Technical Matters and Procedure - Annual Patents Review 2017

15 February 2018

This is the Technical Matters and Procedure chapter of Gordon Harris' Annual Patents Review 2017. For the other chapters of the review, please follow the links below or download the Annual Patents Review 2017 in full.

  1. Introduction
  2. Infringement
  3. Validity
  4. Technical Matters and Procedure
  5. Competition Law, Settlement and Licensing
  6. Employee Inventor Compensation
  7. Summary and Conclusions

4. Technical Matters and Procedure

Dealing first with the case of Anan Kasei v Molycorp[76] , this gave rise to an issue regarding disclosure.

Disclosure of experimental protocol

In a brief interim judgment, Birss J ordered Molycorp to give disclosure in respect of an experimental protocol. He said ([1]-[2]):

The fact that protocol may involve a variation from the steps in example 1 of '412 is not a reason why it does not fall within the earlier order. Therefore, it seems to me that since there is a proper case that this sort of material is in existence, it should be disclosed.

I quite understand, ultimately, your case is going to be that the protocol was developed by your expert Mr Brophy. Therefore this material may have much less or even no significance at all. However, that is a matter for trial.

The trend, supposedly, has been for less disclosure in intellectual property litigation generally, and patent litigation in particular in recent years. However, as has been evident from a number of cases this year, the judges are not afraid to order fairly substantial disclosure if they think it will further the course of justice, or, as in this case, merely ensure a level playing field, even if the issue itself is not likely to proceed much further.

Post-settlement judgment

Another interesting point arose in the case of Varian v Elekta[77]. This was a judgment of Birss J, but after the draft judgment was circulated, the parties settled the case and asked the judge not to hand down final judgment. However, the patent had been found invalid, so Birss J ruled that the public interest in knowing that the patent had been found invalid outweighed any private interests of the parties. Accordingly the judgment was duly handed down. It is not clear what effect that judgment had on the settlement itself.

Listing

In Chugai v UCB Pharma[78], a case heard by Rose J, a technical point arose in relation to listing times.

In December 2016 Chugai had commenced the claim for a declaration that one of its products was not a product which would, but for the licence granted to them, infringe any claim of the defendants' patent, and thus that no royalty should be payable under a previously concluded licence.

The issue underlying their claim was whether their product infringed a US patent.

UCB had not yet served a defence but had issued an application for the claim to be set aside or stayed and a declaration that the court had no jurisdiction or should not exercise it, contending that infringement was inextricably linked with validity, including regarding the construction of the patent in the light of US prosecution history. UCB's application was listed to be heard in late April 2017.

Chugai did not want to wait for the outcome of the jurisdictional challenge before the trial of its claim was set. It wanted the setting of the trial window to take place as soon as possible in order to ensure that it took place within 12 months in accordance with Arnold J's Practice Statement of 7th December 2015.

UCB objected on the basis of the prospects of wasted costs in respect of the main claim, which they estimated could be as much as £500,000.

Rose J considered various previous authorities which dealt with relatively similar situations, and concluded ([20]):

What I take from this is that there are often good commercial reasons why the parties choose a jurisdiction to deal with infringement points that is different from the jurisdiction where the patent was granted. The choice of jurisdiction should not lightly be overridden just because there may be aspects of the dispute that arise on the operation of the licence agreement which might turn tangentially on the validity of the patent. That must have been in the contemplation of the parties when they agreed a choice of law clause and it should not be allowed to defeat that choice.

Rose J then concluded that it would not be right to let the listing of the trial go off until May or June when the result of the jurisdiction challenge was known. She considered the decision of Laddie J in the case of Celltech v MedImmune[79]. She stressed the importance of the court enforcing the choice of jurisdiction clause that the parties had chosen in their licence, even if there was some overlap between infringement issues covered by the clause and invalidity issues which should be heard by the court of the country where the patent is registered.

Rose J noted that the wasted costs point had some merit, though also noted that it was accepted by counsel for Chugai that if costs were incurred and the jurisdiction challenge succeeded, Chugai would have to pay the costs thrown away and they were prepared to do that. The judge acknowledged that this was not a complete answer because there are always some irrecoverable costs, but she felt it did sufficiently mitigate the potential damage suffered by UCB if a stay was not granted.

