News Release

Patents on 7 Out of 10 Top Drugs Set to Expire This Decade: What Next?


A new report about abuses of the patent system by pharmaceutical companies in the United States includes comprehensive patent data for 10 top-selling drugs. The report was released by I-MAK (the Initiative for Medicines, Access and Knowledge). 

TAHIR AMIN;, @realtahiramin
    Amin is the founder and executive director of I-MAK, a nonprofit working to address structural inequalities in how medicines are developed and distributed. 

I-MAK’s report, Overpatented, Overpriced, shows that although the patents on 7 out of 10 of the 10 highest selling drugs in the U.S. are set to expire this decade, without urgently needed patent reforms, pharmaceutical companies will be able to delay those expirations––making it nearly impossible for biosimilar generic drugs to come on the market, shutting out competition, and keeping drug prices high. 

Before the expiration date arrives, companies can file hundreds of patents, creating what I-MAK calls “patent thickets.” Companies create thickets by creating a web of barriers for competitors. “As long as these anti-competitive patenting practices remain legal,” the authors write, “the drug pricing crisis will persist.” 

I-MAK found that drugmakers filed more than 140 patent applications on average per drug; two-thirds were filed after the drug had already been approved. Years later, once a primary patent has expired, companies can continue raking in astronomical profits by extending the patent period. This has become the “integral model,” Amin said, “for pharmaceutical companies to delay competition––and to delay having to go back to the drawing board and actually create new therapies. They don’t have to do the real investment of making new drugs.”

Amin told the Institute for Public Accuracy that the report and database tools will help the public to understand the full patent landscape. Amin highlighted the finding from the report that “Europeans have been able to get competing products on the market” for several drugs that are still locked in patents in the United States. For three top-selling drugs, biosimilar and generic drugs came on the market in Europe nearly eight years before they were expected to in the U.S.; the American public, meanwhile, “will spend an estimated $167 billion on branded versions of just these three drugs.”

Now that the Inflation Reduction Act has become law, Amin suggests that the next step is to address patenting abuse. There are several key reforms that I-MAK is pushing for:

  • Raise the bar for what it means to get a patent. “It shouldn’t be this easy,” Amin said, “to get all these patents.”
  • Greater public participation. “Right now, the system serves private client interests,” said Amin. 
  • Make it easier to challenge patents. Amin noted that this process has gotten prohibitively expensive.   
  • Reduce the number of times a patent application can be filed. By filing different applications (some that simply build on past ones), companies can slow down competition, because each patent is litigated separately.