Another Italian take on the Fulvestrant Saga. The Court of Milan on technical prejudice, plausibility and off-label use.

AstraZeneca has notoriously fought its fulvestrant patent portfolio all across Europe, including Italy, for quite some time (see for instance here, here, here and here). Fulvestrant is an oncological product used for the treatment of breast cancer and is marketed by AstraZenca as Faslodex.

The Court of Milan recently chipped in again with its decision of 3 December 2020 (No. 7930/2020, Judge Rapporteur Ms Alima Zana, AstraZeneca v. Teva, here), delivering a number of interesting points on validity and infringement of second medical use patents.

In particular, the Court argued that the Italian arm of AstraZenca’s European patent No. EP 1 272 195 (“EP195”) lacked inventive step, among other things, as it did not overcome a technical prejudice, that the claimed therapeutic indication was not plausible and that – in any case – AstraZeneca did not offer sufficient evidence of Teva’s off-label infringement.

Photo by Chokniti Khongchum on Pexels.com

Procedural background

In 2018, AstraZeneca filed an action against Teva before the Court of Milan for the alleged infringement of the EP195 patent, titled “use of fulvestrant in the treatment of resistant breast cancer”. Teva counter-claimed arguing that EP195 was invalid.

In May 2020, as Teva was about to launch Fulvestrant Teva into the Italian market, AstraZeneca filed a petition for preliminary injunction based on EP195. The Court refused the PI in August (here) as it deemed that AstraZeneca’s action did not meet the “likelihood of success on the merits” requirement (so-called fumus boni iuris). The Court thus went on to decide the case on the merits.

The patent and the allegedly infringing product

Claim 1 of EP195 reads: “Use of fulvestrant in the preparation of a medicament for the treatment of a patient with breast cancer who previously has been treated with an aromatase inhibitor and tamoxifen and has failed with such previous treatment” – a typical “Swiss-type” claim (for additional information on “Swiss-type” claims, see EPO’s Guidelines, here).

We gather that the patented use of fulvestrant (in “the treatment of a patient with breast cancer who previously has been treated with an aromatase inhibitor and tamoxifen and has failed with such previous treatment”) was not indicated in the SmPC or package leaflet of Fulvestrant Teva. The product’s marketing authorization (“MA”) would confirm this (see the 2016 version of the MA, here, and further updates here, here, here and here).

Expert opinions and foreign decisions

The Court of Milan deemed that EP195 was invalid, going against the opinion of its own Court-appointed expert. This is rather uncommon in Italian patent proceedings since Judges have no technical background and they necessarily rely on their experts’ reports. Here, however, the Court was convinced by the opinion issued by a different expert in the parallel proceedings brought by AstraZeneca against another generic company on EP195 (Docket No. 37181/2018 – this case is referred to in the judgement, but we are not aware of a published decision yet).

Also, the Court relied on the foreign decisions issued on EP195 by the German Bundespatentgericht (here), the Swiss Bundespatentgericht and the Court of Barcelona (order of 18 July 2018, confirmed in 2019, here).

In doing so, the Court stressed that judges can base their decisions also on evidence that is acquired in different proceedings between the same parties, or even different parties. The general rule of Article 116 of the Civil Procedure Code (CPC) – according to which “the judge must assess the evidence according to his or her prudent judgment, unless the law provides otherwise” – fully applies to the Expert Report issued in the parallel proceedings brought by AstraZeneca on EP195. Besides, the “parallel” Expert Report was also filed by the parties to these proceedings and heavily discussed in their briefs, so that there was no surprise argument.

Lack of inventive step

The Court-appointed Expert deemed that the closest prior art to EP195 was the “Gale” article. The Court picked the “Vogel” article instead as the closest prior art and determined the objective technical problem accordingly. Applying the EPO’s “could-would approach”, the Court of Milan concluded that the solution disclosed in EP195 (i.e., to use fulvestrant as a line of treatment for breast cancer after aromatase inhibitors and tamoxifen) lacked inventive step.

According to the Court, the person skilled in the art would have found in “Vogel” an incentive to use fulvestrant as a third line treatment, after tamoxifen and aromatase inhibitors, since (i) “Vogel” mentioned pure anti-estrogens as emerging candidates to be used in the second-to-fourth therapeutic line (ii) fulvestrant was identified as a pure anti-estrogen in a publication (“DeFriend”) referenced in “Vogel” and (iii) “Vogel” specifically taught that pure anti-estrogens inhibit the growth of a tumor already treated with tamoxifen.

