The Food and Drug Administration conducts a public hearing on draft guidances pertaining to a pathway to approval for biosimilar products.
U.S. Representative Lois Capps (D-Calif.) introduces a bill (H.R. 5341) to improve post-market risk identification and analysis associated with medical devices. Titled “Sentinel Assurance for Effective Devices Act of 2012,” the bill would also set a December 31, 2012, deadline for the Food and Drug Administration to release a final rule on the unique device identification system.
The U.S. Department of Agriculture’s Advisory Committee on Biotechnology and 21st Century Agriculture schedules a meeting for May 29-30, 2012, in Washington, D.C. The agenda includes final reports from four working groups and “potential economic impacts on farmers from the escape of certain genetically engineered crops with functional traits.”
The U.S. Patent and Trademark Office requests comments on its proposal to adjust certain patent fees for fiscal year 2012 “to reflect fluctuations in the Consumer Price Index (CPI)” as required under the patent statute. The fee adjustment calculations are based on a CPI increase of 2.9 percent.
The U.S. Patent and Trademark Office implements a pilot program “intended to reduce pendency and applicant costs when an information disclosure statement (IDS) is filed after payment of the issue fee. This pilot program will permit an examiner to consider an IDS after payment of the issue fee without the need to reopen prosecution, effectively obviating the need to pursue a request for continued examination (RCE).”
The U.S. Patent and Trademark Office (USPTO) requests nominations for two public advisory committees that review USPTO’s policies, goals, performance, budget, and user fees with respect to patents and trademarks, respectively.
The Food and Drug Administration issues a final rule on sterility testing of biological products to provide biological product manufacturers greater flexibility and encourage “use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products.” The rule takes effects June 4, 2012.
In a non-precedential ruling, the Federal Circuit Court of Appeals determines that the America Invents Act, which retroactively extinguished “falsemarking” claims filed by individuals on behalf of the government (in qui tam proceedings), does not violate the Takings or Due Process Clauses of the U.S. Constitution. Rogers v. Tristar Prods., Inc., No. 2011-1494, -1495 (Fed. Cir., decided May 2, 2012).