BREAKING: Court of Appeal frames Article 3(a) test as one of "claim requirement", but still upholds Truvada SPC invalidity

The Court of Appeal pawing at a combination SPC this holiday
season ...

It is the most wonderful time of the year.  Or, so they say.  If you haven't been able to enjoy the glittering lights illuminating London, feast upon the myriad of Christmas markets around Europe or have an unexpected snowball fight in Central Park, there is still some Christmas cheer to bring you to your desk.  That is, if you like SPC law. 

This morning the Court of Appeal ([2019] EWCA Civ 2272) dismissed Gilead's appeal of Mr Justice Arnold's (as he then was) September 2018 decision in Teva v Gilead finding that Gilead's SPC protecting its combination HIV anti-retroviral drug, Truvada, was invalid.  The product subject to the SPC was a combination of tenofovir disoproxil and emtricitabine.  Gilead claimed that this product was protected by Claim 27 of European Patent No 0 915 894 (the '894 Patent).  Teva (and a merry band of other generic companies) argued that the '894 Patent did not protect this combination product under Article 3(a) of the SPC Regulation.  Article 3(a) requires that an SPC can only be granted if the product subject to the SPC is "protected by a basic patent in force".  

Background

Back in December 2016, the parties first clashed in a two day trial before Arnold J (as he then was). It was in that judgment, delivered in January 2017, that the Judge referred the question that he previously referred in Actavis v Sanofi to the Court of Justice of the European Union (CJEU).  The reference asked:

"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 Judge, as he said at [96], was hoping that the CJEU would "provide a clear answer this time" as to what Article 3(a) required.  Did it require merely that the product fall within at least one claim of the basic patent applying the Extent of Protection Rules (i.e. Article 69 of the European Patent Convention and the accompanying Protocol), or did it require something stricter?  In his reference, the Judge trotted through the English court's and CJEU's case law Article 3(a) - Takeda, Farmitalia, Daiichi, Yeda, Medeva (and its progeny), Actavis v Sanofi, Eli Lilly v HGS, Actavis v Boehringer, - and found that it was clear that something more was required, but what that "something" was was not clear.  

His view, expressed at [97], was to embrace the "embodies the inventive advance" test.  He explained:  

"...the answer is that the product must infringe because it contains an active ingredient, or a combination of active ingredients, which embodies the inventive advance (or technical contribution) of the basic patent. Where the product is a combination of active ingredients, the combination, as distinct from one of them, must embody the inventive advance of the basic patent. Thus in a case such as the present, where the inventive advance of the Patent consists generally of the compounds of formulae (1) and (1a), including specifically [tenofovir disoproxil (TD)], a medicinal product whose active ingredient is TD is protected by the Patent within the meaning of Article 3(a) because it embodies the inventive advance of the Patent. A medicinal product whose active ingredients are TD and another therapeutic agent such as emtricitabine in combination is not protected by the Patent within the meaning of Article 3(a) because the combination, as distinct from TD, does not embody the inventive advance of the Patent. This is not a question of the wording of the claims of the basic patent, which as discussed above can be manipulated by the patent attorney who drafts it, but of its substance. By contrast, if Gilead (or another inventor) were to obtain a patent for an invention consisting of a combination of TD and substance X which surprisingly had a synergistic effect in treating HIV, then a medicinal product whose active ingredients were TD and X would be protected by that patent since it would embody the inventive advance of that patent. In my view, this interpretation of Article 3(a) would accord with the object of the SPC Regulation, which is to encourage invention in the field of medicinal products by compensating inventors for the delay in exploiting their inventions due to the need to obtain regulatory approval, and not to confer unjustified monopolies."

So thus, Case C-121/17 was born.  An Opinion from Advocate General Wathelet followed.  The AG dismissed the "inventive advance" approach as being one that would invite confusion, but laid down another test that confirmed "something more" was needed at [81]-[82]:

"…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.

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.”

A short 18 months after the question was referred, on 25 July 2018 the CJEU delivered its decision.  It held: 

"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."

A dog-eared copy of this decision with multi-color highlights, scrawls and underlined exclamation marks thereafter appeared on the AmeriKat's bulletin board.  "Necessarily and specifically".  The AmeriKat was necessarily annoyed by the CJEU's decision, and specifically because it provided yet another test (comprised of two parts) to mosaic into the litany of Article 3(a) case law.  Sure enough, like asteroids colliding in space, national courts who subsequently applied the CJEU's decision started to spiral off in different directions.    

