Note that Hepp Wenger Ryffel is involved in this matter on behalf of the plaintiff / appellant.
Please see this Blog here for a discussion of the underlying decision of the FPC. In brief, it is all about an assignment action of Marcel Riendeau against Zehnder Group International AG, concerning two European patent applications, i.e.:
Both EP2 and EP3 had been filed in Zehnder’s name only; the plaintiff had been designated as inventor. The plaintiff had partially suceeded in first instance when the FPC held that the parties are jointly entitled to both patent applications.
On appeal, the plaintiff objected that the facts had been wrongly established in the first instance decision in various aspects, that the burden of proof had been incorrectly allocated and that the FPC had not dealt with the plaintiff’s entitlement to a transfer of the patent applications based on a contractual undertaking.
To cut a long(er) story short: The Supreme Court did not agree and dismissed the appeal. The FPC’s decision is thus final now, and it remains to be seen how the parties get along with their joint entitlement to both EP2 and EP3.
The Supreme Court now dismissed Omega’s appeal, i.e. confirmed the FPC’s decision. EP(CH) 1 837 719 B1 is thus finally declared invalid.
The issues dealt with by the Supreme Court in the decision, in brief:
Age of a prior art document
On appeal, Omega has argued that the FPC took an unrealistic piece of prior art into account in the assessment of inventive step. Indeed, the FPC had considered a document that was published already about a century ago, i.e. US 759,914. In view of the evolution of watchmaking since then, Omega considered it unrealistic that such a document was actually considered as a starting point in the assessment of inventive step. Consequently, Omega alleged a violation of Art. 56 EPC.
The Supreme Court did not buy this argument. It is held in no uncertain terms that everything that had been made publicly available — including old documents — forms part of the prior art. One cannot exclude a document from consideration in the assessment of inventive step just because of its age; see ¶3.1.3.
Écarter un document de ceux que consulterait l’homme de métier en raison de son ancienneté reviendrait à priver les brevets ayant dépasé un certain âge de toute valeur dans le cadre de l’analyse de l’effet invenif. Un telle pratique ne saurait être déduite de l’art. 65 CBE.
Reference to some case-law of the Boards of Appeal of the EPO did not help either: The mere age of a document has not been decisive in T 479/00, T 366/89, T 1000/92 and T 334/92. The Supreme Court notes that the obsolescence or outdatedness of a technology had been the key issue in these decisions, which excluded the respective documents from consideration by the skilled person. Apparently, no such case had been established by the appellant in the present matter.
Incompatibility of technical teachings
The balance wheel of US 759,914 has inertia blocks that must have been placed from the inside, as claimed by the patent in suit; see the screw head on the inner side of the felloe in the figures below.
But what is still missing here is the stud (‘plot’) according according to the patent in suit. Omega argued that the skilled person would not have added studs to the balance of US 759,914 in view of the risk to impair the automatic adjustment of its temperature dependent moment of inertia, which is the sole purpose of this invention. However, the Supreme Court holds that this is not in agreement with the fact findings of the FPC, and thus did not consider this argument any further.
And the Supreme Court indeed acknowledges that it would have been desirable if it had done so.
Ainsi, il eût été souhaitable que la juridiction précédente détaille la première étape de l’approche problème-solution comme elle l’a fait pour les autres étapes de son examen.
But still, in view of the FPC’s detailed discussion of how the skilled person had arrived at the invention starting from US 759,914 without inventive merit, it became sufficiently clear how close both inventions actually are, and why US’914 thus is a reasonably chosen closest prior art.
Late filed auxiliary requests / claim limitations
Omega had filed yet another, even more limited auxiliary request (AR3) with the response to the expert opinion of the judge-rapporteur. The FPC had not admitted this request into the proceedings anymore, with reference to O2015_012.
Omega had challenged this on appeal. But while this appeal has been pending, the Supreme Court ruled on the appeal against O2015_012 — and backed the practice of the FPC in this respect; decision 4A_543/2017 of 08 May 2018, see this Blog here. Accordingly, Omega did not succeed with this argument, either.
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.
In (very) brief, AstraZeneca’s EP(CH) 1 250 138 B2 had been revoked for lack of inventive step over Howell in view of McLeskey. At the main hearing, AZ had further limited its third auxiliary request with an additional feature (marked-up below) as follows:
Use of fulvestrant in the preparation of a pharmaceutical formulation for the treatment of breast cancer by intra-muscular administration to human patients, […] wherein […] the formulation is adapted for attaining a therapeutically significant blood plasma fulvestrant concentration of at least 8.5 ng ml-1for at least two weeks.
AZ had argued that this further limitation was a partial acknowledgment of the complaint which is possible at any stage of the proceedings; Art. 241 CPC. The FPC did not agree. The further limitation only concerned an auxiliary request, i.e. it only came into play when the court had already decided on the main request, i.e. denial of the complaint without any amendments to the claims. At that stage, there is no room anymore for a partial acknowledgment of the complaint. The FPC held that it was faced with new facts to be considered as an auxiliary measure. This is possible in general, but only within the time limits for submission of novae; Art. 229 CPC. Consequently, the FPC had not admitted the newly drafted auxiliary request into the proceedings.
On appeal, AZ requested that the decision be set aside and the patent maintained on the basis of the amended third auxiliary request.
