The never-ending drip of pharmaceutical patents
As expectations for a COVID-19 vaccine grow, so too have concerns about access among the public and even politicians. Democratic presidential candidate Joe Biden recently pledged that if elected he would make sure patents did not block the ability of people outside the U.S. to get the vaccine.
It shouldn’t take a pandemic to recognise that patents can harm public health. Pharmaceutical companies have been exploiting the patent system for decades, regularly amassing dozens — and in some cases upward of a hundred — patents on a single drug for tweaks that are not especially inventive and which don’t make the drug therapeutically better. In some cases, these “patent walls” give companies a lock on the market for 30 years or more, stifling competition and driving high medicines prices that limit access.
As a lawyer who once worked for corporations creating and defending intellectual property, I’m often asked how companies can accumulate so many patents. To find out, my organisation the Initiative for Medicines, Access & Knowledge (I-MAK), analysed every patent in the portfolio of a drug called Imbruvica, a top-selling cancer medication acquired by AbbVie in 2015.
Our results reveal a pattern of patenting practices that we term a “drip” strategy, a common marketing practice of releasing information slowly over time to extract maximum benefits.
Imbruvica, which is projected to be the fourth highest grossing drug in the U.S. by 2024, has an annual list price of $174,000. Since 2013, when Imbruvica was first approved by the U.S Food and Drug Administration, total spending on the drug has exceeded $15 billion. There is a fortress of patents protecting it from competition.
Between 2006 and 2019, 165 patent applications were filed on the drug, 55% of which were after the drug was first approved. That’s the equivalent of one patent filed every month for the last 13 years, and there are undoubtedly more to come. To date, the U.S. Patent Office has granted 88 of them, giving AbbVie a 29-year monopoly on Imbruvica that, barring successful litigation by generics, will last until 2036.
In theory, patent terms are supposed to be 20 years for an invention. In practice, companies regularly get more than that. We took a close look to understand how AbbVie managed to gain an additional nine years of patent exclusivity.
The initial patent filing for Imbruvica was broad. Pharmacyclics, the original inventor, sought patent protection for treatment of two specific conditions but disclosed the possibility of more than 100 others. Since then, Pharmacyclics and AbbVie have filed dozens of additional patent applications, with only slightly more specificity than what appeared in the original patent.
Every patent gets the same 20-year period of exclusivity no matter how meaningful the so-called innovation. AbbVie was able to lengthen Imbruvica’s patent term by drip feeding information to stagger patent filings. The extra nine years of patent exclusivity could mean Americans spending an estimated $41 billion on AbbVie’s Imbruvica instead of benefiting from the savings from possible generic alternatives.
Of course, it’s possible that additional research conducted after the initial filing shed more light on the different indications and dosage forms. It’s also possible that Pharmacyclics and later AbbVie had a solid hunch about them from the start and took advantage of loopholes in the patent system to stretch their patent terms. Those loopholes include an ever-lowering standard for what is considered new and inventive and a one-size-fits all 20-year exclusivity period even for minor tweaks, like converting a tablet to a capsule
Policymakers have done little to close loopholes that incentivize these kinds of patent games, in part because the pharmaceutical lobby has successfully convinced them that more patents equals more innovation and more investment in R&D. It took 155 years for the patent office to issue its first five million patents. It took just 27 for it to issue the next five million.
We need and want pharmaceutical companies to invest in cutting edge research that improves people’s health and longevity. But while companies are patenting more, they’re actually inventing less. Nearly 80 percent of medicines associated with new drug patents are for old drugs, like insulin or aspirin.
Today’s patent system has become less of an engine for real invention than a tool for companies and their lawyers to exploit using sophisticated legal and marketing Jedi tricks while posturing “innovation.” These practices started long before the current pandemic. Unless Congress has the courage to finally raise the bar for the types of inventions that deserve a patent, they will continue long after.
Tahir Amin is the co-executive director of the Initiative for Medicines, Access & Knowledge (I-MAK) and works on systemic changes to intellectual property and the political economy of pharmaceutical innovation.
