Teva UK Ltd & Ors v Gilead Sciences Inc

In these proceedings the Claimants challenge the validity of the Defendant’s (“Gilead’s”) supplementary protection certificate SPC/GB05/041 (“the SPC”) for a product described in the SPC as “Composition containing both Tenofovir disoproxil, optionally in the form of a pharmaceutically acceptable salt, hydrate, tautomer or solvate, together with Emtricitabine”. The SPC covers a product which is marketed by Gilead under the trade mark Truvada. Truvada is an anti-retroviral medication used in the treatment of human immunodeficiency virus (HIV). It is a combination product consisting of two active ingredients, namely (i) 245 mg tenofovir disoproxil (“TD”) in the form of 300 mg of the fumarate (“TDF”) and (ii) 200 mg emtricitabine (also known as FTC) in a single, fixed dose tablet. TD and emtricitabine are both inhibitors of a viral enzyme known as reverse transcriptase. Gilead contends that the product described in the SPC is protected by European Patent (UK) No. 0 915 894 (“the Patent”), but the Claimants dispute this. Accordingly, the Claimants contend that the SPC does not comply with Article 3(a) of European Parliament and Council Regulation 469/2009/EC of 6 May 2009 concerning the supplementary protection certificate for medicinal products (codified version) (“the SPC Regulation”).

The Claimants’ claim was tried before me on 15 and 16 December 2016. For the reasons given in my judgment dated 13 January 2017 ([2017] EWHC 13 (Pat), “my first judgment”), I referred to the Court of Justice of the European Union the following question concerning the interpretation of Article 3(a) of the SPC Regulation: “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?”. I shall assume that the reader of this judgment has read my first judgment.

On 25 July 2018 the Grand Chamber of the CJEU handed down its judgment in Case C-121/17 [EU:C:2018:585]. It ruled as follows:

“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.”

On 9 August 2018 the Claimants issued applications for final judgment in their favour in the light of the CJEU’s ruling.

On 13 August 2018 Gilead issued an application seeking permission to adduce further expert evidence and directions for a second trial.

In its judgment the Court of Justice confirms that, in order to be “protected by a basic patent in force” within the meaning of Article 3(a) of the SPC Regulation, it is necessary, but not sufficient, that the product falls within the scope of protection of the basic patent applying what I called in my first judgment the Extent of Protection Rules, which in the case of a European patent are those contained in Article 69 EPC and the Protocol on the Interpretation of Article 69. More is required, as the Court explains.

In its exposition of what more is required, the Court’s starting point is its judgment in Case C-493/12 Eli Lilly & Co Ltd v Human Genome Sciences Inc [EU:C:2013:835], [2014] RPC 21:

“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.”

In a case such as the present, where the product is not expressly mentioned in the claims of the Patent, the claims must relate to the product necessarily and specifically. In the remainder of the judgment, the Court explains what this requires.

Having drawn attention at [38] to the requirement, under Article 69 EPC and the Protocol, to interpret the claims of the basic patent in the light of the description and drawings, the Court identifies a series of policy considerations which are relevant to the interpretation of Article 3(a):

“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).”

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.

Accordingly, the Court concludes at [43]:

“… 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.”

Having stated at [44]-[45] that this interpretation is supported by Articles 4 and 5 of the SPC Regulation, the Court goes on at [46]:

“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.”

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.

This does not matter greatly, however, because the Court goes on to explain that this involves two tests being satisfied. It describes the first test as follows:

“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.”

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].

The Court describes the second test as follows:

“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.”

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.

The Court then summarises the position at [52] as follows:

“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.”

Having stated at [53] that this interpretation applies to products consisting of combinations of active ingredients, the Court sets out its view as to how it is to be applied to the facts of the present case:

“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.”

Counsel for Gilead submitted that the Court of Justice had exceeded its jurisdiction in setting out the views it expresses at [56]. I do not accept this. The Court has tried to assist the national court by explaining how it understands that its interpretation applies to the facts of the present case, but the Court has explicitly recognised that it is for the national court to make the final decision.