The Court also denied that the use of fulvestrant after tamoxifen overcame a technical prejudice. AstraZeneca argued that because tamoxifen and fulvestrant have a similar mechanism of action, the person skilled in the art would have feared that the breast cancer may have formed resistances and mutations to fulvestrant after administration of tamoxifen. The Court, however, found that tamoxifen and fulvestrant have substantial differences, which were known in the art, and therefore no technical prejudice could arise. On this point, the Court directly referenced the German Bundespatentgericht decision (here), which found that there was no technical prejudice against the choice of fulvestrant as a pure anti-estrogen since:

the person skilled in the art associated the choice of fulvestrant with a reasonable expectation of success because Vogel considers it to be an advantageous example of a pure anti-estrogen, as it does not show any relevant side effects despite its high efficacy and shows fewer side effects than other drugs known to be effective for the endocrine treatment of breast cancer”.

Plausibility (?)

As an additional ground of invalidity, the Court of Milan stressed that the patent would be valid only in relation to a purely palliative treatment (and not as an adjuvant therapy) in a patient affected by breast cancer that was previously treated by an aromatase inhibitor and tamoxifen, where said treatments were unsuccessful. This is because the experimental data mentioned in the patent allegedly “refer only to a palliative use of fulvestrant”. Therefore, these data would show that a “plausible solution to the technical problem was found only in relation to the palliative use” of the active principle. The Court thus held that, in any case, AstraZeneca would have had to submit a limited wording of claim 1.

The Court, however, did not precisely identify which patentability requirement would have been affected by this “plausibility” issue, although novelty, inventive step and sufficiency of disclosure can all be theoretically impacted by a (lack of) plausibility argument (on the “nebulous” plausibility requirement, see a recent article by Rt. Hon. Professor Sir Robin Jacob, here). The Court was arguably hinting at an insufficiency of disclosure in relation to the therapeutic indication. It should be stressed, however, that the EPO does not expect applicants to submit clinical trials for each therapeutic indication. In particular, the EPO Guidelines (here) suggest that:

Either the application must provide suitable evidence for the claimed therapeutic effect or it must be derivable from the prior art or common general knowledge. The disclosure of experimental results in the application is not always required to establish sufficiency, in particular if the application discloses a plausible technical concept and there are no substantiated doubts that the claimed concept can be put into practice (T 950/13 citing T 578/06). Any kind of experimental data have been accepted by the boards. It has also been repeatedly emphasised that ‘it is not always necessary that results of applying the claimed composition in clinical trials, or at least to animals are reported’ (T 1273/09 citing T 609/02)”.

Besides, in an earlier case on fulvestrant (Decision of 24 July 2019, Actavis v. AstraZeneca, concerning the Italian portion of EP 2 266 573: here), the Court of Milan had rejected an insufficiency/plausibility argument by stating that: “The inclusion of examples in the patent specification is not mandatory nor is it a requirement for the sufficiency of the disclosure the completion of a clinical trial at the date of the filing, as it is possible to rely on subsequent trials (decision T 433/05), provided that the effect was plausible at the date of filing” (for a comment on this case see here).

Lack of infringement

To seal the deal, the Court of Milan then went on to say that, in any case, Teva’s product would not have infringed EP195. The Court argument goes as follows:

I. The asserted patent is a patent for a second medical use, the patent being directed at the protection of a known substance, limited to the use claimed;

II. In such a case the infringement cannot be found if the generic medicine in its marketing authorisation contains a clear limitation to uses that do not violate patent rights […]

III. In order for there to be infringement […] it is necessary that the [competitor’s] product is not only abstractly suitable for the claimed use, but that the package leaflet indicates the use of the product for the intended purpose.

This assessment is supported by the numerous proceedings in other jurisdictions that have ruled in favour of non-infringement [e.g. the decision of the Oberlandesgericht Düsseldorf, 9 January 2019, mentioned in the footnote].

The defendant’s argument that Teva’s drug is not ‘suitable’ for the claimed use is therefore correct, as this is not the case from a regulatory (since the product is not authorised for the claimed use) nor from a practical point of view (since the claimed use is not foreseen or included in the oncological practice), nor has the [plaintiff] offered any evidence to the contrary.

Due to the finding of invalidity of EP195, the Court’s non-infringement argument is ad abundantiam and consequently rather short. However, some passages are worth being discussed.

First, as to point (II), it is not entirely clear what the Court is referring to when it says that the MA of Fulvestrant Teva “contains a clear limitation to uses that do not violate patent rights”. Assuming that the Fulvestrant Teva’s MA does not explicitly include the therapeutic indication covered by EP195, the Court could be referring to the following passage in the authorization (see here and here):

The holder of the marketing authorization for the generic drug is solely responsible for full compliance with the industrial property rights of the reference medicinal product and of the patent legislation in force.

The holder of the MA of the equivalent medicine is also responsible for ensuring full compliance with the provisions of Article 14(2) of Legislative Decree 219/2006, which requires that those parts of the summary of product characteristics of the reference medicine which refer to indications or dosages still covered by a patent at the time the medicine is placed on the market are not included in the leaflets”.

