The patent in suit is Lilly‘s EP 1 313 508 B1; see the EPO Register and Swissreg for further details. In a nutshell, EP’508 relates to combination of pemetrexed disodium and vitamin B12. See this Blog here for a discussion about earlier infringement proceedings concerning the same patent.
Now, nullity is at stake.
An Opposition Division of the EPO had maintained the patent as granted with decision of 27 December 2010; an appeal had initially been lodged but withdrawn later. Related decisions in civil proceedings elsewhere had also addressed the validity of EP’508, e.g. in
USA (Court of Appeals for the Federal Circuit, 2015-2067, decision of 12 January 2017 relating to the corresponding US patent 7,772,209 and maintaining the patent);
Japan (IP High Court, 2015 (Gyo-Ke) 10249 et al., decision of 2 February 2017 relating to the corresponding JP patent 5102928 and maintaining the patent).
Thus, it was an uphill fight for the plaintiff. And even though the FPC took the parallel decision of the German FPC into account, it explicitly disagreed. It is held on p 19 (penultimate and lastparagraph), that the German FPC erred with the finding that
[…] bei einer Pemetrexedgabe durch die Blockierung der drei Schlüsselenzyme Thymidylatsynthase (= TS), Dihydrofolatreduktase (= DHFR) und Glycinamidribonukleotidformyltransferase (= GARFT) im «DNA- Zyklus» nicht nur dieser Zyklus, sondern auch der «Methylierungszyklus» blockiert wird.
Consequently, the FPC did not put much weight (if any) on the parallel decision in Germany.
On the contrary, the decision holds that the claimed subject-matter was novel over Worzalla et al. since mere reference to a diet ‘Purina Chow #5001’ did not implicitly, yet clearly and unambiguously, disclose the presence of vitamin B12 (or folic acid).
1. Use of pemetrexed disodium in the manufacture of a medicament for use in combination therapy for inhibiting tumor growth in mammals wherein said medicament is to be administered in combination with vitamin B12 or a pharmaceutical derivative thereof, said pharmaceutical derivative of vitamin B12 being hydroxocobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-chlorocobalamin perchlorate, azidocobalamin, chlorocobalamin or cobalamin.
12. A product containing pemetrexed disodium, vitamin B12 or a pharmaceutical derivative thereof said pharmaceutical derivative of vitamin B12 being hydroxocobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-chlorocobalamin perchlorate, azidocobalamin, chlorocobalamin or cobalamin, and, optionally, a folic binding protein binding agent selected from the group consisting of folic acid, (6R)-5-methyl-5,6,7,8-tetrahydrofolic acid and (6R)-5-formyl-5,6,7,8-tetrahydrofolic acid, or a physiologically available salt or ester thereof, as a combined preparation for the simultaneous, separate or sequential use in inhibiting tumor growth.
It’s all about a combination of the antifolate pemetrexed disodium, vitamin B12 and, optionally, folic acid. Briefly, pemetrexed is an antifolate that inter alia inhibits synthesis of thymidine and thus de novo DNA synthesis. Evidently, antifolates are quite toxic. But according to EP’508, toxicity can be successfully controlled by co-administration of pemetrexed with vitamin B12 and, optionally, folic acid.
EP’508 had already been litigated in infringement proceedings in Switzerland, resulting in a landmark decision of the Supreme Court on the Doctrine of Equivalents and how amendments of the patent during prosecution are to be dealt with in this respect; see this Blog here.
This time, validity of EP’508 is being challenged, based on a lack of novelty or, at least, lack of an inventive step; and added matter. Only inventive step has been pleaded in the hearing. With respect to the other grounds of nullity, the Sandoz merely referred to the written submissions.
It was evident from the pleadings that the opinion of the judge-rapporteur had been in favour of the defendant. This interim opinion is in line with the decision of an EPO opposition division, the Rechtbank Den Haag (Case No. C/09/533354 / HA ZA 17-581; judgment available as Dutch original and inofficial English translation), the IP High Court of Japan and the U.S. CAFC. On the other hand, the German Federal Patent Court had revoked the German part of EP’508; an appeal before the Supreme Court is still pending.
Sandoz started from Jackman as closest prior art in the assessment of inventive step. With reference to Worzalla et al., Jackman describes experiments in which pemetrexed was administered alongside with folic acid. Further, phase I clinical trials had been reported in which pemetrexed was administered together with folic acid (Hammond et al.). In consideration of the biochemical pathways, Sandoz argued that it had been obvious to add vitamin B12 to said known combination.
Eli Lilly of course disagreed. In Lilly’s view, the skilled person would not have pursued a combination of pemetrexed and folic acid, let alone to add vitamin B12. In real life, phase II clinical trials began with pemetrexed alone, irrespective of the experiments of Hammond et al. Toxicity of pemetrexed had intially been deemed controllable. It was only in the course of phase II clinical trials that the therapy scheme was switched because toxicity was found to be too severe.
A significant point of discussion was whether a skilled person would have been motivated to add vitamin B12 in light of some marker experiments. Niyikiza, the main inventor of the patent in suit, had published a report that described a correlation of pemetrexed toxicity with an unspecific marker (homocysteine), but not with the vitamin B12-specific marker MMA (methlymalonic acid). Accordingly, in Lilly’s view, a skilled person would not have been prompted towards the invention.
