Sb Pharmco Pureto Rico v. Mutual Pharmaceutical

• Decision Date: 28 April 2008
• Docket Number: Civil Action No. 08-CV-0549.
• Citation: 552 F.Supp.2d 500
• Parties: SB PHARMCO PUERTO RICO, INC. d/b/a GlaxosmitHkline, et al. v. MUTUAL PHARMACEUTICAL CO., INC., et al.
• Court: U.S. District Court — Eastern District of Pennsylvania

Page 500

552 F.Supp.2d 500

SB PHARMCO PUERTO RICO, INC. d/b/a GlaxosmitHkline, et al. v. MUTUAL PHARMACEUTICAL CO., INC., et al.

Civil Action No. 08-CV-0549.

United States District Court, E.D. Pennsylvania.

April 28, 2008.

Amy K. Wigmore, Jasmine S. McGhee, Mark L. Rienzi, William G. McElwain, Wilmer Cutler Pickering Hale & Dorr LLP, Washington, DC, Joseph R. Heffern, Kevin M. Flannery, Martin J. Black, Dechert, LLP, Philadelphia, PA, William F. Lee, Wilmer Cutler Pickering Hale & Dorr LLP, Boston, MA, for SB Pharmco Puerto Rico, Inc. d/b/a Glaxosmithkline, et al.

Eliot Lauer, Jacques Semmelman, Rachael Yocum, Curtis, Mallett-Prevost, Colt & Mosle LLP, New York, NY, James J. Rodgers, Dilworth Paxson L.L.P., Philadelphia, PA, Leah M. Reimer, Leslie-Anne Maxwell, Steven M. Coyle, Cantor Colburn

LLP, Hartford, CT, for Mutual Pharmaceutical Co., Inc., et al

MEMORANDUM & ORDER

SURRICK, District Judge.

Presently before the Court are Plaintiffs' Motion for Judgment on the Pleadings, (Doc. No. 25), and Defendants-Counterclaimants' Cross-Motion for Leave to Amend Their Answer and Counterclaim, (Doc. No. 37). For the following reasons, Plaintiffs' Motion will be granted and Defendant's Motion will be denied.

I. BACKGROUND

A. Statutory Framework

The introduction of new prescription drugs to the marketplace is governed by the Food, Drug and Cosmetic Act, 21 U.S.C. §§ 301 et seq. ("FDCA"). A company seeking to market a new drug must first receive the approval of the Food and Drug Administration ("FDA") by submitting a New Drug Application ("NDA"). See id. § 355(a) (Supp.2007). 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). An NDA must 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. Id.

Prior to 1984, both brand name and generic drug manufacturers who wished to bring a drug to market were required to file an NDA. 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 Act, which amended the FDCA. See Drug Price Competition and Patent Term Restoration Act of 1984, Pub.L. No. 98-417, 90 Stat. 1585 (1984) (codified as amended at 21 U.S.C. § 355 and 35 U.S.C. § 271(e) (1994)).

Under the Hatch-Waxman Act, a company seeking to market a generic version of a drug may file an Abbreviated New Drug Application ("ANDA"), 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. See 21 U.S.C. § 355(j). The generic manufacturer must show principally that its drug is bioequivalent to the pioneer drug for which it will serve as a substitute. See id. § 355(j) (2)(A). The ANDA is not considered filed until the FDA acknowledges receipt following a preliminary review ensuring that the ANDA is sufficiently complete to permit substantive review. 21 C.F.R. § 314.101(b)(1).

Although Congress was interested in increasing the availability of generic drugs, it also wanted to protect the rights of those holding patents on pioneer drugs. See Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 676-77, 110 S.Ct. 2683, 110 L.Ed.2d 605 (1990) ("These abbreviated drug-application provisions incorporated an important new mechanism designed to guard against infringement of patents relating to pioneer drugs."). An applicant filing an ANDA must certify whether its proposed generic drug will infringe any of the patents listed in connection with the pioneer drug in the Orange Book and, if not, why not. An applicant filing an ANDA has four certification options. It may certify (I) that the required patent information has not been filed, (II) that the patent has expired, (HI) that the patent has not expired but will expire on a particular date, or (IV) that the patent is invalid or will not be infringed by the drug for which the applicant seeks approval. See 21 U.S.C. § 355(j)(2) (A)(vii)(I)-(IV). The last of these options, and the one relevant here, is the so-called Paragraph IV certification.

Hatch-Waxman grants the first entity to file an ANDA with a Paragraph IV certification a 180-day exclusivity period in which to market its generic drug without competition from other ANDA applicants. See 21 U.S.C. § 355(J)(5)(B)(iv); see also Mova Pharm., 140 F.3d at 1064-65 (describing exclusivity period).

