Abbott Laboratories v. Novopharm Ltd.

• Citation: 323 F.3d 1324
• Decision Date: 20 March 2003
• Docket Number: No. 02-1387.,02-1387.
• Parties: ABBOTT LABORATORIES, Plaintiff-Appellant, and Fournier Industrie Et Santé and Laboratoires Fournier S.A., Plaintiffs-Appellants, v. NOVOPHARM LIMITED, Defendant-Appellee.
• Court: United States Courts of Appeals. United States Court of Appeals for the Federal Circuit

323 F.3d 1324

ABBOTT LABORATORIES, Plaintiff-Appellant, and Fournier Industrie Et Santé and Laboratoires Fournier S.A., Plaintiffs-Appellants, v. NOVOPHARM LIMITED, Defendant-Appellee.

No. 02-1387.

United States Court of Appeals, Federal Circuit.

DECIDED: March 20, 2003.

Rehearing Denied: April 30, 2003.

James A. White, Jones, Day, Reavis & Pogue, of Chicago IL, argued for plaintiff-appellant, Abbott Laboratories. With him on the brief were Daniel E. Reidy, John A. Marlott, and Timothy J. Heverin. Charles D. Ossola, Arnold & Porter, of Washington, DC, argued for plaintiffs-appellants Fournier Industrie Sante' and Laboratoires Fournier S.A. With him on the brief were Timothy C. Bickham and Scott A.M. Chambers. Of counsel on the brief was Mark Shanks, Shanks & Herbert, of Alexandria, VA.

Bruce M. Gagala, Leydig, Voit & Mayer, Ltd., of Chicago, IL, argued for defendant-appellee. With him on the brief was M. Daniel Hefner.

Charles R. Wolfe, Jr., Blank Rome Comisky & McCauley LLP, of Washington, DC, for amicus curiae Impax Laboratories, Inc. With him on the brief were D. Christopher Ohly, and Neil R. White.

Before MICHEL, LOURIE, and BRYSON, Circuit Judges.

LOURIE, Circuit Judge.

Fournier Industrie et Santé and Laboratoires Fournier S.A. (collectively, "Fournier"), along with Abbott Laboratories ("Abbott"), appeal from the decision of the United States District Court for the Northern District of Illinois granting Novopharm Limited ("Novopharm") summary judgment of noninfringement of U.S. Patent 4,895,726 ("the '726 patent"). Abbott Labs. v. Novopharm Ltd., Nos. 00 C 2141, 00 C 5094, and 01 C 1914, 2002 WL 433584, 2002 U.S. Dist. LEXIS 4659 (N.D.Ill. Mar.20, 2002). We affirm.

BACKGROUND

Fournier is the assignee of the '726 patent. The '726 patent includes claims directed to a therapeutic fenofibrate composition (claims 1-7), a method for the manufacture of that fenofibrate composition (claims 8 and 9), a method for improving the bioavailability of fenofibrate (claim 10), and a method for treatment of hyperlipidemia or hypercholesterolemia using the claimed fenofibrate composition (claims 11 and 12).

Abbott is Fournier's exclusive licensee under the '726 patent. Abbott also holds a New Drug Application ("NDA") approved by the United States Food and Drug Administration ("FDA"), permitting it to market Fournier's fenofibrate capsules in the United States. Abbott sells the capsules under the tradename TRICOR ®.

Novopharm filed an Abbreviated New Drug Application ("ANDA") in December 1999, seeking the FDA's approval to market a generic micronized formulation of fenofibrate prior to the expiration of the '726 patent. Along with its ANDA, Novopharm submitted a certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (a "paragraph IV certification"), declaring that the manufacture, use, and sale of its proposed fenofibrate formulation would not infringe the '726 patent. Under 21 U.S.C. § 355(j)(2)(B)(i), an ANDA applicant who files a paragraph IV certification is required to include in its application a statement that it will give notice of that filing to the owner of the patent to which the certification pertains, § 355(j)(2)(B)(i)(I), and to the holder of the approved NDA for that drug, § 355(j)(2)(B)(i)(II). Pursuant to those provisions, Novopharm notified Fournier and Abbott, respectively, that it had filed the ANDA and paragraph IV certification. Also, as required by 21 U.S.C. § 355(j)(2)(B)(ii), Novopharm provided in its notice letter a detailed statement of the factual and legal bases for its opinion of noninfringement of the '726 patent.

Fournier and Abbott then filed suit against Novopharm. They alleged that Novopharm's generic version of TRICOR® would infringe one or more claims of the '726 patent, and that Novopharm's submission of an ANDA for approval to sell fenofibrate capsules prior to the expiration of the '726 patent constituted an act of infringement under 35 U.S.C. § 271(e)(2). That provision, in pertinent part, provides that:

It shall be an act of infringement to submit — (A) an application under section 505(j) of the Federal Food, Drug, and Cosmetic Act [codified at 21 U.S.C. § 355(j); i.e., an ANDA] ... for a drug claimed in a patent or the use of which is claimed in a patent, ... if the purpose of such submission is to obtain approval under such Act [i.e., Title 21 of the United States Code] to engage in the commercial manufacture, use, or sale of a drug ... claimed in a patent or the use of which is claimed in a patent before the expiration of such patent.

