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England and Wales High Court (Patents Court) Decisions |
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You are here: BAILII >> Databases >> England and Wales High Court (Patents Court) Decisions >> Eli Lilly And Company v Genentech, Inc [2019] EWHC 388 (Pat) (01 March 2019) URL: http://www.bailii.org/ew/cases/EWHC/Patents/2019/388.html Cite as: [2019] EWHC 388 (Pat) |
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Neutral Citation Number: [2019] EWHC 388 (Pat)
Case No: HP-2017-000044
IN THE HIGH COURT OF JUSTICE
BUSINESS AND PROPERTY COURTS
INTELLECTUAL PROPERTY LIST (CHANCERY DIVISION)
PATENTS COURT
Rolls Building
Fetter Lane, London, EC4A 1NL
Date: 1 March 2019
Before :
MR JUSTICE ARNOLD
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Between :
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ELI LILLY AND COMPANY |
Claimant |
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- and - |
|
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GENENTECH, INC |
Defendant |
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Andrew Waugh QC , Thomas Mitcheson QC and Stuart Baran (instructed by Allen & Overy LLP ) for the Claimant
Michael Tappin QC , Justin Turner QC, Mark Chacksfield and William Duncan (instructed by Marks & Clerk Solicitors LLP ) for the Defendant
Hearing dates: 16-19, 21-25, 30-31 January, 1 February 2019
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Approved Judgment
I direct that pursuant to CPR PD 39A para 6.1 no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.
.............................
MR JUSTICE ARNOLD
MR JUSTICE ARNOLD :
Introduction
Technical background
The Patent
“1. An isolated antibody which specifically binds to an isolated IL-17A/F heterodimeric complex and which inhibits the activity of the IL-17A/F heterodimeric complex to induce production of IL-8 and IL-6, wherein the isolated IL-17A/F heterodimeric complex consists of SEQ ID NO:3 and SEQ ID NO:4, without their associated signal peptides, and further comprises two interchain disulphide linkages between SEQ ID NO:3 and SEQ ID NO:4; and wherein the antibody is human or humanized.
12. Use of an antagonist anti-IL-17A/F antibody as defined in Claim 1 or 2 in the preparation of a medicament for the treatment of rheumatoid arthritis or psoriasis.”
The common general knowledge of the skilled team
The development of ixekizumab
Ixekizumab
The SPC Regulation
13. The SPC Regulation includes the following recitals:
“(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.
…
(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 establishment and the functioning of the internal market.
(8) Therefore, the creation 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.
(9) The duration of the protection granted by the certificate should be such as to provide adequate effective protection. For this purpose, the holder of both a patent and a certificate should be able to enjoy an overall maximum of 15 years of exclusivity from the time the medicinal product in question first obtains authorisation to be placed on the market in the Community.
(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. For this purpose, the certificate cannot be granted for a period exceeding five years. The protection granted should furthermore be strictly confined to the product which obtained authorisation to be placed on the market as a medicinal product”
14. Articles 1, 2, 3 and 4 of the SPC Regulation provide, so far as relevant:
“ 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;
(c) ‘basic patent’ means a patent which protects a product as defined in (b) 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 2
Scope
Any product protected by a patent in the territory of a Member State and subject, prior to being placed on the market as a medicinal product, to an administrative authorisation procedure as laid down in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use or Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products may, under the terms and conditions provided for in this Regulation, be the subject 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;
…
(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.”
Interpretation of the SPC Regulation
“Next, the Court observes that the second sentence of Article 3(2) of Regulation No 1610/96 must be interpreted not solely on the basis of its wording, but also in the light of the overall scheme and objectives of the system of which it is a part (see, by analogy, Case C-292/00 Davidoff [2003] ECR I-389, paragraph 24).”
