Glaxo Wellcome, Inc. v. Andrx Pharmaceuticals
| Decision Date | 22 September 2003 |
| Docket Number | No. 02-1348.,02-1348. |
| Citation | 344 F.3d 1226 |
| Parties | GLAXO WELLCOME, INC., Plaintiff-Appellant, v. ANDRX PHARMACEUTICALS, INC., Defendant-Appellee. |
| Court | U.S. Court of Appeals — Federal Circuit |
Stephen B. Judlowe, Morgan Lewis & Bockius LLP, of New York, New York, argued for plaintiff-appellant. With him on the brief were Dennis J. Mondolino, Janet B. Linn, Jason A. Lief, Philip L. Hirschhorn, Esther H. Steinhauer, and Timothy P. Heaton.
Eric D. Isicoff, Isicoff, Ragatz & Koenigsberg, P.A., of Miami, Florida, argued for defendant-appellee. With him on the brief were Teresa Ragatz and Michael D. Bon. Also on the brief were James V. Costigan, Alan B. Clement, and Katharine G. Loving, Hedman & Costigan, P.C., of New York, New York.
Before MAYER, Chief Judge, NEWMAN and BRYSON, Circuit Judges.
Glaxo Wellcome, Inc. appeals the decision of the United States District Court for the Southern District of Florida, holding on summary judgment that United States Patent No. 5,427,798 (the '798 patent) is valid but not infringed by the bupropion products of Andrx Pharmaceuticals, Inc.1 We conclude that the district court erred in its construction of the '798 claims. On the correct claim construction, we vacate the summary judgment of noninfringement and remand for further proceedings.
The products at issue are the antidepressant medicine having the brand name Wellbutrin® SR and the smoking-cessation medicine having the brand name Zyban®. The active ingredient of both products is bupropion hydrochloride. Glaxo manufactures and sells sustained release formulations of these products; sustained release extends the medicinal action of the bupropion so that less frequent doses are required, and avoids the surge of bupropion that had occasionally caused seizures upon ingestion. Sustained release formulations must maintain an effective level of the medicine in the bloodstream for an optimum period without unacceptable deviation in pharmacologic activity.
Andrx filed two Abbreviated New Drug Applications (ANDA) seeking approval of generic counterparts of the Glaxo sustained release products, asserting identity of active ingredient and properties with those of Wellbutrin ®SR and Zyban®. Andrx also filed a Paragraph IV certification, asserting that the Andrx products do not infringe the Glaxo '798 patent or that the patent is invalid:
21 U.S.C. § 355(j)(2)(A) An abbreviated application for a new drug shall contain —
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(vii) a certification, in the opinion of the applicant and to the best of his knowledge, with respect to each patent which claims the listed drug referred to in clause (i) or which claims a use for such listed drug for which the applicant is seeking approval under this subsection and for which information is required to be filed under subsection (b) or (c) of this section —
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(IV) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted;
The Paragraph IV certification is designed to create a statutory act of infringement, in order to enable adjudication of issues of patent validity and infringement in the absence of actual manufacture, sale, or use of the product:
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if the purpose of such submission is to obtain approval under such Act to engage in the commercial manufacture, use, or sale of a drug or veterinary biological product claimed in a patent or the use of which is claimed in a patent before the expiration of such patent.
Glaxo duly filed suit against Andrx for infringement of the '798 patent, in accordance with these statutory provisions.
CLAIM CONSTRUCTION
Appellate review of the district court's claim construction is plenary, see Markman v. Westview Instruments, Inc., 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577, 38 USPQ2d 1461 (1996); Cybor Corp. v. FAS Technologies, Inc., 138 F.3d 1448, 1454-56, 46 USPQ2d 1169, 1172-74 (Fed. Cir.1998) (en banc), as is our review of the grant of summary judgment. Ecolab, Inc. v. Envirochem, Inc., 264 F.3d 1358, 1363, 60 USPQ2d 1173, 1177 (Fed.Cir.2001).
The following claims of the '798 patent are representative:
said tablet releasing between about 20 and 60 percent of bupropion hydrochloride in water in 1 hour, between about 50 and 90 percent in 4 hours and not less than about 75 percent in 8 hours.
