According to the Drug Price Competition and Patent Term Restoration Act of 1984, what happens to patent terms for innovator drugs?

The Drug Price Competition and Patent Term Restoration Act of 1984, often referred to as the Hatch-Waxman Act, established a pathway for generic drugs to come to market more quickly while also providing a means for innovator drugs to have their patent protection extended. Specifically, the Act allows for a patent term extension of up to five years for innovator drugs if the effective patent life was decreased due to the lengthy approval process by the FDA.

This extension is specifically designed to compensate for the time taken during the regulatory approval process, recognizing that the period of patent protection for many innovative pharmaceuticals can be significantly reduced before a drug even reaches the market. The extension ensures that inventors have a fair opportunity to recoup their investment in research and development during the commercial life of their product.

Other options do not accurately reflect the provisions of the Act. For instance, the reduction of patent terms or elimination of patents is not in line with the intent of promoting innovation while balancing access to medications. Thus, the potential for a five-year extension correctly reflects the law's intent to protect innovative pharmaceuticals.