High Court refuses broad discovery orders in patent infringement case, allowing limited searches on proportionality grounds.
Legislator summary
AI generatedThe High Court refused discovery requests for categories 3, 4, 6, 7, and 8 due to lack of relevance, privilege, or disproportionality. While discovery was ordered for Category 5 and the specific O'Brien study connection in Category 15(i), the court restricted the scope to ensure proportionality. The decision balanced the plaintiffs' need for evidence against the defendants' arguments regarding privilege and the scale of the requested documents.
Legislator headnote
AI generateds. 94 of the Patents Act 1992; s. 33 of the Civil Procedure Rules 1996: Discovery orders must satisfy relevance, necessity, and proportionality, and privileged communications or disproportionate requests are refused.
Keywords
AI generatedCited Legislation
AI generatedCited Case Law
AI generatedRelated Decisions
AI generatedFull text
[2018] IEHC 239
THE HIGH COURT
2017 No. 4024 P
Between:
BIOGEN INC.,
F HOFFMANN-LA ROCHE AG
and
GENENTECH INC.
Plaintiffs
– and –
CELLTRION INC.,
CELLTRION HEALTHCARE HUNGARY KFT.,
MUNDIPHARMA INTERNATIONAL LIMITED
and
MUNDIPHARMA PHARMACEUTICALS LIMITED
Defendants
JUDGMENT of Mr Justice Max Barrett delivered on 4th May, 2018.
I
Background
1. These proceedings concern an action for infringement of (1) Irish Patent No. 1 951 304 entitled ‘Method for treating Joint Damage’
which protects rituximab in the MabThera label use for the treatment of arthritis (valid until 14th November, 2026) (the ‘304 Patent’);
and (2) Irish Patent No. 2 055 313 entitled ‘Treatment of hematologic malignancies associated with circulating tumor cells using
chimeric anti-CD20 antibody’ which protects rituximab in the MabThera label use for the treatment of chronic lymphocytic leukaemia
(valid until 9th November, 2019) (the ‘313 Patent’).
2. The substance of the dispute between the parties can be stated briefly. On or about 17th February, 2017, the European Medicines
Agency granted a marketing authorisation to Celltrion Healthcare Hungary KFT for a biosimilar of the plaintiffs’ medicinal product
MabThera (rituximab) under the designation ‘Truxima®’. Truxima is intended for the treatment of non-Hodgkin’s lymphoma, chronic
lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis. It is the plaintiffs’ case that
Truxima infringes the 304 Patent and the 313 Patent. The defendants contend that each of the 304 Patent and the 313 Patent is
invalid. Accordingly, the defendants have counterclaimed for invalidity and seek orders revoking each of the said patents, on grounds
of added matter, lack of novelty and insufficiency. The prior art documents relied on by the defendants are specified in the particulars
of objection.
3. The within application comprises an application for discovery made by the defendants in the context of the above-titled
proceedings. The defendants sought discovery of 15 categories of documents by letter dated 27th November, 2017. Of those 15
categories, Categories 1, 2, 10, 11, 12, 13, 14, and 15 (ii)-(v) (but not 15(i)) have been agreed either as sought or in an amended
form. Categories 3, 4, 5, 6, 7, 8, 9, and 15(i) are in dispute. The position as regards each of the categories in dispute at the time of
the hearing is as follows:
No. Original Request Counter-Offer (if any).
3 All documents created in the period between
15.12.00-22.10.14 howsoever described
concerning the conception, development
and reduction to practice of the subject-
matter disclosed or claimed in the 304
Patent and for the avoidance of doubt the
earlier related US patent application
737291P (from which the priority date of the
304 Patent is derived), including (but not
limited to) all laboratory notebooks of the
named inventors, Mark Totoritis, Timothy
Mark Shaw, Sunil Agarwal, David Yocum and
Ariella Kelman and their laboratory
technicians, correspondence, files,
memoranda, notes, calendars and research
of the said named inventors and any co-
worker who directly assisted them with
regard to the subject-matter of the 304
Patent in respect of each feature of the 304
Patent or any other equivalent patent.
4 All documents created in the period between
09.11.93 and 29.04.15 howsoever described
concerning the conception, development
and reduction to practice of the subject-
matter disclosed or claimed in the 313
Patent and for the avoidance of doubt the
earlier related US Patent application
107658P (from which the priority date of the
313 Patent is derived), including (but not
limited to) all laboratory notebooks of the
named inventors, Antonio J. Grillo-Lopez and
Christine A White and their laboratory
technicians, correspondence, files,
memoranda, notes calendars and research
of the said named inventors and any co-
worker who directly assisted them with
regard to the subject-matter, of the 313
Patent in respect of each feature of the 313
Patent or any other equivalent patent.
