Full title: Eli Lilly And Company and Reliant Pharmaceuticals, LLC, Plaintiffs, v

Court: United States District Court, S.D. Indiana, Indianapolis Division

Date published: Oct 12, 2001


Defendant Zenith Goldline Pharmaceuticals, Inc., which is now known as IVAX Pharmaceuticals (“Zenith” in this entry), is a wholly-owned subsidiary of IVAX Corporation. Zenith produces and markets generic drugs.

On September 15, 1998, Zenith filed an Abbreviated New Drug Applications (ANDA) 75-461 with the Food and Drug Administration (FDA) seeking approval to market generic nizatidine. That original ANDA 75-461 contained what is called a “Paragraph III” certification. Zenith’s Paragraph III certification stated that Zenith would not market nizatidine until the expiration of the ‘547 Patent. See 21 U.S.C. § 355(j)(2)(A)(vii)(III).

Three weeks later, on October 6, 1998, Zenith amended ANDA 75-461 to include a “Paragraph IV” certification, which asserted that the ‘547 patent is invalid. Zenith’s Paragraph IV certification stated:

Under section 505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act, and 21 C.F.R. § 314.94(a)(12)(k)(A)(4), Zenith Goldline certifies that the following patents are invalid, unenforceable, or will not be infringed by the manufacture, use or sale of Zenith Goldline’s Nizatidine Capsules USP, 300 mg, for which this application is submitted.

• US Patent No. 4,375,547 — Expiry Date: April 12, 2002

We will comply with the notification requirements defined in Section 505(j)(2)(B)(i), Paragraphs I and II of the Federal Food, Drug and Cosmetic Act, (Codified at 21 C.F.R. § 314.95(a)), and the content of our notice will conform to the requirements defined in 505(j)(2)(B)(ii), (Codified at 21 C.F.R. § 314.95(c)).

On November 19, 1998, Zenith sent Lilly a Patent Certification Notice Letter, which is required when a Paragraph IV certification is filed. Ex. 1070. The notice letter informed Lilly of Zenith’s Paragraph IV certification and asserted that the sole claim of the ‘547 Patent is obvious over certain prior art references:

With respect to the ‘547 patent, certification has been made to the FDA as called for by the Act, § 505(j)(2)(A)(vii)(IV), that claim 1 thereof is invalid as being obvious in view of, inter aliaDurant et al., U.S. Patent 4,046,907; Price et al., U.S. Patent 4,128,658; Crenshaw et al., U.S. Patent 4,375,248; Tobias O. Yellin et al. ICI 125,211: A New Gastric Antisecretory Agent Acting on Histamine H2-Receptor, 25 LIFE SCIENCES 2001 (1979); and J. Bradshaw et al., Ranitidine (AH-19065); a new potent, selected histamine H2-Receptor antagonist, PROCEEDINGS of B.P.S. 464P (1979). The composition of matter, nizatidine, is highly structurally similar to compounds disclosed in Durant et al., Crenshaw et al., and to ranitidine, and any differences therebetween are suggested by the prior art. In addition, the properties resulting from both ranitidine and nizatidine are highly analogous.

Within 45 days after receiving the notice letter, Lilly filed this suit against Zenith alleging infringement of the ‘547 patent under 35 U.S.C. § 271(e)(2)(A), and willful infringement under 35 U.S.C. § 285.

Zenith has admitted that its act of amending ANDA 75-461 for nizatidine to add the Paragraph IV certification was an act of infringement of the ‘547 Patent under 35 U.S.C. § 271(e). See Eli Lilly Co. v. Medtronic, Inc., 496 U.S. 661, 676 (1990) (§ 271(e) defined new and “somewhat artificial” act of infringement for ANDA process).



For the reasons detailed in this entry, the court finds that U.S. Patent No. 4,375,547 is not invalid as obvious under 35 U.S.C. § 103(a). The court further finds that Zenith’s act of infringement was willful, made without exercising due care, and that this case is an exceptional case under 35 U.S.C. § 285. The court postponed taking evidence on the amount of any fee award until it was determined whether a fee award would be appropriate. Unless the parties agree or the court later orders otherwise, Lilly shall submit a detailed written fee petition no later than November 30, 2001. (Plaintiff Reliant, which voluntarily joined in this suit earlier this year after signing a license agreement with Lilly, is not entitled to its own fee award.) Zenith shall submit any response no later than January 15, 2002. Lilly may file any reply no later than January 31, 2002. The court will schedule an evidentiary hearing or oral argument on written request, but will otherwise rule based on the written submissions.

So ordered.

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