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Further SPC reference may finally clarify the status of third party MAs

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On 1 March 2019, in his judgment in Eli Lilly v Genentech Mr Justice Arnold (who seems to have dealt with most SPC cases at first instance in recent years) referred a long-awaited question to the CJEU on whether a patentee can rely on a third party marketing authorisation in its application for an SPC.

On 1 March 2019, in his judgment in Eli Lilly v Genentech, Mr Justice Arnold (who seems to have dealt with most SPC cases at first instance in recent years) referred a long-awaited question to the CJEU on whether a patentee can rely on a third party marketing authorisation in its application for an SPC.

Background

A Supplementary Protection Certificate (SPC) extends the period of exclusivity for a medicinal product by up to five years after patent expiry. To be validly granted, an SPC application needs to satisfy a number of conditions, as set out in Article 3 of the SPC Regulation.

In his judgment, Arnold J considered:

  1. the condition in Article 3(a) that the product must be protected by a basic patent in force; and
  2. the issue of whether a marketing authorisation (MA) held by a third party can be relied on by a patentee when applying for an SPC – sometimes referred to as 'SPC squatting' or 'third party MA' - in circumstances where the Article 3 conditions are silent as to the identity of the MA holder.

The SPC application

Genentech is the proprietor of the patent EP 1 641 822 but does not market a product covered by that patent. Eli Lilly holds an MA for and markets the antibody ixekizumab under the trade mark Taltz, as a treatment for moderate to severe plaque psoriasis and psoriatic arthritis in adults.

Genentech contends that Taltz is covered by its patent EP '822, and in 2016, filed an application for an SPC based on EP '822 and Lilly's MA for Taltz. Lilly subsequently brought proceedings against Genentech in the High Court, seeking declarations that Genentech's SPC application did not comply with Article 3(a) and that an SPC granted pursuant to its MA would be invalid.

Lilly also sought revocation of EP '822 in the same proceedings – this was considered by Arnold J in a separate judgment and is not discussed further in this article.

Is the product protected by a basic patent in force?

In considering Article 3(a), Arnold J referred to Teva v Gilead (C-121/17) (see our blogs on this case -  Article 3(a) of SPC Regulation - clarity at last and Further guidance from the CJEU on SPCs for combination products) in which the CJEU ruled that the question of whether a product is 'protected by a basic patent' falls to be judged by the skilled person based on the prior art at the filing or priority date of the basic patent. Although the CJEU's test in Gilead was phrased in terms of a drug composed of several active ingredients with a combined effect, Arnold J nevertheless applied it to ixekizumab, which is a single antibody.

The first limb of the test from Gilead requires the active ingredient to 'necessarily fall under the invention' covered by the patent, from the perspective of the skilled person at the filing or priority date. The second limb requires the active ingredient to be 'specifically identifiable' by the skilled person reading the basic patent at the filing or priority date in the light of their common general knowledge (CGK).

Arnold J considered the application of these two limbs to claims 1 and 12 of EP '822 separately:

  • Claim 1: this claim is to antibodies which bind to IL-17A and IL-17A/F, of which ixekizumab is one.

Arnold J considered it irrelevant that ixekizumab was not created until after the priority date of EP '822 for the purposes of both limbs 1 and 2 of the Gilead test. In the context of limb 2, Arnold J considered that ixekizumab would be specifically identifiable by the skilled team at the priority date, because it is identifiable by reference to the functions specified in claim 1.

  • Claim 12: this claim is to the use of an antibody as defined in claim 1 or 2 in the preparation of a medicament for the treatment of rheumatoid arthritis or psoriasis.

Arnold J concluded that the skilled team reading EP '822 in the light of their CGK as at the priority date would not have considered it plausible that an anti-IL-17A/F antibody would have a discernible therapeutic effect on psoriasis. While there was no dispute that ixekizumab is now known to be efficacious for the treatment of psoriasis, that has only been known since research was carried out after the priority date, and it is clear from Gilead that it is not permissible to take such research into account. From the point of view of the skilled team as at the priority date, ixekizumab therefore did not 'necessarily fall under the invention' covered by claim 12, nor would it be 'specifically identifiable' as being covered by claim 12.

