No exclusivity for data generated to support a hybrid-abridged application

Alongside patent protection, data exclusivity can offer valuable market protection to a pharmaceutical product. But can data in support of a product approved through the so-called hybrid-abridged procedure attract the same kind of protection? The High Court says they can’t.

A straightforward generic – the abridged procedure

The simple version is a straightforward generic product. The European rules explain that a product of this type can be approved for marketing if it is shown to have

“the same quantitative and qualitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence… has been demonstrated…”.

But an application of this kind can only be filed after eight years from the first EU approval, and marketing can only start ten years after that first approval (extendable to eleven where a new therapeutic indication has been approved).

A variant product – the hybrid-abridged procedure

A new version of an old product that isn’t close enough to be a generic can still benefit from the approval of the reference product. Here “the results of appropriate pre-clinical tests or clinical trials” have to be provided. The regulator will need to be satisfied that the “bridging data” shows how the variant product will work as compared to the reference product.

A generic version of a variant product

But what about the situation where a manufacturer wishes to market a generic version of the variant product? There are no specific rules dealing with this situation, but should the manufacturer of the variant get some protection for their bridging data?

Napp's transdermal patch - is there exclusivity over the bridging data?

Napp Pharmaceuticals, in this situation over its opioid analgesic BuTrans, has received a firm no from the High Court.

The reference product, Temgesic, is a sub-lingual tablet first registered in 1992 by Schering-Plough. Napp based its filing for a transdermal patch version on Temgesic, gaining approval in Denmark in 2003. The UK then approved BuTrans through the mutual recognition procedure.

In order to obtain the Danish approval, Napp carried out 26 clinical studies of its own over 9 years to produce bridging data.

When Sandoz then asked for approval for its own transdermal patch Reletrans relying on Temgesic as the reference product and also on Napp’s bridging data, Napp was unimpressed. It has challenged the German regulator’s decision to approve in several countries, including the UK. The question, according to Napp, was unanswered and should be submitted to the European Court for a definitive ruling.

The English court disagreed. Earlier cases answered the question pretty clearly. There could be no protection for bridging data, and the German and British regulators had done the right thing by approving Reletrans.

Napp has also been fighting this battle on the patent front, relying on a patent for a transdermal patch formulation. Napp lost that case at trial because the components required by the patent were not present in the specified ranges in Reletrans. Recent reports suggest a loss on appeal too. So it seems that Sandoz is free to go ahead with its launch.

The question is, in today’s more mixed-up world where a simple division between innovators and generics producers no longer applies, is there enough incentive to do the work on new versions of existing products?

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