Category: Main proceedings

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AZ’s Faslodex®: EP(CH) 2 266 573 and EP(CH) 1 250 138 revoked

Case No. O2015_011 ¦ Decision of 29 August 2017 ¦ “Gutheissung Nichtigkeitsklage”

Case No. O2015_012 ¦ Decision of 29 August 2017 ¦ “Gutheissung Nichtigkeitsklage; Nichtzulassung verspäteter Einschränkung”

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We have reported on the combined main hearing in these nullity cases on this Blog here. In brief:

Fulvestrant (aka ICI 182,780), the active ingredient of AZ’s Faslodex®
AZ’s Faslodex® package

As could be expected after the main hearing, assessement of inventive step in view of McLeskey and Howell was key. The panel of judges essentially followed the expert opinion of the judge-rapporteur and denied patentability for lack of an inventive step in both cases. Besides the (always) very case-specific assessment of inventive step, I feel that some other aspects of these decisions are of more general interest.

  1. Partial priorities / ‘self-collision’

Plaintiff argued that the divisional application EP 1 669 073 A2 is novelty-destroying for its parent, EP’138. With reference to the decision G 1/15 of the Enlarged Board of Appeal (EPO), the FPC did not buy the self-collision argument.

No more poison!

In principle, the claims at stake could well be split into parts that did / did not enjoy priority (‘generic or’-claims) – even though that might well be a challenging task. However, since there was no intervening prior art on file, there was no need to go through that academic exercise. Partial priority was acknowledged, ruling out any self-collision issue.

Es scheint aber insbesondere im Hinblick auf die Entscheidung G 1/15 angebracht, im vorliegenden Fall Teilprioritäten grundsätzlich anzuerkennen und zwar selbst dann, wenn keine explizite Aufteilung der Patentansprüche in die Prioritäten gültig beanspruchende bzw. nicht gültig beanspruchende Teilbereiche vorliegt.

The ‘self-collision genie’ is pushed back in the bottle.

  1. Prior public use / clinical studies

It was beyond dispute that Faslodex® had been in phase-III clinical study in 1998, well before the earliest priority date. The decisions refer to the study as 9338IL/0020, but this appears to be a typo. I trust it should read 9238IL/0020; see EMA ‘Assessment Report for Faslodex’ of 2010, at the bottom of p 29.

Plaintiff argued that clinical studies would generally make the pharmaceuticals publicly available, in the absence of any proof to the contrary. It was referred to T 0007/07 in this respect. Further, it was argued that the patients must have been informed about the exact formulation; and even if this had not been the case, the formulation could have been identified / analysed with ease.

The FPC did not agree. In the case at hand, two ‘Clinical Trial Agreements’ from this study contained confidentiality clauses, and the ‘Written Informed Consent Form’ apparently did not reveal details as to the exact formulation. Finally, the patients got a monthly injection into the gluteal muscle. This is unlikely being done by the patient herself, and thus it is unlikely that the patient ever had access to the pharmaceutical for further investigation of the formulation.

Under the given circumstances, the clinical study was thus held to not constitute a public prior use. Novelty was acknowledged.

  1. Insufficient disclosure to be considered as prior art?

Howell discloses a dosage of 250 mg fulvestrant and mentions an injection volume of 5 ml. Plaintiff argued the this results in a solution with a concentration of 50 mg/ml. Defendant disagreed: The solubility of fulvestrant would be too low to obtain a solution in castor oil. Rather, a dispersion would be obtained. Further additives would be necessary to obtain a solution with such a high concentration of fulvestrant. But there is no indication of any such additives in Howell. Defendant thus argued that Howell must not be considered as prior art, for lack of an enabling disclosure.

This argument is in line with the EPO Guidelines (G-IV, 2) and some BoA decisions referred to therein:

Subject-matter can only be regarded as having been made available to the public, and therefore as comprised in the state of the art pursuant to Art. 54(1), if the information given to the skilled person is sufficient to enable him, at the relevant date (see G‑VI, 3), to practise the technical teaching which is the subject of the disclosure, taking into account also the general knowledge at that time in the field to be expected of him (see T 26/85, T 206/83 and T 491/99).

Where a prior art document discloses subject-matter which is relevant to the novelty and/or inventive step of the claimed invention, the disclosure of that document must be such that the skilled person can reproduce that subject-matter using common general knowledge (see G‑VII, 3.1).

This appears to be a sensible approach at first sight. But is it really in line with the definition of ‘the state of the art’ codified in Art. 54(2) EPC?

The state of the art shall be held to comprise everything made available to the public by means of a written or oral description, by use, or in any other way, before the date of filing of the European patent application.

Frankly, I am not conviced. What is published, is just out there as-is. What the skilled person actually can do based on a specific publication at a given point in time, that’s a different story to me.  Anyway, the FPC did not need to decide on this issue; but I catch the notion between the lines that it is not carved in stone that the FPC would follow the EPO’s approach.

Lässt man die Praxis des EPA unberücksichtigt, ist die D15 vollumfänglich dem Stand der Technik zuzurechnen. […] Ob der erwähnten Praxis des EPA zu folgen ist, kann deshalb hier offen bleiben.

In the case at hand, the  FPC held that Howell did contain an enabling disclosure for the skilled person, and it was considered as prior art.

  1. Belated limitation not admitted into the proceedings

Defendant limited one of his auxiliary requests in O2015_012 with an additional feature (marked-up below) as follows:

Use of fulvestrant in the preparation of a pharmaceutical formulation for the treatment of breast cancer by intra-muscular administration to human patients, […] wherein […] the formulation is adapted for attaining a therapeutically significant blood plasma fulvestrant concentration of at least 8.5 ng ml-1 for at least two weeks.

Defendant argued that this further limitation was a partial acknowledgment of the complaint which is possible at any stage of the proceedings; Art. 241 CPC. The FPC did not agree.  The further limitation only concerned an auxiliary request, i.e. it only came into play when the court had already decided on the main requests of the defendant: Denial of the complaint, without any amendments to the claims. At that stage, there is no room anymore for a partical acknowledgment of the complaint. The FPC held that the defendant in fact present the court with new facts to be considered as an auxiliary measure. This is possible in general, but only within the time limits for submission of novae; Art. 229 CPC. Consequently, the newly drafted auxiliary request was not admitted into the proceedings.

UPDATE October 17, 2017:

The patentee has lodged an appeal to the Supreme Court in both cases.

UPDATE May 30, 2018:

AZ’s appeal re O2015_012 has apparently been dismissed, and the appeal re O2015_011 partially approved. No more information available, for the time being.

UPDATE June 5, 2018:

The Supreme Court has published decisions 4A_541/2017 (appeal against O2015_011) and 4A_543/2017 (appeal against O2015_012) on its website earlier today. Further, 4A_541/2017 is scheduled for publication in the official collection.

