As noted in the Register, both cases have been stayed now; EP’864 in opposition proceedings, EP’241 shortly before grant:
The EPO file wrapper are telling. Bystronic Laser AG joined the pending opposition proceedings re EP’864 in accordance with Art. 105(1) lit. b EPC, based on the requested declaratory judgment of non-infringement which has been requested in O2017_002 besides assignment to co-ownership. Exhaustive arguments and evidence have been submitted. It’s hard to sort this out; the file wrapper is a mess. If you consider downloading it yourself, beware: The docket is huge (about 5’000 pages, 1.1 Gb), unsorted and documentary evidence is unfortunately not marked with identifiers. Good luck.
UPDATE July 4, 2017, further to the above parapraph:
If you are not afraid of big data, I strongly encourage you to do your own research in the online docket. Note that parties to EPO proceedings are not obliged to mark-up documentary evidence with identifiers. The online file wrapper of the EPO is beyond control of the parties.
We did quite some digging in the dockets, and interesting insight may be gained from prior correspondence between the parties’ counsel. Apparently, there have been intense discussions prior to litigation:
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.
Protection of pemetrexed diacid and the pharmaceutically acceptable salts thereof by the basic patent EP 432 677 B1 and a subsequent SPC has lapsed in December 2015.
The FPC had already dismissed Lilly’s request for interim injunctive relief in corresponding summary proceedings S2016_004; see this Blog here. In a nutshell, it had been 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 (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.
The present decision now is a declaratory judgement of non-infringement in main proceedings. The reasons are essentially along the line of arguments as set forth already in summary proceedings S2016_004. But still, there are some interesting aspects beyond that:
1. Three- vs. five-member panel of judges
As a general rule, the FPC makes its decisions as a three-member panel. However, the FPC can make its decisions as a five-member panel on the order of the President where this is in the interest of the further development of the law; Art. 21(2) PatCA.
The defendant requested that the panel of judges be extended to five members, in view of the critical legal questions at stake (equivalence; abandonment of subject-matter during prosecution and its interplay with claim construction in after-grant proceedings).
First, the FPC held that this request is belated. It has only been filed when the parties had already been served with the expert opinion of the judge-rapporteur — which has been unfavorable for the defendant. In the FPC’s view, this might well be the actual motivation of the request, not the complexity of the legal questions at stake.
Im Übrigen gibt die Tatsache, dass der Antrag der Beklagten erst auf den Erhalt des für sie negativ ausgefallenen Fachrichtervotums erfolgte, Anlass zur Frage, ob nicht eher dies — und nicht die Rechtsfragen — Anlass für den Antrag war.
On the merits, the FPC further holds that this is no case of special interest for the further development of the law. Appearance of bias due to prior involvement of the same panel of judges in corresponding summary proceedings cannot be an issue, either; Art. 47(2) lit. d CPC.
2. The ‘core of the invention’
The defendants argued that it was only the combination with vitamin B12 that made pemetrexed reasonably usable in anti-cancer therapy, since pemetrexed alone had been too toxic. This purportedly is the ‘core of the invention’. Even though the Supreme has recently used the term ‘core of the invention’ — yet only with a reference to literature from 1985 — the FPC clearly holds that the concept of a ‘core of the invention’ (resembling the outdated concept of a ‘general gist of the invention’ / ‘allgemeiner Erfindungsgedanke’) is neither necessary nor useful at all in the assessment of infringement. There is either literal infringement or infringement under the DoE, the latter being assessed with the three-step questionnaire.
Für Überlegungen zum Kern der Erfindung bleibt da weder Raum noch Bedarf.
3. Abandonment of subject-matter
The wording of the claims had been narrowed down during prosecution in order to overcome the examiner’s objections re novelty, and to proceed to grant: The broad term antifolate had been amended in the claims to pemetrexed in first place, and finally to pemetrexed disodium.
This limitation is also reflected in the description. The definition in paragraph  of EP’508 had only been introduced during prosecution:
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 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 circumvent this limitation by asserting equivalence.
The FPC notes that an admissible intermediate generalisation of the term antifolate is missing in the application as filed (the FPC refers to this as the onion-shell principle); the patentee has to face the consequences thereof, not the public. 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.
