Define: Hatch–Waxman Act

The Hatch-Waxman Act, officially known as the Drug Price Competition and Patent Term Restoration Act, is a United States federal law enacted in 1984. It was designed to encourage the development of generic drugs while also protecting the interests of brand-name pharmaceutical companies.

The primary goal of the Hatch-Waxman Act is to strike a balance between promoting competition in the pharmaceutical industry and safeguarding the rights of patent holders. It aims to make affordable generic drugs available to consumers while providing incentives for innovation and research by brand-name drug manufacturers.

The Act provides a streamlined process for generic drug manufacturers to gain approval from the Food and Drug Administration (FDA) to market their products. It allows them to rely on the safety and efficacy data of the brand-name drug, known as the reference listed drug (RLD), through an abbreviated new drug application (ANDA) process.

Yes, the Act allows brand-name drug manufacturers to seek patent term extensions, known as “patent restoration,” to compensate for the time lost during the FDA approval process. This provides them with additional exclusivity beyond the original patent term.

The Act established a framework for resolving patent disputes through a legal process known as the Paragraph IV certification. Generic drug manufacturers can challenge the validity or infringement of the brand-name drug’s patents, triggering a patent infringement lawsuit.

The Act grants the first generic drug manufacturer to successfully challenge a brand-name drug’s patent with a Paragraph IV certification a 180-day exclusivity period. During this period, no other generic versions of the drug can enter the market, allowing the first generic manufacturer to enjoy a period of market exclusivity.

Brand-name drug manufacturers can file a lawsuit against generic drug manufacturers to enforce their patents. This can result in a court-ordered injunction, temporarily preventing the generic drug from entering the market until the patent dispute is resolved.

Yes, the Act includes a provision known as the “first filer” exclusivity. The first generic drug manufacturer to file an ANDA with a Paragraph IV certification is granted a period of exclusivity, even if other generic manufacturers subsequently challenge the same patent.

The Act’s provisions for generic drug entry into the market create competition, which often leads to lower drug prices. Generic drugs are generally more affordable than their brand-name counterparts, providing cost savings for consumers and healthcare systems.

As with any legislation, there are ongoing discussions and debates surrounding the Hatch-Waxman Act. Some stakeholders argue for reforms to address issues such as patent thickets, evergreening, and the abuse of the patent system. However, any proposed changes would require congressional action.