Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Impax Laboratories Inc. v. Lannett Holdings Inc.

United States Court of Appeals, Federal Circuit

June 28, 2018

IMPAX LABORATORIES INC., ASTRAZENECA AB, ASTRAZENECA UK LIMITED, Plaintiffs-Appellees
v.
LANNETT HOLDINGS INC., LANNETT COMPANY INC., Defendants-Appellants

          Appeal from the United States District Court for the District of Delaware in Nos. 1:14-cv-00984-RGA, 1:14-cv-00999-RGA, Judge Richard G. Andrews.

          James F. Hurst, Kirkland & Ellis LLP, Chicago, IL, argued for plaintiffs-appellees. Also represented by Marcus Edward Sernel.

          Joseph F. Posillico, Fox Rothschild, LLP, Philadelphia, PA, argued for defendants-appellants. Also represented by Frank T. Carroll; Michael W. Glynn, New York, NY.

          Before Lourie, Dyk, and Taranto, Circuit Judges.

          Lourie, Circuit Judge.

         Lannett Holdings Inc. and Lannett Co. Inc. (together, "Lannett") appeal from the decision of the United States District Court for the District of Delaware concluding, after a bench trial, that claims 4, 11, 12, and 14 of U.S. Patent 6, 760, 237 ("the '237 patent") and claims 6 and 14- 16 of U.S. Patent 7, 220, 767 ("the '767 patent") were not shown to be invalid, see Impax Labs., Inc. v. Lannett Holdings Inc., 246 F.Supp.3d 1024 (D. Del. 2017) ("Opinion"), entering judgment in favor of Impax Laboratories Inc. ("Impax"), AstraZeneca AB, and AstraZeneca UK Limited (together, "AstraZeneca"), and entering an injunction against Lannett pursuant to 35 U.S.C. § 271(e)(4), see Impax Labs. Inc. v. Lannett Holdings Inc., No. 1:14-cv-00984-RGA (D. Del. Apr. 17, 2017), ECF No. 174; J.A. 1-4. For the reasons that follow, we affirm.

         Background

         Triptans are selective serotonin receptor agonists, developed in the early 1980s. The first triptan to be marketed was sumatriptan under the name Imitrex®, which first became available in the U.S. in an injection form in 1993. In 1995, sumatriptan became available in an oral tablet form and later, in 1997, in an intranasal form as Imitrex® (sumatriptan) Nasal Spray ("NS"). Zolmitriptan is another triptan, which first became available in the U.S. in an oral tablet form in 1999 under the name Zomig®. At that time, there were several other triptans that were either on the market or under development.

         AstraZeneca owns and Impax is the exclusive licensee of the '237 and '767 patents, [1] which relate to formulations of zolmitriptan for intranasal administration. The claims at issue in this appeal are directed to pharmaceutical formulations, intranasal administration devices, or aqueous solutions, of zolmitriptan. '237 patent col. 5 l. 4-col. 6 l. 22; '767 patent col. 5 l. 8-col. 6 l. 25.

         Claim 4 of the '237 patent depends from claim 2, which in turn, depends from claim 1. Claims 1, 2, and 4 of the '237 patent read as follows:

1. A pharmaceutical formulation suitable for intranasal administration which comprises zolmitriptan and a pharmaceutically acceptable carrier wherein the pH of the formulation is in the range 4.5 to 5.5.
2. A pharmaceutical formulation according to claim 1 wherein the pH of the formulation is 5.
4. A pharmaceutical formulation according to claim 2 wherein the formulation is buffered.

'237 patent col. 5 ll. 4-9, 12-13.

         Similarly, claims 6 and 15 of the '767 patent read:

6. A pharmaceutical formulation suitable for intranasal administration which comprises zolmitriptan and a pharmaceutically acceptable carrier wherein the pH of the formulation is in the range 3.5 to 5.5, wherein the formulation is buffered by a mixture of citric acid and disodium phosphate.
15. An aqueous solution of zolmitriptan in a buffer at a pH of less than 6.0.

'767 patent col. 5 ll. 23-27, col. 6 ll. 21-22.

         Other formulation claims of the '237 and '767 patents at issue include similar limitations with regard to pH ranges and buffering, and some formulation claims include additional limitations relating to sterility. '237 patent col. 5 l. 4-col. 6 l. 22; '767 patent ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.