EP’825 pertains to a combination of oxycodone hydrochloride (in an amount of 10 to 150g) and naloxone hydrochloride (in an amount of 1 to 50g), in a weight ratio of 2:1.
This combination is an analgesic drug that is available as modified-release tablets under the trade name Targin® by MundiPharma. Oxycodone is an opioid that has pain-relieving effects. Naloxone opposes the effects of opioids but is poorly absorbed when given orally; it stays within the gastrointestinal tract and reduces the local side effects of oxycodone.
Defendant / patentee MundiPharma countersued for infringement.
It was evident from the pleadings that the expert opinion of the judge-rapporteur had held that the patent was invalid for undue extension of subject-matter. Note that the first instance decision at the EPO (11 December 2018) and the Barcelona Commercial Court No. 4 (19 December 2018) came to the same conclusion. While an appeal is still pending at the EPO, the decision in Spain is already final.
The most interesting part of the hearing was actually how the FPC had structured it. Normally, the parties are just given the floor, one after the other, to plead on all relevant aspects of the case. Not so this time. The FPC wanted to hear the parties on a single aspect only, before moving on to the next aspect. Very much like hearings at the EPO are conducted. Apparently, the FPC had also indicated beforehand that a preliminary opinion would be given on each aspect right after the pleadings relating thereto. However, the patentee / defendant objected, and the court thus abstained from doing so.
On a personal note, I don’t see much value in a ‘preliminary’ opinion of the court being issued in the main hearing. Since one cannot take this opinion for granted, one has to effectively ignore it in all the following pleadings, and be prepared for an outcome to the contrary.
But it still is an interesting approach that could well be taken to the next level, in my perception: What about making a break after the pleadings on each aspect for the judges to deliberate and actually decide on that issue, and pronounce the decision right thereafter? That works perfectly fine at the EPO, and a nullity case at the FPC doesn’t differ much.
Lawyers may prove me wrong, but I do not readily see why this shouldn’t be possible in civil proceedings governed by the CPC.
The inventions are all about the capacitive testing of yarns or fabric, wherein the dielectric property of a capacitor arrangement is determined.
It became clear from the pleadings that the defendant’s main request in both cases was that the patent be maintained in amended form only. In my understanding, the expert-opinion of the judge-rapporteur had held that the main request in O2016_010 / EP’250 was allowable, but not in O2016_011 / EP’018.
Novelty has not been an issue anymore, in both cases. Only obviousness, undue extension of subject-matter (interim generalisation) and clarity (of the additional feature) have been discussed. D2 (US 4,843,879; referred to in EP’250, ¶) was apparently agreed to be the closest prior art, and was combined in the assessment of obviousness with either D4 or D11 — both of which have unfortunately not been identified.
For me as a chemist, the highlight of the day was the plaintiff’s emotional release:
That’s not chemistry here; it’s physics!
The formulation of the ‘objective technical problem’ was quite a big deal in the hearing. This is what EP’250 says in ¶ (emphasis added):
It is therefore the aim of the present invention to provide a method for the symmetry adjustment of a device for the capacitive examination of a moving elongated textile test sample which does not have the above disadvantages. The device should be simple, fast, cost-effective and, in particular, automatically adjustable.
Now, can automation be considered as the ‘objective technical problem’? In the plaintiff’s view, the ‘in particular’ is an emphasis of the aim of automation. The defendant disagreed: Automation was an add-on, and the other advantages could well be realised without automation. On the funny side, the following example has been used:
She likes flowers, in particular roses.
Now, imagine that the rose-loving woman visits a florist. Which flowers will she recognise first, amidst all the other flowers? The roses, of course!
Compensation of the ‘necessary expenses’ for the assisting patent attorney pursuant to Art. 3 lit. a and Art. 9(2) CostR-PatC was yet another point of discussion. The plaintiff requested reimbursement of about kCHF 45 for each case and argued, that the defendant triggered the additional costs because the amended claims had only been filed with the rejoinder which then had effectively restarted the whole discussion. I did not get the value in dispute, but the presiding judge indicated that kCHF 45 is about twice as much as the amount that would be awarded for legal respresentation, i.e. ‘according to the tariff’ that is based on the value in dispute.
Now, why is that important?
Since O2012_043, the FPC’s practice is that, as a rule, the ‘necessary expenses’ for the patent attorney may well be within the same order of magnitude of the costs for legal representation. But what about nullity cases? A patent attorney could do that on his/her own, without any legal representative; Art. 29(1) PatCA. Compensation would then be awarded according to the tariff for legal representatives; Art. 9(2) CostR-PatC.
The defendant questioned whether costs incurred for the assisting patent attorney are ‘necessary expenses’ at all, on top of the costs for legal representation according to the tariff, if he/she could have done the whole case on his own.
Use of the technical infrastructure in the court room
It is quite hard for the public to follow the arguments when the representatives just argue with acronyms and references. It’s sometimes frustrating, but I got used to it. But still, one of the basic ideas of a public hearing is to give the public the opportunity to follow the proceedings, isn’t it? But how would you even get a glimpse of what is really at stake when the parties only refer to ‘EP’111’ or ‘D1’ or ‘feature 1da’. That’s not information — it’s just noise.
