How Patent Thickets Block More Affordable Drugs: The Case of Humira

The drug manufacturer AbbieVie Inc. has thrown up a formidable shield of patents around its drug Humira, preventing cheaper versions of the medicine from coming to market. This patent abuse should not be allowed to stand, and Congress, the Department of Health and Human Services, and the Food and Drug Administration should stop this manipulation and enact reforms to combat further abuses.

Humira has been around for over fifteen years and is one of the world's best selling drugs, with over $18 billion in global sales. It is used to treat inflammatory diseases-everything from rheumatoid arthritis to gut disorders-and it is extremely expensive, with a list price of over $50,000 per patient. Humira is also a biologic medicine, meaning it is made from living cells in a process similar to brewing. It accounts for over 60% of AbbieVie's revenue.

The main patent for Humira (which gives the drug manufacturer a monopoly on the drug) expired in 2016, so you would think that consumers could now benefit from biosimilars (cheaper versions of this medicine analogous to generic drugs). But AbbieVie has obtained over one hundred additional patents for Humira, an incredibly number for a single drug, and these patents extend into the 2020s and 2030s. They have 22 patents for various treatments, 14 patents for the drug's formulation, 24 patents on its manufacturing practices, and 15 other patents. Moreover, the company has filed suit to block two biosimilar versions approved by the FDA.

This is a prime example of what FDA Commissioner Scott Gottlieb criticized as "patent thickets" that block biosimilars and generic drugs and thwart competition, making consumers pay much higher prices. The biosimilar versions of Humira would sell at a 10% to 25% discount, which could help a lot of people struggling to afford their medicines.

As a result, AbbieVie still has a monopoly on Humira, and its price has risen to over $60,000 annually for some patients, and that earns over $12 billion in sales in the United States. And they are not the only company doing this. The drug company Johnson & Johnson has also created a thicket of over 100 patents around the anti-inflammatory drug Remicade to block cheaper generic drugs and increase its profits. Evidence shows that patent abuse, where companies file many different patents and make small changes to drugs to extend their exclusivity, is a serious and growing problem.

In Europe, where the legal environment is more friendly to patent challenges, over 20 biosimilar drugs have been approved since 2006, with immense benefits for patients. In the United States, these "patent thickets" have choked off much of the market, and only five versions are available.

One way to reduce patent abuse would be to pass the CREATES Act, a bipartisan bill that would make it easier for medicines whose patents have expired to be sold as cheaper generic versions. It allows generic drug companies to sue patented drug companies to compel them to provide samples they need to make these cheaper versions.

Patents should be used to reward substantive research and real innovation, not to maintain a monopoly and force consumers to pay skyrocketing prices.