A quick recap: Actavis had challenged validity of AZ’s Swiss part of EP 2 266 573 back in 2015, and the FPC had indeed held in 2017 that EP 573 was invalid for lack of inventive step; see this Blog here. However, the Supreme Court overruled that decision and remitted the case back to the FPC for re-assessment of obviousness; see this Blog here. In the second round, the FPC held that the subject-matter of EP 573 did involve an iventive step; see the decision O2018_009 of 27 May 2019. In brief, the FPC held that neither
Howell (referred to as D15) in further view of McLeskey (referred to as D13); nor
rendered the claimed subject-matter obvious. That decision was again appealed to the Supreme Court, and I have been eagerly awaiting a good read. But nothing like that. The Supreme Court only published a dismissal order. The parties have apparently reached an amicable settlement; court fees are shared.
The present main proceedings are following-up on summary proceedings S2017_006 when the FPC granted interim injunctive relief; see this Blog here. Validity of the SPC was not an issue anymore, this had already been affirmed by the Supreme Court; see this Blog here.
The dispute is all about whether or not the scope of an SPC that specifically refers to a unique salt form does extend to other salts; we had reported about the main hearing in this matter on this Blog here. The SPC concerns tenofovir disoproxil fumarat + emtricitabin (emphasis added) . Mepha’s attacked generics (Swissmedic MAs No. 66181 and 66217) instead comprise tenofovir disoproxil phosphate.
The decision holds in ¶26-27 that in order to not frustrate the objective of an SPC the understanding of the term ‘product’ in the context of an SPC must be aligned with the understanding of the same term in the context of the Therapeutic Products Act (TPA). Thus, the scope of protection is not strictly limited to what is named in the MA or in the SPC, but rather extends to derivatives, salt forms, etc. which do not differ significantly in their properties with regard to safety and/or efficacy. In other words, the decision holds that the scope of protection extends to everything for which a simplified approval according to the TPA can be obtained (see Swissmedic Guidelines, ¶1.1.1).
Thus, the decision holds that the ‘product’ in the sense of Art. 140d PatA is (¶28):
Emtricitabine plus tenofovirdisoproxil fumarate and all derivatives (i.e. in particular all salt forms) thereof, provided that they have the same pharmacological effects.
Since the attacked embodiments had been approved by Swissmedic by way of a simplified approval, the decision holds that they are presumed to have the same pharmacological effects and are thus the same ‘product’ in the sense of Art. 140d PatA.
For the sake of completeness, the decision also analyses the alleged infringement under the DoE (¶33 et seqq.). As proposed by some scholars, the scope of protection of an SPC is determined by the content of the claims of the basic patent, whereby the description and the drawings are to be used for interpretation, and the Protocol on the Interpretation of Art. 69 EPC is also to be observed. Since the SPC is only product-related and purpose-related, the patent claim of the basic patent is to be defined artificially as if only the active substance designated in the certificate were mentioned, for the approved use of the active substance as a pharmaceutical. The description and drawings of the basic patent shall be used for the interpretation of the claim so formulated.
In brief, the decision holds that the three questions of the Swiss test for infringement under the DoE are to be answered in the affirmative, i.e. that the ‘same effect’ (Gleichwirkung), ‘obviousness’ (Auffindbarkeit) and ‘same value’ (Gleichwertigkeit) are given. Noteworthy, the decision holds that one cannot assume that the SPC holder made a purposive selection in favor of one salt over other salts mentioned in the specification. If one were to see this differently, equivalence for SPCs in different salt forms would in fact be excluded if only one specific salt had been used for the MA and the wording of the SPC. On the contrary, on the basis of an objective reading of the patent specification and in the knowledge that such an artificial claim is to be interpreted for the scope of protection of an SPC, the skilled person will readily assume that other salts, because they are mentioned in the description, are not excluded from the scope of protection (¶43):
Im Gegenteil wird der fachkundige Dritte bei objektiver Lektüre der Patentschrift und im Wissen darum, dass ein solcher fiktiver Anspruch für den Schutzbereich eines ESZ auszulegen ist, in einer solchen Situation gerade davon ausgehen, dass natürlich diese anderen Salzformen, weil sie in der Beschreibung genannt werden, nicht vom Schutzumfang ausgeschlossen sind.
