On July 5, 2022, the Honorable Colm F. Connolly for the United States District Court for the District of Delaware denied, in large part, Defendants’ motion to dismiss, allowing the End-Payor Plaintiffs’ putative antitrust class action to move forward against AstraZeneca Pharmaceuticals LP. Plaintiffs, alleging that AstraZeneca Pharmaceuticals LP struck deals with Handa Pharmaceuticals LLC, Par Pharmaceutical Inc. and Accord Pharmaceuticals Inc., inducing the generic-drug makers to hold off on launching their generic versions of AstraZeneca's prescription drug treatment for schizophrenia, bipolar disorder and depression, Seroquel XR, for five years. In exchange, the class alleges that AstraZeneca committed to stall the launch of its own generic for six months after Handa, Par and Accord rolled out their products in late 2016. On September 8, 2022, Plaintiffs filed a first amended complaint with the court.
As of November 1, 2022 the case is in discovery.
On November 13, 2020, the Court appointed Cohen Milstein’s Sharon K. Robertson Interim Co-Lead Class Counsel for the putative End-Payor Class.
As of 2016, Seroquel XR was the eighty-sixth most prescribed medication in the United States, with more than 8 million prescriptions and annual sales exceeding $1 billion.
Plaintiffs allege that Defendants engaged in an illegal scheme to delay competition in the United States and its territories for Seroquel XR, a prescription medication approved by the U.S. Food and Drug Administration (“FDA”) for the treatment of: (1) schizophrenia; (2) acute depressive episodes of bipolar disorder; (3) acute manic or mixed episodes of bipolar disorder in conjunction with other medications; (4) long-term bipolar disorder in conjunction with other medications; and (5) major depressive disorder.
Recognizing the huge market for Seroquel XR, in 2008, Handa became the first drug manufacturer to file an Abbreviated New Drug Application (“ANDA”) (No. 90-482) with the FDA seeking approval to market the 50mg, 150mg, 200mg, and 300mg strengths of generic extended-release quetiapine fumarate tablets, with Seroquel XR as its Reference Listed Drug. Accord Pharmaceuticals, Inc. (“Accord”) became the first drug manufacturer to file an ANDA (No. 90-681) for the 400mg strength of extended-release quetiapine fumarate tablets, with Seroquel XR as its Reference Listed Drug. Handa later filed an ANDA for the 400mg strength of extended-release quetiapine fumarate.
Pursuant to 21 U.S.C. § 355(j)(2)(B), both Handa and Accord separately sent AstraZeneca, the manufacture of Seroquel XR, notice letters throughout 2008 and early 2009. In these letters, Handa and Accord each certified that they would seek final FDA approval to launch and market their generic extended-release quetiapine fumarate products prior to the expiration of U.S. Patent No. 5,948,437 (the “’437 Patent”), a follow-on patent, which supposedly covered Seroquel XR.
The ’437 Patent was set to expire on May 8, 2017 and the regulatory exclusivities associated with the ’437 Patent expired on November 28, 2017.
Plaintiffs allege that AstraZeneca sought to block Handa and Accord’s generic version of Seroquel XR by filing multiple patent infringement lawsuits against the generic manufactures in 2008 and 2009. In December 2010, after the FDA granted tentative approval to Handa’s ANDA for generic Seroquel XR in all strengths and it became clear that AstraZeneca was very likely to lose any litigation over the ‘437 Patent, Plaintiffs claim that AstraZeneca induced Handa to drop its patent challenge and delay launching its generic version with a large “reverse payment” in direct violation of antitrust law.
On or about September 29, 2011, AstraZeneca and Handa entered into a settlement agreement concerning Handa’s ANDA (“Handa Non-Compete Agreement”). Under the terms of the Handa Non-Compete Agreement, Handa agreed to abandon the patent fight and delay its launch of generic extended-release quetiapine fumarate in the 50mg, 150mg, 200mg, and 300mg strengths until November 1, 2016. Handa also agreed to abandon the patent fight with respect to the 400mg strength as well, even though it did not hold first filer status for that strength. In exchange for Handa’s delayed generic launch, AstraZeneca agreed not to compete with Handa by launching an authorized generic Seroquel XR during Handa’s 180-day exclusivity period.
Plaintiffs further claim that but for the Handa Non-Compete Agreement and AstraZeneca’s large and unjustified payment, Handa and AstraZeneca would have each launched generic versions of 50mg, 150mg, 200mg, and 300mg strengths of Seroquel XR much earlier, and in any event, well before Handa’s November 1, 2016 launch and AstraZeneca’s May 1, 2017 launch. Additional generics would have launched six months after Handa’s generic extended-release quetiapine fumarate launch, likely resulting in lower prices for Plaintiffs and others.
Handa subsequently assigned this unlawful agreement to Par. On November 1, 2016, Par began selling generic extended-release quetiapine fumarate in the 50mg, 150mg, 200mg, and 300mg strengths and Accord began selling 400mg extended-release quetiapine fumarate.
On May 2, 2017 (180 days thereafter) AstraZeneca launched its own authorized generic versions of Seroquel XR in the 50mg, 150mg, 200mg, 300mg and 400mg strengths. Several other generic competitors launched their own versions of Seroquel XR in all strengths in or around May 2017.
Because of the unlawful Handa Non-Compete Agreement and Accord Non-Compete Agreement (together, the “Non-Compete Agreements”), no generic Seroquel XR was available for Plaintiffs and other Class members to purchase in the United States and its territories until November 1, 2016 and, for a period of six months thereafter, there was only one generic available for each strength of Seroquel XR (marketed by Par in the 50mg, 150mg, 200mg, and 300mg strengths and by Accord in the 400mg strength).
Plaintiffs and the proposed Class seek to recover damages, including treble damages, under the state antitrust and consumer protection laws.
In Re: Seroquel XR Antitrust Litigation, No. 20-1076-CFC (D. Del.)