State’s high court listens to oral arguments in tenofovir lawsuit
Editor’s note: The California Supreme Court is set to hear oral arguments May 6 in a lawsuit against Gilead Sciences filed by about 24,000 people living with HIV who were taking tenofovir disoproxil fumarate (TDF), a drug that’s a component of such HIV medications as Truvada and Viread. The plaintiffs allege that Gilead intentionally delayed development and release of a newer version of the drug—tenofovir alafenamide (TAF)—in order to maximize profits from the older formulation. TDF has been associated with bone and kidney toxicity in some patients, primarily on boosted regimens. (Note that the fixed dose combination of TDF and emtricitabine, under the brand name Truvada, has been safe for the vast majority of people.) Gilead has denied any such delays, arguing that its research and development timelines were consistent with standard scientific and regulatory processes and that its medications were approved as safe and effective by the U.S. Food and Drug Administration.
The case raises novel legal questions about whether a pharmaceutical company can be held liable not only for the safety of an approved drug, but also for decisions about when—or whether—to develop potentially safer alternatives and bring them to market. Lower courts have allowed key claims to proceed, including allegations tied to failure to warn against bone and renal side effects, setting the stage for the state’s highest court to weigh in. Advocates say the outcome could have far-reaching implications for patient rights and corporate accountability, while industry groups warn it could discourage future drug development and innovation.
nFIRST PERSONn COMMENTARY
Imagine that a safer version of a medication you need to take has been discovered. How important and urgent would it be for you to have access to that medication, particularly if you’ve experienced consequences like bone loss or kidney damage due to your current medication?
Now imagine that one pharmaceutical company owns both medications—the new one that promises to be safer and the current one which is associated with a significantly increased risk of injury or death. If that company decided to halt development of the newer medication for five to ten years to maximize profit from the older medication first, how would that feel?
For 24,000 people living with HIV who are suing pharmaceutical behemoth Gilead Sciences, this isn’t a hypothetical scenario. They experienced real, measurable health consequences due to Gilead’s decision to halt the development of a newer form of a medication called tenofovir. The company’s motivations are also not hypothetical or speculative: their intentions were clearly outlined in an unearthed internal memo that explicitly outlined how the company planned to delay development of the newer medication to time market introduction with the end of patent protection for the older version of tenofovir. Why would Gilead delay a safer version of the drug? Money.
This strategy, often called a “patent hop,” incentivizes pharmaceutical companies to delay innovation of promising compounds for business reasons, with no regard to the safety and well-being of patients. And at present, there is little protection for patients in this particular scenario.
The case brought by people living with HIV against Gilead could change that. On May 6, the California Supreme Court is scheduled to hear oral arguments and ultimately determine if patients have a right to hold a company accountable for avoidable harm they experienced due to a patent-hopping strategy.
The plaintiffs’ case has already been upheld in a lower court, but pro-pharma forces have been hard at work to protect the status quo. Several misleading pieces in Forbes, the Wall Street Journal and elsewhere have glossed over important details to make it sound as if the patients involved in the case are irrationally upset over the pace of innovation, that Gilead simply wasn’t inventive fast enough. Forbes has shown significant bias, taking down an excellent commentary in support of the case in January while allowing several misleading pro-pharma op-eds to be posted.
That biased lens, which strips from the narrative the clearly delineated patent hop strategy mapped out by Gilead’s own internal documents, distorts the potential ramifications of the case, sounding the alarm that corporations of all kinds will be sued for being slow to invent new products. That is an overstated view of a case where a healthcare company has already developed a promising new medication that it then holds hostage, all while knowing that patients taking their patent-protected product are experiencing harmful side effects that they believe they could fix by bringing a new product to market.
This case has nothing to do with a “duty to innovate.” The appellate court stressed this distinction, stating that “[p]alintiffs do not claim that a manufacturer…has a legal duty to invent a safer alternative drug.” Their case is “premised on Gilead’s possession” of a less-toxic alternative that it “with[held] from the market. Gilead did not withhold the new drug because of scientific uncertainty; it did so because it knew the safer drug would “only cannibalize” sales of the older drug.
It is worth noting that the degree to which Gilead believed its timely development of the newer form of tenofovir would have benefited patients also isn’t hypothetical. Their own commissioned study estimated that delaying development by 9 years could have led to 16,000 excess deaths and 150,000 excess kidney and bone injuries.
As the California Supreme Court weighs the case, the justices will hopefully see past the fear-mongering and false narratives and put themselves in the shoes of the 24,000 people living with HIV behind the case. If the justices—or their family members—were forced to wait for a newer, better treatment to replace an existing, essential medication that had harmful side effects, wouldn’t they want a legal precedent that protects patients and challenges a company’s business decision to place profits over people? Or would they settle for waiting until a drug company’s business strategy was played out a decade later before the better treatment finally came along?
Jeremiah Johnson is executive director of PrEP4All. He has been advocating for communities affected by HIV since his own diagnosis in 2008. Since joining PrEP4All, he has led the organization’s fight for a National PrEP Program for un- and underinsured populations.