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Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?
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The SPC Manufacturing Waiver (the "Waiver") is now in force, effective from 1 July 2019 (Regulation 2019/933 amending the SPC Regulation 2009/469). The Waiver has been introduced with the stated aim of putting EU generic and...more
This year’s C5’s Pharma Patent Term Extensions Forum arrives at a critical time for the pharmaceutical industry. Overarching developments from the Teva U.K. decision (C-121/17) to the SPC Manufacturing Waiver and the most...more
The Situation: For the pharmaceutical industry, supplementary protection certificates ("SPC") are probably the most valuable IP rights. While the scope of protection of an SPC is determined separately from the scope of...more
On 28 May 2018, the European Commission published a draft regulation amending Regulation 469/2009 concerning the supplementary protection certificate for medicinal products....more
The Board of Appeal of the Italian Patent Office (Commissione dei Ricorsi), by decision published on June 26, 2017, acknowledged the right of the patent holder to ask the Italian Patent Office for the limitation of the...more
The Court of Justice of the European Union (CJ) issued three judgments on grant of Supplementary Protection Certificates (SPCs) on 12 December 2013 in the cases: - C-493/12 Eli Lilly v HGS, - C- 443/12 Actavis v...more
The Court of Appeal recently issued a decision concerning the issues that should be considered when granting an interim injunction. The proceedings related to Novartis' product zoledronic acid, which was used to treat...more