Reported by Martin WILMING

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BIBLIOGRAPHY

Case No. O2015_011 ¦ Decision of 29 August 2017 ¦ “Gutheissung Nichtigkeitsklage”

Case No. O2015_012 ¦ Decision of 29 August 2017 ¦ “Gutheissung Nichtigkeitsklage; Nichtzulassung verspäteter Einschränkung”

Actavis Switzerland AG ./. AstraZeneca AB

Composition of the Board of the FPC:

  • Dr. Dieter BRÄNDLE
  • Dr. Hannes SPILLMANN
  • Dr. Daniel ALDER
  • Dr. Hanny KJELLSAA-BERGER
  • Dr. Prisca VON BALLMOOS

Judge-rapporteur:

  • Dr. Hannes SPILLMANN

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

  • Dr. Michael RITSCHER (MLL)
  • Dr. Mark SCHWEIZER (MLL)
  • Dr. Kilian SCHÄRLI (MLL)
  • Dr. Thorsten BAUSCH (Hoffmann Eitle), assisting in patent matters

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DECISION O2015_011

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THE ‘573 PATENT IN SUIT IN O2015_011

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DECISION O2015_012

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THE ‘138 PATENT IN SUIT IN O2015_012

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Living in a box … no more

Case No. 4A_18/2017 (Supreme Court)] ¦ Decision of 10 July 2017 ¦ ‘HIT Box’

This decision of the Supreme Court of Switzerland concerns an appeal against a decision of the Princely High Court of Liechtenstein in a patent infringement case.

This setup demands for some explanations right from the outset.

Switzerland and the Principality of Liechtenstein form a unitary territory of protection; see the Bilateral Protection Act (‘Patentschutzvertrag‘, an English translation is available here). The Princely High Court is designated as the competent court in civil cases regarding patent matters in Liechtenstein. An appeal to the Swiss Supreme Court is possible with regard to issues of substantive law (BGE 127 III 461, r 3d); the Supreme Court Act applies. On the other hand, issues of international private law (BGE 127 III 461, r 4b) and procedural law of the Principality of Liechtenstein (4A_681/2012 and 4A_683/2012) are not to be dealt with by the Swiss Supreme Court. 

All this may well add a further layer of procedural complexity on top of the inherent complexity of any patent litigation.

But at least the subject-matter at stake appears to be rather straight-forward: It’s all about a plastic container with a lid and snap closure, illustrated as follows:

The snap-mechanism can be released by pushing the nose (15) inwards and pulling the gripping member (9) outwards, illustrated by forces K3 and K2, respectively, in Fig. 4 below. The lid can then be lifted easily with force K1. However, if only the lid is lifted (force K1′) without prior release of the snap-mechanism by forces K2 and K3, the nose 15 slides to the exterior into a safety position; see Fig. 6 below.

The patent EP 0 767 106 B1 (Georg Utz Holding AG; see Swissreg and EPO Register for further bibliographic details) had been granted in 1999 with a single independent claim as follows:

A plastic Container with a lower part (1) and a lid (2) as well as at least one snapping mechanism (9-18) for attaching the lid (2) to the lower part (1), wherein the snapping mechanism comprises a first and a second member (12-15; 9, 11, 17, 18), wherein the members are snapped into each other in a closed position and resist against an opening of the lid (2) by a nose (15) of the first member abutting against a stopping surface (18) of the second member, wherein for opening the lid (2) the members can be brought into an opened position by urging the nose (15) in a first direction from the stopping surface (18) by elastic deformation of at least one of the members, and wherein by exertion of a sufficient opening force (K1′) on the lid, the nose (15) can be urged from the stopping surface (18) in a different second direction and the members can be brought from the closed position into a safety position, where they form a connection positively acting against the opening force, characterised in that an opening (11) is arranged in an edge region of the lid (2), the lower edge of which opening forms the stopping surface (18), and that the nose (15) is connected to the lower part (1).

The complaint (apparently against members of the Hilti group of companies) had been filed back in September 2012. The Princely High Court appointed a court expert to assess validity and infringement of the patent: Dr. Tobias Bremi, who is also the second ordinary judge of the Swiss Federal Patent Court. The expert held that the attacked embodiment is literally covered by claim 1 of the patent, but that the patent is invalid for lack of novelty. However, it may be concluded from the decision that the court-appointed expert somehow indicated that the subject-matter of dependent claim 10 would be valid and infringed.

Later, the patent has been limited in central EPO proceedings by addition of the following feature to claim 1:

the upper border area (3) of the lower part (1) is reinforced by a double wall

No, it’s not what you might expect: The additional feature is not the subject-matter of former claim 10, it rather has been taken from the description. The limited patent has been republished as EP 0 767 106 B3.

The expert accordingly delivered a second opinion on the limited patent in December 2015: The attacked embodiment was still covered by amended claim 1, but the claim was still not novel over the same prior art document. Even worse, the amendment was held to be in violation of Art. 123(2) EPC, i.e. that the amended claim contained subject-matter which extended beyond the content of the application as filed by way of an intermediate generalisation. 

The Princely High Court thus dismissed the complaint with decision of 24 November 2016, ie well after the patent had finally lapsed on 30 September 2016. On appeal to the Swiss Supreme Court the plaintiffs essentially requested that the decision of the Princely High Court be set aside and that the case be remanded to the Princely High Court for reappraisal. The plaintiffs / appellants apparently argued that the amendment to claim 1 was not an unallowable intermediate generalisation. Moreover, it was argued that claim 10 as such was valid and infringed.

In first place, the Supreme Court held that the plaintiffs / appellants had no legitimate interest anymore in injunctive relief since the patent had meanwhile lapsed. The appeal has not been considered to this extent.

Second, the Supreme Court dealt with the aspect of information and accounting. The Supreme Court would have been competent to decide on the merits; Art. 107(2) SCA and Annex I to the Bilateral Protection Act (‘Patentschutzvertrag’) which refers to the Swiss Code of Obligations. However, only remandment to the Princely High Court had been requested. The Supreme Court has thus not considered the appeal to this extent, either.

Finally, the Supreme Court held that partial validity of dependent claim 10 of the patent (as originally granted) had not been at stake in proceedings before the Princely High Court, and any arguments in this respect were new and inadmissible. The Supreme Court noted that the plaintiffs / appellants did not object to the finding of the lower court that claim 1 was not novel, neither in the initially granted form (EP’106 B1) nor in the subsequently limited form (EP’106 B3). However, according to the Supreme Court, already this finding justifies the decision as such.

