The National Institutes of Health (NIH) declined on Monday a petition to override the patent of a prostate cancer drug. The march-in rights appeal was not granted by the U.S. agency.

NIH Director turned down the request to revoke the license of a drugmaker company. Several U.S. consumer groups asked for a march-in right authority to prevent companies from authorizing federally funded medications, which are sold with excessive pricing.

Several consumer groups petitioned to reduce the $129,000-a year list price of Xtandi. Image Credit: Stat News
Several consumer groups petitioned to reduce the $129,000-a year list price of Xtandi. Image Credit: Stat News

The petition was introduced in January, and it was supported by the Union for Affordable Cancer Treatment and two congressmen: Rep. Lloyd Doggett, from Texas and Rep. Peter Welch, from Vermont.

March-in rights

It is a federal grant to control licenses in drug patents that were developed with federal funds. The measure was created in 1980 with the aim of alleviating health and safety needs in those patents that become inaccessible or not available to the public.

Those drugs that are developed with taxpayer funds and whose cost and benefits are not available for U.S. citizens to remove the license and award it to another party. On January, consumer groups appealed to this federal law to override the patent of prostate cancer drug Xtandi.

Several consumer groups petitioned to reduce the $129,000-a year list price of Xtandi. The drug is made by Astellas Pharma, a Japanese drugmaker. Xtandi was developed at the University of California, Los Angeles, using grants from NIH and the US Department of Defense, Government agencies that receive taxpayer money.

Knowledge Ecology International (KEI) asked NIH to expire the license from Astellas and Medivation (Astellas co-maker company), to produce the drug in the U.S. According to the group, the agency could use the march-in rights appeal to override Xtandi patent before it expires. Also, KEI proposed a third party supplier: the Canadian drugmaker Biolyse Pharma. The generic drugmaker claimed it was possible to produce 40-mg tablets of Xtandi for $3 per pill. What seems to be reasonable compared to the high incomes Xtandi is building per year with its current makers.

NIH turns down the request

The National Institutes of Health (NIH) on Monday sent a letter to one of the consumer groups that invoked the law authority in which it rejected the petition alleging that there is no reliable information on whether or not the drug is in short supply or available in the U.S. The letter was sent by

The letter was sent by Dr. Francis Collins, NIH Director and addressed to Knowledge Ecology International (KEI). NIH decision was based on the sufficient supplies of the drug. The agency claimed that the lack of reasons for allowing a generic drugmaker to develop the prostate cancer drug has been what caused the rejection of the petition.

More than 40,000 men are diagnosed with prostate cancer and nearly 11,000 die in the UK each year. Image Credit: BBC News
More than 40,000 men are diagnosed with prostate cancer and nearly 11,000 die in the UK each year. Image Credit: BBC News

As expected, Knowledge Ecology International was not in agreement on NIH decision. In response, the group stated that NIH decision is not consistent with what is required under law. Andrew Goldman, counsel for policy and legal affairs at KEI, said that the response from the NIH Director is supported by royalty-free license stated in the law.

Goldman affirms that the lack of evidence on Xtandi shortage alleged by Collins is not a precondition to override a drug patent funded with taxpayer money.

 “This is contrary to the legislative intent of the law, and sends a terrible signal about the government’s willingness to confront the high drug prices through available legal mechanisms,” said Goldman.

KEI also asserted that NIH failed to consider evidence on the high costs of Xtandi and the consequence such unreasonable prices bring to patients welfare. Xtandi high prices limits patient to have access to the drug for treatments and this fact contradicts one of the main foundations of march-in rights law.

The group affirms that Astellas prices charge US residents with high prices that limit them to get the medicine if the march-in rights appeal was created to avoid drug monopoly, NIH decision lacks in consistency towards the federal regulation.

KEI will appeal NIH’s decision

KEI plans to seek an appeal next year. James Love, the consumer group’s director, said the group will refile the case, and an appeal to override Xtandi’s patent will be presented.

As per Love, the Government agency is not taking proper use of an appeal that could diminish the excessive pricing that some drug companies are imposing on their products. Such drug speculation will force U.S. residents to pay for drug treatments exorbitant amounts of money for products that must be accessible to general public.

Next year, KEI will elect a new president, a propitious time to pose Xtandi case again and to appeal for a march-in rights federal license.

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