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Is IP Rewarding Wrong Part of Drug Discovery Process?

By Anette Breindl
Science Editor

Intellectual property (IP) is a cornerstone of the drug discovery industry. But as that industry is changing, some are questioning whether that cornerstone is starting to do more harm than good, at least the way it currently is constructed.

Though it is not the only type of patent, composition of matter patents are a major kind.

Most patented chemicals, though, never see the light of a pharmacy shelf, creating a mismatch between where value is realized, and where it is rewarded by the patent system.

In the era of vertically integrated pharmaceutical companies, that mismatch didn't matter, because in the rare case where a patented chemical made it to approved blockbuster, "everyone in the company benefited, not just the chemists," Garret Fitzgerald told BioWorld Insight.

Today, though, with drug discovery fragmented between academia, biotech and the pharmaceutical industry, those patent rights as often as not create a monkey trap of sorts. Holding onto a chemical compound for dear life makes it unlikely that its value will ever be realized.

"We have huge amounts of patented material sitting in freezers," Fitzgerald said, stuck in limbo because of its patent protection.

Fitzgerald said the situation is also hindering the repurposing of drugs, which is one way that industry is trying to improve its batting average. (See BioWorld Insight, Oct. 22, 2012.)

The National Center for Advancing Translational Sciences, for example, has a pilot program for discovering new uses for existing therapeutic molecules, where eight pharmaceutical companies have agreed to make patented compounds available for testing in new indications – but "there's no commitment by anyone as to what happens afterwards."

In the Oct. 26, 2012, issue of Science, Fitzgerald has published a suggestion for how to deal with the mismatch. The value of the compound, rather than being concentrated in the chemical compound by way of a composition of matter patent, should be allocated among all its developers depending on where the biggest challenges in its development turn out to be.

Where those challenges are, of course, is not clear in advance. Fitzgerald said that the best way to deal with the uncertainty is to estimate where roadblocks will lie, and divvy up the hypothetical spoils at the beginning of the process, but then keep refining that division as actual data come in.

The current system, of course, tries to do something of the sort, with investments at different stages of drug's life cycle bringing different returns in the event of success. But Fitzgerald said that given the many places where unexpected challenges can crop up, allocating value in advance introduces precisely the sorts of uncertainties that keep development from going forward at all.

In his model, "you postpone the allocation of resources until value is realized," he said. "But you buy into this process on the front end."

Fitzgerald said that this approach would have several advantages. For one thing, a version of this system has worked in nonprofit drug development. In his paper, he gave Medicines for Malaria and the nonprofit drug development company Institute for One World Health as examples. Both of which, he wrote, "the collapse of IP barriers, adherence to timelines, and hand-off of results to the next partner in the chain of production" have enabled several drugs to advance rapidly into the clinic.

Focusing on the approved drug and the actual challenges along the path also offers a way to navigate the more fragmented drug discovery process that is replacing integrated development by one large company.

It answers the question of "how do you engage the best people to work with you? They do not work in one company, or one university, or, usually, in one country." And they are not motivated solely by money. "Their priorities lie elsewhere," he said – most often in the wish to do challenging and/or important work.

Finally, the suggestions can be implemented under the current patent laws. Fitzgerald said it would be better if those laws were changed. "I'm not saying the patent laws shouldn't be rewritten," he said. But if that's not in the cards, "you don't actually have to rewrite the patent laws for this to work."