8 March 2018Big Pharma

German court makes SPC decision of ‘fundamental importance’

The German Federal Patent Court has set aside a decision by the German Patent and Trade Mark Office (DPMA) to reject a supplementary protection certificate (SPC) that GSK Biologicals had applied for, in a decision of “fundamental importance”.

GSK filed the SPC for the product “Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and Haemophilus influenzae type b conjugate, combination vaccine”.

The DPMA dismissed the SPC as it did not embody the inventive advance of the patent.

Bianca-Lucia Vos and Klemens Stratmann of Hoffmann Eitle said in a blog post dated March 2 on The SPC Blog that the decision  addresses an important aspect for determining whether a product is protected by a basic patent in regards to article 3(a) of Regulation (EC) number 469/2009 (the SPC regulation).

The article refers to medicinal products that are the result of long and costly research. It states that such products will not continue to be developed in Europe unless they are “covered by favourable rules that provide for sufficient protection to encourage such research”.

The DPMA rejected the application on the grounds that a product is only protected by article 3 of the regulation if the “respective active ingredient or the active ingredient composition is protected by the basic patent ‘as such’.”

Vos and Stratmann said that, according to the DPMA, for protection ‘as such’ to be affirmed within these terms, “the product in question has to constitute the ‘core inventive advance’ of the basic patent”.

They added that the Federal Patent Court’s decision acknowledges that formulation patents are eligible for an SPC extension in the same way that other patent types are.

“This decision is of fundamental importance since the approach taken by the GPTO [DPMA] in the contested decision would have rendered it impossible to extend the vast majority of formulation patents,” they said.

The decision comes as three referral proceedings concerning the interpretation of article 3 of the regulation are pending before the Court of Justice of the European Union.

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