EP 3 756 767 B1 relates to modular point-of-care devices and uses thereof.
The patent derives from a third-generation divisional application ultimately deriving from the international patent application PCT/US2008/078636, with the international publication number WO2009/046227 A1.
The proprietor is Labrador Diagnostics LLC.
One of the inventors is Elisabeth Holmes from the well-known, now defunct company, Theranos.
The original application (great-grandparent), EP2205968, filed on 02.10.2008, was not opposed but has lapsed in lots of countries in 2013/2014 but not in FR, DE, UK, NL.
The grandparent, EP2657699, filed on 29.04.2009, was not opposed but has lapsed in lots of countries in 2017 but not in FR, DE, UK, NL.
The parent, EP3181228, filed on 29.04.2009, was not opposed but has lapsed in lots of countries in 2020 but not in FR, DE, UK, NL.
There is a 4th generation divisional application, EP 4 450 163, filed on 26.04.2024, which is presently under examination.
Brief outline of the case
Procedure before the EPO
The patent has been opposed at the EPO by bioMérieux and the opposition is ongoing.
In its statements of grounds of opposition, bioMérieux has brought forward a lot of objections which are in their number comparable in their extent with those originally filed at the UPC.
Labrador Diagnostics LLC filed a new MR and AR1-7 in reply to the opposition.
In reply bioMérieux argued that all claims having been drafted from scratch are full of added matter.
Labrador Diagnostics LLC has brought the decision of the UPC to the attention of the OD and insisted on the similarity of attacks before the UPC and before the EPO.
Labrador Diagnostics LLC informed the OD that the claims of AR 3 filed in the opposition match the claims of AR3 maintained by the UPC (with claims 9 and 14 renumbered to 1 and 2).
In view of the litigation before the UPC no request for acceleration has been filed by any party and the OD has not yet summoned to OP.
Procedure before other courts
In France
Albeit in a dispute about another patent, EP1883341, Labrador Diagnostics LLC, has been considered a patent troll that acquired the patents of Theranos. Its action in infringement against bioMérieux has been dismissed and Labrador was order to pay 50 000€ in costs to bioMérieux. The patent has been revoked by decision T 344/23 of 26.06.2024.
Before the UPC
Labrador Diagnostics LLC initiated an infringement action before the CFI LD Düsseldorf against a group of companies of the bioMérieux group, which in turn filed a revocation action before same CFI LD against Labrador Diagnostics LLC.
bioMérieux’ request to refer the counterclaim for revocation to the CD, for consolidation with the Revocation Case, has been allowed.
Thus, the revocation action was discussed before and decided by the CFI CD Milan Section of the UPC.
bioMérieux filed
- about 50 invalidity attacks,
- more than 12 added matter attacks,
- 3 novelty attacks, 1 insufficiency attack, and
- 6 different starting points for 30 inventive steps attacks.
Labrador has put forward various defences, but only against bioMérieux’s argument that claims 9 and 14 of the patent as granted are invalid.
The MR at the UPC consists of claims 9 and 14 as granted.
The CD Milan decision of the UPC
The headnote 1 of the decision UPC CFI 497/2024 / UPC CFI 571/2024 reaads as follows:
“An assessment based on a maximum of different documents to challenge the novelty and to argue for non-inventiveness is indeed appropriate.
The attacks not identified by the party challenging the patent as (most) promising will not be discussed on the merits because, when the party submits a number of attacks that appear to be unmanageable by the Court in accordance with the principles of proportionality (point 3 of the preamble) and speed (point 7 of the preamble[?]), and the same party is unable to re-module some of the attacks in such a way as to allow the Court to organise its time for the efficient management of the proceedings, it must be assumed that if the (most) promising attacks, after assessment of the Court, do not affect the validity of the claim(s), the others wouldn’t have done so either”.
The Court therefore asked bioMérieux to limit the number of attacks. bioMérieux requested that the Court indicate which arguments should be retained and which should be discarded. Instead, the Court asked bioMérieux to rank its arguments in order of importance. Subsequently, bioMérieux has indicated that, in respect of the novelty and inventive step attacks, she will focus the discussion during the oral hearing on a lower number of attacks.
Under R. 104 RoP UPC, relating to the Interim Conference, the Judge Rapporteur (JR) is entitled to ask the parties to limit the attacks and the AR to make their assessment more manageable, or, alternatively, to list them in a logical order, to establish a schedule for the further progress of the proceedings and to clarify the position of the parties as regards the facts in dispute.
At the end of the written procedure, the claimant and defendant must, therefore, consider all arguments and documents put forward by the other party, possibly reshaping their procedural defences based on the opposing party’s arguments, to ensure the interim conference swiftly progresses towards the oral hearing.
A particular feature of the interim conference is therefore the selection of relevant issues and therein all parties are required to contribute to the smooth management of the process so that the UPC’s decisions are issued within a limited time frame and meet the highest quality standards.
If the number of arguments proves unmanageable or overly complex for the panel, the party that filed them must, if not reduce them, at least arrange the legal pleadings in order of importance and likelihood of success.
