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You are here: BAILII >> Databases >> England and Wales Court of Appeal (Civil Division) Decisions >> Merck Serono SA v Comptroller-General of Patents, Designs, and Trade Marks (Rev1) [2025] EWCA Civ 45 (28 January 2025) URL: https://www.bailii.org/ew/cases/EWCA/Civ/2025/45.html Cite as: [2025] EWCA Civ 45 |
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ON APPEAL FROM THE HIGH COURT OF JUSTICE
BUSINESS AND PROPERTY COURTS OF ENGLAND AND WALES
INTELLECTUAL PROPERTY LIST (ChD)
PATENTS COURT
Michael Tappin KC (sitting as a Deputy Judge of the High Court)
Strand, London, WC2A 2LL |
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B e f o r e :
LORD JUSTICE ARNOLD
and
LORD JUSTICE BIRSS
____________________
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Appellant |
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- and - |
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The Comptroller-General of Patents, Designs, and Trade Marks |
Respondent |
____________________
Anna Edwards-Stuart KC, Stuart Baran (instructed by Government Legal Department) for the Respondent
Hearing dates: 11 December 2024
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Crown Copyright ©
Lord Justice Birss:
i) There is a lack of cogency and consistency in CJEU case law in relation to Article 3(d).
ii) The teleological reasoning of the CJEU in Neurim was careful and correct and should be followed, otherwise the SPC Regulation "will not have achieved its key objects for large areas of pharmaceutical research: it will not be fit for purpose" [this is a quote from Jacob LJ in Neurim]. This teleological approach is supported by later judicial consideration, including in the UK, and by the position adopted by the UK Government in the Abraxis reference.
iii) The CJEU's reasoning in Santen is regressive, overly literal, restrictive and conveys no practical benefit to the UK IPO or the public at large.
Could this court depart from Santen?
4(1) A relevant court is not bound by any retained EU case law except as provided in paragraph 2.
(2) A relevant court is bound by retained EU case law so far as there is post-transition case law which modifies or applies that retained EU case law and which is binding on the relevant court.
5. In deciding whether to depart from any retained EU case law by virtue of section 6(4)(ba) of the 2018 Act and these Regulations, a relevant court must apply the same test as the Supreme Court would apply in deciding whether to depart from the case law of the Supreme Court.
Turning to the facts of this case and applying the law above, in my judgment the Hearing Officer and the judge were right in their conclusion that the product which this marketing authorisation authorises to be placed on the market as a medicinal product is safinamide. It is not a combination.
Would this court depart from Santen?
Article 1 Definitions
For the purposes of this Regulation, the following definitions shall apply:
(a) 'medicinal product' means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;
(b) 'product' means the active ingredient or combination of active ingredients of a medicinal product;
[…]
Article 3 Conditions for obtaining a certificate
A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application:
(a) the product is protected by a basic patent in force;
(b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate;
(c) the product has not already been the subject of a certificate;
(d) the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product.
Article 4 Subject-matter of protection
Within the limits of the protection conferred by the basic patent, the protection conferred by a certificate shall extend only to the product covered by the authorisation to place the corresponding medicinal product on the market and for any use of the product as a medicinal product that has been authorised before the expiry of the certificate.
[…]
Pharmacia Italia
MIT
Yissum
Neurim
36. As I observed in AstraZeneca AB v Comptroller-General of Patents, Trade Marks and Designs [2012] EWHC 2840 (Pat), [2013] RPC 25 at [52]-[53], the Court's judgment in Neurim (although not the actual decision) is problematic for two reasons:
37. First, it appears that the Court was intending to depart from its decisions in Pharmacia, MIT and Yissum, and in particular the decisions in Pharmacia and Yissum. This is not clear, however, since it did not refer to those decisions. Thus one does not know if those decisions are to be regarded as having been overruled, or as qualified in some unspecified manner.
38. Secondly, it does not appear that the Court was intending to depart from its earlier judgments in Synthon and Generics, since it cited Synthon at [20]. It is not clear to me, however, how Neurim is to be reconciled with those decisions. The reasoning which the Court relied on in Neurim, namely that the research required to obtain a patent and marketing authorisation for a second medical use of an active ingredient justifies the grant of an SPC for the second medical use despite the fact that the same active ingredient has already been lawfully marketed as a medicinal product, seems to me to be equally applicable to Generics and Synthon, albeit that those cases did not concern Article 3(d). As noted above, Advocate General Trstenjak drew attention to this difficulty in her opinion, yet the Court proceeded as if there was no problem.
Santen
Article 3(d) of Regulation (EC) 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 marketing authorisation cannot be considered to be the first marketing authorisation, for the purpose of that provision, where it covers a new therapeutic application of an active ingredient, or of a combination of active ingredients, and that active ingredient or combination has already been the subject of a marketing authorisation for a different therapeutic application.
Merck's
criticisms of Santen
Conclusion
Lord Justice Arnold:
Lord Justice Lewison:
The issue and legal background
"The questions referred are thus based on the premiss, arising from the judgment in Neurim, that it is possible, in certain circumstances that, according to the referring court, are still to be defined, to obtain an SPC for a new therapeutic application of an active ingredient which has already been the subject of an MA prior to the MA on which the application for that SPC is based."
"It follows from the foregoing considerations that Article 1(b) of Regulation No 469/2009 must be interpreted as meaning that the fact that an active ingredient, or a combination of active ingredients, is used for the purposes of a new therapeutic application does not confer on it the status of a distinct product where the same active ingredient, or the same combination of active ingredients, has been used for the purposes of a different, already known, therapeutic application."
