European Union: What Does Actavis v Eli Lilly Mean For European Patent Litigation Strategy?

Doctrines of equivalents in France, Spain and Germany: How do local patent experts view the UK Supreme Court's judgment in Actavis v Eli Lilly?

This article has been written jointly by the indicated authors and Carolina Pina of Garrigues. It is due to be published in The BioScience Law Review.

In a landmark judgment in July 2017, the UK Supreme Court introduced a doctrine of equivalents into modern UK patent law and by its application, refused Actavis' application for a declaration of non-infringement in respect of Eli Lilly's European patent number 1,313,508 ("EP '508") designating the UK.

The UK Supreme Court also denied Actavis' applications for declarations in respect of the French, Spanish and Italian designations of EP '508; the issue of infringement of the German designation, although originally in issue in the UK case, remains, at the time of writing, the subject of continuing litigation in Germany.

How does the outcome in the UK Supreme Court compare with the jurisprudence and practice in France, Spain, Italy and Germany? And what is the impact of the ruling for European patent litigation strategy?

Perhaps a good place to start is with an understanding of why the question of infringement of the non-UK designations was before the UK court.

Why were the non-UK designations in issue in litigation in the UK?

The overwhelming majority of the time, an issue of infringement of a European patent is litigated in the courts of the country of the relevant national designation of the patent. If there are twenty national designations, there may in theory be litigation regarding issues of infringement in those twenty different countries.

As between the Member States of the European Union (EU), this is a consequence of the legislative regime governing issues of jurisdiction: Regulation 1215/2012. According to this regime, issues of infringement of a European patent may be heard by the courts of the place in which the infringement took place (Article 26) and by the courts of the defendant's Member State of domicile (Article 4). However, pursuant to Article 24(4), the courts of each Member State have exclusive jurisdiction in proceedings concerned with the registration or validity of any European patent granted for that Member State. This has a wide interpretation; a claim for infringement is concerned with validity if invalidity is, or may be, raised as a defence (see GAT v LuK, C-4/03 and Solvay v Honeywell C-616/10).

Accordingly, a defendant alleged to infringe EP designation X in litigation brought in the courts of EU Member State Y may prevent the courts of Member State Y from continuing to hear the question of infringement of EP designation X by challenging the validity of designation X.

However, in the Actavis v Eli Lilly litigation, the claimant, Actavis, sought a declaration of non-infringement; the defendant, Lilly, being the patentee. Actavis also undertook not to challenge the validity of Lilly's patent (at least the UK designation of it) or to contend that it was invalid. Following correspondence between the parties' lawyers in the UK, which was particular to that case, the Patents Court and Court of Appeal of England and Wales were satisfied that Actavis had properly commenced the proceedings in respect of the non-UK designations by the application of the Civil Procedure Rules regarding service.

However, although the litigation proceeded in the UK, Lilly commenced proceedings in Germany against Actavis for threatened infringement of the German designation. Actavis' jurisdictional challenge in Germany was unsuccessful. The dispute regarding the German designation of EP '508 therefore proceed in Germany and Actavis discontinued the part of its claim in the English proceedings which concerned the German designation.

What was the issue regarding infringement?

For all the designations of Lilly's patent in issue before the UK Supreme Court, the question was whether Swiss form claim language to a combination of vitamin B12 and "pemetrexed disodium" was infringed by a combination of vitamin B12 with (a) pemetrexed in its diacid form, (b) pemetrexed ditromethamine, or (c) pemetrexed dipotassium.

For each of the UK, French, Spanish and Italian designations, the UK Supreme Court concluded that the diacid, ditromethamine and dipotassium forms of pemetrexed fell within the scope of the claim language pursuant to the jurisprudence of the relevant country.

How does the UK Supreme Court's ruling on the French designation compare with the jurisprudence and practice in France?

Article 69(1) of the European Patent Convention (EPC) is implemented into French law by Article L. 613-2 of the French Intellectual Property Code. Although the updated (2000) Protocol has not been transposed into the French Code, the French courts have long applied a doctrine of equivalents. It has been emphasised that whereas the application of the doctrine of equivalents cannot result in an excessive protection for the patentee, whereas an infringer should not be able to avoid condemnation by the sole adoption of equivalent means1.

