On 2 January, the Italian Supreme Court put an end to the ‘latanoprost saga’ by rejecting Pfizer Italia S.r.l. (“Pfizer”)’s appeal against the Rome Court of Appeal decision ordering Pfizer to pay the Ministry of Health and the Ministry of Economy and Finance (jointly, “Italian Government”) EUR 13,360,464 as compensation for damage caused by abuse of a dominant position.
The entire summary (in English) can be read here.
The judgment (in Italian) can be read here.
Headnote and Summary: Giovanni Guglielmetti and Giulia Pasqualetto, Bonelli Erede
]]>On 4 March 2024, the Hague Local Division of the UPC issued an order relating to Plant-e’s application under Rule 262A RoP for a confidentiality order covering financial information provided with their reply to an application by Arkyne Technologies (“Bioo”) under Rule 158 RoP for security for costs in the main proceedings.
In their reply to Bioo’s Rule 158 application, Plant-e had provided redacted and unredacted versions of documents that contained commercial information to support their arguments contradicting Bioo’s contention that Plant-e’s financial position would not allow it to cover Bioo’s legal costs in the event that they were ordered to do so. The Rule 262A application for confidentiality was filed alongside this.
The redacted information concerned the investments made in Plant-e by investors and the relevant amount of said investments, information on the sales funnel of Plant-e and projected sales in the near future and more information concerning the financial situation of Plant-e than is publicly available.
In their Rule 262A application, Plant-e also requested:
a) that Bioo be ordered to pay recurring penalty payments for each breach of the confidentiality order;
b) a confidentiality regime in which the redacted information is only to be used by Bioo for the Rule 158 application and no other purposes; and
c) that only one natural person in Bioo may be granted access to the redacted information and that said person may not be involved in sales, procurement of grants and discussions with existing or potential investors, or hold a financial position within Bioo.
Bioo’s Rule 158 application was rejected prior to this order (without the Court considering the redacted information) and on 26 January 2024, the Judge-Rapporteur issued a Preliminary Order giving the parties the opportunity to provide further comments and giving Plant-e the opportunity to withdraw its Rule 262A application.
Plant-e maintained its Rule 262A application, stating that the redacted information had already been submitted and shared with Bioo’s representatives and might become relevant if an appeal was filed against the rejection of the Rule 158 application. Bioo maintained the primary position that the Rule 262A application should be dismissed.
In relation to requests a) and c) above, the parties agreed that if the Rule 262A application is granted no penalty for breach should be imposed, and to establish an “attorneys’ eyes only’’ confidentiality club such that only Bioo’s legal representatives would be allowed access to the redacted information. Plant-e amended its Rule 262A application accordingly.
The parties did not agree on b), the use of the redacted information. Plant-e argued that the use of the redacted information should be limited to the context of the Rule 158 application only. Bioo argued that the use of the redacted information should be permitted for the entirety of the proceedings pending between the parties, including both the main proceedings and the counterclaim.
Legal framework
In the UPC, the protection of trade secrets, personal data or other confidential information is governed by Article 58 of the UPC Agreement (“UPCA”) which has been implemented in Rule 262A RoP. These state the following (with emphasis added).
Article 58 UPCA:
“Protection of confidential information
To protect the trade secrets, personal data or other confidential information of a party to the proceedings or of a third party, or to prevent an abuse of evidence, the Court may order that the collection and use of evidence in proceedings before it be restricted or prohibited or that access to such evidence be restricted to specific persons.”
Rule 262A RoP:
“1. Without prejudice to Article 60(1) of the Agreement and Rules 190.1, 194.5, 196.1, 197.4, 199.1, 207.7, 209.4, 315.2 and 365.2 a party may make an Application to the Court for an order that certain information contained in its pleadings or the collection and use of evidence in proceedings may be restricted or prohibited or that access to such information or evidence be restricted to specific persons.
[…]
6. The number of persons referred to in paragraph 1 shall be no greater than necessary in order to ensure compliance with the right of the parties to the legal proceedings to an effective remedy and to a fair trial, and shall include, at least, one natural person from each party and the respective lawyers or other representatives of those parties to the legal proceedings.”
Decision
The Court considered that the redacted information, being financial information that is not in the public domain, qualified as “confidential information” according to Article 58 UPCA and Rule 262A RoP and Bioo’s response failed to provide convincing arguments to counter this assertion.