16. As is also common ground, the SPC Regulation pursues a number of different objectives and aims to strike a balance between them. This was well described by Advocate General Trstenjak in her opinion in Case C-130/11 Neurim Pharmaceuticals (1991) Ltd v Comptroller-General of Patents [EU:C:2012:268], [2013] RPC 23:
“41. Those rules are intended to achieve a balance between the various interests at stake in the pharmaceutical sector. Those interests include, on the one hand, the interests of the undertakings and institutions, some of which pursue very cost-intensive research in the pharmaceutical sector and therefore favour an extension of the term of protection for their inventions in order to be able to balance out the investment costs. On the other hand, there are the interests of the producers of generic medicines who, as a consequence of the extension of the term of protection of the active ingredients under patent protection, are precluded from producing and marketing generic medicines. It is also relevant in this connection that, in general, the marketing of generic medicinal products has the effect of lowering the prices of the relevant medicinal products. Against that background, the interests of patients lie between the interests of the undertakings and institutions conducting research and those of the producers of generic medicines. That is because patients have an interest, on the one hand, in the development of new active ingredients for medicinal products, but, on the other, they also have an interest in those products then being offered for sale as cheaply as possible. The same applies to State health systems in general which, in addition, have a particular interest in preventing old active ingredients from being brought onto the market in slightly modified form under the protection of certificates but without genuine innovation and thereby artificially driving up expenditure in the health section.
42. Against the background of that complex situation as regards interests, Regulation 1768/92 sought to achieve a balanced solution taking due account of the interests of all parties. In view of the complexity of that balance of interests, it is necessary to proceed with great caution when making a teleological interpretation of the individual provisions of the regulation.”
Article 3(a)
The law
17. I reviewed the case law of the CJEU interpreting Article 3(a) in my judgment in Teva UK Ltd v Gilead Sciences Inc [2017] EWHC 13 (Pat) (“ Teva I ”). As a result, I referred a question to the CJEU asking “What are the criteria for deciding whether ‘the product is protected by a basic patent in force’ in Article 3(a)?”.
18. The Grand Chamber of the CJEU gave its answer to that question in Case C-121/17 Teva UK Ltd v Gilead Sciences Inc [EU:C:2018:585] (“ Teva CJEU ”). The CJEU ruled that Article 3(a) was to 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 . ”
19. I considered and applied that guidance in Teva UK Ltd v Gilead Sciences Inc (No 2) [2018] EWHC 2416 (Pat) (“ Teva II ”).
21. The guidance given in Teva CJEU is specifically addressed to products which are combinations of active ingredients. As I noted in Teva II at [34], however, it represents an elaboration and elucidation of the test which the CJEU propounded in Case C-493/12 Eli Lilly & Co Ltd v Human Genome Sciences Inc [EU:C:2013:835], [2014] RPC 21. That case was concerned with a single active ingredient. Moreover, as explained in Teva I at [72]-[75], it was a case concerned with a claim to an antibody defined in functional terms.
Assessment
Third party MA
Previous case law
30. In Case C-181/95 Biogen Inc v SmithKline Beecham Biologicals SA [1997] ECR I-386 Biogen was the proprietor of two European patents for DNA sequences and intermediaries used in the production of antigens to the hepatitis-B virus. Two French Institutes owned a number of Belgian and European patents in the same field. SKB marketed a vaccine against hepatitis-B called Engerix-B the active ingredient of which was HBsAG. SKB was licensed by Biogen and the French Institutes under their respective patents. SKB held four Belgian marketing authorisations for Engerix-B. Biogen and the French institutes applied for SPCs. SKB refused to supply a copy of the marketing authorisation to Biogen, but did supply copies to the French institutes. The Belgian Ministry of Public Health refused to supply copies to Biogen without SKB’s consent. Biogen brought proceedings against SKB before the Tribunal de Commerce (Commercial Court), Nivelles, contending that SKB had discriminated against it. The Commercial Court referred four questions to the Court of Justice concerning the interpretation of Regulation 1768/92/EEC, the predecessor to the SPC Regulation. The first, third and fourth questions concerned the obligations, if any, of the holder of a marketing authorisation and of the relevant administrative authority to supply a copy of the marketing authorisation to the proprietor of a basic patent. The second question was whether the Regulation precluded the grant of an SPC to each holder of a basic patent where the same product was covered by several basic patents owned by different parties.
31. Advocate General Fennelly observed in his Opinion at [43]:
“The Regulation is silent on the relationship between the holder of a basic patent and the holder of a related marketing authorization for the Member State in question, due again, I imagine, to the implicit assumption on the part of the draughtsman that they would be concentrated in the hands of a single undertaking.”
“… there is nothing to support the defendant's contention that the Regulation was designed primarily to reward the expense and effort involved in developing marketable medicinal products, rather than pharmaceutical research in general, the results of much of which may require further development before marketing. While it is essential under the scheme of the Regulation that research ultimately results in a marketable medicinal product, the recitals in the preamble to the Regulation (such as the first, second and fourth) speak of pharmaceutical research in general, while Article 1(c) of the Regulation suggests that any patent, including one based on the most elementary research, may be designated as a basic patent for the purposes of applying for a certificate.”