Pursuant to the doctrine of equivalents in France, a variant will infringe a patent if

  1. it is used to perform the same function as the claimed means,
  2. in order to reach an identical or similar result to that of the claimed means, and
  3. the function of the claimed means is new.2

The 'function' is the 'first technical effect produced by the execution of the claimed means'3. Case law defining what is a new function is fairly sparse. It is possible for a claimed means to be inventive and yet not to concern a new function, because the claimed invention may be to a new and better way in which the relevant function can be achieved

For example, in Laboratoires Grünenthal, Mundipharma Laboratories v. Sandoz, Paris Court of First Instance, 2 July, 2010, the claim concerned a controlled release formulation containing tramadol, by the use of Tramadol + cellulose ether (M1). The formulation alleged to infringe contained tramadol and with Kollidon SR and xantham gum. The court was satisfied that xantham gum was equivalent means to cellulose ether; the alleged infringing formulation performed the same function to reach a similar result. However, because cellulose ether was known in prior art as delaying the release of the active ingredient, the function of Tramadol and cellulose ether could not be considered as being new and the claim for infringement by equivalence was dismissed.

Nevertheless, the French courts can view a patent as performing a new function if, considering the circumstances, it constituted an improvement and important technical progress having regard to prior art. In the landmark decision Pfizer v. Laboratoires Sarget and Laboratoires Plantier4, French Supreme Court, commercial chamber, 26 January 1993, No 90-16.009 and 90-16.991 a means enabling a result to be achieved "that was impossible to obtain in prior art" was new in its function. The patent in issue related to the manufacturing process of a molecule used in a patented drug.

Turning to the Actavis v Lilly case, at first instance Mr Justice Arnold concluded that the function of "pemetrexed disodium" was its efficacy in inhibiting tumour growth, and that as this was known at the date of the patent, it was not new, and so the doctrine of equivalents did not apply.

However in the Supreme Court, Lord Neuberger concluded that Lilly's EP '508 disclosed that pemetrexed disodium, when administered with vitamin B12, "could be used for a function for which it could not previously have been satisfactorily or safely used in practice", that being to treat cancerous tumours without such severe side effects. In other words, the patent constituted an improvement compared to prior art, thus the function of the claimed means was new.

From the perspective of a French lawyer, Lord Neuberger's approach would seem consistent with the approach that the French courts could be expected to take on the application of the doctrine of equivalents.

However, this is not the end of the analysis. Lord Neuberger said that "While the French courts appear to be more ready to refer to the prosecution file on issues of interpretation or scope than the German or Dutch courts, it is unclear how much, if any, difference there is in outcome".

In the authors' experience, in practice, where it is invoked by a party, French judges do routinely consider the prosecution history as part of the factual context, both when interpreting the claim language and when considering whether there is infringement pursuant to the doctrine of equivalents. French judges pay particular attention to any narrowing of the claim(s) in order to avoid any conflict with relevant prior art, and to secure the grant of the patent. If the patentee has expressly stated its intent to narrow down the scope of the patent protection and to limit it to the particular means claimed, the extent of protection of the claim can be expected to be limited to the particular claimed means and the doctrine of equivalents would not apply. Such waiver needs to be explicit, express and unambiguous5.

When considering whether to cast aside the doctrine of equivalents, French courts do not necessarily distinguish between the different reasons justifying the limitation of the claim. For example, in a Paris Court of first instance decision issued in 20116, the patent claim in issue had been limited after the EPO examiner expressed a view that proposed wording lacked sufficiency and did not have basis in the specification. The judge decided that the claim had to be limited in accordance with the amendments made because of the lack of sufficiency emphasized by the examiner.

In the context of the UK designation of the patent, Lord Neuberger considered the prosecution history of EP '508 and, in the specific circumstances of the case, concluded that the file did not justify departing from his initial view that the patent would be infringed.

Lord Neuberger did not consider whether the French court would take a different approach to the prosecution file of EP '508.

