Biovail Continues to Fight FDA, Anchen, Impax, and Teva to Protect Wellbutrin XL

by David S. Harper



Last August, the U.S. District Court for the Central District of California granted summary judgment of noninfringment to Anchen Pharmaceuticals in its case against Biovail (BVF) over generic Wellbutrin XL. Biovail appealed to the Federal Circuit but in the meantime, on December 15, 2006, the FDA granted final approval to Anchen's ANDA for Wellbutrin XL (bupropion HCl), 150 mg and 300 mg. Shortly thereafter, Anchen selectively waived its 180 day exclusivity period for the 300 mg version in favor of Impax Labs (ILR.F), who, in partnership with Teva Pharmaceutical Industries (TEVA), launched its generic Wellbutrin XL drug product. Wellbutrin XL is an extended release version of Wellbutrin, the popular antidepressant manufactured by Biovail for GlaxoSmithKline (GSK), and had over $1 billion in sales last year.

In response to the Impax approval and launch, on December 16, 2006, Biovail filed a complaint against the FDA in the district of Maryland, seeking declaratory and injunctive relief. Specifically, Biovail asserted that it timely filed a patent infringement suit against Impax and therefore was entitled to a 30 month stay prior to FDA approval of Impax's ANDA. FDA answered Biovail's complaint by asserting that Biovail failed to timely file an infringement action on Wellbutrin XL, 300 mg (although it did timely file an infringement action for the 150 mg version). The case is currently pending.

Furthermore, Biovail has a suit pending against the FDA in the U.S. District Court for the District of Columbia, in which it requested the court to compel FDA action on Biovail's citizen petition prior to approval of generic Wellbutrin XL. On September 6, 2006, the Court denied Biovail's motion for a temporary restraining order requiring FDA to rule on the citizen petition at least one week prior to approving a generic drug.

Undeterred, Biovail filed a second motion for a temporary restraining order on December 18, 2006, concurrently with its suit filed in the Maryland district court. In this second motion, Biovail sought an order enjoining the FDA from approving any ANDAs for generic Wellbutrin XL, and to stay the effectiveness of prior approvals, focusing its attention on the Anchen ANDA approval and the concurrent FDA denial of Biovail's citizen petition. The FDA filed an opposition to Biovail's motion, as did Anchen and Impax/Teva, and Biovail has filed a reply.

Biovail's arguments center on its assertion that the FDA has wrongfully approved generic Wellbutrin XL with a label that falsely and misleadingly implies that the generic product was tested for risk of seizures, while the FDA and intervenors assert that Biovail motion is an attempt to inappropriately extend its monopoly on Wellbutrin XL. It does not appear that the case will be resolved soon.


(This article was published by BioHealth Investor with permission of OrangeBookBlog.com)


RELATED READING:
- Dec. 18 Impax press release
- Dec. 15 Anchen press release
- Aug. 24 OBB post on Biovail's citizen petition
- May 21 OBB post on Wellbutrin SR antitrust suit
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