By Donald Zuhn

On Monday, Canadian pharmaceutical company Biovail (NYSE: BVF) announced that it had reached a comprehensive settlement with Anchen Pharmaceuticals, Impax Laboratories, Teva Pharmaceutical Industries, and Watson Pharmaceuticals with respect to Wellbutrin XL® (bupropion HCl), a once-daily antidepressant which has a low incidence of sexual dysfunction, weight gain, and somnolence, and which is believed to act on norepinephrine and dopamine.

In December 2004, Biovail filed a patent infringement suit in the Central District of California against Anchen Pharmaceuticals, which had filed an abbreviated new drug application (ANDA) for generic 150 mg and 300 mg versions of Wellbutrin XL®.  At that time, Biovail also filed suit in the Southern District of Florida against Abrika Pharmaceuticals, which had filed an ANDA for a generic 150 mg version of Wellbutrin XL®.  Biovail contended that in filing their ANDA’s, Anchen and Abrika had infringed U.S. Patent Nos. 6,143,327 and 6,096,341.  In March 2005, Biovail filed suit in the Eastern District of Pennsylvania against Impax in response to Impax’ submission of an ANDA for generic 150 mg and 300 mg versions of Wellbutrin XL®.

While Biovail noted that certain aspects of the settlement would remain confidential, it did release the following terms of the agreement:

• Biovail’s pending actions against Impax and Watson would be dismissed.

• Biovail had granted an exclusive license to Anchen, Impax, and Teva to market a generic 300 mg version of Wellbutrin XL® from December 13, 2006 until June 13, 2007.

• Anchen, Impax, Teva, and Watson will not market a generic 150 mg version of Wellbutrin XL® until 2008.

• Biovail had granted an exclusive license to Anchen, Impax, and Teva to market a generic 150 mg version of Wellbutrin XL® for 180 days following market entry.

The agreement did not have any impact on Biovail’s infringement action against Abrika, which remains pending.

Additional information regarding this settlement can be found in a release issued by Anchen Pharmaceuticals and a release issued by Impax Laboratories.