What 🍐 vs 🍏 will be cited for? I think it’ll be this: «Das ist, mit Verlaub, Unsinn.»

Est'd reading time: 8 mins

Case No. O2020_014 | Judgment of 2 October 2023 | ‘iMessage’ | not yet final

Apple logo

Rome wasn’t built in a day. But here it is, finally: The judgment in the case that was the longest pending in the last Annual Report of the FPC. It is an infringement case between Pear and Apple about a feature of Apple’s iMessage service that began in 2020; see this Blog here for some background information. Both patents in suit have lapsed already; EP 1 838 074 B1 and EP 1 208 687 B1. It’s all about damages for past infringement, if any.

iMessage icon

Putting it simple, the patents relate to methods for the transmission of information from one mobile phone to another, wherein e.g. an emoji is not transmitted as such between the two devices, but rather as a sequence of signs (e.g. as a descriptive word); see claim 1 of EP 687 and claim 1 of EP 074. The respective emoji associated with the sequence of signs is read out from a local memory at the receiving mobile phone, thereby eliminating the need for actually transmitting the more extensive image data via the mobile network.

Even though the whole thing was only about damages, Apple took this very seriously. Hey, iMessage was at stake! Apple took up the fight, and they did it the Draghi way. Both sides did.

Here’s a simplified timeline of the proceedings (🍐 Pear, Apple, ⚖️ Court; be prepared for some scrolling):

23 Sep 2020:

🍐 Statement of Claim (73 pages)

8 Feb 2021:

Statement of Defense (216 pages)

12 Apr 2021:

⚖️ Instruction Hearing at the FPC (no settlement reached)

14 Jul 2021:

🍐 Reply (376 pages)

2 Sep 2021:

Rejoinder («non-final»)

4 Oct 2021:

Rejoinder (re req. 1-49 and 52-54, w request for protective measures)

22 Oct 2021:

⚖️ Order of the FPC (admission of req. 50-51, unpublished)

4 Nov 2021:

Appeal to SC (re order of 22 Oct 2021)

5 Nov 2021:

⚖️ Order of the SC (no suspensive effect)

17 Nov 2021:

Giving reasons for requested protective measures

24 Nov 2021:

Rejoinder (re req. 50-51)

1 Dec 2021:

⚖️ Judgment of the SC (appeal not taken into consideration, see here)

20 Dec 2022:

🍐 Comments (re protective measures)

4 Jan 2022:

⚖️ Order of the FPC (re protective measures; see here)

24 Jan 2022:

🍐 Comments (on new factual allegations in the rejoinder of 4 Oct 2021 and 24 Nov 2021)

25 Jan 2022:

Comments (request to disregard plaintiff's submission of 24 Jan 2022)

6 Jul 2022:

⚖️ Main hearing (cancelled)

9 Jan 2023:

⚖️ Technical opinion of the judge-rapporteur

21 Feb 2023:

Comments on TO

23 Feb 2023:

🍐 Comments on TO

12 Jun 2023:

⚖️ Main hearing at the FPC

2 Oct 2023:

⚖️ Judgment of the FPC

Nov 2023:

🍐 Appeal to the SC?

On the merits

One could expect a judgment of Arnoldian length. And it indeed is, at least at the face of it. I didn’t check, but it is quite likely the longest judgment of the FPC by now: 163 pages. However, the closer you look, the more the judgment shrinks to more digestible dimension; 90+ pages are eaten up by Pear’s requests from the reply (pages 6-59) and five inter partes limited versions of EP 074 in the annex (pages 124-163; AR1 to AR5).

On the merits, there is not much to say, really. It’s a pretty straight forward assessment of added matter in the first place; see ¶¶31-50 on pages 79-94: Both EP 687 as granted and EP 074 (as granted and AR1 to AR5) failed for this reason alone. Flogging a dead horse, still further grounds for nullity are assessed in depth in the judgment:

Re novelty (¶¶55-59 on pages 98-103), the outcome is mixed: All independent claims of EP 074 (claims 1, 20 and 25) as granted and according to AR1 are anticipated by US 981. On the other hand, novelty of AR2 to AR5 is acknowledged. Likewise, novelty of all independent claims of EP 687 is acknowledged.

The judgment goes on to establish various lines of obviousness for both patents; ¶¶60-73 on pages 103-118. 

In a nutshell, Pear’s complaint was dismissed (invalidity of both patents in suit; infringment not assessed). The judgment is not (yet) final / still open for appeal to the Supreme Court.

The court was not amused, I’d say

There are some hidden gems in the judgment that make pretty clear: The court was not amused. For instance, the main hearing could not be held as planned because the technical opinion of the judge-rapporteur could not be established sufficiently in advance. Why? Because of the party submissions of absurd length:

Further, it was not appreciated that the technical competence of the judge-rapporteur was only put in question after receipt of the technical opinion:

The judgment holds that this is opportunistic and belated in any event:

Still, the court assessed the technical complexity of the matter at hand. It makes me smirk to read that this technology (illustrated with the figure below) is quite understandable for a physical chemist with a doctorate. The complexity was more on the procedural side because both sides did everything to inflate things:

And, finally, this is definitely not how one wishes an argument to be perceived by a court:

Costs

The chapter on costs is noteworthy; ¶¶75-77 on pages 119-121. In the statement of claim, Pear had assumed the value in dispute as kCHF 250. In turn, Apple held in the statement of defense that this was much too low — and assumed CHF 5m. Apparently, Pear did not object in the reply but rather held:

It is not surprising that the defendant concedes that the amount in dispute is too low.

No wonder that the FPC assumed 5m as the value in dispute.

Given the outcome of the proceedings, that’s quite costly for Pear: The court fee is set at kCHF 100. In addition, Pear has to pay a compensation to Apple for legal representation (kCHF 100) and necessary expenses for the assistance of patent attorneys (yet another kCHF 100).

Presumptions re obviousness

I feel there’s a new paragraph in the presumptions on obviousness:

Presumptions are here to stay. Thus, it’s worth having a closer look. The first sentence is pretty straight forward. Fn 43 (erroneously) refers to the EPO Guidelines G-V, 5.1 (there is no G-V, 5.1). Clearly, G-VII, 5.1 is meant:

The closest prior art is that which in one single reference discloses the combination of features which constitutes the most promising starting point for a development leading to the invention.

I agree.

The second sentence of the new paragraph addresses prior art documents that contain several (discrete) embodiments. In my mind, this is inspired by the scissor catalogue situation of T 305/87 (without mentioning the decision, though). That decision was about novelty. And about a document that essentially consisted of discrete embodiments only (various scissors in a catalogue). The gist is that one cannot just pick and choose features from two distinct embodiments, scramble them together and then argue for lack of novelty. That’s common sense, I’d say.

But I wonder whether it is universally true to say that, whenever there are two or more discrete embodiments (in whatever document), only one single embodiment in isolation is a specific combination of features. That may be true for a scissor catalogue. Not so much for, e.g., a typical patent document. I believe that one has to read/understand specific embodiments of, e.g., a patent document in the context of the whole disclosure of the document. In the assessment of novelty, it is commonly accepted (I think) that the disclosure of a specific embodiment in a patent document may well be supplemented with features from the general specification, provided that the embodiment is representative of the general technical teaching of that document. Importantly, it suffices for such a combination being permissible that there are no reasons which would prevent a skilled person from such a combination. An explicit pointer for such a combination is not necessary. See e.g. T 332/87, r. 2.4 (also cited in the Case Law book in chapter I.C.4.2, 5th para.)

The same standard of disclosure should be applied when defining the specific set of features that is taken as the closest prior art in the problem-solution approach. (Else, we were in real trouble.)

