Keeping it local - be afraid of the CJEU
It all started with IP for antibodies. As everyone in the industry knows, antibodies are incredibly complicated items in terms of IP - with a product that cannot be pinned to the wall accurately, and with post-translation modification and environmental factors influencing structure, activity and effect. This leads to long development times in groundbreaking regulatory and IP arenas. The supplementary protection certificate (SPC) in theory gives 5.5 years of extension beyond the original patent duration, and this has been used by a number of organisations to enable effective biological products to be protected to market. Of course, this is a very challenging area of IP, which was not designed to include biological entities, and which refers strongly to the regulations of the original patent. Increasingly, national patent offices are referring tricky cases to the CJEU for clarification, and this is where the wheels are coming off - with very serious consequences for the European commercial environment. Instead of casting light into the darkness, aside from a few notable decisions, the CJEU has instead returned slow, lengthy and impenetrable decisions that make it nearly impossible to make a national decision to grant an SPC. Clarification has been requested but actively avoided by the court, a great example being reference to 'non-European rules governing patents' but without actually saying which ones, even when asked a straight question on the matter.
National authorities are unable to interpret the legal way forward. "I am bound to say that I find this reasoning difficult to follow," says Lord Justice Arnold, and "not only has the Court not answered the question referred, but also the guidance it has provided is not sufficiently clear to enable future disputes to be resolved". Translation: it would seem that Europe has knitted itself a time-bomb for extending protection of biological products. The CJEU, through either a profound lack of understanding of the issues or through wilful incompetence, is preventing the successful exploitation of next-generation therapeutics, and can't be touched. The price will be paid by European companies trying to develop products, by researchers who have dedicated years to the innovation behind biologicals and of course by the patients, who may wait much longer for a groundbreaking therapy. Those products will one day be developed elsewhere and imported into Europe - exactly the opposite of the EC's drive to create a knowledge-driven economy ... and a mess of Europe's own making.