PharmExec Blog

First 'Real' European Patent Imminent

It’s exciting times for patents in Europe. Not everyone’s excitement is pleasurable, but there’s certainly plenty going on, writes Reflector, Pharm Exec‘s EU correspondent.

Much of the excitement is linked to the imminent advent of Europe’s first real European patent. After decades of failed attempts, by the beginning of 2014 the European Union will finally have a ‘unitary patent’ — a system offering a single patent valid across all the member states (or nearly all — two member states have been more excited about the prospect of sabotaging it). For its many supporters, the unitary patent offers real advantages. Probably faster, certainly cheaper, and very much easier to manage than the patents available under the current patchwork of patents granted by national authorities or patents granted by the European Patent Office and requiring subsequent national validation.

The attractions are evident of securing a patent across most of Europe for just €4,725
(UDS$6, 180) instead of the €36,000 (UDS$47,100) it typically costs today, and being able to obtain it with a single application, and just in English, French or German (instead of multiple applications or validations subject to local language rules). In addition, it will be backed by a new international court specialized in patents, empowered to give rulings rapidly, and across every country where a patent is disputed — instead of parallel litigation in national courts leading to inconsistent rulings.

The “sabotage” attempts came from Italy and Spain, the two member states that have consistently held out against a Europe-wide system, largely because they feared negative effects on national innovation from the exclusion of their languages from the new system. They mounted a challenge at the EU’s own court against the creation of a mechanism they object to. But the court threw out that claim in April, ruling that the 25 countries could lawfully go ahead with their plan — particularly since Spain and Italy are free to join it if they so choose.

Even so, there are concerns about how the new system will work in practice. For all the simplicity of the underlying concept, its implementation is necessarily complex. As lawyers and accountants working for the innovative drug industry probe the detail, there is still a lack of clarity about precisely what it can and cannot do, and precisely how much it will cost.

There are concerns among generic manufacturers too. They do not want to see easier patent protection resulting in increased limits on competition.  That, they argue, could have a perverse effect on the EU’s sacred principle of a single market — or internal market, as the jargon terms it. “It is imperative that there is a balance in the rules between the ability of patentees to enforce their rights and the principles of the internal market: freedom of movement and competition”, insists the European Generic Medicines Association in an assessment of the plans for implementing the new system. It is anxious to secure fair competition, and to ensure that generic companies have a voice in decisions on disputes with originators, “without compromising legitimate enforcement of patent rights.” So there should be no easy route for originators to delaying tactics on generic entry, unless a court has duly assessed the validity of the patent.

So between now and the start of next year, a fever of expectation will be matched by a feverish search by all sides to get the best out of the new system. Meanwhile, alongside the moves on the unitary patent, further excitement is sweeping through the world of intellectual property over broader questions of just who should be making decisions on what a patent can and cannot do. Mirroring in some ways the issues raised by generic drug firms, this is emerging as an institutional battle between competition authorities and patent authorities, and it is taking place simultaneously in Europe and in the USA. It goes much wider than the drug industry, as demonstrated by recent decisions by the EU competition authorities questioning the scope of mobile phone patents. But the consequence is that, by a fine irony, just as getting a patent is about to get easier in Europe, hanging on to it may be getting harder.

Plenty of excitement still to come!

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One Comment

  1. Glen Choma
    Posted May 9, 2013 at 9:45 am | Permalink

    Very interesting! We see similar rationaliztion of policy in Canada coming in the years ahead, as 10 provincially administered drug reimbursement formulary lists move to a pan-Canadian format (my prediction). This should help build efficiency into a rather inefficient system.

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