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MEAD JOHNSON & COMPANY v. BARR LABORATORIES

March 5, 1999

MEAD JOHNSON & COMPANY AND BRISTOL-MYERS SQUIBB COMPANY, PLAINTIFFS,
v.
BARR LABORATORIES, INC., DEFENDANT.



The opinion of the court was delivered by: Sprizzo, District Judge.

MEMORANDUM OPINION AND ORDER

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 '027 patent and grants Mead Johnson declaratory and injunctive relief. The Court denies the parties' cross-motions for costs and attorney fees. The following constitutes the Court's findings of fact and conclusions of law.

BACKGROUND

The Parties

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 Patent in Suit

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 ...

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