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You are here: BAILII >> Databases >> England and Wales Court of Appeal (Civil Division) Decisions >> Teva UK Ltd & Ors v Gilead Sciences, Inc [2019] EWCA Civ 2272 (19 December 2019) URL: https://www.bailii.org/ew/cases/EWCA/Civ/2019/2272.html Cite as: [2020] RPC 5, [2019] EWCA Civ 2272 |
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ON APPEAL FROM THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Mr Justice Arnold
Strand, London, WC2A 2LL |
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B e f o r e :
LORD JUSTICE FLOYD
and
LORD JUSTICE DINGEMANS
____________________
TEVA UK LIMITED ACCORD HEALTHCARE LIMITED LUPIN LIMITED LUPIN (EUROPE) LIMITED GENERICS (UK) LIMITED (TRADING AS MYLAN) |
Respondents/Claimants |
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- and - |
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GILEAD SCIENCES, INC. |
Appellant/ Defendant |
____________________
Daniel Alexander QC and Lindsay Lane QC (instructed by Pinsent Masons LLP) for Teva
Daniel Alexander QC and Kathryn Pickard (instructed by Taylor Wessing LLP) for Accord
Daniel Alexander QC and Joe Delaney (instructed by Taylor Wessing LLP) for Mylan
Daniel Alexander QC and Jaani Riordan (instructed by Mishcon de Reya LLP) for Lupin
Hearing date: 10 December 2019
____________________
Crown Copyright ©
Lord Justice Floyd:
Introduction
The procedural history
"What are the criteria for deciding whether the 'product is protected by a basic patent in force' in Article 3(a) of the SPC Regulation?"
The patent
"8. The Patent was applied for on 25 July 1997 with a claimed priority date of 26 July 1996 and granted on 14 May 2003. It is entitled "Nucleotide analogs". The specification states at [0001] that the invention relates to "intermediates for phosphonomethoxy nucleotide analogs, in particular intermediates suitable for use in the efficient oral delivery of such analogs."
9. In the "Summary of the Invention" at [0003]–[0006], the specification states that the invention provides compounds in accordance with two Markush formulae, formula (1a) and formula (1), and methods for preparing such compounds.
10. In the "Detailed Description of the Invention", the specification first defines the substituents in the two Markush formulae and then gives exemplary embodiments of the claimed compounds at [0007]-[0036]. At [0037] the specification discusses the chemical stability of the claimed compounds. The specification goes on to describe synthetic methods for the preparation of the claimed compounds at [0038]–[0043].
11. The specification then describes the utilities of the claimed compounds at [0044] and [0045]. In the first of these paragraphs it states:
"The compounds of this invention are useful in the treatment or prophylaxis of one or more viral infections in man or animals, including infections caused by DNA viruses, RNA viruses, herpesviruses (CMV, HSV 1, HSV 2, VZV, and the like), retroviruses, hepadnaviruses, (e.g. HBV), papillomavirus, hantavirus, adenoviruses and HIV. Other infections to be treated with the compounds herein include MSV, RSV, SIV, FIV, MuLV, and other retroviral infections of rodents and other animals…"
It can be seen from this that the Patent is directed to the treatment of viral infections generally, not just HIV, and to viral infections in both man and animals.
12. Next, the specification describes a wide range of potential pharmaceutical formulations of the claimed compounds at [0046]-[0065]. The description is very bland and general, rather than being specific to the particular compounds or the particular utilities of those compounds. Counsel for the Claimants aptly described this passage as "boilerplate". The range of potential formulations extends to (for example) formulations suitable for topical administration to the eye ([0056]) and veterinary compositions ([0063]).
13. Importantly for present purposes, the specification states at [0047]:
"While it is possible for the active ingredients to be administered as pure compounds it is preferable to present them as pharmaceutical formulations. The formulations of the present invention comprise at least one active ingredient, as above defined, together with one or more acceptable carriers and optionally other therapeutic ingredients. The carrier(s) must be 'acceptable' in the sense of being compatible with the other ingredients of the formulation and not deleterious to the patient."
This is the only reference in the specification to the inclusion of "other therapeutic ingredients". The phrase "other therapeutic ingredients" is not defined or explained in the Patent in any way.
14. The specification goes on at [0068]-[0117] to describe various examples of the invention. Example 16, which is entitled "Antiviral Activity of PMPA and PMPA Carbonates in Tissue Culture", gives data showing antiviral activity of seven compounds in vitro against HIV-1. There is no example involving one of the claimed compounds in combination with any other therapeutic ingredient.
15. It is common ground that emtricitabine is not mentioned or referred to in the Patent."
"A pharmaceutical composition comprising a compound according to any one of claims 1-25 together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients."
