Heads of the U.S. Patent and Trademark Office (USPTO), European Patent Office and Japan Patent Office—collectively known as the Trilateral Offices— confirm their commitment to eliminating unnecessary duplication of work, enhancing patent examination and quality, and working to ensure that stable patent rights can be granted smoothly and easily worldwide. USPTO will host the 31st Annual Trilateral Conference in fall 2013.
The U.S. Patent and Trademark Office (USPTO) chooses the Terminal Annex Federal Building as the site for its Dallas-Fort Worth regional satellite office, where small businesses and entrepreneurs can navigate the patent process, meet with examiners and access USPTO’s comprehensive search databases. Modeled after USPTO’s first satellite office in Detroit, the new office is on pace to have more than 100 patent examiners and 20 administrative judges on board by the end of its first year of operation.
The IP5—a coalition of the world’s five largest patent offices—announces the upcoming release of the “IP5 Statistics Report 2011 Edition.” The report aims to facilitate an understanding of operations and patent procedures among the offices, provide a means for gauging inventive activity and technology flow, and compare procedures. The IP5, which handles about 80 percent of the world’s patent applications, includes the U.S. Patent and Trademark Office, European Patent Office, Japan Patent Office, Korean Intellectual Property Office, and State Intellectual Property Office of the People’s Republic of China.
The Food and Drug Administration (FDA) issues draft guidance titled “Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products” to provide recommendations on the substance and scope of preclinical information needed to support clinical trials for investigational products regulated by the Center for Biologics Research and Evaluation Office of Cellular, Tissue, and Gene Therapies. According to FDA, “The product areas covered by this guidance are cellular therapy, gene therapy, therapeutic vaccination, and xenotransplantation.” The guidance clarifies current expectations for these product areas concerning the preclinical information that supports investigational new drug and biologics license applications.
The Food and Drug Administration (FDA) amends its July 10, 2012, proposed rule to establish a unique device identification system as required by recent amendments to the Federal Food, Drug, and Cosmetic Act. FDA would change some of the proposed effective dates for requirements applicable to implantable, lifesaving (life-supporting), and life-sustaining devices, so that the requirements applicable to these devices will be effective no later than two years from the rule’s finalization. Comments are requested by December 19, 2012.
The Food and Drug Administration (FDA) considers an implementation strategy and policy for the custom device exemption criteria in the Federal Food, Drug, and Cosmetic Act, as amended by the Food and Drug Administration Safety and Innovation Act. FDA seeks information on appropriate uses of the custom device exemption. Comments are requested by January 18, 2013.