Case No. O2016_002 ¦ Order of 23 May 2016 (excerpt) ¦ “Auszug aus der Verfügung: Wiederherstellung Frist Klageantwort (ZPO 148); Abweisung; kein leichtes Verschulden”
This is the first published decision of the FPC dealing with restitution — and it provides some important insight into how such cases are being assessed by the FPC.
1. Timeliness of the request
A request for restitution must be submitted within 10 days of the day when the cause of default has ceased to apply; Art. 148(2) CPC.
It is important to recall the calculation of time limits in Swiss proceedings: Statutory limitation periods are suspended from the seventh day before Easter up to and including the seventh day after Easter; Art. 145(1) lit. a CPC. However, such suspension does not apply in summary proceedings (Art. 145(2) lit. b CPC), and the parties must be made aware of this exception; Art. 145(3) CPC.
It was undisputed that the requesting party got aware of the decision on 29 March 2016. The request for restitution has been filed on 13 April 2016. It therefore was critical whether the time limit was suspended during Easter holidays or not, i.e. up to and including 03 April (the seventh day after Easter): If so, the request would have been timely filed — but if not, it would have been filed to late.
The FPC notes that even though restitution is dealt with in summary-like proceedings the underlying case had been dealt with in main proceedings. Moreover, the parties had not been notified that suspension would not apply, and this would have been mandatory; Art. 145(3) CPC. The FPC thus held that the request fo restitution had been timely filed.
2. Assessment on the merits
A defaulting party has to credibly show that it was not responsible for the default or was responsible only to a minor extent; Art. 148(1) CPC. However, an oversight or obliviousness always qualifies as gross negligence, and negligence of supporting staff is taken fully into account as negligence of the party itself.
The requesting party had undisputedly been served with the writ. But except for the certificate of mailing, the writ and the order setting a time limit for filing the reply apparently remained untraceable and have been lost. The requesting party only got aware of the decision of 17 February 2016 by a third party on 29 March 2016; see above. The actual internal mishandling of the writ could not be narrowed down or identified at all. The FPC held that this reveals severe organisational deficiencies and dismissed the request for restitution.
Note that Hepp Wenger Ryffel is involved in this matter on behalf of the plaintiff. An appeal is pending at the Supreme Court. The following is only a summary of the technical background and the reasons of the decision as such. A more detailed comment on the merits of the case will follow when the decision has become final.
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This decision concerns a nullity suit of Actelion Pharmaceuticals Ltd against the Swiss part of EP 1 200 092 B1, a patent granted on a Euro-PCT application based on WO 2001/08688. According to paragraph [0007] of EP’092, the alleged invention provides particulate preparations of a free drug form of a β-carboline compound having specific and defined particle size characteristics. The defined particle size is said to permit a uniform formulation of stable pharmaceutical compositions. Accordingly, claim 1 of EP’092 reads as follows:
1. A free drug particulate form of a compound having a formula
and pharmaceutically acceptable salts and solvates thereof in which the compound is present as solid particles not intimately embedded in a polymeric co-precipitate, wherein at least 90% of the particles have a particle size of less than about 40 microns.
The filing date of EP’092 is 01 August 2000, and priority of US 60/147,048 of 03 August 1999 is claimed. However, it has been set forth in the writ that the priority is apparently not validly claimed. Further, it has been argued that both WO 01/08686 A1 and WO 01/08687 A1 with filing dates of 26 April 2000 are novelty-destroying for the patent in suit under Art. 54(3) EPC. Further, and irrespective of the validity of the priority claim, it was argued that EP 1 120 120 A1 is novelty-destroying and, alternatively, that the claimed subject-matter is not inventive over either one of WO 95/19978 A1, WO 97/03675 A1 or WO 96/38131 A1. It was also argued for a lack of sufficiency of disclosure.
The patentee did not take up the fight. No domicile for service in Switzerland was named and no answer to the writ was filed. The FPC publicly notified the defendant in the Swiss Official Gazette of Commerce (SOGC) of the extended time limit for the answer, the costs, and the decision itself.
On the merits of the case, the FPC only dealt with the plaintiff’s nullity arguments to the extent necessary to come to a decision. No interim assessment of a reporting judge was obtained since the relevant subject-matter only required some general technical understanding (BGE 4A 52/2008, r. 3.4; Art. 183(3) CPC, Art. 37(3) PatCA).
The priority issue was decisive. The priority application US 60/147,048 named five inventors, i.e. Neil R. Anderson (1), Sandra J. Zeckel (2), Martha A. Kral (3), Gregory L. Stevenson (4) and Kerry J. Hartauer (5). The PCT application WO 2001/08688 was filed in the name of Lilly ICOS LLC, but inventor (2) was not named anymore. No assignment information from any inventor to Lilly ICOS LLC is on file at all in the publicly accessible WIPO and EPO dockets. To the contrary, the USPTO records explicitly hold that no assignment information is available. Not even an informal assignment could be presumed for inventor (2) who is missing on the PCT application. The FPC thus had severe doubts as to the validity of the priority claim of Lilly ICOS LLC. Since the burden of proof lies with the defendant in legal proceedings (Art. 20 PatA), and no evidence in this respect has been on file, the FPC held that the priority claim was invalid. The effective date of the claimed subject-matter was thus only 01 August 2000, i.e. the filing date of the PCT application. With the priority claim being invalid, the rest of the story is quickly told: WO 01/08686 A1 with a filing date of 26 April 2000 was held novelty-destroying for all independent claims, and EP’092 was thus held invalid.
Note that Hepp Wenger Ryffel is involved in this case on behalf of the defendant.
The patent in suit is EP 944 937 B1 of Gustav Klauke GmbH; the plaintiff in this nullity case is Von Arx AG. See Swissreg for further bibliographic details. The patent pertains to a hydraulic pressing device (such as illustrated below) with an automatically actuating return valve for the hydraulic oil. The closed and open positions of this return valve are illustrated in Fig. 1 and 2 of the patent, respectively (click to enlarge):
EP 944 937 B1, Fig. 1
EP 944 937 B1, Fig. 2
Hydraulic pressing device (Klauke)
The main hearing took place on September 3, 2015; see this Blog here.
i) Prior use
The plaintiff alleged that a public prior use of a device PT2 with the serial no. 95112060 was novelty destroying for the patent in suit. In first place, it had to be assessed whether the alleged prior use had actually occured, and what exactly had been made publicly available.
In general terms, the FPC held that it is up to the plaintiff to establish what exactly had been made available to whom, and under which circumstances (BGE 117 II 480, r. 1; Case Law of the Boards of Appeal, I.C.1.9.9; EPO Guidelines of Examination, G-IV, 7.2). Absolute certainty is not required. Rather, it is sufficient if no reasonable doubt remains, or any such doubt appears neglectable (BGE 130 III 321, r. 3.2).
The FPC held that a public disclosure of this device had occured on July 17, 1996, by means of a sale. However, it was also under dispute what actually had been made available to the public at that time. Various technical drawings of the valve of the PT2 device were presented by the plaintiff. Even though the technical drawings of the valve of the PT2 device were not fully consistent, the FPC held that the differences between these drawings were only minor and could be neglected. In particular, the FPC held that none of these differences would imply any functional difference of the valve.
The FPC thus held that a prior use of the PT2 device with a valve as shown in the adjacent figure has been established.
ii) Claim construction
The independent claim as granted required that
the automatically reacting return valve is built such that it is maintained in the open position during the entire return stroke of the hydraulic piston.