Therapeutic agents for the treatment of HIV at the priority date
"There is no evidence that it was known in July 1996 that emtricitabine was an effective agent for the treatment of HIV in humans, still less that this was common general knowledge to the person skilled in the art to whom the Patent is addressed. The European Medicines Agency first approved emtricitabine in October 2003, over seven years later."
The SPC Regulation
"[3] Medicinal products, especially those that are the result of long, costly research will not continue to be developed in the Community and in Europe unless they are covered by favourable rules that provide for sufficient protection to encourage such research.
[4] At the moment, the period that elapses between the filing of an application for a patent for a new medicinal product and authorisation to place the medicinal product on the market makes the period of effective protection under the patent insufficient to cover the investment put into the research.
[5] This situation leads to a lack of protection which penalises pharmaceutical research.
[6] There exists a risk of research centres situated in the Member States relocating to countries that offer greater protection.
[7] A uniform solution at Community level should be provided for, thereby preventing the heterogeneous development of national laws leading to further disparities which would be likely to create obstacles to the free movement of medicinal products within the Community and thus directly affect the functioning of the internal market.
[8] Therefore, the provision of a supplementary protection certificate granted, under the same conditions, by each of the Member States at the request of the holder of a national or European patent relating to a medicinal product for which marketing authorisation has been granted is necessary. A regulation is therefore the most appropriate legal instrument.
…
[10] All the interests at stake, including those of public health, in a sector as complex and sensitive as the pharmaceutical sector should nevertheless be taken into account. …"
"Article 1
Definitions
For the purpose 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;
(c) 'basic patent' means a patent which protects a product as such, a process to obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for grant of a certificate;
…
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.
Article 5
Effects of the certificate
Subject to the provisions of Article 4, the certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations."
Domestic law on the extent of protection afforded by a patent
"(1) For the purposes of this Act an invention for a patent for which an application has been made or for which a patent has been granted shall, unless the context otherwise requires, be taken to be that specified in a claim of the specification of the application or patent, as the case may be, as interpreted by the description and any drawings contained in that specification, and the extent of the protection conferred by a patent or application for a patent shall be determined accordingly.
…
(3) The Protocol on the Interpretation of Article 69 of the European Patent Convention (which Article contains a provision corresponding to subsection (1) above) shall, as for the time being in force, apply for the purposes of subsection (1) above as it applies for the purposes of that Article."
The CJEU case law on Article 3(a)
"According to which criteria is it to be determined whether the product is protected by a basic patent within the meaning of Article 3(a)…"
"precludes the grant of a SPC relating to active ingredients which are not specified in the wording of the claims of the basic patent".
"i) The rules for determining whether the product is protected are those relating to the extent of the invention (in the case of a European patent, those defined by Article 69 and the Protocol): [32].
ii) Recourse may not be had to the rules relating to infringement, such as those in section 60 of the Patents Act 1977: [33].
iii) The fact that the product infringes is not, therefore, "a crucial" factor: [37].
iv) The claims have a key role for the purpose of determining whether a product is protected by a basic patent within the meaning of Article 3(a): [34].
v) An active ingredient which is not identified in the claims by any means (i.e. either a structural or functional definition) is not protected: [38].
vi) It is not necessary for the active ingredient to be identified in the claims of the patent by a structural formula: a "functional formula" will do as well: [39], but:
vii) It must be possible to reach the conclusion on the basis of the claims, interpreted inter alia in the light of the description of the invention, that the claims relate, implicitly but necessarily and specifically, to the active ingredient in question: [39], [44].
viii) It is for the national court to determine the application of this test: [40], [44]."
The First Judgment
The Opinion of Advocate General Wathelet
"… that a product is protected by a basic patent in force, in accordance with Article 3(a) of [the SPC Regulation] if the product falls within the scope of protection of a claim of the basic patent in force, as determined in accordance with Article 69 of the EPC or national legislation derived from that article. Gilead submits that there is no further or other additional requirement under EU law."
"Nevertheless, merely because a substance might fall within the protection of the claims of a patent under Article 69 of the EPC and the Protocol on its interpretation and the provisions of relevant national law, such as [section] 125 of the Patents Act 1977, does not necessarily imply that that substance is a product protected by a patent within the meaning of Article 3(a) of [the SPC Regulation]."
"81. …a product is protected by a patent within the meaning of Article 3(a) … if, on the priority date of the patent, it would have been obvious to a person skilled in the art that the active ingredient in question was specifically and precisely identifiable in the wording of the patent claims. In the case of a combination of active ingredients, each active ingredient must be specifically, precisely and individually identifiable in the wording of the patent claims.
82. The name of the active ingredient does not need to be referred to expressly in the claims, provided that the active ingredient is specifically and precisely identifiable as at the priority date of the patent."