The Supreme Court did not agree, either. Whether or not an additional feature in a claim is an allowable limitation is not just a question of law. It rather requires a factual assessment of whether (or not) the application as filed provides sufficient basis for the amendment. This assessment had not been made in first instance proceedings. The Supreme Court further notes that even further factual assessment may be necessary, e.g. whether further prior art might be cited against the reformulated claim.
The Supreme Court thus held that the FPC correctly did not admit the reformulated auxiliary request into the proceedings for being belated, and dismissed the appeal.
it remains to be seen how parties will adapt their course of action in the future. But I would not be surprised if defendants in nullity cases (and plaintiffs in infringement cases when faced with a plea for nullity in defense) will submit a lot more auxiliary requests at early stages of the proceedings.
In (very) brief, AstraZeneca’s EP(CH) 2 266 573 B1 had been revoked for lack of inventive step over Howell in view of McLeskey. The parties heavily dissented on whether or not Howell contained an enabling disclosure or not. The FPC held that it did, and that the objective technical problem to be solved in accordance with the problem-and-solution approach was only to provide an alternative formulation for sustained release.
AZ appealed and essentially argued that the FPC erroneously assumed a (concrete) pharmaceutical formulation in Howell, thus incorrectly defined the distinguishing features and the (objective) technical problem, and then wrongly concluded for lack of inventive step.
The Supreme Court indeed agreed and remitted the case for re-assessment of inventive step on the basis of an ‘objectively correct’ definition of the problem to be solved; see ¶2.3.5. Further, the Supreme Court notes in ¶2.3.3 that a correct definition is:
Provision of a castor oil-based formulation (i.e. a formulation consisting of castor oil and known suitable solvents and adjuvants in a certain composition and amount) for the administration of up to 250 mg fulvestrant for the treatment of breast cancer, which is well tolerated, has a uniform release profile and achieves the therapeutically decisive concentration of fulvestrant in the blood plasma over a longer period of time.
It is rare (to say the least) that the Supreme Court re-defines the objective technical problem to be solved in the assessment of inventive step. It did so here because the FPC got the meaning of an enabling disclosure wrong:
[…] weil [die Vorinstanz] von einem unzutreffenden Begriff der Ausführbarkeit der Lehre ausgegangen ist […]
Really? The FPC got such a fundamental point of law just wrong!?
This demands for a closer look!
The Supreme Court holds that the FPC failed to recognize the concept of feasibility or sufficient disclosure with the conclusion that ‘the technical teaching of [Howell] could basically be reworked.’ For a technical teaching consists not only of the problem but also of the solution.
Die Vorinstanz hat den Begriff der Ausführbarkeit oder der hinreichenden Offenbarung verkannt mit dem Schluss, dass ‘die Lehre [in Howell] grundsätzlich nacharbeitbar war’. Denn eine technische Lehre besteht nicht nur aus dem Problem, sondern auch aus der Lösung.
However, Howell only suggests that there was a compatible and pharmaceutically effective depot formulation available — but the actual composition of this formulation is not disclosed.
Further, the Supreme Court holds that the FPC did not expand on which concrete formulation the skilled person(s) would have found on the basis of the information in Howell without undue burden and without involvement of an inventive step. The general knowledge that steroids such as fulvestrant can be dissolved in castor oil with certain excipients and solvents in such a way that compatible injections can be produced is not sufficient for the feasibility of a technical teaching, in the Supreme Courts’ view.
In sum, the Supreme Court thus holds that the FPC applied an incorrect legal concept of feasibility with the assumption that no concrete technical formulation was required in order to affirm that there well is a technical teaching in Howell; ¶2.2.4.
Die Beschwerdeführerin rügt im Ergebnis zu Recht, dass die Vorinstanz von einem unzutreffenden Rechtsbegriff der Ausführbarkeit ausgegangen ist mit der Annahme, es bedürfe keiner konkreten technischen Formulierung, um die Offenbarung der technischen Lehre — d.h. hier der in [Howell] beschriebenen Depot-Formulierung — bejahen zu können. […] Die Vorinstanz hat die Offenbarung einer technischen Lehre durch [Howell] zu Unrecht bejaht.
Further down the road, the Supreme Court concluded that the FPC failed in the identification of the differentiating features. It just could not do it correctly because there is no specific disclosure in Howell.
But still, Howell undoubtedly is pre-published. Now, what to do with it?
The FPC had left it undecided whether or not a non-enabling disclosure is ‘prior art’ under Art. 54(2) EPC. But the Supreme Court took over — and answered even more than that. The Supreme Court holds that Howell belongs to the state of the art (contrary to what the EPO typically does, i.e. to just ignore it in toto; see Guidelines, G-IV, 2). But, in the Supreme Court’s view, such a piece of prior art cannot be assessed with the problem-and-solution approach because the objective technical problem is then just to find a working solution to what is insufficiently disclosed therein, and there is an inherent motivation to search for that solution; ¶2.3.2.
Der Beschwerdegegnerin ist zwar zuzustimmen, dass die Information von [Howell], in der das Problem formuliert und Ansätze für die Lösung mitgeteilt werden, zum Stand der Technik gehört. Wird jedoch ein Dokument als ‘nächstliegender Stand der Technik’ beigezogen, das keine technische Lösung offenbart, […] wird der ‘Aufgabe-Lösungs-Ansatz’ verlassen. Denn die objektive technische Aufgabe ergibt sich unmittelbar aus [Howell], wenn darin dem fachkundigen Adressaten mitgeteilt wird, dass es eine Lösung für das Problem gibt […]. […] Eines Vergleichs von Merkmalen zur Ermittlung der objektiven technischen Aufgabe bedarf es in diesem Fall nicht. […] Aufgrund der Information in Howell, dass es eine Formulierung [gibt], wird das Fachteam jedenfalls dazu motiviert, geeignete Depotformulierungen zu suchen.
