Jim Greenwood, CEO of the Biotechnology Industry Organization (BIO) gave a briefing to biotech & pharma bloggers on key issues related to follow-on biologics, patent reform and PDUFA pending legislation. In the conference call, Greenwood provided an overview of the biggest issues for BIO and then fielded questions from the participants. Greenwood acknowledged that the […]

It appears, for now at least, that the legislation creating an approval pathway for follow-on biologics will not be included in the FDA Revitalization Act (FDARA). FDARA would reauthorize the Prescription Drug User Fee Act or PDUFA (pronounced puh-doo-fuh), which expires Sept. 30. PDUFA increases funding for the Food and Drug Administration through fees paid […]

The going has always been tough for getting pharmaceutical patents. The going is getting tougher. See Aventis Pharma Deutschland Gmbh and King Pharmaceuticals, Inc., v. Lupin, Ltd. (06-1530). In a patent infringement action concerning the pharmaceutical compound ramipril, marketed by King as a blood pressure medication under the name Altace®, the U.S. Court of Appeals […]

Well, by a 220-175 vote the U.S. House of Representatives passed its version (H.R. 1908, the Patent Reform Act of 2007) of an overhaul of patent laws designed to trim excessive litigation and improve patent quality, giving high-tech firms what they’ve been clamoring for: a weaker patent system. If made into law, the legislation will […]

The Federal Circuit upheld a judgment upholding the validity of U.S. Reissue Pat. No. 34,712 in favor of Forest Laboratories and H. Lundbeck A/S and enjoining Ivax Pharmaceuticals and Cipla Ltd. from infringing the ’712 patent — but only as it applies to escitalopram oxalate. See Forest Laboratories v. Ivax Pharmaceuticals and Cipla, Ltd. (07-1059). Ivax […]

This video made me wonder more about whether YouTube had jumped the shark than about Patent Reform.

The patent reform bills (H.R. 1908 and S. 1145, the Patent Reform Acts of 2007) were favorably reported by the House and Senate Judiciary Committees prior to the August Congressional recess. According to the schedule for the House of Representatives this week, H.R. 1908 is to be considered by the House this Friday, September 7th. […]

The Patent Office Professional Association (POPA) has weighed in on the patent reform fiasco and has sent a letter to the House Judiciary Committee and a letter to the Senate Judiciary Committee opposing the Patent Reform Act of 2007 (H.R. 1908/S. 1145) and provided a copy of POPA’s position paper on the legislation. POPA believes […]