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  1. Legal news
    11 December 2018
    Pemetrexed: Italian Court reversed the first instance decision ordering a PI on the basis of Eli Lilly's patent
    www.twobirds.com/en/news/articles/2018/italy/italian-court-reversed-the-first-instance-decision-ordering-a-pi-on-the-basis-of-eli-lillys-patent

    Diverging from the previous decision, the Court pointed out that the relevance of the file history to construe the scope of protection of a patent and then the infringement of equivalence has to be carefully and ...

  2. Legal news
    15 November 2018
    Supreme Court defines plausibility in the context of sufficiency
    www.twobirds.com/en/news/articles/2018/uk/supreme-court-defines-plausibility-in-the-context-of-sufficiency

    A majority postulates a new "outward presentation test" to deal with the infringement of second medical use patents.

  3. Legal news
    24 July 2020
    China Updates Drug Registration Rules and the Measures for Monitoring Drug Production – Part 1
    www.twobirds.com/en/news/articles/2020/china/china-updates-drug-registration-rules-and-the-measures-for-monitoring-drug-production

    Overall, the new DRR and AMMDP provide further clarity to the provisions of the new DAL. The obvious step toward improving the review and approval process, and the reduction in the need for onsite review for many ...

  4. Legal news
    16 September 2020
    NMPA and CNIPA issue Draft Patent Linkage Measures in China
    www.twobirds.com/en/news/articles/2020/china/nmpa-and-cnipa-issue-draft-patent-linkage-measures-in-china

    On 11 September 2020, the National Medical Products Administration ("NMPA") and the China National Intellectual Property Administration ("CNIPA") issued the draft "Implementing Measures for Drug Patent Dispute Early ...

  5. Legal news
    17 August 2020
    Advanced Therapy Products Amendment - Hong Kong Pharmacy and Poisons (Amendment) Ordinance 2020
    www.twobirds.com/en/news/articles/2020/hong-kong/advanced-therapy-products-amendment-hong-kong-pharmacy-and-poisons-amendment-ordinance-2020

    On 17 July 2020, the Hong Kong ("HK") Legislative Council enacted the Pharmacy and Poisons (Amendment) Ordinance 2020 ("Amendment Ordinance") that introduced specific provisions covering Advanced Therapy Products ...

  6. Legal news
    07 July 2020
    China releases Latest Draft Amendments to Patent Law
    www.twobirds.com/en/news/articles/2020/china/china-releases-latest-draft-amendments-to-patent-law

    The draft amended Patent Law contains several other new provisions in addition to the Patent Linkage and the SPP provisions, such as the draft Article 24 which proposes a six month grace period of novelty for an ...

  7. Legal news
    06 May 2020
    Our UAE team contribute to the 8th edition of the Life Sciences Law Review
    www.twobirds.com/en/news/articles/2020/uae/our-uae-team-contribute-to-the-8th-edition-of-the-life-sciences-law-review

    The eighth edition of The Life Sciences Law Review covers a total of 33 jurisdictions, providing an overview of legal requirements of interest to pharmaceutical, biotechnology and medical device companies. The chapters ...

  8. Legal news
    18 June 2020
    Transfer of value in France: the long-awaited “anti-gift” decree has finally been published
    www.twobirds.com/en/news/articles/2020/france/transfer-of-value-in-france-the-long-awaited-anti-gift-decree-has-finally-been-published

    The French so-called “anti-gift” provisions strictly frame the conditions under which companies in the health sector are allowed to provide advantages, in cash or in kind, to healthcare professionals ("HCPs”).

  9. Legal news
    03 August 2020
    China Updates Drug Registration Rules and the Measures for Monitoring Drug Production – Part 2
    www.twobirds.com/en/news/articles/2020/china/china-updates-drug-registration-rules-and-the-measures-for-monitoring-drug

    The restating of the expedited review pathways, and the recently published work procedures, appear to be a step toward improving a process that has seemingly changed numerous times over the years.

  10. Legal news
    24 January 2020
    Setting a gold standard in meeting cannabis regulation
    www.twobirds.com/en/news/articles/2020/uk/setting-a-gold-standard-in-meeting-cannabis-regulation

    Medical Cannabis Network speaks with Bird & Bird’s Ben King and Sally Shorthose about the importance of product labelling and the regulation of medical cannabis.