Frankly, it is now me who is not (yet) enabled to fully grasp the implications of this decision. Time will tell, as always.
In a nutshell, the FPC had taken a stepwise approach in O2015_004. In first place, it was held that limitation from antifolate to pemetrexed disodium during prosecution constitutes an abandonment of subject-matter. In an auxiliary assessment, i.e. if one were to consider the limitation not as an abandonment, the FPC denied an infringement under the Doctrine of Equivalents (DoE) since the skilled person would have understood the wording pemetrexed disodium as a strict limitation, in view of the claims and in further consideration of the specification.
As you were! The Supreme Court did not agree with either of these two findings.
1. Abandonment of subject-matter
The wording of the claims had been narrowed down during prosecution: The broad term antifolate had been amended in the claims to pemtrexed in first place and finally to pemetrexed disodium, to restore novelty while at the same time complying with Art. 123(2) EPC.
This limitation is also reflected in the description. The definition in paragraph  of EP’508 had only been introduced during prosecution:
The FPC had held that the patentee is bound by the limitation that he had accepted during prosecution in order to obtain the patent, and that he is therefore prevented under principles of good faith (Art. 2 CC) to now circumvent this limitation by asserting equivalence as if the limitation had not been made.
The Supreme Court notes that behavior in contradiction to one’s prior acts is not generally prohibited under the principle of good faith, but only if the prior act gave rise to a legitimate trust of others which then is frustrated by the later act (BGE 125 III 257, r. 2a). The Supreme Court further holds that the limitation of a claim feature does not readily constitute an abandonment of the protection against infringement under the DoE for that feature without taking the reasons of the limitation into account.
Die Einschränkung eines Merkmals stellt nicht ohne weiteres und unbesehen des Grundes für diese Einschränkung eine Erklärung des Verzichts auf den Schutz gegen Nachahmung dar.
The Supreme Court did not identify any special circumstances that would justify the use of the makeshift of Art. 2 CC to prevent gross injustice, either.
2. Infringement under the DoE
The Supreme Court held that the pemetrexed anion is the active substance with anti-cancer effect and agreed with the FPC’s finding that the diacid and the disodium salt objectively fulfil the same function.
The second question (accessibility / ‘Auffindbarkeit’) is somewhat tricky, again. The Supreme Court recites the FPC in that accessibility of the replacing feature had been answered in the affirmative; ¶5.4.
Die Vorinstanz hat die Auffindbarkeit der abgewandelten Form für den Fachmann bejaht.
This is not very precise. The second question, in the FPC’s approach, asks for the accessibility of the same effect when the skilled person is confronted with both the claimed variant and the replacing variant. The FPC’s second question is not about how to get to the replacing variant; it’s already there.
Anyway, the Supreme Court held that the skilled person had a reasonable expectation that the replacing variant would work. The necessity of some routine experiments to confirm this expectiation is of no avail. Accessibility was thus confirmed, too.
The Supreme Court also answered the third question (same value / ‘Gleichwertigkeit’) in the affirmative. The skilled person had no reason to believe that the patentee had only intended protection for the literal meaning of the claim, i.e. pemetrexed disodium.
Der Fachmann […] hatte keinen Grund zur Annahme, die Patentinhaberin habe Schutz nur für die wortsinngemässe Ausführung beansprucht.
Even though it is noted in paragraph  of the patent (see marked-up excerpt above) that
[t]he ‘antifolate’ or ‘antifolate drug’ for use in this invention is Pemetrexed disodium (ALIMTA®), as manufactured by Eli Lilly & Co.
the Supreme Court held that there is no apparent reason why the patent would expand on the properties and ways of action of antifolates in general if it was intended to limit the claimed scope to the product manufacted by the patentee; ¶5.5.6.
Wenn zudem in der Beschreibung erklärt wird, das für die Erfindung verwendete Antifolat sei das von der Patentinhaberin hergestellte Pemetrexed-Dinatrium der Marke ‘Alimta’, so ergibt sich daraus bei objektiver Betrachtung eine Beschränkung ausschliesslich auf dieses Antifolat im Gesamtzusammenhang der Beschreibung nicht. Denn es ist nicht erkennbar, weshalb im Patent die Eigenschaften und die Wirkungsweise von Antifolaten allgemein beschrieben werden sollte, wenn das von der Erfindung beanspruchte tumorhemmende Produkt ausschliesslich das von der Patentinhaberin hergestellte Markenprodukt sein sollte.
Concluding, the Supreme Court held that use of pemetrexed diacid instead of pemetrexed disodium infringes the patent under the DoE.
The case has been remitted to the FPC with the order to dismiss the suit with respect to the requested declaratory judgment of non-infringement for the diacid, and to also assess the two other salts that had initially been at stake in first instance proceedings.
Reported by Martin WILMING
For ease of reference, here is a list of some corresponding decisions of highest instance available elsewhere, based on the same European patent:
I will update the list when more decisions are available.
Lawyers and patent attorneys are having a hard time nowadays when advising clients on infringment under the DoE.
Maybe it should not be me to overly analyse this decision since my firm has been involved in this matter, as noted above. But I was taken aback by some key elements of the decision which are of relevance far beyond the subject-matter at stake in the present matter, and I will briefly address those aspects on a general level only, to the extent possible.
