By order issued on February 26th, 2016 and only recently made available in a public database, the Court of Milan declared the validity of the paediatric extension granted by the Italian Patent Office for Novartis’ SPC covering the medicinal product Glivec (imatinib mesilate), applied for after Novartis’ voluntary removal of the product from the EU Register of designated Orphan Medicinal Products.

The decision of the Court of Milan anticipated an order issued between the same parties by the Court of Hague on 30 March 2016 on the Dutch counterpart of the Italian SPC. You may find here the comment of Hogan Lovells Amsterdam Life Sciences team on the Dutch decision, which came to conclusions very similar to those of the Italian Court.

Background

Glivec is a medicinal product initially authorised by the European Medicines Agency (EMA). It was designated as an orphan medicinal product under EU Regulation no 141/2000, and benefited accordingly of the ten-year period of orphan market exclusivity. Glivec was subsequently approved for additional therapeutic indications and such additional designations also enjoyed the orphan market exclusivity.

Meanwhile Novartis performed clinical studies in the paediatric population, in accordance with a paediatric investigation plan (PIP). On March 9th, 2012 the EMA’s Paediatric Committee issued a positive opinion on the completion of the PIP.

EU law contemplates different possible rewards for marketing authorisation holders, who successfully completed a paediatric investigation: the common rationale underlying such provisions is to encourage clinical investigation in paediatric patients.

  • Article 37 of EU Regulation1901/2006 on medicinal products for paediatric use provides for a two-year period of orphan market exclusivity, in additional to the ten-year period acknowledged to orphan medicinal products without paediatric indication.
  • If the product is patented, Article 36 of EU Regulation1901/2006 further stipulates that the holder of the patent or supplementary protection certificate can obtain a six-month extension of the ordinary duration of its patent or SPC. However, subsequent paragraph 36 (4) of EU Regulation 1901/2006 clarifies that the six-month extension cannot be cumulated with the two-year period of orphan market exclusivity.

By April 16th, 2012 Novartis had withdrawn all the orphan designations of Glivec under Regulation (EC) 141/2000, or the orphan market exclusivity had already expired. On December 20th, 2013 Novartis applied for the six-month extension of its SPC, as eventually granted by the Italian Patent Office.

Teva vs. Novartis

Ordinary proceedings were then brought by Teva against Novartis, seeking a declaration of non-infringement for a generic copy of Glivec on the assumption that the SPC’s extension would have been invalidly granted. Teva relied upon Article 36 (4) and Recital 29 of EU Regulation 1901/2006, the latter stating that “orphan medicinal products, instead of an extension of the supplementary protection certificate, the ten-year period of orphan market exclusivity should be extended to twelve years if the requirement for data on use in the paediatric population is fully met“.

The finding of the Court

The Court of Milan found it decisive that Glivec did not benefit from the additional two-year period of orphan market exclusivity under Article 37 of EU Regulation 1901/2006 and that the six-month paediatric extension was granted only once the orphan designations for the medicinal product had already been removed from the Community Register of Orphan Medicinal Products pursuant to Article 5 (12) (a) and (c) of EU Regulation 141/2000.

The Court stated that Article 37 EU Regulation 1901/2006 does not allow accumulation of the two-year period of market exclusivity and the six-month of SPC paediatric extension. However, such provision should be interpreted as stipulating two alternatives, both available to the marketing authorisation holder.

Furthermore, according to the Court the ten-year period of orphan market exclusivity already enjoyed by Novartis is not inconsistent with the grant of a paediatric extension in respect of the SPC, as the ten-year exclusivity and the six-month extension (or the two-year period of additional market exclusivity) are rewards granted on different grounds.

On one hand, the ten-year period of market exclusivity is acknowledged on the basis of clinical studies carried out by the marketing authorisation holder to obtain an authorisation as orphan medicinal product.

On the other hand the period set between either the six-month paediatric extension or the two-year period of orphan market exclusivity relates to the independent circumstance that the marketing authorisation holder carried out additional clinical studies on the use of the medicinal product in the paediatric population.

Conclusions

The Court of Milan appears to acknowledge that the purpose of Regulation (EC) No 141/2000 is to provide incentives for the development and placing on the market of designated orphan medicinal products and that this is also the objective of EU Regulation 1901/2006 in respect of the paediatric population. An interpretation that restricts the ability of the marketing authorisation holder to seek an extended patent protection as a reward for a paediatric study on the ground that the concerned product has received an orphan designation on a different basis would be indeed contrary to the rationale of the law. Such interpretation would eventually render an orphan designation for products still under patent protection less attractive.