Medicine Information

By Kristen Osenga

Americans overwhelmingly believe that prescription drugs cost too much. But they're divided about the source of the problem -- and the potential solutions.

Certain activists pin the blame on our legal system and accuse Big Pharma companies of using their armies of lawyers to construct "patent thickets" -- supposedly a series of overlapping patents that prevent brand-name drugs from facing generic competition for decades, even after the original patents on the medicine have long since expired.

One such activist group, the Initiative for Medicines, Access, and Knowledge (I-MAK), recently released a report, Overpatented, Overpriced, arguing that these "patent thickets" are to blame for high costs at the pharmacy counter.

While I-MAK's narrative is politically slick, it simply isn't true. The patent thicket argument sounds plausible to many people. Attempting to create a generic version of a brand-name drug without inadvertently violating one of dozens of patents sounds like walking through a legal minefield. Many generic manufacturers might conclude it's not worth it.

But I-MAK's patent thicket boogeyman is fictitious. Consider Lyrica, prescribed for nerve and muscle pain. I-MAK says that Lyrica has been granted 68 patents. But the FDA's "Orange Book" -- the definitive listing of drug patents -- has only ever listed a total of seven unique patents between Lyrica and Lyrica CR.

I-MAK's narrative relies on an unstated premise that filing many patents is a tell-tale sign of cheating the system.

Nothing could be further from the truth. Multiple patents associated with a single drug often represent innovation that's taken place long after FDA approval.

It's no secret that drug manufacturers regularly continue to innovate drugs long after they're originally proven safe and effective. Botox, for example, was originally approved to treat two rare eye disorders. Three decades later, it has 11 FDA-approved indications, including overactive bladder and lower limb spasticity caused by cerebral palsy. These follow-on innovations often entail additional patents. Drug companies wouldn't have the incentive to make these improvements and conduct the hugely expensive clinical trials needed for FDA approval, if they were prohibited from patenting the improved versions.

Importantly, these additional patents don't affect the original version of a drug. If a company patents a once-a-month injectable version of a medicine, that doesn't extend the patents on an older pill version, for instance.

Sadly, I-MAK's leaders don't seem to think this continued innovation is worthwhile. Many people living with chronic, difficult-to-treat illnesses would disagree.

Consider HIV patients. Until recently, people living with HIV were forced to follow a complicated treatment regimen involving multiple pills each day. But now, thanks to ongoing innovation, some patients are able to maintain a suppressed viral load with injections every other month. A lot of this progress can be traced to improved delivery methods for existing medicines, rather than the invention of brand-new drugs.

Promoting access to medications is a noble cause. But setting fire to America's world-leading patent system won't lead to cheaper medicines -- it'll lead to fewer medicines, as companies drastically scale back research and development.

Kristen Osenga is the Austin E. Owen Research Scholar & Professor of Law at the University of Richmond School of Law.

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