Which brings me to the last sentence of the new paragraph. (Btw, the fn after the last sentence refers to O2017_007, r. 65 f. Don’t look there; it’s r. 54.) It uses the common terms directly and unambiguously — which are non-controversial per se. But I think it is important to keep in mind what that means in the context of specific embodiments in, e.g., patent documents: The general specification may well be used to supplement an embodiment with additional features taken from the general specification, provided that the embodiment is representative of the general teaching of the document. That’s sufficient to establish a direct and unambiguous dicslosure of the combination of features.

It will be interesting to see how the FPC actually applies this new paragraph in the presumptions on obviousness. It’s been uncritical in the case at hand.

✍ MW

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BIBLIOGRAPHY

Case No. O2020_014 | Judgment of 2 October 2023 | ‘iMessage’ | not yet final

Pear AG
./.
(1)
(2)
(3)
Apple Inc.
Apple Distribution International Ltd
Apple Retail Switzerland GmbH

Panel of Judges:

    • Dr. Mark SCHWEIZER
    • Dr. Tobias BREMI
    • Peter RIGLING

Judge-rapporteur:

    • Dr. Tobias BREMI

Court Clerk:

    • Sven BUCHER

Representative(s) of Plaintiff:

Representative(s) of Defendant:

JUDGMENT

PATENTS IN SUIT

EP 1 838 074 B1:

Please consult the EPO Register and Swissreg for status / bibliographic information.

EP 1 208 687 B1:

Please consult the EPO Register and Swissreg for status / bibliographic information.

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Laboratory ceilings: Geometry is (not) just plane fun

Reading time: 2 minutes
DISCLOSURE NOTICE: Hepp Wenger Ryffel is involved in this matter on behalf of the plaintiff.

Case No. O2021_018 | Judgment of 31 August 2023 | ‘Laboratory ceiling’ | Appeal pending

Lüdi logo

This infringement case relates to laboratory ceilings for routing supply lines for certain media and air in laboratories. The patent in suit is EP 1 934 414 B1 of H. Lüdi + Co.

Wobatech logo

The judgment holds that the attacked embodiment of Wobatech does not read on EP 414 because the air supply duct is not substantially flush with the underside of the support frame in the [first] plane of the support frame. The case was accordingly dismissed for non-infringement. The judgment does not elaborate on Wobatech’s nullity plea in defense.

The judgment is not yet final.

✍ MW

BIBLIOGRAPHY

Case No. O2021_018 | Judgment of 31 August 2023 | ‘Laboratory ceiling’ | Appeal pending

H. Lüdi + Co. AG
./.
Wobatech AG

Panel of Judges:

    • Dr. Mark SCHWEIZER
    • Dr. Tobias BREMI
    • André WERNER

Judge-rapporteur:

    • Dr. Tobias BREMI

Court Clerk:

    • Sven BUCHER

Representative(s) of Plaintiff:

Representative(s) of Defendant:

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JUDGMENT

PATENT IN SUIT

See EPO Register and Swissreg for further information.

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Bayer’s blockbuster Xarelto approaching the patent cliff, competition is getting tougher

Reading time: 5 minutes

Case No. S2023_006 | Judgment of 25 July 2023 | ‘Rivaroxaban / Acino’

WHAT YOU NEED TO KNOW

Bayer’s Swiss SPC on rivaroxaban expires on 17 June 2024.

Acino’s out-licensing offer (a service package that includes all regulatory / approval work and manufacturing / packaging) for rivaroxaban does not constitute an imminent threat of market entry of a potential licensee. Bayer’s request for an ex parte PI was accordingly dismissed.

Acino has nevertheless taken rivaroxaban off its list of compounds available for out-licensing, for the time being.

rivaroxaban

This case is about rivaroxaban, a prescription blood thinner. It is used to treat deep vein thrombosis (DVT) and pulmonary embolism (PE). It’s a pretty interesting small molecule that acts as an anticoagulant; it has been the first orally active direct factor Xa inhibitor.

You may grab und turn it in the illustration below to get an idea of its structure in 3D:

Rivaroxaban is marketed by Bayer as Xarelto®. It is only in the U.S. that Bayer has out-licensed the drug to a subsidiary of Johnson & Johnson. Direct sales and license income from J&J make Xarelto® Bayer’s best-selling drug, by far. But sales are declining:

Patents and competition
Bayer logo

The basic compound patent EP 1 526 132 B1 has lapsed in December 2022, but the Swiss SPC C01261606/01 is still in force until 17 June 2024. EP 132 and the corresponding SPC were apparently not challenged by now; validity of the corresponding US 7,157,456 B2 has been confirmed in inter partes proceedings. Accordingly, Bayer’s Xarelto® is currently the only rivaroxaban containing pharmaceutical listed in Compendium. However, quite some competitors have already obtained their MAs for rivaroxaban (Nobel, Sandoz, Spirig and Mepha):

MAs for rivaroxaban (31 July 2023)

Note that Bayer has yet another patent on a dosage regime of ribaroxaban; EP 1 845 961 B1 still runs until until January 2026 (see Swissreg). EP 961 has been maintained in EPO proceedings lately, but is under fire in national proceedings.

acino’s out-licensing offer
Acino logo

Bayer had noted that Acino was promoting rivaroxaban on their website as a new product that was available for out-licensing. Acino’s service of out-licensing apparently comprises the development and subsequent licensing of an entire medicinal product dossier. In addition to the production and delivery of the pre-packaged pharmaceutical, Acino also obtains all necessary authorisations, approvals, etc. The out-licensed products are manufactured in the Basel region. The out-licensing offer comes along with the following footer:

Products which are subject to patent protection are offered with respect of the prevailing patent laws. No sales, prior to the expiry date of valid patents, are foreseen to countries where patents are in force.

Further, Acino has filed its MA request with Swissmedic on 21 June 2023.

Earlier this year, i.e., on 10 June 2023, Acino’s website had indeed listed rivaroxaban as one of the products available for out-licensing:

Acino’s products for out-licensing (10 June 2023)

As per today, rivaroxaban is not listed on that website anymore. Likewise, Acino’s out-licensing brochure of April 2023 mentioned rivaroxaban, while the current version of July 2023 does not.

What’s been decided

The judgment holds that Acino does not (yet) offer any pharmaceuticals containing rivaroxaban, and that it is not credible that market entry is imminent. In practice, not even the granting of a MA by Swissmedic indicates imminent market entry since the MA only gives the right to market the respective pharmaceutical, but there is no corresponding obligation to do so. It is quite possible, and indeed common, to apply for a MA before the final clarification of the IP situation, so that the sale can start promptly after clarification of the IP situation.

Specifically, Bayer could not show any concrete evidence that potential customers of Acino’s out-licensing programme would not respect Bayer’s patents. The abstract threat that a holder of a MA will enter the market before the expiry of the term of protection of relevant IP rights always exists, but this is not sufficient to establish a credible threat of actual infringement.

Accordingly, the President acting as single judge dismissed Bayer’s request for an ex parte PI.

✍ MW

BIBLIOGRAPHY

Case No. S2023_006 | Judgment of 25 July 2023 | ‘Rivaroxaban / Acino’

Bayer Intellectual Property GmbH
./.
Acino International AG
Acino Pharma AG

Single Judge:

    • Dr. Mark SCHWEIZER
  • Court Clerk:
    • Dr. Lukas ABEGG

Representative(s) of Plaintiff:

    • Dr. Simon HOLZER (MLL)
    • Louisa GALBRAITH (MLL)
    • Dr. Ulrike CIESLA (MLL), assisting in patent matters

Representative(s) of Defendant:

JUDGMENT

BASIC PATENT

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Infringement under the Doctrine of Equivalents: There is life in Q3

Reading time: 13 minutes
DISCLOSURE NOTICE: Hepp Wenger Ryffel is involved in this matter on behalf of Mepha Pharma AG.

