Articles

The never-ending debate on the value of second medical use patents

It is well established that a second medical use patent may be validly obtained in Europe for any second or further therapeutic use of a known drug, providing the use is novel and inventive. However, it can be difficult to enforce a second medical use patent if the drug is...

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Blurred Lines

A long-standing complaint of patent applicants and patentees at the EPO has been the strict assessment of added subject matter caused by amendment of an application or patent. Various tests have been developed for the assessment of whether an amendment complies with the requirement that: “The European patent application or...

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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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