In any event, the decision holds that there was no specific, individualized disclosure of tenofovir disoproxil phosphate in the specification of the basic patent.
Injunctive relief was thus granted. However, Mepha shall be permitted to export products that it had on stock when interim injunctive relief had been granted to any of the least developed countries, LDCs, according to the list of the the United Nations.
Note that Hepp Wenger Ryffel is involved in this case on behalf of the defendant.
This case is about an alleged infringement of Gilead’s SPC C00915894; the basic patent is EP 0 915 894 B1 (see EPO Register and Swissreg). Gilead’s product is Truvada®, a pharmaceutical for the treatment of HIV-1 infection. The present main proceedings are following-up on summary proceedings S2017_006 when the FPC granted interim injunctive relief; see this Blog here.
Validity of the SPC is not an issue anymore, it has already been affirmed by the Supreme Court; see this Blog here.
The dispute is all about whether or not the scope of an SPC that specifically refers to a unique salt form does extend to other salts. The SPC concerns tenofovir disoproxil fumarat + emtricitabin (emphasis added) .
The parties agreed to disagree on this issue in the hearing. Gilead insisted that the ‘typical product definition’ has to be applied, in a sense that the fumarate is only to be understood as a ‘reference’ for the assessment of whether or not yet another salt form has the same pharmacological effect. If it had, then it should be considered ‘the same product’.
On the other hand, Mepha argued that the term ‘product’ is defined in Art. 140a(2) PatA, and it is to be construed within the context of the PatA; the Therapeutic Products Act (TPA) was not relevant in this respect. Thus, infringement has to be assessed as it is routinely done, i.e. deciding on whether there is literal infringment or infringement under the DoE. Mepha argued that the SPC is neither literally infringed, nor under the DoE.
The expert opinion of the judge-rapporteur held that the SPC was infringed, apparently essentially along the line of Gilead’s arguments. Still, in case the court followed the expert opinion, Mepha requested the court to provide a full assessment of infringement in the judgment, also including an assessment of literal infringement and infringement under the DoE. The Supreme Court would then be in a position to review the whole matter at once and in a timely manner, without the need to remit the case back to the FPC to carry out yet another assessment.
As mentioned above, Truvada® is a pharmaceutical for the treatment of HIV-1 infection. But Mepha recently obtained the market authorization of its Emtricitabin-Tenofovir-Mepha® in Switzerland also for PrEP – which is short for Pre-Exposure Prophylaxis; see Swissmedic Journal 02/19. More information on PrEP can be found on Gilead’s website here. However, Gilead currrently has no MA for PrEP in Switzerland; Mepha’s MA is the only one in Switzerland for this indication.
PrEP likely is the reason why this case attracted quite some public attention. There has even been an organised Facebook event in St. Gallen; and flyer have been distributed, see here and here.
On a sidenote, when a member of the audience wore a shirt with one of these slogans on it, the presiding judge held that this was an attempt to influence the judges, and thus ordered him to either hide the slogan / change clothes; or to leave the court room.
It was beyond dispute between the parties that the subject-matter of the SPC (tenofovir disoproxilfumarat + emtricitabin) is covered by the basic patent EP’894. The so-called ‘infringement test’ that had been applied in Switzerland since the Supreme Court’s decision BGE 124 III 375 – Fosinopril in 1998 was thus met. However, the CJEU explicitly disapproved the ‘infringement test’ with its decision CJEU C-322/10 – Medeva of 2011, and the plaintiff argued that the ‘infringement test’ should no longer be applied in Switzerland, either.
