Hatch-Waxman safe harbor expansion continues

In a January 28 decision, the District Court of Maryland dismissed a patent infringement suit for failure to state a claim because the accused conduct was immune under the Hatch-Waxman safe harbor. Even though the accused product had received FDA approval and had been commercialized, the safe harbor still applied. Moreover, the court recognized that the safe harbor defense could be raised at the "to dismiss" stage. Thus, patent owners and potential infringers should recognize the enlarged scope of safe harbor and that challenges to a complaint may be raised at the onset of a litigation.

In Classen Immunotherapies, Inc. v. Shionogi, Inc., __ F. Supp. 2d __, 2014 WL 323941 (D. Md. 2014), the Maryland District Court dismissed Classen's action under Fed. R. Civ. P. 12(b)(6) because the accused conduct was protected by the Hatch-Waxman safe harbor, 35 U.S.C. 271(e)(1). The decision highlights the use of 271(e)(1) to dispose of infringement actions at their inception. In addition, the Maryland court, following the Federal Circuit's holding in Momenta Pharm., Inc. v. Amphastar Pharm., Inc., 686 F.3d 1348 (Fed. Cir. 2012), explicitly held that the safe harbor was not limited to pre-FDA approval conduct and implicitly held that it covered so-called "research tools." As to the latter, the court rejected the argument that only patents that could be extended under 156 were subject to the 271(e)(1) safe harbor. Since research tool patents did not meet this "test," some courts had held that 271(e)(1) did not apply to such patents.

Classen asserted that defendants infringed two patents that covered multistep processes that access and analyze adverse event data associated with a product or a device and identify at least one new adverse event associated with the product or device. The claims defined the adverse event as one regulated by a regulatory agency requiring disclosure of the event in a package insert or data sheet. One claim covered the step of identifying a previously unreported method of use of a product or device associated with an essential adverse event and determining the inventors of the discovery. Lastly, both patents covered the creation of a database of essential adverse event information and the commercialization of the unreported method or adverse event information.

The Central District of California had previously described the patents as follows:

The 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 its associated side effects.

Classen Immunotherapies, Inc. v. Somaxon Pharmaceuticals, No. 2:12-cv-06643-GAF-PLA, Dkt. No. 43 at *1 (C.D. Cal, April 11, 2013), aff'd per curiam without opinion, No. 2013-1405, 2014 WL 185171 (Fed. Cir. 2014).

Classen alleged that defendants infringed the patents by commercializing information relating to glycopyrrolate, which is used to treat ulcers and marketed by Classen as Robinul®. Using the patented method, defendants had determined a food-related effect of giving the drug, which is an adverse event regulated by the FDA.

The Complaint was dismissed under Fed. R. Civ. P. 12(b), with the court noting that the 271(e)(1) defense could properly be considered at the "to dismiss stage," even though the general rule is that an affirmation defense may not serve as a basis for dismissal under the rule.

First, the court, citing the Federal Circuit's decision in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., 686 F.3d 1348 (Fed. Cir. 2012), held that the term "invention" in 271(e)(1)'s "patented invention" covers "all" inventions. The court noted the importance of symmetry between 271(e)(1) and 156, but held that symmetry was "not required," citing Abtox, Inc. v. Exitron Corp., 122 F.3d 1019, 1029 (Fed. Cir. 1997). Accordingly, without mentioning the term "research tool," the court implicitly held that research tool patents - which cannot be extended under 156 - are subject to the 271(e)(1) safe harbor.

The court also held, again citing Momenta, that 271(e)(1) was not limited to pre-approval activities. Rather, the key inquiry in this case was whether defendants' actions were reasonably related to obtaining information regarding FDA requirements.

In its analysis, the court noted that generating data for submission to the FDA in a Citizen Petition for a labeling supplement or creating a label disclosing adverse events is reasonably related to obtaining FDA approval. Thus, the identification of a food-related adverse event is protected by 271(e)(1). As such, any activity conducted to alter or modify a label would seemingly be protected.

Lastly, Classen argued that even if the research were protected, the use of the data or information during commercialization of the drug was infringement. The court relied on the Momenta decision to hold that this post-approval conduct was protected.

The case represents yet another instance where the 271(e)(1) safe harbor was applied to immunize commercial activity long after the pharmaceutical was approved and marketed. It also alerts defendants (and plaintiffs) to the use of 271(e)(1) at the "to dismiss stage."

Read more about Research Tools and the Hatch-Waxman Safe Harbor that I wrote for Biotechnology Law Report