Mead Johnson & Company v. Barr Laboratories, Inc.
| Decision Date | 05 March 1999 |
| Docket Number | No. 97 CIV. 6317 JES.,97 CIV. 6317 JES. |
| Citation | 38 F.Supp.2d 289 |
| Parties | MEAD JOHNSON & COMPANY and Bristol-myers Squibb Company, Plaintiffs, v. BARR LABORATORIES, INC., Defendant. |
| Court | U.S. District Court — Southern District of New York |
Fitzpatrick, Cella, Harper & Scinto, New York, NY, Errol B. Taylor, Lee A. Goldberg, of Counsel, for Plaintiffs.
Bryan Cave LLP, New York, NY, Philippe Bennett, of Counsel, for Defendant.
Winston & Strawn, Washington, D.C., Charles B. Molster III, Michael K. Atkinson, of Counsel, for Defendant.
Plaintiffs Mead Johnson & Company and Bristol-Myers Squibb Company (collectively "Mead Johnson") bring the instant action for patent infringement against defendant Barr Laboratories, Inc. ("Barr"), alleging that Barr has infringed U.S. Patent No. 4,258,027 (the "'027 patent") by submitting Abbreviated New Drug Application ("ANDA") No. 71-196 with the U.S. Food and Drug Administration ("FDA"). Mead Johnson seeks declaratory and injunctive relief and its costs and attorney fees incurred in the prosecution of the instant action. Barr also seeks a declaration of noninfringement and its costs and attorney fees. Following a hearing on claim construction and a trial of infringement to the Court, the Court finds that Barr has infringed the cross-motions for costs and attorney fees. The following constitutes the Court's findings of fact and conclusions of law.
Plaintiff Mead Johnson & Company is the owner, through assignment, of the '027 patent, which issued on March 24, 1981, and is to expire on March 26, 1999. Mead Johnson & Company is a wholly-owned subsidiary of plaintiff Bristol-Myers Squibb Company ("Bristol"). Bristol is the holder of approved New Drug Application No. 18-207 for trazodone hydrochloride. Apothecon, a division of Bristol, sells trazodone hydrochloride 150 mg and 300 mg tablets under the trademark Desyrel® Dividose® Tablets. Desyrel® Dividose® Tablets practice the tablet structure taught by the '027 patent.
Barr is a manufacturer and distributor of generic prescription drugs. Barr has filed ANDA No. 71-196 with the FDA to obtain approval to manufacture and distribute generic trazodone tablets in competition with Mead Johnson.
The '027 patent issued upon an application for letters patent filed in the names of Michael K. Ullman, Stephen T. David and Claude E. Gallian for an invention entitled "Multi-Fractionable Tablet Structure." The '027 patent describes certain scored tablet dosage forms that are fractionable into multiple subdosages. The invention allows convenient patient modification of dosage by facilitating the fragmenting of the tablet into at least equal bisectional or equal trisectional dosages through an arrangement of multiple scorings on the surface of the tablet. The object of the '027 patent is
to provide a multi-fractionable tablet structure prepared in a unitary dosage amount and having score markings disposed selectively such that ... the unitary dosage tablet may be readily and conveniently fractured into at least either bisectional or trisectional dosage units as desired for patient consumption.
'027 patent, col. 2, Ins. 53-66.
Claim 1 of the '027 patent is the only claim at issue in this litigation. Claim 1 reads as follows:
A tablet structure which comprises a unitary body having oppositely disposed first and second substantially horizontal surfaces being joined respectively by substantially vertical walls; any of said first horizontal surface, or said second horizontal surface, or said substantially vertical walls containing at least two transverse score markings and at least one other of said surfaces or walls containing a single transverse score marking whereby the unitary body may be fractured into at least equal bisectional or equal trisectional units for consumption.
The Court held a Markman hearing on the construction of claim 1 on April 23, 1998. See Markman v. Westview Instruments, Inc., 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). Prior to the hearing, the parties stipulated to the construction of the claim language as follows:
• A "tablet structure" means "a tablet."
• A "unitary body" means "a unit dose which can be ingested whole."
• The phrase "having oppositely disposed first and second substantially horizontal surfaces being joined respectively by substantially vertical walls" means "the top and bottom (non-side) surfaces and the surfaces that join the top and bottom surfaces."
• The phrase "at least two transverse score markings" in the phrase "any one of said first horizontal surface, or said second horizontal surface, or substantially vertical walls containing at least two transverse score markings" means "two or more notches, lines, grooves or scratches that run continuously and uninterrupted on the same surface from edge to edge."
