Court Rules in Favor of FDA, Mylan in Case Involving Generic Precedex

September 12, 2014

A federal judge has affirmed the FDA’s decision to approve generic versions of Hospira’s sedative Precedex under a pathway that allows manufacturers Mylan and Par to proceed with generics that “carve out” the brand firm’s method-of-use patent in the drug’s labeling.

The agency’s use of the pathway — known as a section viii statement — to approve generic Precedex (dexmedetomidine HCl Injection) was not arbitrary or capricious, but instead was based on a reasonable and sound interpretation of the relevant statute, the Maryland federal judge said in a Sept. 5 summary judgment. The judge also lifted a temporary restraining order that had blocked sales of generic Precedex in the suit brought by Hospira last month against the FDA and the two generics firms.

Mylan said Sept. 8 that it is now free to immediately resume distribution of its generic Precedex. Hospira appealed the ruling and sought an emergency injunction to stop the generic product. But the court on Sept. 8 rejected that motion.

The issue centers on Hospira’s method-of-use patent No. ’867, which covers Precedex’s use in intensive care units (ICUs). That patent expires Oct. 1, 2019, according to court documents.  Mylan and other defendants had claimed that because their ANDAs specifically exclude the use of the drug in ICUs, it adhered to rules governing the section viii carve-out pathway. The FDA agreed when it approved Mylan’s ANDA on Aug. 18 under this method.

In its lawsuit, Hospira countered that the ’867 patent overlaps with its approved uses in the ICU, and before and during surgery.

But the judge rejected Hospira’s arguments. There simply is no overlap between the ANDA’s carved-out labels and Precedex’s use code, the ruling said of the patent in question. The judge also said the FDA has consistently determined that it can approve section viii ANDAs for broad, general indications that may partially overlap with a protected method of use, so long as any express references to the protected use are omitted from the labeling.

The court has tentatively scheduled Oct. 27 to hear oral arguments on the appeal. The drug generated $156.2 million in sales in the 12 months that ended June 30, according to IMS Health data. Hospira already has an agreement with Sandoz allowing for a generic launch in December. — Neal Learner

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.