Pentech Pharmaceuticals, Inc. v. Par Pharmaceutical, Inc.

597 F. Supp. 2d 758, 2009 U.S. Dist. LEXIS 9282, 2009 WL 311071
CourtDistrict Court, N.D. Illinois
DecidedFebruary 9, 2009
Docket04 C 3149
StatusPublished

This text of 597 F. Supp. 2d 758 (Pentech Pharmaceuticals, Inc. v. Par Pharmaceutical, Inc.) is published on Counsel Stack Legal Research, covering District Court, N.D. Illinois primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Pentech Pharmaceuticals, Inc. v. Par Pharmaceutical, Inc., 597 F. Supp. 2d 758, 2009 U.S. Dist. LEXIS 9282, 2009 WL 311071 (N.D. Ill. 2009).

Opinion

MEMORANDUM OPINION AND ORDER

MORTON DENLOW, United States Magistrate Judge.

This case involves a claim for breach of contract and declaratory judgment brought by Plaintiff Pentech Pharmaceuticals, Inc. against Defendant Par Pharmaceutical, Inc., arising out of a contract between them relating to a generic version of

*762 Paxil. The Court conducted a bench trial on December 9-12 and 15-16, 2008 and heard closing arguments on December 22, 2008. The Court has considered the testimony of the witnesses who testified at the trial, the deposition excerpts of the witnesses who were not available to testify in person, the parties’ trial exhibits, the stipulations made by the parties, the proposed findings and conclusions submitted by the parties, and the closing arguments of counsel.

The following constitute the Court’s findings of fact and conclusions of law in accordance with Rule 52(a) of the Federal Rules of Civil Procedure. To the extent certain findings of fact may be deemed conclusions of law, they shall also be considered conclusions of law. Similarly, to the extent matters contained in the conclusions of law may be deemed findings of fact, they shall also be considered findings of fact.

I.ISSUES PRESENTED

1. Whether Section 2.3 or Section 5.2 of the First Amendment to the Supply and Marketing Agreement applies to the dispute.

ANSWER: Section 2.3.

2. Whether the License and Supply Agreement between Par and GlaxoS-mithKline is part of a settlement to which Pentech is a party.

ANSWER: Yes.

3. How much is owed to Pentech from Par arising out of the First Amendment to the Supply and Marketing Agreement.

ANSWER: $49.5 million.

4. How much prejudgment interest is owed to Pentech from Par.

ANSWER: $20,455,476.

II. FINDINGS OF FACT

A. The Parties

1. Pentech Pharmaceuticals, Inc. (“Pentech” or “Plaintiff’) is an Illinois corporation with its principal place of business in Illinois. Pentech is in the business of developing generic pharmaceutical drugs for approval by the United States Food and Drug Administration (“FDA”). PI. Agreed Facts ¶ 1, T. 106:22-107:1. 1

2. Par Pharmaceutical, Inc. (“Par” or “Defendant”) is a Delaware corporation with its principal place of business in New Jersey. Par has, at all relevant times, been engaged in the business of manufacturing, distributing and selling pharmaceutical drugs. Id. ¶ 2.

3. Par is the operating subsidiary of Par Pharmaceutical Companies, Inc., a publicly traded company listed on the New York Stock Exchange. Id. ¶ 3.

*763 B. Paxil

4. In order to market a pharmaceutical drug in the United States, a company must first obtain FDA approval. Id. ¶ 4.

5. FDA approval of pharmaceutical drugs is obtained pursuant to a New Drug Application (“NDA”) or an Abbreviated New Drug Application (“ANDA”). The NDA process applies to new or “brand” drugs. The ANDA process applies to drugs that are therapeutically equivalent to existing “brand” drugs. Id. ¶ 5.

6. Since 1993, SmithKline Beecham Corporation and affiliates (“GSK”) 2 have manufactured and sold paroxetine hydrochloride (“paroxetine”) under the trademark “Paxil” for use in the treatment of depression, among other things. GSK owns patent rights concerning Paxil. Pax-il was approved by the FDA pursuant to an NDA, and is sold only in tablet form. Id. ¶ 6.

7. Paxil was enormously successful for GSK, generating billions of dollars of sales in the United States. In 2000, 2001 and 2002, sales of Paxil in the United States by GSK and affiliates were approximately $1.8 billion, $2.2 billion and $2.2 billion, respectively. Id. ¶ 7 and Def. Agreed Facts ¶ 4.

C. Efforts to Develop a Generic Version of Paxil

8. After GSK launched Paxil, several generic drug companies launched efforts to develop a generic paroxetine competitor to Paxil that would not infringe GSK’s patents on Paxil. Pentech was one such company. During the 1990s, Pentech worked to develop a formulation of paroxetine that would be therapeutically equivalent to Pax-il, but would not violate the Paxil patents. Pentech worked to develop a formulation of paroxetine that would be different from Paxil in several significant respects. First, although Paxil was a hard tablet, Pentech sought to develop its paroxetine product as a soft capsule. Second, the active ingredient contained in Paxil is a hemihydrate (or “crystalline”) form of paroxetine. Pentech sought to develop an “amorphous” (i.e., non-crystalline) form of paroxetine, which Pentech believed would not infringe GSK’s paroxetine patents. In 1997, Pentech was awarded a patent for a paroxetine composition that differed from GSK’s. In 1997, Pentech also submitted applications for two additional patents on paroxetine, and patents on these applications were ultimately awarded in 2003. PI. Agreed Facts ¶ 8 and Def. Agreed Facts ¶¶ 4-5.

9. In March of 2000, Pentech filed an ANDA with the FDA, seeking FDA approval to manufacture and distribute Pen-tech’s form of paroxetine as a generic competitor to Paxil for the treatment of depression. Specifically, Pentech sought FDA permission to manufacture and distribute paroxetine capsules in doses of 10 mg and 20 mg, whereas, Paxil was available in 10 mg, 20 mg, 30 mg and 40 mg dosages. PI. Agreed Facts ¶ 9 and Def. Agreed Facts ¶¶ 6-7.

10. Another company, Apotex, had previously filed an ANDA for a generic tablet version of paroxetine. Under 21 U.S.C. § 355(j)(5) (B)(iv) (“Hatch-Waxman Act”), Pentech’s ANDA had “first-to-file” status with respect to a capsule form of generic paroxetine. PI. Agreed Facts ¶ 10 and Def. Agreed Facts ¶ 8. As a consequence of its first-to-file status, Pentech had a potential opportunity to be the sole generic alternative to Paxil on the market for at least 180 days after the FDA approved its *764 ANDA. The filing of this “first filed” ANDA meant, under the rules of the Hatch-Waxman Act, that if Pentech could actually succeed in (i) manufacturing the amorphous capsule product specified in its ANDA, (ii) defeating any patent-infringement challenges from GSK, and (iii) gaining FDA approval, Pentech could be entitled to a 180-day “exclusivity period” after the launch of its product during which no other company would be permitted to bring a similar paroxetine capsule product to market as a generic competitor, although this would not prevent a generic tablet paroxetine competitor from entering before or during this 180-day period. T. 107:17-108:5; 124:10-125:6.

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Bluebook (online)
597 F. Supp. 2d 758, 2009 U.S. Dist. LEXIS 9282, 2009 WL 311071, Counsel Stack Legal Research, https://law.counselstack.com/opinion/pentech-pharmaceuticals-inc-v-par-pharmaceutical-inc-ilnd-2009.