News & Analysis as of

Standing FDA Approval

Jenner & Block

Client Alert: Access to Mifepristone Still Standing for Now, but Questions Remain

Jenner & Block on

On Thursday morning, the Supreme Court issued its decision in FDA v. Alliance for Hippocratic Medicine. Justice Kavanaugh wrote for a unanimous Court dismissing the Alliance for Hippocratic Medicine from the case for lack of...more

McDermott Will & Emery

ANDA Applicant Has Standing to Appeal IPR Decision, Even with Only Paragraph III Certification

The US Court of Appeals for the Federal Circuit found that a failed inter partes review (IPR) petitioner that maintained a Paragraph III certification had sufficient standing to appeal an adverse decision, but affirmed the...more

Foley & Lardner LLP

Orange Book Listing Creates Injury To Support Standing To Appeal IPR Decision

Foley & Lardner LLP on

Although “any person” except the owner can challenge a patent in an Inter Partes Review (IPR) proceeding, only those who satisfy the constitutional requirements for standing can appeal a decision of the USPTO Patent Trial and...more

Knobbe Martens

Altaire Pharmaceuticals, Inc. v. Paragon Bioteck, Inc.

Knobbe Martens on

Federal Circuit Summary - Before Wallach, O’Malley, and Schall. Appeal from the Patent Trial and Appeal Board. Summary: PGR petitioner has standing to appeal PTAB decision, where petitioner intended to file an ANDA for...more

McDermott Will & Emery

ANDA Update - October 2015

McDermott Will & Emery on

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

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