Classen Immunotherapies, Inc. v. Biogen Idec

• Decision Date: 22 July 2005
• Docket Number: No. CIV. WDQ-04-2607.,CIV. WDQ-04-2607.
• Citation: 381 F.Supp.2d 452
• Parties: CLASSEN IMMUNOTHERAPIES, INC., Plaintiff, v. BIOGEN IDEC, et al., Defendants.
• Court: U.S. District Court — District of Maryland

381 F.Supp.2d 452

CLASSEN IMMUNOTHERAPIES, INC., Plaintiff, v. BIOGEN IDEC, et al., Defendants.

No. CIV. WDQ-04-2607.

United States District Court, D. Maryland, Northern Division.

July 22, 2005.

Joseph J. Zito, Zito TLP, Damascus, MD, for Plaintiff.

Amanda Page Masselam, David Bryan Bassett, Wilmer Cutler Pickering Hale And Dorr LLP, Boston, MA, David Andrew Wilson, Wilmer Cutler Pickering Hale and Dorr LLP, Kevin Barry Collins, Venable LLP, George Brian Busey, Morrison and Foerster LLP, Washington, DC, Jeffrey B. Elikan, Venable Baetjer and Howard LLP, Henry R Abrams, Saul Ewing LLP, Baltimore, MD, Amy E. Carr Trexler, David N. Farsiou, Joseph Lucci, Woodcock Washburn LLP, Philadelphia, PA, James Walter Parrett, Jr., Mary Brewster Graham, Morris Nichols Arsht and Tunnell, Wilmington, DE, Elisabeth Santa Traugott, Michael Allen Jacobs, Morrison And Foerster LLP, San Francisco, CA, Laurie A. Hand, Morrison and Foerster LLP, Mclean, VA, for Defendants.

MEMORANDUM OPINION AND ORDER

QUARLES, District Judge.

Classen Immunotherapies, Inc. ("Classen") has sued Biogen IDEC ("Biogen"), GlaxoSmithKline ("GSK"), Chiron Corporation ("Chiron"), Merck & Co., Inc., Kaiser Foundation Health Plan, Inc., Kaiser Permanente Ventures, Kaiser Permanente International, Kaiser Permanente Insurance Company, The Permanente Federation, LLC, The Permanente Company, LLC, The Permanente Foundation, The Permanente Medical Group, Inc., Kaiser Foundation Hospitals, and Kaiser Foundation Added Choice Health Plan, Inc. for patent infringement. Pending are Chiron, Biogen, and GSK's motions to dismiss, and the various Kaiser, Kaiser Permanente, and Permanente Defendants' motion for sanctions. For the reasons discussed below, the motions to dismiss will be granted, and the motion for sanctions will be granted in part and denied in part.

BACKGROUND

Classen owns the following United States Patent Numbers: (1) 6,420,139 ("the '139 patent"); (2) 6,638,739 ("the '739 patent"); (3) 5,728,385 ("the '385 patent"); and (4) 5,723,283 ("the '283 patent") (collectively, "the patents in suit"). Am. Compl. at ¶ 3. Each patent involves a mechanism for evaluating the safety of vaccine administration schedules by comparing or identifying the adverse events associated with various vaccine schedules. Classen alleges that the Defendants:

collectively license, manufacture, use, market, distribute and sell vaccines for human use.... Defendants' products have participated in studies on the effects of the timing of administration of these vaccines and incidence of chronic immune mediated disorders. The Defendants collectively publish, encourage, recommend and administer the vaccines according to a protocol which is believed to minimize the risk of incidence of chronic immune mediated disorders.

Id. at ¶ 6.

ANALYSIS

A. Motions to Dismiss

1. Standard of Review

Under Federal Rule of Civil Procedure 12(b)(6), dismissal of a complaint for failure to state a claim is not appropriate "unless it appears beyond doubt that the plaintiff can prove no set of facts in support of his claim which would entitle him to relief." Conley v. Gibson, 355 U.S. 41, 45-46, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957). The function of Rule 12(b)(6) is to test the legal sufficiency of the complaint, not the facts that support it. Dist. 28, United Mine Workers of Am., Inc. v. Wellmore Coal Corp., 609 F.2d 1083, 1086 (4th Cir.1979). Thus, a complaint may be dismissed as a matter of law only "if it lacks a cognizable legal theory, or it alleges insufficient facts under a cognizable legal theory." Mates v. N. Am. Vaccine, Inc., 53 F.Supp.2d 814, 822 (D.Md.1999). In determining whether to dismiss a complaint, the court must accept the well-pled material allegations as true, viewing the facts and the reasonable inferences drawn therefrom in the light most favorable to the plaintiff. Chisolm v. TranSouth Fin. Corp., 95 F.3d 331, 334 (4th Cir.1996). The court, however, is "not bound to accept as true a legal conclusion couched as a factual allegation." Papasan v. Allain, 478 U.S. 265, 286, 106 S.Ct. 2932, 92 L.Ed.2d 209 (1986).

