Amgen Claims It All

There’s plenty of excitement about PCSK9, the latest LDL-lowering pathway to make it deep into the clinic. You can tell that companies (and investors) have high hopes for it, since it’s heading right into a market that’s dominated by generic statins. The optimism may well be justified – for example, Sanofi and Regeneron recently presented some impressive data comparing their antibody to Zetia in patients who can’t take higher statin doses, and Amgen has shown similar numbers. There are at least five antibodies and one RNAi in development, in a very tight race to the FDA and to the market. To give you an idea, the latest development was Sanofi and Regeneron paying cash to Biomarin for an FDA priority voucher that reduces their review time to six months instead of ten. (No, I didn’t know that you could do that, either).
Amgen, though, appears to be trying to own the whole racetrack. They’re pushing a patent claim to any antibody to PCSK9, not just their own agent. Update: See below for more on this Here’s their press release; they’re quite up front about this strategy. But I have doubts about how well that’s going to work. Over the years, the judicial trend seems to have been to not go for such broad claims in the biomedical field. There are so many potential antibodies to any given protein, and so many ways of modifying them and dosing them, that I find it hard to imagine a straight patent claim on all that space. It’s a lot like claiming “All inhibitors of enzyme X” in small molecules, and we already know that such claims don’t stand up. It wouldn’t surprise me, in fact, if someone had already tried a broad antibody claim like this and had it shot down (does anyone have an example?)
So I don’t think that the PCSK9 struggle is going to be decided by the patent lawyers. It looks to be fought out in the clinic, at the FDA, and especially out there in the real market. And it will be quite something to see.
Update: see the comments section. Amgen doesn’t seem to be claiming every single antibody; just those against a particular epitope (although a very useful epitope, obviously). And patent litigation in such situations is complex, with precedents (none of them necessarily exact) going both ways. So this will be quite something to watch. Perhaps Amgen is hoping to paid a cut to go away?