Request for March-in on Abbot Patent for Ritonavir, a drug for AIDS

 

On 25th October 2012, four NGOs requested “National Institute of Health (NIH)” under the Bayh-Dole Act of USA to force “Abbott Laboratories” to license others for manufacturing and selling the drug Ritonavir, which is used for the treatment of AIDS. The petitioners are “American Medical Students Association (AMSA)”, “Knowledge Ecology International (KEI)”, “U.S. Public Interest Research Group (PIRG)” and the “Universities Allied for Essential Medicines (UAEM)”. They informed that the citizens have to pay more than the patients of other rich countries of Europe and Canada for purchasing this federally funded drug. They have asked NIH to adopt the two mechanisms to create a more predictable policy and protecting the public’s interest in federally funded drug.

The petitioners challenged the present fundamental drug policy on fixing the price of the medicine that is invented from federally funded research. The petition has created a great debate in the pharmaceutical circles and NGOs. General people are also very much curious about the issue. Already Tedmund Wan, a research fellow from the University of Notre Dame Public Service Initiative Program, has informed that 13 out of 14 NIH federal funded drugs are sold at four to six times higher rate in USA than other high income countries of Europe. Those who are in support of the petition are saying that USA should immediately enact a drug pricing policy of the federally funded drugs for the benefit of the US people.
The proposed change of the two rules is:-

• Rule 1: Ceiling on prices to U.S. residents- The Government should not consider the price of federally funded drug reasonable if the prices are higher than the mean price of the top seven largest foreign countries as measured by GDP, determined by World Bank. In that case, contracts or licenses will be awarded to the competitors for supplying the products to the people of USA at a lower cost.
• Rule 2 : Use of invention for a dependent technology : The Secretary shall grant licenses to third parties to use patented inventions that have benefited from federal funding, subject to the payment of a reasonable royalty and an appropriate field of use, if a product based on those patented inventions: (a) is a drug, drug formulation, delivery mechanism, medical device, diagnostic or similar invention, and (b) is used or is potentially useful to prevent, treat or diagnose medical conditions or diseases involving humans, and (c) its co-formulation, co-administration or concomitant use with a second product is necessary to effect significant health benefits from the second product, and (d) the patent holder has refused a reasonable offer for a license.

Details of the petition will be obtained from here
Robert Weissman, President, Public Citizen questioned about the logic of paying higher prices for the drugs that have been invented by the American tax-payers” money. Government should modify the law known as “march-in rights” to ensure that the countrymen can get the federal funded drugs at an affordable price.
On the other hand, Joseph P. Allen, President of Allen & Associates, Inc. has cited the old hackneyed argument against the petition. He said that the pharmaceutical companies can get approval of one drug from 5000 clinical tests. Therefore, the price of drug is determined by including the cost of research. In his blog at “IP Watchdog”, he ignored that the petitioner has mentioned to fix the price of the only federally funded drugs. In that case, the questions of expenses on other clinical trials do not arise.
Whatever may be the outcome of the petition, it will be a groundbreaking decision in the history of American Health Services.