Articles

Amended UK Exemption for Medicinal Product Assessments

In order to satisfy the public need for generic medicines to obtain approval and reach the market immediately on patent expiry, a statutory EU Bolar exemption was established. This provides exemption from patent infringement for studies, tests or trials conducted with a view to obtaining approval of medicinal products using...

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Will the new biosimilar regulation in the EU cause a rise in UK competition?

What are the notable concerns of releasing biosimilars over the original biologics in terms of existing patents? The most notable issue for the originator and for the biosimilar competitor relates to the scope of a patent claim that protects the original product. Such claims are usually broad enough to cover...

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A big day for Supplementary Protection Certificates at the CJEU – but questions still remain

On 12 December 2013, the CJEU handed down three eagerly awaited decisions on SPCs: C-443/12, Actavis UK Ltd v Sanofi; Case C-484/12, Georgetown University and Case C-493/12, Eli Lilly and Company Ltd v Human Genome Sciences Inc. The first two decisions provide some clarity for patentees on SPCs for combination...

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Bolar-Type exemption from patent infringement in the UK

Background The Bolar exemption allows a generic medicine developer to avoid infringement of patents covering the drug being copied when carrying out the necessary studies, trials and consequential practical requirements to obtain market authorisation from the regulatory authorities. This exemption is named after the landmark US decision in Roche v...

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Myriad and consequences for gene patents in the USA

Background Isolated and purified genetic material, including DNA, has long been protectable by patent in the US, and the USPTO has consistently applied the view that the process of isolation and purification produced a new composition of matter that differs from the naturally occurring material. This position emerged from a...

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