Law Brief®: Mark Rosenberg and Richard Schoenstein Discuss Online Distribution Leakage
Nota Bene Episode 135: Europe Q3 Check In: Brexit, Data Protection, and Block Exemption Regulations with Oliver Heinisch
Daewoong Pharmaceutical announced on October 31 that it has signed a joint sales agreement with Celltrion Pharm to market CT-P41 in Korea. CT-P41, Celltrion’s biosimilar of Amgen’s PROLIA, is scheduled to launch in...more
Lyvette Mercado Velez, a dietitian, entered into a distribution agreement with Insulet Corporation, a leading medical device manufacturer, to promote and sell diabetes treatment products and services in Puerto Rico. Shortly...more
Advanz Pharma (“Advanz”) and Alvotech announced that they entered an exclusive partnership agreement regarding supply and commercialization of five biosimilars in Europe, with Alvotech responsible for the development...more
LARRY G. JUNKER V. MEDICAL COMPONENTS, INC. Before Dyk, Reyna, and Stoll. Appeal from United States District Court for the Eastern District of Pennsylvania. Summary: A letter containing specific delivery conditions,...more
In August 2021, the MDCG issued guidance MDCG 2021-23 for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746. The...more
Parties to corporate transactions often rely on contractual setoff rights to help ensure that they can be paid or at least limit the amounts lost if the counterparty fails to pay. While the Bankruptcy Code generally protects...more
In Washington: The Centers for Disease Control and Prevention (CDC) warned that gym users should wear masks when exercising, even if they are more than six feet apart, and gyms need to improve ventilation. A new agency report...more
In a 63-page decision issued on Jan. 13, 2020, in Lebanon County Employees’ Retirement Fund v. AmerisourceBergen Corporation, Vice Chancellor J. Travis Laster of the Delaware Court of Chancery found that stockholders of...more
The Third Circuit recently held in In re Remicade (Direct Purchaser) Antitrust Litigation that a direct purchaser’s antitrust suit alleging overpayment for a drug purchased pursuant to a distribution agreement with a...more
The case involved an AAA arbitration centering on the lack of performance under an exclusive distributorship agreement (EDA) that a medical supplier signed with a product manufacturer. The supplier failed to order sufficient...more
The Court of Justice of the European Union (“Court”) just released its judgement in Case C-1/18 Oribalt Riga concerning the customs valuation methodologies applicable to generic medicines in the framework of consignment...more
Taiwanese Manufacturer of Smartphones Subject to Personal Jurisdiction in Texas in Patent Infringement Case Because of its Allegedly Purposeful Efforts to Serve the US Market, Even Though all US Distribution was Orchestrated...more
Helsinn Healthcare (“Helsinn”) is the maker of certain treatments for chemotherapy-induced nausea (the “Palonosetron Products”). During the development process, Helsinn entered into two third party agreements for distribution...more
On 1 February 2019, the European Commission published a new Q&A document to give further guidance on the Notice to stakeholders-withdrawal of the United Kingdom and EU rules in the field of industrial products (“the Notice”)....more
We have covered Pfizer’s antitrust suit against Johnson & Johnson, the manufacturer of Remicade® (infliximab). Pfizer’s suit alleges that Johnson & Johnson excluded Pfizer’s infliximab biosimilar from the market through...more
On September 26, 2018, the EU General Court (the Court) upheld the European Commission’s refusal to reinvestigate GlaxoSmithKline SA’s (GSK) Spanish “dual-pricing” distribution arrangements, 20 years after the alleged conduct...more
Berkheimer v. HP Inc., Appeal No. 2017-1437 (Fed. Cir. Feb. 8, 2018) - In Berkheimer v. HP Inc., the Federal Circuit reviewed the District Court’s summary judgment finding that certain claims of a patent were invalid as...more