Case Nos. O2021_004, O2021_005 | Judgment of 20 April 2023 | ‘Deferasirox II’

HEADNOTES

Art. 229 para. 1 CPC
Proper nova
The decision of a Board of Appeal of the European Patent Office which also concerns the patent in suit is a genuinely novel fact within the meaning of Art. 229 (1) (a) of the Code of Civil Procedure.

Art. 8 CC, Art. 1 para. 2 PatA, Art. 56 EPC
Burden of proof
The burden of proving the technical effect(s) of the invention lies with the patent proprietor.

Art. 51 PatA, Art. 66 let. a PatA, Art. 69 EPC
Infringement by equivalent means
If a preferred value is mentioned in the patent and a range is claimed in the claim that includes this value, the skilled person assumes that the patent proprietor has waived protection for values outside the claimed range.

This judgment in litigation between Mepha and Novartis covers both Mepha’s revocation action with respect to EP 202 and EP 018 (O2021_004) and Novartis’ conterclaim for infringement of both patents (O2021_005) by Deferasirox-Mepha® (Swiss market authorization no. 67678).

Fe(III) chelate

Deferasirox is an iron chelating agent; it is frequently referred to simply as DFX. It is mainly used to reduce iron overload in patients who are receiving long-term blood transfusions in the treatment of chronic anemias.

The FPC had issued a PI in summary proceedings in December 2021; see this Blog here. This finding has been reversed with the present landmark ruling in main proceedings, by an enlarged panel of five judges: The judgment holds that both patents are not infringed, neither literally nor under the DoE. This is what hn ③ is all about.

But let’s take it one step at a time, walking through all headnotes.

Board of appeal decision is proper novuM

Hn ① relates to a procedural matter:

Novartis logo

Let me put this into context first. In litigation at the FPC, parties have two unrestricted opportunities to comment on the merits of the case and, in particular, to introduce new facts into the proceedings. Thereafter, new facts and evidence (nova) can only be introduced under the limited conditions of Art. 229 CPC.

According to the Supreme Court (BGE 146 III 416, r. 4.1; see this Blog here), filing of a new claim set is to be treated in the same way as the submission of other nova. In the underlying case of this Supreme Court judgment, the patentee had partially waived the patent in ex parte proceedings at the Swiss IPI (Art. 24 PatA, comparable to limitation proceedings under Art. 105a EPC at the EPO) only after the closure of the file in co-pending litigation, and was barred from introducing the limited claims into the civil proceedings. The Supreme Court considered the limited claims as an improper novum under Art. 229 para. 1 let. b CPC: Even though the limited claims came into existence only after closure of the file, they could have come into existence earlier, only depending on the decision of the patentee with respect to both timing and extent of the partial waiver.

The present judgment holds that the situation in inter partes opposition / appeal proceedings at the EPO is different. First of all, such proceedings are not initated by the patentee. Second, and even though it is the patentee who formulates the wording of all his auxiliary requests, it is difficult for him to predict which of the auxiliary requests (if any) will survive examination on the merits. Finally, the timing of such inter partes proceedings is determined to large extent by the conduct of the other parties and the procedural calendar of the Board of Appeal. In sum, the FPC holds that the patentee is completely deprived of control over the time and at least partially deprived of control over the version in which the patent is maintained.

Mepha logo

Accordingly, the FPC held that the Board of Appeal decision T 1057/21 to maintain EP 018 in amended form is to be considered as a proper novum under Art. 229 para. 1 let. a CPC.

Let’s have a closer look at T 1057/21. EP 018 was maintained based on auxiliary request #48(!) of 71 auxiliary requests in total. Auxiliary request #48 had been initially filed as auxiliary request #38 in first instance proceedings on 19 February 2021, more than a year before closure of the file in nullity proceedings O2021_004. Patentee re-shuffled his requests later, i.e. the Board of Appeal did not deal with 47 requests before it finally allowed auxiliary request #48. Rather, the patentee made this request his new main request in the oral proceedings before the Boards of Appeal on his own volition, and this new main request was found allowable.

Undoubtedly, it is an uncomfortable situation for patentees to coordinate national nullity proceedings (governed by the strict rules on nova after closure of the file under the CPC) with co-pending central opposition / appeal proceedings at the EPO. Which is why some countries rule out national nullity proceedings while EPO opposition / appeal proceedings are still pending (e.g. Germany; see § 81(2) PatA); not so in Switzerland. The FPC’s approach will surely be appreciated by patentees, if and when it is ultimately approved by the Supreme Court.

burden of proof for technical effects

Hn ② relates to the allocation of the burden of proof for the technical effect(s) of the invention. Now we know:

On a quick read, the hn might suggest that it is up to the patentee to actually prove the technical effect, while the plaintiff in invalidity proceedings can sit back and just grouse that the claimed technical effect has not been proven (yet). But beware: The hn only deals with the allocation of the burden of proof.  It does not say anything about the standard of evidence according to the lex fori. The regular standard of ‘full conviction’ applies in Switzerland, which according to settled case law means that the court should have no serious doubts about the existence of the alleged fact, or that remaining doubts appear to be slight.

Now, what does that mean for assessment of an alleged technical effect of an invention?

The proof does not necessarily have to be provided with empirical data or even clinical studies. If the person skilled in the art can conclude on the basis of scientific or theoretical considerations that the claimed technical effect exists, this is sufficient proof. When assessing the evidence, it may also be taken into account which indications speak against the claimed technical effect. If there are no such indications, the requirements for proving the technical effect are lower.

Tango
it takes two …

Not much of a surprise, isn’t it? In practice, it takes two to tango: The more indications are on the table that the effect is not achieved, the harder it will be for the patentee to actually prove the contrary. Even though the burden of proof lies with the patentee in the first place (which is also the case at the EPO, see e.g. T 1188/00 (hn) and G 2/21 (r. 26)), the whole discussion about whether or not a certain technical effect is achieved is an argumentative arm wrestling.

Numerical ranges / infringemement under the DOE

The judgment holds that both EP 202 and EP 018 as amended in opposition/appeal proceedings are valid (r. 46-67) but not infringed, neither literally nor under the DoE.

The decisive feature in terms of infringement is the amount of deferasirox. The independent claims of both patents require 45-60% by weight of deferasirox. The attacked embodiment contained 64.3% by weight, based on the information given in the product information; r. 68. Even the lowest (disputed) analytical value submitted by the patentee was 60.8%. The judgment holds that even in case of the lower value literal infringement is ruled out. The skilled person will typically consider numerical ranges as more precise and more clear than other verbally described technical claim features (in line with the judgments X ZR 168/00Schneidmesser I (r. II 3 lit. d) and X ZR 135/01Schneidmesser II (r. 4 lit. d) of the German Supreme Court). Accordingly, also values within usual tolerances are not literally covered. The skilled person knows, however, that technical numerical ranges are subject to a measuring error. Therefore, as a rule, the last digit of numerical values corresponds to the measurement accuracy. If no other error limits are indicated (as is the case here), the maximum error for the last digit is estimated from the rounding convention; see e.g. T 175/97 (r. 2.6). The judgment holds that this case law developed for prior art disclosures equally applies to the interpretation of numerical ranges in patent claims. Since the claimed range is given without any decimal digits, the range that is still within the literal scope of protection is ≥44.5% to <60.5% if the normal rounding convention is applied.

Accordingly, and in particular in the absence of any teaching in the patents that would point to a broader interpretation of the claimed range, the judgment holds that neither 64.3% nor 60.8% is literally covered by the claims.

Turning to infringement under the DoE (r. 73 et seqq.), the judgment holds that the variant has the same effect; i.e., Q1 of the three prong test is answered in the affirmative (not much out of the ordinary for generics).

