Pharma Giant Fails To Mention — For 18 Years — That US Government Helped Fund A Key Patent Used In Drug That Has Generated $53 Billion In Sales So Far

Patents

from the reasonable-terms dept

It’s no secret that drug prices are often high, and continue to rise — by 32% in the past five years according to one analysis. It’s only natural that many should be willing to pay even exorbitant amounts for drugs. If there is the hope of a cure, or at least of some relief from pain and symptoms, for themselves or their family, most people would probably put that above money.

It’s less obvious why drug prices are so high in the first place. The standard response from the pharma industry is that companies need incentives to develop new treatments, and these are typically in the form of the high prices they can charge. Although plausible, it overlooks the important contribution that publicly-funded research makes here. Many new drugs are made possible thanks to ground-breaking early work by academics in universities or institutes, not in companies. That’s not something that Big Pharma likes to talk about, as this post from James Love on the Bill of Health blog reminds us:

This is a story about U.S. patent number 6,958,335, and how it took more than 18 years for Novartis to acknowledge National Institutes of Health (NIH) funding in a key patent for Gleevec, allowing Novartis to shape the narrative regarding its role in the development of Gleevec, and also to avoid demands that Novartis make the invention “available to the public on reasonable terms,” which is an obligation under the Bayh-Dole Act.

Gleevec is one of the drug industry’s biggest successes. An article on the Nature site explained back in 2008:

Some say it’s a miracle drug. Others call it a silver bullet. Gleevec, also marketed internationally as Glivec and sometimes referred to by its chemical name imatinib, entered the medical world with a bang. This medication was initially approved for use by the U.S. Food and Drug Administration (FDA) in 2001 for the treatment of chronic myelogenous leukemia (CML), a rare form of cancer that affects certain types of white blood cells.

That “miracle drug” has meant big money for Novartis. According to the Bill of Health blog post, by the end of 2018, the cumulative sales for Gleevec exceeded $53 billion. Love notes that as an invention that was partially funded by taxpayers, Novartis ought to have made the invention “available to the public on reasonable terms”. That would presumably have translated to a lower price, and possibly to more people taking the drug, and more lives being saved. Those didn’t happen, because Novartis didn’t acknowledge the NIH funding until now, a mere 18 years late. Sadly, this is not an isolated case of forgetfulness, as Love points out in his conclusion:

[Knowledge Ecology International] has written the NIH on several occasions to identify cases where inventors have failed to acknowledge federal funding in patent applications. Such cases have not been difficult to find. In the 1990s, Congress and [US Department of Health & Human Services] investigated such failures to disclose, and found widespread non-compliance with disclosure mandates, and lax oversight. This is an area where new Congressional oversight would be welcome, particularly as the question of the federal role in drug development is being spun by various parties.

That’s worth bearing in mind the next time Big Pharma tries to justify eye-watering drug prices because of the innovative research required to create them.

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Filed Under: drugs, gleevec, glivec, nih, patents, pharmaceuticals, public funding, reasonable terms
Companies: novartis