Category: Hearing

Posted on

Back to basics: What is an invention, for heaven’s sake?

Reading time: 11 minutes

Case No. B-1711/2023 (FAC) | Hearing of 26 March 2024 | ‘Technicity’

Swiss patent applications are not currently examined on the merits. Thus, appeals against the refusal of a Swiss patent application are rare. And even rarer are appeals of potentially wider interest.

This one is different.

The patent application at stake

The IPI has refused the Swiss patent application no. CH 070623/2021.

Don’t search for it. As a national phase application of WO 2021/185442 A1 (see WIPO’s PatentScope), the Swiss patent application has not been separately published; Art. 60c let. c PatO. The mentioning of 1 January 2022 as the publication date of CH 717 707 in Swissreg is a bug; there is no such publication.

The announcement of the hearing holds that the patent application has been refused because the invention described therein and defined in the patent claims did not constitute an invention within the meaning of the PatA, i.e. it did not have a technical character. It merely defines an insurance calculation and thus a business method.

Please find the IPI file wrapper below.

It does not include the exchange of briefs in appeal proceedings. But that’s a different story. Stay tuned.

The  IPI’s decision to refuse the application begins on p. 315, the (amended) claims that were finally at stake in IPI proceedings begin on p. 210. The various amendments made to the claims are explained in applicant’s response to the first office action (p. 216 et seqq.).

According to the announcement, Swiss Re requests on appeal that the IPI’s decision be set aside and the patent granted, or alternatively that the case be referred back to the lower instance for further prosecution. Swiss Re essentially argues that the IPI went beyond the requirements of the legislator and the case law with its examination of the technical character by covertly examining inventive step.

Le’s put all this into perspective first.

BackgrounD on Technicity: A clash of approaches

The IPI examines the implicitly required ‘technicity’ of an invention by way of a ‘Ganzheitsbetrachtung’, i.e. a holistic approach:

But what does the IPI’s ‘holistic’ approach actually imply? Here is what the IPI Guidelines say:

On the other hand, the EPO only requires at least one technical feature for a claim to pass the technicity hurdle (which is often referred to as the ‘any hardware’ approach); see e.g. T 1173/97 (IBM) and hns 3 and 4 of T 931/95 (‘pension benefits’) of 8 Sept 2000 (emphasis added) :

3.  An apparatus constituting a physical entity or concrete product, suitable for performing or supporting an economic activity, is an invention within the meaning of Article 52(1) EPC.

4.  There is no basis in the EPC for distinguishing between “new features” of an invention and features of that invention which are known from the prior art when examining whether the invention concerned may be considered to be an invention within the meaning of Article 52(1) EPC. Thus there is no basis in the EPC for applying this so-called contribution approach for this purpose.

The IPI’s ‘Ganzheitsbetrachtung’ of a claim in the assessment of technicity strongly reminds me of the ‘contribution approach’ that had been applied at the EPO a looong time ago. Back in the days, at least some prior art had to be taken into account when determining whether a certain subject-matter was excluded for lack of technicity. But this is a thing of the past. The current EPO Guidelines hold:

The question of whether there is an invention within the meaning of Art. 52(1) is separate and distinct from the questions of whether it is susceptible of industrial application, is new and involves an inventive step.

This is why the ‘contribution approach’ always felt strange (to me, at least): It confused technicity with questions of novelty and inventive step when looking for the actual (technical) contribution to the art. This has been overcome at the EPO decades ago. The Enlarged Board of Appeal of the EPO could not be any clearer in their summary of case-law; see e.g. G 1/19:

Accordingly, the mere fact that a claim recites a computer makes the claimed subject-matter as a whole technical. Simply because a computer, undoubtedly, is a technical thing:

And the FPC?

The FPC is committed to apply the EPO’s COMVIK approach, and the Supreme Court endorsed it, too. (COMVIK goes hand in hand with the ‘any hardware’ approach. I cannot readily see how one could have the latter without the other.) The FPC had held that COMVIK is appropriate (‘angezeigt’) since the FPC may also examine obviousness and because it helps to avoid an undesirable split of the legal situation. Notably, the FPC decided to do so for Swiss patents, too:

In my view, however, this is not (only) appropriate because the FPC may also examine obviousness. Where would we be without harmonization on the very basic question of ‘what is an invention?’ — i.e., the metes and bounds of the implicit requirement of technicity? It may easily get messy if different approaches were used for assessment of patent applications in/for one and the same country on such a very basic issue. See e.g. the EWHC judgment ‘CFHP’ ([2005] EWHC 1589 (Pat)), neatly summarizing the differences between the approaches of the UK IPO and the EPO (¶¶43-53):

In short, the difference between the two approaches is that the EPO filters out excluded subject-matter at the stage of considering obviousness – at the last stage – while the UK Patent Office does so at the first stage (when considering excluded subject-matter). Or to put it a little more precisely, what the UK Patent Office does is to consider the exclusion under the description ‘novelty’, but the EPO does so under the description ‘inventive step’.

Note that both the EPO and the UKIPO do examination on the merits (unlike the IPI). Even in such cases, one has to be wary of the fact that different approaches may result in different outcomes (¶48 et seqq.):

So why is it that the difference may matter all the same? It is because, as Renan and Lord Hoffmann said in other contexts, la verité est dans une nuance. Even if the two approaches are the same functionally they may, conceivably, produce different results when it comes to matters of evaluation. That is because cases have to be decided by human beings; but the human mind is affected by the context in which a question is posed. And technological invention cannot reliably be divorced from business context.

As an example, the EWHC referred to the pretty famous invention of the Thermos® flask — which was essentially a prior art Dewar vessel that had been mechanically stabilized — and held (¶52):

It is true that the Thermos flask was not a new business method: it was a new artefact. But, formally speaking, so is a computer when programmed to carry out a new business method.

Interesting, isn‘t it? I will come back to this.

Now, how did the hearing go?

It was an interesting hearing. From the various EPO decisions that have been cited, I find T 154/04 particularly interesting:

Putting it differently: Rejecting a patent application for lack of technicity even though a computer is featured in the claim (e.g. because it is deemed straight-forward to implement a business method on a standard computer) is a no-go. At the EPO, at least. Without reference to the prior art, one just cannot know that a computer is a standard thing. One can only know that when assessing novelty.

At one point, Swiss Re’s representative held with a smirk:

Der Name der Anmelderin ist ja ‘Versicherung’. Das ist schon falsch!

That was countered by the IPI with reference to two other Swiss patent applications of Swiss Re that were granted, i.e. CH 712 882 B1 and CH 714 036 B1. The presiding jugde spontaneously inquired what the difference between e.g. CH 882 and the refused patent application was. The IPI representative answered that there were indeed certain specific measurements featured in the claims; not so in the refused application.

