Classen Immunotherapies, Inc. v. Shionogi, Inc.

• Decision Date: 29 January 2014
• Docket Number: Civil Case No. RWT–13–921.
• Citation: 993 F.Supp.2d 569
• Parties: CLASSEN IMMUNOTHERAPIES, INC., Plaintiff, v. SHIONOGI, INC., et al., Defendants.
• Court: U.S. District Court — District of Maryland

993 F.Supp.2d 569

CLASSEN IMMUNOTHERAPIES, INC., Plaintiff,

v.SHIONOGI, INC., et al., Defendants.

Civil Case No. RWT–13–921.

United States District Court,

D. Maryland.

Jan. 29, 2014.

Joseph J. Zito, Zito TLP, Washington, DC, for Plaintiff.

Jonathan Biran, Biran Kelly LLC, Bonnie J. Beavan, Meng–Wei Peggy Chu, Goodell Devries Leech and Dann LLP, One South St. 20th FL, Baltimore, MD, Lisa J. Pirozzolo, Wilmer Cutler Pickering Hale and Dorr, Boston, MA, Tracey Allen, Wilmer Cutler Pickering Hale and Dorr, Washington, DC, David A. Manspeizer, Wilmer Cutler Pickering Hale and Dorr, F. Dominic Cerrito, Gabriel P. Brier, James E. Baker, Quinn Emanuel Urquhart and Sullivan LLP, New York, NY, for Defendants.

MEMORANDUM OPINION

ROGER W. TITUS, District Judge.

Plaintiff Classen Immunotherapies, Inc. (“Classen”) has sued Defendants Shionogi, Inc. (“Shionogi”) and Merz Pharmaceuticals, LLC, (“Merz”) for infringing two of Classen's patents under 35 U.S.C. § 271 and 35 U.S.C. § 154(d). Defendants have moved to dismiss Classen's Complaint for failure to state a claim under Federal Rule of Civil Procedure 12(b)(6). Their motion will, as explained below, be granted.

The fundamental problem for Classen is that the actions of the Defendants complained of took place in a harbor made safe and immune from Classen's attacks by federal law. Moreover, Classen's attacks, even if unprotected by the safe harbor, also miss their mark.

Classen's infringement allegations must be dismissed under 35 U.S.C. § 271(e)(1), a safe harbor provision added by the Hatch–Waxman Act in 1984 that protects the use of patented inventions in activities “reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs.” 35 U.S.C. § 271(e)(1). In addition, Classen's assertions under § 271 must be dismissed because some of the alleged steps of infringement occurred before the patents were issued, and Classen's § 154(d) allegations must be dismissed because Classen's patent applications are not “substantially identical” to its issued patents. Finally, Merz is only alleged to have infringed one step of the patented processes at issue, and the fact that it only recently acquired a drug developed by Shionogi means that Classen's Complaint against this Defendant in particular must also be dismissed.

FACTUAL BACKGROUND¹

I. Patents '069 and '639

Classen asserts that Defendants infringed two of its patents—U.S. Patent No. 7,984,069 (“'069”) and U.S. Patent No. 7,653,639 (“'639”). Compl. ¶¶ 11–12, 15–16, ECF No. 1. The '069 patent application was published June 27, 2002, and the patent was issued July 19, 2011. ECF No. 1–5. The '639 patent application was published August 31, 2006, and the patent was issued January 26, 2010. ECF No. 1–4.

Each patent is titled “Computer Algorithms and Methods for Product Safety,” and the claims ² of each patent are quite similar. ECF Nos. 1–4, 1–5. The ' 069 patent contains two independent claims, the key claim being claim 1, as it is referenced directly or through incorporation by every other claim except for claim 50, the other independent claim. See ECF No. 1–5. The '639 patent has only one independent claim, claim 1. See ECF No. 1–4.

The first claim in each patent covers a multistep process (referred to as a “method” in each patent) that accesses and analyzes “adverse event data associated with [a] product or device” and “identif[ies] at least one [“new” or “previously unreported”] essential adverse event associated with the product or device.” ECF Nos. 1–5 at 18–19, 1–4 at 18. The claims define the essential adverse event as “one regulated by a regulatory agency requiring disclosure of the event in a package insert or data sheet accompanying the product or device.” ECF Nos. 1–5 at 18–19, 1–4 at 18. Claim 1 of the ' 069 patent also includes a step of “identifying at least one previously unreported method of use of the product or device associated with [the] identified essential adverse event” and “documenting inventorship of the” method identified. ECF No. 1–5 at 19.

In addition, both patents incorporate the creation of a “database” of “essential adverse event information” and the “commercializ[ation]” of either the “previously unreported proprietary method of using a product or device” ['069] or “the proprietary essential adverse event information stored” in the database ['639]. ECF Nos. 1–5 at 19, 1–4 at 19. Claim 1 of the '069 patent defines commercialization as “creating profit from ... exclusive disclosure.” ECF No. 1–5 at 19. Claim 1 of the '639 patent does not define commercialization but ties it to the “exclusive disclosure of the newly-identified proprietary essential adverse information which, once identified, must then accompany the product or device.” ECF No. 1–4 at 19.