5 All documents relating to the decision to
undertake the trial of rituximab for use to
treat chronic lymphocytic leukaemia as
described within the claims of the 313
Patent, which came into existence at any
time between 09.11.96-09.11.00.
6 All documents created in the period between
15.11.00-22.10.14 which disclose or
evidence the consideration (if any) given by
the inventors of the 304 Patent, Mark
Totoritis, Timothy Mark Shaw, Sunil Agarwal,
David Yocum and Ariella Kelman, and/or their
laboratory technicians and/or by or on
behalf of the first-named plaintiff to the
prior art referred to or related to that listed
in the particulars of objections dated
11.09.2017, including any documents
disclosing or evidencing any consideration or
evaluation by the inventors and/or their
technicians and/or by on behalf of the
plaintiffs as to the potential effect of any
such alleged prior art on the patentability of
the subject-matter disclosed in the 304
Patent or any other equivalent patent.
7 All documents created in the period between
09.11.93-29.04.15 which disclose or
evidence the consideration (if any) given by
the inventors of the 313 Patent, Antonio J
Grillo-Lopez and Christine A White, and/or
their laboratory technicians, and/or by or on
behalf of the plaintiffs to the prior art
referred to or related to that listed in the
particulars of objections dated 11.09.2017,
including any documents disclosing or
evidencing any consideration or evaluation
by the inventors and/or their technicians
and/or by or on behalf of the plaintiffs as to
the potential effect of any such alleged prior
art on the patentability of the subject
matter disclosed in the 313 Patent or any
other equivalent patent.
8 All documents created in the period between
15.11.00 and 22.10.14 which concern or
refer to the issue of validity of the 304
Patent which have been shown to, provided
to, sent to or received from any expert,
consultant or in-house counsel and/or
patent attorneys who are or had been
retained by the Plaintiffs in respect of such
issue.
9 All documents created in the period between
09.11.93 and 29.04.15 which concern or
refer to the issue of validity of the 313
Patent which have been shown to, provided
to, sent to or received from any expert,
consultant or in-house counsel and/or
patent attorneys who are or had been
retained by the plaintiffs in respect of such
issue.
15(i) Documents and communications concerning Plaintiffs’ letter dated
the study described in the O’Brien Study 14.12.17:
[1], including but not limited to (i) any
communications between the plaintiffs and In respect of category 15(i),
the authors of the O’Brien Study (Susan plaintiffs offered:
O’Brien, Emil J Freireich, Michael Andreef,
Michael J Keating and/or Susan Lerner) (i) “an electronic search
relating to the O’Brien Study… utilising appropriate search
terms of the discovery
[1] I.e. the publication entitled “Phase I/II previously made by them in
Study of Rituxan in Chronic Lymphocytic the US Massachusetts
Leukaemia (CLL)” (Blood, Vol 92 at page proceedings, with the search
105A by S O’Brien et al, which was published confined to the documents
on 09.11.98) as cited in the defendants’ disclosed in those
particulars of objections. proceedings and search
terms being selected with a
view to locating documents
which would fall within this
category.”
II
Some Introductory Observations
4. The court turns to a consideration of applicable case-law later below and brings same to bear in its consideration of the categories
of discovery now sought. However, it may be useful to commence with a number of introductory observations.
(1) in the general course of events it is untypical to have a discovery application applicable to 14 and 22-year periods;
such a lengthy period of discovery requires very explicit justification.
(2) the proper approach to every discovery application, whether in the patent law context or otherwise, is to look at
each category sought and to assess same by reference to a trinity of criteria (relevance, necessity and proportionality).
It is necessary to note this because in the course of hearing the court was presented with a grid of past discovery
applications in which certain categories of discovery were granted. The most that can be said of such a grid is that it
shows that (a) discovery of Category X was granted in the context of some other Case A and/or B and/or C, and so (b) it
is not unheard of for discovery of Category X to be granted. But in terms of assessing relevance, necessity and
proportionality when it comes to Case D, E, etc., such an assessment falls always to be done on case-by-case basis by
relevance to the individual circumstances at hand. (The grid furnished to the court in the within proceedings was in any
event slightly unusual in that it omitted consideration of the decision of the Court of Appeal in Boehringer Ingelheim
Pharma GmbH v. Norton (Waterford) Ltd [2016] IECA 67, a case which, as will be seen hereafter, is of no little
importance when it comes to determining the application now at hand).