An applicant who makes a Paragraph IV certification is required to give notice to the holder of the patent alleged to be invalid or not infringed, stating that an ANDA has been filed seeking approval to engage in the commercial manufacture, use, or sale of the drug before the expiration of the patent, and setting forth a detailed statement of the factual and legal basis for the applicant's opinion that the patent is not valid or will not be infringed. See 21 U.S.C. § 355(j)(2)(B)(iv). The applicant serves notice of a Paragraph IV certification to the patentee following confirmation from the FDA that the ANDA has been accepted as received. 21 U.S.C. § 355(j)(2)(B)(ii). Upon receiving the notice, the patent owner has forty-five days in which it may initiate a patent infringement suit against the ANDA applicant, or else approval of the ANDA will be effective immediately. 21 U.S.C. § 355(j)(5)(B)(iii). If the patent owner brings such a suit, then approval of the ANDA may not be granted until the court rules that the patent is invalid or not infringed or until the expiration of thirty months, whichever occurs first. Id.

B. Statement of Facts

SB Pharmco Puerto Rico, Inc. and SmithKlineBeacham (collectively, "Plaintiffs"), both doing business as GlaxoSmithKline ("GSK"), bring this action for declaratory judgment on the grounds that the Paragraph IV notice sent by Mutual Pharmaceutical Company, Inc. ("Mutual") and United Research Laboratories, Inc. ("URL") (collectively, "Defendants") on December 21, 2007 was improper and premature.

Plaintiffs hold the patent for the compound sold as COREG CR, and for methods of using this compound to treat hyptertension, myocardial infarction, and heart failure. (Doc. No. 1, Ex. B (United States Patent No. 7,268,156 ("'156 patent"), "Carvedilol Phosphate Salts and/or Solvates Thereof, Corresponding Compositions and/or Methods of Treatment").) The FDA issued this patent on September 11, 2007, having approved Plaintiffs* NDA on October 20, 2006.

On November 19, 2007, Defendants submitted ANDA 90-132 for Carvedilol Phospate Extended Release 80 mg capsules, a generic version of COREG CR. (Doc. No. ¶ 24; Doc. No. 8 ¶ 24.) On December 21, 2007, Defendants filed an amendment to ANDA 90-132 for 40 mg capsules. (Doc. No. 1 ¶ 26; Doc. No. 8 ¶ 26.) The amendment contained a Paragraph IV certification that the '156 patent was invalid, unenforceable, or not infringed. (Id.) Concurrently, Defendants sent Plaintiffs a Paragraph IV notice letter ("December 21 Paragraph IV Notice"). (Doc. No. 1 ¶ 27; Doc. No. 8 ¶ 27.) On December 21, 2007, ANDA 90-132 had not yet been accepted by the FDA for filing. (Doc. No. 1 ¶¶ 25-26; Doc. No. 8 ¶ 25.)

On January 22, 2008, Plaintiffs emailed the FDA regarding the December 21 Paragraph IV Notice. (Doc. No. 1, Ex. A (Letter of G. Buehler to W. Zoffer).) On February 4, 2008, Gary J. Buehler, Director of the Office of Generic Drugs, Center for Drug Evaluation and Research, responded. (Id.) His response, in a two-page letter which discussed the agency's interpretation of the statutory and regulatory process for the approval of ANDAs, concluded as follows:

"FDA has advised Mutual that, because Mutual sent notice to SB Pharmco d.b.a. GlaxoSmithKline of its paragraph IV certification to the '562 and '156 patents before Mutual received acknowledgment from the FDA that ANDA No. 90-132 had been received for review, the notification is invalid and does not trigger either the 45-day period in which SB Pharmco d.b.a. GlaxoSmithKline may file suit against Mutual and obtain a 30-month stay under section 505(j)(5) (B)(iii) of the Act, or the beginning of any related 30-month stay. Mutual must renotify the NDA holder and patent owner(s) within 20 days after the FDA informs it that its application has been received for review."

(Id.) Plaintiffs subsequently requested that Defendants withdraw the December 21 Paragraph IV Notice. (Doc. No. 1 ¶¶ 29, 34; Doc. No. 8 ¶¶ 29, 34.) Defendants refused to do so. (Id.)

On February 4, 2008, forty-five days after receiving the December 21 Paragraph IV Notice, Plaintiffs filed a Complaint in this court. (Doc. No. 1 ¶ 30.) Count I of the Complaint seeks declaratory judgment that:

(1) Defendants' Paragraph IV Notice is improper, null, void, and without legal effect and that Defendants were not entitled to trigger the ANDA patent litigation process; (2) this Court has no jurisdiction over Plaintiffs' alternative claims regarding the '156 patent because Defendants Paragraph IV Notice is null, void, and without legal effect; (3) the Paragraph IV Notice served by Defendants did not commence the 45 day period in which to file a patent infringement action pursuant to 21 U.S.C. § 355(j)(5)(B) (iii); (4) if and when the FDA accepts Defendants' ANDA, Defendants must serve new Paragraph IV Notices on GSK pursuant to 21...