However, for the reasons explained above, it would appear at least possible that a French judge considering the Actavis v Lilly dispute would limit the extent of protection of the patent to the combination of pemetrexed disodium with vitamin B12 because of the limitations implemented during the examination process. It is therefore at least possible that in the end, a French court would have refused to conclude that the Actavis product constituted an infringement by equivalence of Eli Lilly's patent.

How does the UK Supreme Court's ruling on the Spanish designation compare with the jurisprudence and practice in Spain?

Article 69 EPC and its Protocol are integrated into Spanish law by article 68 of the Spanish Patent Law7, which states: "(1) the scope of the protection conferred by the patent or by the patent application is determined by the claims. The description and the drawings serve to interpret the claims; (...) (3) In order to determine the scope of protection in accordance with paragraphs 1 and 2 above, all elements equivalent to an element indicated in the claims must be duly taken into account".

The jurisprudence in Spain has largely followed the approach of the English courts, following the Improver line of jurisprudence; namely, purposive construction in which the questions posed by Hoffmann J may be employed. However, the courts in Spain have not exclusively followed UK authorities; rather, they have developed the approach imported from the English Improver8 case in their own way, and case law from other European countries has been considered also.

Lundbeck v Cinfa9 was a decision of the Supreme Court of Spain (Tribunal Supremo), in which Actavis was involved as one of the defendants. In the judgment the Supreme Court of Spain cast doubt on the applicability of the Improver questions. It said that while the approach is a good starting point to assess whether there has been infringement, this should be assessed on a case-by-case basis, without the assessments of foreign courts constituting a source for Spanish law. In any case, the questions were guidelines, not strict rules.

None of the parties in the Lundbeck case challenged the approach of the court below in applying the three Improver questions. The key issue for the Supreme Court was the second Improver question i.e. was the alternative proposed by the defendant obvious to the person skilled in the art who read the patent at the date of publication? What did the word 'obvious' mean in this context?

The Supreme Court of Spain rejected alignment with the so-called 'obviousness' test for invalidity. For there to be infringement, it said, a "possibility of success" was not enough. Rather, it must be "easy to see or comprehend"; there must be "a degree of predictability" which involves "a high probability", rather than a "reasonable expectation" that the variant would work.

At the priority date of EP '508, was it highly predictable to use Actavis' pemetrexed salts instead of pemetrexed disodium? As noted above, in the UK at first and second instances, Eli Lilly failed on the UK version of the test, because without testing at least the solubility of the active ingredient in question, the skilled person would not be able to predict the effect of the substitution.

In the UK Supreme Court, Lord Neuberger effectively removed the UK Improver questions from the issue of construction, reformulated them, and inserted them into the test for infringement (but still with the reminder that they remain only a guide). Following the reformulation, Lord Neuberger applied them to the facts of the case, reaching the conclusion that Actavis' variants infringed the UK designation because they varied from the invention of EP '508 in a way or ways which is or are immaterial.

Turning to the Spanish designation of EP '508, Lord Neuberger said that at local appellate level, Spanish courts have effectively adopted the approach embodied in the three questions suggested by Hoffmann J in Improver and that it was was common ground between the parties that the Spanish courts had followed the UK approach to the assessment of infringement.

The question therefore arose as to whether the Spanish courts would follow the UK's approach in re-steering the course of the jurisprudence. Lord Neuberger said that he thought, on balance, that the Spanish courts would follow this change, and also, therefore, his conclusion that Actavis' proposed products would infringe pursuant to the new doctrine of equivalents ([97]):

"I incline to the view that judicial comity would tend to suggest that the Spanish courts would follow this court in modifying the Improver questions, not least because this appears to render the UK courts and therefore the Spanish courts more consistent with the German and Dutch courts, and no more inconsistent with the French and Italian courts."

After publication by the Supreme Court of the headline outcome in the case (i.e. that the Actavis products would infringe), and shortly before the publication of the court's reasoned judgment, Actavis applied for "what would amount to a reconsideration" of this conclusion regarding Spanish law. Actavis relied in particular on the Spanish Supreme Court's decision in the Lundbeck case.