The Court considered that unprotected disclosure of this information to employees of Bioo would likely have a negative impact on Plant-e, as the proceedings involved competing small companies with limited staff. Taking into account the interests of both parties, The Court found that giving a natural person of Bioo access to the redacted information would be likely to distort competition, which should be prevented under Article 42.2 UPCA. Withholding the redacted information from a natural person of Bioo would not affect Bioo’s position in the main proceedings (as it was not relevant) or in the Rule 158 application, as sufficient information was available for the Court to take a decision on this without considering the redacted information.
The Court noted that it is not entirely clear whether denying access to at least one natural person of Bioo is in line with the legal framework of the UPC outlined above. The wording of Rule 262A.6 is identical to the wording used in Article 9(3) of Directive (EU) 2016/943, which has been implemented in different ways in member states.
For example, in Germany and Belgium, the provisions of the Directive have been extended to apply to all types of cases in which confidential information is concerned (even as just a side issue), including a strict rule that at least one natural person from each party should be granted access to the confidential information. However, in the Netherlands, the application of the Directive is limited to proceedings concerning the enforcement of trade secrets, and a different regime applies where confidential information is at issue in other proceedings (such as in patent cases), where access to such information can be limited to attorneys only where it is considered to be appropriate and in line with a fair trial.
The Court considered that the differing approaches of contracting member states gave room for flexibility to base access to confidential information in the UPC on both the circumstances of the case and type of confidential information concerned. They found justification for this approach in “the logic that the principle of fair trial is more likely to be impaired when the essence of the case is the trade secret and no natural person of a party would get access to the confidential information, as compared to a case wherein this information is a side issue (like in the case at hand)”.
In interpreting the legal framework of the UPC outlined above, the Court found that the wording of Rule 262A.1 and Article 58 UPCA allowed for a reading that, in addition to limiting access to specific persons, it is also possible in proceedings before the UPC to rule that access to confidential information be prohibited completely, as an alternative. This was specifically due to the use of the wording “restricted or prohibited or (…) restricted to specific persons” (emphasis added).
The Court also went further, and stated that even if a strict rule that at least one natural person from each party must be granted access to the confidential information was read to apply in the situation of this case (following a different interpretation of R.262A.6) it would still be possible for the parties to exclude access by natural persons through mutual agreement, or by the party concerned forfeiting its right to access by a natural person, provided that this does not impact the prospect of a fair trial.
The Court therefore ordered that only Bioo’s legal representatives shall have access to the redacted information and that the redacted information may be used by Bioo for the Rule 158 application and no other purposes.
A copy of the order can be found here.
Headnote by Eden Winlow, Bristows LLP
]]>Court of First Instance, Central Division (Munich Section) – 27 February 2024, and UPC_CFI_14/2023, Actions ACT_459505/2023 and CC_586764/2023
This decision was an Order of the judge-rapporteur András Kupecz relating to procedural matters.
As readers may be aware, the Sanofi Claimants brought a revocation action against Amgen in the Central Division on 1 June 2023. On the same date, Amgen filed an infringement action in the Munich Local Division against the Sanofi Claimants and Regeneron relating to the same patent. Regeneron subsequently filed a counterclaim for revocation of the patent.
Several procedural applications were filed in early February 2024. First, the parties requested to have the cases dealt with together by the Central Division, maintaining the hearing date that was fixed in the initial revocation action. Additionally, Amgen submitted an application to hold an interim conference and admit documents into proceedings. Finally, the Sanofi Claimants requested that they be permitted to use demonstrative evidence, including models and slides, at the main oral hearing to produce a case summary pursuant to Rule 104(e) RoP.
A hearing was held by videoconference.
Combining of actions
Five days after the hearing, a decision was issued in which the judge-rapporteur ruled that the Central Division was in principle prepared to deal with the cases jointly and to hear both cases at the oral hearing date fixed in the revocation action (4 June 2024).
It was noted that all parties must be “on the same page” regarding the grounds for revocation, arguments, facts and evidence such that the Court would be able to prepare for and deal with both cases together on the timescale originally envisaged. All facts, grounds, arguments and evidence exchanged (including all pleadings and applications) must be accepted as submitted by the Claimants in both cases and deemed to have been submitted in both actions, and the Claimants must agree to make identical submissions in both cases going forward. Arguments brought forward by the Sanofi Claimants in the revocation action must be deemed to have been submitted by Regeneron in the counterclaim and vice versa. All defences raised by Amgen must be deemed to have been raised in both actions against all Claimants.
Only costs may be dealt with separately.
