[Home] [Databases] [World Law] [Multidatabase Search] [Help] [Feedback] | ||
England and Wales High Court (Patents Court) Decisions |
||
You are here: BAILII >> Databases >> England and Wales High Court (Patents Court) Decisions >> Teva UK Ltd & Ors v Gilead Sciences Inc [2018] EWHC 2416 (Pat) (18 September 2018) URL: http://www.bailii.org/ew/cases/EWHC/Patents/2018/2416.html Cite as: [2018] EWHC 2416 (Pat), [2019] RPC 4 |
[New search] [Context] [View without highlighting] [Printable RTF version] [Help]
BUSINESS AND PROPERTY COURTS
INTELLECTUAL PROPERTY LIST (CHANCERY DIVISION)
PATENTS COURT
Fetter Lane, London EC4A 1NL |
||
B e f o r e :
____________________
TEVA UK LIMITED ACCORD HEALTHCARE LIMITED LUPIN LIMITED and LUPIN EUROPE LIMITED GENERICS (UK) LIMITED trading as MYLAN |
Claimants |
|
- and - |
||
GILEAD SCIENCES INC |
Defendant |
____________________
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
Thomas Mitcheson QC and James Whyte (instructed by Simmons & Simmons LLP) for Gilead
Hearing date: 12 September 2018
____________________
Crown Copyright ©
MR JUSTICE ARNOLD :
Introduction
"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 judgment of the CJEU
"36. In this respect, the Court has held that Article 3(a) of Regulation No 469/2009 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).
37. Therefore, a product cannot be considered to be protected by a basic patent in force within the meaning of Article 3(a) of Regulation No 469/2009 unless the product which is the subject of the SPC is either expressly mentioned in the claims of that patent or those claims relate to that product necessarily and specifically."
"39. That requirement is in line with the objective of the SPC, which is 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. As indicated in recital 4 of 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 (see, to that effect, judgment of 12 December 2013, Eli Lilly and Company, C-493/12, EU:C:2013:835, paragraphs 41 and 42 and the case-law cited).
40. 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 Regulation No 469/2009, 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.
41. In the light of the need, referred to inter alia in recital 10 of the preamble to Regulation No 469/2009, 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).
42. It must be added that, in view of the interests referred to in recitals 4, 5, 9 and 10 of Directive 469/2009, it cannot be accepted that the holder of a basic patent in force may obtain an SPC each time he places on the market in a Member State a medicinal product containing, on the one hand, an active ingredient, protected as such by the holder's basic patent and constituting the subject matter of the invention covered by that patent, and, on the other, another substance which does not constitute the subject matter of the invention covered by the basic patent (see, to that effect, judgment of 12 March 2015, Actavis Group PTC and Actavis UK, C-577/13, EU:C:2015:165, paragraph 37 and the case-law cited)."
"… having regard to the objectives pursued by Regulation No 469/2009, 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."
"47. With regard to the implementation of that rule, it must in the first place be stated that, in accordance with a principle shared by the patent laws of the Member States and reflected in Article 1 of the Protocol on the Interpretation of Article 69 of the EPC, the claims of a patent are to be interpreted from the perspective of a person skilled in the art and, therefore, 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."
"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."
"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 Regulation No 469/2009 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."
Gilead's application
The Claimants' applications