Lord Neuberger refused to re-open the debate. He said, essentially, that the argument had been raised too late. He also said that he was "by no means convinced" that even if Actavis were permitted to re-argue their case in relation to Spain, on the basis of the Lundbeck decision, a different conclusion would be reached. Finally, Lord Neuberger reiterated that if the German, Dutch, French and Italian courts would all hold that Actavis's products infringed, there would be much to be said for the view that the Spanish courts would follow suit.

Consequently, the UK Supreme Court ruled that Actavis' proposed pemetrexed medicines, which would contain the diacid, ditromethamine or dipotassium salt of pemetrexed in combination with vitamin B12, would infringe Eli Lilly's patent, which had a claim in Swiss form to pemedrexed disodium in combination with vitamin B12.

Italy

The doctrine of equivalents in Italy is beyond the scope of this article.

The Italian designation of Lilly's EP '508 was in issue in the UK litigation between Actavis. As with the French and Spanish designations, Lord Neuberger overturned the first instance judge's conclusion of non-infringement after considering and applying the expert evidence in the case on the Italian law doctrine of equivalents.

In his reasoning, Lord Neuberger essentially distinguished a judgment of the Madrid Appeal Court in Inmobiliaria Masife SL v Vale y Tino10. In that case the Madrid court concluded that a patentee was bound by an exclusion which he had agreed during prosecution. Lord Neuberger said that this had been "to overcome an objection of the examiner based on the prior art", which was "a very different point".

Interestingly, in 2017 Eli Lilly sought from the Court of Milan preliminary injunctive relief against Fresenius Kabi Oncology Plc in respect of the Italian designation of EP '50811. Fresenius sought a declaration that its generic product - based on pemetrexed diacid (with tromethamine) - did not infringe the Italian designation which (again) specified pemetrexed disodium in the claims.

After examining the EPO file history, the Court of Milan concluded that the changes Lilly had made to the claim language in the course of prosecution of EP '508 were a "clear delineation of patent protection" to pemetrexed disodium only. Consequently there was no direct infringement.

Accordingly, in preliminary proceedings, the first instance court in Italy reached a different conclusion to the UK Supreme Court on the application of the doctrine of equivalents.

It is perhaps worth noting also that on the question of indirect infringement, Fresenius was also successful before the Milan court. In this respect Fresenius' Summary of Product Characteristics was relevant. It indicated that reconstitution and dilution of Fresenius' pemetrexed product would happen in a glucose solution (rather than a saline solution - a source of sodium ions - as was the case in the dispute that reached the UK Supreme Court). The Milan Court's conclusion of no indirect infringement is therefore consistent with a conclusion reached by Arnold J in a first instance judgement in the Actavis v Lilly litigation regarding the Actavis pemetrexed products for reconstitution in dextrose rather than saline12, a judgment issued shortly after the Court of Appeal's substantive judgment in that case. However, this first instance judgment of Arnold J was also superseded by the UK Supreme Court's judgement finding infringement by equivalents.

How does the outcome of the Actavis v Eli Lilly case in the UK compare with jurisprudence, practice and the outcome of the parallel litigation in Germany?

i) Determination of the scope of protection and claim construction

The determination of the scope of protection of a patent in Germany finds its legal basis in Section 14 German Patent Act (GPA), implementing Article 69 (1) EPC into German law. It translates as follows:

"The extent of protection conferred by a patent or a patent application shall be determined by the patent claims. Nevertheless, the description and drawings shall be used to interpret the patent claims."

It should be noted in this respect, that the scope of protection of a patent must always be determined by interpretation from the perspective of the person skilled in the art and is generally not limited to the literal use of the features given in the claim(s) but also extends to "equivalents".

Principles of claim construction and permissible documents

As a basic rule under German law it is accepted that the patent claims form the basis for the determination of the scope of protection. 13 At the same time, the specification and the drawings shall be used to interpret the patent claims. However, teachings that are disclosed in the specification but not reflected in the claims can fall outside the scope. 14 In other words, the scope of protection does not extend to those teachings that are disclosed in the specification but are not at all reflected in the claims; i.e. the specification can only be used to interpret the claims insofar as it explains or defines the claims. After all, the claims need to be construed so as to avoid inconsistencies between the claims and the specification.