As to the second question re accessibility of the variant (‘Auffindbarkeit’), the judgment holds that there is currently some uncertainty as to whether this should be dealt with in retrospect (i.e., in knowledge of the variant like in the U.K.), or not (like in Germany); r. 77. It is hoped that the Supreme Court clarifies its position when it gets the chance (which is now):

In the case at hand, the FPC held that it does not matter: The same effect of the variant was ‘accessible’ without involvement of an inventive step in any event; r. 78. Thus, Q2 is answered in the affirmative.

Q3 is meant to safeguard the legitimate interest of the public in legal certainty. Here it is (my own understanding / translation):

Does an objective reading of the patent specification lead the skilled person to the conclusion that the patentee has formulated the claim — for whatever reason — so narrowly that he does not claim protection for an embodiment of same effect (Q1) that is ‘accessible’ for the skilled person (Q2)?

The single embodiment of both patents makes use of 56% of deferasirox (para. [0016] von EP 202; para. [0017] von EP 018). In the claims, however, not this specific value is mentioned, but rather a range of 45% to 60%, which is evidently placed around this specific value. Under these circumstances, the judgment holds (r. 80) that the skilled person assumes that the patentee has specifically and bindingly placed the claimed range around the specific value, i.e. the patentee has deliberately decided to specify the invention to be within this range and thus to dispense with the scope of protection lying outside this range. Under the circumstance, the judgment holds that there is no room to extend this range under the DoE by taking into account generally accepted tolerances going beyond it, because the skilled person may in good faith assume that the patentee has already taken into account possible tolerances when defining the range. In passing, the judgment notes that the range is not symmetrically placed around the specific value; it rather is narrower above than below the specific value. This even underlines the importance of the upper limit. Thus, infringement under the DoE was denied.

This outcome is essentially in line with the U.K. judgment [2022] EWHC 2847 (Pat), para. 232 (emphasis added):

I have found that in the present case the inventive concept of the Patents would be seen by the skilled team as requiring strict compliance with the 45-60% range of deferasirox. On that basis a variant will not be substantially the same as the inventive concept unless it strictly complies. I need not investigate with precision what compliance means numerically as matter of general principle. In my judgment Teva DFX does not comply.

In the Swiss case, Novartis appealed to the Supreme Court. The appeal is still pending at the time of writing.

In accordance with the outcome in main proceedings, the PI was lifted with separate order.

UPDATE 28 Sept. 2023: Novartis’ appeal has been dismissed by the Supreme Court; the decision is final.

✍ MW

BIBLIOGRAPHY

Case Nos. O2021_004, O2021_005 | Judgment of 20 April 2023 | ‘Deferasirox II’

Mepha Pharma AG
./.
Novartis AG

Panel of Judges:

    • Dr. Mark SCHWEIZER
    • Dr. Tobias BREMI
    • Dr. Rudolf RENTSCH
    • Prisca von BALLLMOOS
    • Marco ZARDI

Judge-rapporteur:

    • Dr. Tobias BREMI

Court Clerk:

    • Sven BUCHER

Representative(s) of Plaintiff:

Representative(s) of Defendant:

JUDGMENT
of 20 April 2023 in main proceedings

ORDER
of 12 May 2023 rectifying / supplementing the judgment

JUDGMENT
of 15 December 2021 in summary proceedings

PATENTS IN SUIT

EP 2 964 202 B1:

See EPO Register and Swissreg for bibliographic details.

EP 2 964 202 B2:

See EPO Register and Swissreg for further information.

EP 3 124 018 B1:

See EPO Register and Swissreg for further information.

EP 3 124 018 B2:

Not yet available. Currently being dealt with by the OD again, after T 1057/21,  to compile the set of documents for maintenance of the patent in amended form, based on the following claims:

See EPO Register and Swissreg for further information.

EPO BOARD OF APPEAL DECISIONS

T 0526/21 re EP 202

T 1057/21 re EP 018

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Imholz ./. Emil Gisler: Is coming up with inventions a side task of a sales rep?

Reading time: 6 minutes

Case No. S2023_001 | ‘Bitumen / asphalt recycling’
👉 Order of 15 February 2023
👉 Judgment of 11 April 2023

Environmental sustainability is a huge thing these days. It affects almost every industry. Even roadworks. Did you ever wonder what happens with waste asphalt? Formerly, it was dumped in landfill. Not so anymore. Recycling has arrived in this industry, too. One approach is to crush and screen the recovered asphalt, and to re-use it as gravel or in mixed products. The common disadvantage is that components get more and more fragmented / the fine portion increases. Further, the valuable bitumen is functionally lost.

Obviously, there is still room for improvement, and this is what the present case is all about.

GIPO logo

An employee of Emil Gisler AG Maschinenbau und Hydraulik (the defendant) made an invention pertaining to recycling of asphalt and bitumen, and reported this invention to his employer. This employee, Pius IMHOLZ, has meanwhile left Emil Gisler and founded his own company in order to commercialize this invention, i.e. Imholz GmbH (the plaintiff). But, here’s the issue: His former employer filed the respective patent application for this invention in their own name. It’s the Swiss patent application 70/2022 (still unpublished, but expected to be published in about a month; stay tuned!). Accordingly, it’s a classic dispute concerning the ownership of an invention and the respective patent application.

Swiss law is pretty clear with respect to employee inventions:

    • If an employee comes up with an invention in the course of his work for the employer and in performance of his contractual obligations, such an invention belongs to the employer without any further ado; Art. 332 para. 1 CO. These are so-called ‘Diensterfindungen’.
    • Further, the employer may also reserve the right to acquire inventions made by the employee in the course of his work for the employer but not in performance of his contractual obligations. These are so-called ‘Gelegenheitserfindungen’. This requires a written agreement. The employee must notify the employer of such inventions, and the employer must then inform the employee within six months if he wishes to acquire the invention or release it to the employee. See Art. 332 paras. 2 and 3 CO.

To date, the facts are only told by the plaintiff. (Clearly, defendant did not confirm plaintiff’s summary; they reserved the right to put everything into perspective in main proceedings. They just chose their battles wisely: A register ban will hardly ever be denied, anyway.) So, this is what we know for now: Pius IMHOLZ informed his employer about the existence of his invention on 25 October 2021, and disclosed the details thereof in early November 2021. In co-operation with patent attorneys a draft patent application was compiled, the content of which was approved by Pius IMHOLZ on 20 December 2021. On the same date, at the latest, Pius IMHOLZ made clear that he did not intend to give away (t)his invention for free. The defendant (more precisely, their attorneys-at-law since the filing receipt was apparently addressed to them) nevertheless filed the patent application in their own name on 25 January 2022.

The parties could not reach an out of court settlement since then, which is why plaintiff went to court. In particular, the parties dissent about whether the invention at stake is a ‘Diensterfindung’ in accordance with Art. 332 para. 1 CO. Note that Pius IMHOLZ was employed as a sales representative, not in R&D. Still, defendant claims that coming up with the invention was part of Pius IMHOLZ’s side tasks as sales representative.

In co-pending main proceedings (case no. O2023_002), Imholz seeks assignment of the patent application. The present summary proceedings were all about a register ban. With an ex parte order of 15 February 2023, the President acting as single judge held that the invention at stake was quite likely a ‘Gelegenheitserfindung’. In the absence of any written agreement in the sense of Art. 332 para. 2 CO on file, a register ban was issued. The register ban was confirmed after the defendant had been heard, with judgment of 11 April 2023.