Back on the terra firma of the Patents Court, Mr Justice Arnold (as he then was) was asked by Teva et al to provide his judgment in light of the CJEU's decision.  On 18 September 2018, the Judge held the SPC was invalid.  The first part of the CJEU's test, he said, was 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."

Gilead's SPC failed this part.  The Judge held that the '894 Patent said nothing about tenofovir disoproxil and emtricitabine being combined to treat HIV; emtricitabine is not even mentioned.  There was thus no basis for the skilled person to understand that the combination embodies the technical contribution of the '894 Patent.  Tenofovir disoproxil might be the technical contribution, but not the combination.  

The second part of the CJEU's test was 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. "

Gilead's SPC failed this second part of the test.  Although tenofovir disoproxil was specifically identifiable, emtricitabine was not.  Emtricitabine was not mentioned by the '894 Patent, was not a member of a specific class of  compounds mentioned by the '894 Patent (either by reference to structure or activity) and, although known by the skilled person at the priority date, there was no evidence that it was either known or CGK to be "effective" in the treatment of HIV.  

The Court concluded that this result accorded with the objective of the SPC Regulation in that Gilead has already obtained a marking authorization for the "mono" fumerate form of  tenfovir disoproxil less than 5 years after the '894 Patent was filed - thus not suffering any regulatory delay in exploiting the patent.  The final sentences of the decision referred to Gilead's patent for the combination having been revoked by the Opposition Division and their appeal dismissed.  "Thus Gilead made no invention in devising the combination which warranted the grant of a patent, let alone a SPC."

The Court of Appeal

So, Gilead appealed.  The Court of Appeal hearing was last Tuesday and the decision was handed down this morning. 

Gilead argued that the test was an Extent of Protection test, subject only to the two provisos (i.e. the two part test) provided by the CJEU.  Gilead satisfied both parts of the test.  The first part was meant to exclude products where the claim was only to A, but was said to protect A+B.   The '894 Patent did't fall into this camp as the claim referred to other therapeutic ingredients.  The second  part of the test was meant to "stop the clock" in what knowledge the skilled person could use to determine whether the ingredient was identifiable.  Emtricitabine  was identifiable at the priority date, so Gilead satisfied that test.  Gilead argued that the judge reached these conclusions because he had actually applied the "inventive advance" or "technical contribution" test and had assessed the second part of the test by reference to CGK, despite the court having expressly ruled that all the prior art formed the relevant pool of  knowledge.  Teva argued that the judge using the "technical contribution" test was not objectionable - the AG found the test objectionable only insofar as it conflated SPC law with the tests for patentability and inventive step.  What the Judge was really asking was "is the product the actual subject matter of the patent".  

Lord Justice Floyd gave the decision of the Court of Appeal, with Lord Justice Dingemans and Lord Justice Lewison agreeing.  He kicks off [18] by declaring that there 

"is no doubt that the CJEU has struggled with getting across national courts its understanding of what is meant by a product being protected by a basic patent for the purposes of Article 3(a) of the SPC Regulation."

Floyd LJ then provided an excellent summary of the crescendo of Article 3(a) case law to date, including the AG and  CJEU decisions in the present case and pending cases.  This can be summarized as follows:

• extent of protection can be determined only in the light of non-EU rules that govern patents (Farmitalia)
• no SPCs for products relating to active ingredients which are "not specified [or identified] in the wording of the claims" (Medeva and progeny)
• whether a product is protected depends on (i) the application of Article 69 and the Protocol, not to rules relating to infringement; (ii) the claims play a key role; (iii) active ingredients not identified by the claims by any means (i.e. structural or functional) are not protected; (iv) a structural formula is not necessary, a functional formula will suffice; (v) 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; (vi) it is for the national court to determine the application of the test (Eli Lilly v HGS, as summarized and applied in Sandoz v GD Searle)
• for products that are not expressly specified or identified in the claims, to be protected the products must "relate, implicitly but necessarily and specifically, to the active ingredient in question" 
• The "core inventive advance" of the patent does not apply and is of no relevance in the context of Article 3(a) (AG  Wathelet and CJEU in Teva v Gilead and AG Hogan's Opinion in Sandoz v Searle and Royalty Pharma).  The court has "definitely set its face against the introduction of such a test - be it a "inventive advance" or  "technical contribution of the patent" test.  This is because the express mention of an active ingredient is enough (see [37] of CJEU in Teva v Gilead).  

The Court of Appeal then held that:

(1)  The first part of the Teva v Gilead test is just "a more elaborate exposition of the 'necessarily' part of the first part of the Lilly v HGS test, i.e "the claims relate...necessarily...to the active ingredient in question."  

