Will also drive-up health care costs --- PREVAIL makes challenges more difficult for secondary patents that are lower quality and monopoly-extending and blocks generics from entering the market

These changes would also embolden pharmaceutical companies to double down on the practice of creating patent thickets to wall off competition and generics. This is because the secondary patents that form patent thickets are typically of lower quality than a drug’s primary patent. (Primary patents cover the active ingredient, whereas secondary patents are typically related to elements like dosage, packaging, or delivery of a drug.) These secondary patents are currently more susceptible to challenge if they offer little therapeutic value above and beyond the original patent. The proposed act would make it more difficult to challenge these lower-quality, monopoly-extending patents, and the resulting broad patent protection of brand-name drugs would continue to block generic manufacturers from entering the market.

This would have a direct negative effect on consumers and the health care system as a whole. Without competition from generics, monopoly prices for the branded drugs would remain artificially high for a longer time, negatively affecting patients who rely on lifesaving or life-changing medication as well as the public and private health care insurers who share the costs of those medications. In fact, one study looking at just five drugs over 20 years found that eliminating generic competition of those drugs imposed $4.7 billion in annual costs on the U.S. health care system. Another study estimated that evergreened reformulations increased Medicaid spending by $9.35 billion from 2008 to 2016 alone.

Importantly, one empirical examination of drug pricing and patents found “a correlation between administrative patent challenge procedures, such as IPR, and lower drug prices due to generic entry.” This finding reinforces the importance of maintaining the current IPR process to deter lower-quality patents, enhance competition, and provide much-needed medication to patients and health care organizations at fairer costs.