A closer look a the technology

It appears that GIPO began to showcase its asphalt competence in 2021, e.g. when plant no. 1’000 was commissioned in August 2021 (mentioning that bitumen is separated from stone, without breaking the stone), and with an advertisement in asphalt 5/2021 (published in August 2021, too):

 

A hyperlinked category ‘Asphaltaufbereitung’ on GIPO’s website was archived for the first time when crawled on 28 December 2021; the respective hyperlink itself was crawled only on 29 January 2022 for the first time (i.e., a few days after the filing date), with a brochure about GIPO’s asphalt processing / recycling technology.

Here’s how GIPO currently advertises its approach to bitumen / asphalt recycling:

It will be interesting to see (around end of July 2023) what the invention of the Swiss patent application 70/2022 is all about.

✍ Sarah HENTSCHEL / Martin WILMING

BIBLIOGRAPHY

Case No. S2023_001 | ‘Bitumen / asphalt recycling’
👉 Order of 15 February 2023
👉 Judgment of 11 April 2023

Imholz GmbH
./.
Emil Gisler AG

Single Judge:

    • Dr. Mark SCHWEIZER

Court Clerk:

    • Sven BUCHER

Representative(s) of Plaintiff:

    • Dr. Cyrill RIEDER (FMP)
    • Dr. Peter WALSER (Frei), assisting in patent matters

Representative(s) of Defendant:

    • Dr. Simon HOLZER (MLL)
    • Nicola BENZ (MLL)
    • Dr. Ulrike CIESLA (MLL), assisting in patent matters

JUDGMENT

EX PARTE ORDER

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Spirig’s sitagliptin / metformin fixed-dose combination: Launch failure

Reading time: 6 minutes

Case No. S2022_010 | ‘Sitagliptin Metformin’
👉 Order of 16 January 2023
👉 Judgment of 27 March 2023

MSD logo

Sitagliptin is one of the best selling treatments for type II diabetes; it is sold by MSD as Januvia® (Swissmedic market authorization no. 57863). Sitagliptin is often used in combination with Metformin, a first line anti-diabetic medication. The fixed-dose combination is sold by MSD as Janumet® (Swissmedic market authorization no. 58450).

Putting it simple, metformin reduces the absorption of sugar from the stomach, reduces the release of stored sugar from the liver, and improves the use of sugar in the body. Sitagliptin helps to make the pancreas release more insulin. It also signals the liver to stop producing sugar when there is too much sugar in the blood.

MSD’s full year 2022 financial report acknowledges «lower sales of Januvia and Janumet, primarily reflecting lower demand in Europe as a result of generic competition.» Combined sales dropped by 15%, from USD 5,288 bn (2021) to 4,513 bn (2022).

MSD held two SPCs in Switzerland, i.e.

    • C01412357/01 for the fixed-dose combination of sitagliptin and metformin (granted 31 December 2009, lapsed 7 April 2023); and  
    • C01412357/02 for sitagliptin as such (granted 23 November 2021 as a paediatric extension, lapsed on 4 January 2023).

Both SPCs were based on EP 1 412 357 B1 (lapsed 5 July 2022; see EPO Register and Swissreg).

Spirig logo

Helvepharm, Sandoz and Mepha chose to enter the market with the fixed dose combination only in April 2023, while Spirig (member of the Stada group of companies) apparently took that step already in January 2023 when C01412357/01 was still in place ; see Compendium.

Here’s what happened:

When Spirig had obtained the Swiss market approval for the fixed-dose combination, MSD requested them to confirm that they will respect the two SPCs. Spirig confirmed that it would respect the one for sitagliptin as such, but refused to confirm the same for the SPC on the fixed-dose combination, because the latter was invalid, in their view.

On that basis, MSD sought preliminary injunctive relief on 23 December 2022. The President acting as single judge dismissed MSD’s request for an ex parte PI with order of 3 January 2022 (unpublished). Essentially, it had been held that mere refusal to confirm that one respects an SPC does not mean that infringing acts are imminent:

This could have been it. But it wasn’t. Shortly thereafter, on 12 January 2023 when the inter partes PI proceedings were still ongoing, MSD informed the FPC and provided evidence that Spirig meanwhile had entered the market — and again requested an ex parte PI. This time, indeed, the President issued an ex parte PI on 16 January 2023, yet without reasons. On Spirig’s request, reasons for the ex parte PI were subsequently provided. Spirig did not dispute but rather even confirmed with their request for a reasoned decision that they had taken up commercialization of the fixed-dose combination:

Apparently, Spirig took from certain subsidiary considerations in the President’s (unpublished) order of 3 January 2023 that MSD’s right to an ex parte PI would be forfeited. But it wasn’t: New facts (infringing acts) gave rise to a new assessment by the President.

Turning now to the alleged invalidity of the fixed-dose SPC, the judgment holds that the (meanwhile overcome) ‘infringement test’ still applies to C01412357/01, in view of a Swiss Supreme Court decision of 2018; see this Blog here. What is more, the fixed-dose SPC was the first one to be granted in Switzerland. Accordingly, the President held that the Swiss fixed-dose SPC was prima facie valid.

The situation is different in some other countries, e.g. in Germany where the Federal Patent Court had revoked the fixed-dose SPC because it lacked a further ‘inventive advance’; see 3 Ni 2/20. Note, however, that the fixed-dose SPC was the second one to be granted in Germany. MSD’s appeal is currently pending at the German Supreme Court, with case no. X ZR 64/21.

My reading between the lines is that the Swiss Federal Patent Court does have a different understanding of the ECJ rulings on combination SPCs than the German Federal Patent Court. The FPC explicitly disagrees with Spirig’s pleadings to this effect:

But, hey, the ECJ rulings on SPCs are somewhat cryptic indeed, aren’t they? Accordingly, it comes as no surprise that the Markkinaoikeus of Finland in corresponding proceedings between MSD and Teva asked the ECJ for a preliminary ruling (case no. C-119/22); see the questions here. Maybe, we will soon get some clarification about ‘core inventive advance’, ‘central inventive step’ and/or ‘subject matter of the invention’ from the ECJ (hopefully, it’ll not be a ruling that raises more questions than it answers).

The ex parte PI that had been issued by the President was confirmed by a panel of three judges after Spirig has been heard, with judgment of 27 March 2023.

What is interesting on the precedural side is that MSD was not set a time limit for initiating main proceedings. The SPC lapsed earlier than the 30 days time limit, which is why the excercise was meaningless:

The judgment has not been appealed / is final.

✍ MW

BIBLIOGRAPHY

Case No. S2022_010 | ‘Sitagliptin Metformin’
👉 Order of 16 January 2023
👉 Judgment of 27 March 2023

Merck Sharp & Dohme LLC
./.
Spirig Healthcare AG

Single Judge (Order of 16 January 2023):

    • Dr. Mark SCHWEIZER

Panel of Judges (Judgment of 27 March 2023):

    • Dr. Mark SCHWEIZER
    • Dr. Tobias BREMI
    • Prof. Dr. Daniel KRAUS

Judge-rapporteur:

    • Dr. Tobias BREMI

Court Clerk:

    • Dr. Lukas ABEGG

Representative(s) of Plaintiff:

Representative(s) of Defendant:

    • Dr. Christian HILTI (Rentsch)
    • Dr. Andrea CARREIRA (Rentsch), assisting in patent matters

JUDGMENT

EX PARTE PI

BASIC PATENT

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Harry Winston is hunting after a patent application concerning a wristwatch with two or more cylinder

Reading time: 4 minutes

Case No. S2022_007 | Judgment of 6 January 2023 | ‘Cylinder watch’

With this judgment in summary proceedings the FPC imposes a register ban in view of an entitlement / assignment action brought by Harry Winston against two defendants, i.e. Creaditive and MHM. The patent application at stake is CH 717 766. Main proceedings are co-pending at the FPC; case no. O2022_001.