The FPC had held that it is not appropriate to change the practice. On the contrary, the Supreme Court did now exactly that.
In first place, the Supreme Court reviewed the practice of the CJEU which initially left it to the national courts to decide on what it meant to be protected by a basic patent. Essentially two lines of jurisprudence developed thereafter, i.e. the disclosure theory (‘Offenbarungstheorie’) and the infringement test (‘Verletzungstest’). Only later, the CJEU disapproved the ‘infringement test’; CJEU C-322/10 – Medeva.
The Supreme Court noted that the Swiss SPC legislation had been enacted with the explicit aim to make it materially the same as in the European Union. The ‘infringement test’ cannot achieve this aim anymore, and it thus cannot be maintained; ¶2.2.5-2.2.6:
Die Auslegung […] weicht konzeptionell ab von der Auslegung durch den EuGH. […] Das vom schweizerischen Gesetzgeber angestrebte Zeil, das Schutzniveau für das Institut der ergänzenden Schutzzertifikate mit demjenigen im benachbarten Ausland in Einklang zu bringen, wird damit verfehlt. […] An BGE 124 III 375 kann nicht festgehalten werden.
Supreme Court dismisses appeal against judgment of 3 Oct 2017 in the matter of Mepha Pharma AG v Gilead Sciences, Inc., re Supplementary Protection Certificate (SPC); but in the future, Switzerland will apply the ECJ’s “Medeva” case law to SPC’s, https://t.co/tdY0t602LG
Noteworthy, the Supreme Court also briefly touched the IPI’s prior initiative to amend its SPC granting practice in light of the CJEU’s Medeva case law, and the positive feedback that had been received from (at least some of) the interested circles. The Supreme Court notes that this was a strong indication that the Swiss practice should indeed be changed, and the IPI’s initiative thus paid off. Still, it was good that the IPI’s initiative had been put on hold in view of the present proceedings. In my humble opinion, any change of practice while BGE 124 III 375 – Fosinopril was still formally applicable would have been premature. Just imagine the consequences if the granting practice had been changed and the Supreme Court later did not abstain from the ‘infringement test'(!), for any reason whatsoever. Dreadful.
Now, what is the test instead? Practitioners are familiar with the subtle twists in the various decisions of the CJEU. This is not further clarified in the present decision. Unsurprisingly, the Swiss Supreme Court essentially only summarizes the criteria of these decisions, ¶2.2.6:
Bezeichnet ein Grundpatent nur einen von zwei Wirkstoffen, kann ein Erzeugnis […] nicht als ergänzendes Schutzzertifikat beanspruch werden, wenn es aus zwei Wirkstoffen zusammengesetzt ist. Art. 140b PatG ist vielmehr […] so auszulegen, dass die Wirkstoffe des Erzeugnisses im Grundpatent beansprucht werden müssen, indem sie in den Patentansprüchen benannt werden, oder indem sich die Patentansprüche – im Lichte der Beschreibung ([…]) ausgelegt – zumindest stillschweigend, aber notwendigerweise auf diese Wirkstoffe beziehen, und zwar in spezifischer Art und Weise.
But the Supreme Court did not just change the practice. It did so with a smooth ‘Swiss touch’: Already granted SPCs shall not be affected by the change of practice. The Supreme Court held that, as a rule, formally final administrative decisions cannot be reconsidered or reversed on the basis of a change in case law. In the Supreme Court’s view, the public interest in equal treatment hardly exists in the context of an SPC, contrary to e.g. in social insurance issues. Apart from the fact that the number of SPCs — irrespective of their economic importance — is rather small, the purpose of granting them is precisely to grant privileges to their owners. If a change of the case law now restricts the conditions for granting SPCs in certain cases, the interests of the other market participants are given a higher weighting and the interests — including public interests in health care — are weighed up differently. However, this change in valuation and consideration of the interests involved does not justify the withdrawal of acquired legal positions, in the Supreme Court’s view; see ¶3.6. No national court in the European Union took this approach when the ‘infringement test’ had been abandoned, to the best of my knowledge.
