Opinion ID: 212098
Heading Depth: 3
Heading Rank: 2

Heading: Ivax Pharmaceuticals USA, Inc.'s ANDA filing relating to generic sertraline hydrochloride tablets

Text: 14 Ivax Pharmaceuticals USA, Inc. (Ivax) is a manufacturer of generic pharmaceuticals. In 1999, Ivax, then known as Zenith Goldline Pharmaceuticals, Inc., submitted an ANDA to the FDA for its generic version of sertraline hydrochloride. Since Pfizer had listed both the '518 and '699 patents in the Orange Book in connection with its NDA for Zoloft(R) tablets, Ivax was required to file a certification with respect to each patent as part of its ANDA. Ivax filed a paragraph III certification as to the '518 patent, stating that it was not seeking to market its generic version of sertraline hydrochloride prior to the expiration of the patent. Simultaneously, Ivax filed a paragraph IV certification as to the '699 patent, stating that its generic drug did not infringe the '699 patent, or alternatively, that the '699 patent was invalid. 15 Within forty-five days of its receipt of notice of Ivax's paragraph IV certification, Pfizer filed suit against Ivax for infringement of the '699 patent in the United States District Court for the District of New Jersey. Pfizer, Inc. v. Ivax Pharms. Inc., Nos. 00-408, 01-6007 (D.N.J. Jan. 1, 2000). In 2002, Pfizer and Ivax entered into a settlement agreement whereby Pfizer agreed to grant Ivax a royalty-bearing license on the '699 patent until its expiration in 2010. As a consequence of the agreement, Ivax is in a position to begin marketing its generic version of Zoloft(R) immediately upon expiration of the '518 patent on June 30, 2006. 16 As the first-filer of an ANDA for the generic version of Zoloft(R), Ivax is entitled, under 21 U.S.C. § 355(j)(5)(B)(iv), to a 180-day generic market exclusivity period. This 180-day period will be triggered by the earlier of: (1) the first date of commercial marketing by the first generic applicant or (2) a decision of a court ... holding the patent which is the subject of the [paragraph IV certification] to be invalid or not infringed. 21 U.S.C. § 355(j)(5)(B)(iv)(I-II). 17