…great forces are up against each other and a dispute arises. Fortunately, it is not a war of biblical dimensions, but only a lawsuit, a significant and legally interesting one though, about an Supplementary Protection Certificate. The parties were Teva (Hebrew word for nature) and Gilead (aka Hill of Testimony, a mountainous region east of the Jordan river). As such, it obviously had to be settled in Luxemburg.

Last week the Court of Justice of the European Union gave its eagerly awaited ruling in the Teva v Gilead case (C-121/17) on the criteria for determining whether the product of an SPC (active or combination of actives) is protected by the basic patent or not. Specifically, the case concerned Gilead’s SPC for the combination of tenofovir and emtricitabine. In order to obtain the same, Gilead had relied on a patent (EP 915894) which describes and claims tenofovir but also includes one broadly worded composition claim reading “a pharmaceutical composition comprising a compound according to any one of claims 1-25 and optionally other therapeutic ingredients”. Since emtricitabine was not mentioned in the patent and was in fact not even known at the priority date of the basic patent, the main issue of these proceedings was whether the expression “…optionally other therapeutic ingredients” is sufficient to protect emtricitabine in the sense of Article 3(a) of the SPC regulation No. 469/2009.

In the decision leading to the referral, Justice Arnold considered that the answers previously given by the CJEU on the interpretation of Article 3 (a) in Medeva, Actavis v Sanofi and Lilly were not sufficiently clear and therefore asked question 1 in Actavis v Sanofi again:

“What are the criteria for deciding whether ‘the product is protected by a basic patent in force’ in Article 3(a) of the SPC Regulation?”

The case came before the Grand Chamber of the CJEU, which answered the referral question as follows:

Article 3(a) of Regulation No 469/2009 of the European Parliament and of the Council of 6 May 2009, concerning the supplementary protection certificate for medicinal products, 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, 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.

With this answer, the CJEU did not follow Justice Arnold who had suggested that a product should be considered to be “protected” only if it embodies the inventive advance of the basic patent, even though the final outcome might be the same in the case at stake.

Indeed, it is questionable whether the test proposed by Arnold J. would also be readily applicable and deliver just and fair results in the event that the basic patent is not a product patent but rather a formulation, process or use patent where the “inventive advance” does not lie in the substance itself but rather formulation details, process steps or the claimed use.

The CJEU also did not simply take over the proposal made by the Advocate General who had suggested that Art. 3(a) is fulfilled if “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”. Even though the CJEU clearly recognized the skilled person’s role in interpreting the claims of the patent under Art. 69 EPC (para 47) and in determining whether the product is ‘specifically identifiable’ in the light of the information provided in the patent and of the prior art at the effective date of the patent (para 51), it apparently felt that ‘obviousness’ is not the right yardstick for such an evaluation.

What does this mean for the future SPC practice?

It is now clear and settled that it is not sufficient for the purposes of Article 3(a) that a product would infringe a claim when applying national infringement rules. It is also clear that a prerequisite for Article 3(a) to be fulfilled is that the product falls within the “extent of the protection” conferred by a basic patent according to Article 69 EPC. For the determination of the extent of protection, Article 69 EPC is fully applicable and this includes that the claims of a patent are to be interpreted from the perspective of a person skilled in the art.

Thus, one might think that Gilead might have had an easy case, as a skilled person might readily be of the view that the extent of protection of a claim to a pharmaceutical composition comprising a compound according to any one of claims 1-25 (such as tenovofir) and optionally other therapeutic ingredients includes each and every other therapeutic ingredient, including such that had not been discovered/invented at the priority or filing date. The justification of such an interpretation might be that each of such combinations derives its value from the tenovofir component and its utility against retroviral diseases.

However, this is where the CJEU clearly wants to draw the line, which is also consistent with the Medeva and Georgetown decisions relating to combination vaccines. The Court explicitly states that it is not the purpose of the SPC to extend the protection conferred by the basic patent beyond the invention which the patent covers (paragraph 40):

it is not the purpose of the SPC to extend the protection conferred by that patent beyond the invention which the patent covers. It would be contrary to the objective of Regulation No 469/2009 (…) to grant an SPC for a product which does not fall under the invention covered by the basic patent, inasmuch as such an SPC would not relate to the results of the research claimed under that patent.

