Search Results for pharmaceutical patents

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European Commission Consults on Recalibrating Aspects of Drug Patents, SPCs By Zachary Brennan - Published 19 October 2017

The European Commission last week released for consultation a proposal to re-work certain elements of the EU pharmaceutical patent system and industry group Medicines for Europe is calling for the introduction of a Supplementary Protection Certificate (SPC) manufacturing waiver and for a wider definition of the research exemption.

Categories: News, Europe, EC, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Supplementary Protection Certificate, Bolar exemption, research exemption, pharmaceutical patents

EU Pharma Patent Settlements Still Limiting Entry of Generics By Zachary Brennan - Published 13 December 2016

Almost three-quarters of 125 patent settlements in the EU between originator pharmaceutical and their generic competitors resulted in a lengthening of time to bring the cheaper generic version to market.

Categories: News, Europe, EC, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: pharmaceutical patents, patent settlements with generic drugs

Patents vs. Market Exclusivity: Why Does it Take so Long to Bring Generics to Market? By Zachary Brennan - Published 17 August 2016

It’s well known that generic drugs are just as safe and effective as their brand name counterparts. They’re the cheap knockoffs that help more people around the world gain access to innovative and sometimes life-saving treatments; the boring copycats made by companies you’ve never heard of and sold in plain bottles with little fanfare.

Categories: News, US, FDA, Business Skills, Drugs, Government affairs, Quality, Regulatory intelligence, Regulatory strategy

Tags: pharmaceutical patents, pharmaceutical IP, generic drugs, ANDA approval process

US, EU Face Off Over Permanently Exempting Least-Developed Countries from Pharma Patents By Zachary Brennan - Published 14 October 2015

Tomorrow and Friday, members of the World Trade Organization (WTO) will meet to discuss whether the world's poorest countries should be permanently exempt from rules governing pharmaceutical patents, and the EU and US have publicly taken separate sides.

Categories: News, Africa, Asia, Canada, Europe, US, EC, WHO, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence

Tags: WTO, TRIPs, LDCs, pharmaceutical patents, European Commission