In a significant move to curb drug prices, the U.S. Senate unanimously passed the Affordable Prescriptions for Patients Act of 2023 (S-150) last week. This legislation is designed to foster greater competition from generic and biosimilar drugs against their brand-name counterparts. The act’s primary objective is to impose a limit on the number of patents that pharmaceutical companies can secure to protect their brand-name drugs.
The bill specifically restricts the number of patents that manufacturers of originator biological products can invoke in infringement lawsuits against companies aiming to market a biosimilar version, with certain exceptions and waivers. This measure is intended to curtail the practice of ‘patent thicketing,’ where drug makers surround their products with numerous, often questionable patents. The goal is to facilitate the earlier entry of biosimilar competitors into the market, thereby reducing drug prices. The Congressional Budget Office estimates that this legislation could save U.S. taxpayers approximately USD 1.8 billion annually.
An illustrative case of patent thicketing is AbbVie’s blockbuster drug, Humira (adalimumab), which has been one of the world’s best-selling drugs, generating over USD 200 billion in sales during its two-decade market dominance. Since its introduction in 2002, AbbVie has filed 250 patents for Humira, effectively prolonging its monopoly in the U.S. market. While the original patent was scheduled to expire in 2016, and biosimilar competition emerged in Europe by 2018, AbbVie managed to delay market entry of competitors in the U.S. until January 2023.- Flcube.com
