The National Institutes of Health declined to apply "march-in" authorities to Pfizer's glaucoma therapy Xalatan for similar reasons to the recent Norvir decision.

The non-profit group Essential Inventions filed a petition requesting NIH offer compulsory licenses of Pfizer's Xalatan (latanoprost) under the Bayh/Dole Act. The licenses were needed because the drug is more costly in the U.S. than in Canada and Europe, Essential Inventions argued.

NIH rejected a similar Jan. 29 petition also filed by Essential Inventions that requested the agency exercise "march-in" rights on Abbott's AIDS booster therapy Norvir (ritonavir).

In the Norvir decision, NIH determined that access, not price, was the main consideration in deciding whether to apply "march in" authorities (¹ Also see "Norvir Exclusivity Is Safe; NIH Says "March-In" Test Is Availability, Not Price" - Pink Sheet, 4 August, 2004.).

"Latanoprost has been on the market for and available to glaucoma patients since 1996 when it was introduced and sold under the name Xalatan," a Sept. 17 ² NIH decision says.

"Thus, this invention has reached practical application because it is being utilized and has been made widely available for use by glaucoma patients for at least eight years."

Discrepancies between Xalatan prices in Canada, Europe, and U.S. require NIH intervention, Essential Inventions petitioned.

NIH rejected the claim, saying product pricing is not a sufficient reason for exercising "march-in" rights, and is an issue outside of the purview of the agency.

"NIH believes that the extraordinary remedy of march-in is not an appropriate means of controlling prices," the agency said.

"The issue of whether drugs should be sold in the United States for the same price as they are sold in Canada and Europe has global implications and, thus, is appropriately left for Congress to address legislatively."

Essential Inventions will appeal the decision to HHS Secretary Tommy Thompson.

NIH too narrowly interpreted its legal authority to "march-in" on a company's product exclusivity, the non-profit said Sept. 23.

The "decision completely misinterprets this statutory language, to the benefit of Big Pharma," Essential Inventions said. "It mistakenly asserts that a licensee need only put a product on the market, at any price."

- Lee Kalowski

NIH Will Not “March-In” On Pfizer’s Xalatan

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