Washington Editor

WASHINGTON – Under a new international patent pool, the National Institutes of Health (NIH) is providing access to protease inhibitor-related intellectual property in an effort to make HIV/AIDS drugs more accessible to poorer nations, officials revealed Thursday.

The goal of the Medicines Patent Pool, a newly established Swiss-based initiative supported by UNITAID – a global health financing organization hosted and administered by the World Health Organization – is to speed newer HIV/AIDS medicines to patients and bring down prices by encouraging competition among multiple producers, said Ellen 't Hoen, who will take the reins of the pool on Nov. 1.

The patent pool also is intended to facilitate the development of new drug formulations for children with HIV/AIDS and fixed-dose combinations, in which several medicines are combined into one easy-to-take pill, 't Hoen told BioWorld Today.

She emphasized that the Medicines Patent Pool will operate on a voluntary basis, with patent holders compensated through royalties paid by generic manufacturers on sales of their products.

The license granted by the NIH for the pool, however, is "royalty-free," said Mark Rohrbaugh, director of the agency's Office of Technology Transfer.

While the "driver" for not seeking royalties was out of a "humanitarian" concern, the NIH had other interests of consideration, he said. "It's also in the U.S. interest to improve public health in other countries for diseases that are communicable and could spread" to this country, Rohrbaugh told BioWorld Today.

Granting royalty-free licenses also helps to "build strong, stable governments and populations that are not burdened by public health," he added.

The NIH patents its technologies, Rohrbaugh said, to facilitate and promote the development of products.

But he emphasized that the incentives needed for Western companies may be different than those in the developing world, "so we structure the licenses to balance those needs and goals.

"So we are particularly cautious and careful about striking these agreements so that we have rights available to offer for the promotion of technology in emerging markets and developing countries," he said. "We are able to offer these rights because of our practice of limiting exclusive licenses by scope of geography to that which is needed to promote the development of new drugs and therapeutics."

The initiation of the Medicines Patent Pool follows a similar effort launched last year by GlaxoSmithKline plc and Alnylam Pharmaceuticals Inc., which are offering researchers free access to their intellectual property, discovered compounds, technologies and know-how in the pursuit of finding new medicines for infectious and parasitic diseases affecting the world's poorest nations – the neglected diseases. (See BioWorld Today, Jan. 21, 2010.)

London-based GSK had pledged access to 800 of its patents, while Cambridge, Mass.-based Alnylam said it would contribute 1,500 of its RNA interference patents to the effort, which is being overseen by the nonprofit BIO Ventures for Global Health.

Rohrbaugh said creating patent pools is one of several avenues that can aid in promoting the transfer of technology to emerging markets and lower-income countries.

"This is just one of the many arrows in our quiver to promote this type of transfer," he said.

The intellectual property involved in the license granted to the Medicines Patent Pool is related to protease inhibitors.

The National Cancer Institute at NIH and the University of Illinois at Chicago in 1998 discovered that protease inhibitors were particularly effective at treating HIV/AIDS. The NIH's patents cover methods of treating people with effective amounts of the protease inhibitor darunavir and related compounds.

The NIH previously had granted nonexclusive licenses related to darunavir to Tibotec Inc., a subsidiary of New Brunswick, N.J.-based Johnson & Johnson, which markets the antiretroviral (ARV) drug Prezista, Rohrbaugh noted.

The agency also granted a nonexclusive license to its IP to Hygeia LLC, a now-defunct company, which assigned the license to Gaithersburg, Md.-based Sequoia Pharmaceuticals Inc., he said.

There are other patents relating to darunavir that are owned by different patent holders, officials noted Thursday.

Rohrbaugh said the NIH's license alone would not provide the rights to produce or sell any specific existing drug, and other patent holders would need to share their patents with the pool in order to clear the legal path for production of affordable HIV/AIDS medications.

The patent pool has been in discussions with most of the firms developing ARVs about making their intellectual property available to the pool, 't Hoen said.

Tibotec spokeswoman Pamela Van Houten said that her firm has been in talks with the patent pool, but could not confirm any details about those discussions.

"We need to be sure that licenses of all relevant ARVs are available because AIDS treatment is never a matter of one compound," 't Hoen said. "You always need a combination of several compounds, and no single company actually owns the IP of everything you would need."

She insisted that the patent pool has "something in it for everyone," and encouraged drugmakers and other governments to get on board. "There's a very strong invitation out there to anyone who has ARV patents to come forward and talk to us," 't Hoen said.

The incentive for drugmakers and other governments to join the pool, Rohrbaugh said, is that it is "the right thing with respect to finding ways to meet the goals from a product and market standpoint and do good for people who may not have access to these drugs in middle- and low-income countries."