Lawsuit Claims Allergan Unlawfully Delayed Approval of Generic Alternatives to Restasis [UPDATE]
by Erin Shaak
Last Updated on October 22, 2021
Self Insured Schools of California v. Allergan, Inc
Filed: January 5, 2018 ◆§ 8:18cv17
A proposed class action has been filed in California federal court against Allergan, Inc., claiming the drug manufacturer attempted to delay the entrance of generic alternatives to its cyclosporine ophthalmic emulsion drug, Restasis.
Case Updates
October 22, 2021 – Settlement Proposed for Restasis Buyers
Allergan has reached a nearly $30 million deal with Restasis buyers and third-party payors to end the litigation detailed on this page.
The proposed settlement, which comes a year and a half after Allergan reached a $51 million deal with direct purchasers of the drug, looks to provide cash payments to certain consumers who purchased Restasis with cash or through insurance and third-party payors such as employers or insurers who paid for or reimbursed the purchase of the dry eye drug.
The deal looks to cover purchases made between May 1, 2015 and July 31, 2021 in certain states. More information about who is covered can be found on the settlement website.
According to an October 8 memo, 83.4 percent of the roughly $30 million settlement fund (after attorney fees, costs and service awards have been set aside) will be split among third-party payors while 14.4 percent will go to insured consumers and 2.2 percent will compensate consumers who purchased Restasis without insurance.
Cash-paying consumers will be asked to indicate how many 30-vial, 60-vial or multidose packages of Restasis they purchased, and insured consumers “need only provide the number of prescriptions they paid for,” the memo states. Third-party payors will be asked to provide the total amount they spent on Restasis prescriptions, according to court documents.
If the deal receives preliminary approval, consumers will be able to find more information and file claims through the settlement website, which will be updated within two weeks after the judge enters an approval order.
A proposed class action has been filed in California federal court against Allergan, Inc., claiming the drug manufacturer attempted to delay the entrance of generic alternatives to its cyclosporine ophthalmic emulsion drug, Restasis. The suit claims the defendant attempted to protect its monopoly over the market through “fraudulent patents, sham proceedings, and collusion.”
According to the suit, when Restasis’ patents were set to expire, the defendant misled the Patent and Trademark Office into issuing new patents based on purportedly “unexpected effectiveness and surprising test results.” The manufacturer then listed the new patents in the FDA’s Orange Book, the complaint says, requiring would-be competitors to notify the defendant of their intentions to introduce generic alternatives to the market and thereby allowing Allergan to file “patent infringement action[s]” against them, automatically delaying the approval of their drugs by 30 months.
The lawsuit goes on to claim that Allergan, “[i]mmediately after improperly listing the second wave patents in the Orange Book,” submitted “baseless petitions” to the FDA requesting that it require potential generic competitors to satisfy “expensive, time-consuming, and unnecessary” conditions before their drugs were approved. The FDA allegedly denied the petitions after expending its already limited resources investigating Allergan’s claims.
In December 2016, the complaint alleges, the Patent and Trademark Appellate Board (PTAB) began to review the defendant’s second wave patents. Knowing there was “a reasonable likelihood” they would be invalidated, Allergan transferred the ownership of the patents to the Saint Regis Mohawk Tribe, the suit says, in order to exploit its tribal immunity and have the PTAB’s review dismissed.
As a result of the defendant’s actions, the case claims, the approval of generic alternatives to Restasis was unlawfully delayed and consumers were forced to continue paying inflated prices for the brand-name drug.
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