Rose J placed considerable weight on the practice direction stipulation that a trial should take place within 12 months and that this is not dependent on the claimant having acted promptly in bring its claim. In other words, it is not to be put to one side simply because the claimant has not brought proceedings at the first possible point. There would have to be a very good reason why the practice direction should not be applied. Accordingly the matter was set down for trial. Rose J did however make the following proviso ([33]):

I will reflect my concern about wasted costs to this extent. I will direct that the trial be set down for a window starting no earlier than the beginning of the Hilary term in January 2018 …

The upshot of that slight postponement would be to ensure that the majority of costs in the main action need not be incurred until after the result of the jurisdiction challenge.

Experiments and related mechanisms

Daniel Alexander QC, sitting as a deputy judge again this year, handed down a notable judgment in Magnesium Elektron v Neo Chemicals[80] looking at the law regarding privilege, waiver of privilege, disclosure and other means of providing information in patent cases involving experiments. As well as providing guidance as to what might need to be made available in the course of litigation in the context of experiments, the judgment highlights the need to consider the full palate of options available under the Civil Procedure Rules - the reigning in of disclosure necessitates a broadening of legal strategy.

The issue was whether Magnesium Elektron had complied with a case management order that it "give standard disclosure by list in form N265 (modified as appropriate) (including, for the avoidance of doubt, privileged material pursuant to Mayne Pharma v Debiopharm [2006] FSR 37) in relation to the documents directly associated with or underlying the evidence adduced under paragraph 6 of this Order". Rather than providing a list of documents in the proscribed form, Magnesium Elektron provided a number of witness statements with extensive exhibits.

Daniel Alexander QC went back to first principles. He said that legal professional privilege is a fundamental right, which has long been regarded as essential for the purposes of the rule of law and access to justice (Three Rivers[81]). It extends to communications with a third party for the purposes of litigation because it is a single privilege encompassing both legal advice privilege and litigation privilege. Legal professional privilege can be abrogated by statute, but only by clear words. It may also be voluntarily eroded or destroyed by waiver.

Deployment of a document at trial may result in a waiver of privilege in other related material (Nea Karteria[82]). The scope of the waiver, said the deputy judge, is a function of the contents of the document and the nature of its deployment. This takes account of (a) the material of which the deployed document forms part and (b) the representations express and implied made by the act of deploying the document. Blanket waiver in classes of documents on the footing that part of the class has been deployed is not appropriate save in cases where, for example, a client is suing a solicitor and thereby putting the whole of the relationship in issue.

Turning to experiments in patent cases, the deputy judge said that their purpose and context meant that what was fair and reasonable to reveal or disclose, and what constituted "cherry picking", had to be seen against a different background from that of many other cases concerned with waiver or privilege. Nevertheless, once previously privileged documents were deployed, questions arose as to the scope of the waiver of privilege and the provisions regarding disclosure.

In Mayne Pharma[83], the claimant's case was that the patent was anticipated because the "inevitable" result of putting the prior art into practice was that one obtained the patented invention. Applying the Nea Karteria principles, Pumfrey J concluded that service of the notice of experiments waived the privilege in work-up experiments.

The deputy judge thought there were two kinds of cases in which the Mayne Pharma approach could be clearly and easily applied, namely "inevitable result" cases and "completeness of data" cases (i.e. where the issue is whether an experiment is repeatable or exhibits significant variation in result). However, in other cases, it may be less straightforward to describe material as "work-up" or "directly" related to a particular experiment and a more cautious or focused approach is needed. This is consistent with the modern move away from default standard disclosure towards bespoke solutions for the provision of information.

In the English legal system, disclosure is one of the key weapons for testing an opponent's case, but it can be expensive and disproportionate. Hence the updates to the CPR (Part 31, rule 5) such that standard disclosure is now one of six options. In keeping with the overriding objective, the deputy judge said that disclosure should be restricted to what is necessary in the individual case. In the context of experiments, other options for obtaining information and challenging the opponent's case include requests for further information (Part 18.1), putting written questions to experts (Part 35.6), the provisions regarding statements of case, and rival experiments. The provision of issue-specific information may be more appropriate than general or issue-based disclosure. For example, if a question is why particular criteria were employed and whether they were justifiable, the real answer may lie in the view of an expert. Such considerations are relevant both to the assessment of the scope of any waiver and the appropriate award of disclosure.