4. No infringement under the Doctrine of Equivalents
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 ( 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 FPC thus answered the third question in the negative, expressly consenting with the judgement of the England and Wales Court of Appeal ( 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.
It is highly likely that this decision will be appealed to the Supreme Court.
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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* expressly only commenting on the reply of the defendant of 28 February 2013.
With letter of 14 May 2013, the FPC informed the parties that the exchange of written submissions was finished. However, with letter of 23 May 2013 the plaintiff then expressed his surprise that he was given no further opportunity to comment on facts and evidence raised by the defendant in the rejoinder of 28 February 2013. In the plaintiff’s view, the defendant had denied the plaintiff’s right of action in the rejoinder of 28 February 2013 for the first time. “For the sake of completeness”, the plaintiff submitted assignment agreements signed by the respective inventors back in 2009. Note that the plaintiff had already named these inventors in the writ of 09 February 2009 (marg. no. 17 of the writ). The defendant requested that this submission of the plaintiff be held formally inadmissible; moreover, correctness on the merits was also denied.
First, the FPC held that the plaintiff’s submission of 23 May 2013 was no submission of new facts or evidence in the sense of Art. 229(1) lit. a or b CPC. In contrast, the plaintiff’s intention was obviously to comment on an aspect of the rejoinder of 28 February 2013.
With respect to the initial writ, the ordinary exchange of written submissions was concluded with the rejoinder of 28 February 2013. Only the rejoinder in the counteraction was outstanding, and the FPC accordingly had only set a time limit for this rejoinder. Nevertheless, the plaintiff had the mandatory right to also comment on the rejoinder of 28 February 2013 (“unbedingtes Replikrecht”); no time limit needs to be set by the Court (cf. BGE 138 III 252, r. 2.2; BGE 133 I 98, r. 2.2 and a memorandum of the Supreme Court). However, one has to act immediately in order to safeguard this right. Otherwise, it is deemed that the respective party has abstained from making a further submission. In the present matter, 2 ½ months had lapsed since the plaintiff was served with the rejoinder of the defendant. The FPC held that this was clearly not an immediate action being taken by the plaintiff. Consequently, the FPC excluded the plaintiff’s submission of 23 May 2013 (incl. the assignment agreements) from further consideration, as well as the defendants comments thereon.
As a sidenote, the FPC held that even an immediate comment on the rejoinder of 28 February 2013 would not have helped the plaintiff: The right in the invention had already been discussed in the writ of 09 Februar 2009, and the inventors were already named at that time. The defendant had contested these allegations already in his answer of 29 May 2009. Therefore, this was not a new issue raised only in the rejoinder of 28 February 2013 by the defendant.
Next, the parties will be summoned to the main hearing. The FPC stressed that the parties will then only be allowed to present new facts or evidence in the sense of Art. 229(1) CPC. In view of the above, the plaintiff will thus not be heard anymore with respect to the facts and evidence raised in his submission of 23 May 2013.
Art. 47 CPC: A request for recusal cannot be based on factual circumstances that are not yet reality and for which it is not yet clear whether they will ever come into existence.
(Non-official translation from German into English language)
Two orders in procedural matters have already been published by the FPC in this case; see this blog here and here. Moreover, a hearing is scheduled for 09 July 2013. It was only known by now that the plaintiff sought for a declaratory judgement of nullity in the field of pharmacy. From the present decision, it is at least clear that this case pertains to the field of androgenic alopecia (a specific kind of hair loss); cf. reasons 3 of the decision. No further details on the merits of the case are publicly available by now.
The reporting judge had provided his assessment of the case on September 16, 2012. With reply of October 26, 2012, the defendant put essentially the following requests on file:
The assessement of the reporting judge shall not be relied on.
A court expert with medical or pharmaceutical background, specifically in the field of androgenic alopecia, shall be appointed.
The parties shall be given the opportunity to comment on the questionnaire.
The reporting judge shall recuse or has to be excluded.
The present excerpt of the decision only deals with the fourth request, i.e. recusal of the reporting judge. It is the first decision being published by the FPC concerning a request for recusal of a judge (based on Art. 47 CPC).