35 U.S.C. § 271(e)(2) (2000). Fournier and Abbott sought, among other things, a judgment that the '726 patent was valid, enforceable, and infringed; an order staying the approval of Novopharm's ANDA until the January 19, 2009 expiration date of the '726 patent; and an injunction prohibiting Novopharm from commercially manufacturing, selling, using, or importing infringing fenofibrate compositions.

Novopharm amended its ANDA twice, both times adding a new dosage form and including a paragraph IV certification for the newly added form. Following each of those amendments, Fournier and Abbott filed a new complaint against Novopharm. The district court eventually consolidated all three actions into a single proceeding.¹ Novopharm thereafter moved for summary judgment of noninfringement.

Claims 1 and 10, which are the '726 patent's only two independent claims, define the patented subject matter as follows:

1. A therapeutic composition, which is presented in the form of gelatin capsules and which is useful especially in the oral treatment of hyperlipidemia and hypercholesterolemia, said composition containing a co-micronized mixture of particles of fenofibrate and a solid surfactant, wherein the mean particle size of said co-micronized mixture is less than 15 µ

10. A method for improving the bioavailability of fenofibrate in vivo, which comprises co-micronization of the fenofibrate and a solid surfactant, the said co-micronization being carried out by micronization of a fenofibrate/solid surfactant mixture until the particle size of the powder obtained is less than 15 µ

(emphases added).

Claim 1 of the '726 patent was amended during prosecution, in response to a rejection under 35 U.S.C. § 103. As originally filed, that claim recited the phrase "the said composition containing fenofibrate and a solid surfactant, which have been co-micronized." The amendment made during prosecution replaced that phrase with "said composition containing a co-micronized mixture of particles of fenofibrate and a solid surfactant, wherein the mean particle size of the co-micronized mixture is less than 15 µ." The '726 patent specification includes data showing that the patented composition has improved properties relative to formulations in which: (1) a solid surfactant is added to fenofibrate (impliedly without co-micronization); (2) fenofibrate is micronized on its own; or (3) fenofibrate and surfactant are separately micronized and then intimately mixed. '726 patent, col. 1, ll. 35-43. During prosecution of the application that led to the '726 patent, Fournier also distinguished its composition from prior art formulations in which fenofibrate was granulated in a matrix containing a particle size of between 50 and 500 microns.

The district court found that Fournier had distinguished the claimed invention, as amended, from the cited prior art, on the ground that the prior art did not teach or suggest co-micronization of a mixture of fenofibrate and a solid surfactant, which co-micronization resulted in an improvement in bioavailability and dissolution rate not taught or suggested in the prior art. Abbott, slip op. at 2-3. Fournier further distinguished the amended claim on the basis that co-micronization to produce particles having a diameter of less than fifteen microns was not taught or suggested in the prior art. Id. The court also observed that the '726 patent's specification states that:

the "co-micronization of fenofibrate and a solid surfactant (i.e., the micronization of an intimate mixture of fenofibrate and a solid surfactant) makes it possible to improve the bioavailability of the fenofibrate to a significantly greater extent than that which would be achieved either by adding a surfactant [to fenofibrate], or by micronizing the fenofibrate on its own, or by intimately mixing the separately micronized fenofibrate and surfactant."

Id. at 4 (alteration in original). The court thus concluded that Fournier's claims could not be construed to include "mixtures obtained by adding a surfactant to fenofibrate, or micronizing fenofibrate by itself, and/or mixing separately micronized fenofibrate and surfactant." Id. at 11.

The district court then found that sodium lauryl sulfate ("SLS") was the only example of a solid surfactant, and that a method involving co-micronization of a fenofibrate/SLS mixture prior to the addition of excipients such as lactose or starch was the only detailed example of co-micronization disclosed in the '726 patent. Id. at 4-5. Elaborating on that point, the court found further that "[t]he claims, description, and prosecution history do not indicate that anything other than fenofibrate and a solid surfactant are micronized.... No other excipient is identified as part of this mixture." Id. at 12. The court concluded on the basis of those findings that the term "co-microniz[-ed, — ation]" in independent claims 1 and 10 does not encompass co-micronization of excipients other than fenofibrate and a solid surfactant, but instead "is construed to mean that fenofibrate and a solid surfactant have been micronized together in the absence of other excipients." Id. The court also concluded that the phrase "fenofibrate/solid surfactant mixture" in claim 10 of the '726 patent must be construed, according to Novopharm's proposal, so as to exclude any ingredients other than fenofibrate and solid surfactant, noting that Fournier and...