由美國實務探討逆向付費和解協議於專利法上之適法性

To Study the Legitimacy of Reverse Payment Settlement Agreement under the Patent Law

專利制度賦予專利權人於專利期間內排除他人未經授權實施其專利技術，專利權人並得對侵害其權利之人提起專利侵權之訴。專利侵權爭議，無論訴訟或和解，涉及金錢之支付者，多屬被控侵權者給付予專利權人。逆向付費和解協議（reverse payment settlement agreement），則係由專利權人支付予他人之協議，其目的或僅基於避免繁瑣的訴訟程序、節省鉅額訴訟成本及省時省力；惟，多衍生限制競爭之情事，故又名「遲延競爭之補償給付」（pay for delay）。

For the past two decades, reverse payment settlement agreement has become the strategy in pharmaceutical industry to prevent generic drug entering into the market. According to FDCA, if generic drug company can prove pharmaceutical patent invalid or its generic drug will not infringe the patent, it may file application to FDA for ADNA-IV approval, which will gain it 180-day marketing exclusivity. Patentee (brand-name drug company) reaches agreement with ADNA-IV applicant by paying large amount of compensation to the latter in exchange of latter’s refraining from entering into the market. FTC treated reverse payment settlement agreement as a violation of antitrust laws and filed lawsuit against brand-name drug company frequently.