5 March 2014Big Pharma

Life Sciences Law Forum: UPC: “So much more to be done”

While the political will exists for the introduction of the Unified Patent Court (UPC) next year, much more still needs to be done, according to Adam Cooke, a partner in DLA Piper's IP and technology group.

Speaking on the second day of the 2nd Annual Practical Law Life Sciences Law Forum in London, Cooke said there is a need for the UPC considering the current landscape of fragmented patent litigation in the EU, but it is unlikely that it will be fully implemented before 2016.

A 16th version of the rules of procedure is still being drafted and Chris Mercer, immediate past president of the Chartered Institute of Patent Attorneys and consultant at Carpmaels & Ransford LLP, said the preparatory committee is due to meet this month to discuss procedural issues.

There is still a lot of uncertainty about how the court will operate with regards to fees, as well as the language of proceedings, which Cooke described as “extremely complicated”.

If patent validity and infringement proceedings are bifurcated, they may end up going ahead in different languages, he said.

At the moment, it seems sensible to opt out of the court altogether, Cooke said, even though it is unclear how much it would cost to opt out, or indeed opt back in.

Interpretations of the Bolar exemption may also present difficulties. After a consultation, it was decided that in the UK the exemption should be broadened so that other companies, not just generics, may perform clinical studies on patented products without the fear of infringement.

An amendment to the UK Patents Act that takes this broadening into account is due toward the end of the year. However, this means being left with an act with a Bolar exemption that differs from that outlined in other UPC member states, Cooke said.

Furthermore, the UPC will apply not just to European Patents, but also to supplementary protection certificates (SPCs). According to Cooke, the European Commission is consulting on whether there should be a unitary SPC, or if nationally-issued SPCs will suffice.

He said it would be prudent for patent holders to continue to file for national patents, which allows the opportunity to opt out of the UPC, then opt back in to sue. However, he warned, you cannot be sure whether it will be possible to opt back in.

Mercer recommended that patent owners with a potential blockbuster on their hands file a European Patent to protect it, as well as some national applications. Another strategy would be to designate the European Patent as a bundle and opt out of the court, he said.

The 2nd Annual Practical Law Life Sciences Law Forum in London ended on March 5.

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