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  1. Legal news
    24 July 2019
    When do clinical trial consent disclosures render a patent invalid?
    www.twobirds.com/en/news/articles/2019/australia/when-do-clinical-trial-consent-disclosures-render-a-patent-invalid

    In the recent case of InterPharma Pty Ltd v Hospira Inc (No 5) [2019] FCA 960 the Australian Federal Court has given patentees guidance as to novelty preserving practice in the conduct of clinical trials.

  2. Legal news
    03 September 2019
    China Expands Medical Devices Market Authorization Holder Pilot Project to 21 Provinces/Municipalities
    www.twobirds.com/en/news/articles/2019/global/china-expands-medical-devices-market-authorization-holder-pilot-project-to-21-provinces

    On 1 August 2019, the National Medical Products Administration ("NMPA") issued a notice to extend the pilot project of medical device registrant system (GUO YAO JIAN XIE ZHU (2019) No.33) ("Notice") to 21 ...

  3. Legal news
    20 June 2019
    China to accelerate the development of "Smart Supervision System" for drug and medical devices
    www.twobirds.com/en/news/articles/2019/global/china-to-accelerate-the-development-of-smart-supervision-system-for-drug-and-medical-devices

    The NMPA issued the Drug Smart Supervision Plan aiming to deepen the development of a drug supervision system embracing modern information technologies such as cloud computing, big data, and "Internet+" technologies.

  4. Legal news
    06 September 2019
    China passed new amendments to the Drug Administration Law
    www.twobirds.com/en/news/articles/2019/global/china-passed-new-amendments-to-the-drug-administration-law

    On 26 August 2019, China's National People's Congress passed the final amendments to the Drug Administration Law ("DAL"), which will take effect on 1 December 2019. The DAL was first enacted in 1984, then substantively ...

  5. Legal news
    25 February 2020
    Surgical face masks – filtering out counterfeit copies
    www.twobirds.com/en/news/articles/2020/global/surgical-face-masks-filtering-out-counterfeit-copies

    This article discusses the key IP and regulatory issues relating to surgical masks and penalties for the production of counterfeit products.

  6. Legal news
    03 September 2018
    New IP Act Passed in Australia: implementing Phase 1 recommendations of the Productivity Commission
    www.twobirds.com/en/news/articles/2018/australia/new-ip-act-passed-in-australia

    On 16 August 2018, the Intellectual Property Laws Amendment (Productivity Commission Response Part 1 and Other Measures) Bill 2018 (Bill) passed through both Houses of Parliament and will shortly come into force upon ...

  7. Legal news
    28 August 2018
    China: Regulatory updates on product-related license for API
    www.twobirds.com/en/news/articles/2018/china/regulatory-updates-on-product-related-license-for-api

    While more work needs to be done to bring the Chinese regulatory landscape up to the standards of other industry leading countries, as exemplified in the recent incidents concerning vaccines in the country, China has ...

  8. Legal news
    06 July 2021
    China Patent Linkage News Flash (III) – CNIPA Administrative Adjudication Measures announced on 5 July 2021
    www.twobirds.com/en/news/articles/2021/china/cnipa-administrative-adjudication-measures-announced-on-5-july-2021

    The China National Intellectual Property Administration (“CNIPA”) will now officially accept patent linkage cases according to the “Notice on the Acceptance of Patent Linkage Adjudication” (the “Notice”) because the ...

  9. Legal news
    05 July 2021
    News flash - Patent Linkage Implementing Measures came into force in China on 4 July 2021
    www.twobirds.com/en/news/articles/2021/china/patent-linkage-implementing-measures-came-into-force-in-china-on-4-july-2021

    On 4 July 2021, the National Medical Products Administration (the “NMPA”) and the China Intellectual Property Administration (the “CNIPA”) published the “Implementing Measures for Drug Patent Dispute Early Resolution ...

  10. Legal news
    11 February 2021
    Patent Linkage Update in China - A Pre-Chinese New Year Gift
    www.twobirds.com/en/news/articles/2021/china/patent-linkage-update-in-china-a-prechinese-new-year-gift

    On 9 February 2021, the China National Intellectual Property Administration (“CNIPA”) issued the “Administrative Adjudication Measures for Drug Patent Dispute Early Resolution Mechanism (Draft for Public Opinions)” ...