A robust policy triptych courtesy of BioCentury.
Good News: House passes patent reform bill
The U.S. House of Representatives voted 304-117 to pass the Leahy-Smith America Invents Act (H.R. 1249). The lawmakers also passed by a vote of 283-140 a manager's amendment from Judiciary Committee Chair Lamar Smith (R-Texas) that would end diversion of fees from the U.S. Patent and Trademark Office but would require the PTO to wait for subsequent congressional appropriations acts to access excess funds. Much of the money the PTO collects from fees is currently diverted to fund other parts of the government.
In March, the U.S. Senate voted 95-5 to pass S. 23, its version of the bill. That legislation would allow the PTO to use all the money it collects from fees without fiscal year limitations.
Both bills include elements supported by the biotech industry, such as eliminating the ability of an alleged infringer to invalidate a patent based on the description of the invention's best use and creating a new post-grant review procedure. A joint congressional committee will next be appointed by the House and the Senate to iron out the differences between the two bills.
Joint Reviews: FDA, EMA to accept first application for joint review
EMA and FDA agreed to accept the first application submitted under a pilot program for parallel assessment of Quality by Design components of NDAs and MAAs. The application was submitted by Pfizer for an undisclosed product.
FDA and EMA are collaborating on reviews of seven applications from April 1, 2011 to March 31, 2014 under the program, which is intended to prevent regulatory agencies from applying Quality by Design standards inconsistently.
Preemption Coups: Supreme Court rules for preemption on generics
The U.S. Supreme Court ruled 5-4 on Thursday in Pliva Inc., et al. v. Mensing that FDA-approved labeling for generic drugs preempts claims under state tort law because federal regulations prevent generic drug manufacturers from independently changing a drug's label.
In the court's opinion, Justice Clarence Thomas wrote that today's ruling does not conflict with a 2009 decision in Wyeth v. Levine because branded drug manufacturers can add to or strengthen a drug's label without preapproval from FDA. In that case, the court held that an FDA-approved label for Phenergan promethazine from Wyeth did not preempt state tort law in a product liability suit.
