For further information:
Joy Spencer, +1.202.387.8030 (office), +1.703.727.6761 (cell),
Robert Weissman, +1.202.360.1844 (cell)

"The National Institutes of Health (NIH) announcement that it will hold a public meeting on the Norvir March-In means the Bush Administration will be making policy on how government funded inventions are priced. The Administration will either permit or oppose the most outrageous price increase ever for an AIDS drug. Today Norvir (generic name ritonavir) is the most essential AIDS drug in the United States. This government-funded invention is used with all but one of the protease inhibitors used to treat AIDS. Abbott’s decision to increase the price 400 percent was itself shocking. But the price increase only applies in the United States, and only if Norvir is used with a non-Abbott protease inhibitor. Norvir is now priced 10 times higher in the United States than in Canada or some European countries. If the Bush Administration allows the 400 percent price hike to stand, it sends a signal that there is no limit to how high you can price a government-funded invention. If the Bush Administration issues compulsory licenses to Abbott’s Norvir patents, it will restrain price gouging. Either way, the precedent will be huge." Said James Love, President, Essential Inventions.

"Is Uncle Sam a sucker? If the federal government helps pay for the development of a drug, and then gives the grant recipient exclusive rights to sell it, shouldn't the government make sure the product is available on reasonable terms? Under the Bayh-Dole Act, the government can fix the problem, so the public is not ripped off. But the government has to act. Today’s announcement that the NIH will provide a public meeting on the Norvir dispute will be welcomed by the more than 200 AIDS groups and doctors who had petitioned for a hearing," said Robert Weissman, a lawyer and member of the Essential Inventions, Board of Directors.

Background

Essential Inventions is a nonprofit corporation whose aim is to promote the creation and distribution of essential inventions and other works that support public health, nutrition, learning, and access to information and cultural life.

Norvir is one of the most important drugs used in HIV treatment and is manufactured by Abbott laboratories. In December 2003, Abbott Laboratories increased the price of Norvir by 400 percent. The drug was already more expensive in the US, and now the price of Norvir is as much as 10 times higher than in Canada or European markets, even though the invention was funded by US government grants. In the US, Abbott charges 400 percent more for ritonavir if the drug is used with non-Abbott AIDS drugs. Essential Inventions views this price increase as unreasonable and anticompetitive, and as having a negative impact on the development of new AIDS drugs.

On January 29th, 2004 Essential Inventions asked Secretary of Health and Human Services (DHHS) Tommy Thompson to use his authority under the Bayh-Dole Act to allow generic manufacture of Norvir -- by using the "March-In" provisions of the act to grant compulsory licenses to Abbott’s Norvir patents.

Secretary Thompson asked the NIH to review the request.

On May 25th, the NIH will hold a public meeting where stakeholders and interested parties will comment on use of the government march-in rights (35 U.S.C 201(f), 35 USC 203) to remedy abuses of Abbott’s ritonavir patents.

A key issue will be the obligation to provide for "practical application" of the invention, which includes the obligations to make the invention "available to the public on reasonable terms."

http://www.bitlaw.com/source/35usc/201.html

(f) The term "practical application" means to manufacture in the case of a composition or product, to practice in the case of a process or method, or to operate in the case of a machine or system; and, in each case, under such conditions as to establish that the invention is being utilized and that its benefits are to the extent permitted by law or Government regulations available to the public on reasonable terms.