The ruling of the CJEU brings to mind the test proposed by Warren J. in Eli Lilly v Human Genom Sciences [2014] EWHC 2404 (Pat) (18 July 2014)). Justice Warren found it helpful to examine “what the patent is really about” and suggested that a given product will be protected within Article 3(a), if it falls within the claims, subject to one proviso relating to circumstances where the claims contain some general word or words extending their extent beyond the principal scope of the claims, typically by the use of a word such as “comprises”. Applying this test to the circumstances of the Teva case would produce meaningful results in line with the gist of the CJEU judgement since an expression like “…optionally other therapeutic ingredients” – without any description of these other therapeutic ingredients – does nothing else than extend the extent of protection beyond the principal scope of the claims.

Accordingly, it seems reasonable to interpret the Teva v. Gilead decision in the sense that the CJEU suggests applying a modified “extent of protection” test. In a first step, the extent of protection of the basic patent has to be determined under Article 69 EPC. This has to be accomplished from the perspective of a person skilled in the art, taking the description of the patent (including prior art mentioned therein), the drawings, if any, and the skilled person’s common general knowledge into account. The Protocol on the Interpretation on Article 69 should also be given due regard.

If the product falls within the extent of protection thus determined, it is then to be evaluated in a second step whether the product also falls “under the invention covered by the basic patent” (para 38). In paragraph 43, the CJEU explicitly stated: “Accordingly, having regard to the objectives pursued by Regulation No 469/2009, the claims cannot allow the holder of the basic patent to enjoy, by obtaining an SPC, protection which goes beyond that granted for the invention covered by that patent. Thus for the purposes of the application of Article 3(a) of that regulation, the claims of the basic patent must be construed in the light of the limits of that invention, as it appears from the description and the drawings of that patent.”

The evaluation of what has been the “invention” claimed by the basic patent also has to be made by the person skilled in the art, but the requirements are higher (“without any doubt”) and require a problem-solution-analysis (para 48): To that end, it is necessary to ascertain whether a person skilled in the art can understand without any doubt, on the basis of their general knowledge and in the light of the description and drawings of the invention in the basic patent, that the product to which the claims of the basic patent relate is a specification required for the solution of the technical problem disclosed by that patent.

It is here where SPCs based on basic patents that include broad claims to unspecified “further ingredients or using “comprising” language will normally fail, as it should be difficult to formulate a meaningful problem which is to be solved by an ingredient that has neither been invented nor characterized at the effective date of the patent. In addition, the CJEU has made it crystal clear that it will not accept such SPCs (para 49, 50):

… having regard to the objective of Regulation No 469/2009, recalled in paragraph 39 above, for the purposes of assessing whether a product falls under the invention covered by a basic patent, account must be taken exclusively of the prior art at the filing date or priority date of that patent, such that the product must be specifically identifiable by a person skilled in the art in the light of all the information disclosed by that patent.
Were it to be accepted that such an assessment could be made taking into account results from research which took place after the filing date or priority date of the basic patent, an SPC could enable its holder unduly to enjoy protection for those results even though they were not yet known at the priority date or filing date of that patent, what is more outside any procedure for the grant of a new patent. That would, as pointed out in paragraphs 40 and 41 above, run counter to the objective of Regulation No 469/2009.

All Problems Solved?

On the whole, the Teva v. Gilead decision provides a welcome clarification of the existing case law of the CJEU and a test which can be applied with a reasonable degree of certainty to the majority of cases.
However, there may still be open questions in how to apply this case law in specific situations, such as in cases where a given product clearly falls under a broad Markush formula or a functional definition claimed in the basic patent and thus under its extent of protection, but where this product has not as such been identified in the specification. The problem may be even more acute if this product could only have been found as a result of a further (possibly dependent) invention.