Turning to the present case, the deputy judge concluded that the disclosure required to be given did not extend, for example, to materials recording preliminary investigations leading to the particular experiment. Nor did it extend to legal advice given to Magnesium Elektron by its lawyers or to draft expert reports. Further, although not compliant with the letter of the earlier case management direction, Magnesium Elektron's approach had been "sensible" and Birss J's order should be varied accordingly.

DNIs regarding non-UK designations

Finally in this section, a very significant judgment for European patent litigation strategy was handed down in December, in Eli Lilly v Genentech[84]. In this case, Birss J refused to set aside service of Lilly's claims for declarations of non-infringement in respect of several non-UK designations of Genentech's patent. In the same proceedings, Lilly also sought declarations of non-infringement in respect of the UK designation and challenged the validity of the UK designation.

One might be forgiven for asking what is new about that, given that in Actavis v Lilly[85] the Supreme Court ruled on Actavis' claim for declarations of non-infringement in respect of a number of non-UK designations of Lilly's patent.

The interesting difference is in the facts preceding service of the claim. In the Actavis case, Actavis' lawyers wrote to the individual registered for service in respect of the UK designation of Lilly's EP '508, asking that the letter be treated as also relating to a number of non-UK designations of the same patent. In the course of subsequent correspondence, Lilly's  solicitors accepted service without limiting the acceptance to the UK designation. Actavis then issued and served on Lilly's solicitors its claim for declarations of non-infringement in respect of several designations. Lilly contested service and jurisdiction but Arnold J held that Lilly had consented to service and thereby consented to the jurisdiction of the court over the claim.[86]

Lilly ultimately triumphed in the Supreme Court in the pemetrexed litigation, as discussed above. In 2017, Lilly issued proceedings in the Patents Court seeking revocation of the UK designation of Genentech's EP '822 (UK) and declarations of non-infringement in respect of that designation. In addition, its proceedings included claims for declarations of non-infringement in relation to five other designations of EP '822 - covering France, Germany, Spain, Italy and Ireland - referred to as the "Related Claims".

Lilly obtained from the court on an ex parte basis permission to serve the proceedings out of the jurisdiction on the proprietor Genentech Inc, a US corporation; it duly served them. Genentech then applied to the court to have service set aside, running three cases.

First, Genentech argued that the service gateway (CPR Part 6) was not satisfied. It was not in dispute that Lilly had a "properly arguable case" on the merits of the case. The issue was whether Lilly had "much the better argument" that the gateway of PD 6B 3.1(4A) was applicable, this being that the Related Claims arose out of "the same or closely connected facts".

The judge considered that "the same or closely connected" tolerated differences in the facts provided they were closely connected. The underlying provision had not been enacted in order to fulfil any EU or other treaty obligations. Its purpose was to allow the joinder of such a connected claim so as to further the interests of justice, including taking into account practical considerations such as procedural economy and an avoidance of inconsistent results. An "inconsistent" result (such as a finding that the UK designation of a European patent was infringed but the German designation was not infringed by the same product) is broader than a formally "irreconcilable" result.

The judge noted that it often makes "good practical sense to try claims together if they involve common issues of fact".

In the present case, the Related Claims were claims for the same kind of relief relating to the same product on the same assumed facts as the anchor claim. Although legally distinct claims for which the applicable law for each was that of the relevant state, those laws were all based on the same key legislative materials (Art 69 EPC and the Protocol) and "experience has shown that the Patents Court is well able to deal with that sort of issue". Accordingly, Lilly had "much the better argument" that gateway 4A was applicable to the Related Claims.

