Kevin DeJong (Senior Editor) and Shweta Kumar (Editor) from the Big Molecule Watch recently interviewed Rachel Goode, Ph.D. to discuss an article she recently co-authored.
Strategies for in-house counsel to mitigate risk related to intellectual property | Smart & Biggar jdsupra.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from jdsupra.com Daily Mail and Mail on Sunday newspapers.
The FDA has accelerated the approval process for generics and biosimilars, which has resulted in a slew of biosimilar approvals. But that’s a necessary, not a sufficient condition for biosimilar market entry. Protracted patent battles have delayed the launch of many high-profile biosimilars.
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Rarely must patent infringers demand their right to pay
royalties. But several multinational manufacturers have gone to
court to insist that they – and not other participants in the
supply chain – make payment of any patent royalties. From a
contractual perspective, judicial analysis of such claims has
focused on the non-discrimination prong of the fair, reasonable,
and non-discriminatory ( FRAND ) patent licensing
commitment. In other words, some manufacturers have argued, and
some courts and administrative agencies have agreed, that a
patentee s refusal to provide FRAND licenses at all levels of