I was very happy that the recent hearing in case S2018_006 was different (see this Blog here): Whenever someone referred to a specific document, the President put the same on the screen for it to be easily recognisable by the whole audience and the judges; projector and screen are fixedly installed in the ceiling anyway (see yellow arrow in the image below). Much appreciated!
But that’s not only great for the audience; I strongly feel that it is also beneficial for representatives when arguing their case. When referring to a certain paragraph in a specific document in your pleadings, or a technical drawing, you always want to make sure that all the judges are on the same page, right? But how would you know that, with the judges sitting on a podium that even has an elevated front side that makes sure that nobody reveals a hand up there, behind the monitors. Yes, there are fixedly installed monitors (green arrows in the above image).
Now, did they all pick up the document that you are upon to discuss? You never know. So, why not actually use the monitors that each judge has in front of him/her, and the projector/screen for the audience, to make sure that everybody sees what you want to be seen? I could not think of any more powerful way to focus the discussion and thoughts on a specific argument.
Unfortunately, it didn’t work out that way in this hearing even though the defendant suggested it. I hope this was for technical reasons only, and does not indicate a general change of practice again.
The patentee who deletes their patent from the patent register after the filing of a nullity action is liable to pay the procedural costs even if they have not been forewarned before the filing of the action.
The hn highlights in no uncertain terms the risk associated with maintaining patents of doubtful validity in Switzerland: Even in case of a nullity action out of the blue, and even if the patent is then withdrawn immediately, the patentee / defendant still has to bear the procedural costs.
Frankly, this does not come as a complete surprise. The tendency has already been clear since O2015_010, decision of 5 January 2016. The present order again confirms that Swiss law (unlike Germany, cf. § 93 DE-ZPO) does not provide for an obligation to issue a prior warning letter. With reference to the practice of the cantonal court of Zug (A3 2010 58, ‘Geburtsgel’), the order holds that clapping all costs on the defendant is justified if the defendant had
[…] given the impression by his pre-litigation conduct that he had not had the patent cancelled on mere warning.
Noteworthy, the present order holds that this conclusion can already be drawn from the mere existence of a formally valid patent. This is because the patent is cancelled if the renewal fees due are not paid on time (Art. 15(1) lit. b PatA). It would be unreasonable to assume that the patentee would pay the annuities on time but cancel the patent on first demand.
And, in fact, the patentee in the present matter did not respond immediately to the (informal) notification of the action by cancelling the patent, but rather offered the plaintiff a licence. This suggests that even in the case of a pre-litigation request, the patent would not have been cancelled immediately.
The order has been published in highly truncated form only. But still, I am reasonably sure about the patent at stake. Searches in Swissreg give only a single perfect fit, i.e. EP(CH) 1 204 164 B1 of Feller AG; see Swissreg. Annuities had been validly paid until 30 November 2018, but the patent had been withdrawn shortly before that date, with letter of 6 November 2018 (published in Swissreg on 8 November 2018).
The invention of EP’164 apparently is all about a screwless connecting terminal for electrical conductors, with more secure releasability of the conductors. Claim 1 reads as follows:
Device (1) with screwless terminals for connecting electrical conductors, with at least one spring comprising an elastic terminal arm (7) and a brace (2) which encloses it, where a contact tongue (8) of the terminal arm (7) cooperates with a retaining part (5) of the brace (2) so as to maintain a conductor introduced between the contact tongue (8) and the retaining part (5), where the brace (2) leaves the contact tongue (8) at least partially accessible on both sides of the retaining part (5), so that it can be acted upon from outside the brace (2) on both sides of the retaining part (5), characterized in that the brace (2) comprises a base (3) and a lateral wall (4) the upper part of which is bent so as to form the retaining part (5) in such a way that this retaining part (5) is only connected through its longer side with the lateral wall (4), and that the latter comprises at least one recess (11) in the vicinity of the extremity of the contact tongue (8).
All this is more readily understandable with Fig. 1 of EP’164 at hand:
Unfortunately, I failed miserably to track the plaintiff of this case. If someone out there does know more, please let me know.
Salmon Pharma as the defendant in SPC infringement proceedings neither disputed validity of the basic patent EP 0 716 606 B1 of Genzyme Corporation, nor that the subject-matter of the SPC C00716606/01 is actually covered by the basic patent or that the attacked embodiment (sevelamer carbonate) is covered by the SPC. Rather, the defendant (only) alleged that the SPC was invalid because the IPI wrongfully allowed re-establishment of rights (Art. 47 PatA) with respect to the time limit for filing the SPC application under Art. 140f PatA.
The question as to whether the lists of grounds for nullity in Art. 26 and Art. 140k PatA are exhaustive had indeed not yet been explicitly decided by the Supreme Court before. However, the present judgment refers to an indication in 4A_52/2008, ¶2.2, according to which the grounds for invalidity for the certificate are listed in Art. 140k PatA. Furthermore, in application of the Patent Act of 1888, the Federal Supreme Court had already held that the grounds for invalidity of patents were exhaustively listed therein (28 II 309, ¶5). I just love to read such old decisions. Amazingly straight to the point; and the type face is so stylish:
Unsurprisingly, the Supreme Court takes the case-law of the Court of Justice of the European Union (ECJ) on Art. 15 of Regulation (EC) No 469/2009 (or Regulation (EEC) No 1768/92) into account, in view of the legislator’s explicit intent to bring the Swiss rules into line with European law.