At the face of it, the Supreme Court decision appears to be very straight-forward. But the devil may well be in the unrevealed details. E.g., it would be interesting to learn more about the reasons for the limitation, and what had actually been argued with respect to claim 10.

What is not readily clear to me is how the Supreme Court dealt with the plaintiff’s auxiliary request that had been on file before the Princely High Court. The patentee had eventualiter invoked the patent only to a limited extent, and this limitation actually reflected the additional features of dependent claims 9 and claim 10 (note that claim 10 is dependent on claim 9):

[9. …] in the closed position the nose extends from an inner side into the opening;
[10. …] in the closed position an outer side of the nose is substantially flush with an outer side of the edge region of the lid.

In my perception, validity of the combination of claims 1, 9 and 10 must have been at stake before the Princely High Court, contrary to what the Supreme Court decision suggests. When a patent is invoked only to a limited extent, validity should also be assessed to that extent; see this Blog here.

I am still trying to get a hand on the decision of the Princely High Court, to gain further insight …

Reported by Martin WILMING

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BIBLIOGRAPHY

Case No. 4A_18/2017 (Supreme Court)] ¦ Decision of 10 July 2017 ¦ ‘HIT Box’

  1. A. AG
  2. B. AG

    3. [Utz group of companies]

./.

  1. C. AG (LI)
  2. D. GmbH (DE)
  3. E. mbH (DE)

    4. [Hilti group of companies]

Judge(s):

  • Dr. Christina KISS
  • Dr. Kathrin KLETT
  • Dr. Fabienne HOHL

Court Clerk:

  • Dr. Matthias LEEMANN

Representative(s) of Plaintiff(s) / Appellant(s):

Representative(s) of Defendant(s):

  • Dr. Michael RITSCHER (MLL)

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DECISION IN FULL

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PATENT AS GRANTED (B1)

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LIMITED PATENT (B3)

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To be, or not to be … (protected by an SPC)

Case No. O2107_001 ¦ Main hearing of 21 August 2017

Note that Hepp Wenger Ryffel AG is involved in this matter on behalf of the plaintiff.

This case is all about the SPC granting practice in Switzerland, ie whether or not – and if so, how – the granting practice shall be brought in line with the recent case law of the CJEU post-Medeva.

The question of whether or not a product is protected by a basic patent is decisive for an SPC both in the European Community (Regulation (EC) No. 469/2009, Art. 3 lit. a) and Switzerland (Art. 140b(1) lit. a PatA).

Towards this end, the so-called ‘infringement test’ has been applied in Switzerland since the Supreme Court’s decision BGE 124 III 375 – Fosinopril in 1998. On the contrary, the CJEU explicitly disapproved the ‘infringement test’ with its decision CJEU C-322/10 – Medeva in 2011.

Gilead's Truvada
Gilead’s Truvada®

For more background information see this Blog here and the official court information about the hearing.

The pleadings initially focussed on two issues, ie the relevance of the reasons for harmonization given by the CJEU for Switzerland; and the differently phrased criteria used by the CJEU in its decisions post-Medeva. The court had explicitly invited the parties to extend their pleading to these two issues.

Plaintiff essentially argued that the ratio legis of the Swiss SPC regulation requires that the ‘infringement test’ be set aside, and that this change of practice shall be applicable with immediate effect for SPCs granted under the Fosinopril regime. It has been referred to various other European jurisdictions where this has been the outcome in parallel proceedings.

On the contrary, defendant argued with multiple lines of defense. First, when the legal situation of 2006 was applied, the case should be dismissed. Only if it was now decided in favour of a change of practice, it would still need to be decided whether or not this should have retroactive effect. If one were to accept a retroactive effect, the criteria established by the CJEU would need to assessed. The parties disagreed whether the CJEU has established a sufficiently consistent approach.

All in all, the hearing took very long. The plaintiff’s reply was finished after 2h at about 12am; defendant asked for a break of 2h to adapt his rejoinder which then took about 3h. It remains to be seen whether reply/rejoinder in a hearing in main proceedings is a model for success.

The parties did not enter into settlement discussions.

Reported by Martin WILMING

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BIBLIOGRAPHY

Case No. O2107_001 ¦ Main hearing of 21 August 2017

Mepha Pharma AG ./. Gilead Sciences Inc.

Panel of Judges:

  • Dr. Dieter BRÄNDLE
  • Dr. Tobias BREMI
  • Dr. Christoph GASSER
  • Prof. Dr. Daniel KRAUS
  • Marco ZARDI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

  • Dr. Michael RITSCHER (MLL)
  • Dr. Simon HOLZER (MLL)
  • Dr. Kilian SCHÄRLI (MLL)
  • Dr. Andreas SCHÖLLHORN (LS Partner), assisting in patent matters

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THE BASIC PATENT

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COURT INFORMATION ABOUT THE HEARING

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NOTES BEFORE AND FROM THE HEARING

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Combining a counterclaim with a main claim against a party which hasn’t sued you?

Case No. O2016_016 ¦ Decision of 16 May 2017 ¦ “Einbezug zusätzlicher Parteien mit Widerklage”

HEADNOTE

Art. 64 CPC; Fixation of the parties to the proceedings.

Litispendence results in a fixation of the parties to the proceedings. Further parties cannot be included into pending proceedings – except for an admissible substitution of a party (Art. 83 CPC) or for other reasons provided by law.

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The setup of this case is straightforward: A had sued B for nullity of the patent in suit. B lodged a counterclaim for infringement against A with his reply.

In the very same proceedings, B also sued X AG and Y GmbH for infringement. B argued that this voluntary joinder was admissible in view of Art. 71 CPC: the duties of all these parties result from similar circumstances, ie cooperation with respect to the alleged infringement of the patent in suit.

However, the President held that the parties are fixed upon litispendence; Art. 62 and Art. 64 CPC. Exceptions would only be the admissible substitution of a party (Art. 83 CPC) or other reasons provided by law — which have not been applicable here. A voluntary joinder under Art. 71 CPC would have been possible, but only in separate proceedings.

The President thus dismissed the cases against X AG and Y GmbH for lack of a procedural requirement; Art. 59(1) CPC, Art. 23(1) lit. a PatCA.

Court fees of CHF 10’000,– have been imposed on B. No party compensation has been awarded: There was no need to even invite X AG and Y GmbH to file reply.

Reported by Martin WILMING

P.S.:
Admittedly, I am frustrated that I have no clue about the parties this time …

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BIBLIOGRAPHY 

Case No. O2016_016 ¦ Decision of 16 May 2017 ¦ “Einbezug zusätzlicher Parteien mit Widerklage”

A AG
(Nullity claimant; defendant in countersuit re infringement)

X AG
(Defendant re infringement)

Y GmbH
(Defendant re infringement)

./.

