One of Generation Patient's key policy priorities is patent system reform as a crucial step toward achieving health equity. By advocating for changes that ensure timely access to affordable prescription medicines and encourage genuine innovation in drug development, we aim to help close the healthcare access gap. In July, we voiced our support for a proposed rule from the United States Patent and Trademark Office (USPTO), titled "Terminal Disclaimer Practice To Obviate Nonstatutory Double Patenting Proposed Rule." This proposed rule would help to prevent the misuse of patent laws that can delay the availability of cheaper, life-saving medications. Keep reading to understand how this rule might impact you as a patient!
What is a terminal disclaimer?
A “terminal disclaimer” aligns the expiration date of multiple related patents. This means that if a pharmaceutical company files multiple patents on a drug at different times (“patent thicketing” or “double patenting,” which is often done to extend the amount of time a drug company is allowed to make/profit from a medication) exclusively, patents that are filed later on would still expire at the same time as the initial patent. This helps ensure that companies can’t keep drawing out their monopoly on a medication, particularly if the newer patents are for minor changes (modifications that are not additionally beneficial to patients, like changes in packaging, inactive ingredients, etc.).
The problem:
Despite terminal disclaimers' intended purpose (preventing extensions of patent monopolies and reducing patent thickets), larger pharmaceutical companies have found ways to weaponize terminal disclaimers. These strategic patenting practices actually can contribute to the formation of patent thickets!
USPTO’s proposed solution:
To help address this misuse of terminal disclaimers, the United States Patent and Trademark Office (USPTO) has proposed linking the enforceability of terminally disclaimed patents with their corresponding 'parent' patents.
Currently, terminally disclaimed patents (a newer and original patent) are linked by expiration date but can still be individually enforced in legal actions, meaning they can be used to block competitors even if they do not represent significant new innovations.
The proposal suggests that the enforceability (the ability to use these patents in legal actions to prevent others from entering the market) of these terminally disclaimed patents should be tied to the enforceability of the parent patent.
Essentially, if the parent patent is found to be invalid or unenforceable, the terminally disclaimed patents would also lose their enforceability.
As an organization created by and for young adults with chronic conditions, our community faces decades of enormous financial pressure from the high cost of prescription drugs. We expressed our support for the proposed rule, as this step is an opportunity to ensure timely access to biosimilars and generics and to incentivize true innovation.
Read our full letter, with contributions by our Health Policy Scholars, to the United States Patent and Trademark Office here!