Kirkland & Ellis Hired for Big Pharma Antitrust Suit

A 2020 verdict allowed Teva and other companies to produce generic versions of Vascepa. But Teva allegedly had to scale back its launch because of an inability to obtain the key ingredient, the suit said.

Teva Pharmaceuticals USA Inc. has enlisted Big Law to bring an antitrust suit against Amarin Pharma, an Irish drug company with its U.S. headquarters in Bridgewater, New Jersey.

Teva brought in Kirkland & Ellis for its suit accusing Amarin of seeking to delay generic competition for its cardiovascular health drug, Vascepa. Amarin allegedly aims to thwart lower-cost competitors by cornering the market for the key ingredient in Vascepa, icosapent ethyl, beyond the amount it needs, the suit claims.

Devora Allon, Kirkland & Ellis. Courtesy photo

Teva filed its suit in the District of New Jersey against Amarin, with claims for conspiracy, monopolization and attempt to monopolize under the Sherman Act.

The suit also includes claims for unfair competition under New Jersey common law and violation of the New Jersey Antitrust Act.

Vascepa is used to prevent strokes by lowering harmful triglycerides in the blood, and its revenues were $26 million in 2020, the suit claims. It is Amarin’s only product approved by the Food and Drug Administration, and there is “no meaningful pipeline after Vascepa,” the suit said.

Amarin, allegedly knowing that generic competition could mean an immediate loss of nearly all its Vascepa sales, allegedly sought to orchestrate an artificial limit on the amount of the drug’s key ingredient that was available to generic competitors, the suit claims.

Amarin allegedly cut deals with suppliers who agreed not to sell the key ingredient to any other companies in exchange for a promise by Amarin to purchase certain minimum amounts of that product, the suit claims.

In addition, Teva claims, “Amarin agreed to make a cash payment to maintain exclusivity in the event that Amarin was not able to satisfy the minimum purchase requirement, thus keeping the API [active pharmaceutical ingredient] supplier in question from contracting with another company, like Teva, despite the API supplier having available, unused capacity. Amarin thus committed to pay suppliers cash in exchange for those suppliers agreeing to limit market supply of Vascepa API, which would allow Amarin to preserve its monopoly and keep charging monopoly prices.”

Amarin did not respond to a request for comment about the suit.

Teva is not the first plaintiff to accuse Amarin of hoarding the key ingredient in Vascepa.

Dr. Reddy’s Laboratories raised similar allegations against Amarin in a 2021 suit, and Hikma Pharmaceuticals brought the same claims in a suit against Amarin in 2023, according to court papers. Both are generic drug producers. In addition, Amarin is facing similar allegations in class action suits on behalf of direct and indirect purchasers of Vascepa.

According to court documents, Teva, Dr. Reddy’s and a predecessor of Hikma sought approval in 2016 to make generic versions of Vascepa. Amarin then sued the three generic companies for patent infringement in federal court in Nevada.

Liza M. Walsh of Walsh Pizzi O’Reilly Falanga. Courtesy photo.

In that case, Amarin settled with Teva in 2018.

The settlement pushed back the launch of Teva’s generic Vascepa until 2029, but allowed the date to move up if the Vascepa patent were invalidated in litigation.

Amarin proceeded to trial with Dr. Reddy’s and Hikma, which resulted in the invalidation of the Vascepa patents in 2020, clearing the way for the three companies to proceed with generic versions of the drug, according to court papers.

But Teva allegedly had to scale back its launch because of an inability to obtain the key ingredient, the suit said.

The entry of generics into a market typically causes a branded drug’s market share to drop, but after Teva entered the market in late 2022, Amarin held a 62% share of the market, the suit claims.

“This unusual behavior can only be explained by Amarin’s exclusive API agreements and efforts to lock up icosapent ethyl API,” Teva alleged in its suit.

Teva is represented by Devora W. Allon, Gilad Bendheim and James R.P. Hileman of Kirkland & Ellis along with Liza M. Walsh and Jessica K. Formichella of Walsh Pizzi O’Reilly Falanga in Newark. They did not respond to requests for comment about the suit.