The Foundation of PrEP: Gilead's Early Dominance
Gilead Sciences developed the first branded PrEP medications, Truvada and Descovy, which were significant for HIV prevention. Truvada (TDF/FTC) was initially approved in 2004 for HIV treatment. Publicly-funded research, with CDC assistance, later proved its effectiveness for prevention, leading to FDA approval for PrEP in 2012. Gilead held exclusive patents during this time.
Gilead later introduced Descovy (TAF/FTC), an updated formulation intended to reduce the risk of kidney and bone side effects associated with Truvada. Descovy was also approved for PrEP, though not for preventing HIV from vaginal sex. This newer drug extended Gilead's patent protection for PrEP medications.
The Controversial Patent Battle with the U.S. Government
In 2019, the U.S. government, through HHS, sued Gilead Sciences. The government claimed the CDC's taxpayer-funded research established the effectiveness of the PrEP regimen, leading to government patents on the method in 2015. The government alleged Gilead infringed these patents without paying royalties.
Gilead disputed the validity of the government's patents and asserted its rights to market the drugs for PrEP. Gilead also sued the government for breaching collaboration agreements. Key developments included:
- A 2023 federal jury finding the government's patents invalid.
- Federal court decisions stating the government breached contracts with Gilead.
A settlement resolving the five-year litigation was announced in January 2025. While terms were not public, some public health advocates expressed disappointment. The settlement allows Gilead to license government patents related to PrEP, ensuring its continued operation in the field.
The Arrival of Generic PrEP
The nearing expiration of Truvada's patent opened the door for more affordable PrEP options.
Patent Expiration and Generic Market Entry Truvada's patent expired in 2020, allowing generic competition. Companies like Teva, Amneal, and Aurobindo received FDA approval for generic TDF/FTC, which contain the same active ingredients and are equally effective as branded Truvada. This competition significantly reduced the price of this form of PrEP.
Impact on Accessibility The availability of generics improved PrEP access, particularly where cost was a barrier. This affordability is crucial for expanding access and working to end the HIV epidemic. While Descovy remains under patent, generic TDF/FTC has changed the PrEP landscape.
A Comparison of PrEP Medications
| Feature | Branded Truvada | Generic TDF/FTC | Branded Descovy |
|---|---|---|---|
| Manufacturer(s) | Gilead Sciences | Multiple (e.g., Teva, Amneal, Aurobindo) | Gilead Sciences |
| Active Ingredients | Tenofovir Disoproxil Fumarate / Emtricitabine (TDF/FTC) | Tenofovir Disoproxil Fumarate / Emtricitabine (TDF/FTC) | Tenofovir Alafenamide / Emtricitabine (TAF/FTC) |
| Original Patent Holder | Gilead Sciences | Gilead Sciences | Gilead Sciences |
| Method Patent Holder (disputed) | U.S. Government (CDC) | N/A (Method patent invalidated) | U.S. Government (CDC) |
| U.S. Patent Status (as of 2025) | Expired (allowing generics) | Available | Active (set to expire later) |
| Primary Benefits | Prevents HIV via anal and vaginal sex | Same effectiveness as Truvada | Better bone and kidney profile for some individuals |
| Primary Limitations | Potential for bone/kidney issues in some users | Same potential for side effects as Truvada | Approved only for anal sex in some contexts |
Conclusion
The question of who owns PrEP drugs? involves pharmaceutical innovation, public funding, and legal challenges. Gilead Sciences holds original brand patents and reached a settlement with the U.S. government. However, the landscape now includes generic manufacturers like Teva and Amneal offering more affordable options following Truvada's patent expiration. This demonstrates the tension between incentivizing innovation through patents and ensuring public access to medical advancements, particularly those benefiting from public funding.
Visit the Department of Justice Website for information on the settlement agreement with Gilead
