needs additional resources. These funds should enable hiring additional examiners, implementing a robust electronic processing capability, and creating a strong multidisciplinary analytical capability to assess management practices and proposed changes. In addition, the funds should be used to provide early warning of new technologies being proposed for patenting, and to conduct reliable, consistent, reputable quality reviews that address office-wide as well as subunit and examiner performance. The current USPTO budget does not suffice to accomplish these objectives and to administer an Open Review procedure.

  • Research liability for patent infringement. In light of the Federal Circuit’s 2002 ruling that even noncommercial scientific research enjoys no protection from patent infringement liability, and in view of the academic research community’s belief in the existence of such an exemption, and behavior accordingly, there should be some level of protection for noncommercial uses of patented inventions. Congress should consider appropriately narrow legislation, but if progress is slow or delayed the Office of Management and Budget and the federal government agencies sponsoring research should consider extending “authorization and consent” to grantees as well as contractors, provided that such rights are strictly limited to research and do not extend to any resulting commercial products or services. Either legislation or administrative action could help ensure preservation of the “commons” required for scientific and technological progress.

  • Litigation elements. Three provisions of patent law that are frequently raised by plaintiffs or defendants (rarely by the courts) in infringement litigation depend on determining a party’s state of mind, and therefore generate high discovery costs. These provisions are (1) “willful infringement,” which if proven, exposes an infringer to possible triple damages; (2) the doctrine of “best mode,” which addresses whether an inventor disclosed in an application what the inventor considered to be the best implementation of the invention; and (3) the doctrine of “inequitable conduct,” concerning whether the applicant’s attorney intentionally misled the USPTO in prosecuting the original patent. To reduce the cost and



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