"Eeny, meeny, miny, moe"

Article 37 of Regulation (EC) 1901/2006 on medicinal products for pediatric use provides for a two-year period of orphan market exclusivity, in additional to the ten-year period acknowledged to orphan medicinal products without pediatric indication.

If the product is patented, Article 36 of Regulation (EC)1901/2006 further stipulates that the holder of the patent or supplementary protection certificate (SPC) can obtain a six-month extension of the ordinary duration of its patent or SPC.

However, subsequent paragraph 36 (4) of Regulation (EC) 1901/2006 clarifies that the six-month extension cannot be cumulated with the two-year period of orphan market exclusivity.

Recently in Novartis V. Mylan same issue was discussed by the District Court in the Hague on Deferasirox. Deferasirox is protected both by a patent (with SPC) as well by an Orphan Drug Designation.

Novartis had sued Mylan for infringement of the SPC, under the term of its pediatric extension; Mylan countersued alleging the invalidity of the pediatric extension. The question posed by Mylan is whether the exception to this double incentive also applies to pharmaceuticals that have previously been designated as orphan drugs, but for which the ten-year term of protection has expired.

The court concludes that taking into consideration the objectives of the Pediatric Regulation, Articles 36(4) and 37 of the Regulation may not be interpreted in any other way other than that an SPC’s Pediatric Extension may be granted on a medicinal product, even if this was previously designated as an orphan drug, as long as this designation is no longer valid (either expired or withdrawn).

Similarly Article 14(11) of Regulation (EC) 726/2004 (the EMA Regulation) allows one additional year of market exclusivity to be granted if the holder of a marketing authorization for a medicinal product obtains an authorization for a new therapeutic indication and provides evidence that the medicinal product provides a significant clinical benefit in that indication; and

Article 36(1) of Regulation (EC) 1901/2006 (the Pediatric Regulation) allows for the term of a Supplementary Protection Certificate (SPC) to be extended by six months if the holder of the marketing authorization has performed studies into the pediatric use of the medicinal product.

The prohibition against both extensions being obtained is found in Article 36(5) of the Pediatric Regulation, which prohibits the extension to the SPC term from being granted if the marketing authorization holder has been granted the additional year of market exclusivity under Art 14(11) of the EMA regulation.

In a recent decision the UK Intellectual Property Office (UKIPO) for Tocilizumab, looked at the same issue. Tocilizumab (sold by Roche as RoActemra®) is an antibody treatment for rheumatoid arthritis. After the grant of its initial marketing authorization for the treatment of rheumatoid arthritis, tocilizumab was approved for the treatment of systemic idiopathic juvenile arthritis. Based on which Roche was able to secure both extension of SPC and extension of market exclusivity.

Thus, with the one-year extension, RoActemra®) got an eleven-year period of regulatory protection, which expired in January 2020.

On the other hand, SPC on EP(UK) 0783893 B1 was extended by six-month due to pediatric exclusivity until 6 December 2020.

Just before expiry of the SPC (excluding the pediatric extension), the Patentee wrote to the UKIPO requesting revocation of the pediatric extension on the grounds that it had been granted contrary to Article 36(5) of the Pediatric Regulation.

The UKIPO agreed that the pediatric extension should not have been granted and therefore granted the request for revocation.

The regulations do not allow accumulation of the market exclusivity and the six-month of SPC pediatric extension and therefore marketing authorization holder should carefully choose the right one.

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