The IPI referred to G 3/08 in support of their hesitiation to adopt the ‘any hardware’ approach:

In the IPI’s view, the EPO is in a position to follow this ‘distasteful’ approach merely because they can sort out the bad stuff later, in the assessment of inventive step. Which is what the IPI can’t do.

My two cents

I do see the IPI’s point. I understand that they are hesitant to allow claims that are, at the face of it, directed to a business method merely because a standard computer is featured in the claim.

But from a practitioner’s point of view, it feels wrong to have different standards in/for patents in Switzerland on the very basic question of what is an invention (i.e., what does it take for a claimed subject-matter to be considered technical?). I feel that the answer to this question must not depend on whether or not one  undertakes examination on the merits (like the EPO) or not (like the IPI).

By the way, I strongly disagree with the IPI‘s first and foremost definition of an invention in the decision to refuse the application:

The IPI held (in bold):

[Eine Erfindung ist] eine neue, nicht naheliegende Lehre zum technischen Handeln.

This definition is frequently seen (even in the latest dispatch of the Federal Council in the current revision cycle of the PatA; see here). It goes back to Peter HEINRICH†; he was a brilliant scholar whom I admire. Still, I believe he got this wrong. This definition confuses novelty and non-obviousness with technicity. Notably, the Supreme Court judgment cited by the IPI does not put it this way; see 4A_609/2019, r. 8.2. The Supreme Court merely held:

Eine Erfindung ist eine Lehre zum planmässigen Handeln unter Einsatz beherrschbarer Naturkräfte zur unmittelbaren Erreichung eines kausal übersehbaren Erfolgs.

Too busy
Too busy

I agree! Putting it simple, making an invention is nothing more than coming up with something that reproducibly works. Period. It is widely agreed that a certain technicity is implied. But that’s it. An engineer who nowadays comes up with a wheel has made an invention. Her invention is not new. So be it. But it is an invention that she made. Late, maybe. But she did it. In my reading, Art. 1 paras. 1 and 2 PatA leave no doubt about this concept. Inventions that are not new or that are obvious are still inventions. Undoubtedly, the IPI would grant a patent for a wheel that is known since the 4th millenium BC. It has to.

Now, what about someone who comes up with a hugely complex (business) method of supply chain management which, in passing, features that (unspecified) goods are finally transported on (unspecified) wheels. Swiping aside the wheel (trivial!) and the goods (arbitrary!) and holding that the whole rest of the claim is just a business method: Can that be right? Not with the ‘any hardware’ approach. But, quite likely, with the ‘Ganzheitsbetrachtung’:

Implementing a business method with a wheel or on a computer does not make any difference to me in terms of ‘interaction with forces of nature’. See the Thermos example above.

I am eagerly awaiting the judgment!

✍ MW

—

BIBLIOGRAPHY

Case No. B-1711/2023 (FAC) | Hearing of 26 March 2024 | ‘Technicity’

Swiss Reinsurance Company Ltd.
./.
Eidg. Institut für Geistiges Eigentum

Panel of Judges:

    • Dr. David ASCHMANN
    • Dr. Vera Maria MARANTELLI-SONANINI
    • Daniel WILLISEGGER
  • Court Clerk:
    • Gizem YILDIZ

Representative(s) of Swiss Re:

    • Dr. Fabian LEIMGRUBER (Thomann Fischer)
    • Claudia ERBSMEHL (Thomann Fischer)

Representative(s) of IPI:

    • Peter BIGLER (in-house)
    • Dr. Pascal WEIBEL (in-house)
    • Linda HOFER (in-house)

—

ANNOUNCEMENT

—

BASIC PCT APPLICATION

WO 2021/185442 A1:

—

IPI FILE WRAPPER

—

BE ON THE KNOW

Enter your name and email address below to get notified of new posts by email.

Posted on

Novartis’ pre-filled syringe patents for Lucentis™ under attack 💉

Reading time: 4 minutes
DISCLOSURE NOTICE: Hepp Wenger Ryffel is involved in this matter on behalf of Bioeq.

Case No. O2022_004 | Hearing of 21 November 2023 | ‘Ranibizumab PFS’

Bioeq logo

This is litigation between Bioeq and Novartis about (in)validity of five patents relating to Novartis’ Lucentis® (ranibizumab) in a pre-filled syringe (PFS; see Compendium), for direct application into the eye of a patient. Ranibizumab is designed to block the vascular endothelial growth factor (VEGF) that can build up in the eye. This may help reduce unhealthy swelling, leaking, and growth of blood vessels.

Lucentis PFS

Bioeq seeks invalidation of CH 706 741 B1, EP(CH) 2 869 813 B1, EP(CH) 3 381 444 B1, EP(CH) 3 685 826 B1 and EP(CH) 3 656 373 B1 for insufficiency of disclosure, unallowable amendments and obviousness in view of, inter alia, the EYLEA briefing package for the Division of Transplant an Ophtalmology Products Advisory Committee Meeting (DTOP), WO 2007/035621 A1, the MACUGEN® – Full Prescribing Information, Reuter et al., Lankers and Fries.

Novartis logo

Novartis seeks maintenance of the patents in limited form. In its reply, Novartis requested that the proceedings in relation to EP(CH) 2 869 813 B1 be dismissed as moot due to revocation at the EPO. Further, Novartis had submitted new auxiliary claim sets with the rejoinder.

The pleadings were lengthy. My favourite terms from the pleadings are ‘Sammelsurium’ (mingle-mangle) of features, and ‘Taschenspielertrick’ (parlor trick). Let’s see whether they will make it into judgment. I had to leave at 2:00 pm when both sides had only finished their first pleadings.

Over the years, I have witnessed many a haggle over the duration of breaks. This hearing was no exception. Novartis asked for 30 minutes, but was given only 20 minutes after Bioeq’s first pleadings. I was all the more surprised that the President imposed a break of 30 minutes, even though Bioeq had requested only 10 minutes after the 2.5 h pleadings of Novartis. Someone needed a break, I guess … 😉

The oral proceedings were closed at about 4:00 pm. The President informed the parties that the judgment cannot be expected until next year.

✍ MW

—

BIBLIOGRAPHY

Case No. O2022_004 | Hearing of 21 November 2023 | ‘Ranibizumab PFS’

Bioeq AG
./.
Novartis AG

Panel of Judges:

    • Dr. Mark SCHWEIZER
    • Dr. Tobias BREMI
    • Diego VERGANI

Judge-rapporteur:

    • Dr. Tobias BREMI

Court Clerk:

    • Sven BUCHER

Representative(s) of Bioeq:

Representative(s) of Novartis:

    • Dr. Andri HESS (Homburger)
    • Julian SCHWALLER (Homburger)
    • Dr. Kurt SUTTER (Blum), assisting in patent matters
    • Dr. Zacharias STELZER (Blum), assisting in patent matters

—

PUBLICATION ON

—

ANNOUNCEMENT

—

PATENTS IN SUIT

CH 706 741 B1:

🔗 Swissreg

–

EP 2 869 813 B1:

🔗 EPO Register | Swissreg

–

EP 3 381 444 B1:

🔗 EPO Register | Swissreg

–

EP 3 685 826 B1:

🔗 EPO Register | Swissreg

–

EP 3 656 373 B1:

🔗 EPO Register | Swissreg

—

BE ON THE KNOW

Enter your name and email address below to get notified of new posts by email.