However, the Supreme Court could not infer anything from the ECJ’s case-law in support of Salmon’s position. Rather, the Supreme Court confirms the FPC’s reasoning: The ECJ only affirmed the nullity of certificates due to the non-observance of standards which are not explicitly mentioned in Art. 15 of Regulation No 1768/92 by referring to Art. 15 as interpreted in view of Art. 3.
For example, in C-127/00 — Hässle ./. Ratiopharm, the ECJ held that failure to comply with the transitional regime of Art. 19 of Regulation No 1768/92 may result in the certificate being invalid. The requirement under Art. 19 is to be understood as an implicit substantive requirement additional to the conditions laid down in Art. 3 of the Regulation. A certificate which was granted even though an initial marketing authorisation had already been granted before the date laid down in Article 19 of the Regulation is therefore null and void; ¶¶84-92).
Likewise, in C-195/09 — Synthon ./. Merz Pharma, the ECJ held that Art. 3 of Regulation No 1768/92 necessarily referred to a product falling within the scope of that regulation within the meaning of Art. 2 thereof. A certificate granted for a product falling outside the material scope of the Regulation should be considered null and void; ¶56.
It cannot be inferred from these judgments that the list of grounds for nullity in accordance with Art. 15 of the Regulation is not to be understood as exhaustive. On the contrary, the ECJ stated that it could not be inferred from either the wording or the history of Art. 15 of the Regulation that the list of grounds for nullity of the certificate referred to therein was not exhaustive (Synthon, ¶55; Hässle, ¶¶90-91).
The Supreme Court thus held that the lists of grounds for invalidity of both Art. 26 and Art. 140k PatA cannot be supplemented. Consequently, in the context of a patent nullity action or a nullity action relating to an SPC, only the grounds provided for in these provisions may be invoked. The Supreme Court notes in passing that legal certainty demands for this, too.
Angesichts dessen, dass es sich bei der Nichtigkeit eines Patents bzw. Zertifikats um eine schwerwiegende Folge handelt, entspricht dies dem Gebot der Rechtssicherheit.
Next, the Supreme Court assessed whether non-compliance with the deadline for filing the request pursuant to Art. 140f PatA or wrongful reinstatement pursuant to Art. 47 PatA, could be subsumed under a ground for invalidity pursuant to Art. 140k PatA. However, this is neither apparent nor does it result from the relevant case-law of the ECJ.
Finally, the Supreme Court notes that SPCs and patents are granted by order of the IGE (144 III 285, ¶3.2). Nullity under Art. 26 and Art. 140k PatA is not to be mixed up with the administrative contestability or nullity of the dispositions of the IPI on which the grant of a patent or SPC is based. In other words, the fact that the catalogues of grounds for invalidity under the PatA are exhaustive does not mean that these dispositions cannot be contestable or void, which must be assessed according to general principles of administrative law.
Dass die Kataloge der patentrechtlichen Nichtigkeitsgründe abschliessend sind, bedeutet […] nicht, dass diese Verfügungen nicht anfechtbar bzw. nichtig sein können, was nach allgemeinen verwaltungsrechtlichen Grundsätzen zu beurteilen ist.
Interestingly, the Supreme Court explicitly left the question open whether the decision of grant of the SPC (or the earlier decision of 4 April 2005 concerning reinstatement) could have been challenged by the appellant, as the FPC had assumed: Any relevant time limit had expired since long, anyway. On the other hand, the nullity of a decision must be observed by all authorities applying the law at all times (137 I 273, ¶3.1; 133 II 366, ¶¶3.1-3.2; 132 II 342, ¶2.1; 129 I 361, ¶2; each with further references to case-law).
Incorrect administrative acts are usually not null and void, but only contestable; and they become legally effective when not challenged. Invalidity, i.e. absolute ineffectiveness, of an order is only accepted if it is afflicted with a profound and substantial defect, if this serious defect is obvious or at least easily recognisable and if the legal certainty is not seriously jeopardised by the acceptance of invalidity. Deficiencies in content only rarely result in the nullity of an order, in exceptional cases; this requires an extraordinarily serious deficiency. The main grounds for invalidity are the functional and factual lack of competence of an authority and serious procedural irregularities (such as the fact that the person concerned did not have the opportunity to participate in the proceedings). If an order is not legally binding in this sense, any authority dealing with the matter must comply with it at all times and ex officio (see, inter alia, 138_II_501, ¶3.1; 137 I 273, ¶3.1; 136_II_489, ¶3.3).
Salmon had argued that reinstatement was granted ‘arbitrarily and contrary to the clear and decades-long practice’ of the IPI. Again, the Supreme Court left undecided whether the IPI indeed wrongly allowed reinstatement because the alleged misjudgment could not be a defect that leads to the nullity of the decision. In particular, the Supreme Court held that any such deficiency would be neither obvious nor easily recognisable: By definition, reinstatement is a remedy when something went wrong, i.e. in the event that a time limit prescribed by the law was not observed.
Finally, in simple terms, the Supreme Court notes: The IPI had come to the conclusion that the conditions for reinstatement pursuant to Art. 47 PatA were met. The appellant may not share this view, but the administrative act is still not null and void.
