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Option is a failure with combination SPCs


24th Jan 2020

The recent decision from the Court of Appeal of England & Wales in Teva vs Gilead has given us a first glimpse at how a national appellant court interprets the CJEU’s latest guidance on the meaning of Article 3(a) – what is a “product is protected by a basic patent in force”?

Unfortunately, I found the judgement rather disappointing. Whilst we can now say with reasonable confidence that a claim covering the optional combination of a known, specified, active ingredient with a non-specified active ingredient would not be considered to protect a combination product within the meaning of Article 3(a) [hopefully this will become clearer later!], the decision is so limited that I struggle to see how it will significantly help patent drafters, prosecutors and litigators in the future.

This is all a bit of an anti-climax after the flurry of decisions and opinions from the CJEU on referrals relating to Article 3(a) including this Truvada case (C-121/17), as well as the cases relating to Prezista (C-114/18) and Januvia (C-650/17).

 

A bit of perspective

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

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 filing 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.

It is important to reiterate the facts of these cases in order to bring a bit of perspective to the discussion. The problems surrounding Article 3(a) have arisen because the patents (not just the claims) did not structurally identify the product in question.

 

What the courts say

Perhaps controversially, I am of the opinion that the CJEU has done a good job in addressing these scenarios with their “two limb” test. Although the specific wording of this test is still open to debate, it 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.

The recent Court of Appeal decision only deals with “limb one” of the test. Perhaps not enormously surprisingly, 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. This seems fair enough.

Unfortunately what is still not clear is whether the outcome would have been the same had the claim related to a pharmaceutical composition comprising tenofovir disoproxil and optionally emtricitabine?

“Limb two” of the test was not directly addressed in the Court of Appeal’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 could have on future patent drafting in both the small molecule and biotech sector. I am not convinced that much – if anything – needs to change (not least because this is just one decision from one appellant court in Europe) however, 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 product 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.

Whether it is the chemical formula/INN of a small molecule; reference to a deposited biologic or disclosure of a specific combination of active ingredients, 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).

Looking forward, I am intrigued to see how other courts in Europe will interpret the guidance from the CJEU. I think they’ve done a pretty good job with their two limb test so I am being cautiously optimistic that we will start to see convergent decisions in the future.

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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