"It follows that, contrary to what the Court held in paragraph 27 of the judgment in Neurim, to define the concept of 'first [MA for the product] as a medicinal product' for the purpose of Article 3(d) of Regulation No 469/2009, there is no need to take into account the limits of the protection of the basic patent."
"It follows from the foregoing that the premiss on which the referring court relies, mentioned in paragraph 34 above, must be disregarded and that an MA for a therapeutic application of a product cannot be regarded as the first MA for that product as a medicinal product, for the purpose of Article 3(d) of Regulation No 469/2009, where another MA was granted previously for a different therapeutic application of the same product. The fact that the most recent MA is the first MA to fall within the limits of the protection of the basic patent relied on in support of the SPC application cannot call that interpretation into question."
Departure from previous case law
"(3) Any question as to the validity, meaning or effect of any assimilated law is to be decided, so far as that law is unmodified on or after IP completion day and so far as they are relevant to it—
(a) in accordance with any assimilated case law ... , and
(b) having regard (among other things) to the limits, immediately before IP completion day, of EU competences.
(4) But—
(a) the Supreme Court is not bound by any retained EU case law,
(b) …
(ba) a relevant court or relevant tribunal is not bound by any retained EU case law so far as is provided for by regulations under subsection (5A), and
(c) no court or tribunal is bound by any retained domestic case law that it would not otherwise be bound by.
(5) In deciding whether to depart from any retained EU case law by virtue of subsection (4)(a) or (b), the Supreme Court … must apply the same test as it would apply in deciding whether to depart from its own case law."
"(b) the extent to which, or circumstances in which, a relevant court or relevant tribunal is not to be bound by retained EU case law,
(c) the test which a relevant court or relevant tribunal must apply in deciding whether to depart from any retained EU case law"
"(1) A relevant court is not bound by any retained EU case law except as provided in paragraph (2).
(2) A relevant court is bound by retained EU case law so far as there is post-transition case law which modifies or applies that retained EU case law and which is binding on the relevant court."
"In deciding whether to depart from any retained EU case law by virtue of section 6(4)(ba) of the 2018 Act and these Regulations, a relevant court must apply the same test as the Supreme Court would apply in deciding whether to depart from the case law of the Supreme Court."
Is this court bound by Newron?
"As a general rule the only cases in which decisions should be held to have been given per incuriam are those of decisions given in ignorance or forgetfulness of some inconsistent statutory provision or of some authority binding on the court concerned: so that in such cases some part of the decision or some step in the reasoning on which it is based is found, on that account, to be demonstrably wrong."
"In our judgment, acceptance of the Attorney-General's argument would necessarily involve the proposition that it is open to this court to disregard an earlier decision of its own or of a court of co-ordinate jurisdiction (at least in any case of significance or complexity) whenever it is made to appear that the court had not upon the earlier occasion had the benefit of the best argument that the researches and industry of counsel could provide. Such a proposition would, as it seems to us, open the way to numerous and costly attempts to re-open questions now held to be authoritatively decided."
"I have always understood that the doctrine of per incuriam only applies where another division of this court has reached a decision in the absence of knowledge of a decision binding upon it or a statute, and that in either case it has to be shown that, had the court had this material, it must have reached a contrary decision. That is per incuriam. I do not understand the doctrine to extend to a case where, if different arguments had been placed before it or if different material had been placed before it, it might have reached a different conclusion. That appears to me to be the position at which we have arrived today." (Original emphasis)
"In my view, there is an important distinction in principle between a case in which an argument was not advanced on the earlier occasion and a case in which the legal issue was entirely different: see, by way of example, R (Elias) v Secretary of State for Defence [2006] 1 WLR 3213. In that case, there had been an earlier decision of the Court of Appeal in which a challenge to the very same scheme now under challenge had been rejected: see R (Association of British Civilian Internees: Far East Region) v Secretary of State for Defence [2003] QB 1397. That did not prevent the Court of Appeal from reconsidering the matter (and indeed deciding it in favour of the claimant) because there was an entirely new legal issue and a different ground of challenge advanced in Elias, which had not been raised in the earlier case. In the earlier case, the grounds of challenge were the conventional public law grounds of irrationality and breach of legitimate expectations; whereas, in Elias, the grounds arose under the Race Relations Act 1976. This was not therefore simply a case where different arguments were advanced which had not been made in the earlier case; the legal issues were themselves different." (Original emphasis)
If we were not bound by Newron should we depart from Santen?
"I would not seek to categorise cases in which it should or cases in which it should not be used. As time passes experience will supply some guide. But I would venture the opinion that the typical case for reconsidering an old decision is where some broad issue is involved, and that it should only be in rare cases that we should reconsider questions of construction of statutes or other documents. In very many cases it cannot be said positively that one construction is right and the other wrong. Construction so often depends on weighing one consideration against another. Much may depend on one's approach. If more attention is paid to meticulous examination of the language used in the statute the result may be different from that reached by paying more attention to the apparent object of the statute so as to adopt that meaning of the words under consideration which best accord with it."
" A previous decision on interpretation will not be departed from if it reflects a tenable view. "
"To adapt Lord Bingham's words, the objection to it is not just that the issue in the Esso case should have been resolved differently or the principle formulated differently there. Apart from the fact that even at the time Lord Wilberforce chose not to associate himself with it, the objections to the test are that it has no principled place within the doctrine; that it has been consistently criticised for over 50 years and, although in some quarters loyally applied, the reasoning behind it has, to the best of my knowledge, scarcely been defended; and that the common law has been limping between the continuing authority of the test in our jurisdiction and its rejection in Australia and in parts of Canada."
Result