Counsel for Gilead also submitted that the Court had misapplied the extent of protection test at [56], presumably because it was not a patent court which was used to applying Article 69 EPC and the Protocol. Again, I do not accept this. What the Court says at [56] confirms that the first test is not a pure extent of protection test, but rather a test of whether the skilled person would readily understand from the patent and their common general knowledge that the product embodies the technical contribution made by the patent.

The Court concludes by ruling as set out above.

In considering Gilead’s application, the starting point is that there has already been a trial of these claims. Directions were given prior to the trial for the sequential service of witness statements, first by Gilead, then by the Claimants and finally by Gilead in reply. Neither side sought permission to adduce expert evidence, but as I pointed out in my first judgment at [3]-[4], both sides nevertheless adduced what amounted to expert evidence by unorthodox routes. In the case of Gilead, it served a witness statement from Professor Brian Gazzard CBE, a well-known and eminent expert in the field of HIV treatment, part of which amounted to expert evidence. No objection was raised by the Claimants to the admission of that evidence. It would have been open to Gilead to seek permission to adduce further expert evidence at the trial in December 2016, but it did not do so.

Gilead now seeks permission to serve an expert report from a new expert witness (Professor William Powderly of Washington University, St Louis, USA) by 28 September 2018 with the Claimants having permission to serve expert evidence in answer by 26 October 2018 and Gilead having permission to serve expert evidence in reply by 16 November 2018. Gilead proposes that there should then be a trial lasting 2-3 days, plus one day for judicial pre-reading and one day for preparation of closing submissions, in December 2018 (assuming that the Court can accommodate this).

Gilead contends that the Court has jurisdiction to admit further evidence at this stage of the proceedings because no final order has yet been made, nor indeed has the Court rendered a final judgment: see Re L (Children) [2013] UKSC 8, [2013] 1 WLR 634. The Claimants do not dispute this, and I accept it.

Gilead further contends that it should be given permission to adduce further evidence because the CJEU has articulated a new test which was not anticipated as a possible test by the parties, and therefore it is fair for the parties to be given the opportunity to adduce evidence directed to the new test and for there to be a second trial to consider such evidence. More specifically, Gilead contends that the second of the two tests articulated by the CJEU is new, and one which depends on expert evidence as to the prior art and the common general knowledge of the person skilled in the art to whom the Patent is addressed as at the priority date.

In my judgment it is not appropriate to give the parties permission to adduce further evidence at this stage precisely because it would necessitate a second trial.

It seems to me that there is a strong analogy between Gilead’s application and an application by a patentee to amend the claims of its patent so as to attempt to validate the claims after trial and the rendering by the court of a judgment concluding that the existing claims are invalid. If this would require a second trial, it will usually amount to an abuse of process and therefore will not be permitted: see Nikken Kosakusho Works v Pioneer Trading Co [2005] EWCA Civ 906, [2006] FSR 4, Vector Corp v Glatt Air Techniques Ltd [2007] EWCA Civ 805, [2008] RPC 10 and Nokia GmbH v IPCom GmbH [2011] EWCA Civ 6, [201l] FSR 15 and Generics (UK) Ltd v Warner-Lambert Co LLC [2016] EWCA Civ 1006, [2017] RPC 1.

Counsel for Gilead pointed out that this issue is currently before the Supreme Court in Generics v Warner-Lambert. That is so, but I must take the law as it presently stands. Counsel for Gilead submitted that Gilead’s application could not amount to an abuse of process given that the proceedings had been stayed pending the reference to the CJEU and that there had been no final judgment yet, let alone a perfected order of the Court. He further submitted that the test which the Court should apply, following Re L, was simply to consider whether admitting the further evidence would be in accordance with the overriding objective.

