Introduction
The lawsuit filed by Ahold USA, Inc. against Allergan, PLC (formerly known as Actavis, PLC) is a significant antitrust case that alleges Allergan engaged in a series of anticompetitive practices to maintain its monopoly over the drug Restasis (cyclosporine ophthalmic emulsion, 0.05%). Here is a detailed summary and analysis of the key points in this litigation.
Background of the Case
Ahold USA, Inc. filed the lawsuit on July 19, 2016, in the U.S. District Court for the District of Massachusetts, alleging violations of antitrust laws by Allergan[2].
Allegations Against Allergan
Fraud on the PTO
Ahold alleges that Allergan defrauded the United States Patent and Trademark Office (PTO) to obtain a second wave of patents for Restasis. Allergan misrepresented clinical trial data, cherry-picking favorable results and ignoring those that did not support its claims. This fraud extended the patent coverage for Restasis beyond its legitimate term[1].
Wrongful Orange Book Listings
Allergan listed the second wave patents in the FDA's Orange Book, despite knowing these patents were procured by fraud and did not meet the FDA's listing requirements. This action was intended to block generic competitors[1].
Wrongful FDA Petitions
Allergan filed baseless petitions with the FDA, seeking to impose unnecessary and unsupported requirements on generic competitors. These petitions diverted significant FDA resources and were ultimately denied[1].
Wrongful Patent Enforcement
Allergan pursued infringement actions against potential generic manufacturers, knowing it had no realistic expectation of prevailing. The goal was to delay the FDA's review of generic applications and prevent generics from entering the market[1].
Conspiracy to Monopolize and Contract in Restraint of Trade
After the PTO indicated the second wave patents were likely to be declared invalid, Allergan transferred ownership of these patents to the Saint Regis Mohawk Tribe to exploit the tribe's sovereign immunity and avoid PTO jurisdiction. This transfer was part of an anticompetitive scheme to restrain competition[1].
Impact of Allergan’s Anticompetitive Scheme
Allergan’s actions successfully delayed generic competition in the market for cyclosporine ophthalmic emulsion, 0.05%. As a result, direct purchasers, including Ahold USA, Inc., were overcharged by hundreds of millions of dollars. Generic versions of Restasis, which would have been available as early as May 2014, were prevented from entering the market[1].
Parties Involved
- Plaintiff: Ahold USA, Inc., a Maryland corporation, acting as an assignee of McKesson Corporation, which purchased Restasis directly from Allergan at supra-competitive prices due to Allergan’s scheme.
- Defendants: Allergan, Inc., Allergan PLC (f/k/a Actavis, PLC), and other related entities[1][2].
Legal Claims and Violations
The lawsuit alleges violations of Sections 1 and 2 of the Sherman Act, specifically:
- Monopolization: Allergan’s scheme to maintain its monopoly over Restasis.
- Attempted Monopolization: Actions taken to prevent generic competition.
- Conspiracy to Restrain Trade: The transfer of patents to the Saint Regis Mohawk Tribe to avoid PTO jurisdiction[1].
Court Proceedings and Rulings
The case involves complex antitrust allegations and has seen various legal maneuvers. The court has had to address issues such as the validity of the patents, the legitimacy of the Orange Book listings, and the impact of Allergan’s actions on the market.
Key Takeaways
- Allergan’s alleged anticompetitive practices significantly delayed generic competition, leading to substantial overcharges for direct purchasers.
- The case highlights the importance of patent integrity and the consequences of fraudulent practices in the pharmaceutical industry.
- The use of sovereign immunity by transferring patents to a Native American tribe is a novel and controversial tactic that has been scrutinized in this litigation.
FAQs
What was the primary allegation against Allergan in the lawsuit filed by Ahold USA, Inc.?
The primary allegation was that Allergan engaged in a scheme to unlawfully prolong its monopoly over the sale of Restasis by defrauding the PTO and engaging in other anticompetitive practices.
How did Allergan allegedly defraud the PTO?
Allergan allegedly misrepresented clinical trial data to the PTO, cherry-picking favorable results and ignoring those that did not support its claims, and failed to disclose that the data lacked statistical significance and was prior art.
What was the impact of Allergan’s actions on the market for Restasis?
Allergan’s actions delayed the entry of generic competitors into the market, resulting in direct purchasers being overcharged by hundreds of millions of dollars.
Why did Allergan transfer the patents to the Saint Regis Mohawk Tribe?
Allergan transferred the patents to exploit the tribe's sovereign immunity and avoid PTO jurisdiction, which was part of an anticompetitive scheme to restrain competition.
What are the legal claims made against Allergan in this lawsuit?
The lawsuit alleges violations of Sections 1 and 2 of the Sherman Act, including monopolization, attempted monopolization, and conspiracy to restrain trade.
Sources
- Ahold USA, Inc. v. Allergan, Inc. - ClassAction.org
- Ahold USA, Inc v Allergan, PLC (f/k/a Actavis, PLC) et al - UniCourt
- In re Asacol Antitrust Litig. - Casetext
