FDA Approves Amgen’s Amjevita

By: Sandy King  |   September 27, 2016

On Friday, September 23, 2016, the U.S. Food and Drug Administration approved Amgen Inc.’s Amjevita, which is the biosimilar equivalent of AbbVie Inc.’s immunosuppressant Humira. The drug is approved for more than a half-dozen conditions listed on the branded drug’s label, including severe psoriasis and Crohn’s disease.

Amgen v. Apotex Decision

By: Sandra King  |   July 18, 2016

On July 5, 2016, the Federal Circuit issued its decision in Amgen v. Apotex affirming an order preliminarily enjoining Apotex from launching its version of Neulasta (pegfilgrastim)...Apotex contended that they were not required to provide post-licensure notice to Amgen and that such requirement may not be enforced by an injunction.

More Enhanced Damages on the Way?

By: Andreas Baltatzis & Emily A. Curtis  |   July 5, 2016

Following 2014 opinions changing the standards for attorneys’ fees in patent cases, the Supreme Court lowered the standard for awarding treble damages in patent infringement cases. See Halo Electronics, Inc. v. Pulse Electronics, Inc., Nos. 14-1513 and 14-1520 (S.Ct. June 13, 2016). This decision will affect more than the final award given in a suit.

Subject Matter Eligibility - May 2016 Update

By: Sandra King & Tom Powers  |   June 6, 2016

On May 4, 2016, the USPTO issued a memorandum to Examiners on the topic of “Formulating a Subject Matter Eligibility Rejection and Evaluating the Applicant’s Response to a Subject Matter Eligibility Rejection.” The memorandum addressed how examiners should formulate a subject matter eligibility rejection under 35 U.S.C. § 101 as well as how examiners should evaluate an applicant’s response to a § 101 rejection. The main purpose of the memorandum was to assist examiners in applying the 2014 Interim Guidance on Patent Subject Matter Eligibility as well as the July 2015 Update: Subject Matter Eligibility.

When Every Day Counts: United Therapeutics/Supernus Fight for Lost Patent Term

By: Gideon Eckhouse & Andreas Baltatzis  |   May 17, 2016

United Therapeutics knows how a smart patent strategy can add value. Patent term adjustment is a powerful tool that can be worth millions to patent holders, especially to pharmaceutical companies.