DISCLOSURE NOTICE: Hepp Wenger Ryffel is involved in this matter on behalf of Mepha.
deferasirox
This case is about deferasirox, an iron chelating agent. It is mainly used to reduce iron overload in patients who are receiving long-term blood transfusions in the treatment of chronic anemias.
The FPC has been busy with deferasirox since early 2021 in litigation between Novartis and Mepha. The crucial feature in terms of infringement was the amount of deferasirox. In short, the independent claims of both patents, EP 202 and EP 018, require 45-60% by weight of deferasirox. The attacked embodiment contained 64.3% by weight.
Now, is that an infringement?
It’s apparently been a tricky thing for the FPC:
On request of Novartis, a PI had been issued by the FPC with judgment of 15 December 2021, in view of an infringement under the DoE; see this Blog here.
In main proceedings, the outcome was different. With judgment of 20 April 2023, the FPC (with an enlarged panel of five judges) ruled that there was no infringement under the DoE. See this Blog here.
Novartis appealed, and the Supreme Court meanwhile affirmed the FPC’s finding of non-infringement under the DoE.
What the supreme court said
The FPC had answered the first and the second question of the three prong questionnaire in favor of Novartis. Not so for the third question with respect to ‘equal value’. Accordingly, Novartis’ whole appeal was only about the FPC’s assessment of the third question:
First, the Supreme Court summarizes what the FPC had held: The disclosure of a preferred value in conjunction with a claim that spells out a numerical range that comprises this preferred value is legitimately understood by the skilled person as a waiver of the patentee for values outside of the claimed range:
The Supreme Court has no issues with this assessment. On the contrary (my translation; emphasis added):
[T]the appellant does not explain the purpose of the precisely defined numerical range in the claim, which comprises the preferred value in the description, other than a waiver of values outside the exact range. If the patent proprietor does not wish to be limited to such a range and does not wish to exclude general tolerances beyond this, it is up to it to formulate its claim accordingly. The appellant is responsible for the fact that it did not define a broader or openly phrased numerical range in the claim without providing clear indications that the range could be exceeded.
Putting it differently later, the Supreme Court held (again, my translation; emphasis added):
It cannot be inferred from [the patents in suit] that compliance with the specifically claimed numerical values is not important. In this respect, the assessment of the lower court is in line with BGE 143 III 666, r 5.5.3, where it is stated that the limitation of the scope of protection to the literal embodiments is justified insofar as the third party skilled in the art may understand the patent in such a way that the proprietor has excluded protection for the equivalent embodiments. Whoever expresses his intention expressly or implicitly must be bound by the meaning of his conduct which the addressee may in good faith attribute to this expression.
In my reading, this puts an end to any discussion of infringement under the DoE in the standard cases of a numerical range in the claim and examples within that range in the spec. It remains to be seen whether (or not) specific examples outside of the claimed range, or other strong indications that the invention also works outside of the claimed range, would actually be helpful. I have my doubts. I feel that this might probably even underline the intention of precisely the narrowly claimed range. We shall see. Someone will surely test this out, sooner or later.
what the supreme court did _not_ say
The FPC had tried to get clarification from the SC with respect to Q2 (‘accessibility’), too:
However, the SC did not jump on it in the case at hand. Novartis’ appeal only pertained to Q3 (‘equal value’), and the SC could decide on the appeal without the need to dive into the ‘accessibility’ discussion.
We will thus have to live with Q2 as it stands for a little longer. But clarification is clearly needed. To me, the current assessment of Q2 in retrospect is devoid of any meaning. I stand to be proven wrong, but I believe it is a bogus question that will hardly ever be answered in the negative.
Art. 229 para. 1 CPC ① Proper nova
The decision of a Board of Appeal of the European Patent Office which also concerns the patent in suit is a genuinely novel fact within the meaning of Art. 229 (1) (a) of the Code of Civil Procedure. →
Art. 51 PatA, Art. 66 let. a PatA, Art. 69 EPC ③ Infringement by equivalent means
If a preferred value is mentioned in the patent and a range is claimed in the claim that includes this value, the skilled person assumes that the patent proprietor has waived protection for values outside the claimed range. →
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This judgment in litigation between Mepha and Novartis covers both Mepha’s revocation action with respect to EP 202 and EP 018 (O2021_004) and Novartis’ conterclaim for infringement of both patents (O2021_005) by Deferasirox-Mepha® (Swiss market authorization no. 67678).
Fe(III) chelate
Deferasirox is an iron chelating agent; it is frequently referred to simply as DFX. It is mainly used to reduce iron overload in patients who are receiving long-term blood transfusions in the treatment of chronic anemias.
The FPC had issued a PI in summary proceedings in December 2021; see this Blog here. This finding has been reversed with the present landmark ruling in main proceedings, by an enlarged panel of five judges: The judgment holds that both patents are not infringed, neither literally nor under the DoE. This is what hn ③ is all about.
But let’s take it one step at a time, walking through all headnotes.
Board of appeal decision is proper novuM
Hn ① relates to a procedural matter:
Novartis logo
Let me put this into context first. In litigation at the FPC, parties have two unrestricted opportunities to comment on the merits of the case and, in particular, to introduce new facts into the proceedings. Thereafter, new facts and evidence (nova) can only be introduced under the limited conditions of Art. 229 CPC.
According to the Supreme Court (BGE 146 III 416, r. 4.1; see this Blog here), filing of a new claim set is to be treated in the same way as the submission of other nova. In the underlying case of this Supreme Court judgment, the patentee had partially waived the patent in ex parte proceedings at the Swiss IPI (Art. 24 PatA, comparable to limitation proceedings under Art. 105a EPC at the EPO) only after the closure of the file in co-pending litigation, and was barred from introducing the limited claims into the civil proceedings. The Supreme Court considered the limited claims as an improper novum under Art. 229 para. 1 let. b CPC: Even though the limited claims came into existence only after closure of the file, they could have come into existence earlier, only depending on the decision of the patentee with respect to both timing and extent of the partial waiver.
The present judgment holds that the situation in inter partes opposition / appeal proceedings at the EPO is different. First of all, such proceedings are not initated by the patentee. Second, and even though it is the patentee who formulates the wording of all his auxiliary requests, it is difficult for him to predict which of the auxiliary requests (if any) will survive examination on the merits. Finally, the timing of such inter partes proceedings is determined to large extent by the conduct of the other parties and the procedural calendar of the Board of Appeal. In sum, the FPC holds that the patentee is completely deprived of control over the time and at least partially deprived of control over the version in which the patent is maintained.
Let’s have a closer look at T 1057/21. EP 018 was maintained based on auxiliary request #48(!) of 71 auxiliary requests in total. Auxiliary request #48 had been initially filed as auxiliary request #38 in first instance proceedings on 19 February 2021, more than a year before closure of the file in nullity proceedings O2021_004. Patentee re-shuffled his requests later, i.e. the Board of Appeal did not deal with 47 requests before it finally allowed auxiliary request #48. Rather, the patentee made this request his new main request in the oral proceedings before the Boards of Appeal on his own volition, and this new main request was found allowable.
Undoubtedly, it is an uncomfortable situation for patentees to coordinate national nullity proceedings (governed by the strict rules on nova after closure of the file under the CPC) with co-pending central opposition / appeal proceedings at the EPO. Which is why some countries rule out national nullity proceedings while EPO opposition / appeal proceedings are still pending (e.g. Germany; see § 81(2) PatA); not so in Switzerland. The FPC’s approach will surely be appreciated by patentees, if and when it is ultimately approved by the Supreme Court.
burden of proof for technical effects
Hn ② relates to the allocation of the burden of proof for the technical effect(s) of the invention. Now we know:
On a quick read, the hn might suggest that it is up to the patentee to actually prove the technical effect, while the plaintiff in invalidity proceedings can sit back and just grouse that the claimed technical effect has not been proven (yet). But beware: The hn only deals with the allocation of the burden of proof. It does not say anything about the standard of evidence according to the lex fori. The regular standard of ‘full conviction’ applies in Switzerland, which according to settled case law means that the court should have no serious doubts about the existence of the alleged fact, or that remaining doubts appear to be slight.
Now, what does that mean for assessment of an alleged technical effect of an invention?