Further requests
In relation to the further requests made by the Sanofi Claimants, it was agreed that they are allowed to use a number of slides (but not models) as demonstratives at the hearing and the Defendants are permitted to use the same number. The slides may not introduce any new facts or substance to the case and must cite where in the pleadings or evidence the contents of the slides can be found. The slides must be submitted four weeks in advance of the hearing.
In addition, it was agreed that the parties are allowed to submit a case summary limited to 7,500 words, provided that this does not introduce any new arguments, evidence or facts into the case. At the occasion of submitting the case summary, the Claimants were ordered to provide a consolidated list of exhibits/evidence submitted by all parties to allow each document to be referred to by one unique reference during the hearing.
The Defendant also requested the admission of documents into the proceedings. These documents had been inadvertently omitted when submitting the rejoinder and were therefore admitted by the judge-rapporteur.
In view of the current hearing, the judge-rapporteur informed the parties that he did not see the need for an interim conference.
Value of proceedings and costs
At the hearing, the judge-rapporteur informed the parties that he intended to decide the value of the proceedings for the purpose of applying the scale of ceilings for recoverable costs. The parties were in agreement with the value of the proceedings being set at EUR 100,000,000 for each action and the Court set the value accordingly.
In order for the parties and the Court to assess whether costs incurred are reasonable and proportionate, the Court and parties must have access to information showing a detailed description of the number of hours spent working on this particular case, by whom, what for and at what rate. The Court therefore allowed for the filing of additional exhibits relating to costs.
It was noted that separate submissions on costs should be made in both actions and the ceiling for recoverable costs applies in each action separately. The judge-rapporteur informed the parties that the Court will, in principle, respect an agreement between the parties on the amount of costs that is deemed reasonable and proportionate.
Experts and hearing
The judge-rapporteur informed the parties that the Court does not intend to hear any of the party experts given that reports have been exchanged and the Court did not see any added benefit in formally hearing the experts. However, the parties were permitted to bring their experts to the oral hearing, either in person or by video-link. It was noted that, should the Court have a specific question for an expert, it may ask a question to a party expert.
In reference to the hearing date, the judge-rapporteur stated that it is the Court’s firm intention to conclude the hearing in one day. The second day (5 June 2024, reserved as per the Rule 28 RoP Order) is in principle only reserved for unforeseen events, like technical difficulties.
Filing on the CMS
Finally, the parties were advised that, in order to have complete and up-to-date files in the CMS, all documents must be filed in both actions going forward.
A copy of the decision can be found here.
Headnote by Florence Plisner, Bristows LLP
]]>Correction of ´obvious slip´ in the order of 26 February 2024
`With regard to an obvious slip in Headnote 2, paragraph 3 and in accordance with the reasons of the order of 26 February 2024, Headnote 2 of the order is rectified as follows after having heard the parties:
“2. The patent claim is not only the starting point, but the decisive basis for determining the protective scope of a European patent under Art. 69 EPC in conjunction with the Protocol on the Interpretation of Art. 69 EPC.
“The interpretation of a patent claim does not depend solely on the strict, literal meaning of the wording used. Rather, the description and the drawings must always be used as explanatory aids for the interpretation of the patent claim and not only to resolve any ambiguities in the patent claim.
“However, this does not mean that the patent claim merely serves as a guideline and that its subject-matter also extends to what, after examination of the description and drawings, appears to be the subject-matter for which the patent proprietor seeks protection.
“The patent claim is to be interpreted from the point of view of a person skilled in the art.
“In applying these principles, the aim is to combine adequate protection for the patent proprietor with sufficient legal certainty for third parties.
These principles for the interpretation of a patent claim apply equally to the assessment of the infringement and the validity of a European patent.”
The order can be read here.
]]>Appeal to the Supreme Court regarding fingolimod.
Earlier, Novartis alleged Mylan infringed its Patent. In first instance PI proceedings, the preliminary relief Judge ruled that there was a serious, non negligible chance that the patent would be found to be invalid in proceedings on the merits due to lack of inventive step and denied the injunction.
On appeal, the Court of Appeal (the judgment can be read here) came to the same conclusion, albeit on different grounds, namely added matter.
The Supreme Court now dismisses the Supreme Court appeal without further argumentation as the the assessment of these complaints did not require to answer questions that are important for the unity or development of the law.
The judgment (in Dutch) can be read here.
