Abbott To Assert New Biaxin XL Patent In Ongoing Suits

Abbott is asserting its new pharmacokinetic patent issued for Biaxin XL (clarithromycin extended-release) in ongoing litigation, the company said during its earnings call April 12.

"We're in the process of asserting the new PK patent to the existing litigation where we've already sued these couple of generics for infringement on the existing patents around XL," Abbott VP-Investor Relations John Thomas said.

"We remain very confident that the PK patents that we have, we'll be able to defend XL and if a generic were to attempt to launch at-risk, we think they're betting their company and it would be a very high stakes gamble," Thomas said.

At the SG Cowen health care conference in March, CFO Thomas Freyman maintained the additional intellectual property for the XL formulation will give generic companies "something to think about" (¹ (Also see "Abbott To Bolster Biaxin XL Patent Protection Ahead Of Compound Expiration In May" - Pink Sheet, 15 Mar, 2005.)).

Abbott is currently in litigation with numerous companies over Biaxin patents, including Ranbaxy, Teva, Andrx, Roxane and Genpharm.

Andrx received final ANDA approval for an extended-release clarithromycin formulation in June 2004; the company does not plan to launch its generic before expiration of the compound patent in May (² (Also see "Andrx Receives First Generic Approval For Abbott's Biaxin XL" - Pink Sheet, 25 Jun, 2004.)).

Genpharm and Roxane have ANDA approvals for the immediate-release formulation; Ranbaxy has ANDA approvals for both formulations.

Abbott has been switching patients from Biaxin immediate-release to the extended-release formulation ahead of the compound patent's expiration; 70% of patients use the XL formulation, Abbott said.

- Lee Kalowski