Posted on

Nespresso’s Vertuo pods: Barcodes that aren’t barcodes?

Reading time: 6 minutes

Case Nos. O2021_006 and O2021_015 | Hearing of 22 March 2023 | ‘Vertuo’

Coffee pods are being litigated again! K-fee System GmbH has sued Nestlé Nespresso SA for infringement of three European patents, i.e.

K-fee logo

K-Fee belongs to the Krüger group of companies. Krüger recently partnered with Coca-Cola in the coffee pod business, i.e. with the production of pods that are compatible with the (classic) Nespresso® system.

Vertuo pod

All patents at stake in the present litigation feature a barcode on the pods, according to the independent claims.

The allegedly infringing pods are Nespresso® Vertuo® pods. And, indeed, there is a strange pattern on the rim of the Vertuo® pods. But … is it a barcode? With respect to infringement, that seems to be what the whole argument boils down to.

The Duck Test is positive, I’d say. And even Nespresso’s website says it’s a barcode:

Vertuo uses each capsule’s barcode to work out what temperature, quantity of water and number of revolutions are required to extract the perfect cup of coffee.

Nespresso Vertuo website

But things are more complicated than it seems, sometimes. If it looks like a duck and quacks like a duck but it needs batteries, you probably have the wrong abstraction. The Canard de Vaucanson wasn’t actually a duck.

Nespresso logo

The parties are also litigating in the U.S. The California Central District Court has already issued a Final (Summary) Judgment of Non-Infringement of the corresponding U.S. patents 10,858,176, 10,858,177, and 10,870,531 on 28 June 2022 (case no. CV 21-3402-GW-AGRx). K-Fee appealed to the CAFC (case no. 2022-2042). The proceedings are still pending. Meanwhile, the Joint Appendix (partly redacted; part I and part II) that has been filed with the CAFC is a wealth of information. Apparently, the California Central District Court applied a claim construction that differentiates between a ‘bit-code’ and a barcode:

It was critically important what K-Fee had submitted elsewhere as the interpretation of the Jarisch reference , i.e. what K-Fee had submitted in EPO opposition/appeal proceedings. Note that the Jarisch reference is a Nestec patent application, WO 2011/141532 A1. Here is how the EPO Opposition Division summarized K-Fee’s pleadings re D1, i.e. Jarisch (WO 532):

My best guess is that the Vertuo® pods make use of the Jarisch (WO 532) principle: The Vertuo system was developed in co-operation with Helbling, apparently making use of a lot of 0s and 1s. Further, there is an interesting thread on Reddit about the Vertuo® barcode, i.e. ‘Breaking the Nespresso Vertuo Barcodes’ (part I, II and III). There’s even a Vertuo barcode generator available for download on Github.

But will the FPC construe the claimed feature of a barcode to not cover a ‘bit-code’, as the EPO and the U.S. court did? That’s not a given. We shall see.  If it did, that would be a home-run for Nespresso. But things might get (much) more complicated when the FPC construes barcode in a way that also covers ‘bit-codes’. 

Accordingly, as a matter of precaution, Nespresso also asserts that the patents in suit are invalid for lack of novelty over WO 02/28241 A1 and EP 1 974 638 A1; and obviousness in view of WO 2007/122208 A1,  WO 2010/026053 A1 and  US 2010/0078480 A1.

As a last resort, should the FPC issue an injunction, Nespresso countersued K-Fee for a compulsory license under Art. 37 PatA (lack of patentee’s own use in Switzerland) and Art. 40 PatA (public interest).

EF logo

Interestingly, the EPO dockets reveal that Nestlé has sued K-Fee for assignment of the patents at stake before the Regional Court Düsseldorf; case no. 4b O 1/22. The Statement of Claim is heavily truncated and redacted. However, from K-Fee’s statement filed with the EPO I understand that Nestlé / Nespresso and K-Fee have no contacts in the coffee pod business. However, Nestlé apparently argues that K-Fee got hold of Nestlé’s prior knowledge of the claimed invention via Eugster Frismag. EPO proceedings are currently stayed.

The hearing at the FPC is scheduled for 22 March 2023. It will be interesting to hear how the judge-rapporteur assessed the facts at hand.

✍ MW

—

BIBLIOGRAPHY

Case Nos. O2021_006 and O2021_015 | Hearing of 22 March 2023 | ‘Vertuo’

K-fee System GmbH
./.
Nestlé Nespresso SA

—

—

ANNOUNCEMENT

—

PATENTS IN SUIT

EP 3 023 362 B1:

–

EP 3 521 207 B1:

–

EP 3 521 209 B1:

—

BE ON THE KNOW

Enter your name and email address below to get notified of new posts by email.

Posted on

Schöck and Basys twisting things

Reading time: 5 minutes

Case No. O2020_017 | Hearing of 11 May 2022

DISCLOSURE NOTICE: Hepp Wenger Ryffel is involved in this matter on behalf of the Plaintiff.
Schöck’s logo

Schöck asserts infringement of EP 2 455 556 B1 (cf. EPO Register and Swissreg) and EP 2 455 557 B1 (cf. EPO Register and Swissreg). The attacked embodiments of Basys are the so-called ‘Normalkraftanschlüsse’ of types Basycon N, UZ and Seismolock.

Basycon ‘Normalkraftanschluss’ of type N (illustration taken from the FPC‘s tweet)

According to the announcement of the hearing, Basys argues that the patents were insufficiently disclosed and not novel or obvious in view of no less than 14 documents in total (of which the following are mentioned in the announcement: EP 1 072 729 A1, EP 1 881 119 A2, DE 87 00 301 U1, DE 197 05 698 A1, CH 678 076 A5, DE 200 08 570 U1, CH 690 966 A5, DE 30 05 571 C2, a Basycon Flyer of Jan 2005 and a Basycon catalogue of 2008). Further, the patents were not infringed when construed correctly.

At the beginning of the hearing, Basys presented a sample of an attacked embodiment; Art. 168 para. 1 lit. c CPC. The various features of the sample were briefly discussed, and even some manual tests were made on the sample, by both parties. The President closed this part of the hearing with a smirk:

Oder möchten Sie sonst noch etwas verbiegen?