In consideration of what is discussed in the specification of the patent (in particular paragraphs [0008] and [0020] where only a partial return stroke is outlined), the FPC held that this feature is to be understood as to refer to a (return) stroke until a starting position for the next working cycle is reached again. Thus, the feature neither necessarily requires a (return) stroke until a mechanical stopper is reached, nor is it fulfilled by just an indefinitely small length of a stroke. Note that this claim construction differs from the decision of the German Federal Patent Court; see decision 6 Ni 47/14 (EP), r. 5.2.
With regard to the features in the 2nd auxiliary request, the FPC clarified how the term “return valve consists of a hydraulic piston” is to be construed. “Consists of” cannot reasonably mean that the return valve consists exclusively of a hydraulic piston in the strict sense because a valve cannot consist exclusively of a piston. Therefore, the FPC argues that the term “return valve consists of a hydraulic piston” specifies the object of the invention in a clear and comprehensible manner.
iii) Patentability
The European patent had already been challenged in EPO opposition / appeal proceedings by other parties but had been upheld as granted; cf. EPO file wrapper and decision T 0861/05 for further details.
EP 636 788, Fig. 1
FR 2 563 291, Fig. 1
Novelty of the patent in suit over EP 636 788 A1 and FR 2 563 291 A1 (referred to in col. 1, l. 8-13 of EP’788 with its application number FR 8406346) was again acknowledged by the FPC, but the prior use PT2 was held to be novelty-destroying. Nevertheless, the 2nd auxilliary request was upheld.
iv) Patent maintained in amended form
Claim 1 as upheld according to the 2nd auxilliary request reads as follows (amendments over claim 1 as granted marked-up):
Hydraulisches Pressgerät (2)
mit einem Festteil (26) und einem Bewegungsteil (24),
wobei das Bewegungsteil (24) durch einen Hydraulikkolben (9) relativ zu dem Festteil (26) bewegt wird
und mittels einer Rückstellfeder (10) in eine Ausgangsstellung zurückbewegbar ist,
wobei die Rückbewegung in Abhängigkeit von einem vorbestimmten Pressdruck auslösbar ist durch Ansprechen eines Rücklaufventils (1)
dadurch gekennzeichnet,
dass das selbsttätig ansprechende Rücklaufventil (1) so ausgebildet ist, dass es durch den Druck des zurücklau-
fenden Öls über den gesamten Rückstellweg des Hydraulikkolbens (9) in der Öffnungsstellung gehalten ist und
dass das Rücklaufventil (1) aus einem Ventilkolben (3) besteht, wobei der Ventilkolben (3) mit einer Ventilkolbenfläche (4, 5) ausgebildet ist,
wobei eine im Verschlusszustand wirksame Teilkolbenfläche im Hinblick auf den gewünschten Maximaldruck ausgelegt ist,
wobei die durch den Bohrungsdurchmesser einer mit dem Druckraum (6) verbundenen Bohrung (7) wirksame kleinere Teilkolbenfläche im Zuge der Verpressung mittels des hydraulischen Pressgerätes (2) von dem Öl beaufschlagt ist und
wobei bei Überschreiten einer durch den Bohrungsdurchmesser vordefinierten Höhe des Öldrucks der Ventilkolben (3) des Rücklaufventils (1) über die Teilkolbenfläche aus dem Dichtsitz angehoben wird,
wonach eine wesentlich grössere Kolbenfläche in Wirkung tritt,
wobei weiter das Rücklaufventil (1) in dieser Stellung mit einem wesentlich niedrigeren Begrenzungsdruck als in der Verschlusslage arbeitet, da der Begrenzungsdruck in dieser Stellung nicht mehr durch die Teilkolbenfläche definiert ist, sondern vielmehr durch die Gesamtoberfläche (5) des als Längsschieberkolben ausgebildeten Ventilkolbens(3)
und wobei der Ventilkolben (3) über den gesamten Rückstellweg des Hydraulikkolbens (9) infolge des auf den Ventilkolben(3) einwirkenden Öldruckes in der Öffnungsstellung verbleibt.
v) Interim assessment of the reporting judge
In an interim assessment the reporting judge had assessed the validity of the patent in suit and the validity of the main and auxiliary requests: Assuming the prior use was substantiated, then only the 4th auxillary request was considered new and inventive. The FPC followed this assessment only partially and concluded that claim 1 of the 2nd auxiliary request is admissible, new and inventive (see also section iv), above).
vi) Co-pending proceedings in Germany
This claim had also been presented in parallel proceedings in Germany, but the Federal Patent Court of Germany denied an inventive step; see decision 6 Ni 47/14 (EP), r. 6.4. The German Federal Patent Court only upheld the 4th auxiliary request. Both parties lodged an appeal to the Federal Supreme Court in Germany.
vii) Foreign court rulings in parallel proceedings
The FPC emphasized that it generally does not appreciate any unsolicited submissions. However, the Supreme Court requires that court rulings in parallel proceedings are to be considered. Therefore, parties are expected to inform the court of any foreign rulings immediately; see ¶ 1.6 and also this Blog here.
viii) Costs
Both parties did not prevail entirely. The defendant limited the patent with his 2nd auxiliary request. Therefore, the court held that an apportionment of the costs at 2/3 (defendant) vs 1/3 (plaintiff) is justified.
The decision has not been appealed by either party.
Art. 66(2) lit. b PatA:
Based on Art. 66(2) lit. b PatA in case the court finds infringement there is a substantive entitlement to information and accounting.
[Reference to al. 2 of Art. 66 PatA in the headnote might be misleading; there is no formal al. (2) in Art. 66 PatA. This is marked-up / corrected in the quotation above.]
1. Background of the case
The main hearing in this infringement case has taken place on 15 June 2015; see this Blog here. The patent in suit is EP 899 016 B1 of Nordson Corp.; see Swissreg for further bibliographic details. It pertains to a spray gun for powder coatings like the one shown in Fig. 2:
The only independent claim 1 as granted reads as follows (structured according to the feature analysis recited in the decision):
O1: An apparatus (20) for use in applying coating material to an object
O2: comprising a spray gun (24) having
O3: a handle portion (26),
O4: an extension portion (28)
O5: which is connected with the handle portion (26),
O6: a nozzle (42)
O7: connected with the extension portion (28),
O8: an electrode (46) disposed adjacent to the nozzle (42)
O10: and away from which electrostatically charged coating material flows toward the object,
O11: a coating material flow control member (74)
O12: connected with the handle portion (26) and
O13: manually operable to an actuated condition to initiate a flow of coating material from a coating material passage (62) in said extension portion (28) through the nozzle (42) toward the object,
characterised in that
K14: the spray gun (24) also has a purge air flow control member (110)
K15: connected with the handle portion (26) and
K16: which is manually operable to initiate a flow of air from the coating material passage (62) in the extension portion (28) through the nozzle (42) to remove coating material from the spray gun (24).
2. What’s it all about?
The plaintiff markets a product according to the patent under the tradename Encore®; see the so-called PowerPurge trigger on the handle in the snapshot below:
The defendant is GEMA Switzerland GmbH. Defendant’s attacked product is the OptiFlex 2 GM03 gun:
The attacked embodiment is further specified in the wording of the judgement with three functional illustrations, as follows (with corresponding annotations in English):
1st functional illustration
2nd funtional illustration
3rd functional illustration
As can be seen in the above illustrations, the attacked embodiment has only one trigger (17) at the front of the handle (the Encore® gun has two triggers there; see above illustration). In normal operation, trigger (17) of the attaecked embodiment triggers the powder flow. By means of the key T3 on the backside remote control of the gun, functionality of the trigger (17) can be switched to activate / stop the rinsing process. The Encore® gun does not have such a dual functionality of one and the same trigger, but rather has separate triggers for powder and purge air.
