Because it’s in fascism?

Upfront disclaimer: I work for a small pharma company (I’m one of the guys in the lab trying to design new drugs), so take my comments as you will.

It’s really worth reading the linked pdf in the article that has the summary of the GHJP findings. It’s a little dense if you’re don’t have some familiarity with pharmaceutical patents, but it’s ultimately only two pages and paints a rather different picture than the summary.

Before going into details, it’s worth laying out a general picture of what’s involved in pharmaceutical patents. There’s almost never just a single patent around drugs, but multiple overlapping patents. The most fundamental type is a composition of matter patent, which describes what the actual chemical is that’s the active ingredient in the drug. Beyond that, though, you’ll also usually have formulation patents (describing the crystalline form if there is one, and any additives that are compounded with the active ingredient to form the actual drug product sold), process patents (describing the manufacturing process for making the drug product on scale), and sometimes patents describing new uses for drugs.

The patent situation around Truvada is particularly complex. Truvada is actually a combination of two different drugs- tenofovir disoproxil and emtricitabine. Tenofovir was actually patented back in 1984 in the Czech Republic; while it showed activity against HIV in in vitro studies, it doesn’t look like it was ever taken into clinical trials to try to get it approved as a drug. It wasn’t until it was off-patent, in 1997, that it was shown to have anti-HIV effects in humans through a collaboration between Gilead and UCSF. However, tenofovir itself has poor pharmacokinetics (how the body absorbs, distributes, and metabolizes a drug), and because of that Gilead modified it to create a pro-drug, tenofovir disoproxil, which is what is used in Truvada. Gilead holds the composition of matter patent on tenofovir disoproxil, although I believe this patent has either expired or is close to expiration.

Emtricitabine was discovered independently by a team of researchers at Emory University, and was then licensed to a small company called Triangle Pharmaceuticals for development in 1996. Triangle Pharmaceuticals was acquired by Gilead in 2003, right around the time development of emtricitabine was finishing up (it was also approved by the FDA in 2003). The composition of matter patent on emtricitabine has also expired.

There are also formulation and use patents for the combination of tenofovir disoproxil and emtricitabine as a fixed dose therapy, which is what could be considered the actual "Truvada patent". Gilead owns this patent and it was due to expire in 2017, although Gilead was trying to get it extended (I’m not fully caught up on the status of this fight).

The patent the CDC owns, which this article discusses, is a use patent, describing the use of Truvada for pre-exposure prophylaxis (PrEP)- in plain language, treating people who are not infected with HIV yet to reduce the risk of infection if they’re exposed to the virus. There are actually three patents the CDC owns around this, the first of which was issued in 2015. What this patent would allow the government to do (which they have currently declined to do), is to file patent infringement suits against any companies (Gilead and generics) that have been selling Truvada specifically for the purpose of PrEP from 2015 and onwards. If the government prevailed in these infringement suits they would be able to ask for damages plus impose licensing fees on any further sale of Truvada for PrEP. They could alternatively offer to waive these damages and fees in exchange for concessions (such as the companies selling the drug at reduced prices). What the actual effect of these actions would be depends on the details of the sales of Truvada- it could result in reduced prices if agreeing to that condition proves the most profitable course for the companies involved; it could result in higher prices if the government just decides it wants a cut of the profits; it could result in Truvada no longer being offered for PrEP if there aren’t enough PrEP sales to make the hassle of continuing to deal with the situation worth it to the companies involved.

I’ll let everyone sort out their own feelings on how they believe the government should act in this situation.

For those who have managed to read this far, thank you for taking the time to do so, and I hope that this has proved informative, and above all has demonstrated the importance of understanding the finer details in situations like this. As someone who works in the pharmaceutical industry I’d just like to say that there are a lot of good people and companies in it that are trying their hardest to do solid science and develop new medicines for people, while contending with many of the harsh economic realities in the industry. There are also, unfortunately, also a lot of bad people and companies in the industry who are trying to use the deficiencies in our healthcare systems, legal systems, and regulatory systems to wring out as much profit as they can regardless of the cost to patients (both monetary cost and health costs). The reasons for most of the issues with healthcare and the pharmaceutical industry are complex, with the enabling factors cutting across many legal and regulatory areas, and because of this it is important to take the time to try to understand the details in order to meaningfully discuss the source of the problems. I would implore those reading to dig deeper on stories like this to better understand just what the actual problems are.