Upsher-Smith Secures Summary Judgment Noninfringement Ruling on Testim Patents

In a big win for generic drug company Upsher-Smith Laboratories Inc., a Delaware federal judge Dec. 4 ruled that Upsher-Smith’s application to make a testosterone gel product didn’t infringe any patents covering Auxilium Pharmaceuticals Inc.’s low testosterone treatment Testim (1 percent testosterone gel) (Auxilium Pharm., Inc. v. Upsher-Smith Labs, Inc., D. Del., No. 1:13-cv-00148-SLR, 12/4/13).

Awarding summary judgment to Upsher-Smith, Judge Sue L. Robinson of the U.S. District Court for the District of Delaware said that the company’s proposed testosterone gel product didn’t infringe any of the 10 patents asserted in the case.

The Food and Drug Administration tentatively approved Upsher-Smith’s 505(b)(2) application for its testosterone gel product in August, while the court’s decision was pending. Section 505(b)(2) of the Federal Food Drug and Cosmetic Act expressly permits the FDA to rely, for approval of a new drug application, on ‘‘data not developed by the applicant’’—such as published literature or the agency’s finding of safety and/or effectiveness of a previously approved drug product.

Testim (transdermal testosterone gel) is used to treat hypogonadism in men, which occurs when the body doesn’t make enough testosterone.

Potential Launch? In a Dec. 4 press release announcing the summary judgment decision, Auxilium said the granting of the summary judgment motion means that ‘‘the FDA may now make the approval final, at which time USL [Upsher-Smith] will be permitted to launch its testosterone gel product.’’

‘‘We are very disappointed with the Court’s decision,’’ Adrian Adams, chief executive officer and president of Auxilium said. ‘‘We remain committed to protecting and enforcing our intellectual property rights, and we are currently considering all avenues, including an appeal.’’

Auxilium, which is based in Chesterbrook, Pa., initially sued Upsher-Smith Laboratories, which is based in Maple Grove, Minn., for patent infringement in January 2013 (11 PLIR 134, 2/1/13). The parties agreed that Upsher-Smith’s product didn’t infringe the asserted patents directly, but Auxilium argued that Upsher-Smith’s product infringed the patents under the doctrine of equivalents.

No Equivalent Infringement Found. Under the doctrine of equivalents, a patent owner may charge a defendant with infringement for making, using or selling a device that is similar but not identical to the claimed device.

Robinson said that the doctrine of equivalents was inapposite in this case. ‘‘Plaintiffs cannot now use the doctrine of equivalents to reach beyond what is claimed and described in the patents-in-suit,’’ she said.

Auxilium had argued that ‘‘their narrow claims directed to specific cyclic enhancers nevertheless should cover defendant’s formulation,’’ but Robinson said the patent prosecution history told a different story.

‘‘The claims of the patents-in-suit focus narrowly on one or a subset of five cyclic Hsieh enhancers,’’ the judge said. She noted that the patent specification describes the family of cyclic Hsieh enhancers—materials capable of increasing the rate of passage of androgen through the skin and body membrane—and recites the cyclic structures.

In contrast, she said, Upsher-Smith’s formulation uses a combination of three straight chain enhancers known as Dudley enhancers.

And, she said, during patent prosecution the patentees specifically discussed the straight chain Dudley enhancers in the specification and differentiated them from the cyclic Hsieh enhancers. During patent prosecution, they argued that their invention wasn’t obvious in light of Dudley enhancers, because of the differences between the types of enhancers and the superiority of their Hsieh enhancer compositions.

‘‘Consequently,’’ Robinson said, ‘‘the Dudley enhancers (and combinations thereof) were foreseeable alternatives to Hsieh enhancers and, given the record at bar, a competitor would reasonably believe that the patentees had surrendered enhancers other than Hsieh enhancers.’’

Thus, she said, Auxilium couldn’t rely on the doctrine of equivalents to argue that the Hsieh enhancers are equivalent to the Dudley enhancers.

Notable Decision. Jake M. Holdreith, of Robins, Kaplan, Miller & Ciresi LLP, in Minneapolis, who represents Upsher-Smith in the case, told Bloomberg BNA Dec. 10 that the decision was ‘‘notable because Judge Robinson who issued the order does not ordinarily hear summary judgment motions in Hatch-Waxman cases (or in any bench trials).’’

Holdreith added that Upsher-Smith’s litigation team was ‘‘highly focused on showing the court from the origin of the case that it was appropriate for summary judgment.’’

‘‘We answered the day after the complaint was filed, produced all of our documents prior to the initial scheduling conference and without a request from the other side, and asked for permission to submit a brief on why the case was an excellent candidate for summary judgment to show the judge that it made sense to depart from her usual practice,’’ he said.

Paul J. Berman, Keith A. Teel, Michael N. Kennedy and Erica N. Andersen, of Covington & Burling LLP, in Washington, and Steven J. Balick, Andrew Colin Mayo and Lauren E. Maguire, of Ashby & Geddes, in Wilmington, Del., represented Auxilium.

Thomas J. Fleming and Howard J. Smith, of Olshan Frome Wolosky LLP, in New York, and John M. Seaman, of Abrams & Bayliss LLP, Wilmington, Del., represented Wilmington, Del.-based co-plaintiff FCB I LLC (FCB).

Holdreith, Lars P. Taavola and Jaime R. Kurtz, of Robins, Kaplan, Miller & Ciresi LLP, in Minneapolis, and Frederick L. Cottrell Ill and Travis S. Hunter, of Richards, Layton & Finger PA, Wilmington, Del., represented Upsher-Smith.

By Dana A. Elfin
To contact the reporter on this story: Dana Elfin in Washington at delfin@bna.com
To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com

Reproduced with permission from Pharmaceutical Law & Industry Report, 11 PLIR 1476 (Dec. 13, 2013). Copyright 2013 by The Bureau of National Affairs, Inc. (800-372-1033) http://www.bna.com.