Posts Tagged: "pay for delay"

Five Key Patent Developments in Europe for 2021

As part of its review of 2021, IPWatchdog takes a look back on five patent stories from the past year in Europe, and highlights what further developments to expect in 2022. In 2021, Europe took a giant leap towards the implementation of the Unitary Patent and Unified Patent Court (UPC). After years of delays arising from disputes over rules and language, the U.K. signing up and then withdrawing, and constitutional objections filed in Germany, it now seems highly likely that the new system will launch in late 2022. The pivotal step in this process was the decision by Germany’s Federal Constitutional on July 9 to reject as inadmissible two applications seeking to prevent the country from ratifying the UPC Agreement. (BVerfG, Beschluss des Zweiten Senats vom 23. Juni 2021- 2 BvR 2216/20 -, Rn. 1-81.) Following the decision, reported on IPWatchdog here, Germany ratified the Protocol on the Provisional Application of the UPCA, and Slovenia also did so in October.

The Fifth Circuit Must Preserve the Patent-Antitrust Balance by Upholding Actavis

The pharmaceutical industry presents some of the most important and challenging issues lying at the intersection of the patent and antitrust laws. On the one hand, patents play a crucial role in the industry, which is unique in the cost and duration of reaching the market. But on the other, a complicated regulatory regime and the event of generic entry (which dramatically lowers price and which the brand firm has interest in delaying) opens the door for potentially anticompetitive behavior. One area where this tension has surfaced in recent years has involved the settlement of patent litigation. In 2013, in FTC v. Actavis, the Supreme Court held that agreements by which brand-name drug companies pay generics to settle patent litigation and delay entering the market could have “significant anticompetitive effects” and violate the antitrust laws.

FTC v. Actavis: Where We Stand After 5 Years

It has been five years since FTC v. Actavis. In that landmark ruling, the Supreme Court held that settlements by which brand-name drug companies pay generics to settle patent litigation and delay entering the market could have “significant anticompetitive effects” and violate the antitrust laws. What has happened in these five years? For starters, the number of “pay for delay” settlements (involving payment and delayed entry) has declined.

FTC revives complaint, files motion for stipulated order over pay-for-delay agreement for generic Lidoderm

On January 23rd, the Federal Trade Commission (FTC) announced that it had taken steps to resolve antitrust charges involving business activities employed by Irish/U.S. drugmaker Endo International (NASDAQ:ENDP) designed to delay the entry of generic pain medications into the U.S. to preserve monopoly profits. The FTC filed a complaint for injunctive relief and a motion for entry of stipulated order for permanent injunction against Endo and others in the U.S. District Court for the Northern District of California (N.D. Cal.). These actions revive charges from a lawsuit filed by the FTC last March against Endo involving pay-for-delay patent settlements.

FTC charges Endo Pharmaceuticals with antitrust violations for pay for delay patent settlements

The FTC’s complaint alleges that Endo paid the first generic companies that filed for FDA approval – Impax Laboratories, Inc. and Watson Laboratories, Inc. – to eliminate the risk of competition for Opana ER and Lidoderm, in violation of the Federal Trade Commission Act. The FTC is asking the district court to declare that the defendants’ conduct violates the antitrust laws, and further seeking an order that the companies disgorge their ill-gotten gains. Of course, the FTC asks for a permanent bar to prevent the companies from engaging in similar anticompetitive behavior in the future.