[Ip-health] Response to “Attacking the Patent System for Pricing Issues Is a Non-Starter”

Céline Grillon celine.grillon at medecinsdumonde.net
Fri Mar 13 03:47:00 PDT 2015

Response to “Attacking the Patent System for Pricing Issues Is a Non-Starter”
Richard Bergström seems to have misunderstood the grounds on which Médecins du Monde issued a patent challenge for sofosbuvir.
11 March, 2015 | by Chelsea Radler<http://doctorsoftheworld.org.uk/blog/author/chelsea-radler>

In response to the March 4 article by Richard Bergström entitled “Attacking the Patent System for Pricing Issues Is a Non-Starter<http://pharmaviews.eu/attacking-the-patent-system-for-pricing-issues-is-a-non-starter/>,” Doctors of the World seeks to address several factual errors and misrepresentations.

It seems clear from his piece that Richard Bergström has, at best, misunderstood (and, at worst, intentionally misrepresented) the grounds on which Médecins du Monde (Doctors of the World) issued a patent challenge for sofosbuvir (Sovaldi®) at the European Patent Office. Bergström focuses much of his op-ed on cost. It’s understandable – the exorbitantly high price of Sovaldi merits attention.

But Médecins du Monde’s patent challenge does not hinge on the drug’s cost. The challenge rests on scientific evidence that the patent is undeserved because the drug fails to meet one of the essential requirements of earning patent status: an inventive step. A reduction to the price would simply be a positive by-product of increased competition.

Sofosbuvir is an evolution, rather than a revolution, of direct-acting antiviral treatment for hepatitis C. The improvement in the quality of life that it offers to patients is a breakthrough, but the molecule that comprises the drug is not.

Bergström points to the high research and development (R&D) costs that would have prevented sofosbuvir’s creation if it were not sold at the existing price. Yet in reality, the price asked by Gilead has nothing to do with R&D costs related to sofosbuvir, which was created by the American start-up Pharmasset. Gilead acquired Pharmasset in 2011, banking on high sales of the drug to cover the hefty price tag, which was far greater than the R&D costs associated with sofosbuvir.

What’s more: Pharmasset’s original research relied heavily on discoveries made at the public University of Cardiff. Too often forgotten is the role that public institutions and public funding (including grants and tax credits) play in pharmaceutical development.

Unrelated to the grounds of the patent challenge, though quite relevant to broader public health policy, Bergström underestimates the strain placed on European governments by inflated drug prices. In France, sofosbuvir is rationed only to the sickest patients. For the first time ever the NHS declined to offer a treatment, even after it was approved by the UK’s pharmaceutical regulatory body. The treatment in question: sofosbuvir. The sole reason for delay: cost.

Equally unconvincing is Bergström’s argument that sofosbuvir, though expensive, eliminates the need for even more expensive treatments. It hardly seems appropriate to suggest that drug companies be allowed to price their products specifically based on the damage they can prevent. By this logic, household cleaning supplies should cost just less than entirely new carpeting and routine oil changes just less than a brand new car.

Industry, Bergström suggests, is “prepared to play its part” and is “engaging with payers around the world.” But realistically, this has only been true when patent challenges force companies to compete for customers’ business. In India – where a patent challenge resulted in deals to produce generics – and in America – where competition among private healthcare providers forced prices down – encouraging competition has been the most effective hand at guiding so-called engagement.

Médecins du Monde’s challenge aims to question whether those most in need of treatment should have to pay inflated rates for the use of existing technology, and in so doing sparks a valuable conversation about modern healthcare inequalities and societal values. Industry should and must be allowed to flourish. But companies that manipulate the patent system to monopolize existing technologies should be held accountable for that misuse.

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