(3) the court was repeatedly referred to the actions of the plaintiffs in certain United Kingdom proceedings that
correspond to those at hand. Those United Kingdom proceedings were compromised at the point where standard
disclosure was to be made, which disclosure would apparently have yielded documentation akin to, though not quite as
wide as, that now sought in Category 5. For what it is worth, the court notes in passing that none of Categories 3, 4, 6,
7, 8, 9, and 15(i) were sought by way of discovery in the United Kingdom proceedings.
(4) as regards dealings between the parties in the United States (which related to certain proceedings in the
Netherlands), the court notes that (i) the plaintiffs have offered in respect of Category 15(i) what was offered in the
United States but is being met with the response that in Ireland more is needed, (ii) in respect of Category 3, what was
sought and agreed by defendants in the United States in this regard was far narrower than what is now being sought by
way of Category 3.
III
Some Applicable Law
5. The general principles applicable to an inter partes application for discovery such as that now presenting are identified in the
decisions of the Court of Appeal in BAM PPP PGGM Infrastructure Cooperatie UA v. National Treasury Management Agency [2015]
IECA 246, para. 29, as echoed in Boehringer Ingelheim Pharma GmBH v. Norton (Waterford) Ltd, op. cit., para.12. As noted by Finlay
Geoghegan J. in the latter judgment, at para.12, “The principles applicable to discovery in patent cases…[are] not different to
discovery in other types of cases”. It did not seem to the court that when it comes to the general legal principles applicable there
was much dispute between the parties. What was in issue was the import and consequences of those principles in the context of the
application at hand.
IV
This Case and the Decision in Boehringer
(i) Similarities and Distinctions.
a. Similarities.
6. Categories 3, 4, 6, 7, 8 and 9 in the within proceedings appear to have been quite closely modelled on what was sought in
Boehringer. In this regard the following points seem of especial note: (i) Categories 3, 4, 6 and 7 (a) embrace and go beyond the so-
called ‘inventor’s files’ in respect of each of the 304 Patent and the 313 Patent, (b) are in almost identical terms to the Categories 2
and 3 that were refused by the Court of Appeal in Boehringer; (ii) Categories 8 and 9 (a) seek documents concerning the validity of
the 304 Patent and the 313 Patent and (b) are in almost identical terms to Category 4 which was refused by the Court of Appeal in
Boehringer.
b. Distinctions.
7. The defendants note that (1) the within proceedings are infringement proceedings whereas those in Boehringer were revocation
proceedings, (2) the cost of making discovery has not been identified with the same clarity as in Boehringer. As to (1), there is also
in the within proceedings a counterclaim for invalidity, so the distinction which it is sought to make in this regard is of no practical
consequence. As to (2), the court does not accept that this is so when it has regard to the averments of Ms Murphy as considered in
Part VI below.
(ii) Inventors’ Notebooks.
8. When it comes to the so-called ‘inventors’ notebooks’, the court notes as follows:
(1) as in Boehringer the defendants’ claims concerning lack of inventive step will be determined by reference to objective
evidence from expert witnesses; consistent with Boehringer, para. 32, “[s]econdary evidence of contemporary events
may not be totally excluded…[but] must be kept firmly in its place”;
(2) the defendants have not manifested an intention to call one or more inventors by way of secondary evidence; the
plaintiffs have indicated that they do not anticipate calling any inventors as witnesses (another key similarity with
Boehringer where the fact that no inventor/s was/were to be called was considered material);
(3) as in Boehringer, the evidence before the court is that (a) the burden in terms of assembling the documents specified
in the disputed categories is great (see further the consideration of the affidavit evidence of Ms Murphy in Part VI below),
(b) that burden is accentuated by the lengthy periods in respect of which discovery is sought, (c) that burden is
disproportionate when one has regard to the limited relevance of what is sought. (In passing, and without prejudice to
any of the foregoing, the court notes that it does not accept that an attempt made by defendants pre-hearing to elicit
from the plaintiffs what temporal period the plaintiffs could ‘live with’ is tacit acknowledgement of the excessive temporal
scope of the discovery sought; it was simply an attempt to see if some agreement could be reached without having
recourse to the court, something that is to be encouraged).
(iii) Category 5.
9. Category 5 concerns the so-called ‘inventors’ notebooks’ (and certain other documents that concern the alleged inventions that
are the subject-matter of the impugned patents). As regards the so-called ‘inventors’ notebooks’, the points just made apply with
equal vigour.