In my view Gilead’s application does amount to an abuse of process for similar reasons to those given in the post-trial amendment cases. In substance it amounts to an attempt by Gilead to amend its case and adduce fresh evidence after trial and judgment, and thereby get a second bite at the cherry, in circumstances where it could and should have brought its whole case, including any expert evidence, before the Court at the trial. It is true that the Court has not yet delivered final judgment, but that is only because the case raised an issue of European law upon which a preliminary ruling by the CJEU was required first. Now that the CJEU has given its ruling, the Court is in a position to give its final judgment and make an order accordingly.

In any event, even if the application does not amount to an abuse of process, in my judgment it is not in accordance with the overriding objective to give Gilead permission to adduce further evidence and direct a second trial at this stage, with the consequential expense and delay which that will involve, for the following reasons.

First, the evidence which Gilead wishes to adduce concerns the prior art and the common general knowledge of the person skilled in the art relating to emtricitabine at the priority date of the Patent. Gilead did adduce some evidence on this point at trial in December 2016: see my first judgment at [5], which was based on the evidence of Prof Gazzard, as was the second sentence of [6]. Gilead could have adduced further evidence on the point at that stage. It chose not to do so.

Secondly, I do not accept that the CJEU’s judgment justifies Gilead’s application. It is often the case that a reference to the CJEU results in a development of the law. That, after all, is the point of the procedure. If the fact that the CJEU has developed the law in its judgment were a sufficient justification for parties to adduce further evidence and seek a second trial, then parties would often be in a position to say that they should permitted to do so. But that is not how the procedure is intended to work in a case such as the present. Rather, the procedure is for the national court to make findings of fact, then refer the question of European law to the CJEU, then for the CJEU to answer the question of law and finally for the national court to apply the ruling to the facts previously found. It is different if, exceptionally, a question is referred to the CJEU before the national court has found the relevant facts; but no pre-trial reference was sought or made in the present case.

Furthermore, I do not accept that the CJEU’s judgment represents a new departure in its case law on the interpretation of Article 3(a) of the SPC Regulation. On the contrary, the judgment represents an elaboration and elucidation of the test which the CJEU propounded in the Eli Lilly case.

Thirdly, as counsel for the Claimants submitted, the new evidence which Gilead proposes to adduce would not get Gilead home anyway. The new evidence is directed to the second test laid down by the CJEU, but as explained below the first test is not satisfied. Accordingly, it would not assist Gilead to show that the second test was satisfied even if it could.

The Claimants contend that it is clear that neither of the tests laid down by the CJEU is satisfied in the present case, and accordingly the SPC does not comply with Article 3(a) and must be revoked. I agree with this for the following reasons.

The first test is that, from the point of view of a person skilled in the art and on the basis of the prior art at the priority date, the combination of active ingredients must necessarily, in the light of the description and drawings of the patent, fall under the invention covered by that patent. As explained above, this is not a simple extent of protection test. Rather, the combination must be one that the skilled person would understand, on the basis of the description and drawings and their common general knowledge, to embody the technical contribution made by the patent.

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.

The second test is that, from the point of view of a person skilled in the art and on the basis of the prior art at the priority date, each of the active ingredients must be specifically identifiable, in the light of all the information disclosed by the patent. There is no dispute that TD is specifically identifiable. 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.

As counsel for the Claimants submitted, this result is perfectly consistent with the objectives of the SPC Regulation. As noted in my first judgment at [24], Gilead obtained a marketing authorisation in respect of Viread, which contains TDF, on 5 February 2002, less than five years after the application for the Patent was filed. Thus Gilead did not suffer sufficient regulatory delay in exploiting the Patent to warrant the grant of an SPC in respect of Viread. Moreover, although Gilead applied for and was granted a patent for the combination in Truvada, that patent was revoked by the Opposition Division of the European Patent Office and Gilead’s appeal against that decision was dismissed. Thus Gilead made no invention in devising the combination which warranted the grant of a patent, let alone an SPC.