The U.S. Patent and Trademark Office (USPTO) schedules an Additive Manufacturing Partnership Meeting on January 23, 2013, at its Alexandria, Virginia, campus. Additive manufacturing, or “3D printing,” refers to a group of new technologies that create objects from 3D computer models, usually by joining thin materials, layer upon layer. Among the many fields in which it is used are the dental and medical industries. The meeting will enable USPTO to expand its relationship with individual users as well as serve as a forum for users to share ideas, experiences and insights into this emerging field.
The U.S. Patent and Trademark Office (USPTO) announces a Medical Device Technology Partnership Meeting on January 29, 2013, at its Alexandria, Virginia, campus. Intended to bring medical device and biotechnology stakeholders together to share ideas, experiences and insights on best practices and provide a forum for how USPTO can improve and expand its relationship with medical device technology stakeholders, the meeting is sponsored by Technology Centers 3700 and 1600. Also on the agenda will be discussions about the Leahy-Smith America Invents Act, the Cooperative Patent Classification system and section 101 subject-matter eligibility.
The U.S. Patent and Trademark Office (USPTO) and the European Patent Office (EPO) launch the Cooperative Patent Classification (CPC) system, a global classification system for patent documents. According to USPTO, “CPC is the product of a joint partnership between the USPTO and the EPO to develop a common, internationally compatible classification system for technical documents used in the patent granting process that incorporates the best classification practices from both offices.” USPTO and more than 45 patent offices—a user community including more than 20,000 patent examiners—will use the system and, by sharing the same classifications, will help to establish the CPC as an international standard. USPTO and EPO have worked jointly for two years to develop the system, which includes approximately 250,000 classification symbols based on the International Patent Classification system. Examiners and patent users around the world will be able to access the same classified patent document collections when conducting their searches.
The Food and Drug Administration (FDA) announces a public workshop titled “Accessible Standardized Medical Device Labeling,” to be held April 29-30, 2013, in Silver Spring, Maryland. The workshop aims “to discuss the growing need for medical device labeling to be delivered in a clear, concise, and readily accessible format so that patients, caregivers, and healthcare providers may access and utilize device labeling as efficiently and effectively as possible.” The workshop will also “engage stakeholders in active discussion with FDA and . . . encourage public comments regarding standard content and format for medical device labeling and the use of a repository containing medical device labeling.” It will include publiccomment and topic-focused sessions.
The Food and Drug Administration (FDA) issues draft guidance titled “Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products.” The guidance will provide recommendations to industry “on enrichment strategies that can be used in clinical trials intended to support effectiveness and safety claims in new drug applications (NDAs) and biologics license applications (BLAs).” According to FDA, “the guidance defines and discusses three enrichment strategies: Decreasing heterogeneity, predictive enrichment, and prognostic enrichment. The guidance also discusses general clinical trial design considerations, provides examples of potential clinical trial designs, and discusses regulatory considerations when using enrichment strategies in clinical trials.” Comments are requested by February 15, 2013.