Blog archive

The EU court has given a set of three rulings that strongly support the approach of EU medicines regulator, the EMA, to disclosure of documents.

The story of patenting of CRISPR-Cas9 (discussed here) took a fresh turn recently with a European Patent Office decision going against one of the leading players.

A licence of patented technology can be a substantial investment. The licensee will normally want to carry out due diligence to understand the scope and nature of the rights being granted.

Parallel distribution enables the distribution in the European Union of centrally authorised medicines by a business other than the marketing authorisation holder.

Clustering of life sciences businesses brings important benefits. Collaborations between academic and industrial partners, access to a skilled local talent pool, networking and exchange of ideas, and a strong local supplier base are supported by geographical clustering.

The EU Commission is currently consulting on several features of the patent system particularly relevant to the life sciences sector, focusing on supplementary protection certificates and  exemptions from patent infringement. 

A recent court decision on infringement of IP in an ECG screening service shows how components of the service qualify for different forms of protection.

Working out what infringes a patent has always been a tricky question. In recent years the UK has followed an approach derived from cases such as metal lintels for buildings and epilators, devices for removing body hair.

The court’s ruling that the biosimilar products and dosing regimes planned by Fujifilm Kyowa Kirin Biologics and Samsung Bioepsis/Biogen were obvious by the priority date of AbbVie’s patent application means that no future divisionals filed by AbbVie can impede sales.

In 2016 the Court of Appeal reversed this decision. Unlike the High Court, the Court of Appeal was not satisfied with the approach the MHRA had taken to the glucosamine market as a whole.

AbbVie’s blockbuster drug Humira (adalimumab) generated worldwide sales of around $14bn in 2015, some two thirds of the company’s revenues. Understandably, other producers would like a piece of the action....

A German court ruled the system illegal because of national price-control rules. These provided for a fixed-price system for the supply of prescription-only medicines, and effectively prohibited discounts, bonuses, promotional gifts, etc.