Defendant argued that the reporting judge cannot be expected to be unbiased anymore when it comes to the assessment of the opinion provided by the court expert (since the reporting judge had already provided a written assessment himself); this would contravene the guidelines established by the Supreme Court e.g. in the case no. 4A_3/2012 (r. 2.3).
The Administrative Board of Judges of the FPC is competent to decide on such requests (Art. 11 PR-PatC). The ratio of the decision is clear-cut: It was not established yet whether a court expert will be appointed at all. Thus, the fourth request was held unfounded. Evidently, the fourth request was not construed under the condition of at least the foregoing requests 1. and 2. being granted.
As a sidenote, the Administrative Board of Judges briefly commented on the question whether the defendant should have acted earlier. Apparently, the defendant doubts that the reporting judge is technically competent enough to properly assess the specific questions at stake in the field of androgenic alopecia. However, these doubts were only brought forward when the assessment of the reporting judge was already established, but not when the reporting judge had been appointed. It thus remains to be seen whether the defendant will still be heared with his other request pertaining to the appointment of a court expert. This, however, is a question on the merits of the case which has not to be decided by the Administrative Board of Judges.
This decision of the Administrative Board of Judges is already res judicata.
This order of the FPC relates to a prior order of 03 May 2012, commented in a separate post. The earlier order of the FPC dealt with the presentation of new evidence / nova. In brief, the FPC did not admit the expert opinions from parallel proceedings in other countries into the proceedings – except as evidence for the conclusions drawn in these expert opinions which were explicitly referred to in the writ of the defendant.
Subsequently, the plaintiff requested that the expert opinions were to be sealed until a decision of the whole case has become final, in order to prevent that a member of the board of the FPC or a court expert consults these expert opinions any further. The plaintiff argued that the human nature could otherwise prompt a non-permanent judge or a court expert to revert to these expert opinions – contrary to the gist of the prior order of 03 May 2012.
In reply, the defendant requested an explanation by the FPC as to what extent the expert opinions may still qualify as (i) evidence for statements made in earlier writs of the defendant (except for the writ accompanying the expert opinions); and (ii) counter-evidence for statements made in earlier writs of the plaintiff. With respect to the statements made in the writ accompanying the expert opinions, the defendant argued that the FPC must have access to the expert opinions as such, in order to verify the respective citations. However, the parties evidently had a different understanding of whether or not the expert opinions may still qualify as (counter-) evidence for statements made in other writs of the defendant and the plaintiff.
The FPC now reiterated that the prior order of 03 May 2012 only pertained to the writ accompanying the expert opinions, without any further necessity of explanation. Only if facts (not points of law such as e.g. novelty, inventive step or undue extension of subject matter) would remain under dispute which are legally relevant, a procedure of taking evidence will be conducted in accordance with Art. 150 ff. CPC. If the defendant then would rely on the expert opinions, the FPC would have to judge admissibility of this evidence.
The FPC further held that there is no need to seal the expert opinions. These opinions will not be further consulted anyhow, for the time being: Since it is beyond dispute between the parties that the conclusions of the two expert opinions were correctly cited by the defendant in the writ, there is no need for the FPC to revert to the evidence as such.
Kurz, das Fachrichtervotum wird erstattet werden, ohne dass Einsicht in die beiden Gutachten genommen wird, weil sie weder – über die Noveneingabe hinaus – als Parteivorbringen noch, im gegenwärtigen Stadium, als Beweismittel zu berücksichtigen sind.
Consequently, the requests of both the plaintiff and the defendant were dismissed.
[u]se of alendronate in the manufacture of a medicament for treating osteoporosis in a human in need of such treatment, where said medicament is orally administered to said human as a unit dosage comprising about 70 mg of the alendronate compound, on an alendronic acid active weight basis, according to a continuous schedule having a once-weekly dosing interval.
The Swiss part of this European patent was challenged in two separate nullity suits before the Commercial Court of the Canton of Zurich (HG080018 and HG080082). The present case, which is based on the later one of these nullity suits, was stayed by the Commercial Court until the earlier one has been decided and become final. It was tranferred to the FPC in January 2012.