If this is the case, the Court’s argument on the MA is not particularly convincing. Indeed, this wording – which is boilerplate and often included in MAs – can hardly be read as a “clear limitation to uses that do not violate patent rights”. Infringing uses are technically neither excluded nor forbidden by it, at least under patent law. The Italian Pharmaceutical Authority simply stresses that it is the generics’ responsibility to steer clear of patent rights.

Second, as to point (III), the Court would seem to suggest that patent infringement of a second medical use patent can only occur if the package leaflet “indicates the [claimed] use“. However, the fact that a specific therapeutic indication is missing from the MA, SmPC or package leaflet does not exclude per se that the drug may be used and prescribed for the patented use.

Photo by Pixabay

Besides, the Court’s argument is not fully supported by the case law of the Oberlandesgericht Düsseldorf referred to in the decision (see here and here). Although in the parallel AstraZeneca v. Teva proceedings the Düsseldorf Court found that EP195 was not infringed on the merits of the case, German case law has established that patent infringement can occur also in “off-label” cases, where the pharmaceutical product is (i) suitable to be used according to the patented indication and (ii) the manufacturer or distributor takes advantage of circumstances that ensure that the product is sold and/or is used for the intended purpose. This, in turn, requires a sufficient extent of use in accordance with the patent as well as knowledge (or at least a willful blindness) of this use on the part of the manufacturer or distributor (see Oberlandesgericht Düsseldorf, 5 May 2017, I-2 W 6/17, Estrogen Blocker, § 85, another case on EP195, here).

In any way, the Court of Milan somewhat softens its argument by adding, in the last paragraph, that AstraZeneca did not provide any evidence of the infringement by Teva or that the use of fulvestrant according to EP195 was the current oncological practice in Italy. Conversely – one may wonder – if AstraZeneca had provided sufficient evidence of the off-label use a finding of infringement could have been possible.

For further answers we now look forward to the decision of the Court of Milan in the parallel case (Docket No. 37181/2018) and will report on any interesting development.

Giovanni Trabucco

Court of Milan, 3 December 2020, Decision No. 7930/2020, AstraZeneca v. Teva

Chip patents infringement: Texas jury orders Intel to pay $2.18 billion

On March 2, 2021, a Texas jury (US District Court for the Western District of Texas, Waco), has handed down a verdict ordering Intel Corporation to pay $2.18 billion as a result of the infringement of two patents held by the company VLSI Technology LLC. (full jury’s verdict form available here).

The jury’s verdict was given against Intel after losing a patent-infringement trial over technology related to computer microprocessors (chips).

The jury, through Questions 6, 7 and 8 of the verdict amounted a lump sum of $1.5 billion for the infringement of U.S. Patent No. 7,523,373 and $675 million for the infringement of U.S. patent No. 7,725,759.

VLSI Technology affirmed that Intel was “willfully blind” of the existence of the patents in the infringement. Interestingly, while the jury found Intel guilty of such violation, it denied the existence of a “willful” infringement from Intel (Question 4). In such case, District Judge Alan Albright would have been able to raise the amount up to three times of the amount set by the jury.

A compensation of $2.18 billion is a very considerable amount, given the fact that VLSI profits are not generated from the exploitation of the patent. If endorsed, such verdict will be one of the largest patent damages given in United States history.

Alessandro Gai

US District Court for the Western District of Texas, Waco Division, jury verdict of March 2, 2021, VLSI Technology LLC v. Intel Corp, Case No. 6:21-cv-00057-ADA.




Guess Who’s in the Kitchen? (Vorwerk v. Lidl)

The Commercial Court No. 5 of Barcelona, specializing in patent law, delivered a Judgement on January 19, 2021 (in Spanish) connected to proceedings 1231/2019 (Judgement), involving German company Vorwerk & Co. Interholding GmbH (Vorwerk), manufacturer of the kitchen machine known as Thermomix, against the Spanish subsidiary of Lidl supermarkets (Lidl), distributor of the kitchen machine known as Monsieur Cuisine Connect (MCC) under Silvercrest brand.

The case relates to the infringement of European Patent EP 1269 898, validated in Spain through Spanish Patent ES 201589. Lidl, which commercialized its kitchen robot MCC in Spain from June 2018 would have infringed the “Thermomix patent“, owned by Vorwerk. As a result, Vorwerk launched the relevant proceedings for patent infringement against Lidl, who counterclaimed patent invalidity as a defence, arguing that ES 201589 patent: (i) extended the protection conferred pursuant 123(3) European Patent Convention (EPC); (ii) lacked novelty pursuant Art. 54 EPC; and it was not susceptible of industrial application pursuant Art. 57 EPC – also, the relevant Spanish Patent Law provisions were invoked.

Albeit the decision involved many other aspects, the debate focused on the food weighing function protected under patent EP 1269 898. This function, having an independent circuit from the circuit that controls the movement of the mixing bowl, allows Thermomix weighing the food while the machine works, therefore having two different circuits for mixing and weighing.

