Judge rules Mylan monopoly suit against Celgene can continue

By Fiona BARRY contact

- Last updated on GMT

Mylan has accused Celgene of an illegal monopoly. (Image: William Warby)
Mylan has accused Celgene of an illegal monopoly. (Image: William Warby)

Related tags: Generic drug

Mylan lawsuit accusing Celgene of using REMS to block generic Revlimid and Thalomid should go to trial says US Court.

Mylan launched a case against Celgene in April 2014 accusing it of anti-competitive behaviour over Revlimid and Thalomid to keep Mylan’s generic versions off the market.

Revlimid (lenalidomide) treats blood cell disorders and Thalomid (thalidomide) treats lesions and leprosy.

"The effect of Celgene's conduct is that no generic manufacturer, including Mylan, has been able to bring generic versions of Thalomid and/or Revlimid to market,​" Mylan said. "Through its illegal actions, Celgene has foreclosed Mylan from even attempting to enter the market.​"

Judge Esther Salas found Mylan may have a plausible case for Celgene having a “duty to deal​” with its rivals under anti-competition laws.

She also dismissed Celgene’s claim that Mylan could not suffer injury because it cannot presently enter the market with generic versions while Celgene holds marketing exclusivity.

Mylan is injured by Celgene’s preventing it from entering the market immediately upon the expiration of its patents,​” or if Celgene’s patents were to be found invalid, she said.

Risk evaluation – 'a smokescreen​'?

Mylan claims Celgene is abusing federal legislation on the safe distribution of drugs to deny generic developers access to its drugs for bioequivalence testing. The US FDA requires all applications for generic drugs to include bioequivalence studies comparing them with the branded product.

REMS (Risk Evaluation and Mitigation Strategies) are extra conditions the US FDA can impose on pharma companies beyond standard safety measures. They can require prescribers to impose conditions on patients taking the drug, such as pregnancy tests or liver function monitoring.

But some groups believe drug companies use the safety strategies as an excuse to prevent competition. US Congressmen Steve Stivers (R-OH) and Peter Welch (D-VT) accused branded pharma last October of “abus[ing]” the regulations as a “smokescreen”​ for delaying generic market entry.

Celgene’s REMS programme for Revlimid restricts access to the drug to specially certified prescribers and pharmacies, and allows them to dispense it only to patients enrolled in a strict contraception programme to prevent foetal exposure.

Mylan says it has attempted to obtain Thalomid and Revlimid since 2003 and 2009, respectively.

After it failed to purchase samples of Thalomid through wholesale channels because of REMS restrictions, Mylan says it sent requests directly to Celgene, and provided FDA authorisation to release the products outside the REMS programme (“S.T.E.P.S.”).

Celgene did not provide the drug, citing “concerns about distributing Thalomid outside of the S.T.E.P.S. program [that] are independent of FDA’s regulatory oversight,​” according to court documents.

Mylan continued to send Celgene information on compliance and liability insurance for a year and a half until it “recognized that further engagement with Celgene would be fruitless,​” the generics maker alleges.

Attempts to obtain Revlimid followed a “nearly identical path of delay,​” Mylan claims.

Related topics: Markets & Regulations, Regulations

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