A first aspect of this case pertains to restitution under Art. 148 CPC, granted in accordance with widespread cantonal practice in similar circumstances: The FPC (erroneously) decided to not consider the case since the plaintiff had failed to submit the advance payment of litigation costs. However, it turned out that the plaintiff in fact had submitted the advance payment in time; the defendant agreed to the restitution. Accordingly, the initial decision of the FPC to not consider the case was set aside.
Opposition and appeal proceedings were pending with the EPO, too. A decision of an EPO Board of Appeal dismissed the appeal of the patentee / defendant and confirmed the revocation of the patent in its entirety. This decision was issued before the defendant had to submit the counterstatement with the FPC. The present case had thus become groundless (BGE 109 II 165) and was to be dismissed; Art. 242 CPC. Litigation costs were to be allocated at the discretion of the FPC; Art. 107 para. 1 lit. e CPC. The FPC held that the defendant at its sole discretion decided to lodge an appeal against the decision of the Opposition Division of the EPO to revoke the patent in suit. Due to the suspensive effect of such an appeal, the patent remained in force. Moreover, the plaintiff had sufficient reason to believe that the defendant was upon to lodge a claim of infringement. Since appeal proceedings with the EPO may be longsome, the FPC held that the present nullity suit was an adequate measure taken by the plaintiff. Consequently, the FPC (and likewise the Commercial Court of the Canton of Zurich in the case HG080018) decided to impose the litigation costs on the defendant and ordered a compensation of the plaintiff’s costs to be paid by the defendant.
Mit dem Beharren auf dem nichtigen Streitpatent hat die Beklagte diese dagegen gerichtete Nichtigkeitsklage verursacht, weshalb es angemessen erscheint, ihr die Kosten aufzuerlegen und sie zu einer Prozessentschädigung an die Klägerin zu verpflichten.
Reported by Martin WILMING
Case No. O2012_025 ¦ Decision of 16 July 2012 ¦ “Gegenstandslosigkeit; Kosten- und Entschädigungsfolgen”
Case No. S2012_005 ¦ Decision of 13 June 2012 ¦ “Zulässigkeit eines Feststellungsbegehrens, unlauterer Wettbewerb”
In 2005 the plaintiff entered into an R&D contract with a professor (now defendant). The purpose of this contract was the development of a technology to provide highly porous pellets by using a liquefied propellant gas. More specifically, the envisaged R&D should include experiments concerning the solubility of certain binding agents in various propellants, with or without CO2. According to the contract, it was aimed to subsequently file patent applications based on such R&D; the plaintiff should be the patentee and the defendant should be named as the inventor. The defendant also agreed in the contract to offer any further idea in the field of the experiments (propellant gas technology) to the plaintiff.
The dispute pertains to a European patent later on filed by and granted to the plaintiff, entitled
Manufacturing of a rapidly disintegrating presentation starting from a solid powder and a step of freeze drying
Entitlement of the plaintiff to this European Patent was under dispute between the parties. The defendant denied that the R&D contract (focused on propellant technology) covered the subject matter of the European patent in suit.
A first aspect of this decision pertains to the competency of the FPC, since the plaintiff was domiciled in Switzerland while the defendant was domiciled in Germany. The R&D contract contained a choice of juridiction clause (seat of the plaintiff), in accordance with Art. 23(1) lit. a-c LugC, but applicability of the contract to the present subject matter was under dispute. The patent in suit was not put on file by the parties, and it could not be excluded a priori that the patent was also covered by the contract: The mere title as such does not rule out the use of a liquefied propellant. The FPC held that for deciding on the competency of the court, allegations made by the plaintiff which are of relevance for both the competency of the court and the justification of the complaint are to be assumed true; this is in line with the case law of the Federal Supreme Court (BGE 137 III 32, r. 2.2 and 2.3).
