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Takeda v. Mylan: High-Cost Generic Drugs from Baseless Paragraph IV Certifications

By Gregory M. York
June 29, 2009

The Hatch-Waxman Act has established a process by which a drugmaker can obtain FDA approval to market a generic drug prior to expiration of patents directed to the corresponding brand drug. In accordance with this process, the generic drugmaker files an Abbreviated New Drug Application (“ANDA”) under 21 U.S.C. ' 355(j). The generic drugmaker must include a certification under 21 U.S.C. ' 355(j)(2)(A)(vii) (“Paragraph IV certification”) with respect to each patent listed by the brand drugmaker in the FDA's Orange Book that will not have expired prior to generic market entry. Specifically, the generic drugmaker must provide a legal and factual basis as to why each claim of each such patent will not be infringed or is invalid. The generic drugmaker must also notify the brand drugmaker of the filing. Under 35 U.S.C. ' 271(e)(2), the act of filing an ANDA that includes a Paragraph IV certification constitutes an act of infringement of the relevant listed patents on which the brand drugmaker may file suit.

The Hatch-Waxman Act provides trial courts with discretion to award attorney fees in exceptional cases involving patent infringement based on ANDA filings. Specifically, ” 271(e)(4) and 285, taken together, provide that reasonable attorney fees may be awarded to the prevailing party in exceptional cases regarding infringement based on filing a Paragraph IV certification. In addition, trial courts may invoke their inherent powers to award additional amounts, such as expert fees. Whether a case is exceptional is an issue of fact requiring clear and convincing evidence, subject to review for clear error, whereas an award of attorney and expert fees in an exceptional case is at a court's discretion, subject to review for abuse of discretion.

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