Tuesday, November 12, 2019 - Truvada (tenofovir) is used to treat and prevent the spread of HIV. Truvada pills must be taken daily and used in combination with other safe-sex practices to be effective. The Trump Administration has partnered with Gilead Sciences maker of the anti-HIV PReP drug Truvada to make the drug available in limited quantities for free to individuals who do not have health insurance. Both parties appeared to be cooperating and working with the Center for Disease Control (CDC) to get have the drug on hand and available in early 2020. It came as a shock to many the other day when the US Department of Justice (DOJ) filed a lawsuit claiming the rights to the patent for Truvada because the drug was discovered and developed by scientists at Gilead using US taxpayer grant money. At the very least the US government feels that it is entitled to a royalty on the sales of Truvada. The government's lawsuit claims that Gilead was required to apply for a license to use the government's Truvada patent and instead relied on their claim to the patents. According to ScienceMag.org, "Gilead has profited from research funded by hundreds of millions of taxpayer dollars, but has not paid any royalties to CDC. The lawsuit contends that Gilead's conduct was malicious, wanton, deliberate, consciously wrongful, flagrant, and in bad faith." The most interesting twist in the Truvada patent fight is the logic behind Gilead laying claim to the patent in the first place. Truvada broken bones found to cause osteoporosis which can also cause the bones to become brittle and possibly break.
To understand Gilead's motivation behind claiming the Truvada patent for themselves, it helps to understand what Truvada originally intended to accomplish and the way that the drug's usefulness has morphed over the past decade. Preventing the spread of HIV may today seem like it is the obvious feature of Truvada when in fact HIV prevention is an unintended benefit. Truvada was originally discovered and developed for use by people who already had HIV to stop the virus from developing into full-blown AIDS, a condition thought of before Truvada as a guaranteed death sentence. Gilead contends that the original US government patent for Truvada is invalid as the drug's purpose has changed to being a preventative treatment, not as the treatment for HIV that was originally intended. Gilead attorneys argue that the four original patents underpinning Truvada are invalid since the drug has been modified and repurposed. Gilead claims full ownership of the new patents.
The DOJ lawsuit has put the issue of who owns Truvada's patent into the hands of a federal judge and it could take years to litigate. If Gilead's Truvada patent claims are overturned it could mean that the Federal government may nationalize the production of Truvada and make the drug available in meaningful quantities for much less than the $20,000 annual price tag Gilead now charges in the US.
OnderLaw, LLC is a St. Louis personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. The Onder Law Firm has represented clients throughout the United States in pharmaceutical and medical device litigation such as Pradaxa, Lexapro and Yasmin/Yaz, where the firm's attorneys held significant leadership roles in the litigation, as well as Actos, DePuy, Risperdal and others. The firm has represented thousands of persons in these and other products liability litigation, including DePuy hip replacement systems, which settled for $2.5 billion and Pradaxa internal bleeding, which settled for $650 million. The Onder Law Firm won over $300 million in four talcum powder ovarian cancer lawsuits in St. Louis to date and other law firms throughout the nation often seek its experience and expertise on complex litigation.