As to the merits of the case, the first request was in fact a request for declaratory judgement by interim measure. The FPC held that declaratory judgements ad interim are not available under Art. 262 CPC in cases pertaining to the ownership of intellectual property rights. The FPC did not consider the first request already for this reason. Moreover, the plaintiff did not even address the question of his legitimate interest in this declaratory judgement (as required by Art. 74 of the Federal Act on Invention Patents) – the request would not have been considered by the FPC for this reason, too. Finally, the plaintiff failed to address the threat of a not easily reparable harm (Art. 261 CPC); this would have led to dismissal of the request by the FPC (if it had been considered).
A second request was that the defendant should be obliged to refrain from any statements vis-a-vis third parties that the plaintiff was not the legitimate owner of the patent in suit. The FPC held that the plaintiff did not provide sufficient prima facie evidence of violation of a right to which he is entitled (Art. 261 CPC); no legal basis for his claim was indicated by the plaintiff. The statements made by the defendant were also held to not establish a case of unfair competition. As long as a statement of a subjective legal opinion is not unnecessary offending, it cannot establish a case of unfair competition:
This nullity case regarding the Swiss part of a European patent filed on 18 July 2008 with the Commercial Court of the Canton of Zurich was transferred to the FPC on 17 January 2012. As of 1 January 2012, the FPC has become the competent court according to Art. 41 in conjunction with Art. 26 PatCA.
After transfer of the case, defendant submitted copies of extensive expert opinions requested by the German Federal Court of Justice and the District Court of Rome, Italy, in parallel proceedings and only briefly referred to their respective conclusions in his written submissions. Plaintiff argued that the expert opinions did not constitute evidence in terms of the Swiss civil procedural code (CPC). Further, plaintiff objected to these opinions being treated as defendant’s submissions as the experts’ technical considerations had been enclosed with but not referred to in defendant’s writ.
According to Art. 27 PatCA, the CPC is applicable in cases before the FPC. However, Art. 404(1) CPC states that the previously applicable procedural code (of the respective Canton) remains applicable to pending cases until proceedings within the respective instance are closed. There are no transitional provisions regarding pending cases that have been transferred from cantonal courts to the FPC; only the Guidelines on proceedings before the FPC (Art. 10(2)) hold that the CPC shall be applicable. It has now been decided that based on the fact that Art. 27 PatCA is a lex specialis with regard to Art. 404(1) CPCphone 8582562535 , it takes precedence over the latter. On entering into force of PatCA, the federal procedural code is to be applied to cases transferred to the FPC. However, the parties will be given an opportunity to make submissions pertaining to any issues that they did not need or were not able to make under the terms of the previously applicable cantonal codes of procedure (cf. Art. 10(3) of the Guidelines on Proceedings before the FPC).
As to the merits of the case, it was held that the foreign court expert opinions submitted by defendant were no court opinions in proceedings before the FPC. Likewise, the foreign court expert opinions are no private opinions since they were not commissioned by the defendant. Thus, court expert opinions from separate proceedings are physical records (Urkunden) in the sense of Art. 177 CPC, only. As such, they are formally to be treated like party submissions. As is the case for all party submissions, any statement made in the writ must be substantiated by indicating how the respective statement relates to the physical record on which it is alleged to be based:
In gleicher Weise wie bei Tatsachenbehauptungen hat eine Partei auch bei Privatgutachten oder Gutachten aus anderen Verfahren ihre darauf gestützten Ansprüche möglichst konkret, d.h. substantiiert zu behaupten. Behauptungen (auch wenn sie in Form eines Gutachtens aus einem anderen Verfahren vorgebracht werden) sind in dem Sinne “zu verknüpfen”, dass ohne weiteres und ohne unzumutbaren Aufwand ersichtlich ist, mit welchen Urkunden bzw. Beweisanträgen welche Tatsachen bewiesen werden sollen ([…]).
Facts that can merely be inferred from enclosures need not be considered by the court. In as far as specific passages within the opinions were not indicated to relate to defendant’s writ these opinions were regarded as inadmissible and were not considered.
Wie erwähnt, geht es nicht an, einen Sachverhaltskomplex (d.h. vorliegend die Schlussfolgerung von Gerichtsgutachten) zu schildern und sich zum Beweis am Schluss dieser Behauptungen pauschal auf einen Stoss Akten zu berufen ([…]).