See Transcript of Oral Argument, April 23, 1998 ("Markman Hearing") at 24-25.
At the hearing, the parties contested the construction of the limitation "and at least one other of said surfaces or walls containing a single transverse score marking" and the limitation "whereby the unitary body may be fractured into at least equal bisectional or equal trisectional units for consumption." See Markman Hearing at 26, 70. The Court held at the conclusion of the hearing that the first limitation in dispute requires that one and only one score marking be disposed on at least one surface of the tablet. See id. at 44-52. The Court further held that the second limitation in dispute requires that at least one score marking be so disposed as to facilitate the fracturing of the tablet into equal bisectional units for consumption and that at least two score markings be so disposed as to facilitate the fracturing of the tablet into equal trisectional units for consumption. See id. at 74.
Mead Johnson's claim of infringement arises in the context of the FDA regulatory framework for the approval of generic drugs under the Drug Price Competition and Patent Term Restoration Act of 1984, Pub.L. 98-417, 98 Stat. 1585 (1984). Before a new drug may be marketed in the United States, the FDA must approve a New Drug Application ("NDA") submitted by the manufacturer. See 21 U.S.C. § 355(a). The FDA publishes a list of each drug approved for safety and effectiveness in a publication entitled "Approved Drug Products With Therapeutic Equivalence Evaluations," commonly known as the "Orange Book." See 21 U.S.C. § 355(j)(7). A generic drug manufacturer seeking FDA approval for a generic version of a drug already listed in the Orange Book may file an Abbreviated New Drug Application ("ANDA") in order to shorten the time and effort required for approval. See 21 U.S.C. § 355(j)(2).
When a manufacturer files a NDA, the manufacturer must file with the application information relating to any patents that claim the drug or a method of using the drug. See 21 U.S.C. § 355(b)(1). When a generic manufacturer files an ANDA, the generic manufacturer must address whether the generic drug will infringe any such unexpired patent and whether such patent is valid in a formal statement referred to as "a paragraph IV certification." See 21 U.S.C. § 355(j)(2)(A)(vii). The ANDA applicant must also give notice to the patent owner and holder of the NDA. See 21 U.S.C. § 355(j)(2)(B)(I). The filing of a paragraph IV certification in support of an ANDA is actionable as an act of infringement under the patent laws. See 35 U.S.C. § 271(e)(2)(A).
Since 1987, Barr has been approved by the FDA to sell generic trazodone hydrochloride tablets that are not scored for fracturing into halves and thirds. On June 24, 1997, Barr filed a supplemental ANDA directed to the tablet design at issue in this litigation. The supplemental ANDA sought approval of a generic version of Mead Johnson's Desyrel® Dividose® to be sold in tablets with score markings to facilitate fracturing of the tablets into equal trisectional or equal bisectional units. Barr included a paragraph IV certification stating that its tablets would not infringe the '027 patent and provided notice to Mead Johnson of its application. Thereafter, Mead Johnson commenced the instant action pursuant to 35 U.S.C. § 271(e)(2)(A), alleging that Barr's tablets as disclosed in the ANDA infringe the '027 patent.
The Court having previously ruled upon the contested issues of claim construction, and Barr having failed to claim that the patent in suit is invalid, the sole issue before the Court is whether Barr's tablet design infringes claim 1 of the '027 patent. Although claim construction is an issue of law, infringement, whether literally or by a substantial equivalent, is a question of fact. See General Mills, Inc. v. Hunt-Wesson, Inc., 103 F.3d 978, 981 (Fed.Cir.1997).
Mead Johnson concedes that Barr does not literally infringe; rather, the issue before the Court is whether the Barr tablet infringes under the doctrine of equivalents. To determine whether the Barr tablet infringes, the Court must compare the accused product to the language of claim 1 of the '027 patent, the only claim asserted by Mead Johnson against Barr, focusing upon the actual language of the claim rather than Mead Johnson's commercial embodiment. Zenith Laboratories, Inc. v. Bristol-Myers Squibb Co., 19 F.3d 1418, 1423 (Fed.Cir.1994). The doctrine of equivalents permits a finding of infringement when the accused product varies only slightly from the literal words of the patent claim, thus protecting the inventor from infringers who attempt to evade liability for copying the invention by making minor changes. Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 608 70 S.Ct. 854, 94 L.Ed. 1097 (1950). A product that "performs substantially the same function in substantially the same way to obtain the same...
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