The drug price competition and Patent Term Restoration Act provides how many additional years of patent protection?

The Drug Price Competition and Patent Term Restoration Act, also known as the Hatch-Waxman Act, allows for a restoration of up to five years of patent protection for certain pharmaceutical products. This legislation was designed to balance the interests of brand-name drug manufacturers and generic drug producers, promoting both innovation and accessibility.

The act enables manufacturers to extend their patent protection if they can demonstrate that regulatory delays encountered during the approval process for their pharmaceuticals led to a loss of patent time. This is especially relevant for drugs that require significant time and resources to bring to market, which can delay the time the patent is in effect while the company is trying to recoup its investment.

This extension aims to incentivize pharmaceutical innovation by ensuring that companies have a fair opportunity to benefit from their inventions without facing immediate competition from generic alternatives. The five-year extension is a key component of this act, helping to support the pharmaceutical industry's research and development efforts.