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  • Balancing Accessibility and Sustainability: How to Achieve the Duel Objectives of the Hatch-Waxman Act Act While Resolving Antitrust Issues in Pharmaceutical Patent Settlement Cases

    Brand-name pharmaceutical companies invent innovative medicines patients need. Due to the high cost associated with
    the research and development (R&D), the innovative medicines are expensive. To make the innovative medicines cheaper and more affordable to the public, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984, better known as the Hatch-Waxman Act, to encourage the generic competition. Not only can the generic companies begin developing a generic version of a brand-name drug before the patent expires, they can also use safety and efficacy data in the brand-name company’s original New Drug Application (NDA). Furthermore, the Hatch-Waxman Act also gives an attractive incentive for generic drug companies to challenge brand-name drug companies’ patents before the patent expiration. As a result, patent challenges in the court are intensified. Like any other types of litigation, patent litigation between a brand-name drug company and a generic drug company often settles so that both parties can minimize risk of financial damages.

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