ADVOCATE GENERAL OF THE COURT OF JUSTICE, OPINION OF 9 JUNE 2011, C-125/10

Ever since the introduction of the Pediatric Regulation the question of whether it is permissible to grant a negative or zero term Supplementary Protection Certificate (SPC) has been controversial, with a range of inconsistent decisions across the EU. The Advocate General of the Court of Justice recently gave his opinion in the Merck Sitagliptin reference - so how did the SPC fare?

Introduction

SPCs were introduced1 to compensate for the "loss" of effective patent term resulting from the, often lengthy, delay in obtaining marketing authorization (MA) for pharmaceutical products. The subsequent Pediatric Regulation2 aims to encourage pharmaceutical companies to study their products in the child population. Market forces alone had proven insufficient to encourage this costly research in a relatively small population. Rather than providing a standalone incentive, the Pediatric Regulation rewards compliant pediatric studies with a six-month SPC extension.

The Court of Justice Reference

The basic SPC term is the number of years from patent application to MA grant, minus 5 years, but subject to a maximum 5 year term. The Pediatric Regulation made it beneficial to obtain an SPC with a negative term, if addition of the six-month SPC extension would result in a positive term.

Merck Sharp & Dohme Corp. found itself in precisely this position in relation to its SPC for Januvia3 for the treatment and prevention of diabetes. It had taken 4 years, 8 months and 16 days from patent application to MA grant, leaving a negative SPC term of 3 months and 14 days. The addition of the six-month SPC extension would be a (valuable) positive term of two and a half months.

Merck applied to various Member States for a negative term SPC plus six-month SPC extension. Notwithstanding the application of the same law, there was inconsistency between the decisions. Bulgaria, the Netherlands, and the United Kingdom granted negative term SPCs; Greece granted a zero term SPC; various other states, including Germany, refused to grant any SPC on the basis that only a positive term was permitted (before taking account of the six-month extension). On appeal, the German Federal Patent Court asked the Court of Justice (CJEU) whether negative or zero term SPCs were permissible.

The Advocate General's Opinion

In the Advocate General's opinion negative term SPCs should be permitted:

  • As neither Regulation provides a clear answer, this must be deduced from the aims introduced by the Regulations.
  • As the duration of an SPC is not mentioned as a condition for grant of an SPC itself, or a six-month SPC extension, a positive duration is not a condition of grant.
  • The reason why the SPC Regulation does not expressly permit zero or negative term SPCs is that prior to the Pediatric Regulation there was no need for such an SPC.
  • Failure to allow a negative term SPC would lead to disproportionate results: one day over five years from patent application to MA grant could result in a six-month difference to SPC term. Patentees might postpone their MA application to increase SPC term, which would not be in the public interest.
  • The Community legislator wished to confer on patentees a maximum 15 years and 6 months term (including SPC extension). A zero-term SPC would be inconsistent with this aim. It would "put at risk the fair balance" between the research costs, and cost-effective access to medicines.

What Does it Mean?

The Advocate General's opinion is not the final word; we will have to wait for the CJEU to provide a definitive answer. At the very least the CJEU's decision should provide a consistent position across the EU. Preferably the CJEU will follow the Advocate General's opinion, which strives to respect the clear aims of both Regulations.