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  1. 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 ...

  2. 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.

  3. 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 ...

  4. 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.

  5. Legal news
    21 January 2020
    Transfers of value to “influencers”: new disclosure obligation for companies in the health sector
    www.twobirds.com/en/news/articles/2020/uk/transfers-of-value-to-influencers-new-disclosure-obligation-for-companies-in-the-health-sector

    The list of beneficiaries of transfers of value subject to compulsory disclosure in the French public “transparency” database include “persons who, in the media or on social media, present one or several health ...

  6. Legal news
    12 February 2020
    UK Supreme Court hearing appeal over permitted breadth of patent claims
    www.twobirds.com/en/news/articles/2020/uk/uk-supreme-court-hearing-appeal-over-permitted-breadth-of-patent-claims

    Although concerned with a complex gene technology, the outcome of this appeal will have substantial impact on the validity of patents generally where doubts are raised as to the level of disclosure provided in a patent ...

  7. Legal news
    06 February 2020
    The US/China Trade Agreement: what could it mean for the Pharma Industry?
    www.twobirds.com/en/news/articles/2020/global/the-us-china-trade-agreement-what-could-it-mean-for-the-pharma-industry

    Following a long period of negotiation, Phase I of the US-China Trade Agreement was published on 15 January 2020. An important element of the negotiations from the US side had focussed on the need for China to recognise ...

  8. 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 ...

  9. Legal news
    11 December 2018
    The legal basis for Belgian biobanks enters into force
    www.twobirds.com/en/news/articles/2018/belgium/the-legal-basis-for-belgian-biobanks-finally-enters-into-force

    Each Belgian biobank will have to be declared at the Federal Agency for Medicines and Health Products (FAMHP) in order to operate. It also imposes binding content for agreements on the transfer of human biological ...

  10. Legal news
    11 December 2018
    Changes afoot for Belgian manufacturers of allogeneic ATMPs
    www.twobirds.com/en/news/articles/2018/belgium/changes-afoot-for-belgian-manufacturers-of-allogeneic-atmps

    Last month, the Belgian Parliament voted in favour of a set of measures that are notably meant to clarify the regulatory landscape of the operators active in the manufacturing of Advanced Therapy Medicinal Products ...