The proof does not necessarily have to be provided with empirical data or even clinical studies. If the person skilled in the art can conclude on the basis of scientific or theoretical considerations that the claimed technical effect exists, this is sufficient proof. When assessing the evidence, it may also be taken into account which indications speak against the claimed technical effect. If there are no such indications, the requirements for proving the technical effect are lower.
it takes two …
Not much of a surprise, isn’t it? In practice, it takes two to tango: The more indications are on the table that the effect is not achieved, the harder it will be for the patentee to actually prove the contrary. Even though the burden of proof lies with the patentee in the first place (which is also the case at the EPO, see e.g. T 1188/00 (hn) and G 2/21 (r. 26)), the whole discussion about whether or not a certain technical effect is achieved is an argumentative arm wrestling.
Numerical ranges / infringemement under the DOE
The judgment holds that both EP 202 and EP 018 as amended in opposition/appeal proceedings are valid (r. 46-67) but not infringed, neither literally nor under the DoE.
The decisive feature in terms of infringement is the amount of deferasirox. The independent claims of both patents require 45-60% by weight of deferasirox. The attacked embodiment contained 64.3% by weight, based on the information given in the product information; r. 68. Even the lowest (disputed) analytical value submitted by the patentee was 60.8%. The judgment holds that even in case of the lower value literal infringement is ruled out. The skilled person will typically consider numerical ranges as more precise and more clear than other verbally described technical claim features (in line with the judgments X ZR 168/00 — Schneidmesser I (r. II 3 lit. d) and X ZR 135/01 — Schneidmesser II (r. 4 lit. d) of the German Supreme Court). Accordingly, also values within usual tolerances are not literally covered. The skilled person knows, however, that technical numerical ranges are subject to a measuring error. Therefore, as a rule, the last digit of numerical values corresponds to the measurement accuracy. If no other error limits are indicated (as is the case here), the maximum error for the last digit is estimated from the rounding convention; see e.g. T 175/97 (r. 2.6). The judgment holds that this case law developed for prior art disclosures equally applies to the interpretation of numerical ranges in patent claims. Since the claimed range is given without any decimal digits, the range that is still within the literal scope of protection is ≥44.5% to <60.5% if the normal rounding convention is applied.
Accordingly, and in particular in the absence of any teaching in the patents that would point to a broader interpretation of the claimed range, the judgment holds that neither 64.3% nor 60.8% is literally covered by the claims.
Turning to infringement under the DoE (r. 73 et seqq.), the judgment holds that the variant has the same effect; i.e., Q1 of the three prong test is answered in the affirmative (not much out of the ordinary for generics).
As to the second question re accessibility of the variant (‘Auffindbarkeit’), the judgment holds that there is currently some uncertainty as to whether this should be dealt with in retrospect (i.e., in knowledge of the variant like in the U.K.), or not (like in Germany); r. 77. It is hoped that the Supreme Court clarifies its position when it gets the chance (which is now):
In the case at hand, the FPC held that it does not matter: The same effect of the variant was ‘accessible’ without involvement of an inventive step in any event; r. 78. Thus, Q2 is answered in the affirmative.
Q3 is meant to safeguard the legitimate interest of the public in legal certainty. Here it is (my own understanding / translation):
Does an objective reading of the patent specification lead the skilled person to the conclusion that the patentee has formulated the claim — for whatever reason — so narrowly that he does not claim protection for an embodiment of same effect (Q1) that is ‘accessible’ for the skilled person (Q2)?
The single embodiment of both patents makes use of 56% of deferasirox (para. [0016] von EP 202; para. [0017] von EP 018). In the claims, however, not this specific value is mentioned, but rather a range of 45% to 60%, which is evidently placed around this specific value. Under these circumstances, the judgment holds (r. 80) that the skilled person assumes that the patentee has specifically and bindingly placed the claimed range around the specific value, i.e. the patentee has deliberately decided to specify the invention to be within this range and thus to dispense with the scope of protection lying outside this range. Under the circumstance, the judgment holds that there is no room to extend this range under the DoE by taking into account generally accepted tolerances going beyond it, because the skilled person may in good faith assume that the patentee has already taken into account possible tolerances when defining the range. In passing, the judgment notes that the range is not symmetrically placed around the specific value; it rather is narrower above than below the specific value. This even underlines the importance of the upper limit. Thus, infringement under the DoE was denied.
This outcome is essentially in line with the U.K. judgment [2022] EWHC 2847 (Pat), para. 232 (emphasis added):
I have found that in the present case the inventive concept of the Patents would be seen by the skilled team as requiring strict compliance with the 45-60% range of deferasirox. On that basis a variant will not be substantially the same as the inventive concept unless it strictly complies. I need not investigate with precision what compliance means numerically as matter of general principle. In my judgment Teva DFX does not comply.
In the Swiss case, Novartis appealed to the Supreme Court. The appeal is still pending at the time of writing.
In accordance with the outcome in main proceedings, the PI was lifted with separate order.
UPDATE 28 Sept. 2023: Novartis’ appeal has been dismissed by the Supreme Court; the decision is final.
Chris HOGGETT (Carpmaels), assisting in patent matters
Joe ABDALLA (Carpmaels), assisting in patent matters
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Decision of 20 April 2023 in case of Novartis v. Mepha re Jadenu (deferasirox): in reversal of prelim injunction decision, API content outside claimed range not found infringing under doctrine of equivalents, O2021_004, O2021_005 Urteil 2023-04-20, https://t.co/xg5i0QcTpXpic.twitter.com/GOWrVhRA14
Not yet available. Currently being dealt with by the OD again, after T 1057/21, to compile the set of documents for maintenance of the patent in amended form, based on the following claims:
DISCLOSURE NOTICE: Hepp Wenger Ryffel is involved in this matter on behalf of Defendant.
deferasirox
This case is about deferasirox, an iron chelating agent. It is mainly used to reduce iron overload in patients who are receiving long-term blood transfusions in the treatment of chronic anemias.
Initially, Novartis had sold deferasirox as dispersible tablets under the trademark Exjade®. However, the dispersible tablets have been taken off the market in October 2019. They were replaced by Novartis’ Jadenu®, i.e. swallowable tablets of deferasirox.
Mepha’s Deferasirox-Mepha had been approved by Swissmedic on 24 August 2020, and Mepha lodged nullity proceedings against EP 2 964 202 B1 (EPO Register and Swissreg) and EP 3 124 018 B1 (EPO Register and Swissreg) on 19 April 2021 (case no. O2021_004). The patents in suit are currently also challenged in opposition/appeal proceedings at the EPO; both patents were maintained in limited form in first instance, with their respective main claims as follows:
In response to the nullity attack, Novartis counter-claimed for infringement on 29 June 2021 (case no. O2021_005).
Novartis logo
Shortly thereafter, Novartis requested a preliminary injunction against Deferasirox-Mepha on 11 August 2021, based on EP 202 and EP 018. A request for ex parte preliminary injunctive relief was dismissed with order of 19 August 2021, for lack of particular urgency.
With respect to infringement, it is important to recall that both patents require deferasirox to be present in an amount «from 45% to 60% by weight»; the allegedly infringing embodiment contained 64.3% by weight of deferasirox.
Novartis essentially argued that numerical values are not sacrosanct but need to be construed like any other feature, and that in particular in view of typical tolerances a value of 64.5% by weight would still be literally covered by the range of from 45% to 60% by weight. The FPC did not buy into that, in no uncertain terms:
Now, moving on to the assesement of infringement under the DoE, here is the current Swiss three-step questionnaire (as a reminder), i.e. assessment of i) same effect(s); ii) accessibility; iii) equality / equal value:
Q1: Same effect?
The judgment first elaborates on two essential issues in the assessment of Q1, i.e. the effect(s) of what; and just one, some or all effect(s)?
As to the first issue, the Supreme Court has caused some confusion amongst practitioners with a remark in BGE 143 III 666 — Pemetrexed that, at least at the face of it, might suggest that the effect of the whole claimed subject-matter is decisive, not only the effect of the replaced feature (r. 5.3.3, emphasis added):
Vielmehr muss die abgewandelte Ausführungsform alle diejenigen Wirkungen erzielen, die nach dem Verständnis des Fachmanns mit den einzelnen technischen Merkmalen des Patentanspruchs für sich und in ihrem Zusammenwirken erzielt werden sollen.
However, the Supreme Court has also explicity referred to the case-law of the German Supreme Court in the Pemetrexed case, and the German case-law undoubtedly focusses on the effect(s) of the replaced feature only. In sum, the FPC holds that it cannot see a clear deviation of the Supreme Court from the generally applied focus on the effect(s) of the replaced feature. (I hope the Supreme Court will clarify its position at the next possible occasion.)