Harry Winston’s reputation mainly stems from the jewelry business, in particular relating to some of the most famous diamonds such as the Hope Diamond. Harry Winston meanwhile belongs to the Swatch group. This case, however, is about a patent application for a wristwatch. Well, not an ordinary one. It’s a somewhat special kind of wristwatch that has a plurality of cylinder. And with moving pistons in the cylinders. Like an engine, you know. If you have petrol running through your veins, you may be thinking of Daimler’s  ancient ‘Grandfather Clock’ right now. But that’s not what we’re talking about. First, it only had one cylinder; and second, it wasn’t really a clock.

To give you an idea of how that might look like, just have a look at the Timeburner of Miki Eleta. It exemplifies the principle of a piston moving in a cylinder to indicate the minutes. But it only has a single cylinder:

YouTube player

There will be lovers and haters of such watches, for sure. But whatever you think about it, it is pretty clear that with a plurality of cylinders indicating the minutes it might be hard to figure out at which cylinder one should look at a given time. The patent application offers a solution for this problem (that I would never have guessed existed).

I note that there had been a change with respect to the designation of inventors, i.e. Georg von Tardy has been delisted; see the A8 publication. Bernhard Lederer is currently listed as the only inventor; he is the founder of MHM and has single signatory power for Creaditive. It remains to be seen whether this correction of the designation of inventors somehow relates to the assignment / entitlement action. I would be surprised if it didn’t.

UPDATE 1 Feb 2023: I am indeed surprised now. The file wrapper does not support my assumption that the delisting of the inventor related to the court case. It appears to be a mishap in the Register.

Defendants had requested that the proceedings before the FPC be stayed pending the resolution of co-pending litigation in Geneva; case no. C/19553/2022 7 GSV V (no further information available to date). But the FPC did not spot a risk of conflicting judgments since the litigation in Geneva apparently only concerns the (allegedly insufficient) performance under a contract and restitution for an alleged overpayment. Staying proceedings was thus not considered appropriate; Art. 126 CPC.

In sum, a register ban has been imposed; see Swissreg. Further, the stay of main proceedings on the merits has been lifted.

✍ MW

BIBLIOGRAPHY

Case No. S2022_007 | Judgment of 6 January 2023 | ‘Cylinder watch’

Harry Winston SA
./.
(1) Creaditive AG
(2) MHM Manufacture de haute Horlogerie et Micromécanique SA

Single Judge:

    • Dr. Mark SCHWEIZER

Court Clerk:

    • Sven BUCHER

Representative(s) of Plaintiff:

Representative(s) of Defendant:

    • Marcel EGGLER (KGG)

JUDGMENT

PATENT APPLICATION IN SUIT

IPI FILE WRAPPER
as received on 31 January 2023:

I have received the file wrapper in three parts; I have manually combined the first two parts above: The first part contained the first eleven pages; the second part the subsequent pages. The third part only contained the FPC judgment (not included in the document above).

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Lucentis biosimilar: First commercial use not (yet) imminent

Reading time: 9 minutes

Case No. S2022_003 | Judgment of 3 January 2023

WHAT YOU NEED TO KNOW

Novartis requested a PI in view of Swissfillon‘s involvement in the preparation of pre-filled syringes of a biosimilar of Lucentis, i.e., Ximluci (fka Xlucane) of Stada / Xbrane.

The PI request was dismissed. Swissfillon’s conduct was covered by the marketing authorization privilege.

A written witness statement does not have testimonial quality under Swiss law. But it may be considered as a physical record, with free evaluation of the evidence on file. 

The case relates to a biosimilar of Lucentis® (INN: ranibizumab); see compendium.ch and spezialitätenliste.ch for further infomation.

Novartis logo

Lucentis® is the ophthalmology blockbuster of Novartis with net sales of USD 2.16 bn in 2021. It is a monoclonal anti-angiogenic antibody that targets VEGF-A; it had initially been developed by Genentech. They still market Lucentis® in the United States only, and Novartis markets it elsewhere in the world under the same name. Lucentis® is available in vials and pre-filled syringes (PFS); the present case relates to the latter.

Illustration of Novartis’ PFS

You might think that it doesn’t take much magic for ranibizumab being privided in a PFS. But far from it! Actually, Novartis asserted two patents (both are currently being challenged in EPO opposition proceedings), i.e.,

Swissfillon logo

However, the judgment is not about how the attacked embodiment reads on the claims, and why the patents are valid or not. Defendant Swissfillon neither disputed validity of the patents nor that the PFS would infringe the patents. The emphasis is on would here: Defendant argued that it has so far only taken actions that are covered by the marketing authorization privilege according to Art. 9 par. 1 lit. c PatA.

Accordingly, Novartis had to credibly demonstrate that Defendant had already taken actions according to Art. 8 PatA that go beyond the marketing authorization privilege (risk of re-occurence; ‘Wiederholungsgefahr’); or that the risk of first actions beyond the marketing authorization is imminent (risk of first occurence; ‘Erstbegehungsgefahr’).

I will come back to that in a minute.

Xbrane logo

Let me first complete the picture from a market perspective. At the face of it, the litigants are Novartis and Swissfillon. However, the attacked embodiment stems from a ménage à trois (at least): Xbrane and Stada had entered into a co-development agreement for Xlucane, a Lucentis® (ranibizumab) biosimilar; see the press release of 12 July 2018 here. Don’t be confused by the product name(s): Xlucane has been referred to as Ximluci in more recent times; see e.g. the press release of 16 September 2022 here. It’s just a change of names.

Swissfillon (only) comes into play with respect to filling and packaging of Xlucane / Ximluci; see e.g. this marketing brochure commissioned by Xbrane (10 June 2019):

As mentioned above, the case pertains to PFS only; this is what the patents in suit are all about. Swissfillon is known to join forces with Terumo as a supplier of syringes in particular for ophthalmic drugs; see e.g. here. Terumo’s Plajex™ is a silicone oil-free, ready-to-fill syringe system with i-coating™ stopper; see e.g. here and the judgment in ¶24.

Plajex™ syringe

But did Swissfillon already take actions beyond the marketing authorization privilege with respect to PFS of Xlucane / Ximluci? The judgment holds that this is not the case. Undisputedly, process validation (to the extent necessary for the marketing authorization) was covered by the marketing authorization privilege. Accordingly, the judgment holds that in the absence of any past infringing actions there is no risk of re-occurence (‘Wiederholungsgefahr’).

Assessment of the risk of first occurence (‘Erstbegehungsgefahr’) was a bit more tricky, though. Is an internal fto opinion prepared by Xbrane sufficient for Swissfillon to begin commercial activities, as argued by Plaintiff? Or will Swissfillon only start commercialisation when an independent freedom-to-operate opinion or a judicial clarification of the IP situation is available?

Interestingly, the judgment holds that reliance on an internal fto opinion by Xbrane would indeed not be suitable for averting the risk of an imminent infringement, since Xbrane has an all too obvious interest in downplaying the risk of patent infringement. However, Novartis could not establish that Swissfillon would indeed rely exclusively on Xbrane’s internal fto opinion. In an overall view of the internal and external correspondence submitted by the Swissfillon (a ‘Gesamtschau’, you know), it was credible for the FPC that Swissfillon considers it important to not infringe any IP rights of third parties and does not venture a launch at risk; ¶26. Separately, Stada has apparently lodged a nullity action against both patents in suit in September 2022. (The exact date is unclear; ¶¶19-20 mention the 20th and the 22nd of September as date of the SoC.)

Further, Novartis argued that Stada may likely obtain the markting authorization as early as in Q1 of 2023, apparently implying that infringement is thus imminent. However, the judgment holds that a marketing authorization is not sufficient to establish a threat of first infringement:

Finally, Swissfillon’s refusal to sign a cease and desist declaration had not any weight either (see ¶26):

Since neither the risk of repetition nor the risk of first infringement has been plausibly demonstrated, it cannot be concluded from the refusal to issue a cease and desist declaration that acts of infringement are imminent.