In the first round of pleadings, Schöck asserted various violations of the principle of party disposition in the judge-rapporteur‘s expert opinion. Further, Basys’ comments on the expert opinion contained inadmissible novae that must not be relied on. On the merits, Schöck focused on admissibility of amendments in general, and intermediate generalisations in particular. The judge-rapporteur had apparently held that the omission of the rectangular shape of a plate in an auxiliary request amounts to an intermediate generalisation. But what does «rechteckig hochkant orientiert» in [0045] and [0047] of EP 556 actually mean: a rectangular shape or a rectangular orientation of the plate? With reference to T 1471/10 (r. 3.3.2 et seq.), Schöck held that the feature could well be omitted because there was no indication whatsoever in EP 556 of the relevance of the form of the plate; and the orientation of the plate is already contained in the claim language to the extent necessary.

With respect to novelty and non-obviousness, Schöck addressed a photography on page 1 (similar to this one) and a schematic illustration on page 3 of the Basycon Flyer 2005; and EP 792 (not mentioned in the announcement).

Basys‘ logo

After a 15 min break, Basys’ pleadings began at 11:20 hrs. Basys rebutted selected arguments of Schöck’s latest submissions. Some arguments referred to the skilled person; on the funny side, Basys held that the skilled person cannot be willing and able to understand unclear features of EP 556 on the one hand, and be dull-witted in the assessment of the prior art on the other hand.

An interesting discussion circled around whether (or not) a specific attack (with a certain combination of prior art) of a sub-eventualiter inter partes limitation of a patent can be considered by the court ex officio for higher-ranking requests.

After a lunch break from 12:30 hrs to 13:30 hrs, Schöck and Basys made their respective second submissions, until 14:20 hrs. It appears that the actual expenses for patent attorneys were almost identical on both sides; but the parties disagreed on the responsibility for the costs.

No settlement discussions took place.

Reported by Martin WILMING

—

BIBLIOGRAPHY

Case No. O2020_017 | Hearing of 11 May 2022

Schöck Bauteile GmbH
./.
Basys AG

Panel of Judges:

    • Dr. Mark SCHWEIZER
    • Dr. Tobias BREMI
    • Dr. Markus MÜLLER

Judge-rapporteur:

    • Dr. Tobias BREMI

Court Clerk:

    • Sven BUCHER

Representative(s) of Plaintiff:

Representative(s) of Defendant:

—

—

ANNOUNCEMENT

https://www.documentcloud.org/documents/21582344-o2020_017-informationhauptverhandlung_2022-05-11?responsive=1&title=1

—

PATENTS IN SUIT

EP 2 455 556 B1:

https://www.documentcloud.org/documents/21876401-ep2455556b1?responsive=1&title=1

–

EP 2 455 557 B1:

https://www.documentcloud.org/documents/21876402-ep2455557b1?responsive=1&title=1

—

BE ON THE KNOW

Enter your name and email address below to get notified of new posts by email.

Posted on

Bayer’s uphill fight re sorafenib tosylate

Reading time: 6 minutes

Case No. S2021_006 | Hearing of 4 April 2022

Zentiva logo

Bayer HealthCare is seeking preliminary injunctive relief against Sorafenib Zentiva of Helvepharm, the Swiss branch of Zentiva. Bayer’s product is Nexavar® (see Compendium and Bayer’s Nexavar website for more information); the active ingredient (AI) is sorafenib, a kinase inhibitor inter alia for the treatment of primary kidney and liver cancer.

Sorafenib
Bayer logo

The basic patent on sorafenib is EP 1 140 840 B1 which lapsed on 11 January 2020. An SPC had been in force until 28 March 2021; C01140840/01. The present litigation is about alleged infringement (and validity) of EP 2 305 255 B1 (see EPO Register), specifically claiming the tosylate salt of sorafenib. EP 255 will only lapse on 3 December 2022.

As patent protection is fading out, Bayer’s turnover generated with Nexavar® fell sharply in 2021:

Nexavar® package

Patent practitioners might recall Nexavar® and/or sorafenib tosylate for the first compulsory license that had been issued in India already back in 2012, which has been confirmed through all instances.

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).

Helvepharm logo

From the announcement of the hearing, it had been known that Helvepharm asserts invalidity of EP 255 in view of unallowable amendments, lack of novelty over WO 00/42012 A1 and obviousness in view of Lyons et al. (the acronym BAY 43-9006 refers to sorafenib as such, i.e. the free base; not sorafenib tosylate).

In the hearing, it became clear that the judge-rapporteur‘s expert opinion held that the claimed subject-matter was obvious, in line with the judgments in Germany and the U.K.

Plaintiff urged the court to independently assess the matter, in particular in view of the many expert declarations on file in the present proceedings which the foreign courts had not at hand. Plaintiff emphasized that the skilled person had not been in a position at the priority date to reliably determine the dissolution rate of sorafenib tosylate; the experimental setup previously known in the art had not been suitable. Further, a tosylate had not been a promising candidate for a weak base such sorafenib in any event.

However, the inventors had a moment of genius:

Die Erfinder hatten einen genialen Moment.

With its concluding remarks of the first pleadings, Bayer essentially held that if ever a salt form of a pharmaceutical compound was patentable, then sorafenib tosylate is it.

Expenses for the assistance of a patent attorney were orally indicated (and detailled to some extent) as kCHF 52, but no evidence was handed over.

After a break, the President gave the floor to Zentiva‘s counsel, indicating that the judges had a lively discussion during the break, and that they are now eagerly awaiting Zentiva‘s pleadings:

Die Diskussionen im Spruchkörper in der Pause waren heftig! Wir sind gespannt auf Ihre Ausführungen.

Defendant focused its pleadings on non-obviousness only.

In defendant‘s view, Lyons does not teach that the free base has been used in the clinical trials. Lyons is just silent about this (in my understanding, contrary to what had been held in the judge-rapporteur‘s expert opinion). In any event, the first step would be a salt screening in order to assess the bioavailability of sorafenib — and tosylate would have been included in such a salt screening, essentially as outlined in Bastin. A salt screening involves not only the assessment of solubility, but also the dissolution rate. The skilled person would not have disregarded the tosylate in view of its low solubility. Further, defendant argued that it had well been possible for the skilled person to determine the dissolution rate, actually with reference to an experimental setup that had been known in the art and which is similar to the one used by plaintiff.

Defendant handed over a cost note for assistance of the patent attorney. Further, defendant objected to plaintiff‘s asserted costs of kCHF 52 as somewhat high for summary proceedings („etwas hoch“), and not evidenced anyway.

