Articles

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...

Read more

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...

Read more

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...

Read more

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...

Read more

Intellectual Property or Poverty? An IP Risk Guide for Business

The recent increase in public awareness of Intellectual Property (IP) has not necessarily led to a greater understanding of its generation, use or relevance to modern business. Although the term “risk-management” is generally understood, very few companies understand the risks associated with IP, let alone have a strategy for dealing...

Read more