So, here is some food for further thought:
i) The gist of the DoE?
The Supreme Court comes up with a very pronounced gist of the DoE; see ¶5.5.3:
Der Schutzbereich wird – mit Ausnahme der nachfolgend zu erörternden bewusst gewählten Beschränkung – über die genaue wörtliche Anwendung der Patentansprüche hinaus gewährt in der Erkenntnis, dass es auch bei sorgfältiger und umsichtiger Redaktion unmöglich ist, in einer technischen Anleitung alle möglichen Ausführungen zu benennen. Der Schutz soll daher auch gewährt werden, wenn die technische Anleitung den Fachmann über den zu engen Wortsinn hinaus anweist, wie die Erfindung zu verwirklichen ist.
This can be loosely translated as follows:
With the exception of a deliberately chosen limitation the scope of protection shall extend beyond the literal meaning, in appreciation of the fact that it is not possible to specify all potential embodiments even when the text is redacted with all due care and diligence. Protection shall thus also be granted when the technical teaching instructs the skilled person how to work the invention beyond the overly limited literal meaning.
I do not agree.
This rationale would actually excuse each and every mishap in drafting / prosecution of an application, be it a minor negligence, a gross error or just blatant foolery. All of this could not reasonably be considered deliberately chosen (‘bewusst gewählt’) and would thus not be covered by the exception.
Now, as long as the skilled person nevertheless understands that the teaching of the patent is applicable beyond the literal meaning, it shall still be covered by the scope of the claim under the DoE?
Is this the right balance between legal certainty for the public and forgiveness of drafting / prosecution failures?
The Protocol on Interpretation of Art. 69 is not that strict. It only requires that due account shall be taken of any element which is equivalent to an element specified in the claims when determining the scope of protection. Does ‘due account’ really mean that the only exception is an express and deliberatly chosen limitation?
I am in doubt.
One of the best pieces on the various situations where the DoE is typically invoked that I have come across still is in Arnold J’s judgment at the High Court of Justice in the corresponding matter in the U.K.,  EWHC 1511 (Pat), in ¶104 ff.:
[E]xperience shows that patentees resort to arguments about equivalents in three main classes of case. The first is where, with the benefit of hindsight, it can be seen that the patent was unfortunately drafted, whether because of poor instructions from the inventor or poor drafting by his patent attorney or a combination of these things. […] The second class is where technology has moved on since the priority or filing date of the patent. […] The third class is where the patentee now regrets a decision taken during the course of prosecution of the patent application, whether by himself or by the examiner, and is trying to avoid the consequences of that decision.
Arnold J went on in his assessment of the first and the third class of cases in ¶105 and ¶107, respectively:
In the first class of case, the law recognises that drafting patent claims is a difficult and imprecise art and that third parties should not be allowed to exploit infelicities of drafting where it is reasonably clear that those infelicities should not affect the scope of the claim. This is in order to provide ‘fair protection for the patent proprietor’. The law also recognises, however, the countervailing consideration that third parties are entitled to rely on the drafting of the claim when deciding on a commercial course of action. There is no tort of avoiding a patent claim. Thus it is also necessary to provide ‘a reasonable degree of legal certainty for third parties’. The problem, of course, is that what is fair protection to one person is legal uncertainty to another. Conversely, what is reasonable legal certainty to the second person is a denial of protection to the first. The courts have to strike a balance. […]
In the third class of case, there is no reason why the law should be sympathetic to the patentee. Not only do applicants generally rely on skilled professional advice, but also they can appeal against adverse decisions of examiners during the course of prosecution if they consider that those decisions are wrong. If the courts allow decisions as to claim scope made by the examiner during the course of prosecution which have not been successfully appealed effectively to be overturned by decisions on claim construction, the courts undermine the important role of the examiner. This is still more so if the courts allow decisions as to claim scope made by the applicant during the course of prosecution effectively to be reversed by decisions on claim construction.
ii) The more apparent the replacing feature (but not too much, please!), the more likely the third question would be answered in the affirmative?
There has been a guiding principle in the assessment of equivalents according to the German Federal Supreme Court since the ‘Okklusionsvorrichtung‘ decision (X ZR 16/09):
If the description discloses several possibilities regarding how a specific technical effect can be attained but only one possibility has been included in the patent claim, the use of the other possibilities generally does not constitute an infringement under the doctrine of equivalence.
So, an explicit mentioning of two alternatives in the specification while only one of these alternatives is recited in the claim rules out an infringement under the DoE. Fine.
But what if there is explicit disclosure of a generic class of compounds (‘antifolate’) and only a single specific variant (‘pemetrexed disodium’) in the claims and specification? Luckily, the German Federal Supreme Court had to assess the parallel case in Germany, too (X ZR 29/15): It concluded that this is not sufficient per se. But if there were further indications that the skilled person reads the other variants along in his head (‘unmittelbar mitlesen’), then ‘Okklusionvorrichtung’ might well be applicable. Fine, too.
Now, this is the chemist in me speaking to the other chemists out there: Imagine you readily appreciate the below as a preferred embodiment of a group of compounds (¶5.5.7), can you avoid reading along in your head some very close relatives of this compound?
The chemist in me has a hard time to not think of some close relatives in the upper right of the molecule.
