New patent reform bill
Sen. Jon Kyl, R-Ariz., plans to introduce a patent damages bill that does not include the apportionment provisions opposed by drug lobbyists and contained in legislation sponsored by Sen. Patrick Leahy, D-Vt. (S. 1145). The House and Senate Judiciary Committees each approved versions of Leahy's bill in July 2007, but the bill has since stalled (1"The Pink Sheet," July 23, 2007, p. 20). Leahy's bill would require courts to select one of several methods of calculating royalties. Kyl's legislation, which the senator plans to introduce in September, would codify the so-called "Georgia-Pacific factors": 15 factors for calculating royalty payments for patents, established in a 1970 federal court case...
You may also be interested in...
The House and Senate Judiciary Committees each approved versions of patent reform legislation the week of June 16 that respond to some concerns raised by drug and medical device lobbyists, but that still leave industry unsatisfied and primed to seek changes before the bills go to a floor vote
A trio of newly finalized guidance documents from the US agency dated 25 September explain how the Accreditation Scheme for Conformity Assessment pilot will work, and what biocompatibility and safety standards will apply.
Approval of Alaway Preservative Free (ketotifen fumarate, 0.035) comes 15 months after FDA submitted a complete response letter to Bausch and the active ingredient developer, Eton Pharmaceuticals.