BREAKING: "Specifically, precisely and individually identifiable", AG Wathelet adds to the Article 3(a) SPC Regulation wrangle

The AmeriKat working off her impatience while awaiting
this morning's Article 3(a) Opinion
This morning Advocate General Wathelet handed down his opinion in the reference from Mr Justice Arnold in Teva v Gilead (Case C-121/17) concerning Article 3(a) of the SPC Regulation.  The background to the case was summarized by the AmeriKat's friend Steve Baldwin in this post here last January and the full decision of Arnold J can be read here

The question that was referred was the exquisitely simple and direct question of
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 SPC Regulation]?
So what did AG Wathelet say and did he agree with Arnold J's comments that:
"In the hope that it will assist the Court of Justice to provide a clear answer this time, I will again offer my own suggested answer to this question. As discussed above, it is now clear that it is not sufficient that dealings in the product would infringe a claim applying the Infringing Act Rules. It is also clear that it is necessary that the product falls within at least one claim of the basic patent applying the Extent of Protection Rules. In my view, however, it is not sufficient that the product falls within at least one claim of the basic patent applying the Extent of Protection Rules. As explained in paragraphs 39-43 above, and as the facts of the present case illustrate, the scope of protection test proves too much in this context. Accordingly, more is required. 
What more is required? In my view, the answer is that the product must infringe because it contains an active ingredient, or a combination of active ingredients, which embodies the inventive advance (or technical contribution) of the basic patent. Where the product is a combination of active ingredients, the combination, as distinct from one of them, must embody the inventive advance of the basic patent. Thus in a case such as the present, where the inventive advance of the Patent consists generally of the compounds of formulae (1) and (1a), including specifically TD, a medicinal product whose active ingredient is TD is protected by the Patent within the meaning of Article 3(a) because it embodies the inventive advance of the Patent. A medicinal product whose active ingredients are TD and another therapeutic agent such as emtricitabine in combination is not protected by the Patent within the meaning of Article 3(a) because the combination, as distinct from TD, does not embody the inventive advance of the Patent. This is not a question of the wording of the claims of the basic patent, which as discussed above can be manipulated by the patent attorney who drafts it, but of its substance. By contrast, if Gilead (or another inventor) were to obtain a patent for an invention consisting of a combination of TD and substance X which surprisingly had a synergistic effect in treating HIV, then a medicinal product whose active ingredients were TD and X would be protected by that patent since it would embody the inventive advance of that patent. In my view, this interpretation of Article 3(a) would accord with the object of the SPC Regulation, which is to encourage invention in the field of medicinal products by compensating inventors for the delay in exploiting their inventions due to the need to obtain regulatory approval, and not to confer unjustified monopolies. 
For the avoidance of doubt, this interpretation of Article 3(a) would not prevent a patentee from obtaining an SPC in circumstances where the patent protected a single active ingredient A, but the patentee had only obtained a marketing authorisation for that active ingredient in combination with another active ingredient B. In those circumstances, as the Court of Justice held in Medeva, the patentee could obtain an SPC for product A."
AG Wathelet said:
"Article 3(a) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products precludes the grant of a supplementary protection certificate relating to active ingredients which are not specified in the wording of the claims of the basic patent. The fact that a substance or combination of substances falls within the scope of protection of the basic patent is a necessary, but not sufficient, requirement for it to constitute a product protected by a patent within the meaning of Article 3(a) of Regulation No 469/2009. 
A product is protected by a patent within the meaning of Article 3(a) of that regulation if, on the priority date of the patent, it would have been obvious to a person skilled in the art that the active ingredient in question was specifically and precisely identifiable in the wording of the claims of the basic patent. In the case of a combination of active ingredients, each active ingredient in that combination must be specifically, precisely and individually identifiable in the wording of the claims of the basic patent.."
The AmeriKat has had little time to digest the Opinion, but with other pending Article 3(a) references in the pipeline, this area is not going to be settled for long.
BREAKING: "Specifically, precisely and individually identifiable", AG Wathelet adds to the Article 3(a) SPC Regulation wrangle BREAKING:  "Specifically, precisely and individually identifiable", AG Wathelet adds to the Article 3(a) SPC Regulation wrangle Reviewed by Annsley Merelle Ward on 11:05:00 Rating: 5

3 comments:

Anonymous said...

The AG admits in footnote 4 that he is aware of the other two pending 3(a) referrals, C-650/17 and C-114/18, so one would think that he intended to provide guidance for those as well.
Particularly with the comment in footnote 51: "Or even substances not yet invented on the priority date of the patent."

Anonymous said...

That does not bode well for antibody patents where the antibodies are defined by their CDRs, and there has been subsequent modification to the frameworks or Fc regions.

Anonymous said...

What about Actavis vs. Lilly?

Was it obvious at the priority date that any other salt than pemetrexed disodium was specifically and precisely identifiable in the wording of the claims of the basic patent?

It is clear that the matters are different, equivalents on the one side and SPC on the other, but it is difficult to deny some links.

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