On the second issue, i.e. which / how many effects of the replaced feature one has to look at, the judgment holds that only the desired effects of the replaced features matter (referred to as ‘erfindungsgewollte’ or ‘patentgewollte’ effects) — but that all these desired effects have to be considered (see emphasis in the above citation).
The judgment holds hat the same effect in terms of bioequivalency and swallowability suffices in the case at hand. The mere fact that plaintiff failed to establish the further desired effects of the replaced feature which are outlined in the patents in suit is held to be irrelevant because defendant could not prove that the challenged embodiments do not achieve the corresponding effects either.
Accordingly, Q1 is answered in the affirmative (same effect(s) given).
Q2: Accessibility?
Note that Q2 asks for ‘accessiblity’ of the same effect in retrospect, i.e. when the skilled person is confronted with both the claimed feature and the variant with the replacing feature: In knowledge of both, is the same effect ‘accessible’ for the skilled person?
This approach is in line with e.g. the UK Supreme Court in [2017] UKSC 48 (cf. ¶62), but markedly different to the approach of the German Supreme Court which excludes non-obvious variants from infringement under the DoE, i.e. variants that can only be found with inventive activity.
The FPC notes that, again, the Supreme Court judgment Pemetrexed (BGE 143 III 666) is not fully clear. While the earlier Supreme Court judgment BGE 142 III 772 — Urinalventil explicitly held that an inventive variant (where exactly the replacing feature is inventive over the replaced one) can constitute an infringement under the DoE (cf. r. 6.4), the exact opposite is held in the Pemetrexed case (cf. r. 5.4.1):
The skilled person must, on the basis of his general knowledge, be stimulated by the patented invention to make the variation; if the variation is itself based on an inventive step, accessibility is ruled out.
Notably however, the Supreme Court in Pemetrexed did not refer to the Urinalventil case anymore, but rather to a pretty old case that still applied a ‘gist of the invention’ approach — which is rightly considered overcome today. (Again, I do hope that the Supreme Court will clarify its position at the next possible occasion.)
Finally, the FPC holds that the current wording of Q2 may be criticized with good cause (sic!), but that it surely is not totally off-beat since it is also used by the UK Supreme Court. The FPC did not consider it appropriate to deviate from the current wording of Q2 in summary proceedings; this shall be subject to main proceedings at the FPC — and ultimately the Supreme Court (again).
In application of the current (retrospective) wording of Q2 (cf. p. 52, last para.), the judgment holds that Q2 is to be answered in the affirmative (accessibility given). However, I’m afraid the way the conclusion (and the analysis two paragraphs earlier) is phrased might well add to the confusion:
Q2 as it stands is not about accessibility of the replaced feature per se, but rather about accessibility of the same effect of the replaced feature. (‘Accessibility’ (Auffindbarkeit) is a very misleading term in the context of Q2 anyway, in my perception; ‘recognisability’ (Erkennbarkeit) would make more sense to me.)
Q3: Equal value?
The judgment holds that tolerances beyond a claimed range which are generally accepted in a certain field are covered by the claimed range, under the DoE:
Accordingly, the summary judgment holds that the patents in suit are infringed under the DoE. Interim injunctive relief was thus granted, but not to the extent of storage (‘Lagern’) and possession (‘Besitzen’); cf. p 60 (don’t be misled by the wrong marginal numbers). Further, defendant was ordered to recall the product from commercial customers within three days of receipt of the judgment; 24 hours as requested were considered too short.
As mentioned above, main proceedings are already pending.
Please see this Blog here for a detailed review of the underlying decision of the FPC in this matter.
Both parties had lodged an appeal — but the Supreme Court dismissed both appeals. While the FPC’s judgement was quite a booklet of 50+ pages, it took the Supreme Court only 7 pages to deal with both appeals. Most of the judgment indeed is pretty straight forward. Still, the judgment has quite some interesting aspects, in my perception:
Assignment of a patent does not imply assignment of the universal right to the invention per se
Montres Valgine logo
Guenat had requested that Swiss Finest‘s Swiss patent be annulled based on Art. 26(1) lit. d PatA, i.e. for lack of entitlement. However, such request can only be brought by the entitled person; Art. 28 PatA. Guenat alleged that Frédéric Garinaud transferred ‘full and complete ownership’ of the European patent application to Guenat. But that did not help. Frédéric Garinaud specifically assigned the European patent application to Guenat, but not the universal rights in the ‘invention’ itself. Guenat’s request for declaration of nullity based on Art. 26(1) lit. d PatA was thus held inadmissible for lack of standing.
On appeal, Guenat criticises the FPC’s ‘artificial dichotomy’ between the invention and the related patent application, and claims complete control over the invention in dispute. The Supreme Court didn’t buy into that. The decision holds in ¶3.2 that Guenat’s argument is based on an assumption about the parties’ intention in respect of the transfer agreement of April 2013. This is not a question of law, but of fact. But the FPC had not found that the real and common intention the parties had been to assign all intellectual property rights to the invention and the right to be granted all related patents. On the contrary, according to the FPC, the agreement in question ‘clearly refers only to the European patent application and the resulting European patent, and not to the invention as such’ — which finding is binding on the Supreme Court since it is not ‘arbitrary.’
Thus, the Supreme Court apparently had no doubt that the assignment of a specific patent does not necessarily imply the assignment of the universal rights in the invention itself.
Assessment of inventive step is a question of law, but …
Guenat argued on appeal that the FPC had violated the principle of party disposition because it took facts into account that had not been alleged by the defendant.
Now, what had happened?
The FPC had held that a specific feature (C3-1) was not disclosed in the closest prior art document. Guenat had a different understanding of the specific feature, and had argued that based on a ‘correct’ understanding of the feature it had well been disclosed in the closest prior art.
Swiss Finest logo
On appeal, Guenat argued that Swiss Finest had not even alleged that feature C3-1 was not disclosed in that document. Unfortunately, it is not readily clear from the decision to which version of feature C3-1 that allegation pertained: The feature as construed by the Guenat, or the feature as construed by the FPC?
The Supreme Court held that it had not been disputed that all the factual elements necessary for the analysis of obviousness had been brought on file by the parties. Further, the Supreme Court held that Guenat had not asserted that the FPC had to supplement the facts on its own, and that such conduct was also not apparent from the file. In the Supreme Court’s view, the FPC was thus in a position to assess obviousness, which is a question of law. It is irrelevant in this respect that the presence or absence of specific features in the prior art and/or the patent have been alleged by the defendant or the plaintiff. On the basis of the facts gathered by the parties in order to consider a question of law, the court did not violate the principle of party disposition.
Without any in-depth knowledge of what had or had not been argued by the parties, I just cannot say whether I would agree with the assessment on the merits of the case. But the Supreme Court’s general considerations on questions of law vs. questions of fact trigger some further thoughts.
Clearly, assessment of obviousness is a question of law — but the underlying factual elements still need to be asserted by the parties. But what are the ‘factual elements’? They must be something more specific than just ‘the patent in suit’, ‘D1’ or the like. Else, a court could just combine whatever is on file in its assessment of obviousness, fully detached from the pleadings. This cannot be it. Now, let’s assume that both parties come up with a somewhat strange claim construction, and base all their obviousness attacks / defenses on a wrongly construed claim. In my understanding, claim construction clearly is a question of law, too (see e.g. X ZR 255/01 – ‘Bodenseitige Vereinzelungseinrichtung’ of the German Federal Supreme Court in ¶5, with further reference). But what if no party ever pointed to the relevant underlying ‘factual elements’ (i.e. specific sections of the patent in suit) that support the ‘correct’ claim construction? May the court then even come up with a different / the ‘correct’ claim construction at all?
UPDATE 21 March 2019:
Note that the FPC had held in the recent decision S2018_006 that claim construction is a question of law. In that case, both parties had not construed the feature in question at all, and the FPC came up with a construction on its own:
Wie der Begriff korrekt auszulegen ist, tragen die Beklagten hingegen ebenso wenig wie die Klägerin vor. Da die Auslegung des Patentanspruchs eine Rechtsfrage ist,15 geht die Annahme der Beklagten fehl, das Gericht dürfe den Anspruch mangels entsprechenden Vortrags der Klägerin nicht so auslegen, dass er auch etwas anderes als einen Schneidprozess erfasst.