In sum, the judgment holds that Novartis failed to establish a risk of first infringement (‘Erstbegehungsgefahr’). Accordingly, Novartis’ PI request was dismissed.

The judgment contains some interesting considerations about written witness testimony. Swiss law does not provide for written witness statements; a written statement of a potential witness therefore does not have testimonial quality under the CPC. However, a written statement, even if prepared for court proceedings, contains a person’s record of his or her knowledge and is covered by the concept of a physical record (‘Dokument’) within the meaning of Art. 177 CPC. As a physical record, such a written witness statement is subject to the free assessment of evidence and cannot be simply disregarded. It can provide evidence for factual assertions in conjunction with other evidence or undisputed facts. Further, in particular in summary proceedings, it may well be suitable to make a factual assertion plausible.

On the procedural side, it is interesting to see how the FPC dealt with the various witnesses / party representatives offered by Swissfillon. For one party representative, the judgment holds that he does not need to be heard because he was offered for what turned out to be non-decisive issues anyway (Mr Mahler; Swissfillon); ¶17). For another witness (Mr Amark; Xbrane), the judgment holds that the witness offer was belated; ¶18. Accordingly, both Mr Mahler and Mr Amark have not been heard. However, yet another witness, Mr Koppen (Stada) had been heard during the main hearing of 15 November 2022. But the judgment holds that the witness had been offered only belatedly, and the witness testimony was accordingly disregarded:

Thus, the witness fee is paid by the FPC:

From the main hearing of 15 November 2022, I conclude that a request for marketing authorization of a ranibizumab PFS had already been filed by Stada with the EMA. However, this request had been withdrawn in April 2022, i.e. only shortly before Novartis filed the PI request. Presumably, Novartis had not been aware of the withdrawal. When Mr Koppen was asked for the reasons for the withdrawal, he referred to this as trade secret and refused to answer.

Ximluci in a vial has meanwhile been approved by EMA; see the joint press release of Stada and Xbrane here. I am not aware of a newly filed request with respect to a PFS, though.

✍ MW

BIBLIOGRAPHY

Case No. S2022_003 | Judgment of 3 January 2023

Novartis AG
./.
Swissfillon AG

Panel of Judges:

    • Dr. Mark SCHWEIZER
    • Dr. Tobias BREMI
    • Dr. Philippe DUCOR

Judge-rapporteur:

    • Dr. Tobias BREMI

Court Clerk:

    • Sven BUCHER

Representative(s) of Plaintiff:

Representative(s) of Defendant:

MAIN HEARING

JUDGMENT

PATENTS IN SUIT

EP 3 777 834 B1:

EP 3 685 826 B1:

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Pelliheat repatriated its patent application

Reading time: 3 minutes

Case no. S2022_001 | Order of 10 August 2022 | ‘Pelliheat; assignment’

Pelliheat logo

I have reported about this case last year on this Blog here. In brief, Pelliheat aimed to undo an improper assignment to a (meanwhile former) director of Pelliheat that the EPO had registered. A register ban had been issued ex-parte, and it was maintained after the defendant was heard. I have learned from the EPO docket that the parties have settled meanwhile. The FPC has issued an order to that effect on 10 August 2022, and dismissed the proceedings.

Now, who ‘won’ this case? Neither Pelliheat nor the former director, I’d say. They both had quite some costs, for … what, actually? An EPO Register that will soon look the same as it did before the improper assignment had been registered.

EPO logo

Oh, wait! The EPO charges a fee for registration of an assignment. Ironically, it pocketed the fee twice in this case. First, for registering the assignment and then again for the re-assignment. That’s peanuts, maybe. But, hey, many pennies make a dollar; and the bank always wins. I still find it somewhat disturbing that the EPO registered the first assignment at all, without any further ado. It should have rang alarm bells that the same person signs for both the assignor and the assignee. Frankly, it is anything but an exception that I am enquired by the EPO for less prominent peculiarities in assignment declarations.

Anyway, the EPO has informed the parties that on 1 Feb 2023  the stay will be lifted and the proceedings be continued with Pelliheat AG as the applicant.

✍ MW

BIBLIOGRAPHY

Case no. S2022_001 | Order of 10 August 2022 | ‘Pelliheat; assignment’

Pelliheat AG
./.
Hans SCHÄREN

Single Judge:

    • Dr. Mark SCHWEIZER
  • Court Clerk:
    • Dr. Lukas ABEGG

Representative(s) of Plaintiff:

Representative(s) of Defendant:

ORDER

Proceedings dismissed in view of the settlement (Art. 241 para. 3 CPC):

EX PARTE JUDGMENT

The FPC has published the judgment in anonymized form only; see here. However, the non-anonymized judgment is in the EPO docket here.

INTER PARTES JUDGMENT

PATENT APPLICATION IN SUIT

WO 2020 / 183 432 A1:

Amended claims in EPO proceedings:

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Can the duration of settlement talks be credited against the 14 months requirement for acting diligently?

Reading time: 3 minutes

Case No. S2022_004 | Judgment of 24 August 2022 | ‘Software; urgency’

Entitlement disputes are always interesting to follow. This one is not an exception to the rule. The plaintiff (A) is named as one of two inventors in a patent family, and (s)he sued the applicant (B Sàrl) and his/her fellow co-inventor (C); the latter is the sole owner of B Sàrl.

Plaintiff A requested a register ban and, interestingly, a prohibition to sell shares in B Sàrl, etc. (request no. 5). It appears that no main proceedings have yet been lodged.

Unlike many other entitlement proceedings, this one is not about the typical three step questionnaire about the merits of the invention (see e.g. the judgment in O2019_001, r. 26). It was a non-starter for failure to meet the 14 months rule-of-thumb for diligently requesting interim measures (r. 9) — which is why the President decided the matter sitting as single judge.

Cutting a long(er) story short, the judgment holds that plaintiff did not establish that the parties were even engaged in settlement talks:

By way of an anticipated assessment of plaintiff’s witness testimony that had been offered, the judgment holds that it was not necessary to actually hear A as a witness because no further insight was to be expected.

Calculated from the positive knowledge of the issue to the filing of the request for interim measures, 30 months had already lapsed; i.e. much too long. But even if one would assume that settlement talks were ongoing until late autumn 2020 (as asserted), 18 months had lapsed — which was still too long:

The judgment holds that difficulties in finding fundings for litigation is no excuse (apparently, Foris financed this litigation):

Interestingly, the judgment explicitly leaves undecided whether the duration of ongoing settlement talks can be credited against the 14 months at all:

Accordingly, A‘s request for interim injunctive relief was dismissed.

The parties, you ask?

No deciphering of the judgment this time. I have been tempted (if you know me, you will appreciate that I really was!), but I understand that the judgment has been anonymized on request of a party. Since natural persons are involved as parties, I will leave it at this.

/MW

BIBLIOGRAPHY

Case No. S2022_004 | Judgment of 24 August 2022 | ‘Software; urgency’

A
./.
(1)
(2)
B Sàrl
C

Single Judge:

    • Dr. Mark SCHWEIZER

Court Clerk:

    • Sven BUCHER

Representative(s) of Plaintiff:

    • Hans WEISSBERG (RSP)
    • Dr. Rudolf A. RENTSCH (iPrime), assisting in patent matters

Representative(s) of Defendant:

JUDGMENT IN FULL

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Illumina ./. MGI: Appeal dismissed

Reading time: 4 minutes

Case No. 4A_11/2022 (Supreme Court) | Judgment of 27 June 2022, on appeal against O2019_007 (FPC) | Judgment of 19 November 2021 | ‘Gene sequencing’

DISCLOSURE NOTICE: Hepp Wenger Ryffel is involved in this matter on behalf of the Appellant / Defendant, Latvia MGI Tech SIA.
Illumina logo

Illumina Cambridge had sued Latvia MGI Tech for infringement of two patents, i.e. EP 1 530 578 B1 (cf. EPO Register and Swissreg) and EP 1 828 412 B2 (cf. EPO Register and Swissreg). As mentioned earlier on this Blog here, the FPC held in the judgment of 19 November 2021 that both patents are valid (EP 578: ¶33 et seqq; EP 412: ¶53 et seqq.) and infringed (EP 578: ¶84 et seqq; EP 412: ¶91 et seqq.).