An entertaining aspect of the second round of pleadings circled around the (lack of) plaintiff‘s cost note for patent attorney expenses. Plaintiff was seemingly taken by surprise that the expenses were not accepted by defendant, and asked for a break to come up with written evidence of the expenses in the amount as indicated earlier. The judges were noticeably perplexed (instructions for the hearing typically remind the parties that cost notes shall be provided in the first round of pleadings). Still, the President interrupted the proceedings for ten minutes, for the plaintiff to gather the written evidence of expenses, and defendant to prepare the rebuttal to plaintiff‘s pleadings. Worse comes to worst: Plaintiff apparently had a letter in its electronic dockets that set forth the costs incurred, but could not provide any printout. Defendant did not consent to an on-the-spot visual inspection of the electronic file.

The parties did not engage in settlement discussions.

/MW

—

BIBLIOGRAPHY

Case No. S2021_006 | Hearing of 4 April 2022

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:

—

ANNOUNCEMENT

—

PATENT IN SUIT

—

BE ON THE KNOW

Enter your name and email address below to get notified of new posts by email.

Posted on

The (serious) soap opera, cont’d

Reading time: 5 minutes

Case No. O2019_001 | Hearing of 24 January 2022

The background of this case has already been extensively discussed on this Blog here and here. The hearing earlier today was a continuation of the main hearing of 16 September 2020, with the parties’ closing submissions according to Art.  232 CPC focussing on the witness testimony of Mr. QUADE that had been obtained via judicial assistance of the local court of Alzey, Germany (worth a visit, apparently).

Werner & Mertz

Mr. QUADE was personally present at the FAC today, but did not attend the first round of pleadings because plaintiff offered that the court might address him directly for follow-up questions or clarifications. The President asked defendant‘s representative whether he would agree — which he did not. The President indicated that a formal comment on this will be given by the court only after deliberation (before the lunch break, the President announced that there is no room for interviewing Mr QUADE anymore).

In a nutshell, plaintiff stressed that Mr QUADE‘s testimony was backed-up by contemporary written documents, and that Ms Regine SCHNEIDER‘s testimony was clearly less credible.

Good Soaps

After a short break of about 20 minutes, defendant reminded that the burden of proof is on the plaintiff to establish that i) the invention had been made by its employee(s), i.e. when, where and how; ii) it had been communicated to the allegedly unlawful applicant; and iii) how that corresponds with the claims of the patent application in suit; see e.g. O2015_009. Defendant highlighted that Dr ENDLEIN of Werner & Mertz only recently received the Meyer-Galow award for the development of cleaning products on the basis of European plant-based surfactants. However, Dr Edgar ENDLEIN only joined the plaintiff in 2010 and the respective R&D project ‘Einsatz europäischer Tenside’ had only been started at Werner & Mertz in 2012, i.e. years too late. No mentioning of Mr QUADE in this project whatsoever.

Next, defendant exemplified how Mr QUADE gave testimony on critical issues only in an evasive manner, apparently in knowledge of the file and likely with the desired result in mind. Further, I understood from the pleadings that Mr QUADE had testified that it had been perhaps a little too early in 2009 for an internal invention disclosure notice («wohl auch noch ein bisschen früh»).

At one point, the President intervened and enquired how defendant would explain the content of a letter of Mr QUADE to Kolb, indicating that he sent an Ecover sample to Kolb. Notably, defendant’s representative hesitently expressed in plain language that defendant has serious doubts as to the authenticity of this letter. Defendant had no positive knowledge of this letter since Ms SCHNEIDER had already left Kolb at that time.

As to the question of whether or not Ms SCHNEIDER had already been aware of rapeseed MEE before the meeting with Mr QUADE, Kolb (as a third party) on defendant’s request provided an internal memorandum that predates the meeting of 27 August 2009, indicating that Ms SCHNEIDER had been well aware of the fact that Ecover contained MEE with a chain length of seven:

Ecover, which is based in Belgium, incorporates rapeseed MEE (7-mole) in its laundry wash.

Had the chain length been a topic at the meeting of 27 August 2009? Parties heavily dissent on this aspect. Defendant notes that it is simply implausible that a chain length of seven had been discussed in that meeting, let alone that such a sample had been requested by Mr QUADE, given that subsequently only a sample with a chain length of ten had been provided by Kolb, without any further ado.

Defendant finally emphasized that it has not even been pleaded that on 27 August 2009 Mr QUADE had already made the invention. I understood from the pleadings that the judge-rapporteur’s expert opinion held that the missing pieces actually did still require a certain creative effort, i.e. the invention had not been made at the time, let alone communicated to the defendant.

Finally, defendant requested that the tariff for legal representation be exceeded by 50%, in view of the additional witness testimony via judicial assistance in Germany that had to be attended (2d), and two main hearings — which is not just a standard case anymore.

The second round of pleadings after the lunch break was pretty uneventful. Plaintiff‘s representative rebutted the request to exceed the tariff. On the contrary, judicial assistance had only been necessary because defendant had initated criminal investigations against Mr QUADE which prevented him from coming to Switzerland. In reply, defendant insisted that at least an initial suspicion was well founded.

The President indicated that a judgment can be expected within the next 6-8 weeks (more than three years after the complaint has been filed).

Reported by Martin WILMING

—

BIBLIOGRAPHY

Case No. O2019_001 | Hearing of 24 January 2022

Werner & Mertz
./.
Compad Consulting GmbH

Panel of Judges:

    • Dr. Mark SCHWEIZER
    • Dr. Tobias BREMI
    • Dr. Frank SCHAGER

Judge-rapporteur:

    • Dr. Tobias BREMI

Court Clerk:

    • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

—

ANNOUNCEMENT

—

PATENT APPLICATION IN SUIT

Clean version of the DREX, i.e. the version for which the EPO indicated its intention to grant a patent:

 

Application as filed, published as EP 2 592 134 A2:


—

BE ON THE KNOW

Enter your name and email address below to get notified of new posts by email.

Posted on

Hearing in G1/19 re computer-implemented simulation

The hearing in case G1/19 took place today.

The decision of the EPO’s Enlarged Board of Appeal will undoubtedly be of outstanding relevance for a whole (service) industry with respect to access to adequate patent protection at the EPO.

Here are my notes from the hearing (please be patient, it may take a few seconds to load):

Posted on

Anything but a quick fix: Coram beavering away at knocking out a patent

Reading time: 7 minutes

Case No. S2018_007 | Hearing of 15 April 2019

C&E Fein’s logo

The patent at stake is EP 3 027 362 B1 which is jointly owned by C&E Fein GmbH and Robert Bosch GmbH; see the EPO Register and Swissreg for further information. The invention is about a tool which is intended to be used with a machine tool, in particular a hand guided machine tool. The machine tool has a rotational drive, e.g. an oscillating drive. Examples include a drill, a grinding disc, a cutting disc or a circular saw. If you are interested in such detailed information, you will easily get the gist of the invention from e.g. Fig. 11 of EP’362 (see header picture) when reading the main claim of the patent.


