Drug Regulation Patent

SpicyIP Tidbit: TAG and GHJP file lawsuit for the release of Sovaldi and Harvoni clinical trial data

In what is perhaps of the beginning another chapter to the Sovaldi saga, the Treatment Action Group (TAG) and the Global Health Justice Partnership (GHJP), represented by Yale Law School’s Media Freedom and Information Access Clinic (MFIA Clinic), have filed a federal lawsuit against the FDA and the Department of Health and Human Services, asking for access to the clinical trial information that Gilead Sciences submitted to the FDA on the Sovaldi and Harvoni drugs. The lawsuit comes after Gilead Sciences and the FDA’s lacking responses to similar requests, through direct communication and a Freedom of Information Act (FOIA) application.

The central contention of the plaintiffs in this case that this information is extremely crucial for the prescription and usage of the drug, and that releasing it to the public will allow doctors and policymakers to make more informed choices with regards to public health and allocation of resources. These concerns are especially crucial here as these drugs are astronomically priced, with their initial prices being $84,000 and $94,500 respectively, and because the drug was put on an accelerated track to approval as it was designated Breakthrough Therapy Designation status. In the words of Karyn Kaplan of TAG, as quoted in the original article, “This lawsuit is about access and answers. The astronomical price of these drugs requires Medicaid programs and other providers to make hard choices about how to allocate their resources. They are making these decisions now. Crucial policy determinations about who has access to treatment are being made on incomplete information.

We have covered the issue of Gilead Science’s patents on the hepatitis C drug Sovaldi on the blog on multiple occasions, notably here, here, here, and here. As our readers might remember, Gilead’s patent application had been rejected by the IPO in January this year, and it had announced its plans to appeal the order. We had also noted that the Initiative for Medicines, Access & Knowledge (I-MAK) was contesting the patents in multiple countries. Since we wrote that post, I-MAK’s efforts have been successful in China, with China now joining India as the second country where the patent has been rejected, sending off strong singals to countries where they are pending.

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