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Interpreting Article 3(a) of supplementary protection certificates (SPCs) regulation with respect to combination products


8th Apr 2020

At the end of 2019, a decision from the Court of Appeal of England & Wales (EWCoA) in Teva vs Gilead gave us an idea of how national courts will interpret the CJEU’s latest guidance on the meaning of Article 3(a) – what is a “product … protected by a basic patent in force”?

It is an interesting aspect of European law that a decision of Europe’s highest court, the Court of Justice of the European Union (CJEU), still has to be interpreted by the national courts when deciding a case in their jurisdiction. This means that if there is anything ambiguous in the decision of the CJEU, national courts throughout the European Union may still come to different decisions!

The background

The Teva vs Gilead case was one of three referrals to the CJEU relating to the question of “what is the meaning of Article 3(a)?”. In addition to the Teva vs Gilead referral – also referred to as the Truvada case (C-121/17) – there are the Prezista (C-114/18) and Januvia (C-650/17) cases.

All of these referrals have one thing in common: the “product” (or at least a part thereof) was not known as an active pharmaceutical ingredient at the effective filing date of the patent.

Truvada is a combination of tenofovir disoproxil and emtricitabine for the treatment of HIV. Although tenofovir disoproxil was disclosed in the patent, emtricitabine was not and it was also not known to be effective in the treatment of HIV until many years after the fling date of the patent.

Prezista is another HIV treatment relating to the drug darunavir but instead of disclosing the structure or chemical formula of darunavir the patent only contains a Markush formula that could, according to experts at trial, cover between 7 x 10135 and 1 x 10377 compounds.

And finally Januvia, which relates to the compound sitagliptin for the treatment of diabetes mellitus type 2, is based on patent claims defining a class of compounds as activity-lowering effectors of dipeptidylpeptidase IV (DP IV)-enzymatic activity. Nowhere in the patent is the structure or chemical formula of sitagliptin disclosed.

These facts are important because they give perspective as to why the meaning of Article 3(a) is being questioned. The problems have arisen because the patents (not just the claims) did not structurally identify the “product” in question.

What the courts say

In Truvada, the CJEU provided a “two part” test to determine whether a “product is protected by a basic patent in force”. This test essentially requires that:

  • the product must necessarily fall under the invention covered by the patent; and
  • a person skilled in the art would have been able, in the light of all the information contained in a patent, on the basis of the prior art at the filing date or priority date of the patent in question, to derive the product in question.*

* This “two part” test has been supported by the preliminary opinion of the Advocate General (AG) in Prezista and Januvia handed down in September 2019 but we are still waiting for the CJEU’s judgement.

Unfortunately, the EWCoA decision only dealt with “part one” of the test. The judgement concluded that the combination product Truvada does not necessarily fall under the invention because the only claim in the patent relates to a pharmaceutical composition comprising tenofovir disoproxil and optionally other therapeutic ingredients.

So, an optional, unspecified, active ingredient does not “necessarily” fall under the invention.

What is not clear is whether the outcome would have been the same if the claim related to a pharmaceutical composition comprising tenofovir disoproxil and optionally emtricitabine?

The conclusions we can draw from the CJEU & EWCoA decisions are that failing to specifically identify combinations of active ingredients in a patent is likely to lead to problems if you want to rely of this patent for an SPC on a combination product. It may even be that in the future, data supporting the effect of this combination will be necessary.

“Part two” of the test was not directly addressed in the EWCoA’s judgement, but it was commented on at the end of the decision and one thing is clear, if the product did not even exist at the effective filing date of the patent, it is unlikely to be considered protected by the patent.

What does the future hold?

So where does this all leave us? There is a lot of debate about the impact this decision, and the opinion of the AG in Prezista and Januvia, could have on future patent drafting in both the small molecule and biotech sector. I do not think much – if anything – needs to change but below are a few points that are certainly worth bearing in mind:

  • the scope of protection of a patent – i.e. the broadest claim – does not have to be limited to the specific product that is the subject of the SPC but;
  • don’t expect a patent to meet the requirement of Article 3(a) if the product to be protected did not even exist at the effective filing date of the patent;
  • if the product did exist at the effective filing date, at least disclose it in the description of the patent and at best include evidence that it treats the disorders for which the product is authorised; and
  • if the invention is meant to cover a combination then explicitly disclose (and ideally claim) that combination, don’t make the presence of additional active ingredients optional.

Proof that the product actually existed and was intended to fall within the scope of the claims will go a long way to meeting the requirements of Article 3(a). For example, providing the chemical formula/INN of a small molecule; referencing a deposited biologic; or disclosing a specific combination of active ingredients, will all help to support the argument that a product is protected by the basic patent in force.

As a final point, it is worth noting that this may not be good news for companies working only in drug discovery, where the final target product is not always known, but it looks as though the trend in Europe is going back towards SPCs compensating for obtaining drug approval and not drug discovery.

This article is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking any action in reliance on it.

Author
Robin Ellis
Partner
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Would you like to know more? You can talk to Robin Ellis who will be able to help. Call + 49 (0) 89 206054 267

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