Claim 1 of EP'362

A tool device (1, 1b) which is suitable for use with a machine tool (22), and in particular suitable for use with a hand guided machine tool, which has a driving device moving around a driving axis, and in particular oscillating around the driving axis,

and which has an attachment device (12) by means of which it can be fastened to a machine tool (22) in such a manner that the driving axis and a tool axis of rotation (5) are substantially coincident,

wherein, for receiving a driving force, the attachment device (12) comprises at least two driving area regions (2, 2a, 2b) each having a plurality of surface points (3) and which are spaced from this tool axis of rotation (5),

characterized in that tangent planes (4) at these surface points (3) are inclined relative to an axial plane (7), which includes the tool axis of rotation (5),

wherein the tangent planes (4) are inclined relative to a radial plane (6), which extends perpendicular to the tool axis of rotation (5),

wherein the attachment device (12) comprises a side wall,

wherein the side wall extends spaced radially from the tool axis of rotation (5),

wherein the side wall extends between a first, upper boundary plane (8a) and a second, lower boundary plane (8b), and

wherein the side wall comprises the driving area regions (2, 2a, 2b),

wherein a substantially hollow conical section is formed in the region of the attachment device by means of the side wall, which section has a cross section with a variable spacing of the side wall to the tool axis of rotation in a plane orthogonal to the tool axis of rotation.



The invention aims at providing a tool device in such a manner that the torque which is effectuated by the driving device of the machine is reliably transferred to the tool device. This is achieved by an attachment device (12) which comprises side walls that comprise driving area regions (2). Those driving areas (2) are spaced apart from the tool axis and inclined with respect to the axial plane. It is the function of the driving areas to receive a driving force.

Bosch’s logo

The plaintiffs asserted that EP’362 is infringed by defendant’s saw blades ‘B-Cut’ with ‘Quick Fixture’, and requested interim injunctive relief. Indeed, at least at first sight there are quite some similarities between Coram’s saw blades with ‘Quick Fixture’ (header image, right hand side) and the figures of the allegedly infringed patent (header image, left hand side). But the question of whether or not the allegedly infringing devices actually read on the claim was not an issue in the hearing. Likewise, it was only a sideshow in the hearing whether the matter was urgent, and whether the alleged violation threatened to cause not easily reparable harm to the plaintiffs (Art. 261(1) lit. b CPC).

An allegedly infringing saw blade with ‘Quick Fixture’
Coram’s logo

However, the defendant argued for nullity as a plea in defense, i.e. asserted a lack of novelty over EP 0 596 831 A1 and DE 2 120 669. The defendant construed EP’362 broadly and, thus, found the claimed subject-matter more readily anticipated in the prior art than the plaintiffs — and apparently also more readily than the judge-rapporteur. Specifically, the defendant argued that a ‘side-wall’ not necessarily implies a 3D-structure but is anticipated already by a 2D-surface (as disclosed in Fig. 4 of EP'831). With regard to DE'669, the defendant argued that a feature having a certain function (‘driving area […] for receiving a driving force’) is anticipated by a feature which might not exclusively have that function but nevertheless supports it (‘carrier with an projecting attachment’ as shown in Figs. 5 and 6 of DE'669).

In order to support views on correct claims construction from a Swiss perspective, O2013_008 (‘Sprühpistole’) was cited repeatedly by the parties. Unless the case was settled by agreement after the public part of the hearing, we might gain more insight on this issue soon.

The defendant further argued that the request for interim injunctive relief was overly broad and covered embodiments of the prior art.

Both representatives requested reimbursement of the necessary expenses for the assisting patent attorney in the same amount as are costs for legal representation according to the tariff (~kCHF 25 each).

On the procedural side, it was good to see that the projector / screen infrastructure was used again by at least one party and the court (connection of Windows® devices apparently is unproblematic). Further 8562532553 who call , plaintiffs’ counsel inquired whether the court wishes to be provided with pleading notes or not (see this Blog here for my very personal view, and the results of a little survey). Obviously, some judges appreciate written pleading notes; and some judges don’t. From a personal note of the president, however, it could be inferred that he liked pleadings in free speech. So, now we know!

Reported by Jolanda MINDER and Martin WILMING

—

BIBLIOGRAPHY

Case No. S2018_007 | Hearing of 15 April 2019

C&E Fein GmbH
Robert Bosch GmbH
./.
Coram Tools GmbH

Panel of Judges:

  • Dr. Mark SCHWEIZER
  • Dr. Markus MÜLLER-KÄGI
  • Dr. Stefan KOHLER

Judge-rapporteur:

  • Dr. Markus MÜLLER-KÄGI

Court Clerk:

  • Agnieszka TABERSKA

Representative(s) of Plaintiff:

Representative(s) of Defendant:

—

ANNOUNCEMENT

Fullscreen view (new tab)

—

PATENT IN SUIT

Fullscreen view (new tab)

—

BE ON THE KNOW

Enter your name and email address below to get notified of new posts by email.

Posted on

ViiV seeking injunctive relief against Sandoz’s generic Kivexa®

Reading time: 9 minutes

Case No. S2018_004 | Hearing of 10 September 2018

ViiV logo

Infringement of ViiV‘s SPC based on EP 0 817 637 B1 is at stake. See EPO Register and Swissreg for bibliographic details of the patent; and Swissreg for further bibliographic details of the SPC C00817637/01.

Claim 1 of EP’637 is straight forward — at least when the IUPAC names of the compouds are replaced with the respective INNs:

A combination comprising [abacavir; ABC] or a physiologically functional derivative thereof and [lamivudine; 3TC] or a physiologically functional derivative thereof.

For the chemists out there, these are the molecules:

Abacavir; aka ABC
Lamivudine; aka 3TC

Both these compounds are nucleoside reverse-transcriptase inhibitors (NRTIs). Both compounds alone and the fixed-dose combination thereof are included in the WHO Model List of Essential Medicines.

ViiV’s Kivexa®

ViiV‘s own product is Kivexa® (aka Epzicom® in the U.S.); see compendium.ch.

The European public assessment report (EPAR) of the European Medicines Agency (EMA) provides a wealth of further information about this antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection.

Sandoz‘s generic version ‘Abacavir Lamivudine Sandoz®’ had obtained market approval on December 15, 2017, and it has been listed since April 1, 2018; see compendium.ch.

Sandoz logo

Sandoz contests infringement of the SPC solely on the ground that EP’637 and the SPC are null and void. A lack of novelty and inventive step is alleged, and that the priority claim was not valid. Sandoz had refused to undertake not to put the product on the market before the expiry of the SPC (October 30, 2020); Sandoz rather informed ViiV that it would start marketing in calendar week 21 — and has consequently been sued by ViiV.

