Classen Immunotherapies, Inc. v. Shionogi, Inc.

Because there is no pre/post FDA approval dichotomy under the safe-harbor provision, plaintiffs motion to dismiss under Rule 12(b)(6) was granted.

Spring 2014

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

Case Name: Classen Immunotherapies, Inc. v. Shionogi, Inc., Civ. No. 13-921-RWT, 2014 U.S. Dist. LEXIS 10642 (D. Md. Jan. 29, 2014) (Titus, J.)

Drug Product and Patent(s)-in-Suit: Computer algorithm and method of product safety; U.S. Patents Nos. 7,984,069 (“the ’069 patent”) and 7,653,639 (“the ’639 patent”)

Nature of the Case and Issue(s) Presented: The issue presented was whether Classen filed a complaint with sufficient factual allegations to survive a motion to dismiss for failure to state a claim under Fed. R. Civ. P. 12(b)(6). Classen is the assignee of the ’069  and ’639 patents. The two patents claim methods for generating, organizing, and commercializing “adverse event” information associated with a product or device. They describe a database management methodology for evaluating the efficacy of a therapeutic method and identifying its associated side effects. Classen filed its complaint against defendants Shionogi and Merz Pharmaceuticals, LLC on March 27, 2013. On May 31, 2013, defendants filed a motion to dismiss for failure to state a claim upon which relief could be based. The court found in favor of defendants.

Why Shionogi Prevailed:  Shionogi based its motion to dismiss on the safe-harbor provision of 35 U.S.C. § 271(e)(1). Previous district court decisions had determined that the § 271(e)(1) safe-harbor provision constitutes an affirmative defense. But the court noted that despite the general rule that an affirmative defense may not serve as a basis for dismissal under Rule 12(b)(6), the court may consider affirmative defenses on a motion to dismiss where they are clear from the face of the complaint. The court concluded that Classen’s complaint clearly implicated the safe harbor provision of § 271(e)(1), as it asserted that defendants infringed the ’069 and ’639 patents by improperly commercializing information required to be disclosed pursuant to the federal pharmaceutical regulatory process described in § 271(e)(1). Accordingly, the court concluded that analysis under Rule 12(b)(6) was appropriate.

The court next addressed the function of the safe-harbor provision, which was enacted to shield drug manufacturers from patent-infringement liability for using patented inventions in activities that are reasonably related to the development and submission of information pursuant to the federal regulation of pharmaceuticals. Activities carried out to satisfy FDA requirements fall within the safe harbor. According to the court, the key inquiry for safe-harbor purposes is whether the defendant's actions were carried out to satisfy the FDA’s requirements. Because the text of § 271(e)(1) is not restricted to pre-approval activities, § 271(e)(1) also applies to post-FDA approval activities falling within its scope.

In light of the safe-harbor provision, Classen’s claims of infringement were clearly foreclosed. The processes disclosed in the ’069 and ’639 patents were inherently tied to a regulatory-approval process, as they required that the “novel essential adverse event” described in each patent be “one regulated by a regulatory agency requiring disclosure of the event in a package insert or data sheet accompanying the product or device.” Classen argued that its infringement allegations were not barred by the safe-harbor provision because the patents included claims that were commercialization steps which were not used to develop or submit information to the FDA. This argument was based on the theory that the safe harbor expires after FDA approval is obtained. The court disagreed, finding that recent case law indicated that there is no pre/post FDA approval dichotomy under the safe-harbor provision.

The court went on to address several additional shortcomings related to the sufficiency of Classen’s allegations. First, the claims of the asserted patents required steps that occurred prior to the issuance of the patents in suit. In order to overcome this defect, Classen relied on intervening rights under § 154(d). The court concluded that the statutory language of each section did not support Classen’s argument: § 271 applies to actions taken “during the term of the patent,” while § 154(d) applies to actions “during the period beginning on the date of publication of the application…and ending on the date the patent is issued.” Classen failed to cite to any case law supporting its novel argument that the two sections could be combined in order to create a cause of action for infringement. Secondly, the court found that Classen’s infringement allegations failed under § 154(d) because the published ’069 and ’639 patent applications were not substantially identical to the patents that ultimately issued. When a published patent application’s claims are amended such that their scope is changed, the patent is no longer “substantially identical” to its application. Both the ’069 and ’639 patents underwent enough changes from application to issuance that § 154(d) no longer applied. Finally, the court found that the allegations directed toward co-defendant Merz Pharmaceuticals, LLC had to be dismissed because Merz was alleged to have committed only one step of the patented process: Merz was accused of activities related to “commercialization.” Thus, Classen failed to allege that Merz had undertaken all of the steps required to infringe its patented methods.

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