Section 14 GPA prescribes that the patent specification, in particular the description and the drawings, are the only source of material to be used in claim construction. Since "prosecution files" are neither listed in Art. 69 (1) EPC nor s. 14 GPA, they must generally not be used for claim interpretation. Nevertheless, on some occasions useful guidance can be drawn from the (pre-grant and post-grant) prosecution history. In this respect, courts have accepted reference to patentee's or examiner's statements during examination for evaluation of the understanding person skilled in the art and thus, as indications for the correct interpretation only.15 It should be added however that post-grant prosecution history may play a decisive role in infringement proceedings in defined circumstances: If during opposition/nullity proceedings (Germany uses a bifurcated system) the patentee accepts limitations to the scope of protection in order to maintain the patent he may not invoke the wider interpretation of its protection scope in infringement proceedings. Such self-limitation will however only be taken into account if both (bifurcated) proceedings are pursued between the same parties.

Accordingly, while not explicitly listed as means for claim construction unders. 14 GPA, a statement saying prosecution history is irrelevant in claim construction would therefore not reflect court reality.

Courts' practice on the doctrine of equivalents

Starting over 30 years ago in the "Formstein" decision, German courts have extended the concept of literal claim construction to equivalent embodiments. 16 The jurisprudence since then on equivalent infringement may serve as a fall back option in cases where literal infringement is denied.

In the "Formstein" decision, the decisive question for establishing the equivalence was "whether the person skilled in the art would, based on the invention as protected by the claims, solve the underlying problem with means having the same effect"; such means would also fall within the scope of protection. Subsequently in the so called "Schneidmesser" decisions, the Federal Supreme Court (the Bundesgerichtshof, BGH) further refined the test for establishing equivalent infringement. The crucial questions it formulated are:

  1. Do the modified means have objectively the same effect as the means specified in the claim based on the underlying problem and solution of the patent?
  2. Would the person skilled in the art have come up with the modified means on the priority date without any particular (i.e. inventive) considerations on the basis of his expert knowledge? (obviousness)
  3. Are those considerations conducted by the person skilled in the art in order to arrive at the modification based on the meaning of the teaching in the claims? (parity)

Thus, the scope of the patent usually covers those means which the skilled person, by deliberations based on the subject content of the patent claims, i.e. by studying the invention as described in the patent claims and by drawing on his technical skills, finds to be equivalent in solving the problem. In other words, when the means the variant applies for solving the problem correspond with the features stated in the patent claims with respect to their technical function and these means of solving the problem lead to (substantially) the same effect, then the patented invention is infringed in an equivalent manner.

The BGH subsequently elaborated on the criteria underlying the test in further decisions, aiming to limit a potentially vast extension of the protection scope under the equivalence doctrine. With respect to the "parity requirement" (the crucial element in the Pemetrexed case) the BGH17 clarified that variants will generally fall outside the scope of (equivalent) protection if they are only disclosed in the specification but not explicitly mentioned in the claims (so-called "selective invention").

ii) The "Pemetrexed" litigation in the German courts

District Court of Düsseldorf

After Actavis had initiated proceedings against Lilly in the UK for a declaration of non-infringement in respect of the German designation of EP'508, Lilly sued Actavis for threatened infringement before the District Court Düsseldorf. In its judgment dated 3 April 201418, the District Court Düsseldorf issued an injunction against Actavis for equivalent infringement.

Higher District Court Düsseldorf

On Actavis' appeal, the Higher District Court Düsseldorf lifted the first instance decision and dismissed the case in full (decision by OLG Düsseldorf, dated 5 March 201519), concluding that Actavis' proposed drug did not fall within the scope of protection of EP'508 literally and also when applying the doctrine of equivalents. The court held that EP'508 constituted an instance of "selective invention" and was therefore limited to the formulation explicitly mentioned in the patent claims. Although "pemetrexed dipotassium" was mentioned in the patent's description, only a different and particular pemetrexed-variant (namely "pemetrexed disodium") had been claimed by the patent, being "pemetrexed disodium". According to the court, this selection defined the scope of protection and prohibited the extension of the claim to potential equivalents.

