An interesting situation seems to be developing since the Justice Department filed a lawsuit in federal court in Delaware against Gilead Sciences for patent infringement in respect of Truvada for PrEP (pre-exposure prophylaxis). Truvada is prescription medicine that can help an HIV-negative person reduce the risk of getting HIV-1 through sex, when taken every day and used together with safer sex practices.
In March 2019, the Washington Post headlined the news that Gilead had a rift with CDC and National Institutes of Health over the infringement of Truvada patent. It also brought to the government’s notice that HIV/AIDS researchers and activists were disappointed with the US government’s inaction on the issue even though the patent was awarded in 2015.
The US government claims that the Centers for Disease Control and Prevention (CDC) received patents for Truvada in 2015. It accused Gilead of not obtaining a license from the CDC to use the patented regimens. It also accused Gilead of enriching its coffers by pricing the drug at $21,000 per year per user. Gilead is reported to have recorded $5 billion in sales for the pill in 2018.
Why did the US government to sue Gilead?
A recent Superdrug survey revealed that the average number of sexual partners for men and women in the United States is 7.2. Though there is no definitive study to correlate sex with multiple partners and sexually transmitted infections (STI,) it is advisable to take precautions to ensure safe sex practices. These may include using condoms for various types of sex, exchanging information about sex proclivities and history, taking PrEP pills and taking antiretroviral treatment (ART).
Another study authored by J. S. Santelli and supported by the CDC concluded, “[d]ata have several implications for the prevention of STD infection and unintended pregnancy among adolescents. Both well-to do and poor adolescents are at risk for STDs and pregnancy; thus, certain prevention efforts such as health education should be universal.”
An important statistic from World Health Organization (WHO) which is that worldwide more than 1 million Trusted Source STIs are acquired every single day although many of these don’t cause symptoms.
Basic statistics from the CDC indicate that an estimated 1.1 million people in the United States had HIV at the end of 2016 out of which 14% did not know that they had HIV. Deaths reported on account of HIV stood at 15,807. In 2017, people in the age group 13-24 accounted for 21% of all new HIV diagnoses. In 2017, 38,739 people received an HIV diagnosis in the United States and dependent areas. The annual number of new diagnoses declined 9% from 2010 to 2016 in the 50 states and the District of Columbia.
Since PrEP is 99 percent effective in preventing HIV infection, the intense sales promotion to promote products and services by manufacturers would be useful to motivate people who want to indulge in regular sex with multiple partners to take PrEP provided they could afford the US$21,000 per year price tag.
The Trump administration has set an objective to ensure zero new cases of HIV and AIDS by 2030. The administration’s main strategy is to make available Truvada for PrEP to all. In order to do this the administration has to make the pill affordable, if not free.
From the foregoing it is clear that widespread usage of Truvada for PrEP would be a game changer for the Trump administration to achieve its objective of eradicating HIV from US.
It is possible that the administration saw merit in the pleadings of HIV/AIDS researchers and activists and the president saw his presidential approval rating go up substantially if incidence of HIV is contained. Therefore the administration decided to file the Truvada lawsuit.
It may be noted that Gilead Sciences already faces a lawsuit against the dangerous side effects of Truvada. Now, with the US government’s patent infringement lawsuit, the times are ominous for Gilead Sciences.