The referral proceedings pending in Sandoz et al. v. G.D. Searle et. al [2018] EWCA Civ 49, UK Court of Appeal, Judgment of 25 January 2018, will offer an excellent opportunity for the CJEU to further develop its Case Law and to clarify the situation. The Sandoz referral concerns Searle’s SPC for Darunavir which relies on a basic patent with a very broad Markush claim covering this active ingredient. Since, due to a specific pattern of substituents, the chemical structure of Darunavir is relatively far removed from the concrete compounds disclosed in this patent, the forthcoming judgement of the CJEU will hopefully show where the Court wants to draw the line between the extent of protection under Article 69 EPC and the requirement of “protected by the basic patent” pursuant to Article 3(a) of the SPC regulation. In other words, it will have to be determined what the CJEU meant by stating that “for the purposes of the application of Article 3(a) of that regulation, the claims of the basic patent must be construed in the light of the limits of that invention, as it appears from the description and the drawings of that patent.”

Another interesting question is whether the CJEU’s comments (between-the-lines) about patents arguably conferring protection beyond the invention which the patent covers, will have a bearing on the national case law on the extent of protection of patents under Art. 69 EPC. It may be appropriate to recall that the purpose of Art. 69 EPC and of the SPC regulation is not the same in all aspects, and that even under the CJEU’s own case law (Actavis C-443/12, para 34) an SPC directed to Substance A confers its holder the right to proceed also against a combination of Substance A with Substance B.

Written by Dr. Klemens Stratmann and Dr. Thorsten Bausch


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5 comments

  1. Thorsten,

    Thank you for your comments. However, I must admit that I am extremely confused by one, seeming key aspect of the CJEU’s ruling.

    The judgement states that “It would be contrary to the objective of Regulation No 469/2009 (…) to grant an SPC for a product which does not fall under the invention covered by the basic patent”. However, I had understood that the SPC legislation always included a provision that expressly prevents this from happening (Article 4, which begins with the statement that “WITHIN THE LIMITS OF THE PROTECTION CONFERRED BY THE BASIC PATENT, the protection conferred by a certificate shall extend only to… “).

    The CJEU therefore seems to be creating an imaginary foe in order to justify the creation and deployment of a “weapon” (a modified extent of protection test) to slay that foe. To say the least, that is certainly an “interesting” approach to interpreting the legislation.

    I would also take issue with paragraph 48 of the judgement. That paragraph begins with the words “To that end”, which clearly refers to the matters discussed in the preceding paragraph:
    “With regard to the implementation of that rule, it must in the first place be stated that, in accordance with a principle shared by the patent laws of the Member States and reflected in Article 1 of the Protocol on the Interpretation of Article 69 of the EPC, the claims of a patent are to be interpreted from the perspective of a person skilled in the art and, therefore, the issue whether the product which is the subject of the SPC necessarily falls under the invention covered by that patent must be assessed from that perspective”.

    So, to be clear, the subsequent comments in paragraph 48 (indicating what should be ascertained) provide instructions on how one should determine whether the product “falls under the invention” covered by the basic patent.

    All fine and well, but I thought that the CJEU was NOT COMPETENT to rule upon the interpretation of non-EU laws (such as the laws determining the extent of protection). Or is the CJEU implying that the question of whether the product “falls under the invention” of the basic patent should now be determined by reference to EU law?

  2. Thanks to Thorsten and to Concerned Observer for the blog and the comment.

    The comment raises interesting questions. I would be glad to see some comments on the position of Concerned Observer.

    I have a further one:

    The UPC is meant to deal as well with SPCs. Now the CJEU having given its decision on how to interpret the protection offered by SPCs, any prejudicial question of the UPC in this respect appears moot.

    Unless I miss an important point, it appears also logical that the extent of protection of a SPC cannot be different from the scope of protection offered by the corresponding patent. Do we then still need the UPC in order to define the scope of protection of a patent/SPC? The question is certainly provocative, but appears justified.

    The more one looks into this matter of extent of protection, the more the uncertainty created by Lord Neuberger’s decision on pemetrexed, the more one feels that defining freedom of protection will be difficult. The proprietor will not only benefit from sloppy drafting when it comes to the extent of protection, but now as well with a corresponding SPC.

    Techrights: FINGERS OFF!!!

