Injunctions for All – Speaking of Litigation Podcast
The Labor Law Insider: NLRB Adopts Pro-Labor Remedies for Alleged Unfair Labor Practices, Part III
#WorkforceWednesday: New COVID-19 Testing Guidance, NLRB Increases Use of Injunctive Relief, D.C. Amends Near-Universal Ban on Non-Competes - Employment Law This Week®
The Labor Law Insider: NLRB Adopts Pro-Labor Remedies for Alleged Unfair Labor Practices, Part II
The Labor Law Insider: NLRB Adopts Pro-Labor Remedies for Alleged Unfair Labor Practices
JONES DAY TALKS®: Consumer Protection Enforcement Changes Likely After SCOTUS AMG Decision
Key Takeaways from the AMG Capital Management v. FTC Decision
#WorkforceWednesday: New AB5 Exemptions, EEOC COVID-19 Updates, Joint-Employer Rule Partially Struck Down - Employment Law This Week®
[co-author: Jamie Dohopolski] Love it or hate it, ignore the USPTO Patent Trial and Appeal Board (PTAB) at your peril. The introduction of the PTAB as part of the America Invents Act over ten years ago has forever changed...more
The Medicare program is once again looking to reduce payments to 340B hospitals for Part B drugs and biologicals. As part of its proposed payment regulation for hospitals under the Outpatient Prospective Payment System (OPPS)...more
In the latest dispute surrounding the “patent dance” provisions of the Biologics Price Competition and Innovation Act (BPCIA), Genentech, Inc. has filed a complaint against Amgen, Inc., alleging that after opting into the...more
On Tuesday, Amgen filed its supplemental brief opposing Sandoz’s petition for writ and responding to the Solicitor General’s brief, which we discussed here. In sum, the Solicitor General sided with Sandoz, stating that: ...more
The FDA on Friday approved the first U.S. biosimilar of Humira (adalimumab), AbbVie’s best-selling biologic for treatment of inflammatory conditions. The biosimilar, Amgen’s Amjevita (adalimumab-atto), received approval for...more
As we previously reported, on June 17, Janssen filed two complaints alleging infringement of claims in U.S. Patent No. 7,598,083, one against Celltrion and Hospira, and one against HyClone Laboratories, Celltrion’s supplier...more
On July 5, 2016, the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) unanimously ruled in Amgen v. Apotex that biosimilar makers must provide brand-name rivals with a 180-day notice only after receipt of...more
In a complaint filed June 14, 2016, Janssen Biotech Inc. seeks a preliminary injunction that would bar Celltrion and Hospira from selling the biosimilar version of Remicade® (infliximab) that received FDA approval April 2016,...more
Following months of public outcry and Congressional probes into significant drug price increases, the Senate Judiciary Committee introduced legislation targeting “behavior that blocks competition and delays the creation of...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
Today, the Supreme Court deferred a decision on certiorari in Amgen v. Sandoz, inviting the Solicitor General to file a brief expressing the views of the United States. Sandoz petitioned for review of one aspect of the...more
As we covered in a previous post, following the Federal Circuit’s decision in Amgen v. Sandoz, Sandoz filed a petition for a writ of certiorari asking the Supreme Court to review the Federal Circuit’s interpretation of the...more
Although Amgen originally did not petition the Supreme Court for certiorari to review the first Federal Circuit decision interpreting the BPCIA framework for resolving biosimilar patent disputes, Amgen now has filed a...more
On February 16, 2016, Sandoz, Inc. filed a petition for writ of certiorari to the Supreme Court, asking the Court to overturn the Federal Circuit decision that interpreted the “patent dance” provisions of the Biologics Price...more
As reported on February 17, 2016 in IP Law360, Sandoz has petitioned the U.S. Supreme Court for certiorari to review the Federal Circuit's decision that reversed the District Court in Amgen v. Sandoz. In its decision, two...more
On February 10, 2016, the FDA's Arthritis Advisory Committee recommended approval of biologics license application ("BLA") 125544 submitted by Celltrion, Inc. for CT-P13, a proposed biosimilar to Janssen Biotech Inc.'s...more
Amgen recently sued Apotex under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) over Apotex’s proposed biosimilar of Amgen’s Neulasta (pegfilgrastim), a long-lasting version of Neupogen. This is the first...more
Congress passed the Biologics Price Competition and Innovation Act (“BPCIA”) in 2009 in an effort to bring biosimilar drug products to market. The goal was for the BPCIA to mimic for biologic drugs the Hatch-Waxman statute...more