What a mess there is in the hepatitis C world. Gilead is, famously, dominating the market with Sovaldi, whose price has set off all sorts of cost/benefit debates. The companies competing with them are scrambling to claim positions, and the Wall Street Journal says that AbbVie is really pulling out all the stops. Try this strategy on for size:
In a lawsuit filed in February, AbbVie noted it patented the idea of combining two of Gilead’s drugs—Sovaldi and an experimental drug called ledipasvir, which Gilead plans to combine into one treatment—and is therefore entitled to monetary damages if Gilead brings the combination pill to market. Legally, AbbVie can’t market Sovaldi or ledipasvir because it doesn’t have the patents on the underlying compounds. But it is legal for companies to seek and obtain patents describing a particular “method of use” of products that don’t belong to them.
Gilead disputes the claims of AbbVie and the other companies. A spokeswoman said Gilead believes it has the sole right to commercialize Sovaldi and products containing Sovaldi’s active ingredient, known as sofosbuvir. An AbbVie spokeswoman said the company believes Gilead infringes its patents, and that it stands behind the validity and enforceability of those patents.
You don’t see that very often, and it’s a good thing. Gilead is, naturally, suing Abbvie over this as well, saying that Abbvie has knowing mispresented to the USPTO that they invented the Gilead therapies. I’m not sure how that’s going to play out: Abbvie didn’t have to invent the drugs to get a method-of-use patent on them. At the same time, I don’t know what sort of enablement Abbvie’s patent claims might have behind them, given that these are, well, Gilead’s compounds. The company is apparently claiming that a “sophisticated computer model” allows them to make a case that these combinations would be the effective ones, but I really don’t know if that’s going to cut it (and in fact, I sort of hope it doesn’t). But even though I’m not enough of a patent-law guy to say either way, I’m enough of one to say, with great confidence, that this is going to be a very expensive mess to sort out. Gilead’s also in court with Merck (and was with Idenix before Merck bought them), and with Roche, and will probably be in court with everyone else before all this is over.
This whole situation reminds me of one of those wildlife documentaries set around a shrinking African watering hole. A lot of lucrative drugs have gone off patent over the last few years, and a lot of them are heading that way soon. So any new therapeutic area with a lot of commercial promise is going to get a lot of attention, and start a lot of fighting. Legal battles aren’t cheap on the absolute scale, but on the relative scale of the potential profits, they are. So why not? Claim this, claim that, sue everybody. It might work; you never know. Meanwhile, we have a line forming on the right of ticked-off insurance companies and government health plans, complaining about the Hep C prices, and while they wait they can watch the companies involved throwing buckets of slop on each other and hitting everyone over the head with lawsuits. What a spectacle.