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Despite the fact that open source or so-called “free” software has been available for more than 30 years, and is likely used in the vast majority of software programs being developed today, many people remain confused as to...more
The US Court of Appeals for the Federal Circuit affirmed that patented articles must be marked in order for the patentee to recover pre-notification or pre-complaint damages. Arctic Cat Inc. v. Bombardier Recreational...more
PATENT CASE OF THE WEEK - Arctic Cat Inc. v. Bombardier Recreational Products Inc., Appeal No. 2019-1080 (Fed. Cir. Feb. 19, 2020) - In this week’s Case of the Week, the Federal Circuit addresses issues relating to the...more
Federal grants are an important source of funding for many businesses and research institutions. The Bayh-Dole framework provides contractors the ability to retain title to an invention developed using federal funding, but...more
Assignor Estoppel Does Not Apply in the IPR Context - In Arista Networks, Inc. v. Cisco Systems, Inc., Appeal Nos. 2017-1525, 2017-1577, the Federal Circuit held that the plain language of 35 U.S.C. § 311(a) unambiguously...more
In an opinion issued on December 14, 2017, the United States Court of Appeals for the Federal Circuit held that the 2010 Biologics Price Competition and Innovation Act (“BPCIA”) preempts the use of state law to penalize...more
On June 12, 2017, the U.S. Supreme Court decided two important questions under the Biologics Price Competition and Innovation Act ("BPCIA"), which provides an abbreviated pathway for the approval of generic biologics: (i) the...more
On a sweltering hot D.C. morning, those of us anxiously awaiting the Supreme Court’s opinion in its first case involving biosimilar biological products finally exhaled. The June 12, 2017 opinion followed the parties’ oral...more
In a unanimous decision issued on June 12, 2017, the Supreme Court for the first time interpreted key provisions of the 2010 Biologics Price Competition and Innovation Act (“BPCIA”). See Sandoz Inc. v. Amgen Inc., No. 15-1195...more
On June 12, 2017, in Sandoz Inc. v. Amgen Inc., the United States Supreme Court unanimously held that a drug manufacturer may give a required 180-day notice of its intent to market a biosimilar drug before receiving FDA...more
Yesterday’s unanimous ruling by the U.S. Supreme Court in Sandoz v. Amgen injects much needed certainty into a difficult statute and streamlines the process for biosimilar products to enter the marketplace following FDA...more
The U.S. Supreme Court rendered its first interpretations of the biosimilar patent dispute resolution procedures of the Biologics Price Competition and Innovation Act (BPCIA), ruling largely in favor of Sandoz on both issues...more
BakerHostetler invites you to join us for a one hour complimentary seminar (followed by Q&A) offering practical considerations for managing risk and liability in online and other contracts. Our session will cover trending...more
In other Supreme Court news from Monday, June 20, 2016, the Court invited the Solicitor General to file briefs in the Sandoz v. Amgen (No. 15-1039) and Amgen v. Sandoz (No. 15-1195) appeals to express the views of the United...more
Since August 2015, Amgen and Apotex have been locked in litigation in the US District Court for the Southern District of Florida related to Apotex’s pegfilgrastim product, which is purported to be biosimilar to Amgen’s...more