Notably, in its reasoning, the Higher District Court Düsseldorf also made reference to the prosecution file of EP'508. However, statements contained therein were explicitly not used as mere means for interpretation but only "as indications for evaluating the person skilled in the art's understanding" of the term "pemetrexed disodium". The Court concluded from the examiner's statements that the mention of "pemetrexed disodium" in the claim did not disclose the wider term "pemetrexed". This finding supported the denial of equivalent infringement.

Federal Supreme Court (BGH)

On Eli Lilly's appeal to the BGH, the judgment of the Higher District Court Düsseldorf was annulled in June 201620. The BGH considered there to be an important difference between the facts in issue and the case law referred to by the prior instance.21

Firstly, the BGH confirmed that there was no literal infringement following a narrow claim interpretation, explaining that a wider (functional) interpretation was generally not suitable concerning chemical compounds. In relation to the use of prosecution files for interpretation purposes, the court held that statements contained therein could be used "as indications for the understanding of the knowledge of the person skilled in the art only" but generally could not be used as the sole basis of interpretation. The BGH confirmed the correct handling of the prosecution file by the appellate court in the present case.

On the question of equivalent infringement however, the BGH came to a different conclusion to that of the Higher District Court Düsseldorf22 based on the "parity" criterion of the "Schneidmesser" test. The BGH denied that the presence of a "selective-invention" could be established merely on the information given in the specification, in particular because Lilly had not self-limited the scope of the claim to distinguish the claimed invention from prior art. Accordingly, the BGH clarified that the exact scientific definition used in the claims would not alone be sufficient to deny equivalent infringement.

The case was referred back to the appellate court since further factual findings were needed in order to answer the first two questions of the Schneidmesser test - these remained unaddressed by the Higher District Court. The subsequent decision of the Higher Disttrict Court Düsseldorf is expected to be delivered within the next year.

Parallel preliminary injunction proceedings in Munich Courts

In April 2016, Lilly applied for the grant of preliminary injunctive relief to restrain Actavis' product launch for infringement of EP'508 in the District Court Munich I. The Munich court eventually granted the preliminary injunction for equivalent infringement by judgement dated 24 June 2016, i.e. in awareness and in opposition of the Higher Regional Court Düsseldorf ruling. Not being bound by the Düsseldorf decision, the Munich District Court discussed independently the issue of "selective-invention" (which would bar equivalent infringement), eventually denying it. The Munich District Court also affirmed the two other Schneidmesser questions.

Actavis' appeal was rejected in May 2017 by the Higher District Court of Munich confirming the District Court's judgment. In its grounds, the Higher District Court discussed in detail the Düsseldorf and GBH rulings, eventually putting its decision in line with the BGH's reasoning.

iii) Comparison of the UK Supreme Court and BGH judgments in the pemetrexed litigation

Both the UK Supreme Court and the BGH recognize that there is room for equivalent infringement in the absence of literal infringement; hence, both conduct a twofold assessment. In this regard, both jurisdictions have developed similar requirements that need to be fulfilled when assessing an equivalent infringement. Looking at the third Schneidmesser question (Germany) and the third reformulated Improver question (UK), both may permit consideration of the teaching of the patent rather than being rigidly constraining the claim scope by the language used in the claim (which would of course defeat the point of a doctrine of non-literal infringement).

In this respect it appears also notable, that both jurisdictions are very reluctant as regards references to the prosecution files when interpreting the scope of protection. The German courts practice of finding exceptions does not deliver a lot of legal certainty; it remains to be seen how the more permissive approach to consideration of the prosecution history accepted by Lord Neuberger in the Actavis v Lilly case will play out in the UK courts in the years to come.

What is the impact of the UK Supreme Court's ruling for European patent litigation strategy?

The Supreme Court's decision in Actavis v Eli Lilly plants a doctrine of equivalents firmly within UK patent law and is therefore a very notable judgment. In some cases, in which a patentee may previously have considered its prospects of succeeding in an infringement claim more favourable in Germany (with its doctrine of equivalents) than in the UK, the playing field would appear to have levelled.

