Providing timely access to affordable, safe and effective products should be the central purpose of U.S. legislation that introduces a regulatory pathway for the approval of generic substitutes for biologic pharmaceuticals (also known as “biotech drugs”). Provisions that extend the monopoly protection period of brand-name companies, making it unreasonably difficult to sell affordable biogenerics to patients as soon as possible after patent expiration, would defeat the purpose of the new rules.
To meet these objectives, U.S. biogenerics legislation should include provisions that encourage rapid resolution of patent disputes. Requiring brand-name companies to disclose all relevant patents is one key element to ensure potential generic competitors have sufficient information to make an informed assessment of the potential barriers to competition. Several of the biogenerics proposals under consideration by Congress do not require such disclosure as part of the proposed patent dispute resolution system, or do not contain any provisions governing patent dispute resolution related to biogenerics. Essential Action recommends that biogenerics legislation should incorporate the four principles outlined below.
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