Case Nos. O2021_004, O2021_005 | Judgment of 20 April 2023 | ‘Deferasirox II’
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| HEADNOTES
Art. 229 para. 1 CPC Art. 8 CC, Art. 1 para. 2 PatA, Art. 56 EPC Art. 51 PatA, Art. 66 let. a PatA, Art. 69 EPC |
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This judgment in litigation between Mepha and Novartis covers both Mepha’s revocation action with respect to EP 202 and EP 018 (O2021_004) and Novartis’ conterclaim for infringement of both patents (O2021_005) by Deferasirox-Mepha® (Swiss market authorization no. 67678).
Deferasirox is an iron chelating agent; it is frequently referred to simply as DFX. It is mainly used to reduce iron overload in patients who are receiving long-term blood transfusions in the treatment of chronic anemias.
The FPC had issued a PI in summary proceedings in December 2021; see this Blog here. This finding has been reversed with the present landmark ruling in main proceedings, by an enlarged panel of five judges: The judgment holds that both patents are not infringed, neither literally nor under the DoE. This is what hn ③ is all about.
But let’s take it one step at a time, walking through all headnotes.
Board of appeal decision is proper novuM
Hn ① relates to a procedural matter:
Let me put this into context first. In litigation at the FPC, parties have two unrestricted opportunities to comment on the merits of the case and, in particular, to introduce new facts into the proceedings. Thereafter, new facts and evidence (nova) can only be introduced under the limited conditions of Art. 229 CPC.
According to the Supreme Court (BGE 146 III 416, r. 4.1; see this Blog here), filing of a new claim set is to be treated in the same way as the submission of other nova. In the underlying case of this Supreme Court judgment, the patentee had partially waived the patent in ex parte proceedings at the Swiss IPI (Art. 24 PatA, comparable to limitation proceedings under Art. 105a EPC at the EPO) only after the closure of the file in co-pending litigation, and was barred from introducing the limited claims into the civil proceedings. The Supreme Court considered the limited claims as an improper novum under Art. 229 para. 1 let. b CPC: Even though the limited claims came into existence only after closure of the file, they could have come into existence earlier, only depending on the decision of the patentee with respect to both timing and extent of the partial waiver.
The present judgment holds that the situation in inter partes opposition / appeal proceedings at the EPO is different. First of all, such proceedings are not initated by the patentee. Second, and even though it is the patentee who formulates the wording of all his auxiliary requests, it is difficult for him to predict which of the auxiliary requests (if any) will survive examination on the merits. Finally, the timing of such inter partes proceedings is determined to large extent by the conduct of the other parties and the procedural calendar of the Board of Appeal. In sum, the FPC holds that the patentee is completely deprived of control over the time and at least partially deprived of control over the version in which the patent is maintained.
Accordingly, the FPC held that the Board of Appeal decision T 1057/21 to maintain EP 018 in amended form is to be considered as a proper novum under Art. 229 para. 1 let. a CPC.
Let’s have a closer look at T 1057/21. EP 018 was maintained based on auxiliary request #48(!) of 71 auxiliary requests in total. Auxiliary request #48 had been initially filed as auxiliary request #38 in first instance proceedings on 19 February 2021, more than a year before closure of the file in nullity proceedings O2021_004. Patentee re-shuffled his requests later, i.e. the Board of Appeal did not deal with 47 requests before it finally allowed auxiliary request #48. Rather, the patentee made this request his new main request in the oral proceedings before the Boards of Appeal on his own volition, and this new main request was found allowable.
Undoubtedly, it is an uncomfortable situation for patentees to coordinate national nullity proceedings (governed by the strict rules on nova after closure of the file under the CPC) with co-pending central opposition / appeal proceedings at the EPO. Which is why some countries rule out national nullity proceedings while EPO opposition / appeal proceedings are still pending (e.g. Germany; see § 81(2) PatA); not so in Switzerland. The FPC’s approach will surely be appreciated by patentees, if and when it is ultimately approved by the Supreme Court.
burden of proof for technical effects
Hn ② relates to the allocation of the burden of proof for the technical effect(s) of the invention. Now we know:
On a quick read, the hn might suggest that it is up to the patentee to actually prove the technical effect, while the plaintiff in invalidity proceedings can sit back and just grouse that the claimed technical effect has not been proven (yet). But beware: The hn only deals with the allocation of the burden of proof. It does not say anything about the standard of evidence according to the lex fori. The regular standard of ‘full conviction’ applies in Switzerland, which according to settled case law means that the court should have no serious doubts about the existence of the alleged fact, or that remaining doubts appear to be slight.
Now, what does that mean for assessment of an alleged technical effect of an invention?
The proof does not necessarily have to be provided with empirical data or even clinical studies. If the person skilled in the art can conclude on the basis of scientific or theoretical considerations that the claimed technical effect exists, this is sufficient proof. When assessing the evidence, it may also be taken into account which indications speak against the claimed technical effect. If there are no such indications, the requirements for proving the technical effect are lower.
Not much of a surprise, isn’t it? In practice, it takes two to tango: The more indications are on the table that the effect is not achieved, the harder it will be for the patentee to actually prove the contrary. Even though the burden of proof lies with the patentee in the first place (which is also the case at the EPO, see e.g. T 1188/00 (hn) and G 2/21 (r. 26)), the whole discussion about whether or not a certain technical effect is achieved is an argumentative arm wrestling.
Numerical ranges / infringemement under the DOE
The judgment holds that both EP 202 and EP 018 as amended in opposition/appeal proceedings are valid (r. 46-67) but not infringed, neither literally nor under the DoE.