V
The Compromised Proceedings
10. The defendants submit that the plaintiffs had agreed to make discovery of Category 5 in the United Kingdom. However:
(1) Ms Murphy avers that such agreement as was reached in this regard was “to conduct a reasonable and proportionate
search for such documents and to disclose what was identified”, adding that “It was never the case that the Plaintiffs
agreed to disclose all such documents” [emphasis in original];
(2) the court notes in passing that Carr J., a judge of the High Court of England and Wales, appears to have been quite
sceptical as to the relevance of the standard disclosure, observing on 25th February, 2016, in the later-compromised
United Kingdom proceedings (at p.40 of the transcript submitted to this Court) that “I have already expressed my
concern about this potentially vast disclosure exercise, which may well produce virtually nothing of any relevance….If
that is what the parties have agreed, fair enough, but you might reconsider it”;
(3) the said proceedings, as mentioned, were eventually compromised; the court does not consider that it adds anything
for it to join the defendants in their conjectures as to why the plaintiffs elected in their absolute discretion to compromise
the United Kingdom proceedings.
VI
A Category-by-Category Consideration
11. In addition to the general points touched upon in the preceding pages, the following points might also be made in respect of the
individual categories of discovery sought.
(i) Category 3.
12. Category 3 is a wide category of a type which the Court of Appeal in Boehringer viewed as of such limited relevance that its
necessity and proportionality had to be carefully considered. The key point made in Boehringer was to point out that this material is in
principle of secondary significance. It was also considered a significant factor in Boehringer that this material was not sought in
corresponding proceedings in the United Kingdom (which is the same position here). Relevant too in Boehringer was that it was going
to be a very significant burden on the maker of discovery to make the discovery and that probity had to be assessed in that context.
Category 3 has been referred to as the so-called ‘inventors’ notebooks’ category; however, on close inspection it is considerably
wider than that. Thus it embraces everything concerning conception, development, and reduction to practice. When it comes to the
relevance of this category, its relevance is asserted in the context of inventiveness (with the test for inventiveness being as
identified by Oliver L.J. in his renowned judgment in Windsurfing Intenational Inc. v. Tabur Marine (Great Britain) Ltd [1985] RPC 59,
73, as approved by Finlay Geoghegan J. in Schneider v. C Medsystems [2007] 2 ILRM 300, 310).
13. Turning again to Boehringer, the Court of Appeal was concerned there with categories that were more narrowly cast than the
ones sought in the within application. They were categories of a nature that had been considered and in some instances ordered in
previous cases, and while the Court of Appeal in Boehringer did not change the principles applicable, it reconsidered the
appropriateness of discovery in the context of the existing principles. So if one goes to Boehringer, 4-6, and has regard to the
categories of discovery identified there, one can see that it concerns categories which are very similar to the ones sought here. The
general principles are set out by the Court of Appeal, at 7, with some emphasis being placed on proportionality. Then it is noted at
page 9 that in Medtronic Inc. v. Guidant Corporation (Unreported, High Court, 23rd February, 2007) Kelly J. emphasised the
importance of considering “the necessity for the documents having regard to all the relevant circumstances, including the burden,
scale and cost of the discovery sought”. Then, from 9, some emphasis was placed by the Court of Appeal on what had happened in
parallel United Kingdom proceedings, it being noted, at 11, that in the United Kingdom:
“Arnold J. took the view that the documents which Boehringer was proposing to disclose, but in respect of which there
was a dispute concerning the confidentiality conditions, were not disclosable having regard to the issues in the case. He
stated:-
‘So far as the revocation claim is concerned…the ordinary obviousness case, as I see it, the position is straightforward,
viz. that we have an allegation of obviousness over two prior art documents.’
…It is expressly acknowledged that there is no claim of obviousness over common general knowledge alone and
therefore your client's disclosure, the U-Reports that are talked about in Mr. Cordell’s evidence, I cannot begin to see
that they are of relevance. The only other validity plea is the AgrEvo plea also run on the basis of insufficiency which is
all about plausibility on the face of the patent….
Later in the exchanges with counsel at the same hearing Arnold J. expressed concern that
‘Time after time in the patents court, I see parties agreeing to give disclosure at considerable expense when it turns out
it is of no relevance.’”
(As noted previously above, a similar comment to the last-quoted observation of Arnold J. was made by Carr J. in the United Kingdom
proceedings corresponding to the within proceedings, though only in respect of Category 5 (because the other disputed categories
were not sought in the United Kingdom proceedings)).