I have attended the hearing yesterday; see the official announcement and some live notes below.

The following issues have been discussed:

  1. Is EP’637 entitled to the priorities claimed?

The parties dissent about whether or not EP’637 is actually entitled to the priorities claimed; see a compilation of the two priority documents here. Respondent argued that the whole disclosure of the priority documents is about a combination of three active substances, compared to a combination of only ABC and 3TC finally claimed in the patent in suit; plaintiff disagreed.

If priority was not validly claimed, D1 (WO 96/06844) would be pre-published prior art, i.e. relevant for both novelty and inventive step assessment.

  1. Has D1 (WO 96/06844) to be considered in the assessment of novelty?

From the pleadings, I conclude that in the exchange of briefs the plaintiff himself had submitted that D1 (WO 96/06844) forms prior art that is (only) relevant for the assessment of novelty. Respondent had agreed. Only later, in my understanding in the judge-rapporteur’s expert opinion, it has been held that D1 does not form part of the prior art under Art. 54(3) and (4) EPC 1973 or Art. 7(3) lit. a old PatA, respectively. Respondent disagrees on the merits, and further argued that the principle of party disposition was violated.

  1. Is D1 (WO 96/06844) novelty destroying?

From the pleadings it could be concluded that the expert opinion established by the judge-rapporteur was advantageous for the plaintiff, i.e. that novelty of EP’637 over D1 was given. The EPO’s approach of how to deal with selections from two or more lists of a certain length will be decisive.

Respondent argued that the German Federal Patent Court and a Stockholm court had denied novelty. I could not yet spot any such decision; maybe these were only interim assessments of the courts before the respective parties settled(?).

If you know more, I would be grateful if you would let me know.

UPDATE 12 September 2018:

I have meanwhile been informed of the decision issued in Sweden (Case PMÖ 3565-17 of the Svea Hovrätt), briefly reviewed on EPLAW Blog.

  1. An ‘optional’ disclaimer in summary infringement proceedings?

In a secondary line of defense, plaintiff offered to limit the patent with a disclaimer, to exclude the disclosure of D1 and to restore novelty if necessary.

Defendant argued that this was not possible and referred to an order of the Zurich Commercial Court (HE070010 of 22 August 2007, issued by Dieter BRÄNDLE, the later President of the FPC) that was upheld by the Zurich Court of Appeal (AA070145/U/Ia of 25 January 2008). At that time, it had been held (emphasis in original; cf ¶3.2):

Im Massnahmeverfahren [kann] sich der Kläger somit nur auf ein Zertifikat bzw. das diesem zugrundeliegende Patent in der aktuellen (d.h. uneingeschränkten) Fassung berufen.

Loosely translated:

In summary proceedings the plaintiff may thus only rely on the SPC or the basic patent, respectively, in its current (i.e. unamended) version.

  1. Risk of a not easily reparable harm for the plaintiff?

Further, the requirement of a ‘not easily reparable harm’ for interim injunctive relief to be granted has been addressed at length by the parties. Is the plaintiff actually at risk of a ‘not easily reparable harm’ as required by Art. 261(1) lit. b CPC?

ViiV corporate tree (section), as illustrated by respondent

Respondent firmly insisted that this is not the case, with reference to an illustration similar to the one shown on the right. In brief, plaintiff ViiV Healthcare UK Ltd is the holder of the Swiss SPC, and is fully owned by ViiV Healthcare Ltd; cf the right branch of the illustration.

Likewise, ViiV Healthcare GmbH (holder of the Swiss MA for Kivexa® according to the ‘Spezialitätenliste‘) is fully owned by  ViiV Healthcare Overseas Ltd, which in turn is fully owned by ViiV Healthcare Ltd; cf the left branch of the illustration.

Respondent argued that none of the boilerplate arguments like confusion of the market, price erosion, etc can apply here, since this does not affect the plaintiff / SPC holder. Plaintiff inter alia argued in the hearing that the Swiss MA holder has a license under SPC. This was firmly rebutted by the respondent as ‘not true’, or at least not to be a royalty-bearing license — and procedurally belated in any event. In my understanding, it had not been argued in the written exchange of briefs that a license is in place.

Finally, the parties were asked whether they were interested in settlement discussions. I would have loved to hear the answer, but the public has been excluded on request of the plaintiff even before the general (un)willingness to talk settlement has been indicated.

Reported by Martin WILMING

P.S.: After plaintiff’s initial pleadings, the presiding judge asked whether the pleading notes that had obviously at least partially been read out would be handed over to the court (“not necessarily to the other party”), to ease compilation of the minutes. The parties agreed. A pragmatic approach. Still, I strongly feel that whenever pleading notes are handed over to the court, the other party should get a copy, too. Frankly, I would not feel comfortable when the counter-party submits something in writing that I haven’t seen. How would I know that there was no change or omission in the speech vis-à-vis the pleading notes, and how easily might a different message silently sneak into the minds of the judges …

—

BIBLIOGRAPHY

Case No. S2018_004 | Hearing of 10 September 2018

ViiV Healthcare UK Ltd.
./.
Sandoz Pharmaceuticals AG

Panel of Judges:

  • Dr. Christoph GASSER
  • Dr. Tobias BREMI
  • Marco ZARDI

Judge-rapporteur:

  • Dr. Tobias BREMI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

  • Dr. Simon HOLZER (MLL)
  • Benjamin THOMAS (Simmons), assisting in patent matters

Representative(s) of Defendant:

—

PATENT IN SUIT

Fullscreen view (new tab)

—

ANNOUNCEMENT

Fullscreen view (new tab)

—

LIVE NOTES


—

BE ON THE KNOW

Enter your name and email address below to get notified of new posts by email.

Posted on

Does the wording of an SPC matter?

Case No. S2107_006 ¦ Hearing of 9 October 2017

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

The supplementary protection certificate C00915894 is at stake; see the official court information about the hearing. The basic patent is EP 0 915 894 B1; see EPO Register and Swissreg.

It’s not the first time that the parties litigate about this SPC. Nullity proceedings are co-pending; see this Blog here and here. A major issue at stake now is the alleged infringement of the SPC. The FPC had granted ex parte interim injunctive relief; see this Blog here. Note, however, that the SPC concerns (emphasis added):

tenofovir disoproxilfumarat + emtricitabin

Defendant’s attacked embodiment instead comprises tenofovir disoproxil phosphate.

Tenofovir disoproxil fumarate
CAS no. 202138-50-9
Tenofovir disoproxil phosphate
CAS no. 1453166-76-1

Now, is that still ‘the product’ in the sense of Art. 140d PatA?