MGI logo

Latvia MIG Tech SIA appealed. Unsuccessfully, to large extent. Only the apportionment of costs was slightly corrected by the Supreme Court (20/80 instead of 10/90). On the merits, however, the Supreme Court had no issues with the FPC’s findings concerning Illumina’s legal interest / actual infringing activities in Switzerland; validity of EP 578 (non-obviousness over WO 02/29003 A2 in view of Zavgorodny et al. (1991)); and validity of EP 412 (no unallowable amendments; claim construction / novelty over US 6,355,420 B1; non-obviousness over Braslavsky et al. (2003) in view of van Dijk et al. (2004)).

I had felt that this case was a great opportunity for some clarification and guidance about the limits of claim construction in good faith; and allowability of amendments. To just name a few. But the Supreme Court did not jump on these issues. In view of my involvement in the matter, I will refrain from a critical review of the judgment. There is this famous saying of Nelson Mandela:

I never lose. I either win or learn.

Well, my immediate reactions are sometimes not very Mandela-like.

Meanwhile, Illumina and the MGI group have settled their corresponding US litigation; see Illumina’s SEC filing and MGI’s press release. Inter alia, a jury verdict in proceedings before the Delaware District Court had held that Illumina’s US patents 9,217,178 B2, 9,303,290 B2 and 9,970,055 B2 (all corresponding to EP 412 that had been asserted in Switzerland) were invalid. On the other hand, the jury held that Illumina infringed on CGI’s US patents 9,222,132 B2, 10,662,473 B2 and that these patents were valid. In the settlement, Illumina inter alia agreed to a one-time payment of USD 325m, largely in line with the jury-awarded damages.

/MW

BIBLIOGRAPHY

Case No. 4A_11/2022 (Supreme Court) | Judgment of 27 June 2022, on appeal against O2019_007 (FPC) | Judgment of 19 November 2021 | ‘Gene sequencing’

Latvia MGI Tech SIA
(Appellant / Defendant)
./.
Illumina Cambridge Limited
(Respondent / Plaintiff)

Panel of Judges:

    • Dr. Christina KISS
    • Dr. Martha NIQUILLE
    • Dr. Yves RÜEDI

Court Clerk:

    • Dr. Matthias LEEMANN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

SUPREME COURT JUDGMENT

FPC JUDGMENT

PATENTS IN SUIT

EP 1 530 578 B1:

EP 1 828 412 B2:

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Bayer’s compound claim on sorafenib tosylate held presumably valid; PI issued

Reading time: 5 minutes

Case No. S2021_006 | Judgment of 26 April 2022 | ‘Sorafenib tosylate’

Please see the report about the main hearing for some background information about the case.

Zentiva logo

In brief, Bayer HealthCare was seeking preliminary injunctive relief against Sorafenib Zentiva of Helvepharm, the Swiss branch of Zentiva.

sorafenib (free base)
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The present litigation is about alleged infringement (and validity) of claim 12 of EP 2 305 255 B1 (see EPO Register), specifically claiming the tosylate salt of sorafenib as such; i.e. a classic compound claim.

Lately, EP 255 was held to be invalid both in Germany (Federal Patent Court, judgment of 29 September 2021 in cases 3 Ni 12/20 and 3 Ni 13/21) and the U.K. (judgment of 8 October 2021 in case [2021] EWHC 2690 (Pat); the Court of Appeal decided on 1 April 2022 to hear the appeal). Further (negative) judgments that I could get hold of have been issued in The Netherlands (ECLI:NL:RBDHA:2021:13616), and Spain (ECLI:ES:JMB:2021:2692A). A full summary of corresponding decisions is given in the judgment:

The judge-rapporteur’s expert opinion in the present case had provisionally held that the patent was invalid, similar as the outcome e.g. in UK and Germany. However, the final judgment is the exact opposit: It holds that claim 12 is likely valid, and a PI was issued accordingly.

The whole case hinges on the assessment of obviousness. The judgment discusses both WO 00/42012 A1 and Lyons et al. as potentially closest prior art. In both cases, the judgment holds that the skilled person would well have include the tosylate salt into a salt screening:

Further, the judgment holds that the skilled person would not have given up in view of the low solubility of the tosylate, but would rather also have aimed to test the dissolution rate:

However, the FPC was not convinced that the skilled person could have tested the dissolution rate of sorafenib tosylate with standard methods available at the priority date:

Accorginly, the skilled person would not have realized that sorafenib tosylate had a surprisingly high dissolution rate, despite its low solubility (about as bad as the free base):

Dissolution rates of sorafenib salts and free base

Interestingly, EP 255 itself is totally silent about the advantages of the tosylate salt over other pharaceutical forms of sorafenib. However, EP 255 does disclose animal experiment that indicate an anti-cancer effect — which implies sufficient biovailablity.  Accordingly, the judgment holds that experimental data that have only been generated after the filing date in support of the bioavalability are admissible.

Note that the judgment does not discuss ‘plausiblity’ here. Great!

The FPC acknowledges that its finding of presumable validity of claim 12 of EP 255 differs from the decisions in DE, GR, UK, NL and Spain. Briefly investigation the reasons, the judgment holds that it does not appear to have been disputed elsewhere whether the dissolution rate could have been measured with routine methods at the priority date. However, there is yet another difference over the judgments in the UK and NL: These two judgments hold that the skilled person would have synthesized sorafenib tosylate without any inventive activity (for it to be included in the salt screening), and that claim 12 was invalid for this reason — irrespective of whether or not the skilled person would have realized that sorafenib tosylate is suitable and efficient for oral administration. The FPC disagrees with this assessment (¶59):

Bei auf eine chemische Verbindung als solche gerichteten Patenten genügt es aber zur Begründung der erfinderischen Tätigkeit, wenn der beanspruchte Stoff eine überraschende Wirkung oder Eigenschaft aufweist.

The judgment refers to some (very) old decisions of the German Federal Supreme Court (X ZB 11/68 – Disiloxan; X ZB 2/71 – Imidazoline) and some decisions of the Boards of Appeal of the EPO in a footnote in support of this view. Sounds familiar, doesn’t it? But the judgment also refers to Ralf Uhrich’s PhD thesis ‘Stoffschutz’ (available in full text here) criticizing it. The latter is a phantastic read, indeed. Now, that could have been a very interesting aspect of the decision; but the discussion stops right there.

/MW

BIBLIOGRAPHY

Case No. S2021_006 | Judgment of 26 April 2022 | ‘Sorafenib tosylate’

Bayer HealthCare LLC
./.
Helvepharm AG

Panel of Judges:

    • Dr. Mark SCHWEIZER
    • Dr. Tobias BREMI
    • Dr. Andreas SCHÖLLHORN

Judge-rapporteur:

    • Dr. Tobias BREMI

Court Clerk:

    • Dr. Lukas ABEGG

Representative(s) of Plaintiff:

    • Dr. Simon HOLZER (MLL)
    • Dr. Ulrike CIESLA (MLL), assisting in patent matters

Representative(s) of Defendant:

JUDGMENT

PATENT IN SUIT

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