Das IGE ist zum Schluss gekommen, dass die Voraussetzungen für die Wiedereinsetzung gemäss Art. 47 PatG gegeben waren. Die Beschwerdeführerin mag diese Einschätzung nicht teilen; ein nichtiger Verwaltungsakt liegt jedoch nicht vor.
The Supreme Court now dismissed Omega’s appeal, i.e. confirmed the FPC’s decision. EP(CH) 1 837 719 B1 is thus finally declared invalid.
The issues dealt with by the Supreme Court in the decision, in brief:
Age of a prior art document
On appeal, Omega has argued that the FPC took an unrealistic piece of prior art into account in the assessment of inventive step. Indeed, the FPC had considered a document that was published already about a century ago, i.e. US 759,914. In view of the evolution of watchmaking since then, Omega considered it unrealistic that such a document was actually considered as a starting point in the assessment of inventive step. Consequently, Omega alleged a violation of Art. 56 EPC.
The Supreme Court did not buy this argument. It is held in no uncertain terms that everything that had been made publicly available — including old documents — forms part of the prior art. One cannot exclude a document from consideration in the assessment of inventive step just because of its age; see ¶3.1.3.
Écarter un document de ceux que consulterait l’homme de métier en raison de son ancienneté reviendrait à priver les brevets ayant dépasé un certain âge de toute valeur dans le cadre de l’analyse de l’effet invenif. Un telle pratique ne saurait être déduite de l’art. 65 CBE.
Reference to some case-law of the Boards of Appeal of the EPO did not help either: The mere age of a document has not been decisive in T 479/00, T 366/89, T 1000/92 and T 334/92. The Supreme Court notes that the obsolescence or outdatedness of a technology had been the key issue in these decisions, which excluded the respective documents from consideration by the skilled person. Apparently, no such case had been established by the appellant in the present matter.
Incompatibility of technical teachings
The balance wheel of US 759,914 has inertia blocks that must have been placed from the inside, as claimed by the patent in suit; see the screw head on the inner side of the felloe in the figures below.
But what is still missing here is the stud (‘plot’) according according to the patent in suit. Omega argued that the skilled person would not have added studs to the balance of US 759,914 in view of the risk to impair the automatic adjustment of its temperature dependent moment of inertia, which is the sole purpose of this invention. However, the Supreme Court holds that this is not in agreement with the fact findings of the FPC, and thus did not consider this argument any further.
And the Supreme Court indeed acknowledges that it would have been desirable if it had done so.
Ainsi, il eût été souhaitable que la juridiction précédente détaille la première étape de l’approche problème-solution comme elle l’a fait pour les autres étapes de son examen.
But still, in view of the FPC’s detailed discussion of how the skilled person had arrived at the invention starting from US 759,914 without inventive merit, it became sufficiently clear how close both inventions actually are, and why US’914 thus is a reasonably chosen closest prior art.
Late filed auxiliary requests / claim limitations
Omega had filed yet another, even more limited auxiliary request (AR3) with the response to the expert opinion of the judge-rapporteur. The FPC had not admitted this request into the proceedings anymore, with reference to O2015_012.
Omega had challenged this on appeal. But while this appeal has been pending, the Supreme Court ruled on the appeal against O2015_012 — and backed the practice of the FPC in this respect; decision 4A_543/2017 of 08 May 2018, see this Blog here. Accordingly, Omega did not succeed with this argument, either.
Following-up on a decision granting interim injunctive relief (reported here), the present decision in main proceedings now confirms this outcome. I have reported about the hearing in main proceedings on this Blog here.
As indicated earlier, the defendant neither disputed validity of the basic patent EP 0 716 606 B1 of Genzyme Corporation, nor that the subject-matter of the SPC C00716606/01 is covered by the basic patent or that the attacked embodiment (sevelamer carbonate) is covered by the SPC. Rather, the defendant (only) alleged that the SPC is invalid because the office wrongfully granted re-establishment of rights (Art. 47 PatA) with respect to the time limit for filing the SPC application under Art. 140f PatA.
The FPC now confirms that the list of grounds for nullity of an SPC as set forth in Art. 140k PatA is exhaustive. The alleged wrongful reinstatement is thus no valid ground of nullity. In particular, the decision refers to the dispatch of the Federal Council when the SPCs had been enacted, i.e. the note that Art. 140k is to define the grounds for nullity:
Artikel 140k Nichtigkeit: Absatz 1: Neben dem Erlöschen bzw. der Sistierung des Zertifikats müssen auch die Gründe festgelegt werden, sie seine Nichtigkeit herbeiführen.
Further, the decision reviews the CJEU’s case law and notes that the grounds for nullity according to Art. 15 of the EU SPC Regulation 469/2009 have never been held to be an open list. Rather, the CJEU only interpreted Art. 3, violation of which is referred to as a ground for nullity in Art. 15 of the EU SPC Regulation.
The FPC notes that the defendant could have appealed the decision of reinstatement (Art. 48 ff APA in the version of 09 December 2003), together with the decision of grant of the SPC – but failed to do so. The decision is thus formally final, and the defendant has to live with it.
If there is a take away message for practitioners in this decision, then it is surely to watch out for fresh grants (not only of SPCs, but also patents, trademarks, designs, etc.), to not miss the 30 days(!) time limit for an appeal; Art. 50(1) APA. This will be the only chance to fight against e.g. a wrongful reinstatement — which is more than you will ever get e.g. at the EPO where there is no such chance at all; but still, you need to act quickly.