Second, the judge rejected Genentech's case that the proceedings were "concerned with" the validity of the non-UK designations and thereby engaged Article 24(4) of the Recast Brussels Regulation 1215/2012 regarding exclusive jurisdiction. The judge said that it was clear that under the Regulation, it was acceptable for issues of infringement (i.e. the interpretation of claim scope) to include consideration of consequences for validity. This did not put validity in issue. Further, in the present case it was unclear whether Genentech would claim for infringement, and if it did so, whether Lilly would challenge the validity of the non-UK designations. A complicating factor was the on-going opposition to the patent at the EPO, which Lilly could join if it were sued for infringement. The judge decided that as presently constituted, the proceedings would not engage Art 24(4). Until validity was in issue the court should not set aside service.

Third, Genentech's challenge of forum non-conveniens was rejected too. The judge said that England was clearly and distinctly the most appropriate forum for trying the Related Claims in the interests of all the parties and the purposes of securing the ends of justice. The UK was a major market (possibly the largest in Europe within the lifetime of the patent) and the Patents Court was "well equipped" to handle cases of this kind, including cases which bring together a group of non-UK patents from the same European bundle as the UK patent.

So, for a European patent bundle owned by an entity located outside of the EU/EEA, the English Patents Court would appear willing to accept jurisdiction and permit service of proceedings for declarations of non-infringement spanning many non-UK designations. Actavis v Lilly is not merely an anomaly specific to its facts.

However, where the defendant patentee to be served is within the Brussels or Lugano regimes, the service rules and mechanisms are different. In Parainen v Kristian[87] Arnold J struck out claims for declarations of non-infringement in respect of Finnish and Swedish designations of a European patent. The claimant in that case sought to rely on CPR rule 63.14, which the Court of Appeal had ruled was not permissible in Actavis v Lilly. So rather more imagination will be needed to secure jurisdiction and service of declaratory proceedings against a European defendant.

Links to the other sections of the Annual Patents Review 2017 are below.

  1. Introduction
  2. Infringement
  3. Validity
  4. Technical Matters and Procedure
  5. Competition Law, Settlement and Licensing
  6. Employee Inventor Compensation
  7. Summary and Conclusions

Download the Annual Patents Review 2017 in full.

Footnotes:

[76] Anan Kasei Co., Ltd & Anr v Molycorp Chemicals & Oxides (Europe) Ltd [2017] EWHC 701 (Pat) (30 March 2017) Birss J
[77] Varian Medical Systems International AG v Elekta Limited & Anr [2017] EWHC 712 (Pat) (6 April 2017) Birss J
[78] Chugai Pharmaceuticals Co. Ltd v UCB Pharma S.A. [2017] EWHC 444 (Pat) (28 February 2017) Rose J
[79] Celltech R & D Limited v Medimmune Inc [2004] EWHC 1124 (Pat)
[80] Magnesium Elektron Limited v Neo Chemicals & Oxides (Europe) Limited & Ors [2017] EWHC 2957 (Pat) (24 November 2017) Birss J
[81] Three Rivers District Council v Bank of England (No. 6) [2004] UKHL 48
[82] Nea Karteria Maritime Co v Atlantic & Great Lakes Steamship Corporation [1991] ComLR 138
[83] Mayne Pharma Pty Ltd v Debiopharm SA [2006] EWHC 164 (Pat)
[84] Eli Lilly & Co. & Ors v Genentech, Inc [2017] EWHC 3104 (Pat) (6 December 2017) Birss J
[85] Actavis UK Limited & Ors v Eli Lilly and Company & Ors [2017] UKSC 48
[86] Actavis Group HF v Eli Lilly and Company [2012] EWHC 3316 (Pat); Actavis Group hf v Eli Lilly & Company [2013] EWCA Civ 517
[87] Parainen Pearl Shipping Limited & Ors v Kristian Gerhard Jebsen Skipsrederi AS & Ors [2017] EWHC 2570 (Pat) (18 October 2017) Arnold J


NOT LEGAL ADVICE. Information made available on this website in any form is for information purposes only. It is not, and should not be taken as, legal advice. You should not rely on, or take or fail to take any action based upon this information. Never disregard professional legal advice or delay in seeking legal advice because of something you have read on this website. Gowling WLG professionals will be pleased to discuss resolutions to specific legal concerns you may have.

Related Insights & Resources