2. Analysis

Classen alleges that Chiron infringed and induced infringement of the patents in suit by manufacturing and supplying hepatitis B vaccines, and providing recommendations on a proper immunization schedule. It is undisputed, however, that Chiron does not manufacture, supply, or administer hepatitis B vaccines. Vavricka Dec. at ¶ 3. Nor does Chiron provide instructions or recommendations for hepatitis B vaccines. Id. at ¶ 4.

Classen argues that Chiron licenses hepatitis B vaccines; thus it stated a claim against Chiron in its general allegation that "Defendants Biogen, Chiron, GlazoSmithKline, Merck, and Kaiser-Permanente collectively license, manufacture, use, market, distribute and sell vaccines for human use." Am. Compl. at ¶ 6. Chiron counters that this general allegation does not comply with Federal Rule of Civil Procedure 8(a)(2).

Rule 8(a)(2) requires that pleadings provide "a short and plain statement of the claim showing that the pleader is entitled to relief."

This requirement is by no means onerous; instead, it is designed to ensure that the complaint will give the defendant fair notice of what the plaintiff's claim is and the grounds upon which it rests. The liberal notice pleading of Rule 8(a) is the starting point of a simplified pleading system, which was adopted to focus litigation on the merits of a claim. Under this pleading system, a plaintiff must only set forth facts sufficient to allege each element of his claim.

Slade v. Hampton Roads Reg'l Jail, 407 F.3d 243, 251 (4th Cir.2005) (internal citations omitted). Classen's general allegation fails to delineate the particular acts of infringement attributable to each Defendant; thus it does not provide facts sufficient to inform Chiron of the basis for Classen's claims. See Appalachian Enterprises, Inc. v. Epayment Solutions Ltd., 2004 WL 2813121, *6, 2004 U.S. Dist. LEXIS 24657, *21 (S.D.N.Y.2004) (A plaintiff does not satisfy Rule 8 when the complaint "lump[s] all the defendants together and fail[s] to distinguish their conduct because such allegations fail to give adequate notice to the defendants as to what they did wrong."). Accordingly, Chiron's motion to dismiss will be granted.

Classen alleges that GSK and Biogen violated its patents when they:

participated in, facilitated and/or otherwise conducted a study believed to have begun in the late 1990's and continuing through 2001, to evaluate suggested associations between childhood vaccinations, particularly against hepatitis B and Haemophilus influenza ... type b, and risk of developing type 1 diabetes; and to determine whether timing of vaccination influences risk.

Am. Compl. at ¶ 7. Classen claims that the Defendants "collectively[] publish, encourage, recommend and administer the vaccines according to a protocol which is believed to minimize the risk of incidence in chronic immune mediated disorders." Id. at ¶ 6.

35 U.S.C. § 271(a)provides that "whoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States or imports into the United States any patented invention during the term of the patent therefor, infringes the patent." Section 271(e)(1) provides an exemption to this general rule, which provides:

It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention (other than a new animal drug or veterinary biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Act of March 4, 1913) which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques) solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.

GSK and Biogen have moved to dismiss Counts I, II, and IV of the Complaint (the '139, '739, and '283 patent claims) because their alleged acts of infringement fall within the § 271(e)(1) exemption. Specifically, the Food and Drug Administration ("FDA") collects vaccine data from vaccine manufacturers after their vaccines have been approved. See, e.g., 21 C.F.R. § 601.70 (2005) (requiring annual progress reports of postmarketing studies); 21 C.F.R. § 600.80 (requiring reports of postmarketing adverse reactions to vaccinations). As the Defendants' alleged acts of infringement involve examining risks associated with various vaccination schedules, GSK and Biogen assert that their actions are reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs. Classen argues that the § 271(e)(1) exemption applies only to drugs which have not yet been approved by the FDA, not to post approval activities associated with a drug that is already on the market.

In Merck KGaA v, Integra Lifesciences I, Ltd.,¹ however, the Supreme Court held that § 271(e)(1) "provides a wide berth for the use of patented drugs in activities related to the federal regulatory process." Section 271(e)(1)'s exemption "extends to all uses of patented inventions that are reasonably related to the development and submission of any information under the [Federal Food, Drug, and Cosmetic Act]." Id. (emphasis in original).² Because their alleged participation in a study evaluating risks associated with various vaccination schedules was reasonably related to the development and submission of information required under the Federal Food, Drug, and Cosmetic Act, GSK and Biogen's motion to dismiss Counts I, II, and IV will be granted.

B. Kaiser Defendants' Motion for Sanctions

Classen alleges that "Kaiser-Permanente infringes [its patents] through the administration of vaccines...