Recent CJEU decisions on SPCs have brought little clarity to the meaning of ‘product’, and a recent Advocate General opinion in Bayer CropScience AG threatens to muddy the waters even further, says Paul England.
There has been a considerable amount of activity in the Court of Justice of the European Union (CJEU) recently on the subject of supplementary protection certificates (SPCs). A number of rulings have come down, and others have been referred to the court. Some of these have concerned what ought to be regarded as one of the most simple elements of the legislation: what is meant by a ‘product’, as defined, for the purpose of being capable of protection by an SPC?
But this question has proved to be anything but simple. This is unfortunate, because if something qualifies as a ‘product’ then it is potentially capable of up to five years’ additional exclusivity protection when the patent that protects it expires.
The recent rulings from the CJEU on products have concerned SPC protection for medicinal products, under Regulation (EC) No 469/2009 (the medicinal SPC regulation). These have been controversial. The reason is that under earlier authorities it had been understood that a product, as the regulation itself stipulates, is restricted to an active ingredient or combination of active ingredients. As a result, products which are, for example, new salts of previously authorised active ingredients are not capable of SPC protection.
Life Sciences Intellectual Property Review (LSIPR) tracks the increasing challenges for intellectual property specialists in the rapidly evolving world of life sciences. From gene patents to stem cell research, we provide the very best news and analysis.
To continue reading this article and to access 4,500+ articles, our digital magazines and special reports published for LSIPR subscribers only then you will need a subscription.
If you are already subscribed please login.
Official LSIPR subscribers include:
Allen & Overy
Arnold & Siedsma
Birch, Stewart, Kolasch & Birch LLP (BSKB)
Carpmaels & Ransford
Cooley
European Patent Office
Finnegan LLP
GH Research
Gowling WLG
George Washington Law School
HGF Limited
IQVIA
Kirkland & Ellis International LLP
Marks & Clerk
Mintz Levin
NiKang Therapeutics Inc.
Powell Gilbert LLP
Procopio, Cory, Hargreaves & Savitch LLP
Taylor Wessing
The United States Patent and Trademark Office (USPTO)
Valea AB
World Intellectual Property Office
For multi-user price options, or to check if your company has an existing subscription we can add you into for FREE, please contact Atif at achoudhury@newtonmedia.co.
If you have any technical issues please email tech support.
CJEU, SPCs, Bayer CropScience, Neurim, safeners