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 over generic Wellbutrin XL. Biovail has 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. Having obtained final approval, Anchen could have launched at risk, but it chose not to. Instead, Anchen selectively waived its 180-day exclusivity period for the 300 mg product in favor of Impax, who, in partnership with Teva (being deep-pocketed and less risk-averse) launched its own generic Wellbutrin XL, 300 mg. Wellbutrin XL is an extended release version of Wellbutrin, the popular antidepressant manufactured by Biovail for GlaxoSmithKline, and had over $1 billion in sales last year.
In response to the Impax approval and launch, on December 18, 2006, Biovail filed a complaint against the FDA in the U.S. District Court for the District of Maryland, asserting that it was entitled to a 30-month stay prior to FDA approval of Impax's ANDA. At the same time, Biovail filed a motion for temporary relief. The FDA opposed Biovail's motion, asserting that while Biovail timely filed an infringement action against Impax on Wellbutrin XL, 150 mg, Biovail failed to timely amend its complaint to include an infringement count with respect to the 300 mg dosage form. Teva intevened, filing its own opposition brief. On December 21, 2006, the court denied Biovail's motion, thereby allowing Teva/Impax to continue marketing its generic product. Patent owners must file suit within 45 days of receiving notice of a paragraph IV certification, and it appears that Biovail's delay in this case may have been costly.
Biovail also has a suit pending against the FDA in the U.S. District Court for the District of Columbia. In that case, on December 18, 2006, Biovail filed a motion seeking to enjoin the FDA from approving any ANDAs for generic Wellbutrin XL and to stay the effectiveness of prior approvals, focusing its attention on the Anchen approval and the December 14, 2006, FDA denial of a Biovail citizen petition concerning Wellbutrin XL. The FDA has filed an opposition to Biovail's motion, as have Anchen and Teva/Impax (as intervenors), and Biovail has filed a reply. Biovail's arguments center on its assertion that the FDA 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's motion is an attempt to inappropriately extend its monopoly on Wellbutrin XL. The court has not yet decided Biovail's motion.
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