Unitary Patent – what is it and why the hold up? - European Medical Journal

Unitary Patent – what is it and why the hold up?

2 Mins
EMJ GOLD
What if we told you we could revolutionise your route to work? A brand-new bridge has been built that will get you there for less money and in half the time. The catch? It has been under construction for 8 years and no one has ever stepped on it
Words by Isabel O’Brien

The Unitary Patent (UP) and Unitary Patent Court (UPC) package is much like a major engineering project. It has had backers and opposers, leaps forward and steps back, but it has pressed on with the intent of streamlining an aged and inefficient process.

The UP provides significant cost savings where innovators need patent coverage across a wide range of European countries

Under the current system, you can pay >£100,000 over 6 years to secure patent protection for a new drug in the US and Europe. On the other hand, UP would enable protection in up to 26 EU member states by submitting a single request to the European Patent Office (EPO) with texts only needing to be translated into English, French, and German.

“The UP provides significant cost savings where innovators need patent coverage across a wide range of European countries,” says David Holland, Partner at London IP firm, Carpmaels & Ransford.

“These savings come from both the reduced translation costs on grant and the reduced cost of the single UP renewal fee… a big plus, which is why I expect the UP will be widely embraced once, that is, when major players are comfortable with the UPC.”

The UPC would be a centralised court system based in Paris, Munich, and London – Life Sciences in the latter – that would mean an end to patent hearings in individual countries, with each state having varying timings, costs, and abilities to prosecute infringements.

“The court [UPC] will have panels of specialist patent judges aided by specialist technical judges, which may mean the decisions are more consistent and high quality compared to some less specialist courts at present,” comments Holland. The UPC will be expected to hear all patent opposition cases within a year and come to a decision within 1 day, making it not only more specialised, but also more efficient.

“The downside will always be that if the UPC revokes a patent, it will fall in 15–20 states,” says Liz Cohen, Partner and IP specialist at London law firm, Bristows. “But chances are that the UPC will be a very fair and perhaps a slightly more pro-patentee court than some European countries. Good patents will very likely be upheld.”

The downside will always be that if the UPC revokes a patent, it will fall in 15–20 states

UP and UPC were approved by the EU Parliament in 2012, and only the UK, France, and Germany – the leading patent applicants in Europe – need to ratify the package for it to come into effect. Both France and the UK have completed, but a legal bombshell has seen Germany halt their proceedings.

“In March 2017, a private individual lodged a complaint with the German Constitutional Court (FCC), challenging the constitutionality of the German legislation implementing the UPC Agreement,” says Rachel Bateman, Partner at IP firm, D Young & Co. “This led to a request from the FCC to the German Government not to sign that legislation into law, which was heeded.”

What has been deemed unconstitutional? Largely, the fact the German Government has not approved the divestment of sovereign powers to the UPC and the legality of the UK’s involvement post-Brexit.

Speaking on this, Cohen of Bristows concludes, “Without that German challenge, the UPC would have started, if not on 1st December 2017, then with near certainty before end-2018. As it is, we still await the decision of the German Constitutional Court. And unfortunately, that delay has meant that if, and when, the German Government is permitted to ratify, it will have to decide whether it still wishes to do so in the light of the political and legal consequences of Brexit which did not exist in 2018.”

Without that German challenge, the UPC would have started, if not on 1st December 2017, then with near certainty before end-2018

With most major, engineering projects taking >10 years, perhaps we should have always prescribed this timeline for UP and UPC. Establishing a brand-new multinational legal system was never going to be easy, but for the pharmaceutical industry, there are several indicators that suggest it will be worth the wait.

Rate this content's potential impact on patient outcomes

Average rating / 5. Vote count:

No votes so far! Be the first to rate this content.