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27 January 2022GenericsAlex Baldwin

Virginia judge says court should deny class cert in Zetia antitrust suit

A Virginia district court judge has recommended that buyers of cholesterol drug Zetia (ezetimibe) should not be granted class certification in pay-for-delay litigation against MSD  (known as ' Merck & Co' in the US) and Glenmark Generics.

The two companies had allegedly worked together to delay generic ezetimibe from hitting the market for five years. The case, which has been ongoing since 2018, has already seen two classes formed to bring combined antitrust action.

Following a remand from the US Court of Appeals for the Fourth Circuit, 35 companies, comprising drug wholesalers and distributors, are looking to form a third class in the vast antitrust battle.

Class certification was first sought in the US District Court for the Eastern District of Virginia in November 2019, in which judge Douglas Miller recommended certification of the first class, but remained concerned about the potential “inefficient expenditure” of joining class members, which were spread across multiple states and Puerto Rico. The district court also granted a second class in the case.

However, a third class was set to be certified but was denied and appealed to the Fourth Circuit, which vacated and remanded class certification for legal error as the court’s analysis had not properly considered “the impracticability of individual suits”.

On remand, the Fourth Circuit claimed that the district court should “conduct the requisite full-throated analysis” of the possibility that the members would each launch individual suits if denied class status, therefore delaying proceedings.

In a report and recommendation submitted Tuesday, January 25, Judge Miller recommended that the court again deny the formation of a third punitive class.

He held that the would-be members had not “met their burden” in establishing that the class was “so numerous that joinder of all members is impracticable” in place of full class certification.

According to Miller, the case is “already so complex” that any extra burden in regards to docket management, courtroom staffing and the differences in costs of discovery between the parties would not be mitigated by class action.

Case background

Merck first sued Glenmark, which was the first generic manufacturer to seek Food and Drug Administration (FDA) approval to market generic Zetia in 2006, claiming that the generic make had infringed its active ingredient covered by its patent,  US number RE37,721.

Glenmark fired back, claiming that the patent was unenforceable as compounds outlined in the patent had been disclosed years earlier and were invalid for anticipation. Merck later conceded that the ’721 patent was invalid

“Had the case resulted in a decision on the ultimate merits, Glenmark would have prevailed”, the class claimed in their amended complaint.

Rather than proceed to trial, Merck settled with Glenmark out of court. According to the class, the agreement saw Merck pay Glenmark to stay out of the Zetia market for “almost five years”.

Buyers of Zetia claimed that, if the case had proceeded to trial, then generic Zetia could have launched as early as December 2011, well before Glenmark’s first launch of its generic in December 2016.

“The class has likely paid hundreds of millions in overcharges as a result of Merck and Glenmark’s unlawful agreement,” the punitive class said in its original amended complaint.

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More on this story

Americas
28 September 2021   Wholesale buyers of MSD’s cholesterol treatment Zetia have asked a Virginia court to recertify their class status and move to trial following a recent fourth circuit ruling that reversed the court’s prior certification.
Americas
7 January 2021   Pharmaceutical companies MSD and Glenmark have argued that the class certification of wholesale buyers of cholesterol drug Zetia should be reversed because the circumstances of the class members do not justify an award of class status.

More on this story

Americas
28 September 2021   Wholesale buyers of MSD’s cholesterol treatment Zetia have asked a Virginia court to recertify their class status and move to trial following a recent fourth circuit ruling that reversed the court’s prior certification.
Americas
7 January 2021   Pharmaceutical companies MSD and Glenmark have argued that the class certification of wholesale buyers of cholesterol drug Zetia should be reversed because the circumstances of the class members do not justify an award of class status.

More on this story

Americas
28 September 2021   Wholesale buyers of MSD’s cholesterol treatment Zetia have asked a Virginia court to recertify their class status and move to trial following a recent fourth circuit ruling that reversed the court’s prior certification.
Americas
7 January 2021   Pharmaceutical companies MSD and Glenmark have argued that the class certification of wholesale buyers of cholesterol drug Zetia should be reversed because the circumstances of the class members do not justify an award of class status.