Save the Public’s Right to Challenge Bad Patents Driving Up Drug Prices

Alex Moss | June 8, 2023

Patents are supposed to encourage scientific progress by giving limited monopolies to creators of new and useful inventions. But the Patent Office gets so many applications that it can’t them all carefully enough to avoid granting patents on things that are old, obvious, and useless. Once granted, these invalid patents can do incalculable harm. They stop others from creating and commercializing their own inventions, depriving the public of innovation, competition, and access to knowledge. That’s why Congress established a procedure for the public to challenge wrongly granted patents as part of the America Invents Act of 2011 (AIA).

Unfortunately, the public’s right to use this procedure is in danger. That danger comes from rules the Patent Office has proposed that would impose a host of new restrictions on the process for reviewing wrongly granted patents, including strict limits on who can challenge them. Together, these limits would make it all but impossible for individual Americans and organizations advocating for them to challenge invalid patents. These limits might benefit a handful of companies that profit from invalid patents, but they will harm countless Americans.

Limiting access to post-grant patent challenges would be especially harmful to those of us who depend on prescription drugs and medical devices. Post-grant challenges have been crucial to successful efforts to reduce drug prices. For example, prices for an important drug used to treat opioid use disorder, Suboxone (buprenorphrine and naloxone), dropped by 50% after a successful post-grant review combined with other litigation. Prices for an insulin injector pen dropped by 65% after the Patent Office confirmed that patents covering it should never have been granted. After another successful patent challenge to patents on an essential prostate cancer drug, generics became available for $2 to $19 per dose—compared to $88 for the brand version. If Americans lose access to patent challenges, they will lose access to life-saving medical care.

The only way to protect the public’s right to challenge invalid patents and access essential products and services is to convince the Patent Office to withdraw its proposed rules. To do that, we need you to speak out against those rules and in support of AIA patent challenges. You don’t need to be a scientist, a lawyer, or any kind of expert to tell the Patent Office what you think. You just need to care about your own health and wellbeing or that of your friends, families, or community.

There’s an easy way to tell the Patent Office what you think: submit comments online using the federal government’s online portal.

Here’s an example:

I oppose the new rules the USPTO has proposed for inter partes review and other post-grant review proceedings. The proposed rules should be withdrawn because they will make it more difficult for people to challenge invalid patents, which deter innovation, block competition, and artificially inflate prices, including for essential medical treatments. The USPTO should withdraw its proposal and, instead, propose rules that encourage people to challenge invalid patents and make it easier for them to do so. That is what Congress intended and what the American people need.

Feel free to cut-and-paste the example above, but comments that express your voice will be even more compelling. We encourage you to add a sentence (or more), describing any experience you’ve had with the patent system, including experiences you’ve had trying to access patented products and services.  We also welcome you to write your own comment entirely.

Restricting access to patent challenges will chill innovation and endanger the health of millions of Americans, but that is what the Patent Office is proposing to do. It needs to hear from you how harmful its proposed restrictions will be. Together, we can convince it to do what’s right.