B
(Nullity defendant; counter-claimant re infringement)

Composition of the Board of the FPC:

  • Dr. Dieter BRÄNDLE

Court Clerk:

  • Esther SCHEITLIN

Representative(s) of A AG:

Representative(s) of B:

  • Dr. Simon HOLZER (MLL)
  • Dr. Mark SCHWEIZER (MLL)
  • Dr. Dirk BÜHLER (Maiwald), assisting in patent matters
  • Dr. Andreas LEDL (Maiwald), assisting in patent matters

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DECISION IN FULL

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Bystronic Laser AG ./. Tomologic AB

We have reported on this matter already on February 3, 2017 when ex parte interim measures have been denied; see this Blog here.

At that time, it has only been an educated guess that Bystronic Laser AG and Tomologic AB were involved. But it is confirmed now: We can catch a glimpse of what is going on in main proceedings O2017_002 at the FPC from the EPO online files of EP 2 485 864 B1 (see EPO Register) and EP 2 694 241 (published as WO 2012/136262 A1; see EPO Register).

As noted in the Register, both cases have been stayed now; EP’864 in opposition proceedings, EP’241 shortly before grant:

EPO Register: EP 2 485 864 B1
EPO Register: EP 2 694 241

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:

Details of the intervention of Bystronic Laser AG in opposition proceedings re EP’864:

Correspondence with the EPO’s legal division with respect to the stay of the proceedings:

It will be interesting to read more from the FPC on this matter. Stay tuned …

Reported by Ingo LUMMER and Martin WILMING

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Confirmed in main proceedings re Pemetrexed: The counterion matters!

Case No. O2015_004 ¦ Decision of 09 March 2017 ¦ “Pemetrexed: Feststellungsklage auf Nichtverletzung gutgeheissen, Bindung an Einschränkung im Erteilungsverfahren”

Please note that Hepp Wenger Ryffel is involved in this matter on behalf of the plaintiff.

The patent in suit is Lilly‘s EP 1 313 508 B1 which is litigated in various countries; see the EPO Register and Swissreg for further details. It’s all about a generic version of Lilly’s Alimta®, ie Actavis’ Amtiris®. While the claims of Lilly’s EP’508 specifically require pemetrexed disodium, Amtiris® comprises pemetrexed diacid.

Pemetrexed disodium
Pemetrexed diacid

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 [0022] of EP’508 had only been introduced during prosecution:

Amended description during prosecution (mark-up)

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 ([2015] EWCA Civ 555, #71) in this respect.

Finally, the third question asks whether it is evident for the skilled person that the replaced feature has the same effect, starting from the teaching of the patent in suit. Would the skilled person have understood the wording pemetrexed disodium as a strict limitation? The FPC notes that other components are defined more broadly in the claims, ie vitamin B12 or a pharmaceutical derivative thereof. Not so for pemetrexed disodium. The skilled person would thus have understood this as an intentional limitation, in further view of the specification.

The FPC thus answered the third question in the negative, expressly consenting with the judgement of the England and Wales Court of Appeal ([2015] EWCA Civ 555, #72) in this respect. The FPC also sides with the German Federal Supreme Court’s decision X ZR 29/15 in parallel proceedings in that the present matter is not an abandonment in the sense of X ZR 16/09 – Okklusionsvorrichtung. In Okklusionvorrichtung the replacing feature had been explicitly mentioned in the specification; not so in the present matter. However, the FPC notes that this does not automatically mean that a contrario the third question is to be answered in the affirmative.

Der BGH fokussiert sich bei der Beurteilung der dritten Äquivalenzfrage allerdings sehr auf diese Frage des Verzichts. Dem kann nicht gefolgt werden. Die Tatsache, dass kein Verzicht gemäss Okklusionsvorrichtung vorliegt, bedeutet keineswegs automatisch im Umkehrschluss, dass die 3. Äquivalenz-Frage zu bejahen ist. Das greift zu kurz.

It is highly likely that this decision will be appealed to the Supreme Court.

Reported by Martin WILMING

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BIBLIOGRAPHY

Case No. O2015_004 ¦ Decision of 09 March 2017 ¦ “Pemetrexed: Feststellungsklage auf Nichtverletzung gutgeheissen, Bindung an Einschränkung im Erteilungsverfahren”

Actavis Switzerland AG

./.

(1) Eli Lilly and Company
(2) Eli Lilly (Suisse) SA

Composition of the Board of the FPC:

  • Dr. Dieter BRÄNDLE
  • Dr. Roland DUX
  • Prisca VON BALLMOOS

Reporting Judge:

  • Dr. Roland DUX

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

—

DECISION IN FULL

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—

WHAT’S GOING ON ELSEWHERE

A comprehensive summary on the current status of proceedings relating to Lilly’s Alimta® can be derived from Lilly’s Form 10-K (Annual Report); see p 93-94.

If you are interested in the fulltext decisions, there is a long series of decisions to read from the UK, ie [2012] EWHC 3316 (Pat), [2013] EWCA Civ 517, [2014] EWHC 1511 (Pat), [2015] EWCA Civ 555 and [2016] EWHC 234 (Pat).

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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It’s just not the right time …

Case No. O2016_012 ¦ Decision of 22 February 2017 (excerpt) ¦ “Rechtliches Gehör, unbedingtes Replikrecht, Prozessleitung, Waffengleichheit”

A previous version of this post mentioned Bruno MEYER as an assisting patent attorney on behalf of the defendant. I have been informed that this is wrong; he is actually engaged on behalf of the plaintiff. This has been corrected hereinbelow.

This procedural order is almost a blueprint of a published order in the case O2012_039; see this Blog here. Again, an alleged infringer argued for nullity as a plea in defense with his answer to the suit. Prior to the preparatory hearing, the plaintiff had been ordered and actually provided a reply only with respect to the alleged nullity, for the time being. So far so good.

But the defendant filed a factual rejoinder concerning the (in)validity of the patent in suit. This evidently frustrated the court’s intention to have one(!) reply of each party on file pertaining to the questions of infringement and nullity. Consequently, the FPC decided to not take the defendant’s submission on file at all, for the time being. The defendant may re-file the same after the preparatory hearing, with his rejoinder.

Die Prozessleitung ist Sache des Gerichts (Art. 124 Abs. 1 ZPO). Wenn die Beklagten hier nun ungefragt mit einer faktischen Duplik zur Bestandesfrage reagieren, wird das Bestreben des Gerichts, die Waffengleichheit der Parteien zu wahren, unterlaufen. Das ist zu unterbinden. Entsprechend ist die Eingabe der Beklagten (samt Beilagen) aus dem Recht zu weisen. Es steht den Beklagten frei, das Vorgebrachte (nach der Instruktionsverhandlung) im Rahmen der dann einzuholenden Duplik erneut vorzutragen.

