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The Court of Justice of the EU has ruled that a supplementary protection certificate (SPC) can be granted to a medicinal product comprising more than one active ingredient only if each of those ingredients is “specifically identifiable” in the basic patent on which the SPC is based.

The ruling is significant in that it revolves around a UK SPC awarded to Gilead Sciences for its HIV combination product, Truvada, which contains tenofovir disoproxil (TD) plus emtricitabine (case C-121/17). The validity of the SPC was challenged in the English High Court by Teva and other generics firms on the grounds that the basic patent on which the SPC was granted does not specify the combination of ingredients in Truvada, only the TD element.

The CJEU ruling is on a specific point of EU law, and does not say whether or not the Truvada SPC should not have been granted – this is a matter that the High Court will have to decide.

Nonetheless, according to Mike Snodin of patent law firm Park Grove IP, the ruling represents “unsettling news” for innovators, because for combination products it introduces “an additional hurdle to showing compliance with Article 3(a) of the SPC legislation, which is a key provision for assessing the validity of SPCs and requires the product to be “protected by a basic patent in force.”

Snodin said it also “raises many more questions than it is likely to resolve” and “casts doubt upon the correctness of many past Article 3(a) assessments (for combination products).”

SPCs were granted for Truvada based on the tenofovir patent by the French, UK and Swiss patent offices, while the Netherlands, Italy and Greece rejected their grant. The UK SPC was awarded in 2008 on the basis of claim 27 of the basic patent, which cites “a pharmaceutical composition comprising a compound according to any one of claims 1-25 together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients.”

Teva et al claimed the SPC did not meet the condition laid down in Article 3(a), which requires the product to “be specified in the wording of the claims.” They said the wording does not specify emtricitabine, and that the expression “other therapeutic ingredients” does not specify any active ingredient, whether structurally or functionally, so the TD/emtricitabine combination “cannot therefore be considered to be protected by a basic patent in force,” the CJEU noted.

By contrast, Gilead contends that the expression “other therapeutic ingredients” relates “implicitly but necessarily to emtricitabine” and so satisfies Article 3(a).

The High Court noted that despite several earlier judgments having been delivered by the CJEU on the interpretation of Article 3(a), the meaning of the provision was still unclear, and divergent decisions had been taken by different EU member states on the issue.

It therefore decided to refer this question to the CJEU: “What are the criteria for deciding whether ‘the product is protected by a basic patent in force’ in Article 3(a) of Regulation No 469/2009?’

The Ruling

In its ruling, the CJEU concludes that Article 3(a) "must be interpreted as meaning that a product composed of several active ingredients with a combined effect is ‘protected by a basic patent in force’ within the meaning of that provision where, even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination.”

For that purpose, the ruling says, “from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent, the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent.”

Truvada SPC Under Threat?

The ruling is broadly in line with the opinion of Advocate-General Melchior Wathelet, which was handed down in May. The matter now goes back to the English court for a decision as to whether the Truvada SPC meets the Article 3(a) criteria.

The CJEU does not go as far as the AG, who said that in his view, “and subject to verification by the referring court, as the active ingredient emtricitabine is claimed solely through the use of completely indeterminate expressions such as ‘comprising’ and ‘optionally other therapeutic ingredients’,” Truvada “is not protected by the basic patent within the meaning of Article 3(a).”  (Also see "EU Legal Opinion In Truvada Case Could Complicate SPC Grant Process" - Pink Sheet, 14 May, 2018.) 

The CJEU, does however, appear to “venture a step farther in its decision than merely proposing a framework for the construction of Article 3(a), as it seems to suggest in paragraph 56 that Gilead’s Truvada SPC does not fulfil the criteria laid out by the CJEU in its decision,” law firm Kromann Reumert points out.

The ruling says: “In the present case it is apparent, first, from the information in the order for reference that the description of the basic patent at issue contains no information as to the possibility that the invention covered by that patent could relate specifically to a combined effect of TD and emtricitabine for the purposes of the treatment of HIV. 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 TD, necessarily falls under the invention covered by that patent.”

“It will be interesting to follow the developments with the national courts,” Kreumann Ruemert says.

Gilead Response

Noting that the CJEU judgment “is not specific to Gilead’s Truvada SPCs,” Gilead told thePink Sheetin a statement: “While we digest the full judgment, we continue to believe Gilead’s Truvada SPCs are valid in all member states in which they were granted and reserve the right to protect and enforce any intellectual property that is infringed. The National Courts will decide whether to uphold Gilead’s Truvada SPCs where they were granted and we await their individual judgments in the light of the new CJEU judgment.”

Snodin said it was “likely (though perhaps not certain) that the new Article 3(a) test established by the CJEU will resolve the dispute relating to the validity of the SPC to the combination of tenofovir disoproxil and emtricitabine."

Health advocate Ellen ‘t Hoen, who runs the Medicines Law & Policy website, said in an emailed statement that “in general SPCs are granted too easily in Europe. The SPC for Truvada should never have been granted in the first place and I hope that the CJEU ruling will mean the end of the Truvada SPC in the UK.”

She said the case also showed that a deeper reform of the SPC system in the EU was needed. “Gilead’s annual sales for Truvada amount to around $3bn,” she said, adding that it was “hard to argue that the extension of a market monopoly is needed to recoup R&D investment for such a successful product. We would therefore like to see the granting of SPCs linked to the disclosure of R&D expenditure and global sales.”

Wider Implications

As for the wider implications of the ruling, Snodin said that “in common with the opinion of Advocate-General Wathelet… the Article 3(a) test established by the CJEU does not appear to have any basis in (an interpretation of) the wording of the SPC legislation. Instead, the CJEU’s justification for the test appears to consist solely of oblique references to objectives pursued by the SPC legislation.”

With this in mind, he says, “a key question raised by the CJEU’s judgement is whether the new Article 3(a) test provides a ‘fair’ result (i.e. one that strikes an appropriate balance between all of the objectives pursued by the SPC legislation) in factual scenarios differing from that in C-121/17.”

It also raises other questions such as whether the new test relates only to combination products, and what “specifically identifiable” means – for example, the precise form of the active ingredient(s) in the product or a more generic description of the relevant active ingredients.

Future CJEU judgements likely to come in the next 12 months “could well provide answers to at least some of the unresolved questions outlined above,” he continues.

“Nevertheless, it seems almost certain that the CJEU’s decision in C-121/17 will provoke yet more requests for that court to further clarify the interpretation of Article 3(a). Thus, by establishing a test that raises more questions than it answers, the CJEU appears to have guaranteed itself a steady stream of new SPC cases for the foreseeable future.”

From the editors of Scrip Regulatory Affairs.

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