CJEU clarifies ‘basic patent’ meaning in SPC dispute

Earlier today, the Court of Justice of the European Union (CJEU) clarified when a product is ‘protected by a basic patent’ within the meaning of article 3(a) of regulation 469/2009 (the SPC regulation).

According to the court, even when the combination of active ingredients in the product is not expressly mentioned in the claims of the basic patent, the product will be ‘protected by a basic patent’ if the claims “relate necessarily and specifically to that combination”.

The CJEU went on to clarify that the combination of the ingredients must, in light of the description and drawings of the patent, fall under the invention covered by it.

It added that each of the ingredients must be “specifically identifiable” in light of all the information disclosed by the patent.

The English High Court had asked the CJEU to clarify the meaning of whether a product is ‘protected by a basic patent’ in January last year.

In April this year, advocate-general (AG) Melchior Wathelet said that the request for a preliminary ruling afforded the court a “further opportunity to rule on the thorny issue” of the criteria for determining whether a product is ‘protected by a basic patent in force’.

The dispute involves an SPC for Gilead-marketed Truvada (emtricitabine/tenofovir disoproxil), an anti-retroviral medication used to treat HIV.

Teva, Accord Healthcare, Lupin and Mylan challenged the SPC’s validity, disputing that it is protected by European patent (UK) number 0,915,894.

In response, Gilead claimed that for article 3(a) to be satisfied, it is sufficient that the product falls within the scope of protection of at least one claim of the basic patent.

According to Gilead, the combination of tenofovir disoproxil and emtricitabine falls within the scope of protection of claim 27, which cites a pharmaceutical composition comprising tenofovir disoproxil “together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients”.

Teva alleged that the product must be “specified in the wording of the claims” and, where the claim contains a functional definition, it must “relate implicitly but necessarily and specifically” to that product.

According to Teva, emtricitabine isn’t specified in the wording of claim 27 and the expression ‘other therapeutic ingredients’ doesn’t specify any active ingredient.

In its decision today, the CJEU said that it falls to the English High Court to determine whether the expression ‘other therapeutic ingredients’ satisfies the requirement that the claims of the basic patent relate necessarily and specifically to the product.

“Consequently, it does not seem possible that a person skilled in the art, on the basis of the prior art at the filing date or priority date of that patent, would be able to understand how emtricitabine, in combination with tenofovir disoproxil, necessarily falls under the invention covered by that patent,” said the court.

The CJEU concluded that the onus is on the referring court to check whether this is the case.

The English High Court must also establish whether emtricitabine is specifically identifiable by a person skilled in the art.

Glyn Truscott, partner at Elkington + Fife, noted that the CJEU chose not to follow significant parts of the AG’s opinion.

“In particular, the AG’s explicit exclusion of the ‘core inventive advance’ test has not been included in the final judgment. The AG’s requirement for the product to be ‘precisely’ identifiable has also not been followed."

While the CJEU didn’t repeat Wathelet’s proposal for it to be “obvious at the priority date” that the active ingredient is identifiable, the court did use the essence of this principle and the decision states that the information disclosed by the patent can include prior art at the filing or priority date.

“Overall, the judgment may appear to have a familiarity to it because it endorses the previous decisions in Medeva v Comptroller General of Patents, Designs and Trade Marks and HGS v Eli Lilly and concludes that each active ingredient in a combination must be specifically identifiable. This guidance does shine some light on the thorny issue of combination SPCs,” Truscott concluded.

However, according to the Elkington + Fife partner, it is possible that it will still be a challenge for national IP offices and courts to assess whether a product is “specifically identifiable” by a given patent or claim.

The two pending article 3(a) cases before the CJEU may provide further guidance, Truscott concluded.

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