Reported by Martin WILMING

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BIBLIOGRAPHY

Case No. O2016_012 ¦ Decision of 22 February 2017 (excerpt) ¦ “Rechtliches Gehör, unbedingtes Replikrecht, Prozessleitung, Waffengleichheit”

A AG

./.

(1) B GmbH
(2) C GmbH

Composition of the Board of the FPC:

  • Dr. Dieter BRÄNDLE
  • Dr. Tobias BREMI

Reporting Judge:

  • n/a

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

  • Dr. Michael RITSCHER (MLL)
  • Dr. Kilian SCHAERLI (MLL)

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DECISION (EXCERPT)

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Actelion ./. ICOS: Supreme Court ruling on service of process

Case No. 4A_222/2016 (Supreme Court) ¦ Decision of 15 December 2016 ¦ “Nullity; service”

Note that Hepp Wenger Ryffel is involved in this matter on behalf of Actelion Pharmaceuticals Ltd.

Little time? Read the summary.

This decision relates to a nullity suit of Actelion Pharmaceuticals Ltd against the Swiss part of EP 1 200 092 B1; see Swissreg and the European patent register for any further bibliographic details on the patent in suit.

EP’092 relates to a formulation of Lilly’s drug Cialis® for treatment of erectile dysfunction. But this is not the only indication: The very same active ingredient tadalafil is also used in the treatment of pulmonary arterial hypertension, marketed under the tradename Adcirca®. EP’092 would have reached its maximum term only in August 2020.

Stakes are high: Cialis® still is one of Lilly’s top-selling drugs; it has generated a worldwide revenue of $2,311 million in 2015. Cialis® had been protected by the compound patent EP 740 668 B1 (see Swissreg and the EPO Register for further details, in particular the legal status information), but the patent had reached its maximum term already back in January 2015. However, Cialis® is still protected by supplementary protection certificates (SPCs) which are about to lapse in ‘major European countries’ in November 2017 (see Lilly’s Annual Report 2015, p F31 and F16; and e.g. the SPC in the German Register).

Swissmedic granted market approval #56018 for Cialis only on May 4, 2004, and this is why the timeline is different in Switzerland. The Swiss SPC C00740668/01 for tadalafil is valid until May 3, 2019.

EP’092 would have reached its maximum term only about 1.5 years after the end of the term of the SPC. But the FPC had declared EP’092 invalid with decision O2015_007 of 17 February 2016, commented on this Blog here. Noteworthy, this was a decision rendered in absentia. The defendant / patentee had undoubtedly been served with the writ via diplomatic channels — but did not take up the fight.

It turned out later that the writ apparently had been internally mishandled and that ICOS only got aware of the proceedings when the decision had already been issued. ICOS tried to re-start the first instance proceedings via restitution, but the FPC dismissed ICOS’ request for restitution; see this Blog here. This dismissal has not been appealed.

ICOS also lodged an appeal against the first instance judgement in absentia and requested that the first instance judgement be lifted, the case be remitted to the FPC and that a time limit be set to respond to the writ. This appeal has now been dismissed.

Now, what is this appeal all about?

A firm of patent attorneys had been indicated as ‘representative’ in the Swiss patent register Swissreg. However, the writ had been served to and well received by the patentee in the U.S.; the appeal is all about whether or not this service had been correctly effected.

i)   Is the firm of patent attorneys listed as ‘representative’ in Swissreg an active representative in the sense of Art. 137 CPC?

A legal entity may well represent clients before the Patent Office in administrative proceedings; Art. 1(3) PatAA. Not so before the FPC. The Supreme Court thus holds that an active representation can be ruled out for this reason alone.

ii)   Is the firm of patent attorneys an address for service of process, a passive representation / domicile for service in the sense of Art. 140 CPC?

The decision discusses the various changes to Art. 13 PatA; it now reads as follows (emphasis added):

(1) Any person who is involved in administrative proceedings provided for in this Act and does not have a residence or principle place of business in Switzerland, must designate an address for service in Switzerland. […]

Earlier versions explicitly recited representation also before civil courts, but this has been deleted with effect as of January 1, 2011. The Supreme Court thus holds that the writ had not to be served to firm of patent attorneys listed as representative in Swissreg; this would actually have been unlawful. Rather, it had been correctly served to the patentee according to Art. 137 CPC.

iii)   Did the FPC violate the good faith principle?

All those who participate in proceedings must act in good faith; Art. 52 CPC. The Supreme Court leaves no doubt about the fact that service of process had been correctly effected, and that neither the FPC nor the plaintiff had any reason to act differently.

The Supreme Court thus dismissed ICOS’ appeal and the Swiss part of EP 1 200 092 B1 is finally revoked; see Swissreg.

What’s going on elsewhere?

The subject-matter is currently being litigated in various countries. To the best of my knowledge, no decision has upheld EP’092 by now.

A publicly available judgement has e.g. been issued by the District Court of The Hague, the Netherlands, on 26 October 2016 (case no. C/09/493389 / HA ZA 15-862), revoking the patent on substantive grounds. You will find a brief review of this decision on EPLAW Patent Blog.

Likewise, EP’092 has been held invalid by the England and Wales Patents Court (Birss J) with judgment of 10 August 2016 (case no. [2016] EWHC 1955 (Pat)). A brief review of this decision can be found e.g. on Lexology.

Reported by Martin WILMING

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BIBLIOGRAPHY

Case No. 4A_222/2016 (Supreme Court) ¦ Decision of 15 December 2016 ¦ “Nullity; service”

Icos Corporation ./. Actelion Pharmaceuticals Ltd

Composition of the Board of the Supreme Court:

  • Dr. Christina KISS
  • Dr. Kathrin KLETT
  • Dr. Gilbert KOLLY
  • Dr. Fabienne HOHL
  • Dr. Martha NIQUILLE

Court Clerk:

  •  Dr. Matthias LEEMANN

Representative(s) of Icos Corporation:

Representative(s) of Actelion Pharmaceuticals Ltd:

—

SUPREME COURT

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FPC DECISION ON THE MERITS

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—

FPC DECISION ON RESTITUTION

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—

SUMMARY

The FPC had declared ICOS’ EP 1 200 092 B1 invalid with decision of 17 February 2016 (O2015_007); the patent relates to certain formulations of tadalafil, the active ingredient of one of Lilly’s top-selling drugs, Cialis®. This decision had been rendered in absentia; ICOS had failed to respond. The writ had been served to and received by ICOS in the U.S., but has apparently been mishandled internally. A request for restitution has been dismissed by the FPC with decision of 23 May 2016 (O2016_002). ICOS also appealed the decision of 17 February 2016 and alleged incorrect service of process. The Supreme Court now dismissed the appeal and held that the writ had correctly not been served to the firm of patent attorneys listed as representatives of the patent in Swissreg. The Swiss part of EP’092 is thus finally revoked.

