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

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

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

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

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

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

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

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

Background

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

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

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

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

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

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

Summary

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

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