34. In Novartis Pharmaceuticals UK Ltd v MedImmune Ltd [2012] EWHC 181 (Pat), [2012] FSR 23 I said at [61]:
“As noted above, in the present case the SPC is based upon a product obtained by means of an allegedly infringing process and upon a marketing authorisation obtained by an alleged infringer of the Patent. It might be thought that it was not the purpose of the Regulation to enable a patent owner to obtain an SPC in such circumstances, since the owner has not been delayed in getting the product to market by the need to get a marketing authorisation, and therefore no extension to the term of the patent is needed to compensate him for that delay. Counsel for MedImmune accepted that it was not clear from the judgment of the Court of Justice in Case C-181/95 Biogen Inc v. SmithKline Biologicals SA [1997] ECR I-386 that this was permissible. Nevertheless, counsel for Novartis made it clear that Novartis was not taking this point.”
36. In its judgment the CJEU stated:
“41. Moreover, it should be recalled that the SPC is designed simply to re‑establish a sufficient period of effective protection of the basic patent by permitting the holder to enjoy an additional period of exclusivity on the expiry of that patent, which is intended to compensate, at least in part, for the delay to the commercial exploitation of his invention by reason of the time which has elapsed between the date on which the application for the patent was filed and the date on which the first MA in the European Union was granted …”
43. As stated in recital 4 in the preamble to Regulation No 469/2009, the purpose of that additional period of exclusivity is to encourage research and, to that end, it is designed to ensure that the investments put into such research are covered.
43. In the light of the objective of Regulation No 469/2009, the refusal of an SPC application for an active ingredient which is not specifically referred to by a patent issued by the EPO relied on in support of such an application may be justified – in circumstances such as those in the main proceedings and as observed by Eli Lilly – where the holder of the patent in question has failed to take any steps to carry out more in-depth research and identify his invention specifically, making it possible to ascertain clearly the active ingredient which may be commercially exploited in a medicinal product corresponding to the needs of certain patients. In such a situation, if an SPC were granted to the patent holder, even though – since he was not the holder of the MA granted for the medicinal product developed from the specifications of the source patent – that patent holder had not made any investment in research relating to that aspect of his original invention, that would undermine the objective of Regulation No 469/2009, as referred to in recital 4 in the preamble thereto. ”
37. In Teva CJEU the Court of Justice stated:
“49 . In the second place, having regard to the objective of Regulation No 469/2009, 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.
50 . Were it to be accepted that such an assessment could be made taking into account results from research which took place after the filing date or priority date of the basic patent, an SPC could enable its holder unduly to enjoy protection for those results even though they were not yet known at the priority date or filing date of that patent, what is more outside any procedure for the grant of a new patent. That would, as pointed out in paragraphs 40 and 41 above, run counter to the objective of Regulation No 469/2009.
51 . Therefore, for the purposes of determining whether a product which is the subject of an SPC is protected by a basic patent, within the meaning of Article 3(a) of that regulation, that product must be identifiable specifically by a person skilled in the art in the light of all the information disclosed by the basic patent and of the prior art at the filing date or priority date of that patent.
38. In Sandoz Ltd v GD Searle LLC [2018] EWCA Civ 49 Floyd LJ (with whom Kitchin LJ and Lewison LJ agreed) said at [105]:
“Such help as the judgment in Eli Lilly gives as to what underlies the specificity requirement is to be found, not in its core reasoning, but in paragraph [43] of the judgment. That paragraph appears to be one designed to give the national court assistance in arriving at its judgment in the main proceedings. It is true that that paragraph is in the context, additionally, of an application for a SPC based on a third party’s marketing authorisation. But the first part of the paragraph seems to me to indicate, albeit without great clarity, that the court considers that at least one way of preventing or hindering the marketing authorisations of third parties from being used as the basis for SPCs is to insist on a high degree of specificity in the basic patent. That might help to prevent a patentee spreading the net in his patent claims widely and unspecifically, and subsequently fastening on a competitor’s successfully marketed drug to obtain an extended term which he has not earned. That is a consideration which does not only arise in the context of functional claims …”
Summary of Lilly’s contentions
Summary of Genentech’s contentions
“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.”
Conclusion
“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
Conclusion