Earlier today, FDA’s Office of Generic Drugs posted a letter on its website requesting comment on certain 180-day exclusivity forfeiture and Orange Book patent “delisting” issues concerning at least one ANDA submitted to the Agency containing a paragraph IV patent certification requesting FDA approval for …
Late today, the U.S. Senate passed FDA reform legislation by unanimous consent. The Senate vote follows the House’s action yesterday when it passed H.R. 3580, the FDA Amendments Act of 2007. Earlier in the day there was some concern that the Senate vote on the …
House and Senate staff have reportedly reached an agreement on omnibus FDA reform legislation that would, among several other things, reauthorize the Prescription Drug User Fee Act (“PDUFA”) through fiscal year 2012. Earlier today, a “staff agreement” (427 pages) and summary of the legislation was …
Earlier today, the U.S. District Court for the District of Columbia denied Apotex’s motion for a temporary restraining order and preliminary injunction in a case against FDA involving Apotex’s ANDA for a generic version of AstraZeneca’s PRILOSEC (omeprazole) Delayed-Release Capsules and the effects of AstraZeneca’s …
On August 1, 2007, the U.S. Court of Appeals for the Federal Circuit affirmed (errata) the U.S. District Court for the District of Columbia’s December 2005 ruling declaring that the District of Columbia’s Prescription Drug Excessive Pricing Act of 2005 (the “Act”) is preempted by …
In December 1992, FDA promulgated final regulations under which the Agency will accelerate the approval of certain new drugs and biologics for serious or life-threatening illnesses, and when such products provide a meaningful therapeutic benefit to patients over existing treatments. These regulations, which are commonly …
Legislation that would permit the U.S. Patent and Trademark Office (“PTO”) to exercise discretion to accept untimely filed Patent Term Extension (“PTE”) applications has reportedly been added to the “Patent Reform Act of 2007” (S. 1145) by Senator Edward Kennedy (D-MA). Representative William Delahunt (D-MA), …
Support for legislation that would create a biogenerics approval path is reportedly crumbling. Last month, the Senate Health, Education, Labor, and Pensions (“HELP”) Committee passed S. 1695, “the Biologics Price Competition and Innovation Act of 2007.” Although neither the full Senate, nor the House Energy …
For the third time in as many years, FDA has been requested to provide an advisory opinion on the Agency’s policy for the submission of patents for Orange Book listing that cover drug delivery systems (e.g., metered-dose and dry powder inhalers, and transdermal patches) that …
In a July 3, 2007 filing with the Securities and Exchange Commission (“SEC”), Altus Pharmaceuticals Inc. announced that the company was notified by FDA’s Office of Orphan Products Development (“OOPD”) that the orphan drug designation granted in January 2002 to ALTU-135, also know as TheraCLEC, …
On June 29, 2007, the U.S. District Court for the District of Columbia, in Mylan v. Leavitt, issued a memorandum opinion denying Mylan’s Emergency Motion for a Temporary Restraining Order that asked the court to order FDA to relist Pfizer’s U.S. Patent No. 4,879,303 covering …
Our “blogfather” over at the Orange Book Blog already has a preliminary post up about the recent victory in the district court by Bristol-Myers Squibb and Sanofi-Aventis over Apotex relating to the enforceability and validity of the patent on the active ingredient in Plavix. Long …
In chemistry, enantiomers are stereoisomers that are non-superimposable complete mirror images of one another. Enantiomers may be either “right-handed” (dextro-rotary) S(+)-isomers, or “left-handed” (levo-rotary) R(-)-isomers. A racemic mixture is one that has equal amounts of “left- and right-handed” enantiomers of a particular chiral molecule. For …
In a previous post, we reported on an assessment conducted by the Analysis Group, Inc. on the effects of authorized generics on paragraph IV patent certifications. There, the authors concluded that “[t]here is no evidence to suggest that authorized generic entry causes delayed generic entry.” …
There is a wise political maxim, “Fool me once, shame on you; fool me twice, shame on me.” Not to be fooled a second time, the U.S. Senate has passed legislation that would, if enacted, make significant changes in the way FDA handles so-called “generic …
