Gilead False Claims Case: Government Opposes Supreme Court Review But Thinks Suit Should Be Tossed
US Solicitor General says facts lacking on what government knew about alleged product misrepresentations; FDA may be burdened with discovery requests if suit proceeds to discovery and trial.
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Gilead disputed Campie FCA decision, Amgen challenged Repatha ruling, and Merck challenged "unclean hands" defense against damages. Patent and Trademark Office wants court to determine if its attorneys' fees should be covered by patent applicants challenging its decisions.
Government seeks dismissal of 10 qui tam complaints related to pharma reimbursement support services, asserting the lawsuits were brought by a ‘professional’ whistleblower and lack merit.
Policy revisions on individual liability for corporate misconduct, noncompliance with agency guidance documents and dismissal of False Claims Act cases suggest a greater willingness by DoJ leadership to reconsider arguments often raised by life sciences companies, attorneys say at a Food and Drug Law Institute conference.