By taking a uniform approach to the outcome of the issue of infringement, with a nod to the policy principle underpinning this approach in relation to the Spanish designation of EP '508 in particular, the UK Supreme Court has reached a consistent outcome as between Eli Lilly and Actavis in several larger EU countries in respect of a patent that pushes the boundaries of the jurisprudence everywhere. In accordance with EU Regulation 1215/2012, the UK Supreme Court's judgment is binding and enforceable between the parties to that litigation in France, Spain and Italy as well as the UK.

However, the question of whether the courts of France, Spain and Italy are bound by the UK court's ruling as to the extent of protection conferred by the patent, in litigation involving a different alleged infringement, is rather less clear in the governing legislation. The Court of Milan did not consider itself bound. Indeed, in Germany, the national jurisdictional structure actively facilitates different first instance courts in Germany reaching different conclusions (as has been seen in the two different cases brought by Lilly in Germany noted above).

If and when the Unified Patent Court (UPC) opens, a harmonised approach to the doctrine of equivalents can be expected to emerge. In testing cases this may facilitate greater consistency in the outcome of infringement claims, both as between different defendants and as between different jurisdictions.

In the meantime, is the business of pan-European declaratory relief in respect of European patents now to be considered open?

In December 2017, the Patents Court of England and Wales refused to set aside service of claims brought by Eli Lilly for declarations of non-infringement in respect of several non-UK designations of a European patent owned by Genentech Inc. Genentech being a US corporation, the rules governing service upon it of English court proceedings for declaratory relief are governed by the procedural rules in respect of the English common law, rather than EU Regulation 1215/2012.

However, in practice this may not prevent a court in another Member State accepting proceedings regarding the question of infringement of the same patent between the same parties. Italian torpedo actions have at times caused delays but have tended to miss their target. UK catapult litigation may prove more successful. But if so, be alert to other European courts, for example the Netherlands courts, which have a history of pushing the boundaries in European patent litigation, enhancing their water-gun tactics.

We look forward to continued development in European patent litigation strategy!

Footnotes:

1 Lyon Court of First Instance, 13th November 2014, No 07/02964

2 French Supreme Court, commercial chamber, 8th December 2015, No 14-13.751; French Supreme Court, commercial chamber, 29th September 2015, No 14-12.430; French Supreme Court, commercial chamber, 23rd November 2010, No 09-15.668

3 Paris Court of Appeal, 17th May 2016, No 14/10335

4 French Supreme Court, commercial chamber, 26th January 1993, No 90-16.009 and 90-16.991

5 Paris Court of Appeal, 4th section, 4th March 2009, No 07/08437, confirmed by French Supreme Court, 23rd November 2010, No 09-15.668

6 Paris Court of First Instance, 20th September 2011, No 10/02548

7 Spanish Patent Law 24/2015, of July 24th.

8 Improver Corpn v Remington Consumer Products Ltd 1990 FSR 181

9 Lundbeck v Cinfa, no 223/2015, 29 April 2015

10 Inmobiliaria Masife SL v Vale y Tino SA (decision 268/2013)

11 Fresenius Kabi Oncology Plc and Ors v Eli Lilly & Company and Ors (N.R.G. 54470/2016)

12 Actavis UK Ltd & Ors v Eli Lilly & Co 2016 EWHC 234 (Pat) (12 February 2016) Arnold J

13 Federal Supreme Court, GRUR 2004, 1023 - Bodenseitige Vereinzelungseinrichtung

14 Federal Supreme Court, GRUR 2011, 701 - Okklusionsvorrichtung.

15 Federal Supreme Court, NJW 1997, 3377, 3380, Weichvorrichtung II

16 First decision to explicitly address equivalence: Federal Supreme Court, GRUR 1986, 803 - Formstein.

17 Federal Supreme Court, GRUR 2011, 701 - Okklusionsvorrichtung

18 Federal Supreme Court decision; Docket no. 4b O 114/12

19 Federal Supreme Court decision; docket no. I-2 U 16/14

20 Federal Supreme Court decision, GRUR 2016, 921 - Pemetrexed

21 In particular Federal Supreme Court Decision - Okklusionsvorrichtung.

22 As a reminder: The Higher Regional Court had denied "parity" despite the specification's disclosed that the invention could be fulfilled with other folates, too. The Court found justification in the "selective-invention"-argument.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions