Thursday, 17 May 2018
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... rising from the ashes of the expired patent
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... rising from the ashes of the expired patent
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The SPC Blog has set up an auxiliary SPC Blog: Resources website, which offers links to relevant national and European SPC case law as well as to basic legal texts.
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Useful links to organisations
BioIndustry Association (BIA)
European Federation of Pharmaceutical Industries and Associations (EFPIA)
European Generic Medicines Association (EGA)
European Medicines Agency (EMEA)
International Generic Pharmaceutical Alliance (IGPA)
Medicines for Children Research Network (MCFN)
United Kingdom Intellectual Property Office (UK-IPO) Guide for SPC applicants here
European Federation of Pharmaceutical Industries and Associations (EFPIA)
European Generic Medicines Association (EGA)
European Medicines Agency (EMEA)
International Generic Pharmaceutical Alliance (IGPA)
Medicines for Children Research Network (MCFN)
United Kingdom Intellectual Property Office (UK-IPO) Guide for SPC applicants here
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3 comments:
Michael Lin (Marks & Clerk Hong Kong) writes: "At a recent IP conference I attended in Shanghai, a communist party member said that they were seriously considering it, but as far as I know there is no specific announcement about what form/shape it would take, nor the actual timing of such a policy/law change. This would also require coordination between the CFDA as well as the new SMSA – and since the SMA was just announced a few months ago, I am sure there will be at least a few months or a year of reorganization of existing departments that needs to be done before any major policy like a PTE/CPC is considered." He also indicates that China will establish its own online "orange book". If you would like more information, feel free to contact Michael at MLin@marks-clerk.com.hk
We've conducted a bit more investigation and while it seems likely that a SPC for a max of 5 years will be enacted before the end of 2018, no other specific details or timing is available. his looks to be part of a holistic overhaul in the Chinese pharma environment, as additional provisions for patent linkage, data exclusivity, data protection for successful generics, etc. are also being discussed. However, none of these have been fixed and/or are open to public review as far as we know. We will keep the SPC Blog informed if we hear of anything. Pls. feel free to let us known if you have any questions.
We also did some digging and agree that most of the news in this area is not (fully) correct. In my opinion, the most important take-home message seems to be that China is providing most of the incentives to those companies that perform their trials and early registration in China. More details here: http://www.gevers.eu/en/news/2018-05-28/china-strengthen-data-and-patent-protection-mechanisms-pharmaceutical-industry.
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