The U.S. Patent and Trademark Office (USPTO) slates its next Software Partnership meeting for October 17, 2013, at the U.C. Berkeley School of Law in California. The meeting will provide “an opportunity to bring stakeholders together to share ideas, experiences and insights and to provide a forum for an informal discussion on topics specific to the software community.” Also on the agenda will be an overview by senior USPTO officials on “executive actions related to patent assertion entities and U.S. innovation initiatives called for in President Obama’s executive actions on June 4th.” Those wishing to attend must RSVP by September 27, 2013.
The U.S. Patent and Trademark Office (USPTO) seeks comments on its estimate of the time burdens associated with preparing filings undertaken after USPTO allows an application for a patent to issue. These include (i) filing the specified issue fee to avoid abandonment of the application, (ii) requesting corrections of errors in issued patents, and (iii) submitting applications for reissue patents. Comments must be submitted by September 23, 2013.
The U.S. Patent and Trademark Office issues estimates of the time burdens related to collecting and submitting information required to deposit biological material on which inventions sought to be patented rely. Those involved in the biological material deposit requirement include both patent applicants and depositories, which must demonstrate that they are qualified to store and test the biological material submitted. Comments on the information collection burdens are requested by September 25, 2013.
The U.S. Patent and Trademark Office requests comments on the estimated time burdens of gathering information and preparing the filings required to seek patent term extensions for drug products, medical devices, food additives, or color additives or to seek reinstatement of patent term adjustments. It estimates that this process can take from one to 25 hours depending on the complexity and type of filing. Comments are requested by September 23, 2013.
The U.S. Food and Drug Administration (FDA) issues “Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed.” To protect the rights and welfare of human biomedical research subjects, the guidance was designed to “assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in fulfilling [their] responsibilities . . . and determining whether an investigational new drug (IND) application or investigational device exemption (IDE) is required.”
The U.S. Food and Drug Administration (FDA) seeks comments on a draft guidance for industry titled “ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers.” The document is intended to clarify “stability testing recommendations for abbreviated new drug applications (ANDAs) . . . [and] addresses public comments regarding FDA’s recommendation to generic drug manufacturers to follow International Conference on Harmonisation (ICH) stability guidances Q1A (R2) through Q1E.” Comments are requested by October 28, 2013.