Pharma's Preferred Patent Reforms May Be Too Expensive
This article was originally published in The Pink Sheet Daily
Sen. Schumer supports exempting Rx industry from inter partes review, but tells BIO conference that legislators must find $1.2 billion to enact it; calls for industry code of conduct on pricing.
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Legislation is targeting a wide range of patent practices, from product hopping to patent infringement settlements and inter partes review.
Promotion does not adequately communicate the diabetes drug’s indication, limits of use and risks, FDA says. It objects to distracting visuals in video and less prominent risk information. Agency had previously relayed its concerns to Lilly about Trulicity promotions.
Generic manufacturers are being cautious on label carve-outs to avoid claims of induced infringement. Bright line rules are necessary, attorney says, and if GSK v. Teva decision is not reversed, legislation will be needed to preserve skinny label. Insurers also face potential liability for placement of skinny-label generics on formularies.