"87. To my mind, and subject to verification by the referring court, as the active ingredient emtricitabine is claimed solely through the use of completely indeterminate expressions such as 'comprising' and 'optionally other therapeutic ingredients', terms which may cover multiple substances that are not specifically and precisely identifiable on the priority date of the patent, the combination containing the active ingredients TD and emtricitabine, that is to say, the medicinal product marketed under the name Truvada, is not protected by the basic patent within the meaning of Article 3(a) of Regulation No 469/2009, even though that combination may fall within the protection of claim 27 of the patent at issue in the main proceedings under Article 69 of the EPC and the Protocol on its interpretation and section 125 of the Patents Act 1977.
88. It would appear, subject once again to verification by the referring court, that, on 26 July 1996, the claimed priority date of the patent at issue in the main proceedings, it would not have been obvious to a person skilled in the art that the active ingredient emtricitabine was specifically and precisely identifiable in the wording of the claims of that patent."
The judgment of the Court of Justice
" … does not, in principle, preclude an active ingredient which is given a functional definition in the claims of a basic patent issued by the EPO being regarded as protected by the patent, on condition that it is possible, on the basis of those claims as interpreted inter alia in the light of the description of the invention, as required under Article 69 of the EPC and Protocol on the Interpretation of that provision, to conclude that the claims relate implicitly but necessarily and specifically to the active ingredient in question (see judgment of 12 December 2013, Eli Lilly and Company, C-493/12, EU:C:2013:835, paragraph 39)." (emphasis supplied).
"38. For that purpose, in accordance with the case-law cited in paragraph 36 above, the description and drawings of the basic patent must be taken into account, as stipulated in Article 69 of the EPC read in the light of the Protocol on the Interpretation of that provision, where that material shows whether the claims of the basic patent relate to the product which is the subject of the SPC and whether that product in fact falls under the invention covered by that patent."
"However, it is not the purpose of the SPC to extend the protection conferred by that patent beyond the invention which the patent covers. It would be contrary to the objective of [the SPC Regulation], reiterated in the preceding paragraph, to grant an SPC for a product which does not fall under the invention covered by the basic patent, inasmuch as such an SPC would not relate to the results of the research claimed under that patent" (emphasis supplied).
"In the light of the need, referred to inter alia in recital 10 of the preamble to [the SPC Regulation], to take into account all the interests at stake, including those of public health, to accept that an SPC could grant to the holder of the basic patent protection which goes beyond the protection guaranteed by that patent in connection with the invention it covers would be contrary to the requirement to balance the interests of the pharmaceutical industry and those of public health as regards the encouragement of research within the European Union by the use of SPCs (see, by analogy, judgment of 12 March 2015, Actavis Group PTC and Actavis UK, C-577/13, EU:C:2015:165, paragraph 36 and the case-law cited)." (emphasis supplied).
"36. In the light of the need, referred to, inter alia, in recital 10 in the preamble to [the SPC Regulation], to take into account all the interests at stake, including those of public health, if it were accepted that all subsequent marketing of an active ingredient in conjunction with an unlimited number of other active ingredients which do not constitute the subject-matter of the invention covered by the basic patent would confer entitlement to multiple SPCs, that would be contrary to the requirement to balance the interests of the pharmaceutical industry and those of public health as regards the encouragement of research within the European Union by the use of SPCs (see, to that effect, judgment in Actavis Group PTC and Actavis UK, EU:C:2013:833, paragraph 41)." (emphasis supplied).
"Accordingly, having regard to the objectives pursued by [the SPC Regulation], the claims cannot allow the holder of the basic patent to enjoy, by obtaining an SPC, protection which goes beyond that granted for the invention covered by that patent. Thus for the purposes of the application of Article 3(a) of that regulation, the claims of the basic patent must be construed in the light of the limits of that invention, as it appears from the description and the drawings of that patent."
"It follows from the above that the subject matter of the protection conferred by an SPC must be restricted to the technical specifications of the invention covered by the basic patent, such as claimed in that patent."
"… the issue whether the product which is the subject of the SPC necessarily falls under the invention covered by that patent must be assessed from that perspective.
48. To that end, it is necessary to ascertain whether a person skilled in the art can understand without any doubt, on the basis of their general knowledge and in the light of the description and drawings of the invention in the basic patent, that the product to which the claims of the basic patent relate is a specification required for the solution of the technical problem disclosed by that patent."
"In the second place, having regard to the objective of [the SPC Regulation], recalled in paragraph 39 above, for the purposes of assessing whether a product falls under the invention covered by a basic patent, account must be taken exclusively of the prior art at the filing date or priority date of that patent, such that the product must be specifically identifiable by a person skilled in the art in the light of all the information disclosed by that patent."
