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In its second significant recent decision addressing patent term extensions (PTEs) in Australia, the Federal Court of Australia, in Merck...

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The ABPI (Association of British Pharmaceutical Industries, the UK trade association for producers of prescription medicines) launched...

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As part of our on-going podcast series - At the intersection of Science and Law, DLA Piper partners Ellen Scordino and Susan Krumplitsch...

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With the upcoming application of the new EU Clinical Trials Regulation (‘CTR’), the conduct of clinical trials in the European Union...

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The Australian Therapeutic Goods Administration (TGA) has introduced changes to permit the use of COVID-19 rapid antigen self-testing and...

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DLA Piper’s Life Sciences team has updated our recent vaccine guide for employers. The changes include the additions of Sweden and...

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In the last week of September 2021, the Polish Cabinet finally published the Plan for Rare Diseases for 2021-2023 (the "Plan"). We...

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Portugal initiated the 2015/1535 notification procedure of the decree-law establishing the rules applicable to the reprocessing and...

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Background

The Medicines & Healthcare products Regulatory Agency (MHRA) is holding an open consultation to gather views on possible...

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In a recent webinar titled “Protecting Medical Devices in Europe – Avoiding Common Pitfalls”, Kieran Killough (Partner at HGF) pointed to...

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For decades, scientists have studied the seemingly endless possibilities of custom-made messenger RNA, or mRNA. Kathy Fernando, Head Vice...

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New EU regulations governing medical devices and in-vitro diagnostic devices were introduced in May 2017 - the Medical Devices Regulation...

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In this article, the authors provide an overview of recent US Food and Drug Administration (FDA) interest and activity relating to the...

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For many years, the following question awaited judicial determination under Australian law: is a DNA-based diagnostic method patent...

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Summary

In a significant victory for pharmaceutical patentees, the Federal Court in Ono Pharmaceutical Co. Ltd v Commissioner of Patents...

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Since 2013, medicinal cannabis has been legalized in the Czech Republic due to the amendment to the Act on pharmaceuticals, otherwise...