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Green lights given to Stadler’s KISS

Case No. 4A_427/2016 (Supreme Court) ¦ Decision of 28 November 2016 ¦ “Patent; novelty-destroying publication”

Note that Hepp Wenger Ryffel is involved in this matter on behalf of the defendants.

For a review of the FPC’s underlying decision O2012_043 of 10 June 2016, please see this Blog here. In brief, Bombardier alleged infringement of EP 1 963 157 B1 (see EPO Register and Swissreg for bibliographic details). Stadler’s electric double-deck trains RABe 511 KISS were at stake, more specifically the pairwise arrangement of transformer units and power converter units at the wheel units of the train. The defendants of the Stadler group of companies essentially argued for nullity as a plea in defense and alleged a prior user right; Art. 35 PatA.

The FPC held that EP’157 is not novel over documents which had been sent by ABB to both Siemens and Stadler in parallel, in an informal reply to a request for an offer from Siemens. The mere fact that ABB deliberately distributed the documents not only to Siemens but also to yet another third party (the defendant) made clear that ABB had no interest in any confidentiality. The alleged prior user right had been acknowledged in the interim assessment (Art. 35 PatA), but could be left undecided in view of the lack of novelty of the patent in suit.

For further details on the background of the case and the actual subject-matter at stake, please see the report from the main hearing on this Blog here.

The Supreme Court now had a second look at it:

The plainfiff’s appeal was all about whether or not the exchange of the novelty-destroying documents had been subject to implied confidentiality between ABB, Siemens and Stadler. Towards this end, the plaintiff had requested before the FPC that a witness be heard with respect to the (existence of a) development cooperation between ABB, Siemens and Stadler. However, the witness had not been heard. On appeal, the plaintiff alleged a violation of his right to be heard. The Supreme Court holds that even if a development cooperation had existed, this would not have been sufficient to conclude that an implied confidentiality had existed with respect to the relevant documents at stake.

Die Vorinstanz hat die von der Beschwerdeführerin behauptete Zusammenarbeit zwischen den Beschwerdegegnerinnen, Siemens und ABB im Ergebnis zutreffend als nicht hinreichend für den Schluss angesehen, dass die beanspruchte Lehre durch die Korrespondenz vom April/Mai 2003 (wegen vereinbarter Geheimhaltung) nicht neuheitsschädlich vorweggenommen ist.

The Supreme Court thus held that hearing of the witness would not have been of any legal relevance (BGE 133 III 295, r 7.1; 4A_607/2014, r 2.2; 4A_452/2013, r 3.1). Consequently, the plaintiff’s right to be heard was not violated by not hearing the witness (Art. 29(2) FC, Art. 8 CC, Art. 152 CPC).

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. 4A_427/2016 (Supreme Court) ¦ Decision of 28 November 2016 ¦ “Patent; novelty-destroying publication”

Bombardier Transportation GmbH

./.

(1)  Stadler Altenrhein AG
(2)  Stadler Bussnang AG
(3)  Stadler Rail AG

Composition of the Board of the Supreme Court:

  • Dr. Christina KISS
  • Dr. Kathrin KLETT
  • Dr. Fabienne HOHL

Court Clerk:

  • Dr. Christoph HURNI

Representative(s) of Plaintiff / Appellant:

  • Dr. Michael RITSCHER (MLL)
  • Dr. Mark SCHWEIZER (MLL)

Representative(s) of Defendant:

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SUPREME COURT

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FEDERAL PATENT COURT

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Decision on costs: The winner takes it all?

Case No. O2014_002 ¦ Decision of 21 November 2016 ¦ “Urinalventil: Kosten- und Entschädigungsfolgen (Rückweisung)”

As reported earlier, the Supreme Court has reversed the FPC’s judgement in this matter. In brief, the FPC had decided that the first generation device infringed but the second generation device did not infringe EP 1 579 133 B1. The Supreme Court held that the second generation also infringed — and remitted the case to the FPC to accordingly adjust the ruling on costs. And here we are: The present decision only deals with the apportionment and fixing of costs.

The value in dispute had initially been set to CHF 300’000,–. Proceedings against the present defendant have later been separated since bankcruptcy proceedings had been initiated for the other defendant (Enswico AG; meanwhile liquidated). Now, how does this affect the value in dispute of the separated proceedings? In the event of the voluntary joinder of parties or joinder of actions, the values of the claims are added together insofar as they are not mutually exclusive; Art. 93 CPC. The FPC held that a contrario the value in dispute is to be allocated in case of a separation of proceedings. The present defendant was a contract manufacturer of the other defendant; it did not even own the molds. The value in dispute was thus fixed to only CHF 75’000,–, as requested by the defendant.

The court fee to be borne by the defendant was fixed at CHF 12’000,– in accordance with Art. 1 CostR-PatC. A compensation for legal representation of CHF 15’000,– was awarded to the plaintiff, ie well within the tarif (Art. 5 CostR-PatC). Expenses for the plaintiff’s patent attorney were awarded only with a sharp cap at CHF 15’000,–, ie corresponding to the compensation for legal representation. One may like it or not, but this approach is established case-law since O2012_043. A 50% share of the patent attorney’s overall costs incurred for both defendants would have resulted in more than twice as much.

Reported by Martin WILMING

—

BIBLIOGRAPHY

Case No. O2014_002 ¦ Decision of 21 November 2016 ¦ “Urinalventil: Kosten- und Entschädigungsfolgen (Rückweisung)”

Daspaco AG ./. Von Allmen AG

Composition of the Board of Judges:

  • Dr. Dieter BRÄNDLE
  • Dr. Tobias BREMI
  • Dr. Christoph GASSER
  • Werner ROSHARDT
  • Dr. Ralph SCHLOSSER

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) Patentee:

Representative(s) of Defendant:

—

DECISION IN FULL

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Supreme Court confirms HeatCut decision, appeal dismissed

Case No. 4A_371/2016 (Supreme Court) ¦ Decision of 14 October 2016 ¦ “HeatCut”

For a review of the FPC’s underlying decision O2014_009 of 04 May 2016, please see this Blog here. In a nutshell, Saurer’s HeatCut system had been held to infringe Lässer’s EP 1 983 083 B1.

The Supreme Court has now dismissed Saurer’s appeal, to the extent it has been considered at all.

First, the appellant apparently aimed at protective measures for the documents to be provided in compliance with the FPC’s order on information and accounting accounting. The Supreme Court did not grant protective measures, in the absence of a specific request towards this end. A procedural — and unspecific — request was not sufficient.

