High Court holds that Napp Pharmaceuticals was not entitled to a period of data exclusivity for its analgesic skin patch under the Article 10(3) hybrid-abridged procedure

29 Jul 2016

In a judgment handed down today, Mrs Justice Whipple rejected an attempt by Napp to assert a period of data exclusivity for “bridging data” provided by it in support of its application for a marketing authorisation (MA) for its product BuTrans®/Norspan® under the “hybrid-abridged” procedure laid down in Article 10(3) of the Medicines Directive (Directive 2001/83).

The “hybrid-abridged” procedure can be used where a manufacturer seeks to obtain an MA for a product that differs in certain respects, such as in the route of administration or therapeutic indication, from another manufacturer’s product that already has an MA (known as the “reference medicinal product” or “RMP”). The RMP in this case was an analgesic developed by another manufacturer in the form of a pill placed under the tongue: Napp then developed BuTrans®, which used the same analgesic in the form of a skin patch. Under the hybrid-abridged procedure, which requires the provision of “appropriate” pre-clinical tests and trials, it could and did obtain an MA by relying on the original documentation for the RMP combined with “bridging data” in the form of test results showing that the skin patch method was safe and effective.

Some 11 years later, Sandoz applied for MAs in a number of EU countries, including the UK, for its own analgesic skin patch. In its application, it referred to the RMP, the bridging data provided by Napp for BuTrans® and to its own studies demonstrating bioequivalence between its product and BuTrans®.

The UK Medical and Healthcare Products Regulatory Agency (“MHRA”), along with the equivalent authorities in other EU Member States, granted Sandoz an MA on that basis. Napp sought judicial review of the MHRA’s grant of an MA to Sandoz, claiming that the Medicines Directive did not permit the MHRA, in assessing Sandoz’s application for MAs, to allow it to rely on the “bridging data” provided by Napp. Napp also brought equivalent proceedings in other EU countries. At the hearing, Napp sought a reference for a preliminary ruling to the Court of Justice of the EU, arguing that there was a “lacuna” in the Directive to the extent that it did not lay down a period of exclusivity for “bridging data”: it pointed out that Article 10(1) provided for a period of exclusivity for the manufacturer of the RMP so as to prevent generic manufacturers relying on those data to secure an MA for their own product.

Whipple J observed that, as a matter of language, the reference in Article 10(3) to “appropriate” pre-clinical tests or clinical trials did not preclude the MHRA from accepting as “appropriate the data provided by Sandoz, namely the bridging data originally provided by Napp for BuTrans® together with Sandoz’s own studies demonstrating bioequivalence between its product and BuTrans®. That approach did not conflict with the purpose of the Directive of ensuring that medicines were safe and effective. Moreover, the Court of Justice’s case-law had refused to allow periods of exclusivity where the company in Napp’s position also held the MA for the RMP – had Napp also held the MA for the RMP in this case, BuTrans® would, under Article 6(1), have been held to be a “line extension” of the RMP and would not have had any additional period of exclusivity beyond that granted in relation to the RMP under Article 10(1): but there could be no reason for distinguishing the case where Napp held the MA for the RMP from the actual case, where it did not. She further noted that the Commission had expressed the same view in its Notice to Applicants. So she dismissed Napp’s challenge, holding that the MHRA had been correct to grant the MA, and refused to make a reference to the Court of Justice.

George Peretz QC acted for the MHRA.

To read the judgment, please click here.