Patented fundamentals

It’s a tough competition, but few pharmaceutical topics have more nonsense spoken about them than patents. I’m not talking about patent law itself, although a spirited conversation between patent attorneys might leave an onlooker wondering. No, I’m talking about a confusion that goes all the way down to the fundamentals of what can be patented and why.

One place it’s especially in evidence is the situation with traditional medicines. You can find a lot of passionate opinions on the subject, the passion roughly correlating with the opinion that the drug industry (and its patents) are destructive, money-grabbing agents of the Devil. I admit that I’ve known a couple of those in my time, but I don’t think that the pharmaceutical industry employs them to a greater extent than any other.

There are two common myths that largely contradict each other, although some people may be nimble enough to hold both simultaneously. The first is that drug companies aren’t interested in traditional medicines, because they can’t patent them. The second is that not only can drug companies patent traditional medicines, but they’re also cheating the original practitioners when they do. 

Let’s deal with those one at a time. The patentability of traditional knowledge is a very messy area, with varying interpretations in different parts of the world. Patentability improves greatly if a clear inventive step can be shown – something new that distinguishes the subject of a patent from what’s come before. Given the often ill-defined state of the art in the field, there are plenty of opportunities for invention; any company that seriously wanted to patent an ancient medicine could surely find a way.

This leads to the second misconception. One of the clearest inventive steps is purification and isolation of a new active compound, which is just what a company would want to do with a traditional remedy anyway. If the beneficial effects are due to a single constituent, then discovering what that is should be worth something. Moreover, that natural product can often be improved, like the development of aspirin from the salicylic acid in willow bark.

But that brings us to one of the real reasons that drug firms aren’t as interested in this area as they might be: what if the activity isn’t due to just one or two constituents? There are many cases where a whole plant preparation might have an effect, but none of its fractions is useful alone. Since many ancient medicines are mixtures of many different materials, you could have a problem that might not be worth solving unless the activity involved is impressive. 

And that’s another problem. You wouldn’t get this impression from the popular press, but ethnobiologists and natural product chemists know the truth: most traditional remedies aren’t very efficacious. It may be a bit culturally insensitive to point that out, but it’s true, and it’s no disgrace.

Think of the pre-modern state of medicine in the West, when Oliver Wendell Holmes pointed out that if all the medicines known in his day could be tossed into the sea, it would have been ’so much the better for mankind – and all the worse for the fishes’. 

But what about those times when something good does emerge? When a marketed therapy is developed from a traditional lead, it’s generally been altered tremendously along the way.

If a particular dried root is known by some culture as medicinal, that amounts to furnishing a discovery lead, not a final compound. There’s a lot of work to get past, because the capsules that make it to market aren’t filled with ground roots: finding the active components, determining how they work, modifying them for better absorption and toxicity profiles, and finding a viable production route for them, for starters. 

That said, I think that the people who identified the drug lead should be compensated for that. Good drug leads are valuable things, although a lot more value is added to them on their way to becoming drugs.

Even that value isn’t a stable thing, though, because patents, with their set lifespan, are the very definition of a wasting asset. And keep in mind what happens to patented non-traditional compounds – other companies take a look at them and try to follow up with something similar but better.

Traditional remedies, in other words, can come out of one jungle only to land in an even bigger one. 

Derek Lowe is a medicinal chemist experienced in preclinical drug discovery