Yet another interesting aspect of the decision is the assessment of the value in dispute. The parties heavily disagreed. Plaintiffs had considered it to be CHF 5m, while the defendant only estimated it to be CHF 500k. The FPC had thus to decide on this issue, too; Art. 91(2) CPC. Towards this end, it relied on some interesting rules of thumb:
one third of the turnover of the originator’s product is replaced by the generic within about 2 years;
the profit margin of a generic is 50%.
Based on these rules of thumb, and the plaintiffs’ own statement of an annual turnover in Switzerland of CHF 2.25m p.a., the FPC considered the the value in dispute as CHF 750k, for the roughly two years of protection at stake before the SPC will finally lapse in February 2019.
UPDATE 18 July 2018:
The decision has been appealed to the Supreme Court.
In (very) brief, AstraZeneca’s EP(CH) 1 250 138 B2 had been revoked for lack of inventive step over Howell in view of McLeskey. At the main hearing, AZ had further limited its third auxiliary request with an additional feature (marked-up below) as follows:
Use of fulvestrant in the preparation of a pharmaceutical formulation for the treatment of breast cancer by intra-muscular administration to human patients, […] wherein […] the formulation is adapted for attaining a therapeutically significant blood plasma fulvestrant concentration of at least 8.5 ng ml-1for at least two weeks.
AZ had argued that this further limitation was a partial acknowledgment of the complaint which is possible at any stage of the proceedings; Art. 241 CPC. The FPC did not agree. The further limitation only concerned an auxiliary request, i.e. it only came into play when the court had already decided on the main request, i.e. denial of the complaint without any amendments to the claims. At that stage, there is no room anymore for a partial acknowledgment of the complaint. The FPC held that it was faced with new facts to be considered as an auxiliary measure. This is possible in general, but only within the time limits for submission of novae; Art. 229 CPC. Consequently, the FPC had not admitted the newly drafted auxiliary request into the proceedings.
On appeal, AZ requested that the decision be set aside and the patent maintained on the basis of the amended third auxiliary request.
The Supreme Court did not agree, either. Whether or not an additional feature in a claim is an allowable limitation is not just a question of law. It rather requires a factual assessment of whether (or not) the application as filed provides sufficient basis for the amendment. This assessment had not been made in first instance proceedings. The Supreme Court further notes that even further factual assessment may be necessary, e.g. whether further prior art might be cited against the reformulated claim.
The Supreme Court thus held that the FPC correctly did not admit the reformulated auxiliary request into the proceedings for being belated, and dismissed the appeal.
it remains to be seen how parties will adapt their course of action in the future. But I would not be surprised if defendants in nullity cases (and plaintiffs in infringement cases when faced with a plea for nullity in defense) will submit a lot more auxiliary requests at early stages of the proceedings.
This case started off already on 27 February 2016, between Harcane and Comadur. There is not much known about the plaintiff, but the defendant is a company of the Swatch Group, specialising in hard materials. Noteworthy, the owner of Harcane, Rui Carolla, apparently had spent part of his career with Comadur; see SHAB.
Quite some background information was already included in the official announcement of the hearing. The plaintiff in first place requests that CH 707 572 B1, concerning a binder for an injection molding composition, be declared null and void. As an auxiliary measure, it is requested that the patent be assigned to the plaintiff. Allegedly, the patent lacks novelty over US 5,266,264, several PhD theses and the sale of a certain “feedstock” including the patented binder. The defendant had allegedly been provided with it back in November 2012. Further, the plaintiff alleges that the mixture according to CH 707 572 B1 had in fact been invented by Mr. Lestarquit, who was at the time an employee of the Plaintiff.
The defendant holds the view that the claimed subject-matter is new and inventive. All the compositions had been developed by Mr. Cartier, an employee of the defendant since 1999. The “mix sheets” developed by Mr. Cartier allegedly have only been put into practice by employees of the plaintiff, including Mr. Lestarquit. The defendant thus requests that the case should be dismissed in its entirety.
In the hearing, the alleged obviousness of CH 707 572 B1 was intensely discussed. Both parties had identified the characterizing part of claim 1 as the distinguishing feature, but proposed (opposing) problem-and-solution approaches (EPO Guidelines, G-VII, 5). The expert opinion of the judge-rapporteur had apparently been in favor of the plaintiff. Further, it was discussed whether the feedstock that had been exchanged between the parties during the collaboration had become public / is part of the prior art.
Initially, the defendant had no interest in settlement discussions, in view of some parallel proceedings elsewhere. Rather, the defendant requested that the present proceedings be stayed until after such parallel proceedings are concluded. Still, the defendant finally agreed to enter into settlement discussions as a first step.
Note that CH 707 572 B1 (filed 15 July 2013) has no further family members. However, we came across patent family WO 2014/191304 A1, claiming priority of CH 01021/13, filed 28 May 2013 and published as CH 708 097 A2, which is pretty similar to the patent in suit. It remains to be seen how all this will be sorted out.