3. Claim construction and infringement
Essentially, only three claim features were under dispute with respect to claim construction and infringement.
3.1 Are control members (74) and (110) separate elements or not?
The claim requires a coating material flow control member (74); see feature O11. Feature K14 of the claim further requires that (emphasis added)
the spray gun (24) also has a purge air flow control member (110).
Parties dissented on the question of whether or not the material flow control member (74) and the purge air flow control member (110) are to be distinct elements or whether they could both be embodied by one and the same element. Evidently, in the Encore® gun and in the specific embodiments of the patent, these elements are distinct.
The FPC held that both elements may well be realized according to the patent by one and the same element having two functionalities. It is emphasized that embodiments may not be relied on in order to construe the claim in a more limited way than the claims demand for. The general specification and the claims do not mandatorily require that both elements are distinct. The attacked embodiment was thus held to realise feature K14.
But what about the “also” in K14, you ask? Interesting point. Note that the Dusseldorf Regional Court had come to a different conclusion; see decision 4b O 25/13. The Dusseldorf court relied on the German term “ausserdem” (see the German version of claim 1 of EP 899 016 B1). The term used in the (original) English language of the patent is “also”, and the FPC thus exclusively relied on the term “also” (in the sense of “auch”).
3.2 What does connected with the handle portion (26) actually mean?
Feature K15 requires that the purge air flow control member (110) be connected with the handle portion (26). The FPC held that this wording even allows for an indirect connection of purge air flow control member and handle portion.
In a function-oriented construction of this feature, the FPC concluded that the connection has to allow for the purge air flow control member being reachable by a user holding the gun at the handle portion. Thus, the purge air flow control member has to be arranged such that a one-handed operation of the gun is enabled.
From an illustration in marketing material of the defendant, it is evident that this functionality is realised by the attacked embodiment.
3.3 And what is the meaning of to initiate a flow of air?
Feature K16 requires that the purge air flow control member (110) be manually operable to initiate a flow of air from the coating material passage (62) in the extension portion (28) through the nozzle (42) to remove coating material from the spray gun (24). It was a matter of dispute whether this covers embodiments where (i) a flow is only initiated if the purge functionality has been unlocked beforehand (by means of another key); or (ii) the flow is not initiated directly, but rather only indirectly by a downstream controller in response to a keystroke on the purge air flow control member. Both situations were held to be covered by this claim feature, and the attacked embodiment was thus held to realise feature K16.
4. Patentability
The defendant had argued for nullity as a plea in defense. Allegedly, the claimed subject-matter was not novel over D1. However, D1 is silent about the actual location of the purge air flow control element. The FPC thus held that novelty was given, in line with a decision of the Federal Patent Court of Germany in parallel proceedings (see below). Note that D1 is recited as prior art in the patent in suit (see para. [0001] of EP 899 016 B1) and had already been considered during EPO prosecution).
Defendant also argued that the claimed subject-matter was not novel over D2. This gun has a trigger (36) that allows for a flow of air to be directed through channels (51) to the nozzle.
US 3,740,612, Fig. 1
US 3,740,612, Fig. 2 and 3
However, there is no flow of air through the powder path, as essentially required by feature K16. Air in D2 is used to generate a swirl into which the powder is then supplied; the purpose is thus a different one compared to the purge air of the patent in suit. Note that there is disclosure of purge air for the supply channel of the powder in D2, but this one is being operated manually by a valve on a separate control panel (11) on the powder pump, i.e. not on the gun itself. Novelty over D2 was thus acknowledged, too. Again, this is in line with the decision of the Federal Patent Court of Germany in parallel proceedings (see below).
Defendant further alleged a lack of inventive step over D1 in further view of the knowledge of the person of skill in the art, exemplified by D3, D4, D5, D6. Apparently, only the argumentation with respect to the combination with D3 had been elaborated in detail. It was beyond dispute that D1 can reasonably be considered as the closest prior art. As mentioned above, D1 is silent about the actual location of the purge air flow control element. From D1 alone, it cannot be concluded that a location for such a control element on the handle was obvious. Other locations such as illustrated in D2 would also be reasonable. Moreover, a foot pedal, clocked or sensory air pulses, or a control element to be used with the other (free) hand of the operator could be envisaged. Thus, the FPC concluded that D1 in further view of the knowledge of the person of skill in the art does not render the claimed subject-matter obvious. This is where the Federal Patent Court of Germany explicitly concluded differently:
Ein derart häufig und darüber hinaus auch noch leicht zu aktivierender Spülluftstrom vermittelt dem Fachmann jedoch, dass das Spülluftstromregelungselement in seiner unmittelbaren Nähe positioniert sein muss und demzufolge nicht entfernt von der Spritzpistole platziert sein kann, da er die Steuerung der Spülluft zudem individuell und somit manuell vornehmen wird. Da die D1 selbst keine Angaben macht, wo ein derartiges Regelungselement angebracht ist, positioniert der Fachmann dieses in unmittelbarer Nähe des Bedieners, wobei die Spritzpistole selbst als Ort der Positionierung am nächstliegenden erscheint.
The FPC held that the German court erred and had based its conclusion on an undue ex-post-facto analysis: D1 is silent about a location in close proximity, and a remote location is not indictated as disadvantageous. Moreover, not even a manual operation / initiation is mentioned in D1. Finally, the combination of D1 with D3 failed mainly because D3 does not concern a powder spray gun, but rather a hydraulic spray gun for liquid substances. Again, the German Federal Patent Court concluded differently. However, the German court obviously relied on a further document D30 (see p. 22, last paragraph) in addition to D3, but this document was not put on file in the Swiss proceedings, for whatever reason.
Further prior art documents D4, D5 and D6 relate to applicators for more-component reactive compositions instead of powder coatings. The FPC thus held that the person skilled in the art would not even consider these documents.
5. Legal aspects and costs
5.1 Plea of free prior art
Defendant also presented a plea of free prior art, interpreted by the FPC as a plea for nullity. However, patentability over the cited prior art was acknowledged; see above. The FPC held that a plea of free prior art could only be considered if an infringement under the doctrine of equivalents were at stake. In case of a literal infringement, this plea is pointless:
Die Einrede des freien Stands der Technik könnte ohnehin nur zum Zug kommen, wenn nicht eine wortsinngemässe Patentverletzung, sondern Äquivalenz zu beurteilen ist.
5.2 Substantive entitlement to information and accounting
This is what the headnote is all about. As outlined above, validity and infringment of the patent had been established, but the plaintiff had not provided further reasoning or evidence with respect to the financial compensation sought for in this action by stages. In a nutshell, the defendant argued that only the quantification is deferred to the second stage of the proceedings, but not the whole burden of proof as to the further legal requirements for financial compensation. For instance, the plaintiff had not presented any allegations as to the bad faith of the defendant — a requirement for recovery of defendant’s profits. With respect to damages for lost profits, the plaintiff had neither argued nor substantiated that he makes any profits with products according to the patent.