Now, what is next? Respondent’s counsel already noted on Kluwer Patent Blog that it remains unclear how pending SPC applications shall be dealt with, but they suggested that the infringement test should also apply in these cases. I feel this could well be handled differently. No subjective right has yet been granted in these cases, and I cannot readily see an overriding interest of the applicants to still get SPCs granted contrary to the changed practice. To strike a balance, one might as well just give applicants a chance to amend their pending applications in view of the changed practice instead.
It was beyond dispute between the parties that the subject-matter of the SPC (Tenofovir Disoproxilfumarat + Emtricitabin) is protected by the basic patent EP’894. The so-called ‘infringement test’ that has been applied in Switzerland since the Supreme Court’s decision BGE 124 III 375 – Fosinopril in 1998 was thus met.
On the contrary, the CJEU disapproved the ‘infringement test’ with its decision CJEU C-322/10 – Medeva of 2011, and plaintiff argued that the ‘infringement test’ should no longer be applied in Switzerland either.
The FPC held that it is not appropriate to change the practice, and affirmed the ‘infringement test’ – at least for the time being.
The FPC’s reasons are as follows:
The law is clear
It is (only) required by the law that the product is protected by a patent; Art. 140b(1) lit. a PatA. The Supreme Court had held in the Fosinopril decision that it is not necessary that the product be explicitly named and described in the patent (‘ausdrücklich genannt und beschrieben’). Rather, it is decisive whether the product is covered by the scope of the basic patent. Well, that’s the ‘infringement test’.
The FPC notes in passing that the Introduction of further criteria might require a change to the law.
Die Einführung zusätzlicher, über den […] Schutz durch das Basispatent hinausgehende Anforderungen an das Basispatent für die Erteilung von Schutzzertifikaten würden wohl eine entsprechende Regelung durch den Gesetzgeber voraussetzen.
The rationale of Medeva is not applicable for Switzerland
The CJEU aimed to harmonize the SPC practice in the EU in order to preclude ‘obstacles to the free movement of medical prodcuts with the EU that would affect the establishment and functioning of the internal market’; see ¶24 of Medeva.
Switzerland is not part of that internal market, in particular not for medical products with state-regulated prices. Further, the FPC notes that the EU has harmonised the grant of market authorizations by the European Medicines Agency; Regulation (EC) No 726/2004. On the contrary, Switzerland has its own market approval procedure via Swissmedic; Therapeutic Products Act, TPA. The FPC concludes that even if one were to change the Swiss pratice in accordance with Medeva, this would not result in harmonised protection by SPCs with the EU.
Voluntary alignment with Medeva would not improve legal certainty and consistency
The FPC analysed the CJEU’s series of decisions dealing with SPCs, i.e.
The FPC held that the CJEU had been asked to answer essentially the very same question again and again, i.e. what exactly the criteria are to decide whether or not a product is ‘protected’ by the basic patent.
In the FPC’s view, Medeva raised more questions than it answered, and this uncertainty has not yet been resolved by the CJEU’s subsequent decisions. Defendant referred to the different wording used by the CJEU as ‘salad’. The FPC notes that this might well be an oversimplification. But still, the FPC identifies a terminological muddle, or at least a substantial unclarity.
Wenn die Beklagte die Formulierungen des EuGH als ‘Salat’ bezeichnet […], greift das wohl auch zu kurz, aber ein gewisses ‘terminologisches Durcheinander’, wie die Beklagte das auch nennt, oder zumindest eine erhebliche Unklarheit, scheint durchaus vorzuliegen.
