Public Interest Groups to Senate: Protect Us, Not Invalid Patents Driving Up Drug Prices

Alex Moss | May 7, 2024

A coalition public interest groups have sent a letter to members of the Senate Judiciary Committee, urging them to protect mechanisms allowing the Patent Office to reconsider and, when appropriate, cancel wrongly granted patents. The letter also highlights potential threats to the accessibility and effectiveness of these mechanisms, in particular, proposed legislation, like S.2220, the Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL), that would ensure low quality patents keep drug prices unjustifably high.

This mechanism, an administrative process called inter partes review (IPR), allows any member of the public to challenge granted patents at the Patent Trial and Appeal Board (PTAB). At the PTAB,  administrative patent judges  consider evidence that a particular patent should not have issued because of its similarity to earlier advances in the field.    The letter explains that IPR has played a crucial role in preventing  wrongly granted patents from driving up drug prices, thus enabling competition and increasing the availability of affordable medications. Indeed, a growing body of empirical evidence shows the IPR system can have a powerful effect on drug prices. For example, one study found that the price of prasugrel, a cardiovascular disease treatment, fell by 97% after an IPR proceeding, and that prices of treatments for prostate cancer, multiple sclerosis, dementia, and opioid addiction fell by similar magnitude. Another recent study confirms that IPR proceedings have been used effectively to eliminate invalid patents preventing makers of biosimilar products from entering the U.S. market.

PREVAIL’s proposed changes would make the IPR system less accessible and effective. One especially concerning change is the prohibition on IPR requests from members of the public who lack standing to file suit in federal court. That change would deprive many people who can currently file IPR requests of the right to do so, including medical patients and researchers, who lack legal standing, but feel the effects of invalid patents that prevent competition in the market and the lab. Another change that would severely reduce IPR’s effectiveness is PREVAIL’s drastic increase to the evidence required for the PTAB to declare a patent invalid. This would prevent PTAB judges from cancelling patents that they can cancel now based on their objective and even-handed view of the evidence. The scales would be tilted so far in patent owners’ favor that IPR would no longer be a fair and effective mechanism for evaluating patents.

We hope members of the Senate Judiciary Committee will recognize the proven benefits of the IPR system and reject any proposals that would weaken it. Such proposals would ensure invalid patents keep inflating drug prices, benefiting big pharmaceutical companies at the expense of patients, consumers, and health care agencies. To protect the public’s ability to lower drug prices and increase health care access, we need to the protect the public’s capacity to challenge and the PTAB’s capacity to cancel wrongly granted patents.

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