Second, the appellant essentially argued that the injunction as ordered by the FPC reaches beyond the scope of the patent. The Supreme Court did not agree: The injunction requires that the tip only penetrates the layer which is to be cut, and this is well within the scope of the patent.

The appellant also objected to the claim construction and its application on the attacked embodiment. Both objections were held unfounded, to the extent considered at all.

Reported by Martin WILMING

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BIBLIOGRAPHY

Case No. 4A_371/2016 (Supreme Court) ¦ Decision of 14 October 2016 ¦ “HeatCut”

Saurer AG (appellant) ./. Lässer AG Stickmaschinen (patentee)

Composition of the Board of the Supreme Court:

  • Dr. Christina KISS
  • Dr. Kathrin KLETT
  • Dr. Martha NIQUILLE

Court Clerk:

  • Dr. Christoph HURNI

Representative(s) of appellant:

Representative(s) of patentee:

—

DECISION IN FULL

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Doctrine of Equivalents: It’s not only about asking the right questions

Case No. 4A_131/2016 (Supreme Court) ¦ Decision of 03 October 2016 ¦ “Urinalventil”

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Little time? Read the summary.

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I have reported on the main hearing before the FPC on this Blog here. For a brief review of the underlying decision O2014_002 of the FPC, see this Blog here.

boy-214906_960_720Long awaited, now here it is: The first decision of the Supreme Court on the Doctrine of Equivalents since ages; see fulltext below. You hoped for a ready-mix for assessment of equivalency? I’m sorry, there is none.

But let’s have a look at the very basic facts first.

The patent in suit is EP 1 579 133 B1 (embedded below), and it’s all about a non-return valve for a urinal. The independent claim reads as follows (mark-up added):

A non-return valve (3), comprising an inlet section (5) in the form of a self-supporting trough-shaped section and an outlet section, the outlet section being made of a flexible resilient material connected to the inlet section (5), whereby the outlet section comprises a flat flexible resilient strip (6) with a high inherent degree of flexibility, the strip (6) being connected with the inlet section (5) at its upper edge; and further comprising a component that is separate from the strip (6) providing a complementary surface against which the lower end of the flexible strip (6) may seal.

The technology is not difficult to understand: The strip (6) and the ‘component with a complementary surface’ — actually, yet another strip — are arranged in a way as to allow fluid passing through the valve in the one direction of the valve. The valve closes when the fluid has passed, to prevent unpleasant odor from rising up. Flattened tubes instead of separate strips had been known in the prior art for the same purpose; see D1, US 3 835 857).

EP’133, Fig. 1 and 2
“Key-System” (Enswico)
Fig. 3 of D1

LITERAL INFRINGEMENT

The million dollar word is “separate”. What does the feature

[…] a component that is separate from the strip (6) providing a complementary surface against which the lower end of the flexible strip (6) may seal

actually mean? There is no explicit definition of “separate” in the patent. Actually, the word as such was not even used in the application as filed at all. It had been introduced during prosecution, based on the overall specification and figures which all show (completely) separate strips; see figures 1 and 2, above.

On the other hand, the two strips are interconnected by lateral connectors in the attacked embodiment. Noteworthy, this configuration is protected by EP 2 553 299 B1 of the defendant (embedded below; EP’299 explicitly acknowledges the patent in suit as closest prior art in para. [0003]-[0005]).

attacked embodiment
attacked embodiment

The assessment of the Supreme Court is straight forward — and in line with the decision of the FPC. In light of the figures, the description and in differentiation over the prior art (flattened tube) the feature is construed to imply a full-length separation. The Supreme Court explicitly holds that the embodiment with loose ends is not merely a preferred embodiment:

Die Ausführungsbeispiele weisen auf dieses Verständnis eindeutig hin, ohne dass Anhaltspunkte für ein weiteres Verständnis von ‘separate’ in dem Sinne bestehen würden, dass das Ausführungsbeispiel mit den losen Enden nur als eine – wie die Beschwerdeführerin behauptet, bevorzugte – Ausführung erschiene.

Thus, no literal infringement.

INFRINGEMENT UNDER THE DOCTRINE OF EQUIVALENTS

Almost no decision on equivalency is uncontroversial, and people mostly have a very firm opinion pro or contra infringement under the Doctrine of Equivalents. So do I. But I feel there are plausible arguments for both views in the present matter, and I won’t take position for either side. No use crying over spilt milk anyway; this case has been finally decided now.

But let’s have a closer look at what can be learned about how the Supreme Court nowadays assesses infringement under the Doctrine of Equivalents on the basis of the three-step questionnaire as defined by the FPC (see S2013_001).

THE FIRST QUESTION

Do the replaced features have the same objective function? (same effect / “Gleichwirkung”)

Erfüllen die ersetzten Merkmale [Austauschmerkmale] die objektiv gleiche Funktion? (Gleichwirkung)

First of all, what is the replacing feature? The Supreme Court identifies the replacing feature essentially as follows:

[…] component and the strip (6) are separate for a sufficient length to allow for a sealing effect when a fluid has passed.

The first question is a no-brainer here: Fulfilment of the same function has been beyond dispute.

THE SECOND QUESTION

Are the replaced features and their same objective function made obvious to the skilled person by the teaching of the patent? (accessibility / “Auffindbarkeit”)

Werden die ersetzten Merkmale [Austauschmerkmale] und deren objektiv gleiche Funktion dem Fachmann durch die Lehre des Patentes nahe gelegt? (Auffindbarkeit)

This question had unfortunately been left undecided by the FPC (since the third question was answered in the negative). Nevertheless, the FPC had clarified in the headnote of the underlying decision how it expects this question to be addressed; see this Blog here. This hn reads as follows:

The assessment of accessibility is not to be confused with the assessment of inventiveness. Starting point for the assessment of accessibility is not the general state of the art, but the patent in suit. Therefore it is not to be assessed whether the replaced feature is inventive in view of the state of the art. It is rather to be assessed whether, starting from the teaching of the patent in suit, it is evident for the skilled person that the replaced feature has the same effect (r. 6.5.2.4).
(Clarification of the case law with respect to S2013_001, decision dated 21. März 2013)

The reasons 6.5.2.4 referred to in the hn read as follows:

It is to be determined whether, once the features are replaced, the same effect is evident for the person of skill in the art when objectively assessed in consideration of the teaching of the patent.

Zu beurteilen ist, ob, wenn die Merkmale ausgetauscht sind, die Gleichwirkung für den Fachmann bei objektiver Betrachtung unter Berücksichtigung der Lehre des Patents offensichtlich ist.

According to the hn in light of the reasons, this test compares two already given situations (one with the replaced/claimed feature and another one with the replacing feature) and only then asks whether the same effect is evident. As I have outlined earlier, this really makes a big difference.