The decisive feature in terms of infringement is the amount of deferasirox. The independent claims of both patents require 45-60% by weight of deferasirox. The attacked embodiment contained 64.3% by weight, based on the information given in the product information; r. 68. Even the lowest (disputed) analytical value submitted by the patentee was 60.8%. The judgment holds that even in case of the lower value literal infringement is ruled out. The skilled person will typically consider numerical ranges as more precise and more clear than other verbally described technical claim features (in line with the judgments X ZR 168/00 — Schneidmesser I (r. II 3 lit. d) and X ZR 135/01 — Schneidmesser II (r. 4 lit. d) of the German Supreme Court). Accordingly, also values within usual tolerances are not literally covered. The skilled person knows, however, that technical numerical ranges are subject to a measuring error. Therefore, as a rule, the last digit of numerical values corresponds to the measurement accuracy. If no other error limits are indicated (as is the case here), the maximum error for the last digit is estimated from the rounding convention; see e.g. T 175/97 (r. 2.6). The judgment holds that this case law developed for prior art disclosures equally applies to the interpretation of numerical ranges in patent claims. Since the claimed range is given without any decimal digits, the range that is still within the literal scope of protection is ≥44.5% to <60.5% if the normal rounding convention is applied.
Accordingly, and in particular in the absence of any teaching in the patents that would point to a broader interpretation of the claimed range, the judgment holds that neither 64.3% nor 60.8% is literally covered by the claims.
Turning to infringement under the DoE (r. 73 et seqq.), the judgment holds that the variant has the same effect; i.e., Q1 of the three prong test is answered in the affirmative (not much out of the ordinary for generics).
As to the second question re accessibility of the variant (‘Auffindbarkeit’), the judgment holds that there is currently some uncertainty as to whether this should be dealt with in retrospect (i.e., in knowledge of the variant like in the U.K.), or not (like in Germany); r. 77. It is hoped that the Supreme Court clarifies its position when it gets the chance (which is now):
In the case at hand, the FPC held that it does not matter: The same effect of the variant was ‘accessible’ without involvement of an inventive step in any event; r. 78. Thus, Q2 is answered in the affirmative.
Q3 is meant to safeguard the legitimate interest of the public in legal certainty. Here it is (my own understanding / translation):
Does an objective reading of the patent specification lead the skilled person to the conclusion that the patentee has formulated the claim — for whatever reason — so narrowly that he does not claim protection for an embodiment of same effect (Q1) that is ‘accessible’ for the skilled person (Q2)?
The single embodiment of both patents makes use of 56% of deferasirox (para. [0016] von EP 202; para. [0017] von EP 018). In the claims, however, not this specific value is mentioned, but rather a range of 45% to 60%, which is evidently placed around this specific value. Under these circumstances, the judgment holds (r. 80) that the skilled person assumes that the patentee has specifically and bindingly placed the claimed range around the specific value, i.e. the patentee has deliberately decided to specify the invention to be within this range and thus to dispense with the scope of protection lying outside this range. Under the circumstance, the judgment holds that there is no room to extend this range under the DoE by taking into account generally accepted tolerances going beyond it, because the skilled person may in good faith assume that the patentee has already taken into account possible tolerances when defining the range. In passing, the judgment notes that the range is not symmetrically placed around the specific value; it rather is narrower above than below the specific value. This even underlines the importance of the upper limit. Thus, infringement under the DoE was denied.
This outcome is essentially in line with the U.K. judgment [2022] EWHC 2847 (Pat), para. 232 (emphasis added):
I have found that in the present case the inventive concept of the Patents would be seen by the skilled team as requiring strict compliance with the 45-60% range of deferasirox. On that basis a variant will not be substantially the same as the inventive concept unless it strictly complies. I need not investigate with precision what compliance means numerically as matter of general principle. In my judgment Teva DFX does not comply.
In the Swiss case, Novartis appealed to the Supreme Court. The appeal is still pending at the time of writing.
In accordance with the outcome in main proceedings, the PI was lifted with separate order.
✍ MW
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BIBLIOGRAPHY
Case Nos. O2021_004, O2021_005 | Judgment of 20 April 2023 | ‘Deferasirox II’
Mepha Pharma AG
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Novartis AG
Panel of Judges:
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- Dr. Mark SCHWEIZER
- Dr. Tobias BREMI
- Dr. Rudolf RENTSCH
- Prisca von BALLLMOOS
- Marco ZARDI
Judge-rapporteur:
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- Dr. Tobias BREMI
Court Clerk:
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- Sven BUCHER
Representative(s) of Plaintiff:
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- Andrea MONDINI (Times)
- Dr. Andreas WELCH (Hepp Wenger Ryffel), assisting in patent matters
Representative(s) of Defendant:
Decision of 20 April 2023 in case of Novartis v. Mepha re Jadenu (deferasirox): in reversal of prelim injunction decision, API content outside claimed range not found infringing under doctrine of equivalents, O2021_004, O2021_005 Urteil 2023-04-20, https://t.co/xg5i0QcTpX pic.twitter.com/GOWrVhRA14
— Swiss Patent Court (@PatentCourt) May 8, 2023
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JUDGMENT
of 20 April 2023 in main proceedings
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ORDER
of 12 May 2023 rectifying / supplementing the judgment
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JUDGMENT
of 15 December 2021 in summary proceedings
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PATENTS IN SUIT
See EPO Register and Swissreg for bibliographic details.
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See EPO Register and Swissreg for further information.
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See EPO Register and Swissreg for further information.
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Not yet available. Currently being dealt with by the OD again, after T 1057/21, to compile the set of documents for maintenance of the patent in amended form, based on the following claims:
See EPO Register and Swissreg for further information.
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EPO BOARD OF APPEAL DECISIONS
T 0526/21 re EP 202
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T 1057/21 re EP 018
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