The Court dismissed the invalidity counterclaim filed by Lidl and found there was an direct infringement of European Patent EP 1269898, validated in Spain as Spanish Patent ES 201589.

In the Judgement Lidl was ordered to, inter alia: (i) cease any import, storage, commercialization -even through its distributors-, or advertising of the kitchen machine MCC; and (ii) pay damages, to be calculated in the enforcement phase of the Judgement, once the decision becomes final.

However, the enforcement of the Judgement – including the withdrawal of allegedly infringing products- will have to wait, since Lidl recently filed an appeal to the above mentioned decision. Now, the Court of Appeals of Barcelona shall decide on the merits of a case that, without a doubt, may have a paramount impact on the ability to commercialize the MCC, not only within the Spanish territory, but in other member States of the European Patent Office where EP 1269898 patent was validated.

Rubén Cano

Commercial Court N. 5 of Barcelona, January 19, 2021 – Proceedings 1231/2019 (Vorwerk & Co. Interholding GmbH v. Lidl Supermercados S.A)

Artificial inventors – the EPO President requested to comment on the Dabus case

We already referred about the Dabus case (see here, and here) and that appeal proceedings are pending before the EPO, against two decisions of 27 January 2020 that refused the applications designating an AI system as the inventor.

Now the EPO President requested the Board of Appeal to comment on the relevant questions (here). The EPO decisions held that the inventor must be a human being to fulfil the requirement for designation of inventor in the procedural and substantive terms. This seems also an international standard (based on discussions with the IP5 offices). The applicant contests such a standard. Given the importance of the issue and that this is the first time the EPO will take formal position on this, the President requested to comment on it.

The Board of Appeal granted the EPO President’s request (here). There are two main topics on which he wishes to comment. And the BoA made some additional thoughts:
(i) If the inventor must be a human being from a formal and substantive angle – what is the purpose of such requirement? Is it redundant?

The BoA advanced that:

  1. one possible view is that the sole purpose is to enhance the protection of the inventor’s right to be mentioned as such. In this case, if the application does not mention a person with legal personality as inventor, it could be argued that the requirement to designate the inventor is redundant.  This would be based on the concept that human intervention is not an inherent element of a patentable invention under Art. 52 EPC.
  2. On the other hand, if the concept of “invention” was limited to human-made inventions, the function of the inventor designation rules would also be to facilitate examination of a substantial requirement.
Risultato immagini per robots making experiments

(ii) Does the EPO have competence to examine the acquisition of the rights on the invention? If yes, what principles should the EPO apply?

The President now has 3 months to deliver his comments. More updates soon.

Francesco Banterle

EPO Board of Appeal, communication of 1 February 2021, in the appeal proceedings relating EP 3564144

No artificial inventors in UK, again

On 21 September 2020 (full text, here), the England and Wales High Court (Patents Court – Judge Marcus Smith) dismissed the appeal brought by Dr. Thaler against the IPO decision of 4 December 2019 rejecting two patent applications indicating as inventor an AI system, a creativity machine called “Dabus”. 

Can an AI be an inventor? Not yet. | MIT Technology Review
AI inventor MS TECH / GETTY, PIXABAY

We reported that both the USPTO and the EPO rejected the corresponding US and EU applications filed by Dr. Thaler, with Dabus named as the inventor (here). Similarly, in its previous decision the IPO held that Dabus fails to meet the requirements of the Patents Act 1977 and that the “inventor” must be a person – meaning a natural person and not merely a legal person. Secondly, there could be no transfer of patent right to Dr. Thaler. Dabus cannot “own” anything capable of being transferred and had no power to assign any rights it might have.

The High Court substantially confirmed the IPO decision and dismissed the various grounds of appeal advanced by Dr. Thaler:

  • Inventor must be a person. Dr. Thaler did not contend that Dabus was a natural or legal person, and focussed instead on the contention that the “inventor” of statute is a legal construct detached from the question of personality. Inventorship should not be a substantial condition of the grant of patent.  On the contrary, the Court held that under the Patents Act 1977 the applicant for a patent must be a “person” and a patent can only be granted to a “person” – whatever the meaning of the term “inventor”. This means that there is a correlation between the inventor and the first “owner” of the invention. Also, the inventor is defined by the Patents Act 1977 as the “actual deviser” of the invention. Although there is no express statement that an inventor must be a person, the term “deviser” at least implies “someone” devising “something”. The natural reading is thus that the inventor is a person and the invention a thing.
  • AI as “inventor” is incapable of conveying any property on the invention to its owner. The law differentiates between the first creation of rights in property and their subsequent transfer. Even if Dabus was capable of being an “inventor”, Dabus would by reason of its status as a thing a not a person be incapable of “own” any initial right and of conveying any property to Dr. Thaler. In sum, AI lacks any ability to “own” and “transfer”.
  • No analogy with computer-generated works. Any analogy with computer-generated works provisions under UK copyright law is to be rejected. The Court emphasized the formal role of patent applications: merely inventing something does not result in a patent being granted to the inventor. A patent must be applied for and that must be done by a person. There must either be an application by the inventor (not Dabus as it is not an inventor nor a person) or the inventor must have transferred the right to apply enabling Dr. Thaler to apply (which again cannot be the case).
Astrological and mystic robot USD 99231 (1936) by J.P. Wilson (as noticed here)

