Capsule: Get Ready for a Gilead, HHS Truvada Patent Shootout

Welcome to Capsule, where we’ll give you your weekly dose of what to watch out for in the health-care space. Each Monday reporters Jacquie Lee and Madison Alder get you prepped for the week’s hottest health-care topics.

Madison: It feels like Gilead Sciences is always making waves in the health world recently. Its latest move challenging the government’s patents for use of Gilead’s Truvada as HIV prevention could end up having a ripple effect. Shortly after President Donald Trump announced his plan to end HIV by 2030, advocates argued Gilead has been infringing government-held patents for HIV prevention for years. Gilead last week decided to fight the government’s claims and asked a federal patent office to review the Department of Health and Human Services patents.

Jacquie: It’s rare for a company to challenge a government-held patent and could open the floodgates for other such challenges. “Pharmaceutical companies are always looking for the greatest innovation—not just in the lab but also in the legal department,” Robin Feldman says. She’s a huge drug policy wonk who has testified extensively on Capitol Hill. “If Gilead succeeds on this front, other companies may follow suit,” she says.

Madison: Those challenges, if successful, could also affect the new iteration of Gilead’s HIV prevention medication, Descovy. A second round of “inter partes review” or IPR requests filed by Gilead on Friday ask the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board to look at the HHS’s more recent patents on HIV prevention, one of which includes the use of Descovy as HIV prevention. Whether that patent actually covers Descovy as pre-exposure prophylaxis, or PrEP, is ultimately up to a judge to decide, a Gilead spokesperson tells me.

Jacquie: In case you need a quick refresher: Truvada is the only PrEP drug on the market right now, but that could change soon. Gilead is asking the Food and Drug Administration to approve Descovy as PrEP. Right now it’s used to treat people who already have HIV.

Neither drug is more effective than the other at preventing the disease, but Descovy’s PrEP clinical trial showed signs that Descovy as prevention could be easier on people’s bones and kidneys than Truvada. It’s not clear whether those signals will play out in clinical outcomes, but Descovy’s safety profile has been a major selling point for Gilead.

Madison: In Gilead’s eyes, the government’s patents shouldn’t exist in the first place. The family of patents held by the HHS is built on government research that Gilead says didn’t find any novel uses for its drugs. Using Truvada as PrEP was being suggested long before the HHS’s research proved the effectiveness of that use, the company says. But others aren’t so sure Gilead has a shot. Patent attorney Chris Morten tells me it’s not likely Gilead will win its challenges. Morten previously analyzed the government patents and determined they were perfectly sound.

Jacquie: Remember that drug companies are doing a lot of the heavy lifting in the innovation space—like running huge clinical trials and commercializing the drug—which is all expensive and doesn‘t always pan out. But the government is a huge player in the drug industry too. Research funded by the National Institutes of Health was associated with every one of the 210 new drugs approved by the FDA between 2010 and 2016.

What Else We’re Watching:

Remember PhRMA—the drug lobby for brand medicines—is meeting with the Office of Management and Budget today to discuss bringing global drug prices to the U.S. We’ll be watching this closely, so if you’ve got thoughts, make sure to send them our way.

Today’s also the day an Oklahoma judge will decide whether Johnson & Johnson is liable for the opioid epidemic in that state.

And in e-cigarette news: Someone has officially died from vaping. So expect to see more health officials and politicians call for answers and federal investigations into their safety.