Case Initial Text 1

Hagens Berman is co-lead counsel representing a proposed class of direct purchasers in this lawsuit alleging an unlawful monopolistic scheme to delay competition and prolong supra-competitive pricing of Sensipar (cinacalcet hydrochloride), a medicine that treats hyperparathyroidism.

Case Status
Active
Position
Co-Lead Counsel
Court
U.S. District Court for the District of Delaware
Judge Assigned
Hon. Leonard P. Stark
Case Number
19-md-2895
Defendant(S)
Amgen Inc.
Teva Pharmaceuticals USA, Inc.
Watson Laboratories, Inc.
Actavis Pharma, Inc.
File Date

ABOUT THE SENSIPAR LAWSUIT

The complaint alleges that Amgen, the branded Sensipar manufacturer, delayed competition from generic manufacturers by suing them for patent infringement and then using “acceleration” and “grace” provisions in a series of settlements from 2017 to 2018. Under these agreements, numerous generic manufacturers would be permitted to come to market if any generic launched a cinacalcet product “at risk” (i.e., without Amgen’s authorization), but only if Amgen did not block other generics’ “acceleration” to the market by agreeing with the at-risk launcher to cease the sale of the at-risk generic within the “grace” period. These agreements disincentivized early generic entry, because entry by multiple generics would quickly commoditize the market, driving down the price and the ability to turn a profit for cinacalcet. These agreements also unlawfully lengthened Amgen’s monopoly over Sensipar.

When a generic competitor, Teva, finally did launch its generic product at risk in late December 2018, Amgen and Teva quickly entered into a settlement agreement in which Amgen and Teva allocated the Sensipar market and Teva got paid off. Teva was allowed by Amgen to retain hundreds of millions in profits so long as it did not sell any additional product, Teva also received an “acceleration” clause of its own, signaling to other generics that if they launched at risk, Teva would immediately come back to market, driving down the price for generic Sensipar. With Teva off the market, Amgen continued selling Sensipar at supra-competitive prices without further generic competition, and at least ten additional generics were effectively blocked from coming to market. 

Absent the anticompetitive scheme by Amgen and its market allocation and delay agreement with Teva, the purchasers allege, several non-infringing generic competitors would have come to market by May 2018, and the price of cinacalcet would have decreased significantly.  The direct purchasers have pleaded monopolization counts against Amgen, and conspiracy to allocate the cinacalcet market and entry into an agreement in restraint of trade against both Amgen and Teva, all in violation of the Sherman Antitrust Act.  The class is seeking treble damages for the overcharges paid, plus attorneys’ fees and the costs of suit.

Briefing on anticipated motions to dismiss is expected to close in late May 2021. 

Case Timeline
Description

Defendants’ deadline to move to dismiss the Second Amended Consolidated Direct Purchaser Class Action Complaint

Date
Description

Direct Purchasers file Second Amended Consolidated Class Action Complaint

Date
Description

Judge Stark denies defendants’ motions to dismiss, accepting in part and rejecting in part the report and recommendations of Magistrate Judge Hall 

Date

CASE TIMELINE

Defendants’ deadline to move to dismiss the Second Amended Consolidated Direct Purchaser Class Action Complaint

Direct Purchasers file Second Amended Consolidated Class Action Complaint

Judge Stark denies defendants’ motions to dismiss, accepting in part and rejecting in part the report and recommendations of Magistrate Judge Hall 

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