Each legal team is therefore called upon to cooperate with the court by limiting attacks and AR, facilitating the court’s work in accordance with the principles of proportionality and fairness set out in the preamble.
However, given the judge’s impartiality, it is not the court’s role to indicate which attacks it considers to be the most promising or likely to be successful.
Consequently, the court may ask the party to arrange their legal defence in order of likelihood of success and argue that if the attacks the party considers most promising are unsuccessful, the others will be too.
Decision of the CFI CD Milan
The Court reached the conclusion that the MR and AR1 lack N because the claimed subject matter is disclosed directly and unambiguously in WO 95/08774=D5 in opposition before the EPO.
The court also held that AR2 and 3 are novel over D5=WO 95/08774, but the subject matter of the AR2 extends beyond the content of the Mother Application.
AR 3 is the combination of AR1 and 2.
The court insisted on the fact that the skilled person will not only consider the literal meaning of a certain word used in the patent claim but will also claim the technical function of a certain part addressed in the patent claim.
In other words, what matters is not the claim but what is in the description.
Comments
The last word is not yet said in the matter as the UPC’s decision can be appealed.
The opposition procedure before the EPO has barely started, but Labrador LLC was prompt to inform the OD of it success in Milan.
Limitation of the number of attacks and requests at the UPC
There is a fundamental difference in proceedings between the EPO’s BA (and the ODs) and the UPC.
An Interim Conference, cf. R 104 RoP UPC is unknown at the EPO.
In both cases, there is a JR (or an examiner in charge),but the JR at the UPC has a wealth of powers and can, based on R 104.1 RoP UPC, dealing with the Interim Procedure, limit the number of attacks and requests. This is unknown in European procedure. This is somehow worrying.
In the end bioMérieux was allowed to launch 3 N attacks and 3 different starting points to argue for non-inventiveness at the UPC.
It is interesting to note that the panel does not refer to any Article of the UPCA in its decision, but refers in two places of the preamble of the UPCA and to R 104 RoP UPC.
If the panel of a court finds itself not in the position to deal with the requests of a party, then it should simply resign and not come up with a very specious interpretation of its founding treaty.
Furthermore, whilst I could find “proportionality” in the preamble, I could not find “speed”. I am open for readers to show me where “speed”, or the like, can be found in the preamble.
Art 41(3) UPCA requires that the “Rules of Procedure shall guarantee that the decisions of the Court are of the highest quality and that proceedings are organised in the most efficient and cost effective manner”.
It cannot be inferred that the RoP authorise the court to curtail the number of attacks presented by a party in revocation proceedings. What about party disposition?
At the EPO bioMérieux launched 3 N attacks and 6 different starting points to argue for non-inventiveness of claim 9 as granted=claim 1 of the MR at the UPC.
It is also to be noted that, during an oral hearing at the UPC (=Oral Proceedings at the EPO), the presiding judge can decide when the panel is sufficiently informed and thereby limit a party’s oral submissions, cf. RoP 113.3 UPC. That filibustering should not be tolerated, but cutting the word to a party is going a trifle too far.
Respect of the right to be heard?
I wonder whether the limitation of the number of objections and requests imposed upon the parties is at all compatible with the right to be heard as acknowledged in Art 76(2) UPCA [or Art 113(1) EPC].
The present developments show once more that, when the UPCA was ratified, the parliaments were not presented with the RoP UPC. The RoP have introduced a series of procedural rulings which could not be expected when reading the UPCA.
When ratifying the UPC, the parliaments bought a pig in a poke.
It can be argued that amongst a plurality of IS attacks, some appear more successful than other, but since the procedure before the UPC is front-loaded, then a party seeking revocation should be allowed to start as many attacks as it thinks necessary. It is not for a JR to limit the number of attacks of a party or the requests of a proprietor. Is party disposition a notion which has been abolished at the UPC?
The opposition procedure at the EPO is as well front-loaded, so that limiting a priori the number of attacks, or dismissing some of them, at the choice of the opponent, is unheard and would boil down to a clear violation of the right to be heard. The same goes for the number requests. Timely filed and substantited there is a priori no limitation of the number of requests at the EPO.
An important negative side of the UPCA
Numerous authors have warned during the time leading to the ratification process, that the UPC was opening a single door for patent trolls to attack European industry.
If a French court went as far as qualifying Labrador LLC as a troll, it is difficult to deny this fact. But the proponents of the UPC were deaf on both ears to this risk.
It is also to be remembered that Ms Holms came within a hair’s breadth of being shortlisted for the Inventor of the Year at the EPO.
Legal Status of the Milan Section of the UPC
In two blog entries, Roku I and Roku II, I made clear what I thought of the legal status of the Milan Section of the UPC. No need to repeat it here.
Should Labrador LLC attempts to have the UPC decision enforced in France, it is to be hoped that a “question prioritaire de constitutionalité” or a “pre-emptive constitutionality question” will be raised in view of the legaly unclear situation of of the UPC CFI CD Section Milan.
Word of thanks
The present blog entry has been triggered by an entry in Kluwer Patent Blog.
I added a comparison between the procedures before those legal bodies.
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