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Classen Immunotherapies, Inc. v. Shionogi, Inc.

United States District Court, Fourth Circuit

January 28, 2014

SHIONOGI, INC., ET AL., Defendants.



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.


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, 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 ...

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