Gilead Sciences ($GILD) might have expected a hepatitis C patent challenge in India. But in Europe? Not so much. But that's exactly what Gilead is getting. After losing its bid for a new Indian patent covering its blockbuster treatment Sovaldi, Gilead is now threatened with a similar action at the European Patent Office in Munich.
Medicine du Monde (MdM), a medical-aid charity, filed the challenge, citing the "exorbitant" cost of the drug, which boasts high cure rates and fewer side effects than old interferon-based treatment cocktails. The group argues that Gilead is "abusing" its patent to charge "unsustainable" prices.
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| Jean-François Corty |
"We are defending universal access to healthcare: the struggle against health inequality involves safeguarding a healthcare system based on solidarity," Jean-François Corty, French programs director of MdM, said in a statement. "Even in a 'rich' country such as France, with an annual drugs budget of €27 billion, it's hard to meet this cost and already we're seeing an arbitrary rationing approach that excludes patients from care."
The group claims that while the use of Sovaldi in hep C is a noteworthy advance, the drug itself, sofosbuvir, "is the result of work by many public and private researchers" and isn't "sufficiently innovative" in itself to justify a patent.
That argument replicates the successful challenge in India, where patent office officials snubbed Gilead's attempt to win new IP protections for its drug. Gilead appealed that decision, and the Delhi High Court ordered a rehearing.
MdM cited a £33,000 price in the U.K., or about $50,160. The cost-effectiveness watchdogs at the National Institute for Health and Care Excellence backed Sovaldi for use on the National Health Service, but NHS officials have said the system can't bear the cost of using Sovaldi in its many hep C patients.
Meanwhile, France happens to be one country that has negotiated a cut-rate price on Sovaldi for its citizens. Gilead agreed to volume-based discounts, along with money-back guarantees, in return for the government's pledge to cover Sovaldi at 100%, with no copay for patients.
In the U.S., payers have been pitting Gilead and its drugs against AbbVie ($ABBV) and its Viekira Pak to win discounts in exchange for exclusive or preferred formulary placement. The pricing war has spooked investors, sending Gilead shares reeling and AbbVie analysts scrambling to downgrade its stock. But Gilead's Sovaldi and a follow-up combo pill, Harvoni, are still expected to bring in more than $10 billion in 2015, with AbbVie's cocktail estimated at $3 billion in 2015 sales.
If the European patent challenge succeeds, Gilead could lose exclusivity for Sovaldi in the 34 EU countries, Bloomberg notes. But the challenge itself will take several years, patent officials said. Meanwhile, Gilead's patent will remain in force. In addition to the challenged patent, Gilead has another Sovaldi patent application pending with the EPO.
- see the MdM statement
- read the Bloomberg story
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