Opinion ID: 76321
Heading Depth: 3
Heading Rank: 1

Heading: Zenith's and Geneva's ANDAs

Text: 9 Abbott manufactures Hytrin, a brand-name drug with the active ingredient dihydrate terazosin hydrochloride. 8 Hytrin is used to treat hypertension and enlarged prostate, and has been a very successful product for Abbott. Abbott obtained FDA approval of its NDA for Hytrin in 1987 and has held a number of patents related to terazosin hydrochloride over the years. Its first patent, issued in 1977, covered the basic terazosin hydrochloride compound. See Abbott Labs. v. Novopharm Ltd., Nos. 96-C-611 & 95-C-6657, 1996 WL 131498,  (N.D.Ill. March 15, 1996). That patent has since expired, though Abbott has been issued other patents for various crystalline forms of the compound and various methods of using and preparing the compound. 10 Geneva filed four ANDAs based on Hytrin between 1993 and 1996, each time making paragraph IV certifications with respect to Abbott's listed patents. Abbott brought infringement suits under 35 U.S.C. § 271(e), invoking the 30-month stay of FDA approval of Geneva's ANDAs. On April 29, 1996, Geneva filed two additional ANDAs based on Hytrin, one for a capsule form of terazosin hydrochloride and one for a tablet form, 9 making paragraph IV certifications with respect to the relevant patents. Within forty-five days of receiving notice of Geneva's paragraph IV certifications, Abbott filed an infringement suit based on the submission of the tablet ANDA, asserting that the Geneva's tablet terazosin hydrochloride product infringed Abbott's Patent No. 5,504,207 (the '207 patent). 10 In the suit, Geneva admitted infringement but contested the patent's validity. Apparently through oversight, Abbott failed to file an infringement suit based on the submission of the capsule ANDA. FDA consideration of that ANDA, therefore, proceeded unhindered, and Geneva's capsule ANDA was approved in March of 1998. When Abbott was notified of this approval, it began efforts to amend its complaint to allege that Geneva's terazosin hydrochloride capsule infringed the '207 patent. 11 Zenith, meanwhile, filed an ANDA for a terazosin hydrochloride drug 11 in June of 1994, making a paragraph IV certification with respect to Abbott's Hytrin patents. Abbott was issued a patent claiming forms of terazosin hydrochloride on May 2, 1995, Patent No. 5,412,095 (the '095 patent), and another on April 2, 1996, the '207 patent. Abbott timely filed this patent information with the FDA, which then required Zenith to amend its ANDA to make a certification with regard to these newly listed patents. Zenith resisted, hoping to avoid the 30-month stay of approval and the 180-day delay of approval based on Geneva's earlier-filed ANDAs. 12 Instead of certifying, Zenith brought suit against Abbott in an attempt to force Abbott to delist its '095 and '207 patents, relieving Zenith of the obligation to certify with respect to those patents, and seeking a declaration that its terazosin hydrochloride drug did not infringe those patents. Zenith's suit alleged that Abbott listed the '095 and '207 patents knowing that the patents did not claim Hytrin or a method of using Hytrin. Abbott counterclaimed for infringement. Zenith's attempt to obtain a preliminary injunction against the listing of the patents was unsuccessful. See Zenith Labs. v. Abbott Labs., No. 96-1661, 1997 U.S. Dist. LEXIS 23954 (D.N.J. Oct. 1, 1997). Zenith appealed the denial to the Federal Circuit.