Bloomberg BNA's Pharmaceutical Law & Industry Report helps you stay informed of regulatory and litigation developments affecting the pharmaceutical and biotech industries....
Sept. 28 — Elan Pharmaceuticals Inc. isn't subject to charges that it infringed a Classen Immunotherapies Inc. patent in submitting study data on its Skelaxin muscle relaxant ( Classen Immunotherapies, Inc. v. Elan Pharms., Inc. , 2016 BL 318007, D. Md., No. 1:04-cv-03521-RDB, 9/27/16 ).
The U.S. District Court for the District of Maryland ruled Sept. 27 that Elan's provision of information on the safety and efficacy of the underlying drug, metaxalone, to the Food and Drug Administration falls within the “safe harbor” of the Hatch-Waxman Act.
The safe harbor is important to companies on both sides of patent litigation because it can exempt from liability infringing activity that's “reasonably related to the development and submission of information” to the FDA.
Brand and generic manufacturers have been battling over the limits of the safe harbor provision for the past eight years, resulting in arguably conflicting decisions by the U.S. Court of Appeals for the Federal Circuit, particularly regarding activities conducted after FDA approval.
Classen's 12-year-old case is likely ended with the decision, as the Federal Circuit, in effect, guided the district court to this conclusion.Source Material:
Fed. Cir. decision: 786 F.3d 892 (May 13, 2016)
U.S. Patent:No. 6,584,472
The Hatch-Waxman safe harbor provision in question, 35 U.S.C. §271(e)(1) , provides an exception for otherwise infringing acts, usually by generic makers. But under Federal Circuit law, it can extend to brand name makers as well.
Here, the FDA approved Elan's new drug application (NDA) for Skelaxin in 2001. Responding to a third party's data, though, the FDA sought Elan's feedback on a proposal to change the drug label. Elan conducted a clinical trial to characterize the effect of food on the absorption of metaxalone and submitted that information to the FDA to revise Skelaxin's product label and to propose changes to the approval requirements for generic versions of the drug.
Classen asserted U.S. Patent No. 6,584,472 , alleging infringement by the study, the information that would be on the label and Elan's activities related to filing for new patents in light of what it learned in the study.
In 2012, the district court granted summary judgment in favor of Elan under the safe harbor, not reaching decisions on infringement or validity. The Federal Circuit affirmed and remanded only because the original district court opinion didn't say enough about whether some of Elan's activities met the “reasonably related” characterization. Classen Immunotherapies v. Elan Pharms., Inc., 786 F.3d 892, 114 U.S.P.Q.2d 1920 (Fed. Cir. 2015) (13 PLIR 731, 5/22/15).
On remand, Judge Richard D. Bennett quoted extensively from “observations of the record” in the Federal Circuit's opinion that detailed how it expected the district court to assess those other activities.
Classen argued that “reanalyzing the clinical data to identify patentable information and filing patent applications” is aimed at commercialization and so is outside of the safe harbor. But Bennett simply restated the appeals court's caution that filing patent applications is not a commercial event.
He also rejected Classen's contention that a revised Skelaxin label was integral to making and selling the product. Bennett said that the safe harbor can apply to the disclosure and use of clinical study results “even for purposes other than regulatory approval.” Elan's use of the data here was far less “commercial” in nature than prior cases that have invoked the safe harbor, he said.
The judge further said that even if Classen's claims weren't barred as a matter of law, it still hadn't raised a genuine issue of material fact regarding infringement.
“Here, with discovery long complete and this case having worn on for nearly twelve years, Classen has produced no evidence of Elan’s alleged reanalysis of the data for commercial purposes so as to raise a genuine issue of material fact regarding Elan’s infringement,” Bennett said.
Elan is now part of Dublin-based Perrigo Co. plc. Bloomberg BNA contacted Perrigo's U.S. subsidiary, Allegan, Mich.-based Perrigo Co., Sept. 28, but the company declined to comment on the ruling. Bloomberg BNA also contacted Baltimore-based Classen but no one was available to comment.
DNL Zito, Washington, represented Classen. Finnegan, Henderson, Farabow, Garrett & Dunner LLP, Washington, represented Elan.
To contact the editor responsible for this story: Mike Wilczek at email@example.com
Text of the decision is at http://src.bna.com/iX9.
Copyright © 2016 The Bureau of National Affairs, Inc. All Rights Reserved.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to firstname.lastname@example.org.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to email@example.com.
Put me on standing order
Notify me when new releases are available (no standing order will be created)