IP Law Daily, PATENT—D. Md.: Hatch-Waxman safe harbor protected drug makers’ labels disclosing adverse effects of ulcer treatment drug, (Jan 30, 2014)

By Cheryl Beise, J.D.

The Hatch-Waxman Act safe harbor barred Classen Immunotherapies’ suit against two pharmaceutical companies that allegedly infringed Classen’s patented methods for disclosing treatment-related adverse effects, the federal district court in Greenbelt, Maryland has ruled (Classen Immunotherapies, Inc. v. Shionogi, Inc., January 28, 2014, Titus, T.). Even without the safe harbor bar, Classen’s infringement claims fell short, according to the court.

Classen Immunotherapies, Inc. sued Shionogi, Inc. and Merz Pharmaceuticals, LLC, for infringing two of Classen’s patents under 35 U.S.C. § 271 and 35 U.S.C. § 154(d). U.S. Patent No. 7,653,639 (the '639 patent) was issued January 26, 2010 and U.S. Patent No. 7,984,069 (the '069 patent) was issued July 19, 2011. Both patents were entitled “Computer Algorithms and Methods for Product Safety” and claimed methods for generating, organizing, and commercializing “adverse event” information associated with a product or device. Essentially, they described a database management methodology for evaluating the efficacy of a therapeutic method and identifying its associated side effects.

Shionogi’s manufactured drug products (Robinul®, Robinul Forte®, and CUVPOSA®) that contained glycopyrrolate, a substance used to treat ulcers. In August 2012, Merz acquired the brand name CUVPOSA® for the liquid form of the glycopyrrolate drug from Shionogi.

Classen alleged that the defendants infringed the patents “by commercializing information related to glycopyrrolate,” in reference to food effects disclosures and the impact of food consumption on the use of glycopyrrolate. According to Classen, the act of selling glycopyrrolate products “with labeling [that] notifies the user of the food effect adverse event” constituted infringement.

Shionogi and Merz moved to dismiss Classen’s complaint under Federal Rule of Civil Procedure 12(b)(6). The court granted the motion.

Hatch-Waxman safe harbor. The court first held that the defendants’ activities were protected under the Hatch-Waxman Act safe harbor, 35 U.S.C. § 271(e)(1). Section 271(e)(1) provides that “[i]t shall not be an act of infringement to … use … a patented invention … 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 …”

Classen’s infringement allegations clearly implicated the safe harbor provision, according to the court. The processes embraced by the '069 and'639 patents were “inherently tied to a federal regulatory approval process” as described in § 271(e)(1) because they expressly 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.” Moreover, both patents purportedly were infringed when Shionogi performed the steps of each patent, including the step of “identif[ying] a food related…adverse event associated with glycopyrrolate that is regulated by the FDA, and requires disclosure accompanying glycopyrrolate.”

In April 2013, the Central District of California dismissed Classen’s accusations that a drug maker had infringed the same two patents at issue in this case, holding that “data…collected and eventually used to create…patented labels was generated as part of the FDA approval process and therefore falls within the purview of the safe harbor.” Classen Immunotherapies, Inc. v. Somaxon Pharmaceuticals, Civil Case No. 2:12-cv-06643-GAF-PLA, (C.D. Cal. 2013). The decision was affirmed without opinion by the Court of Appeals for the Federal Circuit on January 17, 2014. The Somaxon court’s reasoning was equally applicable to the facts of this case, in the court’s view.

Classen argued that its patent infringement allegations were not barred by § 271(e)(1) because its patents included claims for “commercialization steps which are not used to develop or submit information to the FDA.” Classen contended that the safe harbor protection expires after FDA approval is obtained. Classen cited Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011) for the proposition that the safe harbor “’does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained.’”

However, the Federal Circuit later clarified that there is no pre/post FDA approval dichotomy under the safe harbor provision, the court observed. Momenta Pharm., Inc. v. Amphastar Pharm., Inc., 686 F.3d 1348, 1354 (Fed. Cir. 2012). According to the Federal Circuit, the key inquiry for safe harbor purposes is whether the defendant’s actions were carried out to satisfy the FDA’s requirements. Moreover, to extent that there is any tension between Biogen and Momenta, Momenta as the later decision is controlling, the court noted.

Shionogi’s actions were according protected by the § 271(e)(1) safe harbor, the court concluded.

Infringement under § 271. The court additionally held that Classen’s allegations under § 271 had to dismissed because not all of the alleged steps of infringement transpired after the issuance of Classen’s patents.

The Federal Circuit has held that when a “method” or “process” patent like the '069 or '639 patents is at issue, each of the steps of the patented method must occur post-patent issuance for infringement under § 271 to occur. Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352 (Fed. Cir. 2007).

Classen conceded that Shionogi performed some steps of the method before issuance and some steps after issuance, but nevertheless argued that it should be able to combine pre-issuance activities addressed in § 154(d) and post-issuance activities addressed in § 271 into a single cause of action that would cover pre- and post-patent issuance activities. The court rejected Classen’s argument, noting the absence of any authority supporting the proposition that the two sections could be combined “to create a super cause of action,” the court observed.

Infringement under § 154(d). Classen’s § 154(d) allegations of infringement also missed the mark because the published applications for the '069 and '639 patents were not “substantially identical” to the patents that ultimately issued.

An actionable claim of infringement under § 154(d) requires that (1) the alleged infringer had “actual notice of the published patent application” and (2) the “invention as claimed in the patent” is “substantially identical to the invention as claimed in the published patent application.”

Both the '069 and the '639 patents underwent enough changes from application to issuance that § 154(d) did not apply, the court determined. For example, the applications for both patents lacked language tying the patented process to a regulatory process. The limitations were added later to overcome PTO rejections.

Allegations against Merz. Lastly, the court held that Classen failed to state a claim against Merz because Merz did not commit the necessary steps required to find it liable under § 154(d) or § 271.

Classen’s pre-issuance claims under § 154(d) failed because Merz was only accused of activities related to “commercialization” and Merz did not acquire the brand name CUVPOSA® for the liquid form of the glycopyrrolate drug until 2012, after the patents-in-suit issued. Merz also was not liable for infringement under § 271 because Classen conceded that certain steps of its patents were necessarily infringed pre-patent issuance.

The court concluded that § 271(e)(1) safe harbor fully shielded the defendants from Classen’s claims, and, even if it had not, the claims fell “far wide of the mark.”

The case is No. RWT-13-921.

Attorneys: Joseph J. Zito (Zito TLP) for Classen Immunotherapies, Inc. Jonathan Biran (Biran Kelly LLC) for Shionogi, Inc. Bonnie J Beavan (Goodell DeVries Leech and Dann LLP) for Merz Pharmaceuticals, LLC.

Companies: Classen Immunotherapies, Inc.; Shionogi, Inc.; Merz Pharmaceuticals, LLC

Cases: Patent MarylandNews