The FPC held that the defendant’s substantive duty of disclosure and accounting is directly based on Art. 66lit. b PatA since an infringement had been established. At the first stage of the proceedings, the plaintiff is not obliged to establish the further legal requirements for recovery of defendant’s profits, or damages.
5.3 Costs
The value in dispute was CHF 2.6 m, and the parties apparently put an enormeous effort into it. Compensation for legal representation in the amount of CHF 80’000,– was awarded to the plaintiff, according to Art. 3 ff. CostR-PatC. Noteworthy, costs awarded for the patent attorney were even higher, i.e. CHF 114’185,64.
6. Parallel decisions in Germany
With decision of April 29, 2015 the German Federal Patent Court had maintained the patent only in a more limited extent, i.e. as follows (marked-up; see 4 Ni 26/13 for details):
An apparatus (20) for use in applying powder coating material to an object comprising a spray gun (24) having a handle portion (26), an extension portion (28) which is connected with the handle portion (26), a nozzle (42) connected with the extension portion (28), an electrode (46) disposed adjacent to the nozzle (42) and away from which electrostatically charged coating material flows toward the object, a coating material flow control member (74) connected with the handle portion (26) and manually operable to an actuated condition to initiate a flow of coating material from a coating material passage (62) in said extension portion (28) through the nozzle (42) toward the object, characterised in that and a coating material passage (62) in said extension portion (28), characterised in that the apparatus has a valve (94), a conduit (98) and a controller (70) which, simultaneously with opening of a valve (54) and closing of a switch (78), operates the valve (94) to an open condition to enable electrode wash air under pressure from a source (96) of electrode wash air to flow through the conduit (98) to the handle portion (26) and from the handle portion (26) of the spray gun (24) through the extension portion (28) of the spray gun (24), the spray gun (24) also has a purge air flow control member (110) connected with the handle portion (26) and which is manually operable to initiate a flow of air from the coating material passage (62) in the extension portion (28) through the nozzle (42) to remove coating material from the spray gun (24).
These amendments in the German proceedings were not based on dependent claims; the added features were taken from the description.
In infringement proceedings, the Düsseldorf Regional court decided for non-infringement of the patent as granted, neither literally nor under the doctrine of equivalents; see decision 4b O 25/13.
What’s next?
The decision has been appealed to the Supreme Court. A decision can be expected by mid 2016.
This case is an assignment action of Marcel Riendeau against Zehnder Group International AG. The IP rights concerned are two European patent applications and the co-pending PCT applications, i.e.:
Back in 2009, the parties apparently entered into a cooperation based on a novel heat exchanger technology that had been invented by the plaintiff. A first patent application was filed in the name of Zehnder Verkaufs- und Verwaltungs AG — subject to final contracts to be concluded. This never happened. In the meantime, this application proceeded to grant as EP 2 618 090 B1; see the European Patent Register for any details. Interestingly, it has been assigned by Zehnder Group International AG to Westwind Ltd, the one-man business of Mr Riendeau. However, this assignment is already a story in itself: Apparently, Zehnder Verkaufs- und Verwaltungs AG first assigned the application to Marcel Riendeau with an agreement dated 5 May 2014. But later, it turned out that Zehnder Verkaufs- und Verwaltungs AG did not exist anymore at that date. Its legal successor was Zehnder Group International AG, the defendant on file.
At the technical side, the invention(s) pertain to heat exchanger elements schematically illustrated in the following figures. EP’834 and EP’836 explicitly recite polymer films being provided on the perforated plate element, while EP’090 holds that “[a]ccording to the inventions, the polymer is supplied as a dispersion”; see paragraph [0016].
Figures EP’090
Figures EP’834 (EP2)
Figures EP’836 (EP3)
The parties apparently also discussed the so-called extensions of the first patent. The importance to safeguard a filing date well before publication of the first application (EP’090) was apparently discussed, too. But the plaintiff did not trust the defendant to do so. Therefore, on 19 July 2013 he filed US 2013/269906 A1 on his own. Note that the two applications in suit were filed only later, i.e. 22 July 2013.
For the corresponding PCT applications WO’544 and WO’543 two additional inventors have been designated, i.e. defendant’s in-house patent attorney and the head of the R&D department.
This is only a rough overview of what appears to be a perfect mess. Interested in any further details? Plaintiff’s writ is available in its entirety from the EPO online files:
Proceedings at the EPO are currently stayed on request of the plaintiff, in both cases.
In parallel main proceedings (O2015_009; no publication yet), plaintiff essentially requests that both patent families are to be assigned to him; and that the designations of the two additional inventors are to be withdrawn. As an interim measure, plaintiff essentially requested to impose a ban on defendant’s authority to dispose of the applications in suit.
Now, what did the defendant say? Interestingly, the decision holds that plaintiff’s detailed and well documented allegations remained essentially undisputed on the merits. The improper assignment of EP’090 did the rest to establish a certain risk / lack of due care if authority over the applications in suit remained with the defendant. Finally, the interim measures were held proportinate: defendant himself submitted that no transfer, granting of rights or amendments to the applications in suit was envisaged. However, no unconditional and binding declaration was submitted. Consequently, interim measures were granted as requested.
This decision in summary proceedings has already become final.
This is yet another case relating to the contraceptive drospirenone. See this Blog here, here and here for details on an earlier case (with different parties) and relevant background information.
The plaintiff again sought for preliminary injunctive relief and invoked two European patents: EP 1 149 840 B2, which had already been at stake in the earlier case; and — for the first time — the only recently granted EP 2 168 974 B1 (a divisional of EP’840). Both patents relate to methods for the production of drospirenone (DRSP), a compound used in contraceptives (birth control pills).
Plaintiff (1) is the registered proprietor of the Swiss part of EP’840, i.e. Bayer Pharma AG. Plaintiff (2) is the registered proprietor of the Swiss part of EP’974, i.e. Bayer Intellectual Property GmbH.
The independent claims of EP’840 and EP’974 only differ slightly. The single claim of EP’974 reads as follows:
Process for preparing drospirenone from [well, let’s call it ‘precursor A’] in isolated form by water elimination.
On the other hand, the single claim of EP’840 reads as follows:
Process for preparing drospirenone by water elimination from [precursor A] through addition of p-toluenesulphonic acid to [precursor A].
EP’974 thus requires [precursor A] in isolated form, but is not limited to a certain catalyst for water elimination. To the contrary, EP’840 explicitly recites p-toluenesulphonic acid as the catalyst, but does not require the isolated form of [precursor A].
Reasoning presented by the plaintiffs as to why these products are infringing both EP’840 and EP’974 was an intricate issue: From a LOT number imprinted on the blisters, it was concluded that the Spanish company Laboratorios Léon Farma S.A. was the manufacturer. In turn, this company allegedly obtained drospirenone inter alia from the Italian company Industriale Chimica s.r.l.; both companies are parties in opposition proceedings re EP’974 at the EPO (see EPO register). Moreover, it has been alleged based on information from parallel proceedings in Germany, Spain and Switzerland that the method for manufacturing the drospirenone used by Industriale Chimica s.r.l. was as follows:
This was a non-starter. The defendant denied that the method outlined above had been used. Rather, defendant argued that a one-step palladium-catalyzed synthesis was used:
The defendant even provided exhaustive evidence in support of this synthesis being used, i.e. purchase orders, declarations of personnel of both Laboratorios Léon Farma S.A. and Industriale Chimica s.r.l., as well as an excerpt from the “Drug Master File Drospirenone D., Module 999: Description of manufacturing process and process controls”.