But, again, what if both parties came up with a claim construction mutually agreed upon — but which, in the courts view, is just wrong? Or, what if both parties come up with different constructions which are both wrong in the court’s view? Can the court then correct such (a) construction(s) if it would have to rely on ‘factual elements’ that have never been pointed at by the parties, just because it is a question of law? And if that was the case, then where is the limit in the assessment of obviousness — which is a question of law, too?
The theory of separating questions of law from questions of fact is simple. But life is complicated …
On a sidenote: Wouldn’t it be good to establish common ground on what the claim actually is all about before diving any deeper? This is what a Markman hearing in the U.S. is all about. Even though I am not overly enthusiastic about quite some aspects of patent litigation in the U.S., this one certainly is useful.
The FPC handed down the decision in this remarkable litigation about a highly complex mechanical writing system. Please see this Blog here for a report about the main hearing and some background information.
What follows is a rather lengthy post, but this is due to the complexity of the case, both procedurally and technically.
Party positions in a nutshell
It started off with Guenat‘s request that Swiss Finest‘s CH 704 790 B1 be declared invalid; note that the patent has been limited in March 2017 and re-published as CH 704 790 C1, see Swissreg for further bibliographic details. Guenat argued that the invention had been made by Frédéric Garinaud, an independent inventor who is quite renown for being the mastermind behind the Harry Winston Opus 8. Frédéric Garinaud had filed a patent application for a writing instrument; this patent application has then been assigned to Guenat and a patent was granted; EP 2 479 648 B1, see Swissreg and European Patent Register for further bibliographic details.
In Guenat’s view, the subject-matter of the Swiss Patent was invented by Frédéric Garinaud before it was used by Swiss Finest, and Frédéric Garinaud never transferred his patent rights to Swiss Finest. Guenat further argued that the invention of the Swiss Patent is obvious in view of a PowerPoint Presentation which had been sent to a third party without confidentiality obligation. Frédéric Garinaud being the only creator of the technical teachings contained in Garinaud’s European Patent and having transferred his patent rights to the plaintiff, Guenat argues that the defendant has no right to the Swiss Patent.
Swiss Finest countersued and requested that Guenat’s EP’648 be declared invalid, or assigned to Swiss Finest. Swiss Finest argued that in autumn 2010, Frédéric Garinaud had only a vague idea but had not yet completed an invention at that time. The invention was only made later with the substantial contribution of Swiss Finest’s employees after Frédéric Garinaud’s appointment as Creative Director, and any rights in the invention had been assigned to the defendant by employment contract.
Later, Swiss Finest argued that if Frédéric Garinaud was nevertheless considered to have already conceived the invention in the fall of 2010, the patent rights in this invention had been transferred to a simple partnership founded by Fabrice Thueler (owner of Swiss Finest) and Frédéric Garinaud in the preparation of a company ‘Garinaud SA’ which was foreseen to exploit the invention in dispute. Swiss Finest held thus to be the legitimate owner of the rights in the invention which is the subject of the Swiss Patent and, since the invention of the European Patent is the same, it is also entitled to the European Patent. Further, the subject-matter of the Swiss Patent was new and inventive in Swiss Finest’s view, since the PowerPoint presentation had not become publicly available because it had been sent only under an implicit confidentiality obligation. Even if one were to consider that the presentation was to be considered as prior art, the subject-matter of the Swiss patent is nonetheless inventive.
As if all this was not confusing enough, the case was spiced up further with Swiss Finest’s counterclaim for infringement by the Mechanical Fountain Pen RMS05:
Fountain Pen RMS05 by Richard Mille
This product has some amazing mechanics; see yourself:
In brief:
It’s complicated. Very complicated.
The parties’ requests — and why they failed
The stage is set with a rather complicated factual situation. But at least some of the request could be dealt with quite straight forward by the court:
Nullity for lack of entitlement
Guenat had requested that Swiss Finest’s Swiss patent be annulled based on Art. 26(1) lit. d PatA, i.e. for lack of entitlement. However, such request can only be brought by the entitled person; Art. 28 PatA. Guenat alleged that Frédéric Garinaud transferred ‘full and complete ownership’ of the European patent application to Guenat. Even though the inventions in both (Guenat’s) European and (Swiss Finest’s) Swiss patent may well be the same, this did not help. Frédéric Garinaud specifically assigned only the European patent application to Guenat, but not to the invention itself.
Guenat’s request for declaration of nullity based on Art. 26(1) lit. d PatA was thus held inadmissible for lack of standing.
Nullity for lack of inventive step
Novelty of Swiss Finest’s Swiss patent after partial surrender was not contested anymore. But Guenat alleged obviousness over the PowerPoint presentation that had been sent to Hamdi Chatti of Louis Vuitton in 2010, in further view of i) F. Lecoultre, Les Montres Compliquées, 3ème éd. Neuchâtel 1985; ii) Huguenin / Guye / Gauchat, Les Echappements, 2ème éd. Neuchâtel 1974; and/or EP 1 221 383 A1.
Louis Vuitton logo
With respect to the PowerPoint presentation, the parties dissented whether or not it had been sent to Hamdi Chatti with an implied confidentiality obligation. The last page of the PowerPoint presentation mentioned ‘breveté’ (‘patented’), even though the Swiss patent application had not yet been filed. Frédéric Garinaud was apparently aware of this faux-pas; he wrote to his patent attorney:
I confess I anticipated the patent application.
The decision holds that under the specific circumstances there was no implicit confidentiality obligation associated with the PowerPoint presentation.
It then remained undisputed that the PowerPoint presentation was the closest prior art. However, quite a lot of differentiating features were missing. The missing features could be grouped into three aspects, and three partial problems are dealt with in the decision:
amovibilité
the removable endpiece allows wide access to the pen holder, and indirectly to the other components housed in the front part of the writing instrument, avoiding manipulation by the writing tip;
échappement
the choice of an escapement as a control mechanism offering a simple and proven solution to control energy release, while producing an audible indication;
verrouillage
cooperation between the actuator and the locking system to unlock the power source to release the writing tip when the actuator is actuated, without additional action.
This is the only picture from the PowerPoint presentation in the decision:
PowerPoint presentation
As to the locking system (‘verrouillage‘), the decision holds that this was readily obvious (if not implicitly disclosed already in the PowerPoint presentation). Likewise, the escapement (‘échappement‘) is held obvious in further view of Lecoultre:
Lecoultre, p. 113
However, the removable endpiece (‘amovibilité‘) was more tricky, and the decision holds that this was not obvious from the cited prior art. When seeking a solution to the problem of replacing the ink cartridge, the skilled person would not have thought of a removable endpiece. Instead, he would have e.g. made a pen in which the writing tip as such is detachably mounted on the body or tip, like e.g. in EP'383:
EP 1 221 383 A1, Fig. 1
Thus, the subject-matter claimed in Swiss Finest’s Swiss patent was held to be non-obvious over the cited prior art.
Nullity for yet further reasons
Guenat argued for nullity of Swiss Finest’s Swiss patent for yet further reasons.
First, an alleged undue extension of subject-matter (Art. 26(1) lit. c PatA) in the course of the partial surrender according to Art. 24 PatA; see the B1 and the C1 version of the Swiss patent below.
Without setting out all the details here, both these alleged grounds of nullity failed for apparently straight forward reasons.
Entitlement to Guenat’s European patent
The invention disclosed in the European Patent was already disclosed or was obvious to a large extent from the PowerPoint Presentation prepared and sent by Mr. Garinaud on November 17, 2010; see above — with the only exception of the removable endpiece. This removable endpiece was first mentioned by Frédéric Garinaud’s patent attorney François-Régis Richard (e-patent). In an email dated December 9, 2010, he wrote to Frédéric Garinaud:
I am also realizing that for the change of the cartridge, it would probably be simpler to disassemble the pen by its front part to avoid exposing the watch mechanism in the back.
This undisputedly was the first note of the removable endpiece. Whether the rights to this creative contribution were transferred to Frédéric Garinaud, as alleged by Guenat, could remain open. In any event, it had not been alleged that François-Régis Richard transferred the rights to Swiss Finest. Rather, Swiss Finest only held that the invention was made by Frédéric Garinaud when he was employed at Swiss Finest — which could not be true given the PowerPoint presentation and the email of December 9, 2010.
The decision thus holds that the subject-matter of claim 1 of the Swiss patent was created by Frédéric Garinaud before its use by Swiss Finest — with the exception of the removable endpiece which was proposed by François-Régis Richard without having assigned his rights in this contribution to the defendant.
