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  1. Legal news
    13 December 2017
    Patent Term Extensions
    www.twobirds.com/en/news/articles/2017/australia/patent-term-extensions

    In Australia the application of the Patent Term Extension provisions of the Patents Act 1990 have been construed narrowly so that PTEs are applicable to only certain types of pharmaceutical patents.

  2. Legal news
    19 April 2017
    Full Federal Court Confirms an Application to list on the PBS Prior to Patent Expiry is a non infringing Act
    www.twobirds.com/en/news/articles/2017/australia/full-federal-court-confirms-an-application-to-list-on-the-pbs-prior-to-patent-expiry

    Late last week, the Full Federal Court of Australia confirmed that the mere act of filing a Pharmaceutical Benefits Scheme (PBS) application for a generic pharmaceutical product is not, of itself, an act of infringement ...

  3. Legal news
    24 July 2017
    Government moves to legislate to increase generic and biosimilar medicine uptake and cut medicine prices
    www.twobirds.com/en/news/articles/2017/australia/government-moves-to-increase-generic-and-biosimilar-medicine-uptake-and-cut-medicine-prices

    Australia has long lagged behind the USA and UK in its use of generic pharmaceuticals – only around 58% of medicines dispensed in Australia are the generic versus up to 80% in the USA and UK.

  4. Legal news
    13 December 2017
    Amsterdam to host the European Medicines Agency after Brexit
    www.twobirds.com/en/news/articles/2017/netherlands/amsterdam-to-host-the-european-medicines-agency-after-brexit

    It has been clear for some time now that the European Medicines Agency (EMA), based in Canary Wharf, London since its establishment in 1995, will be relocated to another EU Member State as a result of the UK’s decision ...

  5. Legal news
    16 November 2017
    Actavis v ICOS– No interim injunction pending Supreme Court appeal
    www.twobirds.com/en/news/articles/2017/global/actavis-v-icos-no-interim-injunction-pending-supreme-court-appeal

    On 10 November 2017, Henry Carr J in the English Patents Court delivered a significant decision which will be of great interest to litigants in the field of generic pharmaceuticals.

  6. Legal news
    07 December 2017
    Equivalents Unchained
    www.twobirds.com/en/news/articles/2017/global/equivalents-unchained

    The Actavis v Eli Lilly decision of the UK Supreme Court has been described by some commentators as being a minor gloss on the law of patent infringement and claim scope.

  7. Legal news
    13 December 2017
    New rules on clinical trials and other key changes in the Slovak pharmacy sector
    www.twobirds.com/en/news/articles/2017/global/new-rules-on-clinical-trials-and-other-key-changes-in-the-slovak-pharmacy-sector

    The rules for clinical trials on medicinal products for human use are to change early next year. There is currently a draft bill before the Slovak Government aimed at reflecting and implementing the EU Regulation on ...

  8. Legal news
    13 December 2017
    Obtaining evidence on the planned launch of generic products subject to price reimbursement
    www.twobirds.com/en/news/articles/2017/global/obtaining-evidence-on-the-planned-launch-of-generic-products-subject-to-price-reimbursement

    It is common practice that patentees obtain evidence directly from the price and reimbursement authority on the planned launch date of a generic product by requesting disclosure of the application for price ...