This decision comes as no surprise and furhter confirms the same position taken by the USPTO and the EPO. According to the Court, despite the absent definition of “inventor”, the law is clear (and so the concept of “inventor” as “person”). And the emerging role of AI as inventor is mostly a policy problem that lawmakers (not Courts) have to cope with.

The question is however still debated. On 7 September 2020, the UK government published a call for views on the future relationship between AI and IP (here). And WIPO conversation in July 2020 (here) showed different approaches to the inventorship issue. See for example a Chinese view from HE Juan (Senior Judge of the Intellectual Property Court of the Supreme People’s Court of the People’s Republic of China): “for AI- generated-inventions, as long as they meet the legal requirements, they are not excluded from patent protection […] There are no obstacles to recognizing AI as an inventor at the legal and practical levels. Even if the inventor is credited to be only a natural person, there is the possibility of creating a legal subject status for AI” (here). Yet, most western scholars firmly see AI as a mere tool.

In any case, Dr. Thaler is not desisting. He filed appeals in the EPO in March 2020 (here). More updates soon…

Francesco Banterle

England and Wales High Court (Patents Court), Judge Marcus Smith, decision of 21 September 2020, Stephen L Thaler v. the Comptroller-general of Patents, Designs and Trade Mark

USPTO: no room for artificial inventors

Not surprisingly, also the USPTO came to that conclusion: inventorship is limited to natural persons. Thus, this is in line with the EPO‘s and the UKIPO‘s recent decisions.

Similarly to the European cases, the decision issued on 22 April 2020 (here) came in response to two patent applications on inventions created by an AI system called “Dabus”, in the context of the Artificial Inventor Project. Dabus is also known as the Creativity machine, which was developed by Dr. Stephen Thaler, who is named as the applicant and assignee in the patent applications. The Artificial Inventor Project has filed patent applications via the Patent Cooperation Treaty in various countries including the US, UK, Germany, and China.

The applicant (Dr. Thaler) referred that the Creativity machine is programmed as a series of neural networks trained with general information to independently create. It was the machine, not a person, who recognized the novelty and salience of the inventions at stake.

The application was listing a single inventor (Dabus) and the family name “invention generated by artificial intelligence”.

The main argument of the USPTO is similar to that of the EPO:  US patent law refers to inventors as humans, individuals, or persons. The term “inventor” therefore means the individual who invented the subject matter of the invention. The patent statues preclude a broad interpretation where “inventor” could be construed to cover machines. This view was confirmed by the Federal Circuit that (albeit referring to inventorship in the context of corporations) explained that patent laws require the inventor to be a natural person (see University of Utah v. Max-Planck-Gesellschaft zur Forderung der Wiessenschaften e.V., 734 F.3d 1315 (Fed. Cir. 2013), here: “[t]o perform this mental act, inventors must be natural persons“).

Also, the Manual of Patent Examining Procedure explains that inventorship requires “conception”. And “conception” is defined as a mental act, that is the formation in the mind of the inventor of the idea of the invention. Reference to “mental” and “mind”, again, points to a natural person.

The Office has also explained that inventorship has long been a condition for patentability, as naming an incorrect inventor is a grounds for rejection.

Last, the Office has refused to enter into any policy considerations on the advantages of supporting allowing AI as inventor, as in any case “they do not overcome the plain language of the patent laws”.

Is the end of the story? As the UKIPO said, further debate is needed. It will be interesting to see what local patent offices in other countries will say, especially after a Chinese court held AI-written articles protected by copyright – see here – although a human element still appears necessary.

Francesco Banterle

The Court of Rome affirms its jurisdiction in a torpedo case

In a post of some months ago, after noting that none of the torpedoes launched in Italy after the Asclepion ruling [Italian Court of Cassation, 10 June 2013, no. 14508, in Giur. ann. dir. ind., 2013 (for a full English translation, see IIC, 2014, pp. 822 ff.)] had been successful, we envisaged a possible end to the Italian torpedo story. A recent decision of the Court of Rome shows, however, that the end is yet to come. In a non-infringement action brought against an Austrian patentee (and two other defendants, also from Austria) with regard to the Italian part and several foreign parts of a European patent, the Court of Rome firmly stated that

the Italian courts have jurisdiction … for the French, German, Austrian and UK parts of the patent, on the basis of art. 5.3, EU Council Regulation 44/2001 of 22 December 2000, whereby the courts for the place where the harmful event occurred or may occur have jurisdiction, and on the basis of art. 27 of the Regulation, concerning jurisdiction for related actions”.