Now, this is what the Supreme Court asked (mark-up added):

[…], whether the skilled person who intends to add a fixation at the lower end of the strips instead of the loose ends will readily understand that the strips have to be separate at a length which is sufficient to achieve the effect which the patent intends to achieve.

[…], ob der Fachmann, der statt der losen Enden der Streifen am unteren Ende der Streifen eine Befestigung anbringen will, ohne weiteres erkennt, dass die Streifen auf einer hinreichenden Länge getrennt werden müssen, um die mit dem Patent angestrebte Wirkung zu erreichen.

I don’t think that this is what the FPC had in mind when drafting the hn and r. 6.5.2.4. In the assessment of the FPC, there is no need at all for a skilled person intending to add a fixation. The skilled person rather only compares two given scenarios, i.e. the claimed solution and the attacked embodiment. If the same effect of these two embodiments is evident, the question is to be answered in the affirmative. Else, it’s not. Frankly speaking, I just cannot say whether the Supreme Court is supportive of this approach or not.

THE THIRD QUESTION

With due consideration of the wording of the claim in the light of the description, would the skilled person have considered the replacing features as a solution of equal value? (equal value / “Gleichwertigkeit”)

Hätte der Fachmann bei Orientierung am Anspruchswortlaut im Lichte der Beschreibung die ersetzten Merkmale [Austauschmerkmale] als gleichwertige Lösung in Betracht gezogen? (Gleichwertigkeit)

Assessment of this question by the Supreme Court in r. 6.3.2 starts with a summary of what the FPC had held, i.e. that the skilled person would not have considered the replacing features as an equivalent solution, with due consideration of the claim. Really? Is that it? I feel the FPC did more than that — and there is more to do according to the wording of the third question recited above, i.e. to give due consideration to the claim wording in view of the description. And it had been the description and the figures which strictly limited the term “separate” to only cover loose ends. Consequently, the FPC had discussed the actual meaning of the claim wording (see section 6.5.2.5 of the underlying decision O2014_002):

Thus, it is not apparent for the skilled person in view of the claim construction that the claimed subject-matter (separately) could equivalently be replaced with a modification of this feature (lateral connectors).

So ist in diesem Fall für den Fachmann bei Orientierung am ausgelegten Anspruchswortlaut auch nicht erkennbar, dass die anspruchsgemässe Lehre (separat) mit einer Abwandlung des betroffenen Merkmals (Verbindungsstege) gleichwertig realisiert werden kann.

From the decision as such, it is not clear to me whether (or to which extent) the Supreme Court has paid attention to the description when answering the third question. The meaning of “separate” is interpreted more broadly again, based only on the wording of the claim as such:

Actually, a complete separation […] with loose ends is not required by the wording of the claim as such.

Eine vollständige Trennung […] mit losen Enden wird vom Anspruchswortlaut für sich genommen gerade nicht verlangt.

If that was indeed the case, then why is there no literal infringement?

The Supreme Court finally holds:

Thus, the loose end of the strips can equally be replaced by a fixation.

Danach lässt sich das lose Ende der Streifen gleichwertig durch eine Befestigung ersetzen.

In my perception, the great achievement of the third question reaches far beyond that. It had been intended to be all about providing a reasonable degree of legal certainty for third parties, i.e. to reasonably confine the potential scope under the Doctrine of Equivalents. Therefore, it essentially asks whether the skilled person would really have considered the replacing feature as an equivalent, with due consideration of the claim and the description — not merely whether it objectively is an equivalent replacement.

The Supreme Court notes in passing that the attacked embodiment has been patented (explicitly over the patent in suit as prior art), but holds that this does not change the fact that it still makes use of the patent in suit. The bottom line of the decision is a reference to a famous Swiss legal scholar:

Subsequent inventions are directly covered by the scope of the prior teaching if this prior teaching is fully embodied while providing for an improved, non-obvious variant; and inventions which make use of the core of the inventions that has been patented earlier (ALOIS TROLLER, Immaterialgüterrecht, Bd. II, 3. Aufl. 1985, S. 891). Art. 36(1) PatA provides for a non-exclusive license in such cases (cf decision 4C.502/1997 of April 20, 1998, r. 5b).

Vom Schutzbereich der älteren Lehre direkt umfasst sind spätere Erfindungen, wenn sie die ältere Lehre vollständig anwenden, aber eine verbesserte, nicht naheliegende Ausführung lehren, und ebenso Erfindungen, bei deren Anwendung der Kern der früher patentierten Erfindung mitverwendet wird (ALOIS TROLLER, Immaterialgüterrecht, Bd. II, 3. Aufl. 1985, S. 891). Dafür sieht Art. 36 Abs. 1 PatG eine nicht ausschliessliche Lizenz vor (vgl. Urteil 4C.502/1997 vom 20. April 1998 E. 5b).

Reference to Art. 36(1) PatA looks like an easy way out, but the right to be granted a non-exclusive license is explicitly only given by law if the invention represents an important technical advance of considerable economic significance in relation to the invention that is the subject-matter of the prior patent. It will not necessarily be easy to meet this precondition.

I hope we will see further decisions of the Supreme Court in the near future which provide some more guidance on the actual interpretation of the second question and how the reasonable degree of legal certainty for third parties is to be safeguarded when answering the third question. Addressing infringement under the Doctrine of Equivalents with a set of three questions that somehow resemble the questionnaires used in the U.K. and Germany surely is an achievement of harmonization. But I do not yet see much harmony in how the questions are interpreted and answered.

Reported by Martin WILMING

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BIBLIOGRAPHY

Case No. 4A_131/2016 (Supreme Court) ¦ Decision of 03 October 2016 ¦ “Urinalventil”

Daspaco AG ./. Von Allmen AG

Composition of the Board of the Supreme Court:

  • Dr. Christina KISS
  • Dr. Kathrin KLETT
  • Dr. Gilbert KOLLY
  • Dr. Fabienne HOHL
  • Dr. Martha NIQUILLE

Court Clerk:

  •  Dr. Christoph HURNI

Representative(s) of Appellant / Patentee:

Representative(s) of Defendant:

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DECISION IN FULL

Download (PDF, 694KB)

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PATENT IN SUIT

Download (PDF, 303KB)

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DEFENDANT’S PATENT

Download (PDF, 437KB)

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SUMMARY

The good news from the first decision of the Supreme Court on the Doctrine of Equivalents since ages: The third question of the FPC’s questionnaire is approved. The sad news: There is little to no guidance in the decision with respect to how the second and the third question are to be interpreted. In particular, it still remains unclear how the reasonable degree of legal certainty for third parties is to be safeguarded when answering the third question.

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