Pushing the limits of patent protection

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Some methods of extending exclusivity rights raise legal and ethical questions

Developing new drugs is hard. It’s also expensive, and seemingly getting more so. Therefore it’s only natural that companies will try to wring as much value out of the few drugs that make it all the way to market.

There are various ways to do that, and various mechanisms in place through regulatory bodies to legitimately reward companies with extended market exclusivity. Qualifying for these lucrative extensions rightly requires investment and innovation on behalf of the company.

One of the more more controversial is to discover a different disease that your drug works to treat, and get a new patent, with the associated exclusivity. This was what Warner-Lambert (now part of Pfizer) did with epilepsy drug Lyrica (pregabalin). The company found the drug might be good for treating certain types of pain, so applied for a second use patent, and eventually launched the drug, with the associated monopoly.