The brief reasoning of the decision (full text, in Italian) exclusively stems from a quotation of the Asclepion ruling of the Court of Cassation mentioned above. With regard to this ruling and its impact on torpedo actions (as well as for a review of the most recent decisions issued in Italy on the topic), we refer to the considerations already made here.

Riccardo Perotti

Court of Rome, 5 February 2018, Anki v. Stadlbauer 

A requiem for torpedo actions? A catalogue of the most recent decisions on the issue

 

Actions

(i) relating to a European Patent

(ii) aimed at obtaining a declaration of non-infringement of different national portions of said European Patent

(iii) brought before Italian Courts

(iv) against a patentee who is not domiciled in Italy

are commonly known as Italian torpedoes (the expression is a fortunate coinage of Mario Franzosi).

These actions are often started to take advantage of the rules concerning lis pendens. Where a non-infringement action is pending before a Court (say an Italian Court) with regard to the national portion of a European Patent (say the German portion), any infringement action subsequently brought before the Court of another country (say a German Court) with regard to the same portion of the same European Patent may be stayed. This stay – and the consequent delay in ascertainment of infringement – is the goal of torpedo-launchers.

Of course, the slower the jurisdiction, the longer the stay. Thus, launching a torpedo is particularly effective in slow jurisdictions, like – at least in the past – that of Italy.

Traditionally Italian Courts have not looked with favor on such actions, seeing them as tools for misusing the (flaws of the Italian) legal system.

This traditional view was authoritatively expressed by a 2003 decision of the Joint Divisions of the Court of Cassation (the Windmöller decision), which deracinated torpedo actions on the grounds that Article 5.3 of the Brussels Convention of 1968 does not apply to non-infringement claims (Italian Court of Cassation, decision no. 19550/2003, in Giur. Ann. Dir. Ind., 2004, pp. 61 ff.). If it is the plaintiff itself which denies the existence of a harmful event, said the Court, then by definition there cannot be jurisdiction under Article 5.3 of the Brussels Convention.

A few years later, in the GAT case (here), the EU Court of Justice struck another blow against torpedoes by stating that the rule of exclusive jurisdiction laid down by Article 16.4 of the Brussels Convention of 1968 [corresponding to Article 22.4 of Regulation 44/2001] concerns all proceedings relating to the registration or validity of a patent

“irrespective of whether the issue is raised by way of an action or a plea in objection” (the principle was later incorporated in Article 24.4 of Regulation 1215/12).

As a result – and even regardless of the restrictive interpretation of Article 5.3 of the Brussels Convention given by the Windmöller ruling -, in order not to fall into the exclusive jurisdiction under Article 16.4 of the Brussels Convention and 22.4 of Regulation 44/2001, torpedo actions had to be based on pure non-infringement arguments.

In this scenario, most certainly not favorable to torpedoes, a decision of the Joint Divisions of the Court of Cassation reopened the discussion on the admissibility of this kind of action (Court of Cassation, 10 June 2013, in Giur. ann. dir. ind., 2013, pp. 60 ff.: the Asclepion case; a full English translation of the decision has been published in IIC, 2014, pp. 822 ff.). In the context of a non-infringement case brought before the Court of Rome by a German company with regard to the Italian and German portions of a European Patent owned by a US company, the Joint Divisions – quoting, word for word, the EUCJ Folien Fischer decision (here) – stated that

(aArticle 5.3 of Regulation 44/2001 … must be interpreted “as meaning that an action for a negative declaration seeking to establish the absence of liability in tort, delict, or quasi-delict falls within the scope of that provision”

and also that

 (btherefore [pertanto, in the original Italian text] with regard to the declaration of non-infringement sought … before the Court of Rome, the Italian Courts must be considered to have jurisdiction, on the grounds that they are the Courts of the place where the harmful event may occur, also with regard to the “German portion” of the European Patent” [my translation].

The 2013 Asclepion ruling certainly lent itself to interpretation as a general permit to launch torpedoes, at least when they do not rely on any arguments of invalidity. This is, indeed, what the Court said. But, looking more closely, a missing step can be seen in the reasoning of the Asclepion ruling, between statements (a) and (b). This significantly limits its practical impact.

If closing the jurisdictional door of Article 5.3 of Regulation 44/2001 to non-infringement actions, as the Windmöller 2003 decision did, fatally blocks any attempt to launch torpedoes, interpreting Article 5.3 as covering both infringement and non-infringement actions does not necessarily mean – in spite of the adverb “therefore” used by the Court of Cassation – that the Italian Courts have jurisdiction under this provision over actions concerning the foreign portions of a European Patent. To this end, something more must exist, and namely a link with Italy.

