Federal judge limits antitrust scrutiny of pharmaceutical reverse payments to settlements involving monetary transfers
Recently, a federal judge in the US District Court for the District of New Jersey held that only patent settlements involving a reverse monetary payment will be subject to antitrust scrutiny under the framework articulated by the Supreme Court last year in FTC v Actavis. In affirming its earlier ruling dismissing the direct purchaser complaint, the court held that nothing in Actavis altered the conclusion it had reached previously under the US Court of Appeals for the Third Circuit’s ruling in In re K-Dur Antitrust Litigation that the settlement did not, in fact, contain a reverse ‘payment’ because there was no transfer of money between the parties. This most recent development in the ongoing debate regarding these agreements is significant not only because it is the latest effort by the courts to clarify and develop the framework put in place under Actavis but also because it constitutes a departure from other recent district court rulings that have suggested that Actavis may apply to non-monetary forms of compensation.
The agreements at issue in the case settled patent litigation between GlaxoSmithKline (GSK) and Teva Pharmaceuticals related to GSK’s drug, Lamictal, which is used to treat epilepsy and bipolar disorder and is available in chewable and tablet forms. Under the terms of the agreement, Teva was permitted to sell generic chewables approximately 37 months prior to expiration of the relevant patent and generic tablets approximately six months prior to patent expiration. GSK also granted Teva an exclusive licence to the relevant Lamictal patent, which was exclusive even as to GSK during Teva’s first-filer exclusivity period. The result of this provision was that GSK would not compete with Teva through marketing of an authorised generic version of Lamictal in either chewable or tablet formulations during that period of time…
Click on the link below to read the rest of the Hogan Lovells briefing.
Sign in or Register to continue reading this article
It's quick, easy and free!
It takes just 5 minutes to register. Answer a few simple questions and once completed you’ll have instant access.Register now
Why register to The Lawyer
In-depth, expert analysis into the stories behind the headlines from our leading team of journalists.
Identify the major players and business opportunities within a particular region through our series of free, special reports.
Receive your pick of The Lawyer's daily and weekly email newsletters, tailored by practice area, region and job function.
More relevant to you
To continue providing the best analysis, insight and news across the legal market we are collecting some information about who you are, what you do and where you work to improve The Lawyer and make it more relevant to you.
News from Hogan Lovells
News from The Lawyer
Briefings from Hogan Lovells
The decision of the US Court of Appeals has raised questions about how issuers should present their disclosures on conflict minerals under Exchange Act Rule 13p-1 and Form SD.
An interesting judgment was delivered by the Honourable J Majiki on 19 November 2013 in the Eastern Cape High Court, Port Elizabeth.
Analysis from The Lawyer
As international firms question their future in these small, closely linked markets, local lawyers too are eyeing the business environment with caution
Beyond the headline infrastructure projects, UK construction work is still recovering from the clobbering it took during the slump