In anticipation of this outcome, Swiss Finest apparently modified its position later and alleged that it had obtained rights in the European Patent by virtue of a simple partnership agreed between Frédéric Garinaud and Fabrice Thueler in preparation of a company ‘Garinaud SA’ to be established.
However, this was not convincing, either. The decision holds that it is unclear how the right to the patent, even if it had been transferred to the simple partnership, should finally reside with Swiss Finest. Members of a simple partnership are joint owners of the assets, with the consequence that they can only dispose of them jointly. In any event, according to the defendant’s allegations, Frédéric Garinaud and Fabrice Thueler were the partners of the simple partnership. A patent right could therefore only belong to them jointly. However, the defendant did not allege that Frédéric Garinaud agreed to transfer the right to the patent to it.
Injunctive relief
Swiss Finest’s request for injunctive relief in respect of the ‘Mechanical Fountain Pen RMS05’ failed for a lack of concreteness of the attacked embodiment. See e.g. this Blog here (O2012_004, ‘Leichtbeton’) for further information on the necessary concreteness of a request for injunctive relief.
Swiss Finest did not argue for literal infringement, but rather only for infringement under the Doctrine of Equivalents (DoE); see below. Still, the request for injunctive relief merely recited the wording of the claims, and was thus held inadmissible.
Infringement by the Mechanical Fountain Pen RMS05
RMS05 (annotated)
Even though the request for injunctive relief was held inadmissible, the court still dealt with had to assess whether or not the RMS05 was infringing. Confused? I will clarify this later; see below.
It was undisputed that the RMS05 did not comprise a removable endpiece (’embout amovible’). However, Swiss Finest alleged that the function of the removable endpiece is to allow the writing tip to be removed from the pen body to allow an ink cartridge to be inserted or replaced. Swiss Finest further alleged that the fountain pen holder (indicated by the white arrow in the annotated figure) can be unscrewed and removed from the body using a wrench formed in the cap of the pen to place and replace an ink cartridge. In Swiss Finest’s view, the removable fountain pen holder inserted into the endpiece of the RMS05 amounts to an infringement under the DoE.
First, the court carefully defined the function of the removable endpiece in the context of the invention and reverted to ¶ [0015] of the Swiss patent:
It can still be noted that, to have access to the pen holder, the endpiece is screwed on the body and can therefore be unscrewed. The ink supply can then be changed by disassembling the pen holder and the intermediate holder.
The decision holds that this function does not exist in the RMS05. The endpiece is not removable and the disadvantage of the access to the fountain pen holder still remains in the RMS05. The fact that the fountain pen holder of the attacked embodiment can be removed does not change anything in this respect, because according to the Swiss Patent, after unscrewing the endpiece and facilitating access, the fountain pen holder is also removed to replace the cartridge.
As can be seen in the below screenshot of this video on YouTube, the fountain pen holder can be gripped with the cap and removed to replace the ink cartridge. However, the endpiece is fixed (indicated by the white arrow in the screenshot below).
RMS05, replacement of ink cartridge
Therefore, there is no removable endpiece in the RMS05, neither literally nor under the DoE, because the function of the removable endpiece is not realized in this pen. Thus, already the first question of the questionnaire established with O2014_002 was denied.
In sum, neither party succeeded with any attack. This somehow reminds me of the ‘Hornberg salute’:
‘Hornberger Schiessen’
What the decision might be cited for
Competency for assignment of all national validations of a European patent
Swiss Finest had requested that Guenat’s European patent be assigned to them. This was interpreted by the court as to concern all national validations of the meanwhile granted patent. To the best of my knowledge, it had been mentioned for the first time in O2015_009, ¶ 2.1, that the FPC is competent to decide also on ownership of foreign rights — without any in-depth discussion because it had not been decisive anymore in that case.
Not so here. The court now took the chance to set out its reasoning in any detail in ¶ 10 of the decision. The question of ownership of IP rights does not fall within the exclusive jurisdiction under Art. 22(4) of the Lugano Convention; see decision C-288/82 of the ECJ, Ferdinand M.J.J. Duijnstee ./. Ludowijk Goderbauer and further literature in fn 1 of the decision. Under Swiss national law, international jurisdiction for disputes relating to intellectual property rights is governed by Art. 109 CPIL. However, only validity and infringement actions are mentioned, but not assignment actions. Jurisdiction for actions for the assignment of an IP right, in particular a patent, is therefore determined in accordance with the general rule of Art. 2 CPIL, according to which the Swiss judicial or administrative authorities of the defendant’s domicile are competent. As the plaintiff (defendant of the counterclaim) is domiciled in Switzerland, the FPC is also competent for counterclaims relating to the transfer of foreign patents.
Right to accounting
The court re-visited the right to accounting based on Art. 66 lit. b PatA in view of critical voices in the aftermath of O2013_008; see ¶ 58 of the decision (note that fn 33 erroneously refers to O2012_008). However, the decision explicitly confirms the FPC’s practice that in case the court finds infringement there is a substantive entitlement to information and accounting based on Art. 66 lit. b PatA.
Request for accounting with reference to a trademark / product name
As mentioned above, the request for injunctive relief was held inadmissible for lack of concreteness. Still, the court did the whole exercise of infringement analysis. It had to because of the request for accounting. The request for accounting referred to the ‘Mechanical Fountain Pen RMS05’. Such a description would be perfectly inadmissible in a request for injunctive relief, because the product name could be changed at any time. But not so in a request for accounting. The name of a product that has been sold in the past cannot be changed anymore:
However, in the case of conduct that has taken place in the past, it is permissible to specify the allegedly infringing object by means of a type designation or trademark. Such a designation cannot be changed for the past and one therefore knows exactly which product — namely in this case the product previously offered under the designation ‘Mechanical Fountain Pen RMS05’ — is the subject of the information request.
I guess we will see more such simplified requests for accounting in the future.
No mixing-up of functions of features in the test for infringement under the DoE
There is an interesting general remark in ¶ 63 of the decision, i.e.:
One cannot reasonably expand the function of a claim feature and argue that this expanded function is fulfilled by another feature of the attacked embodiment, when the same element (penholder) with the same functionality (can be dismantled to replace the cartridge) is found in the invoked patent in parallel to claimed features, and independently of it (removable endpiece).
Reported by Martin WILMING
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IMAGE CREDIT
Header image (Hôtel de Ville de Neuchâtel, Salle du Conseil Général) courtesy of Lucas Vuitel – ArcInfo.
Frédéric Garinaud apparently is a master of complicated mechanics. He developed the Harry Winston Opus 8, a manually-wound watch with a ‘digital’ display of the hours and minutes.
The numbers appear only on demand, when a slide on the right side of the watch is activated. I could not help but do some further research on the Opus 8. It was a limited edition of 50 pieces only, on 9 July 2018 seen at luxurybazaar.com with a price tag of US$ 350’125,–. A somewhat fair deal in view of a purported retail price of US$ 449’700,–.
As reported earlier on this Blog here, the Supreme Court had remitted the case 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.
Well, the first part is a no-brainer. The FPC is bound to the legal assessment of the Supreme Court, and it thus dismissed the suit with respect to the diacid.
As to the two other salts, i.e. pemetrexed dipotassium and pemetrexed ditromethamine, the FPC briefly assessed infringement under the doctrine of equivalents.
The first question to be answered in the assessment of infringement under the DoE is whether the replaced feature and the replacing feature have the same objective function. The decision holds that it is only the cation that is different, and that the dianion is the same in any event. Further, it is held that both the dipotassium and the ditromethamine salt will be dissociated under physiological conditions, and everything suggests that the mode of action is determined by the dianion.
Pemetrexeddikalium unterscheidet sich von Pemetrexeddinatrium bzw. Pemetrexeddisäure lediglich durch das Kation. Das Dianion ist in allen Fällen identisch. Pemetrexeddikalium liegt bei physiologischem pH dissoziiert in Kation und Dianion vor. Es spricht alles dafür, dass die Wirkungsweise durch das Pemetrexed-Dianion gegeben ist.
Aus diesen Gründen ist eine Gleichwirkung für Pemetrexeddikalium gegeben ist.
One may like or dislike the outcome as it is. Be this as it may. What is troubling me is that this reasoning is only focused on the mode of action of the dianion. Note that the dianion neither is the replaced feature nor the replacing feature. Does this reasoning actually address the first question of the FPC’s questionnaire for the assessment under the DoE at all?