It is precisely because of the (non-) existence of this link that the torpedo actions brought before Italian Courts after the Asclepion ruling have been stopped.

In Schindler v. Otis, in line with Asclepion, the Court of Milan (Judge Dr. Marina Tavassi; decision of 27 January 2014, published in Giur. ann. dir. Ind., 2014, pp. 741 ff.) admitted that, in itself, a non-infringement action may be brought against a foreign defendant under Article 5.3. Nevertheless, it declined its jurisdiction on the non-infringement claims submitted against a US patentee, insofar as the Spanish portions of the European patent in suit were concerned. According to the Court,

Italy can be the place where the harmful event occurs or may occur only with regard to the Italian portion of a European patent, because there cannot be harm – actual or potential – caused in Italy by the alleged infringement of the Spanish portions of the patents in suit. Indeed, any national portion of a European patent is effective only in the relevant country and may be infringed only in that country” [my translation].

Therefore, in the opinion of the Court of Milan, when it comes to the infringement/non infringement of foreign portions of European patents owned by foreign patentees, there can never be a link with the country of Italy.

In the more recent Basf v. Bayer case, the Court of Milan (Judge Dr. Alessandra Dal Moro; the decision, dated 14 December 2016, published in Riv. dir. ind., 2017, I, pp. 309 ff. and also available here) fully confirmed the above approach and declared its lack of jurisdiction over the non-infringement of the foreign portion of a European patent (in particular, the German portion). In doing so, the Court explicitly dealt with the reasoning of Asclepion, clarifying why, in its view, the Court of Cassation’s decision could not be read as allowing torpedoes:

the fact that article 5.3 of Regulation 44/2001 (now replaced by Regulation 1215/2012) may be applied to non-infringement actions in no way changes the stance of the Supreme Court with regard to the existence of jurisdiction in the case of infringement (or non-infringement) of non-Italian portions of European Patents. A claim seeking a declaration whereby certain conduct does not constitute infringement of a patent means that the patent is effective, and this effectiveness is geographically limited to the perimeter of the legal system to which it refers. Outside that perimeter of effectiveness, it is not possible to discuss infringing or non-infringing conduct and it is therefore not even possible to allege an, actual or potential, ‘harmful event’” [my translation].

A further decision was issued on torpedoes in 2014, but on different grounds. In Agilent v. Oerlikon, the Court of Genova (Judge Dr. Rossella Silvestri; the decision, dated 23 April 2014, is available here) declined its jurisdiction because the torpedo-launcher had raised invalidity arguments in support of non-infringement claims concerning the German portion of a European patent and a German utility model. The claims thus fell into the exclusive jurisdiction of the Courts of the place of registration.

Hence, all the torpedoes launched in Italy after the Asclepion ruling have been dismissed on the grounds of lack of jurisdiction. Does this mean that the torpedo saga has finally come to an end?

Riccardo Perotti

The Court of Milan says that standard-essential patents may be only “optionally” implemented in compliant products.

This past September the Court of Milan issued an interesting – and so-far unpublished – decision in a patent infringement cahtc-legendse involving smartphones and standard-essential patents. The decision is noteworthy as it addressed (albeit briefly) the dynamics of standard-setting and the concept of essentiality, in partial reversal of previous decisions from the same Court and other Italian Courts.

The facts first. The case involved, on the one side, TLC giant HTC and, on the other, IPCom: a German non-practicing entity. Around 2010 IPCom pressed criminal charges against HTC, claiming that a number of HTC smartphones infringed three of its patents (EP 1 236 368, EP 0 913 979 and EP 1 226 692) that had been declared essential to a number of standards (e.g. WDCMA, SAP and UMTS). In response to this, in September 2010, HTC summoned IPCom before the Court of Milan, looking for a declaration of invalidity and non-infringement of said patents. IPCom counterclaimed for infringement, but only for EP 1 226 692 (hereinafter “EP ‘692“).

A (complex and very lengthy) technical investigation phase followed suit, with the appointment of an independent expert. In particular, it was questioned whether HTC smartphones would have directly or indirectly infringed EP ‘692, which was preliminarily deemed valid by the Court-appointed expert.

In assessing infringement, the experts and the Court had to first come at odds with the fact that EP ‘692 had been declared “essential” to ETSI, a prominent standard-setting organisation, for the UMTS standard. And that HTC smartphones were undisputedly compliant to said technical norm.

IPCom contended that since EP ‘692 was formally declared essential to the UMTS standard, every product that proved to be complaint with said standard would automatically infringe its patent.

The Court of Milan, however, viewed things differently.