"Having regard to all the foregoing considerations, a product is 'protected by a basic patent in force' within the meaning of Article 3(a) of [the SPC Regulation] in so far as, if that product is not expressly mentioned in the claims of the basic patent, one of those claims relates to it necessarily and specifically. For that purpose, that product must, from the point of view of a person skilled in the art and in the light of the description and drawings of the basic patent, necessarily fall under the invention covered by that patent. The person skilled in the art must be able to identify that product specifically in the light of all the information disclosed by that patent, on the basis of the prior art at the filing date or priority date of the patent concerned."
"54. Thus, as regards the issue whether a claim such as claim 27 of the basic patent in fact covers a combination such as the TD/emtricitabine combination which is the subject of the SPC at issue, it falls to the referring court to determine whether the general expression 'other therapeutic ingredients', associated with the term 'optionally', satisfies the requirement that the claims of the basic patent must relate necessarily and specifically to the product.
55. In particular, it is for the referring court to ascertain, in accordance with the considerations in paragraphs 47 to 51 above, whether, from the point of view of a person skilled in the art, the combination of active ingredients of which the product which is the subject of the SPC at issue consists necessarily falls under the invention covered by that patent, and whether each of those active ingredients is specifically identifiable on the basis of the prior art at the filing date or priority date of that patent.
56. In the present case it is apparent, first, from the information in the order for reference that the description of the basic patent at issue contains no information as to the possibility that the invention covered by that patent could relate specifically to a combined effect of TD and emtricitabine for the purposes of the treatment of HIV. Consequently, it does not seem possible that a person skilled in the art, on the basis of the prior art at the filing date or priority date of that patent, would be able to understand how emtricitabine, in combination with TD, necessarily falls under the invention covered by that patent. The onus is nevertheless on the referring court to check whether such is indeed the case. Secondly, it is also for that court to establish whether emtricitabine is specifically identifiable by that person skilled in the art in the light of all the information contained in that patent, on the basis of the prior art at the filing date or priority date of the patent in question."
"Article 3(a) of [the SPC Regulation] must be interpreted as meaning that a product composed of several active ingredients with a combined effect is 'protected by a basic patent in force' within the meaning of that provision where, even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination. For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent:
- the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and
- each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent."
The Second Judgment
"In a nutshell, what the Court is saying is that the purpose of the SPC Regulation is to enable the holder of the basic patent to obtain supplementary protection for what the patentee actually invented and not for what the patentee did not invent."
"Taken in isolation, it is unclear what the Court means by "the technical specifications of the invention covered by the basic patent". The Court is using terminology derived from patent law, but not in accordance with its meaning in that field."
"Counsel for Gilead submitted that this test was a pure extent of protection test. I do not accept that submission. The Court is clearly saying that more is required than that the product should fall within the scope of the claim: the skilled person must understand that the product is "a specification required for the solution of the technical problem". Again, this is not as pellucid as one would hope, because the Court is again using terminology derived from patent law inaccurately. Nevertheless, the sense is tolerably clear: the product must be one that the skilled person would understand, on the basis of the description and drawings and their common general knowledge, as embodying the technical contribution made by the patent. This is confirmed by what the Court says later in the judgment at [56]." (emphasis added).
"Thus the product must be specifically identifiable by the person skilled in the art in the light of the description and drawings and the prior art, which must mean their common general knowledge, as at the filing date or priority date of the patent, and not merely in the light of information which becomes available later."
"As the Court of Justice rightly says at [56], the Patent says nothing about the possibility that TD and emtricitabine may be combined to treat HIV. Indeed, it does not even mention emtricitabine. All it says at [0047] is that the claimed compounds may be administered as pharmaceutical formulations with optionally other therapeutic ingredients. Accordingly, as the Court rightly indicates, there is no basis for the skilled person to understand that the combination embodies the technical contribution of the patent. TD embodies the technical contribution of the Patent, but that is a different matter."
"In my view it is clear that emtricitabine is not specifically identifiable. Once again, it is not mentioned in the Patent. It is not even a member of a specific class of compounds mentioned in the Patent, whether by reference to their structure or activity, as being suitable for combination with the compounds of the invention. Furthermore, although emtricitabine was known at the priority date, there is no evidence that it was known that emtricitabine was an effective agent for the treatment of HIV in humans, still less that this was common general knowledge to the person skilled in the art to whom the Patent is addressed."
The Advocate General in Sandoz v Searle
"…the 'core inventive advance' of the patent does not apply and is of no relevance in the context of Article 3(a)."
"It follows that if, from the point of view of the person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent, the claims in a patent in relation to a product are not required for the solution of the technical problem disclosed by a patent, the first part of the test in that judgment is not satisfied…"
"requires that it be established that 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 is not the case where, in the light of all the information contained in a patent, a product or constituent element of the product remains unknown to a person skilled in the art on the basis of the prior art at the filing date or the priority date."
The appeal
Discussion
Lord Justice Dingemans:
Lord Justice Lewison: