Patent Baristas

The FDA’s Office of Generic Drugs posted a letter requesting comment on certain 180-day exclusivity forfeiture and Orange Book patent “delisting” issues.  This concerns an ANDA submitted to the FDA containing a paragraph IV patent certification requesting FDA approval for a generic version of Bayer Pharmaceuticals’ PRECOSE (acarbose) Tablets. Before marketing a new branded drug, […]

President Bush has signed the FDA Amendments Act of 2007 into law. The Senate passed the bill, H.R. 3580, by unanimous consent on Sept. 20, a day after the House approved it in a 409-17 vote. The massive 422-page FDA bill, the biggest overhaul to the FDA in the last decade, renews device and drug […]

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 […]

Kurt Karst of the FDA Law Blog ran a nice update on patent term extension (PTE) legislation. The legislation, known as the “Dog Ate My Homework Act,” would permit the U.S. Patent and Trademark Office to exercise discretion to accept untimely filed Patent Term Extension (PTE) applications has been added to the Patent Reform Act […]

In a follow-up on our earlier discussion regarding the Supreme Court’s broad scope of the research exemption to the Integra case, the question came up asking if a patented delivery formulation — say, a sustained release formulation as opposed to a therapeutic itself — would fall within the exemption from infringement under the Food and […]

In a long-awaited — and some would say long-feared — update in the regulatory pathway for FDA approval of follow-on biologics, the Senate’s Senate Health, Education, Labor and Pensions HELP Committee gave the thumbs up to the Biologics Price Competition and Innovation Act of 2007 (S. 1695), which will address the scientific, regulatory and legal […]

Mylan Laboratories has announced that the U.S. Food and Drug Administration (FDA) has confirmed Mylan’s current status as the only approved ANDA for all strengths of Amlodipine Besylate Tablets. The decision came to light in a filing on Wednesday with the U.S. District Court for the District of Columbia, which had enjoined the FDA from […]

As a follow-up on yesterday’s article on the road to biogenerics, Food and Drug Administration deputy commissioner Janet Woodcock testified before an Oversight Committee held to examine the prospects and need for a pathway that would allow the FDA to approve safe and affordable generic versions of biotech drugs. Witnesses included representatives of FDA, pharmaceutical […]