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# AIDS Groups Sues Gilead to Invalidate Drug Patents
- URL: https://www.fdaweb.com/aids-groups-sues-gilead-to-invalidate-drug-patents/
- Published: 2016-01-26T12:00:00.000Z
- Updated: 2026-09-15T02:31:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134566

AIDS Healthcare Foundation (AHF) filed a federal lawsuit 1/26 against Gilead Sciences seeking to invalidate patents on key AIDS drugs held by the drug maker. The complaint was filed in Northern District of California ([Case # 3:16-cv-00443](http://www.aidshealth.org/wp-content/uploads/2016/01/Complaint-as-filed.pdf?ref=fdaweb.com)) and concerns tenofovir, a key HIV/AIDS drug which was first synthesized over thirty years ago in the Czech Republic. Tenofovir is a component in [Genvoya](http://www.aidsmeds.com/archive/genvoya%5Felvitegravir%5Fcobicistat%5F2986.shtml?ref=fdaweb.com), Gilead’s four-in-one fixed dose combination (FDC) to treat HIV/AIDS patients as well as Gilead’s similar predecessor, [Stribild](http://www.aidsmeds.com/archive/stribild%5Felvitegravir%5Fcobicistat%5F2716.shtml?ref=fdaweb.com). AHF’s lawsuit also names Japan Tobacco Inc. and Emory University and asserts anti-competitive violations of the Sherman Act ,15 U.S.C. §§ 1 & 2.

In its complaint, AHF asserts that: 

*“In a relentless effort to maximize its profits, Gilead manipulated the patent system and engaged in anticompetitive practices to prevent economical access to TAF – an antiviral agent used in the treatment of HIV.TAF is not a new compound.TAF is a prodrug of the compound tenofovir, which was first synthesized over thirty years ago in the Czech Republic. Nor was TAF the first prodrug of Tenofovir. Several years before Gilead obtained a patent on TAF, Gilead had patented a similar prodrug called Tenofovir Disoproxil (‘TDF’). Despite similarities between TAF and TDF and the weakness of the patents covering TAF, Gilead illegally seeks to extend the period of patent exclusivity for drugs incorporating Tenofovir by decades.* 

*“Gilead’s attempt to extend the period of patent exclusivity for drugs incorporating Tenofovir arises from Gilead manipulating the patent system, entering into a licensing agreement with Japan Tobacco, and using a preexisting patent licensing agreement with Emory University to block entry by potential competitors and prevent competition. Gilead’s actions have directly harmed AHF, which in 2015 alone purchased millions of dollars of antiviral drugs from Gilead.”* 

The lawsuit comes after AHF recently [asked](http://www.aidshealth.org/?ref=fdaweb.com#/archives/24662) FDA to take enforcement action against Gilead for off-label promotion of its Truvada [(emtricitabine and tenofovir disoproxil fumarate)](http://www.truvada.com/?ref=fdaweb.com) for situational pre-exposure prophylaxis (PrEP) to prevent HIV infection ([see earlier story](https://www.fdaweb.com/gilead-promoting-truvada-off-label-use-aids-group/)). A recent letter to FDA acting commissioner **Stephen Ostroff** says:“In contravention of statute and regulations, Gilead appears to be promoting situational use of its AIDS treatment Truvada for PrEP, misleading viewers into believing that Truvada is safe and effective for use on a situational basis, despite knowing that the drug is not FDA approved for such use.” 

The letter follows publication of a news article on Australia’s Gay News Network focusing on a video that appears to promote situational rather than daily use of Truvada “for men who enjoy recreational sex and drug use but do not test regularly for HIV.” The article said that the campaign “is supported by Gilead Sciences, manufacturer of Truvada.” The TV ad entitled “I Like to Party” has a slate at the end reading “Supported by funding from Gilead Sciences” and also crediting Public Health Solutions, a New York City-based non-profit, and Connected Health Solutions, described as a Brooklyn-based organizational development consultancy.