Safeguarding legal certainty for the public has always been an issue. The following is taken from Miller v. Bridgeport Brass Co. of ancient 1881:
[I]t must be remembered that the claim of a specific device or combination, and an omission to claim other devices or combinations apparent on the face of the patent, are, in law, a dedication to the public of that which is not claimed. It is a declaration that that which is not claimed is either not the patentee’s invention, or, if his, he dedicates it to the public.
In my perception, this still holds true nowadays; equivalence must not extend to what is apparent on the face of the patent, but remained unclaimed.
I have been a strong believer in the power of the questionnaires. But, frankly, I am getting more and more frustrated. When cases come up where the result based on just two questions appears to be inappropriate, a third one is added (Germany and Switzerland). If the result with three questions appears to be inappropriate, the questions are amended (UK). Still, judgments on equivalence are frequently reversed even in one and the same jurisdiction, and are rarely consistent across jurisdictions. So, what is it all worth? The questionnaires apparently only provide an illusion of certainty, don’t they? And they are not the law. (If you catch me red-handed when using the questionnaire nevertheless, don’t blame me for this paragraph. I am just conforming with the landmark case law …)
iii) What about inventive equivalents?
The Supreme Court elaborates on the second criterion (accessibility / ‘Auffindbarkeit’) in the assessment of equivalents in ¶5.4 ff. It is held in ¶5.4.1:
Der Fachmann […] muss aufgrund seines Allgemeinwissens durch die patentierte Erfindung zur Abwandlung angeregt werden; beruht die Abwandlung ihrerseits auf erfinderischer Tätigkeit, ist die Auffindbarkeit ausgeschlossen (vgl. BGE 125 III 29 E. 3b S. 32 mit Verweisen).
Loosely translated as follows:
The skilled person must be prompted to the replaced feature by his common general knowledge and based on the patented invention; accessibility is ruled out if the replacing feature itself is based on an inventive step ([…]).
The decision suggests in ¶5.4.1 that this is common ground for the Supreme Courts of the UK, Germany and Switzerland.
The second test applied by the German courts, as I understand it, at least sometimes appears to require the variation not to be inventive, but I am not sure that that is an appropriate requirement, although it is unnecessary to decide that point on this appeal. If the variation represents an inventive step, while it may render it less likely that the patentee will succeed on the second reformulated question, I find it hard to see why that alone should prevent the resultant variant from infringing the original invention. It may entitle the infringer to a new patent, in the same way as the invention of a novel use for a patented invention can itself be patented, but like such a novel use I see no reason why the variant should not infringe the original patent.
I am not even sure if this holds true for Switzerland. The Supreme Court’s own landmark ruling ‘Urinalventil’ (4A_131/2016) marches to a different drummer, in my perception. In that later case, the replacing feature in the attacked embodiment was in fact patented by the EPO, with the patent in suit being explicitly acknowledged as closest prior art. The attacked embodiment had nevertheless been held to infringe the patent in suit under the DoE. See this Blog here for a detailed review of the ‘Urinalventil’ case.
Moreover, the second question in the FPC’s questionnaire in no way excludes inventive equivalents; see this Blog here. The headnote in O2014_002 reads as follows:
The assessment of accessibility is not to be confused with the assessment of inventiveness. Starting point for the assessment of accessibility is not the general state of the art, but the patent in suit. Therefore it is not to be assessed whether the replaced feature is inventive in view of the state of the art. It is rather to be assessed whether, starting from the teaching of the patent in suit, it is evident for the skilled person that the replaced feature has the same effect (r. 220.127.116.11).
(Clarification of the case law with respect to S2013_001, decision dated 21. März 2013)
iv) Should one care (more) about the title?
There are multiple references to the title of the patent in particular in the reasons of the Supreme Court’s decision (p. 2, section A; ¶5.5.5; ¶5.5.6:
[…] Patent[s] […] dessen Gegenstand umschrieben ist als “Combination containing an antifolate and methylmalonic acid lowering agent” […];
In der Beschreibung ist – wie im Titel des Patents – allgemein von Antifolaten die Rede.
This emphasis on the title puzzles me. It is required by the EPC that the title of the invention must be contained in the request for grant form and that it shall clearly and concisely state the technical designation of the invention (R. 41(2) lit. b EPC), no doubt about it. However, the title is not part of the description (R. 42 EPC) which shall be used to interpret the claims (Art. 69(1) EPC) in accordance with the Protocol on Interpretation of Art. 69.
I am not aware of any relevant decision on equivalents that has put this much emphasis on the title.On a personal note, I couldn’t have cared less about the title by now. A negligence?
v) Final thoughts
There were times (in particular in Germany after introduction of the third criterion (‘Gleichwertigkeit’)) when the DoE effectively was dead. In my perception, the pendulum now swings back and we see decisions more to the contrary. Over time, the ‘truth’ will be somewhere in between. Hopefully.
Exhausted from equivalents, I remain
If you came here on a shortcut, you missed a lot. Anyway, I will assume this was your ‘delibarately chosen limitation’ of information. The decision holds:
Limitation of ‘antifolate’ to ‘pemetrexed disodium’ during prosecution did not constitute an abandonment of subject-matter.
A composition comprising pemetrexed diacid infringes a claim specifying pemetrexed disodium under the DoE.
The case is remitted to the FPC to with the order to dismiss the suit with respect to the requested declaratory judgment of non-infringement for the diacid, and to also assess the two other salts that had initially been at stake in first instance proceedings.
This decision of the Supreme Court of Switzerland concerns an appeal against a decision of the Princely High Court of Liechtenstein in a patent infringement case.
This setup demands for some explanations right from the outset.
Switzerland and the Principality of Liechtenstein form a unitary territory of protection; see the Bilateral Protection Act (‘Patentschutzvertrag‘, an English translation is available here). The Princely High Court is designated as the competent court in civil cases regarding patent matters in Liechtenstein. An appeal to the Swiss Supreme Court is possible with regard to issues of substantive law (BGE 127 III 461, r 3d); the Supreme Court Act applies. On the other hand, issues of international private law (BGE 127 III 461, r 4b) and procedural law of the Principality of Liechtenstein (4A_681/2012 and 4A_683/2012) are not to be dealt with by the Swiss Supreme Court.
All this may well add a further layer of procedural complexity on top of the inherent complexity of any patent litigation.
But at least the subject-matter at stake appears to be rather straight-forward: It’s all about a plastic container with a lid and snap closure, illustrated as follows:
The snap-mechanism can be released by pushing the nose (15) inwards and pulling the gripping member (9) outwards, illustrated by forces K3 and K2, respectively, in Fig. 4 below. The lid can then be lifted easily with force K1. However, if only the lid is lifted (force K1′) without prior release of the snap-mechanism by forces K2 and K3, the nose 15 slides to the exterior into a safety position; see Fig. 6 below.
A plastic Container with a lower part (1) and a lid (2) as well as at least one snapping mechanism (9-18) for attaching the lid (2) to the lower part (1), wherein the snapping mechanism comprises a first and a second member (12-15; 9, 11, 17, 18), wherein the members are snapped into each other in a closed position and resist against an opening of the lid (2) by a nose (15) of the first member abutting against a stopping surface (18) of the second member, wherein for opening the lid (2) the members can be brought into an opened position by urging the nose (15) in a first direction from the stopping surface (18) by elastic deformation of at least one of the members, and wherein by exertion of a sufficient opening force (K1′) on the lid, the nose (15) can be urged from the stopping surface (18) in a different second direction and the members can be brought from the closed position into a safety position, where they form a connection positively acting against the opening force, characterised in that an opening (11) is arranged in an edge region of the lid (2), the lower edge of which opening forms the stopping surface (18), and that the nose (15) is connected to the lower part (1).
The complaint (apparently against members of the Hilti group of companies) had been filed back in September 2012. The Princely High Court appointed a court expert to assess validity and infringement of the patent: Dr. Tobias Bremi, who is also the second ordinary judge of the Swiss Federal Patent Court. The expert held that the attacked embodiment is literally covered by claim 1 of the patent, but that the patent is invalid for lack of novelty. However, it may be concluded from the decision that the court-appointed expert somehow indicated that the subject-matter of dependent claim 10 would be valid and infringed.
Later, the patent has been limited in central EPO proceedings by addition of the following feature to claim 1:
the upper border area (3) of the lower part (1) is reinforced by a double wall
No, it’s not what you might expect: The additional feature is not the subject-matter of former claim 10, it rather has been taken from the description. The limited patent has been republished as EP 0 767 106 B3.
The expert accordingly delivered a second opinion on the limited patent in December 2015: The attacked embodiment was still covered by amended claim 1, but the claim was still not novel over the same prior art document. Even worse, the amendment was held to be in violation of Art. 123(2) EPC, i.e. that the amended claim contained subject-matter which extended beyond the content of the application as filed by way of an intermediate generalisation.
The Princely High Court thus dismissed the complaint with decision of 24 November 2016, ie well after the patent had finally lapsed on 30 September 2016. On appeal to the Swiss Supreme Court the plaintiffs essentially requested that the decision of the Princely High Court be set aside and that the case be remanded to the Princely High Court for reappraisal. The plaintiffs / appellants apparently argued that the amendment to claim 1 was not an unallowable intermediate generalisation. Moreover, it was argued that claim 10 as such was valid and infringed.
In first place, the Supreme Court held that the plaintiffs / appellants had no legitimate interest anymore in injunctive relief since the patent had meanwhile lapsed. The appeal has not been considered to this extent.
Second, the Supreme Court dealt with the aspect of information and accounting. The Supreme Court would have been competent to decide on the merits; Art. 107(2) SCA and Annex I to the Bilateral Protection Act (‘Patentschutzvertrag’) which refers to the Swiss Code of Obligations. However, only remandment to the Princely High Court had been requested. The Supreme Court has thus not considered the appeal to this extent, either.
Finally, the Supreme Court held that partial validity of dependent claim 10 of the patent (as originally granted) had not been at stake in proceedings before the Princely High Court, and any arguments in this respect were new and inadmissible. The Supreme Court noted that the plaintiffs / appellants did not object to the finding of the lower court that claim 1 was not novel, neither in the initially granted form (EP’106 B1) nor in the subsequently limited form (EP’106 B3). However, according to the Supreme Court, already this finding justifies the decision as such.
At the face of it, the Supreme Court decision appears to be very straight-forward. But the devil may well be in the unrevealed details. E.g., it would be interesting to learn more about the reasons for the limitation, and what had actually been argued with respect to claim 10.
What is not readily clear to me is how the Supreme Court dealt with the plaintiff’s auxiliary request that had been on file before the Princely High Court. The patentee had eventualiter invoked the patent only to a limited extent, and this limitation actually reflected the additional features of dependent claims 9 and claim 10 (note that claim 10 is dependent on claim 9):
[9. …] in the closed position the nose extends from an inner side into the opening;
[10. …] in the closed position an outer side of the nose is substantially flush with an outer side of the edge region of the lid.
In my perception, validity of the combination of claims 1, 9 and 10 must have been at stake before the Princely High Court, contrary to what the Supreme Court decision suggests. When a patent is invoked only to a limited extent, validity should also be assessed to that extent; see this Blog here.
I am still trying to get a hand on the decision of the Princely High Court, to gain further insight …
This case relates to a folding buckle for watchbands featuring biometric recognition of individual vein patterns. For further background information on the assignment action, please see this Blog here (S2017_003, decision of 25 April 2017).
The plaintiff had lodged an appeal to the Supreme Court against the FPC’s interlocutory decision in summary proceedings, but only challenged the apportionment of costs. However, apportionment of costs in summary proceedings does not cause irreparable harm in the sense of Art. 93(1) lit. a SCA since apportionment can be challenged with an appeal against the final decision; Art. 93(3) SCA (see decisions 4A_24/2017, r 2.2; 135 III 329, r 1 and 138 III 94, r 2).
There is one main proceeding pending (infringement and nullity) at the end of the reporting year which is just outstanding. It had been pending at a cantonal court for already 1’335 days, and is still pending at the FPC since 810 days. This makes a total of 2’145 days, ie almost six years. I guess it’s this semi-submarine here. I trust the decision will be a nice read — if it ever emerges …
Well, the case took yet another procedural twist (ie an interim excursion to the Supreme Court), with no apparent progress on the merits.
The plaintiff had been granted legal aid for his infringement complaint; see the review of the matter on this Blog here, with further reference. One of the appointed representatives moved to another law firm later. This is not in itself a problem. But unfortunately he moved to the law firm who represented the defendant.
Whatever can go wrong, will go wrong.
The representative stepped back and a new representative needed to be appointed. The other already appointed representative indicated that he was still willing and able to further represent the plaintiff, together with a further attorney of the same firm. The FPC issued an order in this respect, and this could have been it. But the plaintiff would meanwhile have liked to be represented by a different attorney from yet another law firm – and lodged an appeal to the Supreme Court.
The Supreme Court’s ruling is clear cut. Legal aid does not generally provide for a free choice of the representative. No special circumstances had been brought forward that would render the appointed representatives unacceptable for the plaintiff, either.
I remain in eager expectation of the next read in this matter. Next, it will have to be established on a preliminary basis whether or not the claim is already time-barred.
The patent in suit is CH 701 971 B1; see Swissreg for further details. In a nutshell, ECC claimed CH’971 is a patent for the technology it alleges Nestlé Nespresso uses to block its capsules. The suit had been flatly dismissed with decision O2015_001 of 12 July 2016. The FPC held that the phrase ‘toute capsule’ / ‘any capsule’ means (literally) any capsule that is suitable for use in the machines to prepare coffee, irrespective of whether or not the capsule is retained in the machine thereafter.
[…] l’expression «toute capsule» signifie dans le présent contexte toute capsule susceptible d’être utilisée dans le dispositif (machine à café) en question, de façon à permettre la préparation d’une boisson extraite (un café), ceci indépendamment de la question de savoir si une telle capsule est retenue dans la cage après l’extraction.
The plaintiff had admitted that ECC’s modified capsules were not retained in the attacked devices. Likewise, the defendant had submitted that not all capsules are retained in the attacked devices. Concluding, the FPC held that the attacked embodiments evidently did not retain ‘toute capsule’ / ‘any capsule’. The FPC further held that the request for injunctive relief reached beyond the scope of protection conferred by the patent, and the suit had to be dismissed for this reason, too.
For further background information and details of the underlying decision O2015_001, please see this Blog here.
It had been known since April 11 that the Supreme Court had dismissed ECC’s appeal with decision of 07 April 2017:
ECC essentially argued that the generic term ‘any capsule’ meant ‘capsule of any kind’ or simply ‘capsule’ — and that the claim does not require that systematically all capsules deformable upon contact with hot water are retained. Rather, it would suffice if only a relatively high number of such capsules were retained. In a nutshell, the Supreme Court holds that there is apparently no specific meaning of the term ‘any capsule’ in the specific technology, and that the literal meaning is perfectly clear. The appellant did not identify any part of the specification of the patent that would allow for a different interpretation.
Stakes are high: Cialis® still is one of Lilly’s top-selling drugs; it has generated a worldwide revenue of $2,311 million in 2015. Cialis® had been protected by the compound patent EP 740 668 B1 (see Swissreg and the EPO Register for further details, in particular the legal status information), but the patent had reached its maximum term already back in January 2015. However, Cialis® is still protected by supplementary protection certificates (SPCs) which are about to lapse in ‘major European countries’ in November 2017 (see Lilly’s Annual Report 2015, p F31 and F16; and e.g. the SPC in the German Register).
Swissmedic granted market approval #56018 for Cialis only on May 4, 2004, and this is why the timeline is different in Switzerland. The Swiss SPC C00740668/01 for tadalafil is valid until May 3, 2019.
EP’092 would have reached its maximum term only about 1.5 years after the end of the term of the SPC. But the FPC had declared EP’092 invalid with decision O2015_007 of 17 February 2016, commented on this Blog here. Noteworthy, this was a decision rendered in absentia. The defendant / patentee had undoubtedly been served with the writ via diplomatic channels — but did not take up the fight.
It turned out later that the writ apparently had been internally mishandled and that ICOS only got aware of the proceedings when the decision had already been issued. ICOS tried to re-start the first instance proceedings via restitution, but the FPC dismissed ICOS’ request for restitution; see this Blog here. This dismissal has not been appealed.
ICOS also lodged an appeal against the first instance judgement in absentia and requested that the first instance judgement be lifted, the case be remitted to the FPC and that a time limit be set to respond to the writ. This appeal has now been dismissed.
Now, what is this appeal all about?
A firm of patent attorneys had been indicated as ‘representative’ in the Swiss patent register Swissreg. However, the writ had been served to and well received by the patentee in the U.S.; the appeal is all about whether or not this service had been correctly effected.
i) Is the firm of patent attorneys listed as ‘representative’ in Swissreg an active representative in the sense of Art. 137 CPC?
A legal entity may well represent clients before the Patent Office in administrative proceedings; Art. 1(3) PatAA. Not so before the FPC. The Supreme Court thus holds that an active representation can be ruled out for this reason alone.
ii) Is the firm of patent attorneys an address for service of process, a passive representation / domicile for service in the sense of Art. 140 CPC?
The decision discusses the various changes to Art. 13 PatA; it now reads as follows (emphasis added):
(1) Any person who is involved in administrative proceedings provided for in this Act and does not have a residence or principle place of business in Switzerland, must designate an address for service in Switzerland. […]
Earlier versions explicitly recited representation also before civil courts, but this has been deleted with effect as of January 1, 2011. The Supreme Court thus holds that the writ had not to be served to firm of patent attorneys listed as representative in Swissreg; this would actually have been unlawful. Rather, it had been correctly served to the patentee according to Art. 137 CPC.
iii) Did the FPC violate the good faith principle?
All those who participate in proceedings must act in good faith; Art. 52 CPC. The Supreme Court leaves no doubt about the fact that service of process had been correctly effected, and that neither the FPC nor the plaintiff had any reason to act differently.
The Supreme Court thus dismissed ICOS’ appeal and the Swiss part of EP 1 200 092 B1 is finally revoked; see Swissreg.
What’s going on elsewhere?
The subject-matter is currently being litigated in various countries. To the best of my knowledge, no decision has upheld EP’092 by now.
A publicly available judgement has e.g. been issued by the District Court of The Hague, the Netherlands, on 26 October 2016 (case no. C/09/493389 / HA ZA 15-862), revoking the patent on substantive grounds. You will find a brief review of this decision on EPLAW Patent Blog.
Likewise, EP’092 has been held invalid by the England and Wales Patents Court (Birss J) with judgment of 10 August 2016 (case no.  EWHC 1955 (Pat)). A brief review of this decision can be found e.g. on Lexology.
The FPC had declared ICOS’ EP 1 200 092 B1 invalid with decision of 17 February 2016 (O2015_007); the patent relates to certain formulations of tadalafil, the active ingredient of one of Lilly’s top-selling drugs, Cialis®. This decision had been rendered in absentia; ICOS had failed to respond. The writ had been served to and received by ICOS in the U.S., but has apparently been mishandled internally. A request for restitution has been dismissed by the FPC with decision of 23 May 2016 (O2016_002). ICOS also appealed the decision of 17 February 2016 and alleged incorrect service of process. The Supreme Court now dismissed the appeal and held that the writ had correctly not been served to the firm of patent attorneys listed as representatives of the patent in Swissreg. The Swiss part of EP’092 is thus finally revoked.
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Note that Hepp Wenger Ryffel is involved in this matter on behalf of the defendants.
For a review of the FPC’s underlying decision O2012_043 of 10 June 2016, please see this Blog here. In brief, Bombardier alleged infringement of EP 1 963 157 B1 (see EPO Register and Swissreg for bibliographic details). Stadler’s electric double-deck trains RABe 511 KISS were at stake, more specifically the pairwise arrangement of transformer units and power converter units at the wheel units of the train. The defendants of the Stadler group of companies essentially argued for nullity as a plea in defense and alleged a prior user right; Art. 35 PatA.
The FPC held that EP’157 is not novel over documents which had been sent by ABB to both Siemens and Stadler in parallel, in an informal reply to a request for an offer from Siemens. The mere fact that ABB deliberately distributed the documents not only to Siemens but also to yet another third party (the defendant) made clear that ABB had no interest in any confidentiality. The alleged prior user right had been acknowledged in the interim assessment (Art. 35 PatA), but could be left undecided in view of the lack of novelty of the patent in suit.
For further details on the background of the case and the actual subject-matter at stake, please see the report from the main hearing on this Blog here.
The Supreme Court now had a second look at it:
The plainfiff’s appeal was all about whether or not the exchange of the novelty-destroying documents had been subject to implied confidentiality between ABB, Siemens and Stadler. Towards this end, the plaintiff had requested before the FPC that a witness be heard with respect to the (existence of a) development cooperation between ABB, Siemens and Stadler. However, the witness had not been heard. On appeal, the plaintiff alleged a violation of his right to be heard. The Supreme Court holds that even if a development cooperation had existed, this would not have been sufficient to conclude that an implied confidentiality had existed with respect to the relevant documents at stake.
Die Vorinstanz hat die von der Beschwerdeführerin behauptete Zusammenarbeit zwischen den Beschwerdegegnerinnen, Siemens und ABB im Ergebnis zutreffend als nicht hinreichend für den Schluss angesehen, dass die beanspruchte Lehre durch die Korrespondenz vom April/Mai 2003 (wegen vereinbarter Geheimhaltung) nicht neuheitsschädlich vorweggenommen ist.