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FTC Set To Take Enforcement Action Against Drugmakers Over Orange Book Patent Listings

 
• By Brenda Sandburg

Merger reviews could take into account sponsor's Orange Book behavior. FTC's statement does not detail what would make a patent listing 'improper' but the precedents from court cases against various sponsors should offer industry some guideposts.

Orange Book
FTC targets improper patent listings in FDA's Orange Book • Source: Shutterstock

The US Federal Trade Commission may take legal action against brandname drug manufacturers who improperly list patents in the US Food and Drug Administration’s Orange Book and factor this behavior in merger reviews. 

At their 14 September meeting, the three FTC Commissioners voted unanimously to adopt a policy statement that the agency...

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• By Dean Rudge

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US Supreme Court Requests Solicitor General Input On Hikma Skinny Label Case

 
• By Dean Rudge

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• By Dean Rudge

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AAM Celebrates Court Backing Over Minnesota Pricing Law

 
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Biocon Agreement Provides Multiple Oncology Biosimilars To Malaysian Cancer NGO

 
• By Dean Rudge

Biocon Biologics will look to combine its “scientific expertise with the National Cancer Society of Malaysia’s strong community outreach and patient support network,” after signing striking up a partnership with the NGO providing for supply of three biosimilars.

Cigna Claims BMS Tied Revlimid Settlements to Pomalyst ‘Pay-for-Delay’ Scheme

 
• By Dean Rudge

Among other schemes, Cigna alleges that Celgene and parent Bristol Myers Squibb “paid” generic challengers – via lucrative Revlimid profit-sharing agreements – to delay generic market entry for Pomalyst until 2026, unlawfully extending their monopoly and overcharging purchasers.

US Supreme Court Requests Solicitor General Input On Hikma Skinny Label Case

 
• By Dean Rudge

The US Supreme Court is seeking a brief “expressing the views of the United States,” following the US Federal Circuit’s decision to reopen Amarin’s claim of induced infringement against Hikma relating to its ‘skinny-label’ generic Vascepa (icosapent ethyl) product.