SmithKline Beecham Corp. v. Apotex Corp.

383 F. Supp. 2d 686, 2004 U.S. Dist. LEXIS 20348, 2004 WL 2222388
CourtDistrict Court, E.D. Pennsylvania
DecidedSeptember 29, 2004
DocketCivil Action Nos. 99-CV-4304, 00-CV-4888, 01-CV-0159, 01-CV-2169, 99-CV-2926, 00-CV-5953, 02-CV-1484, 00-CV-1393, 00-CV-6464, 01-CV-2602, 01-CV-1027, 01-CV- 3364, 02-CV-8493, 01-CV-2981, 03-CV-6117, 03-CV-3365
StatusPublished
Cited by9 cases

This text of 383 F. Supp. 2d 686 (SmithKline Beecham Corp. v. Apotex Corp.) is published on Counsel Stack Legal Research, covering District Court, E.D. Pennsylvania primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
SmithKline Beecham Corp. v. Apotex Corp., 383 F. Supp. 2d 686, 2004 U.S. Dist. LEXIS 20348, 2004 WL 2222388 (E.D. Pa. 2004).

Opinion

MEMORANDUM & ORDER

SURRICK, District Judge.

Presently before the Court are the Motions to Dismiss filed by SmithKline Beec-ham Corporation, SmithKline Beecham, P.L.C., Beecham Group, P.L.C. and Glax-oSmithKline, P.L.C. (“SmithKline”), (Doc. Nos.112, 124), and the Motion to Dismiss and/or Strike filed by PAR Pharmaceuticals, Inc. and Pentech Pharmaceuticals, Inc. (“PAR/Pentech”), (Doc. No. 117). SmithKline and PAR/Pentech have moved to dismiss certain counterclaims made by Defendants Apotex Corporation, Apotex, Inc., and Torpharm, Inc. (“Torpharm”). After the parties briefed these Motions, Torpharm filed a Motion for Leave to File a Sur-Response, (Doc. No. 140), which SmithKline and PAR/Pentech opposed. Local Rule 7.1(c) provides in part that “[t]he Court may require or permit further briefs if appropriate.” Due to the complexity of the issues presented in the Motions to Dismiss, we will grant Torpharm’s Motion for Leave. For the following reasons, we will grant in part and deny in part the Motions to Dismiss.

*689 I. BACKGROUND 1

These consolidated cases began with claims of patent infringement made by SmithKline. The patents at issue cover certain forms of paroxetine hydrochloride, processes for making paroxetine hydrochloride, and uses of paroxetine hydrochloride. SmithKline manufactures the hemih-ydrate form of paroxetine hydrochloride, and then tablets and sells that product in the United States under the trademark Paxil® (“Paxil”). Paxil is an anti-depressant drug used to treat a variety of disorders, and is one of the most widely prescribed prescription drugs in the United States. Torpharm and PAR/Penteeh are among a number of companies that seek to manufacture and sell a generic form of Paxil, and, as a result, find themselves as defendants in patent infringement suits brought by SmithKline. Torpharm filed an answer denying SmithKline’s claims in civil action nos. 99-CV-4304, 00-CV-4888, 01-CV-0159, and 01-CV-2169 and asserting various counterclaims. Some of Torpharm’s counterclaims seek declaratory judgments that SmithKline’s patents are invalid, unenforceable, improperly listed, and/or not infringed. Torpharm also asserts counterclaims against SmithKline for monopolization, conspiracy to monopolize, attempted monopolization, tortious interference with prospective economic advantages, common law fraud, statutory fraud, and unfair and deceptive trade practices. As explained in more detail below, Torpharm alleges that beginning in 1994, SmithKline began to deliberately pursue a strategy of delaying and destroying generic competition by Torpharm and others in order to maintain and extend SmithKline’s monopoly in the market for paroxetine hydrochloride. (Civil Action No. 99-CV-4304, Doc. No. 103 (“Counterclaim”) ¶ 1.) In addition, Torpharm alleges that Smith-Kline conspired with PAR/Pentech to allow PAR/Pentech to prematurely compete with Torpharm in the generic Paxil market, and thereby punish Torpharm for challenging SmithKline’s paroxetine hydrochloride monopoly. In furtherance of this scheme, SmithKline agreed to settle the patent infringement lawsuit it had brought against PAR/Pentech and grant PAR/Penteeh a license to sell a generic form of Paxil under certain circumstances. Accordingly, Torpharm brings third-party claims against PAR/Pentech for attempted monopolization and conspiracy to monopolize. SmithKline and PAR/Pentech have moved to dismiss and/or strike Torpharm’s antitrust claims to the extent those claims are based on the settlement between Smith-Kline and Par/Pentech, and to dismiss Torpharm’s tortious interference claims in their entirety.

