Tag Archives: Daiichi Sankyo

Federal Circuit Upholds USPTO Post-Wyeth Patent Term Adjustment Procedures

In Daiichi Sankyo Co. v. Lee, the Federal Circuit upheld the USPTO’s post-Wyeth Patent Term Adjustment (PTA) procedures, and found that the USPTO did not abuse its discretion when it limited the Interim Procedures to petitions filed within 180 days of the patent’s grant date. This decision highlights the deferential standard of review applied to USPTO … Continue reading this entry

Apotex Has Standing Despite Benicar Patent Disclaimer

In Apotex Inc. v. Daiichi Sankyo, Inc., the Federal Circuit held that Apotex has standing to seek a declaratory judgment that it does not infringe Daiichi Sankyo’s patent, even though Daiichi Sankyo has disclaimed the patent such that there can be no infringement as a matter of law. The court reached this decision because only … Continue reading this entry

District Court Again Rejects Equitable Tolling For Patent Term Adjustment Case

In Daiichi Sankyo Co. v. Rea (D. D.C. Dec. 3, 2013), the U.S. District Court for the District of Columbia rejected the plaintiff’s arguments that equitable tolling should apply to permit its claim for additional Patent Term Adjustment (PTA) under Wyeth. In so doing, the court followed much of the reasoning in Novartis AG v. Kappos … Continue reading this entry

Licensees Obtaining Data from Other Licensees

When a drug candidate is licensed to different licensees in different territories, the ability of each licensee to obtain marketing approval for the product may depend on access to data generated by the other. While license agreements do not always address this issue, there are some terms that can be useful in this type of situation. Case Study … Continue reading this entry