The settlement grants Alcon the right to introduce its brimonidine 0.15% product on Sept. 30, 2009, or earlier if "certain market conditions" are met.
Fort Worth, TX-Alcon Laboratories Inc. and Allergan Inc. have agreed to split exclusivity rights for brimonidine tartrate 0.15% ophthalmic solution for the reduction of IOP in patients with open-angle glaucoma and ocular hypertension-an agreement that settles two patent lawsuits initiated by Allergan.
The settlement, announced March 9 in prepared statements from both companies, grants Alcon a co-exclusive license with Allergan, giving Alcon the right to introduce its brimonidine 0.15% product on Sept. 30, 2009, or earlier if "certain market conditions" are met. The companies said the "primary trigger" would be the extent to which prescriptions of Allergan's product have been converted to Allergan's other brimonidine-containing products. Alcon said it will also pay royalties to Allergan on U.S. sales of the product once it has been launched.
The lawsuits, filed in the U.S. District Court for the District of Delaware and the District of California, claim that Alcon is infringing four patents. One lawsuit claims that Alcon's proposed brimonidine tartrate 0.15% solution made with polyquaternium-1 (Polyquad) preservative infringed two Allergan patents. Alcon's product was tentatively approved by the FDA in 2005, but final approval is pending resolution of the litigation.
The settlement provides Alcon with marketing rights "at least a decade before the expiration of Allergan's patents," said Cary Rayment, Alcon's chairman, president, and chief executive officer, in the statement.
The "delayed-entry license . . . respects our intellectual property portfolio" and is "in line with Allergan's long-term strategy" for the brimonidine franchise, said Allergan's chairman and chief executive officer, David E.I. Pyott, in his company's statement.
Alcon spokeswoman Carol Massey said she was prohibited from providing additional information, citing legal reasons. Allergan spokeswoman Heather Katt said the "trigger" that would allow Alcon to introduce its product is based on the percentage of Alphagan P 0.15% prescriptions that are converted to other Allergan products, including Alphagan P 0.1% and, if approved in the United States, its brimonidine tartrate 0.2%/timolol 0.5% solution (Combigan).
The FDA issued an approvable letter for the solution last year.
"If the trigger is reached prior to September 30, 2009, Alcon would receive the license earlier and be permitted to bring its proposed brimonidine 0.15% product to the market at that time," Katt said.