The U.S. Food and Drug Administration (FDA) issues draft guidance titled “Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants.” According to FDA, “[t]he guidance assists sponsors and applicants in generating and submitting a meeting request and the associated meeting package to FDA for biosimilar biological products.” Comments are requested by May 31, 2013.
The U.S. Food and Drug Administration extends the comment period relating to its April 29-30, 2013, public workshop titled “Accessible Standardized Medical Device Labeling.” Comments are requested by May 17, 2013.
The U.S. Food and Drug Administration (FDA) issues guidance titled “User Fees and Refunds for Premarket Approval Appplications (PMAs) and Device Biologics License Applications (BLAs).” The document is intended to “identify the types of PMAs and BLAs subject to device user fees, including supplements and other submissions, as well as those that do not have an associated user fee. The guidance also identifies industry and FDA actions on these submissions that may result in a refund of the fee.”
The U.S. Patent and Trademark Office revises its rules of practice to implement changes to inter partes review under the Leahy-Smith America Invents Act. This final rule “eliminates the nine-month ‘dead zone’ for filing an inter partes review petition challenging a first-to-invent patent or reissue patent.” Such petitions may now be filed upon patent issuance. The rule took effect March 25, 2013.
The U.S. Patent and Trademark Office issues an interim final rule addressing Leahy-Smith America Invents Act revisions to patent term adjustment. Effective April 1, 2013, the changes clarify that “the fourteen-month patent term adjustment period and the three-year patent term adjustment period will be measured from the same date: the date on which an application was filed under 35 U.S.C. 111(a) in an application under 35 U.S.C. 111; or the date of commencement of the national stage under 35 U.S.C. 371 in an international application.” Comments are requested by May 31, 2013.
The U.S. Patent and Trademark Office announces an April 11, 2013, awards ceremony at the Dirksen Senate Office Building in Washington, D.C., for “patent holders who have made use of patented technologies to address humanitarian challenges.” The Patents for Humanity program was launched in February 2012 with the support of the Ewing Marion Kauffman Foundation as “part of an Obama administration initiative promoting game-changing innovations to solve longstanding development challenges.”
The U.S. Patent and Trademark Office (USPTO) schedules the Kansas Regional Independent Inventors Conference, April 19-20, 2013, in Wichita, Kansas. The event “will feature senior USPTO staff, successful inventors, and seasoned entrepreneurs to provide attendees with expert advice, intellectual property (IP) information and resources.”