Do rules experience culture shock – Article from #1 2019

ABSTRACT

In order to stimulate product development and innovation in the pharmaceutical industry, the United States Congress in 1984 enacted Title II of the Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), also known as the Hatch-Waxman Act. One goal of the Hatch-Waxman Act was to extend patent life to compensate patent holders for a portion of the patent term lost while awaiting review of the safety and efficacy of the product by the Federal Drug Administration. Influenced by the United States, the European Union (EU) introduced legislation in 1992 offering the possibility for a patent holder to apply for an additional time of protection as compensation for the regulatory delays caused by marketing authorization procedures. This additional time period of protection is granted in the form of a Supplementary Protection Certificate (SPC), governed by an EU Regulation.1 As the subject matter protected by the SPC, the product is defined as “the active ingredient or combination of active ingredients of a medicinal product.”2 The term product within the context of the SPC Regulation is an independent term which cannot be equated with the patented invention or marketing authorization.3 The product for which the SPC is sought must be protected by a basic patent in force,4 which is also a condition for patent term extension in the United States.5 The interpretation of product and its relation to the patent in force is a central condition to determine if a certificate may be granted.6 There has been divergence in the application of this condition by the national courts and a stream of requests for preliminary rulings. Legal uncertainty in interpretation remains due to the lack of clear guidance from the Court of Justice of the European Union (hereinafter “CJEU”). This article examines the material condition of the SPC Regulation requiring that a product be protected by a basic patent, from its origin in the United States to the legislation and institutions of the European Union, in order to investigate rules as an institutional phenomenon. Do the issues of interpretation with Article 3(a) of the SPC Regulation arise at the fault of the borrowed material legal solution itself, or do they occur from transplanting the solution from its native environment into a new legal system? The answer as the reader will discover is both.

  1. Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (hereinafter “SPC Regulation”).
  2. SPC Regulation, article 1(b).
  3. The German Association for the Protection of Intellectual Property, Journal of Intellectual Property Law & Practice, 2013, vol 8, no. 9, p. 723, citing German Federal Court of Justice (BGH), GRUR 2002, p. 415 Sumatriptan.
  4. SPC Regulation, article 3(a).
  5. Title 35 United States Code §156(a)(1).
  6. SPC Regulation, article 3(a).