Does the replacing feature objectively fulfil the same function? (‘Gleichwirkung’)
Is there a need to rephrase the first question? Time will show, I guess.
The FPC answered the second and third question in the affirmative, too. It did so by mere reference to the considerations of the Supreme Court.
In sum, all three pemetrexed forms (diacid, dipotassium and ditromethamine) are held to infringe the patent in suit.
Timing could not have been much better: The latest decision of the Swiss Supreme Court on the DoE has just been handed down earlier this week; see this Blog here.
Thus, the stage is perfectly set for the annual VIPS/VESPA autumn seminar 2017 (November 3):
If this is the first time that you read about the pemetrexed litigation saga, please see this Blog here for a review of the decision O2015_004 under appeal and some further background information.
The patent in suit is Lilly‘s EP 1 313 508 B1; see the EPO Register and Swissreg for further details. It’s all about a generic version of Lilly’s Alimta®, i.e. Actavis’ Amtiris®. While the claims of EP’508 specifically require pemetrexed disodium, Amtiris® comprises pemetrexed diacid.
Pemetrexed diacid
Pemetrexed disodium
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 [0022] of EP’508 had only been introduced during prosecution:
Amended description during prosecution (mark-up)
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 [0022] 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
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CORRESPONDING DECISIONS
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.
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COMMENTS
Attorney’s dilemma
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?
Finding balance
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., [2014] 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?
Pemetrexed disodium
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. 6.5.2.4).
(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
Martin WILMING
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SUMMARY
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.
Protective letters are frequently used. See the most important do’s and don’ts here. In addition, note that protective letters can be filed by a legal representative or the party itself, but not by a patent attorney.
The audience unanimously critcized decisions D2015_035 of 08 March 2016 (hn: A protective letter may not be withdrawn) and, to less extent, D2015_035 of 09 February 2016 (no later addendum to a protective letter, except for proper and improper novae).
By the way: A protective letter may not only be useful in anticipation of a request for ex parte interim injunctive relief, but also in anticipation of a request for preliminary measures to secure evidence like this one here.
ii) Ex parte interim measures
Decisions S2016_007 (“don’t play games”) and S2017_001 were only briefly touched.
S2017_002 and S2017_003 made clear which requirements are to be fulfilled for an ex parte register ban to be successful; the former failed, the latter has been successful.
It became clear in the discussion that the surprising effect is not the only motivation for practitioners to request ex parte interim measures. Actually, ex parte interim measures are perceived by some as the only way to get speedy relief. Interim measures typically take seven to twelve months if they really dive deep into the subject-matter at stake (which is more the rule rather than the exception). Some participants questioned whether there is actually any difference to main proceedings, besides the fact that judicial vacations are not applicable. Sure, court fees are reduced — but so is the party compensation. On the other hand, parties typically do not perceive that the reasonable effort in summary proceedings is reduced by half.
iii) Service of process
Two Swiss parts of European patents have been recently revoked by the FPC in judgements rendered in absentia; O2015_007 and O2015_017. The patentees / defendants did not respond at all. At least for O2015_007, it is clear meanwhile that this happened by accident; see the detailed discussion here. In both cases, the U.S. patentee / defendant had been directly served with the writ in accordance with the Hague Convention and Art. 137 CPC. In accordance with U.S. rules, the Swiss embassy in the U.S. thus served the writ to the patentees / defendants by registered letter. In the absence of any reaction, the FPC had published subsequent notifications to the patentees / defendants only in the Swiss Official Gazette of Commerce; Art. 141 CPC.
It has been proposed that the FPC could at least bring the subsequent publications in the Swiss Official Gazette of Commerce also to the attention of the representative on file at the Swiss Federal Institute of Intellectual Property for the patent in suit.
On a personal note: I have my doubts. (I have been involved in O2015_007, but this case is finally concluded now.) It may well appear formalistic to only publish a notification in the Swiss Official Gazette of Commerce when contact details of a representative of the patent are available from Swissreg. As a patent attorney on file in Swissreg, one may easily find it unsatisfactory to just be ignored. But it’s the law. Even if such an additional notification would not constitute a breach of judicial confidentiality: It surely is more than what is required by law. Nota bene: In inter-partes proceedings. Any assistance by a court for the potential benefit of one party is of potential disadvantage for the respective other party; and I cannot see any superordinated public interest, either. This is why I am hesitant. But may the lawyers have their say on this.
iv) Doctrine of Equivalents
Discussion of decision 4A_131/2016 of the Supreme Court highlighted the apparent gap in the assessment of literal infringement and infringement under the DoE; see this Blog here. But let’s focus on the positive: The three-step questionnaire for the assessment of infringement under the DoE is approved. Let’s await the next decision(s) of the Supreme Court which hopefully provide further guidance.
As to the assessement of the third question in O2015_004, it has been discussed whether the actual wording of a claim is more binding if the alternatives are readily apparent — both for the person skilled in the art reading the patent, as well as for the patentee when drafting the application. (Note that Hepp Wenger Ryffel is involved in this matter, and the decision is not yet final. It can thus not yet be discussed in detail here.)
v) Abandonment of subject-matter
A further interesting aspect of O2015_004 surely is the issue of abandonment of subject matter; see this Blog here for further details. (Note that Hepp Wenger Ryffel is involved in this matter, and the decision is not yet final. It can thus not yet be discussed in detail here.)
vi) Miscellaneous
Discussion briefly touched decisions 4A_427/2016 of the Supreme Court with respect to the legal standard of implied confidentiality (see this Blog here) and S2016_002 with respect to the admitted prior art as supporting basis for claim construction (see this Blog here).
Reported by Martin WILMING
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The patent in suit is Lilly‘s EP 1 313 508 B1; see the EPO Register and Swissreg for further details. EP’508 is heavily litigated in many countries. The present decision in Switzerland concerns Lilly’s request for interim injunctive relief in summary proceedings. Main proceedings are still pending (O2105_004).
The independent claims of EP’508 read as follows (emphasis added):
1. Use of pemetrexed disodium in the manufacture of a medicament for use in combination therapy for inhibiting tumor growth in mammals wherein said medicament is to be administered in combination with vitamin B12 or a pharmaceutical derivative thereof, said pharmaceutical derivative of vitamin B12 being hydroxocobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-chlorocobalamin perchlorate, azidocobalamin, chlorocobalamin or cobalamin.
12. A product containing pemetrexed disodium, vitamin B 12 or a pharmaceutical derivative thereof said pharmaceutical derivative of vitamin B12 being hydroxocobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-chlorocobalamin perchlorate, azidocobalamin, chlorocobalamin or cobalamin, and, optionally, a folic binding protein binding agent selected from the group consisting of folic acid, (6R)-5-methyl-5,6,7,8-tetrahydrofolic acid and (6R)-5-formyl-5,6,7,8-tetrahydrofolic acid, or a physiologically available salt or ester thereof, as a combined preparation for the simultaneous, separate or sequential use in inhibiting tumor growth.
Pemetrexed disodium (see structural formula below) is marketed by Lilly under the trademark Alimta®. Stakes are high for Lilly: Alimta® generated a worldwide revenue of $2,493 million in 2015; see Lilly’s Annual Report 2015, p F31. The drug is used as a cancer medication that interferes with the growth and spread of cancer cells in the body; see drugs.com for further information.
Pemetrexed disodium
Pemetrexed diacid
The attacked embodiment is Actavis‘ Amtiris® which makes use of pemetrexed diacid instead of pemetrexed disodium (see structural formula above). Amtiris® had been approved by Swissmedic on 23 March 2016; see Swissmedic Journal 03/2016. Please refer to the interactive 3D structure below to get an idea of how pemetrexed dicacid actually looks like:
Literal infringement was not an issue. The present decision is all about the question of whether or not the use of pemetrexed diacid might constitute an infringement under the Doctrine of Equivalents (DoE).
Note that the wording of the claim had been narrowed down during prosecution in order to overcome the examiner’s objections and to proceed to grant: The broad term antifolate had been more precisely defined as pemetrexed in first place, and finally even further as pemetrexed disodium. The FPC thus assessed whether the DoE is applicable at all to the feature pemetrexed disodium. The FPC notes that the patentee is bound by limitations 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 circumvent this limitation by asserting equivalence. The FPC refers to a decision HG060066 of the Commercial Court Zurich in this respect. This is not to be confused with the Prosecution History Estoppel known in the U.S. — it rather highlights that the prosecution history is not just irrelevant.
