NIH blocks effort for generic latanoprost

November 1, 2004

Washington, DC-Pfizer Ophthalmic's patented formulation of latanoprost (Xalatan) is safe from competition for now, after the National Institutes of Health (NIH) has refused to step in and license generic versions.

Washington, DC-Pfizer Ophthalmic's patented formulation of latanoprost (Xalatan) is safe from competition for now, after the National Institutes of Health (NIH) has refused to step in and license generic versions.

A nonprofit company formed by consumer advocates had asked the government to allow it to produce cheaper, generic versions of latanoprost before Pfizer Ophthalmic's patent expires July 28, 2006. The company, Essential Inventions, alleged that Pfizer Ophthalmics priced the drug above the market and failed to make the drug, which was developed in part with federal grants, available "on reasonable terms."

According to the company's interpretation of the 1980 Bayh-Dole Act, that would allow the NIH to "march in" and grant licenses to competitors.

"Pfizer [Ophthalmics] has met the standard for achieving practical application of the applicable patents by its manufacture, practice, and operation of latanoprost and the drug's availability and use by the public," the NIH said. "Because the market dynamics for all products developed pursuant to licensing rights under the Bayh-Dole Act could be altered if prices on such products were directed in any way by the NIH, the NIH believes that the extraordinary remedy of march-in is not an appropriate means of controlling prices."

Instead, the agency said, the issue of whether drugs should be sold for the same price in the United States as they are in Canada and Europe is for Congress to decide.

Pfizer Ophthalmics spokesman Daniel Watts said he was unaware of any previous efforts against the company to engineer this kind of "march in."

"It was an appropriate decision," Watts said.

Essential Inventions general counsel Robert Weissman, who was not immediately available for comment, said in a statement that the company would appeal the decision to the secretary for Health and Human Services. He said the NIH misinterprets the statutory language and benefits "big pharma."

"It mistakenly asserts that a licensee need only put a product on the market, at any price," he said.