In the first place, it held that a declaration of essentiality is a “necessarily unilateral” statement, particularly referring to paragraph 3.2 of the ETSI Guide on IPRs, wherein the Institute specifies that it “cannot confirm, or deny, that the patents/patent applications are, in fact, essential, or potentially essential” (for the latest version of the ESTI Guide on IPRs see here). Therefore, the Court affirmed that it had to assess the infringement on a factual and technical basis, implicitly affirming that it could not presumptively do so, on the basis of the patent’s declaration of essentiality alone.

In the second place, the Court of Milan further reviewed the UMTS technical specification at stake, noting that the execution of the activities covered by the patent (relating to the so-called PDCP layer), although regulated in the standard, were only optional for standard-compliant products. To ascertain this, the Court ordered for tests to be carried out on HTC smartphones, simulating both the network operations and the phones’ connection to the providers. As the test revealed that “the phones communicated to the base station that they cannot do” the particular operations mentioned in the patent and that, in any case, “Italian providers don’t ask them to do” said operations, the Court excluded the occurrence of both a direct and an indirect infringement of IPCom’s EP ‘692 patent.

This passage of the decision highlighted a circumstance that is often disregarded in the SEPs discourse: namely that technically-essential patents may be indeed essential, but in relation to portions of the standard that are only optionally implemented in compliant products.

In light of the above, the Court of Milan seems to have stepped away from a previous case law of 2008, where – in line with the technical report drafted by Court-appointed expert – it established infringement of a standard-essential patent by referring only to its essentiality and to the product’s necessary compliance to the standard: a sort of presumptive assessment of the infringement (see Court of Milan, 8 May 2008, Italtel s.p.a. et al. v. Sisvel s.p.a et al.; similar reasoning were put forward – although in preliminary injunction matters – also by Court of Genoa, 8 May 2004, Koniklijke Philips Electronics N.V. v. Computer Support Italcard s.r.l., in Giur. ann. dir. ind. 2006, 4949; Court of Trieste, 23 August 2011, Telefoaktiebolaget L.M. Ericsson v. ONDA Communication s.p.a. ,in Giur. ann. dir. ind. 2013, 5951).

The approach here suggested by the Court of Milan in determining the infringement of SEPs seems to better take into account the inherent technical and legal nuances of the standard setting dynamics, where the possibility of the so-called “over-disclosure” phenomenon — i.e. claiming essentiality for non-essential patents – is considered to be wide spread, and where specific technical features may often be only “optionally” implemented within standard-compliant products.

Giovanni Trabucco

Court of Milan, IP division, decision of 21 September 2016, No. 10288

Time limits for amending patent claims in pending litigations: the opinion of the Tribunal of Milan

The Tribunal of Milan (full text here) has recently ruled (for the first time) over a thorny issue concerning the Patent Limitation Procedure regulated by art 79.3 of the Italian Industrial Property Code (“CPI”). The norm states that “In a proceeding concerning nullity, the owner of the patent has the right to submit to the Court, at any stage or instance of the trial, modified claims that remain within the limits of the content of the patent application as initially filed and that does not extend the protection conferred by the patent granted” (emphasis added).

T1he facts of the dispute are simple. Thermorossi S.p.A. claimed that several competitors infringed its European patent’s Italian Portion No EP 2 083 221 on “heating apparatuses such as pellet-fired stoves and thermostoves”. As counterclaim, the defendants filed an action for the declaration of invalidity of EP ‘221.

Since an Opposition was filed against EP ‘221 and the EPO decision (through which the Patent was amended) was published only after the Italian final hearing, the owner presented to the Tribunal a set of amended claims only in the final statement.

Despite Thermorossi had known EPO’s decision only after its final hearing, Milan’s Tribunal stated that the new set of claims could not be considered in that procedure because the final hearing had already identified the object of the trial. According to the Tribunal, in light of the Constitutional principle of reasonable delay (Article 111.1 Italian Constitution), the right to file a new set of claims cannot be exercised after the final hearing.

Due to this reason, the Tribunal took into account the patent as originally approved by the EPO. Furthermore, it declared the Italian portion of EP ‘221 invalid and consequently rejected all the requests filed by Thermorossi.

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The Tribunal rightly points out that Article 79.3 CPI should be interpreted in light of the Constitutional principle of reasonable delay. This consideration is certainly well founded considering that the limitation procedure (which requires the modified claim to be within the content limits of the patent application as initially filed and does not allow to extend the protection conferred by the patent previously granted), often requires an in-depth technical analysis. However, while it is true that in applying Article 79.3 CPI the Judge has to respect the principle of reasonable delay, it is equally true that the Court must make a case by case assessment. The words “at any stage of the trial ” seem to admit the reformulation of the claims even after the final hearing if this is deemed necessary for the overall economy of the judicial procedure (the opposite solution would require the institution of a new trial).

Giovanna Sverzellati

Tribunal of Milan, IP section, decision of 20 October 2016, No. 11544