Für die Beurteilung der Bedeutung dieser von der Patentinhaberin im Laufe des Erteilungsverfahrens vorgenommenen Einschränkung ist davon auszugehen, dass die Schweiz, wie andere Europäische Länder auch, keine Prosecution History Estoppel, wie sie in USA angewandt wird, kennt. Das heisst aber keineswegs, dass die Erteilungsgeschichte in der Schweiz völlig ausser Acht gelassen werden kann.
The FPC consequently held that the request for interim injunctive relief had to be dismissed for this reason alone.
For the sake of completeness, the FPC additionally assessed infringement under the DoE. The FPC’s 3-step questionnaire has recently been approved by the Supreme Court.
The first question to be answered is whether the replaced features have the same objective function. The FPC essentially relied on the fact that the attacked embodiment is a Swissmedic approved generic version of Alimta®, ie the pemetrexed disodium containing product. The same objective function was thus held to be given.
The second question asks whether the replaced features and their same objective function are made obvious to the skilled person by the teaching of the patent. See also the clarifying headnote of O2014_002 on how the FPC expects this question to be addressed. The FPC held that the skilled person knows that pemetrexed diacid would be at least partially deprotonated under physiological conditions, and that both pemetrexed diacid and pemetrexed disodium will result in the same pemetrexed dianion. Concluding, the skilled person would thus have expected the diacid to have the same effect (based on the anion). The FPC expressly dissents with the judgement of the England and Wales Court of Appeal ([2015] EWCA Civ 555, #71) in this respect.
Finally, the third question asks whether it is evident for the skilled person that the replaced feature has the same effect, starting from the teaching of the patent in suit. Would the skilled person have understood the wording pemetrexed disodium as a strict limitation? The FPC notes that other components are defined more broadly in the claims, ie vitamin B12 or a pharmaceutical derivative thereof. Not so for pemetrexed disodium. The skilled person would thus have understood this as an intentional limitation, in further view of the specification. The patent refers to antifolates in paragaph [0022] as follows (emphasis added):
The terms “antifolate” and “antifolate drug” generally refer to a chemical compound which inhibits at least one key folate-requiring enzyme of the thymidine or purine biosynthetic pathways, preferably thymidylate synthase (“TS”), dihydrofolate reductase (“DHFR”), or glycinamide ribonucleotide formyltransferase (“GARFT”), by competing with reduced folates for binding sites of these enzymes. The “antifolate” or “antifolate drug” for use in this invention is Pemetrexed Disodium (ALIMTA®), as manufactured by Eli Lilly & Co.
The FPC thus answered the third question in the negative, expressly consenting with the judgement of the England and Wales Court of Appeal ([2015] EWCA Civ 555, #72) in this respect. The FPC also sides with the German Federal Supreme Court’s decision X ZR 29/15 in parallel proceedings in that the present matter is not an abandonment in the sense of X ZR 16/09 – Okklusionsvorrichtung. In Okklusionvorrichtung the replacing feature had been explicitly mentioned in the specification; not so in the present matter. However, the FPC notes that this does not automatically mean that a contrario the third question is to be answered in the affirmative.
Der BGH fokussiert sich bei der Beurteilung der dritten Äquivalenzfrage allerdings sehr auf diese Frage des Verzichts. Dem kann nicht gefolgt werden. Die Tatsache, dass kein Verzicht gemäss Okklusionsvorrichtung vorliegt, bedeutet keineswegs automatisch im Umkehrschluss, dass die 3. Äquivalenz-Frage zu bejahen ist. Das greift zu kurz.
The FPC thus dismissed Lilly’s request for interim injunctive relief in summary proceedings. Main proceedings are still pending (O2015_004).
As to Germany, there is the most recent decision X ZR 29/15 of the Federal Supreme Court. Please find the whole course of proceedings through the various instances in Germany here. Interim injunctive relief has been granted by the Regional Court Munich I in matters 21 O 22243/15 and 21 O 5583/16.
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SUMMARY
The FPC dismissed Lilly’s request for interim injunctive relief in summary proceedings concerning a generic version of Lilly’s Alimta®, ie Actavis’ Amtiris®. While the claims of Lilly’s EP 1 313 508 B1 specifically require pemetrexed disodium, Amtiris® comprises pemetrexed diacid. The FPC held that limitation from antifolate to pemetrexed disodium during prosecution constitutes an abandonment of subject-matter. But even if it would not be considered an abandonment, the FPC denied an infringement under the Doctrine of Equivalents since the skilled person would have understood the wording pemetrexed disodium as a strict limitation, in view of the claims in view of the specification. Main proceedings are still pending (O2015_004).
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I have reported on the main hearing before the FPC on this Blog here. For a brief review of the underlying decision O2014_002 of the FPC, see this Blog here.
Long awaited, now here it is: The first decision of the Supreme Court on the Doctrine of Equivalents since ages; see fulltext below. You hoped for a ready-mix for assessment of equivalency? I’m sorry, there is none.
But let’s have a look at the very basic facts first.
The patent in suit is EP 1 579 133 B1 (embedded below), and it’s all about a non-return valve for a urinal. The independent claim reads as follows (mark-up added):
A non-return valve (3), comprising an inlet section (5) in the form of a self-supporting trough-shaped section and an outlet section, the outlet section being made of a flexible resilient material connected to the inlet section (5), whereby the outlet section comprises a flat flexible resilient strip (6) with a high inherent degree of flexibility, the strip (6) being connected with the inlet section (5) at its upper edge; and further comprising a component that is separate from the strip (6) providing a complementary surface against which the lower end of the flexible strip (6) may seal.
The technology is not difficult to understand: The strip (6) and the ‘component with a complementary surface’ — actually, yet another strip — are arranged in a way as to allow fluid passing through the valve in the one direction of the valve. The valve closes when the fluid has passed, to prevent unpleasant odor from rising up. Flattened tubes instead of separate strips had been known in the prior art for the same purpose; see D1, US 3 835 857).
EP’133, Fig. 1 and 2
“Key-System” (Enswico)
Fig. 3 of D1
LITERAL INFRINGEMENT
The million dollar word is “separate”. What does the feature
[…] a component that is separate from the strip (6) providing a complementary surface against which the lower end of the flexible strip (6) may seal
actually mean? There is no explicit definition of “separate” in the patent. Actually, the word as such was not even used in the application as filed at all. It had been introduced during prosecution, based on the overall specification and figures which all show (completely) separate strips; see figures 1 and 2, above.
On the other hand, the two strips are interconnected by lateral connectors in the attacked embodiment. Noteworthy, this configuration is protected by EP 2 553 299 B1 of the defendant (embedded below; EP’299 explicitly acknowledges the patent in suit as closest prior art in para. [0003]-[0005]).
attacked embodiment
The assessment of the Supreme Court is straight forward — and in line with the decision of the FPC. In light of the figures, the description and in differentiation over the prior art (flattened tube) the feature is construed to imply a full-length separation. The Supreme Court explicitly holds that the embodiment with loose ends is not merely a preferred embodiment:
Die Ausführungsbeispiele weisen auf dieses Verständnis eindeutig hin, ohne dass Anhaltspunkte für ein weiteres Verständnis von ‘separate’ in dem Sinne bestehen würden, dass das Ausführungsbeispiel mit den losen Enden nur als eine – wie die Beschwerdeführerin behauptet, bevorzugte – Ausführung erschiene.
Thus, no literal infringement.
INFRINGEMENT UNDER THE DOCTRINE OF EQUIVALENTS
Almost no decision on equivalency is uncontroversial, and people mostly have a very firm opinion pro or contra infringement under the Doctrine of Equivalents. So do I. But I feel there are plausible arguments for both views in the present matter, and I won’t take position for either side. No use crying over spilt milk anyway; this case has been finally decided now.
But let’s have a closer look at what can be learned about how the Supreme Court nowadays assesses infringement under the Doctrine of Equivalents on the basis of the three-step questionnaire as defined by the FPC (see S2013_001).
THE FIRST QUESTION
Do the replaced features have the same objective function? (same effect / “Gleichwirkung”)
Erfüllen die ersetzten Merkmale [Austauschmerkmale] die objektiv gleiche Funktion? (Gleichwirkung)
First of all, what is the replacing feature? The Supreme Court identifies the replacing feature essentially as follows:
[…] component and the strip (6) are separate for a sufficient length to allow for a sealing effect when a fluid has passed.