]]>The Unified Patent Court (‘UPC’) Court of Appeal has overturned an earlier decision of the Munich Local Division that had awarded a preliminary injunction (‘PI’) to 10x Genomics in its dispute with NanoString Technologies. The Court of Appeal considered it more likely than not that the unitary patent in issue, EP 4 108 782 B1 (‘EP ‘782’) would be held to be invalid in the main proceedings due to a lack of inventive step, and therefore there was no sufficient basis for granting the PI.
The applicants (‘10x Genomics’) issued the request for a PI on the first day of operation of the UPC – 1 June 2023 – pursuant to Article 62(1) of the UPC Agreement (‘UPCA’) and Rule 211.1 of the UPC Rules of Procedure (‘RoP’) to restrain the respondent’s (‘NanoString’) activities in respect of its CosMx Spatial Molecular Imager (SMI) products for RNA detection.
Rule 211.2 RoP requires the court to have a “sufficient degree of certainty” that the patent in suit is valid. In granting the PI, the Munich Local Division found that this should be interpreted as meaning “a preponderant likelihood is necessary, but also sufficient. Therefore, for a sufficiently certain conviction on the part of the Court, it must be more probable that the patent is valid than that it is not valid”.
NanoString appealed. The Court of Appeal hearing took place on 18 December 2023, with the reasoned decision – the Court of Appeal’s first ruling on the substance of a PI application – being issued on 26 February 2024.
The Court of Appeal overturned the first instance decision. Unlike the Munich Local Division, it determined that EP’782 was likely to be held to be invalid due to a lack of inventive step. The court therefore considered that the test for awarding a PI in UPC proceedings had not been met.
The Court of Appeal provided guidance on the assessment of the merits for awarding provisional measures, such as a preliminary injunction, in accordance with the RoP. It confirmed that, in order for such measures to be granted, the court must consider it on the balance of probabilities at least more likely than not that the applicant is entitled to initiate proceedings and the patent will be infringed.
However, in respect of validity, it stated that a sufficiently certain conviction is lacking, if the court considers, on the balance of probabilities, it to be more likely than not that the patent is invalid. In contrast, the Munich Local Division had stated that such conviction requires that the validity of the patent in suit is more likely than invalidity.
The Court of Appeal went on to note that while the burden of proof for establishing the right to bring proceedings and the infringement (or imminent infringement) of the patent lies with the applicant, the burden of proof for establishing invalidity lies with the defendant.
In assessing validity, the Court of Appeal agreed with the Munich Local Division that claim 1 of EP’782 was not anticipated by the prior art. However, unlike the Munich Local Division, it found that a “sufficient degree of certainty” existed that an obviousness argument could be successfully made in main proceedings against the validity of granted claim 1 of EP’782. This finding was a result of the Court of Appeal taking a different view to the interpretation of claim 1.
The court outlined the principles for claim interpretation pursuant to Article 69 of the European Patent Convention (‘EPC’) and the Protocol on the Interpretation of Article 69 EPC, confirming that the description and drawings in the patent must always be consulted as explanatory aids for the interpretation of the relevant claim and not only be used to resolve any ambiguities in the claim. With this approach in mind, the Court of Appeal adopted a wider interpretation of claim 1 of EP’782 than the Munich Local Division, leading it to conclude that a successful obviousness argument may be made and therefore that the validity of the patent had not been established with the required “sufficient degree of certainty”.
Overall, the Court of Appeal found that there was no sufficient basis for the issuance of a PI.
This decision will provide at least some temporary relief to NanoString, despite the UPC declining to stay the proceedings even though NanoString recently filed for Chapter 11 bankruptcy in the US. Also worth noting is the fact that an injunction is still in place in Germany in favour of 10x Genomics and the oral hearings in the main UPC proceedings for both EP ‘782 and EP ‘928 are expected to take place later this year, so the outcome of this dispute is still far from certain.
As a final comment, it is worth noting that Court of Appeal implicitly confirms the Munich Local Division’s rejection of the defendants’ argument that according to German national case law, the revocation of the patent only needs to be possible. Despite many comments about the expected influence of ‘couleur locale’, and in particular, the influence of German case law, the UPC appears to be taking an independent approach to developing its own case law on the application of the UPCA and the RoP.
]]>EPLAW members have received a link which they can forward to their eligible associates. An informal reception will take place on 28 April from 7 to 11pm in The Merode, which is walking distance from the venue.
A limited number of rooms have been reserved at a discounted price in The Hotel. The reservation link can be found in the registration form.
The full program will be available approximately one month before the event.
The Young EPLAW Congress is an event for lawyer associates of current EPLAW members, who are on track to become members of EPLAW in the future. EPLAW is an Association of experienced patent lawyers in the European community with the aim of promoting the equitable and efficacious handling of patent disputes across Europe.
