From October 2016 to March 2017 the team is joined by Guest Kats Rosie Burbidge and Eibhlin Vardy, and by InternKats Verónica Rodríguez Arguijo, Tian Lu and Hayleigh Bosher.

Monday, 20 April 2015

Falling off cliffs and clutching at straws: a new event on pharma patent extensions

The SPC Regulation before
the CJEU got to it ...
The drift from simplicity to complexity in modern intellectual property law is nowhere better reflected than in the law governing the extension of the duration of pharmaceutical patents in the European Union through the grant of supplementary protection certificates (SPCs).  The codified re-enactment of the SPC Directive (Regulation 469/2009 of 6 May 2009 concerning the supplementary protection certificate for medicinal products) is a relatively short and simple document, only eight pages in length, even if you include the recitals, the provisions relating to enlargement of the EU and the table of amendments. You can even read the whole thing in a single sitting and come away with the feeling that you have understood it.

... and after
There is however a parallel universe in which the words and phrases used in this Directive are tested to destruction though the search for alternative interpretations, ambiguities and deeper meanings which are refracted through the prisms of competition law and investment policy and then fixed with fresh meanings through the medium of questions referred to the Court of Justice of the European Union (CJEU). Readers of this weblog need little reminding that the CJEU is a court whose judges tend to have had little if any contact with pharmaceutical patents and the world they inhabit, and that it is a tribunal that deals with abstract issues, not live patent disputes, and has little intuitive feel for the tussle between proprietary pharma companies and manufacturers of generic products for the right to sell patented medicines. Virtually every concept in SPC law is open to this sort of rigorous verbal and conceptual analysis, with the Court and its national counterparts being asked to explain what is the meaning of a 'product', what counts as a market authorisation, how should we count days, and so on.

Worth fighting for
The rulings of the CJEU, often criticised, frequently misunderstood and sometimes arguably incomprehensible, are themselves a further cause for uncertainty and error when national courts seek to apply them but reach inconsistent results in relation to the same patented products. Indeed, there is a recondite weblog, The SPC Blog, which has a following of over 2,000 email subscribers and which owes not only its content but its existence to the application -- and misapplication -- of simple principles and complex interpretations of them to the facts of individual situations. Given the sheer scale of the sums that can be at stake if a pharma patent is extended even by a day or two. it is unsurprising that owners of pharma patents should clutch at any available straws in their efforts to prolong the term of their patents. It is equally unsurprising that makers of generic pharma products should utilise every trick in the book to assist patent medicines to enter the public domain as speedily and painlessly as possible.

Against this backdrop, it is unsurprising that events are organised at which the law on SPCs is examined and discussed.  The SPC Blog's annual seminar is a good example, and many patent conferences contain sessions dedicated to them. However, the "big one" is C5's annual Pharmaceutical Patent Term Extensions Forum, a two-day event that is now in its 14th year.  This year's version, subtitled "Maximising pharmaceutical patent lifecycles to foster innovation and growth", takes place at The Hotel Excelsior, Munich, from 22 to 23 June and is followed by a Masterclass on 24 June on how to draft solid pharma patent claims in light of the CJEU's rulings in Neurim, Medeva, Georgetown, Eli Lilly and Actavis v Sanofi.  According to the organisers' blurb:
“Big Pharma” has reached a critical tipping point, due to the notable patent cliff which will occur this year. It is estimated that in 2015 $47.5 billion of lost sales will affect the industry overall. It is critical for pharmaceutical companies to capitalise on their R&D expenditure by obtaining Supplementary Protection Certificates in Europe, but there are also other legal and technical ways to maximise a patent's lifecycle in Europe and around the world. 
This conference will examine the ways in which exclusivity on a patent can be extended for the longest term, such as re-patenting, data exclusivity, paediatric exclusivity and regulatory extensions. It will also provide you with implementable tools to maximise your patents’ lifecycle in those countries which don’t offer patent term extensions and will dig deeper into the challenges you face in critical markets such as China, India and Brazil.
Like-minded?
As one might expect, there's a strong cast of knowledgeable speakers, including leading SPC author Christopher Brückner (Stolmár & Partner, Germany), Laëtitia Bénard (Allen & Overy, France) and Edward Oates (Carpmael & Ransford, London). While the Forum is plainly conceived as a place where like-minded pharma innovators, their friends and allies can gather and share their interest in extending patents, Merpel suspects that there might be more than a couple of discreetly low-profile generic manufacturers in attendance too, taking careful notes and planning their counter-strategies.

Details of the programme and registration details can be found by clicking here. This Kat is pleased to inform readers that they are entitled to the benefit of a 10% discount on their registration fee if they quote the VIP KatCode “IPKAT10” when registering.

1 comment:

Ashley Roughton said...

Jeremy; nice piece, as always.

Problem one is the law of unintended consequences resulting in a law which says that you have to look at the contribution of the patent (or it is the research effort expended upon it?) to understand how far the SPC regulation goes and that this concept (nowhere stated in the body of the rules) decides whether you are entitled to an SPC or not.

I am truly tired of saying it (or is it weary?) but this sort of legislating by judicial construct gives the CJEU and the "European project" a bad name, at a time when it could really do with a good one.

I also think that part of the problem is the slightly disdainful way in which the CJEU treats certain of our patents judges. They deserve better.

Ashley

Subscribe to the IPKat's posts by email here

Just pop your email address into the box and click 'Subscribe':