A. Regulatory Framework for FDA Approval of Prescription Drugs

Torpharm is the holder of Abbreviated New Drug Application (“ANDA”) No. 75-360 for paroxetine hydrochloride anhyd-rate, and was the first entity to file an ANDA seeking approval to market a bioe-quivalent form of Paxil. (Id. ¶ 2.) Because Torpharm’s status as the first entity to file such an ANDA is so important to its claims, we will briefly discuss the regulatory scheme governing prescription drugs.

The introduction of new prescription drugs to the marketplace is governed by the Food, Drug & Cosmetic Act. See 21 U.S.C. §§ 301 et seq. (1999) (the “FDC Act”). Generally, any company seeking to market a new drug must first receive the approval of the Food and Drug Administration (“FDA”) by submitting a New *690 Drug Application (“NDA”). See id. § 355(a). The NDA is a thorough, time-consuming, and costly process in part because the application must include data from clinical studies that support the proposed drug’s safety and effectiveness. See Mova Pharm. Corp. v. Shalala, 140 F.3d 1060, 1063 (D.C.Cir.1998).

Prior to 1984, both brand name and generic drug manufacturers who wished to bring a drug to market were required to file a NDA. 2 Concerned that the NDA was a “cumbersome drug approval process [that] delayed the entry of relatively inexpensive generic drugs into the market place,” Mylan Pharm., Inc. v. Shalala, 81 F.Supp.2d 30, 32 (D.D.C.2000), Congress enacted the Hatch-Waxman Amendments to the FDC Act. See Drug Price Competition and Patent Term Restoration Act of 1984, Pub.L. No. 98-417, 90 Stat. 1585 (1984) (codified in scattered sections of Titles 21, 35, and 42 of the United States Code). The Hatch-Waxman Amendments simplified the approval mechanism for generic versions of drugs that the FDA had approved via the NDA process.

Under the Hatch-Waxman Amendments, a company that wishes to market a generic version of a pioneer drug no longer needs to file a NDA. Instead, Congress created the ANDA process, by which a generic manufacturer can rely on the clinical studies performed by the pioneer drug manufacturer and is not required to prove the safety and effectiveness of its generic drug from scratch. Instead, the generic manufacturer must principally show that its drug is bioequivalent to the pioneer drug for which it will serve as a substitute. See 21 U.S.C. § 355(j)(2)(A).

Although Congress was interested in increasing the availability of generic drugs, it also wanted to protect the rights of those holding patents that claim pioneer drugs. The Hatch-Waxman Amendments, therefore, require that a NDA contain a list of any patents “which claim[ ] the drug ... or which claim[ ] a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug.” 21 U.S.C. § 355(b)(1). The FDA maintains a record of the patents that claim approved drugs in its publication entitled Approved Drug Products with Therapeutic Equivalence, commonly known as the Orange Book. See 21 U.S.C.

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383 F. Supp. 2d 686, 2004 U.S. Dist. LEXIS 20348, 2004 WL 2222388, Counsel Stack Legal Research, https://law.counselstack.com/opinion/smithkline-beecham-corp-v-apotex-corp-paed-2004.