Order — ECLI:EU:C:2019:687
Date: 2019-09-05
Language of the case: English
Court formation: Ninth Chamber
Subject matter: Intellectual, industrial and commercial property;Approximation of laws
Procedure: Reference for a preliminary ruling - inadmissible
Origin: United Kingdom

Summary of Lilly 's contentions
39. Lilly contends that it is the object of the SPC Regulation to compensate research
organisations for the delay caused by going through the regulatory process to obtain a
marketing authorisation, and the consonant loss of monopoly time in which to market
their product. An undertaking which is not one that has suffered that lost time, because
it is not the one that obtained the marketing authorisation, needs and deserves no such
compensation. Accordingly, Lilly contends that an SPC cannot validly be granted on
the basis of a third party MA. Lilly argues that these contentions are supported by the
statements of the CJEU in Lilly v HGS and Teva CJEU and by the statements of the
national courts in Novartis v MedImmune and Sandoz v Searle quoted above. Lilly
accepts, however, that the point is not acte clair, and therefore a reference to the CJEU
is necessary to determine it.
Summary of Genentech 's contentions
40. Genentech points out that it appears from section 13.3.1.1 of the Study on the Legal
Aspects of Supplementary Protection Certificates in the EU commissioned by the
European Commission from the Max Planck Institute for Innovation and Competition
and published in 2018 that it is the consistent practice of the national offices to grant
SPCs on the basis of third party MAs, although some national offices require the
applicant to provide a copy of the marketing authorisation relied on. In sections 13.2
and 13.9, however, the Max Planck Institute concludes that the question has not been
clearly answered by the case law of the CJEU.
41. Genentech contends that it is implicit in Biogen v SKB that the basic patent and the
marketing authorisation may be held by different and unconnected parties; that LiIly's
contention requires the Court to read into the SPC Regulation words which are simply
not present; and that, in accordance with recital (17) to European Parliament and
Council Regulation 1610/961EC of 23 July 1996 concerning the creation of a
supplementary protection certificate for plant protection products, the SPC Regulation
should be interpreted in accordance with Article 3(2) of Regulation 1610/961EC which,
so Genentech argues, makes it clear that SPCs can be based on third party marketing
authorisations. Article 3(2) of Regulation 1610/96/EC provides:
"The holder of more than one patent for the same product shall not be granted
more than one certificate for that product. However, where two or more
applications concerning the same product and emanating from two or more
holders of different patents are pending, one certificate for this product may be
issued to each of these holders."
42. Genentech contends that the law is acte clair in its favour, but in the alternative argues
that a question should be referred to the CJEU.
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Conclusion
43. In my judgment the law on this issue is not clear. In my opinion the policy arguments
recognised by the cmu in Eli Lilly and Teva CJEU and by the national courts in
Novartis v Medlmmune and Sandoz v Searle support Lilly's interpretation. This
interpretation is also supported by Jens Schovsbo, Ulla Callesen Klinge and Timo
Minssen, "Reap what you sow! But what about SPC squatting?" [2018] JIPLP 569,
although the authors opine that reliance upon a third party MA should be permissible
in some circumstances. The arguments advanced by Genentech cannot lightly be
dismissed, however.
44. Accordingly, I consider that a question should be referred to the Court of Justice along
the following lines:
"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?"
The need for a reference
45. It can be seen from the Patent Judgment that I have concluded that all the claims of the
Patent defended by Genentech are invalid. If that conclusion is correct, then it
necessarily follows that the Application must fail. In those circumstances, it would at
first blush appear that there is no need to refer the question identified above to the cmu
because the answer to the question would be academic.
46. Anticipating that outcome, counsel for Lilly submitted that a reference would
nevertheless be necessary for the following reasons.
47. First, he pointed out that it was likely that Genentech would attempt to appeal against
any such conclusion. If Genentech were granted permission to appeal and were
successful in that appeal, then the answer to the question would cease to be academic.
As he pointed out, however, as matters currently stand, there is a very real possibility
that the courts of the UK will lose their jurisdiction to make references to the CJEU on
29 March 2019. Since any judgment of the Court of Appeal would necessarily be given
some time after that, it could well be the case that, whereas this Court currently has
jurisdiction to make a reference, the Court of Appeal would not have jurisdiction to do
so. In those exceptional circumstances, this Court should make a reference now. As he
pointed out, it would be possible for the reference to be withdrawn later if circumstances
changed.
48. Secondly, he submitted that, in any event, it would not be correct to say that a judgment
that the Patent was invalid rendered the third party MA question academic. He pointed
out that what LilIy sought in the present action was a declaration that an SPC based on
the Application would not be valid. He argued that a declaration that an SPC based on
the Application would not be valid because of the third party MA point would still serve
a useful purpose even if the Patent was invalid. The reason for this was that the dispute
between LiIly and Genentech was not confined to the UK. Genentech had filed parallel
applications for SPCs based on the Patent and the Taltz MA in other EU Member States.
Accordingly, an Elf-wide answer to the question was required, which only the CJEU
could provide.
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49. Thirdly, he pointed out that this issue had arisen in previous cases, as discussed above,
but for varying reasons no question had been referred to the CJEU. Moreover, it was
one which had been discussed by commentators. Accordingly, he submitted that it was
an issue for the pharmaceutical industry generally which should be resolved sooner
rather than later. Only the CJEU could provide a definitive resolution.
50. I accept these arguments, and in particular the first one. Accordingly, I conclude that,
in the current exceptional circumstances, it is necessary to refer the question to the
Court of Justice even though I have concluded that the Patent is invalid.
Conclusion
51. For the reasons given above, I shall refer a question to the eJEU along the lines set out
in paragraph 44 above. 1will hear counsel as to the precise wording of the question.
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