A federal court in the Central District of California recently examined both of these patents in Classen Immunotherapies, Inc. v. Somaxon Pharmaceuticals, describing them as follows:

These two patents teach methods for generating, organizing, and commercializing ‘adverse event’ information associated with a product or device. Essentially, they describe a database management methodology for evaluating the efficacy of a therapeutic method and identifying its associated side effects.

Somaxon, Civil Case No. 2:12–cv–06643–GAF–PLA, Dkt. No. 43 at *1 (C.D.Cal. Apr. 11, 2013) (citations omitted), aff'd per curiam without opinion, 550 Fed.Appx. 897, No. 2013–1405, 2014 WL 185171 (Fed.Cir. Jan. 17, 2014).

II. Alleged Infringement of Patents '069 and '639

Classen alleges that Shionogi, previously known as Sciele Pharma, Inc. (“Sciele”),³ and Merz infringed both the '639 and the ' 069 patents in violation of 35 U.S.C. §§ 271 and 281 and 35 U.S.C. § 154(d). Compl. ¶¶ 1, 5–6.⁴

According to Classen, Shionogi “manufactures and distributes ... pharmaceutical products,” including Robinul®, Robinul Forte®, and CUVPOSA®, that contain glycopyrrolate, a substance used to treat ulcers. Compl. ¶ 7. Classen alleges that “Sciele determined that the efficacy of glycopyrrolate can be affected by the timing of consumption of food, including the determination that glycopyrrolate should not be given between 1 hour before to 2 hours after a meal, and [it] protected this development through proprietary filings,” including a number of patent applications. Compl. ¶ 8. Classen also asserts that sometime “[o]n or around August 27, 2012, Merz acquired the brand name CUVPOSA® for the liquid form of the glycopyrrolate drug from Shionogi,” and that “CUVPOSA® has been commercially available since July 2010.” Compl. ¶ 10.

A. Patent '069

Classen alleges that both Defendants have infringed the '069 patent “by commercializing information related to glycopyrrolate,” Compl. ¶ 33, presumably in reference to the food effect disclosure. In particular, Defendants allegedly infringed the patented method of the '069 patent and “identif[ied] a food related, previously unreported essential adverse event associated with glycopyrrolate that is regulated by the FDA, and requires disclosure accompanying glycopyrrolate.” Compl. ¶ 16. Shionogi supposedly “developed a dosage requirement for glycopyrrolate[,] ... documented inventorship of the new dosage[,] and established a patent application and publication related to [the] new restricted use dosage.” Compl. ¶ 16. The “new dosage requirement” was “commercialized” through “the requirement for the information[ ] to mandatorily accompany glycopyrrolate,” Shionogi's efforts to obtain patent rights and sell “glycopyrrolate with labeling,” and its “sale [of] the patent protected brand to Merz.” Compl. ¶ 16. Classen asserts that Merz in particular “commercializes by continuing to seek ... patent rights through continued pending patent applications, through maintaining and enforcingits patent rights [,] and through the sales of glycopyrrolate.” Compl. ¶ 17.

B. Patent '639

Classen alleges that both Defendants have infringed the '639 patent “by commercializing information related to glycopyrrolate,” Compl. ¶ 23, apparently referring to the impact of food consumption on the use of glycopyrrolate. In particular, Shionogi allegedly “accessed at least one adverse event data source[,] analyzed the adverse event data[,] and identified a food related adverse event associated with glycopyrrolate [that is] regulated by the FDA” and required to be disclosed “in a package insert or data sheet accompanying glycopyrrolate.” Compl. ¶ 12. Classen claims that Shionogi “commercialized the proprietary information by obtaining patent protection and advocating the requirement of disclosure of the information accompanying glycopyrrolate.” Compl. ¶ 12. Shionogi also allegedly “continued to commercialize through the ... sales of glycopyrrolate with labeling ... and the sale of the patent protected brand to Merz.” Compl. ¶ 12. According to Classen, the act of selling glycopyrrolate products “with labeling [that] notifies the user of the food effect adverse event” infringes the '639 patent. See Compl. ¶ 13.

III. Procedural History

Plaintiff Classen filed its initial Complaint against Defendants Shionogi and Merz in this Court on March 27, 2013. ECF No. 1. On May 31, 2013, Defendants filed a Motion to Dismiss for failure to state a claim pursuant to Federal Rule of Civil Procedure 12(b)(6). ECF No. 19. Plaintiff filed an Opposition on June 17, 2013, ECF No. 23, and Defendants filed a Reply on July 3, 2013, ECF No. 24. This Court held a hearing on Defendants' motion on November 1, 2013.

STANDARD OF REVIEW

A motion to dismiss pursuant to Federal Rule of Civil Procedure 12(b)(6) tests the sufficiency of the complaint. Edwards v. City of Goldsboro, 178 F.3d 231, 243–44 (4th Cir.1999). A court must consider all well-pleaded allegations in a complaint as true, see Albright v. Oliver, 510 U.S. 266, 268, 114 S.Ct. 807, 127 L.Ed.2d 114 (1994), and must construe factual allegations “in the light most favorable to the...