The first question is a no-brainer here: Fulfilment of the same function has been beyond dispute.
THE SECOND QUESTION
Are the replaced features and their same objective function made obvious to the skilled person by the teaching of the patent? (accessibility / “Auffindbarkeit”)
Werden die ersetzten Merkmale [Austauschmerkmale] und deren objektiv gleiche Funktion dem Fachmann durch die Lehre des Patentes nahe gelegt? (Auffindbarkeit)
This question had unfortunately been left undecided by the FPC (since the third question was answered in the negative). Nevertheless, the FPC had clarified in the headnote of the underlying decision how it expects this question to be addressed; see this Blog here. This hn 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. 6.5.2.4).
(Clarification of the case law with respect to S2013_001, decision dated 21. März 2013)
The reasons 6.5.2.4 referred to in the hn read as follows:
It is to be determined whether, once the features are replaced, the same effect is evident for the person of skill in the art when objectively assessed in consideration of the teaching of the patent.
Zu beurteilen ist, ob, wenn die Merkmale ausgetauscht sind, die Gleichwirkung für den Fachmann bei objektiver Betrachtung unter Berücksichtigung der Lehre des Patents offensichtlich ist.
According to the hn in light of the reasons, this test compares two already given situations (one with the replaced/claimed feature and another one with the replacing feature) and only then asks whether the same effect is evident. As I have outlined earlier, this really makes a big difference.
Now, this is what the Supreme Court asked (mark-up added):
[…], whether the skilled person who intends to add a fixation at the lower end of the strips instead of the loose ends will readily understand that the strips have to be separate at a length which is sufficient to achieve the effect which the patent intends to achieve.
[…], ob der Fachmann, der statt der losen Enden der Streifen am unteren Ende der Streifen eine Befestigung anbringen will, ohne weiteres erkennt, dass die Streifen auf einer hinreichenden Länge getrennt werden müssen, um die mit dem Patent angestrebte Wirkung zu erreichen.
I don’t think that this is what the FPC had in mind when drafting the hn and r. 6.5.2.4. In the assessment of the FPC, there is no need at all for a skilled person intending to add a fixation. The skilled person rather only compares two given scenarios, i.e. the claimed solution and the attacked embodiment. If the same effect of these two embodiments is evident, the question is to be answered in the affirmative. Else, it’s not. Frankly speaking, I just cannot say whether the Supreme Court is supportive of this approach or not.
THE THIRD QUESTION
With due consideration of the wording of the claim in the light of the description, would the skilled person have considered the replacing features as a solution of equal value? (equal value / “Gleichwertigkeit”)
Hätte der Fachmann bei Orientierung am Anspruchswortlaut im Lichte der Beschreibung die ersetzten Merkmale [Austauschmerkmale] als gleichwertige Lösung in Betracht gezogen? (Gleichwertigkeit)
Assessment of this question by the Supreme Court in r. 6.3.2 starts with a summary of what the FPC had held, i.e. that the skilled person would not have considered the replacing features as an equivalent solution, with due consideration of the claim. Really? Is that it? I feel the FPC did more than that — and there is more to do according to the wording of the third question recited above, i.e. to give due consideration to the claim wording in view of the description. And it had been the description and the figures which strictly limited the term “separate” to only cover loose ends. Consequently, the FPC had discussed the actual meaning of the claim wording (see section 6.5.2.5 of the underlying decision O2014_002):
Thus, it is not apparent for the skilled person in view of the claim construction that the claimed subject-matter (separately) could equivalently be replaced with a modification of this feature (lateral connectors).
So ist in diesem Fall für den Fachmann bei Orientierung am ausgelegten Anspruchswortlaut auch nicht erkennbar, dass die anspruchsgemässe Lehre (separat) mit einer Abwandlung des betroffenen Merkmals (Verbindungsstege) gleichwertig realisiert werden kann.
From the decision as such, it is not clear to me whether (or to which extent) the Supreme Court has paid attention to the description when answering the third question. The meaning of “separate” is interpreted more broadly again, based only on the wording of the claim as such:
Actually, a complete separation […] with loose ends is not required by the wording of the claim as such.
Eine vollständige Trennung […] mit losen Enden wird vom Anspruchswortlaut für sich genommen gerade nicht verlangt.
If that was indeed the case, then why is there no literal infringement?
The Supreme Court finally holds:
Thus, the loose end of the strips can equally be replaced by a fixation.
Danach lässt sich das lose Ende der Streifen gleichwertig durch eine Befestigung ersetzen.
In my perception, the great achievement of the third question reaches far beyond that. It had been intended to be all about providing a reasonable degree of legal certainty for third parties, i.e. to reasonably confine the potential scope under the Doctrine of Equivalents. Therefore, it essentially asks whether the skilled person would really have considered the replacing feature as an equivalent, with due consideration of the claim and the description — not merely whether it objectively is an equivalent replacement.
The Supreme Court notes in passing that the attacked embodiment has been patented (explicitly over the patent in suit as prior art), but holds that this does not change the fact that it still makes use of the patent in suit. The bottom line of the decision is a reference to a famous Swiss legal scholar:
Subsequent inventions are directly covered by the scope of the prior teaching if this prior teaching is fully embodied while providing for an improved, non-obvious variant; and inventions which make use of the core of the inventions that has been patented earlier (ALOIS TROLLER, Immaterialgüterrecht, Bd. II, 3. Aufl. 1985, S. 891). Art. 36(1) PatA provides for a non-exclusive license in such cases (cf decision 4C.502/1997 of April 20, 1998, r. 5b).
Vom Schutzbereich der älteren Lehre direkt umfasst sind spätere Erfindungen, wenn sie die ältere Lehre vollständig anwenden, aber eine verbesserte, nicht naheliegende Ausführung lehren, und ebenso Erfindungen, bei deren Anwendung der Kern der früher patentierten Erfindung mitverwendet wird (ALOIS TROLLER, Immaterialgüterrecht, Bd. II, 3. Aufl. 1985, S. 891). Dafür sieht Art. 36 Abs. 1 PatG eine nicht ausschliessliche Lizenz vor (vgl. Urteil 4C.502/1997 vom 20. April 1998 E. 5b).
Reference to Art. 36(1) PatA looks like an easy way out, but the right to be granted a non-exclusive license is explicitly only given by law if the invention represents an important technical advance of considerable economic significance in relation to the invention that is the subject-matter of the prior patent. It will not necessarily be easy to meet this precondition.
I hope we will see further decisions of the Supreme Court in the near future which provide some more guidance on the actual interpretation of the second question and how the reasonable degree of legal certainty for third parties is to be safeguarded when answering the third question. Addressing infringement under the Doctrine of Equivalents with a set of three questions that somehow resemble the questionnaires used in the U.K. and Germany surely is an achievement of harmonization. But I do not yet see much harmony in how the questions are interpreted and answered.
Reported by Martin WILMING
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BIBLIOGRAPHY
Case No. 4A_131/2016 (Supreme Court) ¦ Decision of 03 October 2016 ¦ “Urinalventil”
The good news from the first decision of the Supreme Court on the Doctrine of Equivalents since ages: The third question of the FPC’s questionnaire is approved. The sad news: There is little to no guidance in the decision with respect to how the second and the third question are to be interpreted. In particular, it still remains unclear how the reasonable degree of legal certainty for third parties is to be safeguarded when answering the third question.
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Case No. 4A_131/2016 (Supreme Court) ¦ Decision of 03 October 2016 ¦ “Urinalventil”
For a brief review of the underlying decision O2014_002 of the FPC, see this Blog here. The decision of the Supreme Court has been published today.
An important take-away message is: The third question (which has been applied by the FPC for the first time in S2013_001, somewhat similar to Schneidmesser in Germany and Improver in the UK) has now been approved by the Supreme Court. Welcome!
With due consideration of the claim wording in view of the description: Would the person skilled in the art have taken the replacing features into account as being an equivalent solution? (“Gleichwertigkeit”)
On the merits of the case, the Supreme Court overruled the FPC’s decision on equivalence. It will take me a few days to digest the decision and to put it into perspective. Asking three questions is a first step; the devil surely is in the detail of the answers. Stay tuned.
Reported by Martin WILMING
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BIBLIOGRAPHY
Case No. 4A_131/2016 (Supreme Court) ¦ Decision of 03 October 2016 ¦ “Urinalventil”
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