The FPC further noted that yet another referral to the CJEU has been made by Arnold J in the co-pending case in the U.K.; see  EWHC 13 (Pat). Undoubtedly, Arnold J has immense knowledge and experience in SPC matters. The FPC took the fact that Arnold J again seeks advice from the CJEU on the question
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?
as a further indication of the substantial uncertainty even in the EU. In the court’s view, an attempt to harmonise the Swiss practice in alignment with Medeva would not improve legal certainty and consistency.
Application of the Medeva principles in the case at hand would not give a clear result
Finally, the FPC holds that it was unclear whether or not the unspecific reference to ‘optionally other therapeutic ingredients’ in claim 27 of the basic patent would be sufficient to meet the CJEU’s criteria, i.e. ‘specified in the wording of the claim’.
The FPC holds that if harmonisation with the CJEU case-law should be made at all, it would be too early: In the court’s view, there is just not yet a comprehensible and practicable case-law to align with.
Sollte überhaupt eine Harmonisierung mit der EuGH-Rechtsprechung in Betracht gezogen werden, scheint deshalb auf jeden Fall der Zeitpunkt, die Schweizer Rechtsprechung anzupassen, verfrüht, solange seitens des EuGH nicht eine nachvollziehbare und eindeutig umsetzbare Rechtsprechung vorliegt. Ein Versuch der Übernahme der Rechtsprechung des EuGH im gegenwärtigen Zeitpunkt würde nur eine Erhöhung der Rechtsunsicherheit nach sich ziehen. […] Deshalb ist, jedenfalls solange keine etablierte und die Rechtssicherheit sowohl für die Antragsteller als auch für die Dritten erhöhende Rechtsprechung des EuGH vorliegt, eine Änderung der Schweizer Rechtsprechung in keiner Weise angezeigt. Die strengen Voraussetzungen für eine Praxisänderung [BGE 138 III 270 , r. 2.2.2] sind eindeutig nicht erfüllt.
Two further aspects of the decision relate to the costs:
First, the parties had agreed on the English language to be used by the parties; Art. 36(3) PatCA. The main hearing, however, was held in German on request of the defendant. This required translation at the main hearing, and the defendant has to bear the costs for the interpreter.
Second, the FPC did not order any reimbursement of expenses incurred by defendant’s patent attorney. Note that expenses for assisting patent attorneys are not reimbursed according to a tariff (unlike the compensation for legal representation); see Art. 3 lit. a and Art. 9(2) CostR-PatC.
The requested amount has to be specified and substantiated, preferably by means of a detailed debit note. This has not been done, and the FPC accordingly did not award reimbursement of such unspecified and unsubstantiated expenses for the assisting patent attorney.
It’s not the first time that the parties litigate about this SPC. Nullity proceedings are co-pending; see this Blog here and here. A major issue at stake now is the alleged infringement of the SPC. The FPC had granted ex parte interim injunctive relief; see this Blog here. Note, however, that the SPC concerns (emphasis added):
Plaintiff essentially argues that an SPC would always extend to all salts of (a component of) a product, irrespective of its wording. On the contrary, defendant argues that this is a misunderstanding of the ‘Farmitalia’ decision of the ECJ (C-392/97): In that case, the market authorisation related to a specific salt, but the ECJ had allowed the registration of an SPC also for salts and esters. It had been held in ¶27 that
[…] where an active ingredient in the form of a salt is referred to in the marketing authorisation concerned and is protected by a basic patent in force, the certificate is capable of covering the active ingredient as such and also its various derived forms such as salts and esters, as medicinal products, in so far as they are covered by the protection of the basic patent.
The ECJ’s judgment only concerned the requirements for grant of an SPC, but not the scope of protection. The FPC will now have to decide on the scope of an SPC directed to a combination product wherein a first component is identified as a specifically named salt (fumarate) which is not used in the attacked product (using a phosphate instead); and wherein the second component (emtricitabin) is not mentioned at all in the basic patent.
The President noted that no expert opinion of the judge-rapporteur will be established. The parties did not enter into settlement discussions.