AIDS Healthcare Foundation v. Gilead Sciences et al
Area: Pharmaceutical Patents & Antitrust
Court: Northern District of California Federal Court
Berger & Hipskind represents the largest non-profit provider of HIV and AIDS medical care in the United States in a suit to stop Gilead Sciences illegal business practices which prevent affordable access to important, lifesaving HIV and AIDS therapies.
Gilead, in concert with Japan Tobacco and Janssen Sciences undertook a monopolistic scheme that tied the sales of Tenofavir Alafenamide Fumarate (“TAF”) to the sale of other drug products used in the treatment of HIV and AIDS. Defendants’ anticompetitive practices arose in response to the upcoming expiration of Gilead’s patents covering Tenofovir Disoproxil Fumarate (“TDF”) in 2017, which will lead to generic entry in the TDF market and cut into Gilead’s multi-billion dollar profits. TDF has been used by physicians to treat HIV and AIDS for the past 15 years in conjunction with a variety of other drugs in various combinations and dosages to form a variety of highly active antiretroviral therapies (“HAART”) tailored for individual patients.
Because TAF is as efficacious as TDF, but in significantly smaller dosages, thus making it much safer for patients, TAF is replacing TDF as the backbone of HAART therapies. Concurrent to its development of TDF, Gilead identified TAF as offering superior benefits to those suffering from HIV/AIDS as compared to TDF. However, instead of promptly developing TAF, and to maximize its profits and extend its monopoly in the field of Tenofovir treatments, Gilead sought to delay the release of TAF to ensure that TAF exclusivity did not overlap with its TDF monopoly until generic entry in the TDF market was imminent.
While Gilead sat on its research regarding the safety of TAF for over a decade, HIV patients were given TDF and exposed to potentially life threatening kidney damage and bone toxicity. Gilead’s delay in making TAF available was directly related to gaming the patent system and regulatory regime so Gilead could profit while HIV patients were deprived a drug known by Gilead to be a safer alternative.
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