Conclusion

On this basis, the judge concluded that an SPC based on claim 1 would comply with Article 3(a), but not one based on claim 12. However because Arnold J held in his separate judgment in the same proceedings that all claims of EP '822 were invalid, Genentech will not in any event be able to obtain an SPC for ixekizumab unless Arnold J's decision on the validity of EP '822 is reversed on appeal.

Third Party MA

Both parties submitted that the law on whether the applicant for an SPC could rely on a third party MA was unclear, and that a reference to the CJEU was therefore required, although in the case of Genentech this was argued as an alternative to their primary position that the law was clear and that it could rely on Lilly's MA in its SPC application.

Lilly's main contention was that the object of the SPC Regulation was to compensate research organisations for the time taken to go through the regulatory process of obtaining an MA and for the attendant delay to the marketing of their product. It argued that an organisation which had not applied for an MA and therefore not suffered any such delay did not need to be compensated, and that an SPC therefore could not be granted on the basis of a third party MA.

In support of its contention that SPCs could be granted based on a third party MA, Genentech referred to the 2018 Study on the Legal Aspects of Supplementary Protection Certificates in the EU, from which it appeared that it was the consistent practice of national patent offices to grant SPCs based on third party MAs. It also argued that it was implicit from Biogen v SmithKline Beecham (C-181/95) that an MA may be held by a different and unconnected party – in that case, the CJEU held that where the basic patent and MA were held by different entities, an application for an SPC by the patentee could not be refused solely because it was unable to provide a copy of the MA. Genentech further argued that the SPC Regulation should be interpreted in accordance with Article 3(2) of the Plant Protection SPC Regulation, which it claimed made clear that SPCs could be granted based on third party MAs.

Arnold J concluded that the law on this issue was not clear. While he considered that the policy arguments recognised by the CJEU in previous cases supported Lilly's interpretation, he did not feel that Genentech's arguments could be dismissed lightly, and therefore referred the following question to the CJEU:

Does the SPC Regulation preclude the grant of an SPC to the proprietor of a basic patent in respect of a product which is the subject of a marketing authorisation held by a third party without that party’s consent?

Interestingly Arnold J referred this question despite revoking the basic patent, which would ordinarily render the question of academic interest only. This decision was based on Lilly's arguments that:

  1. If Genentech appealed, there was a real possibility the Court of Appeal would no longer have jurisdiction to make references to the CJEU by the time it handed down its judgment, as the UK was at the time scheduled to exit from the EU on 29 March 2019. It would in any event be possible for the reference to be withdrawn if the circumstances changed.
  2. Genentech had also filed applications for SPCs based on EP '822 and Lilly's MA in other EU Member States. This meant an EU-wide answer to the referred question was required, which only the CJEU could provide.
  3. A question on the third party MA issue had never been referred to the CJEU before. However it was a general issue for the pharmaceutical industry which needed to be resolved sooner rather than later.

Comment

These proceedings have given Arnold J an opportunity to apply the Gilead Article 3(a) test less than six months after he handed down his final judgment in that case. It is noteworthy that he decided, without much debate, that the Gilead test applies to a drug composed of a single active ingredient despite the CJEU in Gilead phrasing its decision in terms of a combination drug.

While Arnold J was clear on how Article 3(a) should be applied, he considered that further guidance from the CJEU was necessary in order to decide whether an applicant for an SPC could rely on a third party MA. It is striking that despite this issue having been considered over 20 years ago in Biogen v SmithKline Beecham, a question on the issue had not been referred to the CJEU until now. Indeed, over 7 years ago, Arnold J himself noted in Novartis v MedImmune that he considered it inevitable that there would be further references to the CJEU. This reference may finally provide a valuable opportunity for the CJEU to provide clarity on whether applicants for SPCs can rely on third party MAs. Of course, this assumes that the CJEU manages to hear the case before it ceases to have jurisdiction over the UK.

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