14. A controlled sustained release tablet comprising an admixture of 100 mg of bupropion hydrochloride and hydroxypropyl methylcellulose which after oral administration of a single one of said tablets in adult men produces plasma levels of bupropion as free base ranging between the minimum and maximum levels as shown in Fig. 5 over twenty-four hours.
18. A sustained release tablet containing a mixture of (a) 100 mg of bupropion hydrochloride and (b) means for releasing between about 25 and 45% of bupropion hydrochloride in one hour, between 60 and 85% in 4 hours and not less than 80% in eight hours in distilled water said means comprising hydroxypropyl methylcellulose.
In determining the meaning and scope of patent claims, the court gives primary consideration to the specification and the prosecution history, and may consider the prior art and technical treatises and dictionaries. If relevant and helpful, the court may receive the testimony of experts in the field of the invention. See Fed.R.Evid. 702.
The issues of claim construction and infringement focused on the controlled release agent, hydroxypropyl methylcellulose (HPMC). HPMC is defined in the Handbook of Pharmaceutical Additives as follows:
Definition: Propylene glycol ether of methyl cellulose
Properties: White powd.; swells in water to produce a clear to opalescent visc. colloidal sol'n.; nonionic, insol. in anhyd. alcohol, ether, chloroform; sol. in most polar solvs.
Trade Names: Benecel® Hydroxypropyl Methylcellulose; Methocel® E3 Premium; Methocel® E4M Premium; Methocel® E5P; Methocel® E6 Premium; Methocel® E10MP CR; Methocel® E15LV Premium; Methocel® E50LV Premium; Methocel® E50P; Methocel® E Premium; Methocel® F4M Premium. . . .
M. & I. Ash, Handbook of Pharmaceutical Additives 552 (1995).
A
The specification describes the hydroxypropyl methylcellulose release agent as follows:
This invention is directed to control sustained release (SR) tablets containing bupropion hydrochloride (as the drug or active ingredient), preferably hydroxypropyl methylcellulose (Methocel®) for controlling drug release rate, and cysteine hydrochloride or glycine hydrochloride.
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Methocel® is the brand name for hydroxypropyl methylcellulose (HPMC) from Dow Chemical. Other companies also supply HPMC.
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In order to prepare the controlled sustained release (SR) tablets of this invention, particles of bupropion hydrochloride are preferably blended with microcrystalline cellulose and hydroxypropyl methylcellulose (Methocel®) to form an admixture of blended powders.
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In the practice of this invention, for every part by weight of bupropion hydrochloride, the amount of hydroxypropyl methylcellulose is 0.19 to 1.1 and more preferably 0.267 to 0.68 parts by weight. . . .
'798 patent, col.1:67-col.3:14. The specification describes the HPMC used in the examples as follows:
Hydroxypropyl Methylcellulose 2910, USP used in the examples, conforms to 28.0 to 30.00% methoxyl substitution and 7.0 to 12.0% hydroxypropyl substitution. The preferred nominal viscosity of 2% solution in water is not less than 3,000 centipoise and not more than 5,600 centipoise. It is supplied by Dow Chemical Company, Midland, Mich. as Methocel E4M Premium CR.
'798 patent, col.5:13-20.
During prosecution of the '798 patent, the examiner required that all the claims be limited to hydroxypropyl methylcellulose as the release agent. For example, claim 14, as originally submitted, was as follows:
14. A controlled sustained release tablet comprising an admixture of 100mg of bupropion hydrochloride and means for providing a shelf life of at least one year and after oral administration of a single one of said tablets in adult men producing plasma levels of bupropion as free base ranging substantially between the minimum and maximum levels as shown in Fig. 5 over twenty four hours.
The examiner stated:
The rate of release is directly related to the release retarding effect of hydroxypropylmethylcellulose. While other excipients have been disclosed, the particular cellulose is considered critical for controlled and/or sustained release and should be incorporated into the independent claims. The disclosure of a single species does not provide a basis for claiming a generic concept.
The applicant acquiesced, and limited all the claims to hydroxypropyl methylcellulose. However, the examiner did not require limiting the hydroxypropyl methylcellulose to any specific grade or molecular weight. What the examiner required was:
Applicants are claiming a tablet which provides a distinct release profile. The advantages provided by the unique tablet differ from an instant release tablet. The limitations of claims 2-3 are considered critical and should be incorporated into claim 1 for proper enablement.
In response, the applicant amended claim 1 to include the...
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