Alendronate (Fosamax): Apotex's appeal on early entry into market foiled by CAFC

Apotex failed to enter early into the market during the 180 days exclusivity of Teva (Teva's exclusivity started on 6th February, 2007) w.r.t Alendronate (Fosamax) tablets. Apotex tried to trigger 180 days exclusivity of Teva in 2006, when innovator issued 'convenant not to sue' to Apotex. Apotex at that time was not satisfied and appealed to district court against convenant not to sue (Apotex wants decision from court that its ANDA do not infringe Orange book patents, which could have triggered Teva's 180 days exclusivity early). However, district court in its decision opined that when innovator has alreday issued convenant not to sue, there is no controversy and rejected Apotex appeal.
However, based on courts decision in Caraco v. Forest Apotex appealed in CAFC, which observed that the said case is diffrent from Caraco case as Teva has already started its 180 days exclusivity and as a result, Apotex no longer suffers a delay in entering the market under either the thirty-month stay provision or the 180-day exclusivity provision that is traceable to Merck and redressible by a court judgment.

Earlier in 1999, Teva filed an ANDA for a generic version of Fosamax, with paragraph IV certifications to all ten Orange Book-listed patents. Teva was the first ANDA filer, earning 180-day exclusivity. The Federal Circuit affirmed the validity of the product patent '077, but, in 2005 held two claims of the '329 patent (Method of use claims w.r.t 35 and 70 mg dose to be invalid for obviousness).

Apotex filed its ANDA for generic Alendronate Sodium sometime later, with a paragraph III certification to the product patent '077 and paragraph IV certifications to the rest of Orange Book listed patents. Merck sued Apotex for infringement and Apotex counterclaimed for invalidity and noninfringement. Following discovery, Merck granted Apotex a covenant not to sue and moved to dismiss the case.

Now, Apotex will enter into the market afetr the expiry of 180 days exclusivity on August 5, 2008.
CAFC vacated the district court's dismissal of Apotex's counterclaims as moot. (Opinion of court Here)