Pregabalin: Where stand plausibility, Swiss-form claims, late amendment and more?

The Speakers:

• Lord Hoffmann
• Judge Edgar F. Brinkman (Senior Judge, Court of The Hague)
  
  File

  ucl-ibil_20nov2018_pregablin_brinkmann.pdf

• Dr Matt Fisher (UCL IBIL)
• Dr. Ursula Kinkeldey (Former Chair of a Technical (Biotech) Board of Appeal of the European Patent Office; Former Permanent Member of the Enlarged Board of Appeal of the European Patent Office)
• Dr Matthias Zigann (Presiding Judge at the Regional Court Munich I)
  
  File

  ucl-ibil_20nov2018_pregablin_zigann.pdf

The Chair: Professor Sir Robin Jacob, UCL IBIL

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About this event

The IBIL Innovation seminar 2018, “Pregabalin: Where stand plausibility, Swiss-form claims, late amendment and more?” will investigate and analyse the content and impact of the Supreme Court’s highly anticipated decision in Warner-Lambert v Mylan.  Argued in the context of a Swiss-form European patent for the second medical use of pregabalin in the treatment of neuropathic pain, the Supreme Court was asked to consider a number of critical elements of patentability and patent infringement.  Its decision will undoubtedly set the scene for patent litigation in this area for years to come.  The main issues under consideration included:

• the role of plausibility within the patentability enquiry;
• the correct interpretation and scope of the Swiss-form claim; and
• whether a post-trial application to amend an invalid patent claim to limit it to a part found to be plausible is an abuse of process.  

The Swiss-form claim has been variously described as a “piece of judicial lawmaking which fudged some of the difficult issues”, an “adequate but exceptional solution” to the problem of enabling protection for second medical indications under the EPC 1973 and (somewhat less charitably) as a “chimeric Franken-cuckoo” hatched from the unsuspecting nest of the EPC.  Taking shape as purpose-bound process claims – i.e. claims directed towards a manufacturing process applied for a particular end – the Swiss-form was originally conceived as an attempt to navigate treacherous waters – waters bordered by two seemingly immutable prohibitions on patenting: the excluded and the old.  A jury-rigged solution to a thorny problem, the Swiss-form claim promised to extend patent law’s incentives to the discovery of new and useful functions of existing medicaments: repurposing the old to create the new.  Created for undoubtedly noble reasons, the Swiss-form claim nevertheless left “intractable problems for an infringement court”. Such issues are only now being grappled with.
 
Plausibility is a similarly original concept.  It finds no mention in the Patents Act 1977 or the European Patent Convention, and yet in recent years has become a buzzword in patent litigation – being raised as an issue under the umbrella of inventive step, industrial application and sufficiency as a means of weeding out so called ‘speculative’ patents.  Indeed, as the authors of the 18th Edition of Terrell on the Law of Patents note: despite the previous edition containing “no reference to the objection of want of plausibility. At the time of writing most cases of invalidity being argued before the Patents Court now contain an allegation that the teaching of the patent is not plausible.”  However, with the Supreme Court’s decision its continued application lies in the balance.  
 
Our expert panel will discuss the implications of the decision and debate whether or not it got things right this time...

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