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In Lubby Holdings LLC v. Chung, the Federal Circuit held corporate officers and employees who actively assist with their corporation’s infringement may be personally liable for inducing infringement even without any piercing...more
The Federal Circuit in Lubby Holdings v. Chung overturned a jury verdict finding that Lubby satisfied Sec. 287(a)’s requirement to notify Chung of his infringement. Was this reversible error, or has the court determined that...more
The COVID-19 pandemic has delayed civil trials across the country. This includes patent cases, which are often complex and must be filed in federal court. Arbitration offers a possible alternative venue. While arbitration is...more
On April 8, 2020, the Federal Court of Appeal (FCA) released a decision finding that the Federal Court Notice to the Profession re: Experimental Testing (Notice) does not apply to pre-litigation testing: Apotex v Bayer, 2020...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
The patent marking statute, codified at 35 U.S.C. § 287(a) appears straightforward: Patentees, and persons making, offering for sale, or selling within the United States any patented article for or under them, or importing...more
The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was passed as part of health reform signed into law by President Obama in March 2010. This year, the BPCIA turns 10. While the U.S. Biosimilars Pathway has...more
Recently, in ZTE (USA) Inc. v. Fundamental Innovation Int’l LLC, IPR2018-00425, Paper No. 34 (Feb. 6, 2019), the Patent Trial and Appeal Board (“PTAB”) allowed Petitioner’s motion to retroactively correct its defective IPR...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
PATENT CASE OF THE WEEK - Click-to-Call Technologies, LP v. Ingenio, Inc., Appeal No. 2015-1242 (Fed. Cir. Aug. 16, 2018) In an appeal of an inter partes review, the Federal Circuit reviewed for the first time the...more
On December 14, the Federal Circuit issued a decision that further clarifies the ground rules for disclosures of product information by manufacturers of biosimilar pharmaceutical products. In particular, the Federal Circuit...more
District Court Abused Discretion in Not Finding Case Exceptional - In Rothschild Connected Devices v. Guardian Protection Services, Appeal No. 2016-2521, the Federal Circuit held that a district court abused its discretion...more
In borrowing a page from the '80s band "Men Without Hats," on June 12, 2017, the U.S. Supreme Court brought greater certainty for both biosimilar applicants and originator companies. In Sandoz Inc. v. Amgen Inc., the Supreme...more
On Monday, June 12, 2017, the United States Supreme Court in a unanimous decision held that manufacturers making biosimilars of biologic drugs did not have to wait until after gaining federal approval of the biosimilar to...more
On June 12, 2017, the Supreme Court issued a unanimous opinion in Sandoz v. Amgen, interpreting key provisions of the Biologics Price Competition and Innovation Act (BPCIA) in favor of biosimilar manufacturers...more
The Supreme Court handed down its opinion in Sandoz Inc. v. Amgen Inc., marking the first time the Court has interpreted the Biologics Price Competition and Innovation Act (“BPCIA”) for the approval of biosimilar drugs. On...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
In Sandoz Inc. v. Amgen Inc., the Supreme Court brought greater certainty to two key issues relating to the “patent dance” under the Biologics Price Competition and Innovation Act (BPCIA). First, the Court held that where a...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
The Supreme Court could issue its decision in the Amgen v. Sandoz biosimilar patent dance case any day now. Last week I participated in a panel discussion with industry stakeholders considering how the decision might–or might...more