Background

The further development of an original product with other therapeutic indications, active ingredient strengths or dosages that have their own authorisation is subject to the global authorisation of the original product, and cannot be protected on its own.

The principle of global authorisation is not invalidated if the further development, based on a comprehensive application or following the submission of new documents with a different designation, was independently authorised. Further, the principle of global authorisation applies to the authorisation of generic products in the national procedure under Article 3(3) of EU Regulation 726/2004, in conjunction with Articles 6(1) and (2) of EU Directive 2001/83/EC, to the extent that the reference medicinal product has been approved in the centralised European procedure under EU Regulation 2309/93.

Facts

The case at hand concerned the issue of whether a further development of a reference medicinal product which contains a different therapeutic indication, effective strength or dosage – and thus has its own authorisation – enjoys protection from the date of its own authorisation, or whether the principle of global authorisation applies to such further development.

On September 27 2013, in the national procedure, the respondent granted the petitioner authorisation for the generic product for reference medicinal product B. Product B was a further development of reference medicinal product A, for which the joined party had received a European authorisation under Article 3 of Regulation 2309/93. Product B had its own authorisation of April 15 2005. The active ingredients of both medicinal products were the same, but differed in terms of:

  • areas of application;
  • the strength of the active ingredients; and
  • the dosage regimen.

The joined party to the national procedure filed a third-party objection to the grant of authorisation, citing as grounds the protection of the data submitted for product B.

In an April 1 2014 ruling the respondent rejected the third-party objection, and the joined party filed suit at the Cologne Administrative Court. It again cited the protection for product B and stated that the principle of global authorisation under Article 6 of Directive 2001/83/EC did not apply, since Article 6 was insufficiently transposed into national law. Further, product A and product B lacked the connection necessary for a global authorisation because product B had been approved on the basis of its own application under its own name in the centralised procedure.

The administrative court rejected the suit, holding that the 10-year protection period for product A had expired, and that the further development did not trigger an independent 10-year protection period. The joined party appealed.

Decision

The Munster Higher Administrative Court rejected the appeal (November 27 2014, Reference 13B 950/14).

The court based its decision primarily on the fact that the Cologne Administrative Court had correctly assumed that product B was covered by the global authorisation of product A as a further development, and therefore it did not enjoy an independent protection period.

The court stated that in principle, the legal basis for authorisation of a generic product in the national procedure is Section 24b(1) of the German Medicinal Products Act and Article 3(3) of Regulation 726/2004 in conjunction with Article 10 of Directive 2001/83/EC (as amended by Directive 2014/27/EU). However, Section 24b(1) of the act did not apply to the calculation of the protection period, since the authorisation for the further development of product B was requested before October 30 2005. Accordingly, the protection period under Section 24a of the act in the version applicable until September 5 2005 applied for such medicinal products. This provided for a 10-year protection period.

The court further stated that this standard governs only the length of the term of protection, but not how the term of protection should be calculated. This follows from Section 141(5) of the act, which provides only for the continued validity of the prior law with respect to the term of the protection period, but contains no reference to facts. Consequently, there would have to be a separate examination of how EU law – implemented in Sections 24 of the existing act and Section 24a(1)(3) of the previous version of the act – should be interpreted. Since the licensing of product B was requested before November 20 2005, the protection periods under Article 13(4) of Regulation 2309/93 applied (Article 13(4) refers to Article 4(2)(8)(III) of Directive 65/65/EEC). However, under this provision, it should not be assumed that product B, with its further development of product A, would trigger an independent protection period based on the principle of global authorisation, according to which the authorisation of additional strengths, pharmaceutical forms, dosages, routes of administration and indications are – with respect to the marketing authorisation holder of the original product – to be viewed as an additional component of the initial authorisation for the original product. This principle also follows from Article 3(3) of Regulation 726/2004, which refers to Articles 10(1) and 6(1)(2) of Directive 2001/83/EC, and further from the reference to Article 10(1) of the directive in Article 3(3)(a) of Regulation 736/2004. This is supported by the fact that Article 14(11) of Regulation 726/2004 provides explicit provisions regarding protection.

No relation of precedence may be inferred from the statutory provisions. Such assumption also runs counter to the objective of the regulations: to adapt the provision to the requirements of Directive 2001/83/EC. Further, this assumption does not conflict with the transitional arrangement in Article 89 of Regulation 726/2004 and Article 2 of Directive 2004/27/EC. This transitional arrangement provides for the continued validity of the prior law only with respect to time, but not with respect to other arrangements. Accordingly, Article 89 of Regulation 726/2004 mentions only Article 14(11) and not, as in Section 141(9) of the Medicinal Products Act, transitional periods with respect to the arrangement for global authorisation.

In any event, in the case at hand, by applying Article 6(1)(2) of Directive 2001/83/EC product B was to be viewed as a component of the licensing for the same active ingredient of product A. The different therapeutic indications and the dosage recommendation for product B that partially deviated from the dosage of the original product did not run counter to this, as these were not further developments that would trigger an independent protection period. This follows from the fact that Section 24b(2)(1) of the Medicinal Products Act and Article 3(3) of Regulation 226/04/EC in conjunction with Article 10(2)(b) of Directive 2001/83/EC for the authorisation of a generic product require only that the medicinal product feature the same qualitative and quantitative composition of active substances and the same pharmaceutical form as the reference medicinal product, and that bioequivalence be demonstrated through bioavailability studies. In such provisions, the area of application is just as unspecified as the dosage recommendation.

In all other respects, the rejection of separate protection periods based on the change of indication and dosage also corresponded to European Court of Justice (ECJ) case law, which does not positively enshrine the principle of global authorisation. In fact, Article 4(2)(8)(III) of Directive 65/65/EEC was to be interpreted according to ECJ case law, to the effect that further developments of an authorised medicinal product do not trigger an independent protection period. If the medicinal products are essentially alike, the decision can be based not only on information relating to the original product, which has been authorised for at least 10 years, but also on previous information regarding other therapeutic indications. The same applies to information submitted for a medicinal product to be administered in different dosages from the original product. Here, too, case law indicated further development of the original product. It is not clear that Directive 2001/83/EC – which in defining a 'generic product' in Article 10(2)(b) would have captured the ECJ's definition regarding substantial equality and, in Article 6(1)(2) its considerations regarding protection for further developments of original products – was intended to govern anything different.

Further, the assumption of protection does not follow from the fact that an independent application had been filed for reference medicinal product B. Otherwise, the principle of global authorisation could always be circumvented.

Based on the principle of global authorisation, no protection for a medicinal product derives from the authorisation of additional strengths, pharmaceutical forms, dosages, routes of administration and indications; rather, in respect of the marketing authorisation holder of the original product, these are to be viewed as components of the initial authorisation. In addition, the area of application of the principle of global authorisation is independent of the type of selected authorisation procedure and of the selection of a new separate designation or the submission of new documents.

Thus, the court held that in the application of the principle of global authorisation, whether the reference medicinal product was approved before October 30 2005 is irrelevant. The principle of global authorisation already applied before October 30 2005 and continues to apply. The law provides that the one-year extension for certain further developments applies only after October 30 2005. The new law triggers no independent protection period.

For further information on this topic please contact Markus von Fuchs or Ilja Czernik at SKW Schwarz Rechtsanwälte by telephone (+49 30 889 26 50 0) or email (m.vonfuchs@skwschwarz.de or i.czernik@skwschwarz.de). The SKW Schwarz Rechtsanwälte website can be accessed at www.skwschwarz.de.

This article was first published by the International Law Office, a premium online legal update service for major companies and law firms worldwide. Register for a free subscription.