More about the European Pharmaceutical Sector: Procedural Changes

Earlier, I described the European Commission’s recent examination of the pharmaceutical sector.  Part of the EC's inquiry focuses on procedural concerns. 

 

Perhaps the most pressing concern for the EC is the lack of any unified system of litigation. The EC’s pharmaceutical sector inquiry examined transaction costs needed to enforce rights across all member states and concluded that, “[t]he total cost of patent litigation in the EU relating to the 68 medicines on which litigation was reported for the period 2000 – 2007, is estimated to exceed € 420 million, of which a significant proportion could have been saved” if a cross-border litigation system could have been enacted.

 

A separate review of the European patent system by Prof. Dietmar Harhoff, Ph.D states:

 

The results obtained here suggest that currently, between 146 and 311 infringement cases are being duplicated in the Member States. By 2013, this number is likely to increase to between 202 and 431 cases. Total private savings in 2013 would span the interval between EUR 148 and 289 million.

 

Meanwhile, it appears that the EC is rapidly moving toward a unified litigation system for all types of patents. This raises a more profound question: to what degree is a uniform litigation system desirable?

The Harnoff study considers literature studying the U.S. Court of Appeals for the Federal Circuit, which has provided a unified system for patent litigation at the appellate level since 1982.  This includes Rethinking Patent Law's Uniformity Principle, a paper by Craig Nard and John Duffy, which, as Harnoff describes "questions the values of uniformity altogether."   In their paper, Nard and Duffy point out that "uniformity is not a proxy for quality," and propose a "polycentric decisionmaking structure that would allow for a diversity of peer appellate voices to be heard."  Certainly, Nard and Duffy's proposal has been subject to debate, including an article co-authored by Lynne E. Pettigrew and the Federal Circuit's Hon. S. Jay Plager, Rethinking Patent Law's Uniformity Principle:  A Response to Nard and Duffy, 101 Nw. U. L. Rev. 1735 (2007).  It will be fascinating to see whether the EC considers these issues when contemplating these large structural changes to its system.