Patent Law

Thomson Scientific's October-December 2007 issue of Pharma Matters looks at a few of the companies beginning to make their mark on the US generics market either with their finished dose product or active ingredients, and analyze trends and statistics relating to the market as a whole.  The following is an excerpt from this quarterly report:

Bioequivalent generic versions of drugs that are not protected by patents can be produced and marketed in the US by any company, subject to FDA approval. However, a generic company may obtain FDA approval  before patent expiry if it certifies its product does not infringe the listed patents or the patents are invalid (paragraph IV certification). Patent holders may then sue the ANDA filer for patent infringement. If the patent holder sues the ANDA filer within 45 days of notification, the FDA may not approve the ANDA for 30 months from the date of notification. If no suit is filed within 45 days, the FDA may approve the ANDA at any time.

In order to encourage generic companies to develop noninfringing products and challenge invalid patents, the Hatch-Waxman act provides the incentive of 180 days of market exclusivity for the first company to file an ANDA with paragraph IV certification for a product. The 180-day period may begin from the date a company begins commercial marketing of the generic drug product, or from the date of a court decision finding the patent invalid, unenforceable, or not infringed.

 

In the last quarter of 2007, we learned of first paragraph IV patent challenges on seven new products, among them AstraZeneca?s blockbuster high cholesterol treatment Crestor® (rosuvastatin calcium). At the time of writing, Teva was by far the most prolific filer of ANDAs with patent challenges. We are currently linking them to challenges on 78 products.

Read the full report here.