SigmaPharm, Inc. v. MUTUAL PHARMACEUTICAL CO.

772 F. Supp. 2d 660, 2011 U.S. Dist. LEXIS 21267, 2011 WL 743394
CourtDistrict Court, E.D. Pennsylvania
DecidedMarch 2, 2011
DocketCivil 10-430
StatusPublished
Cited by3 cases

This text of 772 F. Supp. 2d 660 (SigmaPharm, Inc. v. MUTUAL PHARMACEUTICAL CO.) 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
SigmaPharm, Inc. v. MUTUAL PHARMACEUTICAL CO., 772 F. Supp. 2d 660, 2011 U.S. Dist. LEXIS 21267, 2011 WL 743394 (E.D. Pa. 2011).

Opinion

MEMORANDUM OPINION & ORDER

RUFE, District Judge.

In its First Amended Complaint, Plaintiff SigmaPharm, Inc. brings claims for violation of Section 1 of the Sherman Act *663 (count I), 1 Pennsylvania common law barring restraint of trade (count II), and Section 17200 of the California Business and Professions Code barring unlawful and unfair competition 2 (count III) against Defendants Mutual Pharmaceuticals Company, Inc. (“Mutual”), United Research Laboratories, Inc. (“United”), and King Pharmaceuticals, Inc. (“King”). Plaintiff also asserts a claim for breach of contract under Pennsylvania common law against Mutual and United only (count IV). Before the Court are: (1) a Motion to Dismiss counts I through III by Defendant King [doc. no. 40]; (2) a Motion to Dismiss all counts by Defendants Mutual and United [doc. no. 41]; (3) a motion to stay discovery pending this Court’s resolution of the motions to dismiss by all Defendants [doc. no. 44]; and (4) a motion to compel discovery by SigmaPharm [doc. no. 57]. For the reasons set forth below, the Court will dismiss the federal antitrust claim for failure to state a claim, decline to exercise supplemental jurisdiction over the state law claims pursuant to 28 U.S.C. § 1367(c), and dismiss the discovery motions as moot.

I.Factual & Procedural Background

SigmaPharm, a Delaware corporation, develops pharmaceutical technologies and products and enters into agreements with other entities to commercialize them. 3 Mutual and United (collectively “Mutual”), both Pennsylvania corporations, and King, a Tennessee corporation, develop, manufacture, market, sell, and distribute pharmaceutical drugs. 4 SigmaPharm’s First Amended Complaint alleges that Mutual and King conspired to restrict the output of generic equivalents to King’s brand-name drug SKELAXIN, in violation of federal and state antitrust law and in breach of SigmaPharm’s development agreement with Mutual.

A. The SigmaPharm-Mutual Employment & Development Agreements

In March 1999, Mutual and SigmaPharm entered into two agreements: (1) a development agreement between Mutual and SigmaPharm; and (2) an employment agreement between SigmaPharm’s President, Dr. Spiridon Spireas, and Mutual. The employment agreement provided that Spireas would serve as Mutual’s Vice President of Research and Development, and assume responsibility for Mutual’s laboratory and research activities related to obtaining Food and Drug Administration (“FDA”) approval of any new drugs it developed. Under the development agreement, SigmaPharm served as a contractor to develop “innovations” for Mutual. “Innovations” are inventions, improvements or enhancements to Mutual’s pharmaceutical products developed by SigmaPharm for which Mutual secures a patent or which Mutual otherwise deems to be an “innovation.” 5 The development agreement pro *664 vided that Mutual had sole ownership of all rights, title and interest in any “innovation” in the U.S. market as well as ownership of any U.S. Patents that might issue, 6 but SigmaPharm was entitled to royalties from Mutual’s manufacture and sale of any such pharmaceuticals in the United States. For generic equivalents of name-brand drugs developed by SigmaPharm that required approval under the FDA’s Abbreviated New Drug Application (“ANDA”) process, SigmaPharm was to receive 10% of gross profits from Mutual’s U.S. sales. 7 But if additional generic competitors entered the market, the royalties would decrease: with the entry of one, two or three additional competitors, royalties declined to 5%, 2.5%, or 0%, respectively. 8 And if Mutual licensed or sold the right to sell the product, or “agreed to refrain from selling such product,” SigmaPharm was to receive 25% of the gross profit from the licensing fees or royalties from that license, sale, or agreement. 9

B. The Abbreviated New Drug Application Process

The ANDA process was established by the Drug Price Competition and Patent Term Restoration Act of 1984 (“HatchWaxman Act”). 10 The Hatch-Waxman Act establishes relaxed FDA approval procedures for generic equivalents of previously approved pharmaceutical drugs, allowing generic manufacturers to submit abbreviated applications. 11 Those procedures allow a generic drug manufacturer to bypass the safety and efficacy studies required for all new drugs so long as they establish the generic’s bioequivalence 12 to a drug previously approved by FDA as safe and effective. 13 - The ANDA must also provide information to show that the labeling for the generic is the same as the labeling approved for the listed drug, unless certain exceptions apply. 14 If a patent claims the previously approved drug that the generic copies, or claims a use for the previously approved drug for which the ANDA applicant seeks approval, the generic manufacturer must certify either that patent information has not been filed, the patent has expired, the date on which the patent will *665 expire, or that the “patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted.” 15 This last certification is known as a “Paragraph IV certification.” 16 The generic manufacturer must notify the brand-name manufacturer and patent holder of its ANDA, after which the patent holder has 45 days to bring an infringement suit. 17 This notification is not required if the applicant certifies that the patent at issue protects only methods of using the drug and the patent does not claim a use for which the applicant is seeking approval 18 — a “Section viii” certification. If an infringement suit is filed, the FDA must stay approval of the ANDA until the earliest of: (1) the date the patent expires; (2) the date the district court holds the patent invalid or the generic non-infringing; or (3) 30 months from the date of the notice have elapsed. 19 If the generic is approved, the generic manufacturer enjoys a 180-day period of market exclusivity. 20

C. Mutual’s Second Generic to SKELAXIN & King’s Method Patents

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Cite This Page — Counsel Stack

Bluebook (online)
772 F. Supp. 2d 660, 2011 U.S. Dist. LEXIS 21267, 2011 WL 743394, Counsel Stack Legal Research, https://law.counselstack.com/opinion/sigmapharm-inc-v-mutual-pharmaceutical-co-paed-2011.