Case No. O2017_016 ¦ Main Hearing of 25 April 2018
I have attended the hearing in this matter earlier today. Infringement of the Swiss SPC C00716606/01 concerning sevelamer is at stake; the basic patent is EP 0 716 606 B1 of Genzyme Corporation. Interim injunctive relief had been granted in earlier proceedings S2016_009; see this Blog here.
Notably, infringement per se is undisputed, as well as validity of the basic patent. However, the defendant (only) alleges that the SPC is invalid because the Office wrongfully granted re-establishment of rights (Art. 47 PatA) with respect to the time limit for filing the SPC application under Art. 140f PatA.
The parties had been summoned to the main hearing after a single exchange of briefs; plaintiff’s reply and defendant’s rejoinder were pleaded in the hearing. Since the only question at stake is a legal one, this worked out smoothly. It was also noted that no expert opinion of the judge-rapporteur will be established.
Now, can the SPC still be challenged for wrongful reinstatement in the present civil proceedings?
Undisputedly, wrongful reinstatement is not explicitly listed as a ground for nullity in Art. 140k PatA. However, the parties dissent on whether or not the list is exhaustive.
Defendant essentially argued that the Swiss legislator voluntarily aligned the Swiss law with the respective EU regulation, and that also further developments of the EU law need to be taken into account; BGE 129 III 135, ¶6. In the view of the defendant, the ECJ in all its decisions on SPCs essentially declared SPCs invalid whenever its grant had not been objectively justified — irrespective of whether or not the ground was explicitly listed in Art. 15 of Regulation (EC) 469/2009.
Plaintiff disagreed; the ECJ never introduced additional grounds of nullity but rather only interpreted the grounds that are explicitly mentioned. Further, the nullity grounds referred to in Art. 140k(1) lit a PatA explicitly only refer to Art. 146(1). However, the time limit for filing the SPC request is defined in Art. 146(2). The plaintiff noted that this focus only on paragraph 1 underlines the legislator’s intent to not include paragraph 2 into the list of grounds for nullity. Plaintiff further argued that any interested third party could well have appealed the decision of reinstatement (Art. 48 ff APA in the version of 09 December 2003), together with the decision of grant of the SPC – but the defendant failed to do so. See also the summary judgment in ¶3.5 in this respect. The decision on reinstatement is thus formally final, and the defendant has to live with it. Plaintiff further referred to BGE 90 I 186 (¶3) which held that re-establishment of rights according to Art. 47 PatA only concerns the relationship of the patentee to the Office; the effects on third parties are regulated exhaustively (sic!) by Article 48 PatA with the prior user right for bona fide third parties.
The later the day, the more pronounced the arguments: The parties reproached each other for having not been able to refer to a prior decision on precisely this issue to their favour. On the funny side, plaintiff noted that this is only because so far just no one has come up with this absurd idea.
The parties were then asked by the presiding judge whether they were interested in settlement discussions. Unfortunately, I cannot tell what the answer was because it was requested that the public be excluded before the question is answered, and this request was granted.
UPDATE 05 May 2018:
I meanwhile obtained the request and the grant of reinstatement.
Reported by Martin WILMING
Case No. O2017_016 ¦ Main Hearing of 25 April 2018
The single independent claim 1 as granted reads as follows:
Balance for a timepiece movement including a felloe (3), arms (4) connecting the felloe (3) to the balance staff and inertia blocks (11) for adjusting the unbalance and regulating the moment of inertia, characterized in that the felloe (3) includes studs (7) directed inwards, a threaded hole (9) into which said inertia blocks (11) are screwed from the inside, passing through said felloe (3) and said studs (7).
This is best understood with the figures of the patent at hand:
The attacked embodiments are Tudor‘s calibres MT5621 and MT5612. Defendants Tudor and Detech denied infringement and countersued for invalidity.
Let’s get to the details now, at least to some extent. The decision is a booklet of 58 pages, and I will thus only comment on what I believe are the most relevant issues of the case.
Faced with a counterclaim for invalidity, Omega defended the patent substantially as granted as the main request (MR; see the slight amendment in feature #5, below), and with two auxiliary requests (AR1 and AR2) to a more limited extent only. In the feature analysis below, claim 1 according to the MR is structured into features 1-7. Claim 1 according to AR1 comprises features 1-8, and AR2 comprises features 1-9, respectively.
Balancier pour mouvement d’horlogerie
Balance for a timepiece movement
comportant une serge (3)
including a felloe (3)
des bras (4) reliant la serge (3) à l’axe de balancier
arms (4) connecting the felloe (3) to the balance staff
et des masselottes (11) permettant d’ajuster le balourd et de régler le moment d’inertie
and inertia blocks (11) for adjusting the unbalance and regulating the moment of inertia
caractérisé en ce que la serge (3) comporte des plots (7) dirigés radialement1 vers l’intérieur
characterized in that the felloe (3) includes studs (7) directed radially1 inwards
ladite serge (3) et lesdits plots (7) étant traversés par un trou taraudé (9)
a threaded hole (9) passing through said felloe (3) and said studs (7)
dans lequel lesdites masselottes (11) sont vissées depuis l’intérieur
into which said inertia blocks (11) are screwed from the inside
les masselottes peuvent être mues indépendamment les unes des autres2
the inertia blocks can be moved independently of each other2
le serge présente unse surface externe de diamètre constant sur tout son pourtour3
the felloe has an external surface of constant diameter all around its circumference3
1 Note that ‘radialement’ / ‘radially’ is not included in claim 1 as granted. 2 Additional feature of claim 1 in AR1 vis-à-vis the MR. 3 Additional feature of claim 1 in AR2 vis-à-vis AR1.
