The U.S. Food and Drug Administration (FDA) announces the availability of draft guidance for industry titled “Labeling for Human Prescription Drug and Biological Products Approved under the Accelerated Approval Regulatory Pathway.” The document presents FDA’s recommendations for developing the indication and usage statements in the prescribing information for drugs approved under the accelerated approval regulatory pathway. It also discusses “labeling considerations for indications approved under accelerated approval when clinical benefit has been verified and FDA terminates the conditions of accelerated approval, or when FDA withdraws accelerated approval of an indication while other indications for the drug remain approved.” Comments are requested by May 27, 2014.
The U.S. Patent and Trademark Office schedules an April 10, 2014, roundtable event “regarding the use of crowdsourcing and third-party preissuance submissions to identify relevant prior art and enhance the quality of examination as well as the quality of issued patents.” Thosewishing to speak must have made their request in writing by March 27, and those wishing to participate in person or via Webcast must register by April 4. Comments are requested by April 25.
The U.S. Patent and Trademark Office slates Patent Trial and Appeal Board roundtables throughout the United States for administrative patent judges “to share information about [inter partes review] trials and collect public input and suggestions.” They will take place Tuesdays and Thursdays, April 15 through May 8, 2014, in Alexandria, Virginia; New York City; Chicago, Illinois; Detroit, Michigan; silicon Valley, California; seattle, Washington; Dallas, Texas; and Denver, Colorado.
The U.S. Patent and Trademark Office launches a pilot program that will require participants filing software-related patents to include a glossary section in their patent application to define terms used in the patent claims. The goal is to “enhance claim clarity in the specification of software-related patent applications by encouraging and gauging the use of glossaries by patent applicants.” Those participating in the program “will receive expedited processing and be placed on an examiner’s special docket prior to the first office action, and will have special status up to issuance of a first office action.”