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FDA Biologics License Application ("BLA")
In contrast to regulations for new drug applications, which provide detailed explanations of the type and quality of information required...
York Faulkner
2021年2月25日読了時間: 8分
FDA Abbreviated Biologics Application ("aBLA") for Biosimilar Products
Abbreviated Biologics Applications for biosimilar products are governed by 42 U.S.C. § 262. Section 262(k) requires an applicant seeking...
York Faulkner
2021年2月23日読了時間: 8分
Patent Disputes Regarding Biosimilar & Interchangeable Biological Products
As an overview, the patent dispute resolution procedures under the Biologics Act include (1) the confidential disclosure of the aBLA...
York Faulkner
2021年2月21日読了時間: 9分
Procedural Aspects of Generic Drug Patent Litigation
... The Hatch Waxman Act also created a new framework for innovator-generic drug patent litigation that promotes early resolution of...
York Faulkner
2021年2月19日読了時間: 19分
Generic Drug Patent Infringement Litigation & Trial under the Hatch-Waxman Act
... the artificial act of infringement and timing of the lawsuit create unique challenges for proving patent infringement. The challenges...
York Faulkner
2021年2月17日読了時間: 20分
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