Opinion ID: 1190929
Heading Depth: 1
Heading Rank: 1

Heading: BACKGROUND Hatch-Waxman Settlement Agreements

Text: Bayer is the owner of the patent relating to the active ingredient in Cipro, which has been described as the most prescribed antibiotic in the world. The Cipro patent, U.S. Patent No. 4,670,444, was issued on June 2, 1987 and was scheduled to expire on December 9, 2003. [1] In 1991, Barr sought to market a generic version of Cipro pursuant to the expedited FDA approval process established by the Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Act), Pub.L. No. 98-417, 98 Stat. 1585. Under the Hatch-Waxman Act, a pharmaceutical company can seek approval to market generic versions of an approved branded drug without having to re-establish the drug's safety and effectiveness by filing an Abbreviated New Drug Application (ANDA). 21 U.S.C. § 355(j)(2)(A), (8)(B). Where, as here, a generic manufacturer seeks to enter the market before the expiration of the branded firm's patent, it must file a pre-expiration challenge (paragraph IV or ANDA-IV certification). 21 U.S.C. § 355(j)(2)(A)(vii)(IV). The ANDA-IV certification requires the generic firm to demonstrate the bioequivalence of its proposed version of the drug, see 21 C.F.R. § 314.94(a)(9), and to state the basis for its claim of invalidity or noninfringement of the branded firm's patent, see 21 U.S.C. § 355(j)(2)(B)(iv)(II). An ANDA-IV certification itself constitutes an act of infringement, triggering the branded manufacturer's right to sue. 35 U.S.C. § 271(e)(2)(A). Indeed, the branded manufacturer must sue within 45 days of receiving notice of the ANDA-IV in order to stay the generic firm's entry into the market. 21 U.S.C. § 355(j)(5)(B)(iii). [2] Thus, the Hatch-Waxman Act redistributes the relative risks between the patent holder and the generic manufacturer, allowing generic manufacturers to challenge the validity of the patent without incurring the costs of market entry or the risks of damages from infringement. See Ark. Carpenters Health & Welfare Fund v. Bayer AG (In re Ciprofloxacin Hydrochloride Antitrust Litig.), 544 F.3d 1323, 1338 (Fed.Cir.2008). The first generic firm to file an ANDA-IV is rewarded with a 180-day exclusive right to market its generic version of the drug. 21 U.S.C. § 355(j)(5)(B)(iv). [3] However, only the first-filed ANDA-IV is eligible for the 180-day exclusivity period: even if the first filer loses, withdraws, or settles its challenge, subsequent filers do not become eligible for the exclusivity period. [4]