    1. By way of an answer to your provocative question, I would merely emphasise that the CJEU is not competent to rule upon the extent of protection provided by a basic patent. Instead, with respect to Article 3(a), they can only interpret what is meant by the term “protected”.

      This may sound like a nonsensical answer, but that is where things stand. This is because the CJEU has itself ruled that the meaning of “protected” MUST be determined in the light of non-EU laws (such as Article 69 EPC). However, the latest case seems to add an extra “gloss” to this approach, as it means that merely falling within the extent of protection as determined by non-EU laws is a necessary but not sufficient requirement for demonstrating compliance with Article 3(a).

      What more is required? Despite the CJEU providing its views (or should that be Delphic utterances?), I think that the answer is that we do not yet know with any degree of clarity. As indicated in my comment above, I am not persuaded that key parts of the CJEU’s reasoning make any sense at all … which makes it very difficult indeed to understand the binding part of the CJEU’s ruling (in particular, the meaning of terms such as “specifically identifiable”).

      What is clear is that opinions on the meaning of the ruling will differ. Indeed, I have already seen evidence of this. Sadly, unless and until the CJEU provides any clearer answers, the likely outcome of the ruling is INCREASED disharmony… which begs the question of whether the preliminary reference procedure is serving its intended purpose.

  3. Dear Concerned Observer,

    Thanks for your reply. My question/comment was of the type “tong in cheek” which you clearly spotted.

    I take it that “the extent of protection as determined by non-EU laws is a necessary but not sufficient requirement for demonstrating compliance with Article 3(a)”. It might sound naive, but I have difficulties in understanding why the scope of protection of an SPC could be different from the scope of protection offered by a patent.

    I also agree with you that the preliminary reference procedure does not seem to serve its intended purpose. Could it be that national courts use it too often. One could think that some courts want to pass on the monkey to the CJEU rather than to decide by themselves. May be another provocative question….

    Techrights: FINGERS OFF!!

    1. Why should the scope of protection of an SPC could be different from the scope of protection offered by a patent? To be honest, there is no straightforward answer to that question.

      The simplest way of explaining it is that the CJEU seems to have decided that keeping things simple could, in some cases, lead to what they perceive to be “unfair” results (such as, to put it in terms used in C-121/17, patent proprietors receiving “undue protection”).

      In other words, the CJEU seems to interpreted Article 3(a) by way of a two-step process. The first step involves the CJEU deciding what, in their view, would be a “fair” result in the case in front of them. The second step then involves the CJEU devising a (hopefully plausible) chain of logic that arrives at the desired result.

      This is no doubt a process that occurs in many courts, not just the CJEU. However, applying this approach to the SPC legislation tends to get the CJEU into all sorts of trouble.

      Firstly, the complexities of SPC cases often mean that the CJEU does a poor job at retro-fitting of a chain of logic that arrives at their desired solution. The problems that I highlighted above are a good example of this (eg despite not being competent to do so, the CJEU has arrived at a ruling that appears to tell us all how we should go about determining the extent of protection provided by a patent).

      Secondly, the CJEU rarely looks beyond the end of its nose. It therefore has a terrible tendency to provide ruling that arguably leads to a “fair” result in the case before them but that unarguably creates horrible difficulties (and leads to extremely unfair results) in other cases having different fact patterns.

      Finally, a major trouble with the interpretative approach outlined above is that it is prone to being unduly influenced by the subjective views of those within the CJEU who are responsible for preparing opinions and judgements. This is probably why there are several examples of pairs of cases (handled by different individuals at the CJEU) that are both supposedly good law but that are (almost) impossible to reconcile with one another.

      I feel very sorry for the national courts who, by and large, have a far better grasp of the complexities of SPC law and that (at least on occasion) demonstrate an ability to think about knock-on consequences of their preferred interpretations of the law. This is because the CJEU has made such a mess of interpreting certain provisions, and Article 3(a) in particular, that it makes it very hard for the national courts to justify NOT making preliminary references to the CJEU.

      Whilst this mess might not be all of the CJEU’s making, I cannot help but think that they are now in a hole on Article 3(a) and ought to stop digging.

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