Plaintiffs did not allege that the one-step palladium-catalyzed synthesis would infringe EP’840 and EP’974. Rather, only the actual use of the palladium-catalyzed synthesis was disputed. Plaintiffs argued that defendant’s documentation had not been approved by an independent third party. Moreover, the palladium-catalyzed synthesis would be too expensive and more difficult to handle, for security reasons.
The FPC held that the documentation provided by the defendant in support of the palladium-catalyzed reaction was credible. Plaintiffs’ suspicion of false testimony was held unfounded, as well as the arguments with respect to the feasibility of the palladium-catalyzed process for cost and security reasons.
Consequently, the plaintiffs have failed to furnish prima facie evidence for a patent infringement. To the contrary, defendant’s documentation was held to credibly establish a case of non-infringement, by prima facie evidence. The plaintiffs’ request for interim injunctive relief was thus dismissed.
Note that Hepp Wenger Ryffel is involved in this case on behalf of the plaintiff.
This nullity suit pertains to Merck Sharp & Dohme’s patent und relating SPC on the the contraceptive Cerazette®.
Generally speaking, there are two main kinds of hormone contraceptives: On the one hand, the combined pill, commonloy referred to as ‘the pill’, which contains two types of female sex hormone (an oestrogen and a progestogen). On the other hand, the progestogen-only pill, sometimes referred to as ‘POP’ or ‘mini-pill’, which does not contain an oestrogen. Cerazette® is such a ‘mini-pill’, marketed in Switzerland by MSD Merck Sharp & Dohme; see compendium.ch for details.
Most POPs work primarily by preventing the sperm cells from entering the womb but they do not always prevent the egg cell from ripening, which is the main way that combined pills work. According to the manufacturer, Cerazette® is different from most POPs in having a dose that in most cases prevents the egg cell from ripening, making it a highly effective contraceptive.
In contrast to the combined pill, Cerazette can be used by women who do not tolerate oestrogens and by women who are breast feeding.
The progestogen contained in Cerazette® as the active ingredient is desogestrel. This compound as such was already known at the filing date of the patent in suit. The invention of EP 491 443 B1 pertains to the use of 70 to 80 micrograms of e.g. desogestrel as sole contraceptive. The independent claims cover this concept in different categories and read as follows:
1. A combination and contraceptive kit comprising sequential daily dosage units for oral administration each containing as the sole contraceptively effective ingredient from 70 to 80 micrograms of desogestrel, 3-ketodesogestrel, or mixtures thereof.
5. The use of an oral daily dosage unit consisting essentially of 70 to 80 micrograms of a progestogen selected from the group of progestogens consisting of desogestrel, 3-ketodesogestrel, or mixtures thereof, in the preparation of a drug delivery system, said drug delivery system characterized by consisting of daily dosage units containing only a progestogenic compound as sole therapeutically effective ingredient.
6. A drug delivery system comprising a package containing 26 to 30 daily sequential dosage units consisting essentially of from 70 to 80 micrograms of a compound selected from the group consisting of desogestrel, 3-ketodesogestrel, and mixtures thereof.
7. A contraceptive kit of the type containing progestogen-only daily dosage units, wherein the improvement comprises using from 70 to 80 micrograms of 3-ketodesogestrel, desogestrel, or mixtures thereof as the progestogen in said daily dosage units.
8. A process of manufacturing a drug delivery system comprising:
mixing predetermined quantities of a progestogen selected from the group consisting of desogestrel, 3-ketodesogestrel, and mixtures thereof, with predetermined quantities of excipients and converting the mixture into dosage units each containing 70 to 80 µg of desogestrel, 3-ketodesogestrel, or mixtures thereof, and packaging a plurality of said dosage units into a kit.
The nullity suit had been lodged already on July 12, 2013. The defendant answered on March 6, 2014. A first hearing was held on June 4, 2014; no settlement could be reached. Reply and rejoinder followed on September 2, 2014 and October 22, 2014, respectively. With his rejoinder, the defendant indicated to limit the patent to embodiments with 28 daily doses, as an auxiliary measure. Various submissions of both parties followed, and the parties were then summoned to the main hearing on June 2, 2015.
But the main hearing did not take place anymore, since neither party was interested in it. The reporting judge had provided her assessment on February 6, 2015, and both parties had commented on that assessment in writing. The SPC C00491443/01 (based on EP 491 443 B1 and the market authorization of Cerazette®) finally lapsed on March 27, and the President asked both parties on March 31, 2015 to comment on their remaining legal interest.
The defendant declared that no monetary claims will be raised against the plaintiff for marketing a generic version — Cevanel® — before the SPC had lapsed. Thus, both parties agreed that no legal interest in a decision on nullity remained. Proceedings had become groundless and the case was dismissed; Art. 242 CPC.
As a general principle, the unsucessful party has to bear the costs; Art. 106(1) CPC. However, someone has to pay the bills even if no decision is being taken. According to Art. 107(1) lit e CPC, the FPC may allocate the costs at its own discretion if proceedings are dismissed as groundless. Towards this end, the FPC had nevertheless to assess the probable outcome of the case, in order to allocate the costs.
Novelty was undisputed, but the plaintiff argued for lack of an inventive step essentially over three prior art documents:
In a nutshell, desogestrel had already been used in combined pills. Moreover, it had also been known that desogestrel completely prevents ovulation when given at a dosage of more than 60 microgram/day, and it had been suggested to further pursue desogestrel to be administered as sole contraceptive. And, finally, it had been known that dosages of 125 and 150 microgram/day of desogestrel were well tolerated. The reporting judge thus held that determination of a beneficial dosage of desogestrel within the aforementioned boundaries was just a matter of routine experimentation. Limitation of the claims to embodiments with 28 daily doses did not help, either: POPs with this dosage regime had also been known before.
The defendant objected that the reporting judge had chosen the wrong closest prior art in her assessment of inventive step according to the problem-and-solution approach. Starting from prior art POPs, inventive merit should be acknowledged. However, anything that is obvious having regard to the [whole] state of the art is not patentable as an invention; see Art. 1(2) PatA. With reference to T 967/97 (hn I and II) and BGE 138 III 111 (r 2.2), the FPC emphasized that it is sufficient to show that the person of skill in the art would have arrived at the alleged invention without inventive activity in at least one way.
The finding of lack of an inventive step is in line with a decision on the same European patent and corresponding SPC in Germany; see decision 3 Ni 21/12 of the Federal Patent Court in Germany of May 6, 2014. The Dusseldorf Regional Court had issued a preliminary injunction on November 15, 2012 (4bO 123/12), but the Dusseldorf Higher Regional Court lifted that decision on November 7, 2013, since validity of the patent was doubtful (I-2 U 94/12).
Likewise, the Tribunal de Grande Instance de Paris had also held that the basic patent was invalid inter alia for lack of an inventive step (decision of December 5, 2014).
The FPC thus concluded that the plaintiff would presumably have entirely succeeded and allocated the whole costs on the defendant (party compensation of CHF 114’080,– and court fee of CHF 30’000,–, based on a value in dispute of CHF 500’000,–).
This is not a new case. A first decision had been issued already on 29 January 2014 in the same matter. At that time, a request for recusal of Dr. Dieter BRÄNDLE had been dismissed. Moreover, the request for legal aid had also been dismissed — but only inasmuch as it concerned the request for recusal. The plaintiff’s request for legal aid also covered potential infringement proceedings, and this is what the present decision is all about.
