Depositions of Party Witnesses. The procedures for taking depositions of Japanese witnesses diverge depending on the status of the...

...Similar to actions before the U.S. International Trade Commission, Japanese import suspension proceedings provide abbreviated and...

Typical EDVA Case Schedule EDVA Local Rule 16(B) establishes four significant scheduling events along the short road to trial before the United States District Court for the Eastern District of Virginia. Those four events, discussed in turn below, include (1) the Local Rule 16(B) Order, (2) preparation and submission of the Parties’ Discovery Plan, (3) the Initial Pretrial Conference/Order, and (4) the Final Pretrial Conference. 1. The Local Rule 16(B) Order EDVA Local Rul

One of the fastest growing categories of new FDA filings includes applications for the approval of biological drug products, which are...

In contrast to regulations for new drug applications, which provide detailed explanations of the type and quality of information required...

Abbreviated Biologics Applications for biosimilar products are governed by 42 U.S.C. § 262. Section 262(k) requires an applicant seeking...

As an overview, the patent dispute resolution procedures under the Biologics Act include (1) the confidential disclosure of the aBLA...

... The Hatch Waxman Act also created a new framework for innovator-generic drug patent litigation that promotes early resolution of...

... the artificial act of infringement and timing of the lawsuit create unique challenges for proving patent infringement. The challenges...