]]>Plant-e Knowledge B.V & Plant-e B.V. v Arkyne Technologies S.L – Court of First Instance – The Hague (NL) Local Division, 15 February 2024, Case no. UPC_CFI_239/2023
A topic often discussed prior to the UPC’s opening was the prospect that local and regional divisions may elect to bifurcate proceedings where a revocation counterclaim was filed to an infringement action, and how this may impact timing of decisions and harmonisation of laws.
So far, however, the issue has not arisen, with the court taking a pragmatic approach to case management, and electing to not bifurcate proceedings.
(This is of course, separate to cases where a revocation action is filed before the Central Division, and a separate infringement action before a Local or Regional Division.)
The court’s pragmatic approach has been reinforced by a recent order by the Hague Local Division which decided to hear both the infringement action and revocation counterclaim in a dispute relating to technology for generating electricity with plants.
The claimants (‘Plant-e’) issued an infringement action before The Hague Local Division, and the defendant (‘Arkyne’) responded with a counterclaim for revocation. Article 33(3) of the UPC Agreement (‘UPCA’) provides the court with a number of options in such scenarios. The local or regional division concerned may either proceed with both actions (Article 33(3)(a) UPCA), refer the counterclaim for revocation to the Central Division and either stay or proceed with the infringement action (Article 33(3)(b) UPCA), or refer the entire case to the Central Division (Article 33(3)(c) UPCA).
In this case, as is required, the court invited the parties to comment on the application of Article 33(3) UPCA. Both the claimants and defendant asked the court to proceed with both claims. The court agreed with this approach, on the grounds that jointly hearing both actions was appropriate for reasons of procedural expediency and would avoid any delay caused by bifurcating, thus continuing to emphasise the UPC’s commitment to its aim of reaching decisions quickly.
The court commented that hearing both actions would be preferable to ensure a uniform interpretation of the patent in suit by the same panel composed of the same judges, demonstrating a commitment to the overall aim of harmonising laws.
Finally, the court noted that this course was also the parties’ preference.
While apparently unremarkable, the order is nevertheless of interest because it follows three earlier orders of a different local division – the Dusseldorf Local Division – which also chose not to bifurcate (myStromer AG v Revolt Zycling AG UPC_CFI_260/2023; N.V. Nutricia v Nestlé Health Science (Deutschland) GmbH UPC_CFI_201/2023; Franz Kaldewei GmbH v Bette GmbH UPC_CFI_7/2023).
While it is still early days, is perhaps starting to demonstrate a developing trend. However, these cases have followed the same reasoning, and it is notable that the approach taken was that preferred by the parties. Where the parties disagree on bifurcation will be the real test to the UPC’s approach, and with the increasing number of complex disputes coming before the UPC, this will likely arise in the future.
The order can be read here.
]]>Method of transporting mushroom compost. No infringement:
“Placing blocks on pallets in this manner does not meet the characteristics that stacked compost blocks are supported by spacer(s), providing rows and columns of stacked blocks, leaving a vertical space between those stacked blocks for ventilation, adapted to regulate temperature, carbon dioxide content, and/or humidity (characteristics d), e), and g))”
The judgment (in Dutch) can be read here.
]]>SUMMARY:
“Pursuant to the “Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence” (October 30, 2023), the United States Patent and Trademark Office (USPTO or Office) is issuing inventorship guidance for inventions assisted by artificial intelligence (AI). The guidance provides clarity for USPTO stakeholders and personnel, including the Central Reexamination Unit and the Patent Trial and Appeal Board (PTAB or Board), on how the USPTO will analyze inventorship issues as AI systems, including generative AI, play a greater role in the innovation process. This guidance explains that while AI-assisted inventions are not categorically unpatentable, the inventorship analysis should focus on human contributions, as patents function to incentivize and reward human ingenuity. Patent protection may be sought for inventions for which a natural person provided a significant contribution to the invention, and the guidance provides procedures for determining the same. Finally, the guidance discusses the impact these procedures have on other aspects of patent practice. The USPTO is seeking public comments on this inventorship guidance for AI-assisted inventions.
DATES:
Applicability Date:
“The inventorship guidance for AI-assisted inventions is effective on February 13, 2024. This guidance applies to all applications, and to all patents resulting from applications, filed before, on, or after February 13, 2024.”
Comment Deadline Date:
“Written comments must be received on or before May 13, 2024.”
The notice can be read here.
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