According to Art. 117 CPC, a person is entitled to legal aid if he does not have sufficient financial resources (lit. a); and if his case does not seem devoid of any chances of success (lit. b). The claimant receives state benefits; his indigence was thus acknowledged (Art. 117 lit. a CPC). But the chances of success remained to be evaluated (Art. 117 lit. b CPC). In this respect, it is not necessary that the chances of success are outstanding. A case is not deemed to be devoid of any chances of success even if the risk of loss is slightly higher than the profit prospects. However, the profit prospects must not be be substantially lower than the risk of loss. In simple terms, it is decisive whether a party having the necessary financial resources would reasonably decide to lodge the suit. This has to be assessed by the President acting as single judge (Art. 23(1) lit. c PatCA) in summary proceedings (Art. 119(3) CPC).
Evidently, the chances of success depend on (i) the validity of the patents in suit; and (ii) whether the attacked embodiments actually infringed said patents. This assessment requires technical exerptise, and the President thus consulted a technically trained judge (Art. 35 PatCA).
The patents in suit are discussed in more detail in an ealier post. It’s an eventful history of limitations; the latest (second) published limitations are CH 687 352 C3 and CH/EP 0 660 960 H3. Yet another series of (third) limitations is mentioned in the decision (allegedly filed on 1 October 2013), but cannot yet be tracked in Swissreg. Thus, both patents are to be assessed on the basis of the second limitation only. In general terms, the claimant alleged that these patents were infringed by a method and system carried out / installed in Switzerland for collecting the heavy vehicle charges.
As to the validity of the patents on the basis of the prior art that is readily apparent, the technically trained consulting judge concluded that: —
infringement of claim 9 of CH 687 352 C3 is plausible;
infringement of claim 9 of CH/EP 0 660 960 H3 is plausible, but still subject to yet further amendments to this claim corresponding to the other indepent claims. Note that the reference to claim 9 most likely is a typographical error; the second independent claim of CH/EP 0 660 960 H3 is claim 12, not 9.
The President also agreed with this opinion, but the latter (potential) further amendment of CH/EP 0 660 960 H3 was not taken into consideration; the facts are to be considered as they are on the filing date of the request for legal aid (Supreme Court decisions 139 III 475, r 2.2 and 138 III 217, r 2.2.4 with further reference). Nevertheless, in view of at least one claim having been plausibly infringed, the case could not be held devoid of any chances of success.
The decision also expands on the implications of the fact that both patents in suit have already expired back in 2012 and 2013, respectively. Therefore, there is no injunctive relief at stake any more; the potential plaintiff might only invoke financial claims. In general terms, the claimant apparently mentioned Art. 41 ff, Art. 423 and Art. 62 ff CO. However, a claim under Art. 41 ff CO requires fault, and a claim under Art. 423 CO requires bad faith. Only a claim for restitution in view of an unjust enrichment (Art. 62 ff CO) neither requires fault or bad faith; see Mark SCHWEIZER, Zivilrechtliches Verschulden bei der Verletzung von Schutzrechten, sic! 2015, p 1ff. In this respect, it is to be noted that the second series of limitation of the patents in suit was inter alia based on features taken from the description of the patents. Fault or bad faith of the potential defendants is thus doubted in the decision; only the (usually lower) restitution under Art. 62 ff CO would thus remain as a basis of a financial claim.
In passing, the decision also notes that the defendants might refer to the defence of limitation, which is to be taken into consideration in the assessment of whether or not legal aid is to be granted; see Supreme Court decision 119 II 368, r 5a. But from the file as-is, no clear conclusions could be drawn in this respect.
Legal aid was thus granted, for the time being. However, it is noted in the decision that — depending on the reasons given in the suit to be filed — the legal aid might be again withdrawn later on.
One of the defendants is the inventor / registered proprietor of the aforementioned patents, i.e. Giuseppe Sarcinella — a former member of the board of Thermoself until 2011. The other defendant is Suricate SA. The patent families in dispute pertain to flexible container with built-in auto-heating or -cooling, e.g. for beverages. In this video of Thermaself, it is explained how such systems can be used for mulled wine:
Some similarities of the product presentations of Thermoself and Suricate are astonishing: Even the same icons are used; see below.
Sounds like an explosive mixture, doesn’t it? But no, the case did not even get under steam. JHD Acquisitions SA is a company incorporated in Panama. In view of this international context, the defendants requested that the plaintiff be obliged to provide security for the defendants’ costs (Art. 99(1) lit. a CPC) in the amount of CHF 75’000,–. The plaintiffs then argued that the rights in the patents had been resold to MPMC Intellectual Property SA (a company incorporated in Switzerland). This company would replace JHD Acquisition SA as a plaintiff, and the security for the defendants’ costs would thus have become moot. It did not work out that easy. The FPC held that the transfer of the position as a plaintiff had not been sufficiently established, and the security for defendants’ costs was fixed by the FPC to CHF 62’000,–.
Now, how to reduce that security? It depends on the value in dispute. Next, the plaintiffs tried to reduce the value in dispute to only CHF 30’000,–, since the patents had not yet generated any income and the defendants had acted in bad faith. Even though the plaintiffs had estimated the value in dispute to “at least” CHF 30’000,– in the writ, the FPC had already fixed the value in dispute to CHF 500’000,–. And, noteworthy, the plaintiffs had duly provided the accordingly calculated advance payment of court fees of CHF 25’000,–. Unsurprisingly, the FPC had no reason to reduce the value in dispute at this stage of the proceedings: It is not decisive whether the patents had already generated income or not; it rather is the potential interest of the parties that counts. And the alleged bad faith of the defendants can only be taken into consideration after examination of the case on the merits.
Finally, the plaintiffs did not provide the required security for the defendants’ cost, and the FPC consequently did not consider the case. Nevertheless, the court fee was set to CHF 20’000,–. Obviously, the case was cumbersome and time-consuming for the FPC:
A causa delle insolite modalità seguite dalle parti nel compiere gli atti processuali, per il Tribunale la causa è risultata impegnativa. Conclusioni manchevoli, confusione riguardo alla contemporanea introduzione di una causa presso il Tribunale d’appello di Lugano nonché riguardo alla rappresentanza della attrici e un atto inammissibile inoltrato dalle attrici hanno richiesto continui interventi da parte del Tribunale. A queste complicazioni si aggiunge anche il dispendio in rapporto con l’esame dell’invocata sostituzione di parte e con la richiesta di cauzione.
In the meantime, the decision has already become final.
Case No. S2014_008 ¦ Decision of 04 February 2015 ¦ “Begründung Massnahmebegehren unter Bezugnahme auf Klagebegründung im ordentlichen Verfahren; unbedingtes Replikrecht im Massnahmeverfahren; Anordnung einer Verfügungsbeschränkung im Patentregister (Registersperre)”
This is further to an earlier post in this matter.
In brief, both the plaintiff Gilead Pharmasset LLC and the defendant AbbVie Inc. had filed patent applications on a combination of sofosbuvir and ledipasvir (marketed by Gilead under the tradename Harvoni), and Gilead had lodged an assignment action against AbbVie in main proceedings (O2014_013). A block of the patent register had been ordered without hearing the defendant beforehand, to prevent that the enforcement might be jeopardized.