(2)  For a combination product to be protected, the claim must require the presence of two compounds.  This is not a simple Extent of Protection test - it goes further in that it demands that the claim "requires" each component be present in the claim. 

(3) Claim 27 refers to "other therapeutic ingredients" as expressly being optional. The convenience in claim drafting of making it optional, so as to avoid writing out separate claims, was not a good enough reason to find that the combination was protected.    The wording of the claim making it optional means that it is not "required".  Claim drafting is important in this area (citing Actavis v Boehringer (C-577/13)- although the AmeriKat takes issue with over-reliance on that case as being an Article 3(a) case...).  

(4)  Although the CJEU did not hold that the word "optionally" was fatal to Gilead's case, it still drew attention to the word.  The role that "optionally" plays in this assessment is a matter for the national courts.  

(5)  There is nothing in the '894 Patent that suggests to the skilled person that Claim 27 "requires the presence of another ingredient.  Everything points the other way. The skilled person might well know from the common general knowledge that other anti-viral agents would be useful in practice in the treatment of HIV, but he would not therefore assume that the presence of such an agent was required by the claim."  

(6) The breadth of Claim 27 is a factor.  The claim is not limited to a pharmaceutical composition containing tenofovir disoproxil for the treatment of HIV, nor is the phrase "other therapeutic ingredients" limited to anti-viral agents either.  Claim breadth is another reason for not reading a requirement for the presence of a second anti-viral agent into Claim 27.  At [83] the Court of  Appeal continues:

"To put it another way, drawing on paragraph [48] of the court’s judgment, there is no basis for the skilled person to conclude that “the product [i.e. TD plus another therapeutic ingredient] is specified as required for the solution of the technical problem disclosed by the patent”."

(7) Wading into the second-part of the test presents difficult questions of who knew what, when and by what means (i.e. all prior art or CGK?) and is unnecessary, given the failure under the first-part of the test (see [85]). Floyd LJ explained that he "would prefer to leave those issues to a case in which their resolution affected the result".  However, importantly, he said that:

"I would only add that I would not wish to endorse the view, implicit in the judge’s paragraph [39], that if emtricitabine was otherwise sufficiently identified, it would be necessary to show that it was known at the priority date to be an effective agent for the treatment of HIV in humans, or approved for such use, or that these facts were by then, common general knowledge. Given that none of this was known for [tenofovir disoproxil] at the priority date, it may be that this is to impose too high a standard."

Comment

According to the Court of  Appeal, patent claims apparently cannot be the Harry Potter-style "Room of Requirement" when it comes to satisfying Article 3(a) of the SPC Regulation.  The second active ingredient cannot just appear in the room if you need it, if it wasn't there when you first walked in.  But is that or, more accurately, should that be right when given the constraints on claim drafting and ticking clocks in a first-to-file system? 

There still seems to be a tension between saying the SPC confers the "same rights" as under the patent under Article 5, but then saying they are also "limited".  The only form of statutory limitation is that under Article 4 (to which Article 5 is subject), but that limitation is by reference to the product subject to the SPC.  If the patent protects A+B, then the SPC should protect A+B if the product subject to the MA is A+B.  However, the case law says that although the patent might protect A+B, if B is not "required" by the claims then an SPC cannot protect  A+B.  So the SPC is not "conferring the same rights" as that of the patent (assuming "rights" and "protection" are the same thing...).  This is consistent with the "something more" that the case law of the CJEU and of the Patents Court keeps referring to.  The "something more" is actually a limitation, contrary to Article 5.  Of course, one would rightly argue that the logic of some of the above is essentially an infringement test by the backdoor, which has been expressly rejected.  Medeva at [25] also that states that it follows from Article 5 "that Article 3(a) of the regulation precludes the grant of a SPC relating to active ingredients which are not specified in the wording of the claims of the basic patent".  But, like Lord Justice Arnold, the AmeriKat has never understood how "it follows", unless you misunderstand patent law. But maybe that is the point...

But while the AmeriKat rustles around with this ball of yarn until she tires herself out, in-house patent attorneys will - subject to an appeal to the Supreme Court - likely be considering how to carve around the Court of Appeal's directions on claim drafting, "optionally" language, unity of invention and filing in time before the clinical trials are public.  

So there you have it.  Happy holidays to all you SPC-lovers out there - a meaty little judgment for you to get your teeth into with your holiday champagne - the AmeriKat hopes it is a big bottle...