2006/6/17

Paragraph IV certification

Please check below website for updated list! This is very important source for players in Generic drug field!

http://www.fda.gov/cder/ogd/ppiv.htm

 

Currently, every patent listed by a brand name manufacturer can delay competition for 30 months. The law requires the FDA to automatically stay approval for 30 months if the brand name sues a generic company certifying that a relevant patent is either invalid or will not be infringed if the generic product is brought to market. This is known as a Paragraph IV certification. This automatic stay creates a perverse incentive because regardless of the merits of the litigation, the brand name secures an additional 30-month monopoly simply by filing suit.

 

The innovator is required to list all relevant patents (patents to which a claim of infringement could reasonably be asserted) and certify to the FDA that the listing is complete and accurate.

 

GAAP would prospectively eliminate the automatic 30-month stay. Innovators would be able to seek a preliminary injunction from the courts.

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