In the meantime, the defendant was belatedly heard and the FPC now finally decided on the requested interim measures (Art. 265(2) CPC). And: The interim measures were upheld to a large extent, but examination and grant proceedings may now continue. Still, it will be highly interesting to see how the case will be decided on the merits in co-pending main proceedings.
However, also the present decision has some interesting procedural implications:
i) SUBSTANTIATION BY REFERENCE TO WRIT
The plaintiff had filed the assignment action in main proceedings on the very same day as the request for interim measures. In order to avoid unnecessary repetition in the substantiation of the request for interim measures, the respective parts of the writ were incorporated by reference. The defendant argued that this was inadmissible. And indeed, the FPC held that global references to other documents are regularly not sufficient. But in the present matter, it was. The underlying facts in both proceedings are the same and the plaintiff’s allegations are thus evident. Under these circumstances, it would be an excessive formalism to insist on a complete repetition in summary proceedings.
ii) UNCONDITIONAL RIGHT TO REPLY IN SUMMARY PROCEEDINGS
The defendant had filed his reply to the request for interim measures on December 22, 2014. The FPC then informed the parties that an exchange of further written submissions is dispensed with. In addition, the plaintiff was informed that any remarks on the defendant’s reply would have to be submitted in due course, and the FPC further held that remarks filed by no later than January 19, 2015 would be considered timely filed. Apparently, the plaintiff then filed very extensive remarks, along with two folders of exhibits. The defendant refrained from making any further remarks on the merits, but essentially argued that the new allegations were to be ignored by the court.
The FPC held that the plaintiff’s submission of January 2015 is to be considered as a submission made under the condition of the unconditional right to reply. With reference to the decision 4A_815/2014 (r. 3.2) of the Supreme Court, the FPC clarified that this decision has not ruled out submissions under the unconditional right to reply in summary proceedings, but rather only relativised its scope. Anyhow, the plaintiff’s submission was only considered inasmuch as it was occasioned by the defendant’s reply (analogous to BGE 4A_487/2014, r. 1.2.4).
iii) BELATED SUBSTANTIATION OF A NOT EASILY REPARABLE HARM
Interim measures are ordered when the plaintiff credibly shows that a) a right to which he is entitled has been violated or a violation is anticipated; and the violation threatens to cause not easily reparable harm to the plaintiff (Art. 261(1) CPC). The plaintiff had argued in the initial request that three potential actions of the defendant could cause an irreparable harm, i.e. (1) an assignment of the patent applications to a third party; (2) the granting of rights (licences or pledge); and (3) changes to the contents of the applications (Art. 51 and 64 PatR).
However, the plaintiff was silent on a not easily reparable harm that could come along with a continuation of the examination and grant procedure as such. The FPC took note that the plaintiff presented arguments in this respect for the first time only in the submission of January 19, 2015. But the FPC held that this was belated and did not consider those arguments any further.
In sum, the FPC thus partially lifted the ban on AbbVie’s patent applications, and the examination and grant proceedings of CH 707 029 and CH 707 030 may now continue. As to the remaining potential actions (1)-(3) outlined above, the defendant basically accepted the request for interim measures: The defendant confirmed to the court that he did not even think of any of these actions. Thus, the FPC upheld the interim measures to that extent.
iv) AMOUNT IN DISPUTE
The court fee depends on the amount in dispute. Contrary to Art. 221(1) lit. c / Art. 219 CPC the plaintiff did not indicate the amount in dispute for the summary proceedings. In main proceedings, the plaintiff estimated the amount in dispute to “exceeding CHF 1m”. The defendant estimated the amount in dispute (for the main proceedings) to “exceeding CHF 10m”. All this did not help much to figure out the actual amount in dispute in summary proceedings. However, the defendant had requested a security of CHF 5m in case the ban with respect to the examination and grant proceedings would have been upheld. The FPC took this as a sufficient indication of the amount in dispute and thus fixed it to CHF 5m (BGE 92 II 62, r. 3). This results in a court fee of CHF 30’000,– (which is moderate in view of the value in dispute; see CostR-PatC), provisionally borne by the plaintiff (still subject to the outcome in main proceedings).
Reported by Martin WILMING
— BIBLIOGRAPHY —
Case No. S2014_008 ¦ Decision of 04 February 2015 ¦ “Begründung Massnahmebegehren unter Bezugnahme auf Klagebegründung im ordentlichen Verfahren; unbedingtes Replikrecht im Massnahmeverfahren; Anordnung einer Verfügungsbeschränkung im Patentregister (Registersperre)”
Case No. S2014_001 ¦ Decision of 11 February 2015 ¦ “Vorsorgliche Massnahmen; Bedeutung ausländischer Nichtigkeitsurteile für die Glaubhaftmachung der Nichtigkeit des Streitpatents”
— THE DECISION IN A NUTSHELL —
AstraZeneca’s patent on an extended release formulation of quetiapine (Seroquel®) is heavily litigated in many countries. The FPC now dismissed AZ’s request for interim injunctive relief, essentially on the basis of parallel decisions in various European jurisdictions that held the patent invalid for lack of an inventive step.
— THE DECISION IN MORE DETAIL —
This case is all about 2-{2-[4-(Dibenzo[b,f][1,4]thiazepin-11-yl)-1-piperazinyl]ethoxy}ethanol.
Getting confused? No worries.
This molecule is better known as quetiapine (international non-proprietary name, INN) or under the tradename Seroquel® of AstraZeneca. It is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and along with an antidepressant to treat major depressive disorder.
Seroquel is still a blockbuster drug, even though revenues have drastically declined since 2011 (see below). It was first approved by the FDA in 1997, and today generics are already available.
Seroquel XR by AstraZeneca
Revenues generated with Seroquel
The plaintiff / patentee had requested interim injunctive relief about one year ago, based on EP 0 907 364 B1; the underlying PCT application is WO 97/45124 A1. The patent on quetiapine as such (EP 0 240 228 B1) has already lapsed. Note that EP 0 907 364 B1 only protects an extended release formulation thereof. Independent claim 1 at stake reads as follows:
A sustained release formulation comprising a gelling agent and [quetiapine] or a pharmaceutically acceptable salt thereof, together with one or more pharmaceutically acceptable excipients.
It was undisputed that the formulations marketed by the defendant contained — besides quetiapine — lactose and Viscarin GP 209. However, while the plaintiff / patentee argued that Viscarin GP 209 was a gelling agent, this was disputed by the defendant. Further, the defendant alleged that the patent-in-suit was invalid for various reasons: Insufficient disclosure of the invention; lack of novelty or, at least, lack of an inventive step.
In summary proceedings, the standard of proof is only prima facie evidence; see Art. 261(1) CPC, Art. 77 PatA. This also applies to a defendant’s plea in defense (see e.g. BGE 132 III 83, r. 3.2; BGE 103 II 287, r. 2; BGE 4P.228/1996). The national parts of EP 0 907 364 B1 had been revoked for lack of an inventive step in already five jurisdictions: Germany, the United Kingdom, the Netherlands, Spain and Italy. Only a decision of the Commercial Court of Vienna (Austria) held that the claimed subject matter involved an inventive step. I have collected copies of some of these decisions as follows: 3Ni 43/10 of the Federal Patent Court of Germany (also an inofficial EN translation is available) and the second instance decision X ZR 41/13 of the Federal Supreme Court of Germany; the decision of the High Court of Justice and the second instance decision of the Court of Appeal in the United Kingdom; the decision of the Appeal Court The Hague (Netherlands).