Omega’s requests for injunctive relief are adapted accordingly in MR, AR1 and AR2, to conform with the respective requests to maintain the patent. The requests for injunctive relief additionally refer to an illustration of the attacked embodiment that is reproduced below. However, I have amended the reference numbers in accordance with those used in the patent.
The element marked-up with ‘Δ’ in the above illustration refers to a feature which was not literally fulfilled by the attacked embodiment, but for which infringement under the DoE was alleged, i.e. feature #7 in the table above:
the inertia blocks (11) are screwed [into the threaded hole (9)] from the inside
Rather, the request for injunctive relief read as follows:
les masselottes sont dépourvues de tête et dotées de lobes internes permettant leur vissage depuis l’extérieur de la serge
I.e., in English language:
the inertia blocks are headless and equipped with internal lobes allowing them to be screwed from outside the felloe
Claim construction re feature #7
Now, what does it mean in French that
les masselottes sont vissées depuis l’intérieur?
Does it only require that the inertia blocks can be adjusted from the inside, irrespective of how / from which direction they had been initially placed in the hole, i.e. from the inside or outside of the felloe? Or is it mandatory that the inertia blocks at least could have been placed in the hole from inside of the felloe? Note that EP’719 only discloses inertia blocks with heads (13) that cannot go through the hole, i.e. they must be / have been placed from inside of the felloe; see e.g. ¶.
Anyway, I leave this tricky linguistic question to the francophones to decide for themselves. The decision holds that this feature #7 only requires that the inertia blocks could have been inserted and screwed from the inside during the assembly of the balance wheel (by an access between the serge and the centre of the serge) in the hole traversing the stud and the felloe.
Consequently, feature #7 does not cover inertia blocks which, already present in the tapped holes of the serge and the studs, can be screwed from the inside for the purpose of adjusting the inertia and unbalance, but which would not have previously been inserted and screwed into the corresponding hole from the inside of the felloe.
The balance wheel in DE 864 827 comprises a stud (‘plot’) in the sense of feature #5; see the section 1g in the figures below. But since the screws with the inertia blocks have a head on the outside of the felloe, they do not meet the definition of feature #7 as construed above.
On the other hand, the balance wheel of US 759,914 has inertia blocks must have been placed from the inside; see the screw head on the inner side of the felloe in the figures below.
But what is missing here is the stud (‘plot’) according to feature #5. Thus, novelty was acknowledged over US 759,914.
The balance wheel of US 2,958,997 has some axial screws (21) which are not inertia blocks. On the other hand, it is not possible that the inertia blocks (3) have been placed from the inside since the screw head is outside of the felloe.
Features #6 and #7 were not considered anticipated, and novelty was thus acknowledged.
Finally, novelty over the balance wheel ‘Jean Martin’ is discussed, a photograph of which is reproduced in the decision (don’t blame me for the poor quality, it’s in the original):
Here, the studs are arranged axially on top of the felloe. The hole thus only passes through the stud, not through the felloe. Features #6 and #7 were not considered anticipated, and novelty was thus acknowledged.
Inventive step has been assessed on the basis of US 759,914 as closest prior art; see figures above. The distinguishing features are #6 and #7, i.e. the studs (which are directed inwards), and the inertia blocks arrangeable in a hole through the stud (and the felloe) from the inside.
Following Omega’s proposal, the objective technical problem has been defined as follows:
Increasing the diameter of a balance wheel without modifying its inertia.
Now, here is the definition of a stud (‘plot’) according to Berner (FR/EN):
Petite pièce métallique, généralement cylindrique qui sert de butée ou qui renforce la partie d’une pièce qui doit recevoir une goupille ou une vis.
Small metal part, usually cylindrical, used as a stop or as a means of strengthening a part that takes a pin or screw.
It is held in the decision that, with this skilled person’s knowledge in mind, it was obvious to arrange studs on the felloe to reinforce the holes. But on which side? On the inside or the outside of the felloe? When placed on the inside, the diameter of the felloe can be larger. Anyway, with reference to T107/02 and T739/08, it is held that a choice from a very limited number of alternatives without an unexpected effect cannot be considered inventive.
The auxiliary requests did not succeed, either. As to AR1, the inertia blocks can be moved independently of each other already in US 759,914. As to AR2, the felloe has an external surface of constant diameter all around its circumference already in US 759,914.
Late request – belated?
Omega had filed yet another, even more limited auxiliary request (AR3) with the response to the expert opinion of the judge-rapporteur. This request was not admitted into the proceedings anymore, with reference to O2015_012. In particular, the decision holds that the expert opinion did not contain new facts or arguments of a technical nature which had not been argued by the parties.
In a nutshell
Omega’s claim for infringement has been rejected, Tudor’s / Detech’s counterclaim for invalidity has been allowed and EP(CH) 1 837 719 B1 declared invalid.
The decision can still be appealed to the Supreme Court.
UPDATE 14 May 2018:
The decision has been appealed to the Supreme Court.
UPDATE 22 October 2018:
The appeal has been dismissed by the Supreme Court (4A_282/2018; reasons not yet available).