OPINION
10/28/2018 06:00 am ET

A Humira Prescription Costs $38,000 A Year Because Our Patent System Is Being Abused

ASSOCIATED PRESS

Sue Lee, 76, has plaque psoriasis, an incurable, chronic skin condition that causes itchy, painful sores. To give her some relief, Lee’s doctor prescribed Humira, a patent-protected drug with no generic option. In 2012, the drug cost about $19,000 a year. Today, it costs more than $38,000 a year. Even with Medicare, Lee, who retired last year and lives in Kentucky, would have to drain the little savings she has in order to afford the drug.

Retirement should be the peaceful denouement of a lifetime of work. Instead, millions of seniors are being forced to draw down on their retirement savings or forgo necessities like food and rent to pay for arbitrarily and mercilessly high-priced prescription drugs. Some skip doses to make ends meet or, like Lee, simply suffer in silence. As the proportion of seniors to the total population grows, the problem is only going to get worse.

Not surprisingly, older Americans are hit especially hard by high drug prices. People ages 65 and older use far more prescription drugs than younger Americans; at any given time, older Americans are taking an average of 4.5 different prescriptions. Seniors are also three times more likely than those in their 20s to need costly specialty drugs, like Humira, that treat relatively uncommon conditions and have few, if any, generic alternatives. Making matters worse, over the last decade drugs widely used by older Americans have tripled in price on average, far exceeding the rate of inflation.

With 1 in 5 Americans expected to be 65 or older by 2030, the country is staring down the barrel of a massive health care and fiscal crisis.

There are a lot of reasons why drug prices in the U.S. are so high. They aren’t regulated, so pharma companies can and do set prices as high as they want. And Medicare, the largest purchaser of drugs, is forbidden from negotiating those prices down. But another important and often overlooked factor is the ongoing manipulation of our patent system.

An analysis released last month by my organization, the Initiative for Medicines, Access & Knowledge, shows that there have been an astonishing 247 patents filed on Humira, nearly half of them in just the last four years. Richard Gonzalez, CEO of the drug’s maker, AbbVie, has said that “any company seeking to market a biosimilar version of Humira will have to contend with this extensive patent estate, which AbbVie intends to enforce vigorously.” In other words, the company has created such a morass of patents around Humira as to deter generic competition in the U.S. for years to come.

It’s a deliberate strategy designed to prolong the company’s monopoly, and AbbVie isn’t alone in using it. In a separate report released by I-MAK in August, we found there are an average of 125 patent applications filed and 71 patents granted for each of the 12 highest-grossing drugs in America. In many cases, these “add-on” patents were for minor or obvious modifications — a different dosage form, for example — that don’t meet the standard for breakthrough invention that the patent system was designed to reward. Still, they have often succeeded in prolonging exclusivity well beyond the 20 years of protection intended under U.S. law. For example, the U.S. patent on Humira expired in 2016, but add-on patents and reported settlements made with generic suppliers will keep generic alternatives out of reach of patients until at least 2023.

For Lee in Kentucky, the high cost of Humira in the U.S. means her psoriasis hasn’t been treated in nearly a year. When the sores get really bad, she puts ice packs on her body, sits at her desk and fights back tears.

With 1 in 5 Americans expected to be 65 or older by 2030, the country is staring down the barrel of a massive health care and fiscal crisis. Unless something is done to stop frivolous patents from delaying generic entry, Medicare and the millions of seniors who rely on it will experience unprecedented strain.

Overpatenting is a problem that needs to be brought into full public view, starting with our representatives in Congress holding hearings so that patent abuse can be exposed. Right now, America’s patent system is far more sympathetic to claims of “originality” than those of other countries, and less likely to consider public health impact. It will ultimately take a motivated and mobilized citizenry to enact the necessary reforms to stop this root cause of high drug prices.

If we don’t act now, every one of us will one day face the nightmare of not being able to afford and access the medicines we need. For the millions of Americans like Lee who are in desperate need of relief, that nightmare is right now.

Priti Krishtel is the co-founder and co-executive director of I-MAK.org, a global nonprofit organization of attorneys, scientists and health experts who have worked to lower drug prices for 15 years.

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