With reference to the decision 4P.89/2004 (r. 3.1-3.2) of the Supreme Court, the FPC unequivocally held that
[f]or the sole reason that the patent had been declared invalid by five European courts, the defendant’s plea for nullity is credible. […] Accordingly, the request for interim measures would have to be readily dismissed, […]. Nevertheless, in terms of a diligent assessement, an opinion of the reporting judge […] was obtained.
The FPC held that the alleged insufficiency of disclosure of the invention in the patent-in-suit was unfounded,
[…] at least to the extent of the specific embodiments disclosed in the patent-in-suit. However, this does not mean that the invention is workable over the whole scope of the claim, as required by Art. 83 EPC.
However, the FPC did not expand further on the alleged insufficiency of disclosure, but rather exhaustively discussed the parallel European decisions referred to above. The FPC held that the five decisions denying an inventive step were convincing, while the only dissenting decision of the Commercial Court of Vienna was held to be not conclusive.
Be that as it may, the FPC held that the defendant had credibly established a lack of inventive step by prima facie evidence on the basis of the parallel European decisions.
The plaintiff had submitted amended / restricted sets of claims of the patent in suit, as auxiliary requests. However, the amendments did not revert the FPC’s findings re inventive step. The amendments related to the amount of the gelling agent to be added to the formulation, but no non-obvious effect of the amounts had been alleged by the plaintiff. The FPC could not spot any such effect, either. Therefore, the request for interim injunctive relief was dismissed.
Reported by Martin WILMING
— BIBLIOGRAPHY —
Case No. S2014_001 ¦ Decision of 11 February 2015 ¦ “Vorsorgliche Massnahmen; Bedeutung ausländischer Nichtigkeitsurteile für die Glaubhaftmachung der Nichtigkeit des Streitpatents”
Both Gilead Pharmasset LLC and AbbVie Inc. hold patent applications on the combination of the sofosbuvir and ledipasvir for the treatment of hepatitis C. This combination is marketed by Gilead under the tradename Harvoni™. Gilead has sued AbbVie for assignment of their Swiss patent applications. In first place, a block of the register for these patent application was ordered as an interim measure.
— THE DECISION IN MORE DETAIL —
This decision pertains to new pharmaceuticals for the treatment of hepatitis C.
1. BACKGROUND
Undisputedly, sofosbuvir has been a breakthrough in the treatment of this widespread disease. It is a ribonucleotide analog inhibitor of the RNA-dependent RNA polymerase of hepatitis C virus (HCV).
Sofosbuvir causes chain termination by competing at the triphosphate level with natural nucleotides for incorporation into elongating RNA. The triphosphate serves as a defective substrate for the NS5B protein (which is the viral RNA polymerase), and thus acts as an inhibitor of viral RNA synthesis; see Antimicrob Agents Chemother. 2014 Jul; 58(7): 3636-45.
Sofosbuvir has received the FDA’s Breakthrough Therapy Designation and has been marketed since 2013. Compared to previous treatments, sofosbuvir-based regimens are reported to provide a higher cure rate, fewer side effects, and a two- to four-fold reduced duration of therapy.
In October 2014 a combination of sofosbuvir with the viral NS5A inhibitor ledipasvir was approved by the FDA.
The combination of sofosbuvir and ledipasvir is marketed by Gilead under the tradename Harvoni™; see also the Harvoni™ patient information. It is reported to provide high cure rates in people infected with genotype 1 (the most common subtype in the U.S., Japan, and much of Europe).
This question will be dealt with in co-pending main proceedings (O2014_013). Both parties had filed patent applications on this combination of drugs. The present decision only deals with a block on the register as an interim measure (see below). However, the plaintiff exhaustively argued on the merits of his rights in the invention, in order to get the block on the register issued. And, indeed, it was issued even without hearing the defendant beforehand.
The plaintiff essentially argued as follows:
As the legal successor of Gilead Sciences, Inc., Gilead Pharmasset LLC owns all rights and interest in this invention that is subject of patent applications (for the assignment see the request for a change under R. 92bis PCT and the corresponding notification issued by the WIPO). An outline of this patent family is shown below. Claim 3 of WO 2013/040492 A2 is directed to the combination of sofosbuvir (referred to as “compound 10”) and ledipasvir (referred to as “compound 6”).
Gilead Sciences, Inc. had acquired Pharmasset LLC in January 2012, incl. the rights to sofosbuvir (PSI-7977). On the other hand, ledipasvir had been developed in-house at Gilead. Gilead’s first priority application had been filed on September 16, 2011 (at a time when a takeover bid for Pharmasset LLC had already been placed), and this application already included the combination of sofosbuvir and ledipasvir (GS-5885) for the treatment of HCV (in particular of genotype 1) for twelve weeks, with or without the further antiviral agent ribavirin, but in any case without interferon. Thus, the plaintiff had been in possession of the invention already on September 16, 2011.
The defendant’s patent applications are outlined below, in chronological order. The two Swiss patent applications that are litigated here are given in the last line. There are two series of applications, one with and one without the yet further antiviral agent ribavirin.
As can be seen, the defendant had filed the first priority application on October 21, 2011, i.e. only after the plaintiff’s first priority application of September 16, 2011. Ledipasvir as such is not referred to by the defendant in his first priority application, but rather only the identifier GS-5885. Neither the chemical structure is given, nor the specific combination of GS-5885 and sofosbuvir. The plaintiff points at two peculiarities in the subsequent time line of the defendant’s priority filings:
First, the plaintiff had mentioned the combination of GS-5885 and sofosbuvir for the first time in an investor phone conference on February 02, 2012. However, the structure of GS-5885 had not been made publicly available. About two weeks later, the fourth priority applications had been filed and disclose the specific combination of sofosbuvir and GS-5885 for the first time in the series of priority applications.
Second, only the sixth priority applications of the defendant (filed June 06, 2012) disclose the structure of ledipasvir / GS-5885. This is about six weeks after the plaintiff had made the structure of GS-5885 publicly available for the first time on April 18, 2012 at the 25th International Conference on Antiviral Research in Sapporo, Japan. The defendant does not rely on clinical data in the patent applications, but rather used computer models to predict the advantageous combinations of drugs.
3. NOW, WHAT HAS BEEN DECIDED?
Both parties are domiciled in the U.S.; competency for interim measures is thus governed by Art. 10 IPRG. The requested interim measures aim to preserve the status quo for as long as the assignment suit has not yet been decided in co-pending main proceedings (O2014_013). In main proceedings, the courts of Switzerland have jurisdiction (Art. 109(1) IPRG; Art. 29 PatA). Moreover, the requested interim measures (block of the register) are to be executed in Switzerland. Competency of the FPC is thus given, and Swiss law is to be applied (Art. 110(1) IPRG).
Interim measures are ordered when the plaintiff credibly shows that a) a right to which he is entitled has been violated or a violation is anticipated; and the violation threatens to cause not easily reparable harm to the plaintiff (Art. 261(1) CPC). Prima facie evidence is sufficient. Further, a certain urgency must be given and the requested interim measures must be proportinate. The FPC held that all these prerequisites were fulfilled in the present matter. The block of the register was ordered without hearing the defendant beforehand, to prevent that the enforcement might be jeopardized.
It remains to be seen how the defendant defeats the allegations. The defendant will now belatedly be heard and the FPC will then finally decide on the requested interim measures (Art. 265(2) CPC).
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