1. Pink Sheet

Restasis Patent Review Back On Track As Federal Circuit Quashes Mohawk Tribe's Sovereign Immunity Claim

 
• By Brenda Sandburg

Appeals court says inter partes review is more like an agency enforcement action than a civil suit and thus tribal immunity does not apply to the proceeding; PTAB now to determine patentability of Restasis patents.

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The US Court of Appeals for the Federal Circuit vanquished Allergan Inc.'s bid to eliminate an inter partes review (IPR) challenge of its Restasis (cyclosporine) patents, finding that tribal sovereign immunity does not apply to IPR proceedings.

After Allergan transferred rights to the patents to the Saint Regis Mohawk Tribe, the tribe asked the US Patent and Trademark Office's Patent Trial and Appeal Board (PTAB) to terminate the IPR proceeding on the grounds of its sovereign immunity. The Board rejected the request, and in a July 20

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• By Neena Brizmohun

European companies, in particular small and midsize enterprises, spin-offs and start-ups have a hard time expanding within the single market “because of a complex regulatory framework that is perceived as slow and burdensome,” according to the European Commission.

New EU Filings

 
• By Neena Brizmohun

Brensocatib, Insmed's investigational treatment for non-cystic fibrosis bronchiectasis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

‘Tectonic’ Arkansas PBM Legislation May Upend Industry

 
• By Tim Casey

Industry will fight hard to prevent other states or the federal government from adopting measures similar to Arkansas' law preventing PBMs from owning pharmacies.