Plaintiff essentially argues that an SPC would always extend to all salts of (a component of) a product, irrespective of its wording. On the contrary, defendant argues that this is a misunderstanding of the ‘Farmitalia’ decision of the ECJ (C-392/97): In that case, the market authorisation related to a specific salt, but the ECJ had allowed the registration of an SPC also for salts and esters. It had been held in ¶27 that

[…] where an active ingredient in the form of a salt is referred to in the marketing authorisation concerned and is protected by a basic patent in force, the certificate is capable of covering the active ingredient as such and also its various derived forms such as salts and esters, as medicinal products, in so far as they are covered by the protection of the basic patent.

The ECJ’s judgment only concerned the requirements for grant of an SPC, but not the scope of protection. The FPC will now have to decide on the scope of an SPC directed to a combination product wherein a first component is identified as a specifically named salt (fumarate) which is not used in the attacked product (using a phosphate instead); and wherein the second component (emtricitabin) is not mentioned at all in the basic patent.

The President noted that no expert opinion of the judge-rapporteur will be established. The parties did not enter into settlement discussions.

Reported by Martin WILMING

Header image reproduced with kind permission and copyright of the Swiss Federal Administrative Court (St. Gallen) where the hearings of the FPC take place.

—

BIBLIOGRAPHY

Case No. O2107_001 ¦ Hearing of 9 October 2017

Gilead Sciences Inc. ./. Mepha Pharma AG

Panel of Judges:

  • Dr. Dieter BRÄNDLE
  • Dr. Tobias BREMI
  • Marco ZARDI

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

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

Representative(s) of Defendant:

—

THE BASIC PATENT

Download (PDF, 1.75MB)

—

COURT INFORMATION ABOUT THE HEARING

Download (PDF, 20KB)

—

BE ON THE KNOW

Enter your name and email address below to get notified of new posts by email.

Posted on

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

—

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

—

THE BASIC PATENT

Download (PDF, 1.75MB)

—

COURT INFORMATION ABOUT THE HEARING

Download (PDF, 48KB)

—

NOTES BEFORE AND FROM THE HEARING

BE ON THE KNOW

You liked this? And you would like to be notified of new posts? Here you go.

Posted on

Applied Nanostructures, Inc. ./. Nanoworld AG

Case No. O2013_013 ¦ Main hearing of 23 June 2016

This case is a nullity suit of Applied NanoStructures against the Swiss part of Nanoworld‘s European patent EP 1 860 424 B1, pertaining to self-aligning scanning probes for scanning probe microscopes; see Swissreg for further bibliographic details. More precisely, EP’424 pertains to scanning probes for alternative use, claimed as follows:

1.   Scanning probes (1) for alternative use in a scanning probe microscope where the scanning probes (1) have a micro cantilever beam (4) whose one end (5) has a scanning tip (6) for scanning a sample and whose other end (13) has a holding element (2) for the non-permanent attachment of the scanning probe (1) a probe holder, and where the scanning probes (1) have a support element (3) secured in position on the probe holder for coupling and aligning the scanning probe (1), wherein corresponding alignment elements (8, 8′, 8″), (16, 16′, 16″) are incorporated in the holding element (2) and in the support element (3) that align the holding element (2) in automatically reproducible fashion relative to the probe holder when coupled with the support element (3) and wherein the micro cantilever beams (4) of the scanning probes (1) have different lengths (14) and in each case the distance (12) between the scanning tip (6) and a defined reference point (9) of the holding element (2) is constant, characterized by the feature that the reference point (9) is arranged in all cases of the scanning probe (1) at he same distance and in the same position to the alignment elements (8, 8′, 8″) of the holding element (2).

2.   Scanning probes according to claim 1, characterized by the feature(s) that with the scanning probe (1), the distance (24) in each case between the defined reference point (9) of the holding element (2) and a front edge of the holding element (2) that is associated with the micro cantilever beam (4) is variable, depending on the length (14) of the micro cantilever beam (4).

This can be best understood with Figure 3 of EP’424 at hand:

EP 1 860 424 B1, Fig. 3
EP 1 860 424 B1, Fig. 3

A first court order in this matter has already been published more than two years ago, in April 2014; see this Blog here. The suit had already been filed in September 2013. Nothing has surfaced since then. But the parties have been quite busy in the meantime, with 26(!) submissions in total.

The plaintiff apparently argued in the writ that the subject matter of independent claim 1 is not novel over EP 0 444 697 A2 (referred to as D1), or — relatively global — at least not inventive. With the rejoinder, the defendant/patentee had submitted various auxilliary requests to maintain the patent at least in more limited form. I understood from what has been discussed in the hearing that the plaintiff did not expand on the lack of novelty and/or inventive step of these requests in his comment on the rejoinder. Rather, elaborated arguments with respect the alleged lack of an inventive step were only submitted later, i.e. with the comment on the interim assessment of the reporting judge. Apparently, these belated arguments had been held inadmissible by the court and were not considered any further. The plaintiff requested reconsideration in the hearing, though without success.

Apparently, the reporting judge had concluded that claim 1 as granted was not novel over EP’697 (D1), but that the combination of claims 1 and 2 was valid (see quotation above for the wording of claim 2). While the defendant/patentee did not agree with the novelty assessement of the reporting judge, it was pretty clear in my perception that maintenance of the patent in amended form (combination of claims 1 and 2) was kind of acceptable.

It has been noted in the hearing that co-pending proceedings at the Federal Patent Court in Germany (5Ni12/14(EP)) have also moved forward. In an interim assessment of 16 March 2016, the German court apparently held that claim 1 as granted is novel, but not inventive. This interim assessement of the German court has been accepted into the proceedings as proper novum; Art. 229 CPC.

As to the costs, it comes at no surprise that 26 submissions aren’t a bargain buy. The plaintiff incurred costs of CHF 217’000,–. On the other hand, the defendant/patentee submitted a cost note of EUR 85’000,– for the assisting patent attorney. Note that compensation for professional legal representation will be awarded within the ranges of Art. 5 CostR-PatC, in accordance with a value in dispute of CHF 250’000,–.

I had to leave before the parties were asked whether they wish to enter into settlement negotiations; but I have the dim feeling that, maybe … — well, let’s wait and see.

Reported by Martin WILMING

— BIBLIOGRAPHY —

Case No. O2013_013 ¦ Main hearing of 23 June 2016

Applied NanoStructures, Inc ./. Nanoworld AG

Subject(s):

  • Nullity

Board of Judges:

  • Dr. Dieter BRÄNDLE
  • Dr. Tobias BREMI
  • Peter RIGLING

Reporting Judge:

  • (not identified)

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

  • Dr. Michael RITSCHER (MLL)
  • Dr. Mark SCHWEIZER (MLL)
  • Peter KLOCKE (Abacus), assisting in patent matters

— PATENT IN SUIT —

Download (PDF, 637KB)