On April 17, 2008, U.S. Representatives Steve Buyer (R-IN) and Jim Matheson (D-UT) introduced H.R. 5839, the “Safeguarding America’s Pharmaceuticals Act,” which would substantially expand federal drug pedigree requirements. Among other things, the legislation would authorize destruction of counterfeit drugs at ports-of-entry, revise federal drug …
As we previously reported (see post here and article here), FDA has been seeking stiffer sentences under the U.S. Sentencing Guidelines for at least the past five years. For the preceding four years, the FDA’s pleas seemed to fall on deaf ears, but in this …
On May 7, 2008, the U.S. Court of Appeals for the Federal Circuit is scheduled to hear oral argument in Lupin Ltd. v. Abbott Labs. This is a patent infringement action concerning U.S. Patent #4,935,507 (“the ‘507 patent”) with respect to Abbott’s antibiotic drug product …
