International Life Sciences Update - October 2014



In this edition we report on a range of recent developments and decisions, at EU national level, relating to patent law and regulatory matters. We hope you enjoy reading this update and are happy to address any comments or questions you may have, either through your usual contact or through any of the contacts listed in this update.

Patents and SPC Decisions

EU: Proposed revisions to the guideline on the assessment of immunogenicity for biotechnology derived proteins and its relevance to biosimilars

Over recent years, the landscape of blockbuster medicines in Europe has been changing, moving from small molecule drugs to biologicals. Biologicals, mainly biotechnology-derived proteins, now dominate the top 10 list of best-selling medicinal products in Europe: currently, eight of the top 10 best-selling medicinal products are biologicals. As the patents for all of these blockbuster biologicals have either already expired or will expire by 2022 at the latest, these blockbuster biologicals are targets for biosimilars developers.[1] To date, 20 biosimilars have been granted a marketing authorisation by the European Medicines Agency ("EMA")... Read more>>

France: Syngenta: The epilogue - no combination SPC despite a valid patent limitation

Syngenta is the holder of a European Patent titled “fungicides”, which relates to compounds that contain the active ingredient “azoxystrobin” (the "Basic Patent").

Syngenta obtained a first Supplementary Protection Certificate (“SPC”) on the product “azoxystrobin” and, on the basis of the same Basic Patent, applied for a second SPC for a product consisting of the combination of “azoxystrobin + folpel” ( the "Combination SPC”)...
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Poland: Implementation of the Falsified Medicinal Products Directive into Polish Pharmaceutical Law

On 29 July 2014, the Polish Council of Ministers approved the draft Act transposing Directive 2011/62/EU of the European Parliament and of the Council dated 8 June 2011, amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of entry into the legal supply chain of falsified medicinal products...
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EU: CJEU holds that synthetic cannabinoids do not qualify as a medicinal product

The Court of Justice of the European Union ("CJEU") found in a judgment of 10 July 2014 (joined cases C-358/13 and C-181/14) that according to EU law, mixtures of herbs containing synthetic cannabinoids cannot be regarded as medicinal products under the definition of Article 1 (2) b of Directive 2001/83, that defines medicinal products as "any substance or combination of substances which may be used in or administered to human beings with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making diagnosis". The reasoning of the Court states that synthetic cannabinoids merely have the effect of modifying physiological functions but are not such as to have any beneficial effects, either immediately or in the long term, on human health and are consumed solely to induce a state of intoxication and are, as such, harmful to human health....
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Italy: New developments on the validity of SPCs for a combination of active ingredients

In July 2014 the Court of Milan filed two judgments declaring the invalidity of the Italian supplementary protection certificate ("SPC") on the combination of telmisartan and hydrochlorothiazide ("HCTZ") (the "Combination SPC") owned by Boehringer Ingelheim Pharma GmbH & Co. KG ("Boehringer")...
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EU: In A-G's Opinion parthenotes do not fall within the term 'human embryo'

On 17 July 2014, Advocate General Cruz Villalón delivered his Opinion concluding that unfertilised human ova whose division and further development have been stimulated by parthenogenesis should be excluded from the term 'human embryos' in Article 6(2)(c) of Directive 98/44/EC on the Legal Protection of Biotechnological Inventions (the "Directive"), as long as those parthenotes are not capable of developing into a human being and have not been genetically manipulated to acquire such a capacity (Case C-364/13)...
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Regulatory News

China: Implementation of new supervisory and administration regulations on medical devices

On 7 March 2014, China's State Council promulgated the new Medical Device Supervision and Administration Regulations (the "Regulations"). The Regulations, which came into effect on 1 June 2014, contain some significant changes covering product and manufacturing approvals, clinical trials, operation and use of medical devices, sale and advertising and monitoring of adverse events...
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