14. Moving on with the consideration of the Court of Appeal’s judgment in Boehringer, Finlay Geoghegan J., at 15–17, addresses
precisely the arguments invoked by Celltrion in the support of the within application, observing:
“There is no dispute that the claim of obviousness or the issue of inventive step over the cited prior art must be
determined in accordance with the well-known statements of Oliver L.J. in Windsurfing….The primary evidence at trial
will be that of properly qualified expert witnesses. Secondary evidence of contemporary events may not be totally
excluded in accordance with the decision in Molnlycke AV v. Proctor and Gamble Limited (No 5) [1994] RC 49. However,
as is clear from that judgment, secondary evidence of that type must be kept firmly in its place and will vary from case
to case.”
15. The secondary evidence in Boehringer was testimony of the inventor. In the within case it is not presently anticipated that the
inventors will be giving any evidence.
16. Finlay Geoghegan J. continues:
“I do not understand Teva to have made any case in the High Court or before us that they were proposing to call
secondary evidence [i.e. evidence of inventors] of the type envisaged in Molnlycke. The fact that the claim is
obviousness over cited prior art and not over common general knowledge may explain this. [Court Note: the same
applies here.] I have noted that…[Arnold J.] in his comments identified that this was a case of obviousness over specified
prior art and not over common general knowledge prior to expressing his view of lack of relevance of the proposed
disclosure of what might be generically referred to as inventor’s note books.”
…In the course of the hearing before this Court, counsel for Boehringer confirmed that they were not intending to call
an inventor and counsel for Teva indicated likewise.
…Insofar as the claim of lack of sufficiency or plausibility is concerned, it appears to be accepted that such claim falls to
be determined by objective construction of the patent and that again expert evidence will be the only relevant evidence.
…
In my view the trial judge was correct in concluding that categories 1 to 4 include documents which as a matter of
probability are relevant in accordance with the Peruvian Guano test as disclosing a line of inquiry which may assist
Teva’s case or damage that of Boehringer or indeed damage Teva’s case or assist that of Boehringer. Each of the
categories were categories which had been allowed in prior High Court decisions and for so long as in this jurisdiction we
continue to apply the Peruvian Guano test for relevance it cannot be said that the High Court judge erred in his
conclusion on the question of relevance. However, it is important to note for the question of necessity that it does not
appear that Teva has established that any of the categories as a matter of probability contain documents potentially
admissible in evidence having regard to the claims made...”.
17. The last-mentioned point applies with equal rigour in the context of the within proceedings.
18. Finlay Geoghegan J. continues:
“However it is important to note for the question of necessity that it does not appear that Teva has established that
any of the categories as a matter of probability contain documents potentially admissible in evidence having regard to
the claims made, the nature of the evidence to be adduced and the absence of any intention to call an inventor.
…The conclusion reached by the trial judge on necessity of each category requires separate consideration. However,
there is one general claim of necessity made by Teva which applies to all categories. Teva submits that once it is
established that the documents are relevant, then the fair or just disposal of the proceedings requires that the
documents be discovered to them. They submit that if this is not done, they are precluded from having documents
available to them for the purpose of both instructing their own expert witnesses and cross examining the expert
witnesses of Boehringer that are available to Boehringer in instructing its expert witnesses and giving instructions for the
cross examination of Teva’s expert witnesses.”
19. These, the court notes in passing, are precisely the points that are made in the affidavit evidence furnished by the defendants.
20. Finlay Geoghegan J. continues:
“This, Teva submits, means there is not equality of arms or gives to Boehringer a litigious advantage if discovery is not
ordered….
I accepted such a submission in Schneider as a second reason for which I considered discovery of the inventor's
notebooks in that case as necessary for the fair disposal of those proceedings. I remain of the view that it is a matter
properly to be taken into account by a trial judge in determining whether or not he should make an order for discovery
of documents determined to be relevant. However, it is only a factor, albeit an important one which must be taken into
account, and as is clear from the Supreme Court decisions in [Ryanair plc v.] Aer Rianta [CPT [2003] 4 IR 264] and
Framus [v. CRH plc [2004] 2 IR 20], a judge, in considering whether or not an applicant for discovery has satisfied him or
her that it is necessary to make an order for discovery of relevant documents, must also consider the proportionality of
making the order sought having regard to the particular facts of the case and the reasons for which the applicants
contend discovery is necessary and the grounds of objection made by the respondent to the application. Included in the
latter are questions such as the numbers of documents sought, the cost of carrying out the discovery and potential
confidentiality issues.”
21. At hearing, some criticism was made of Ms Murphy’s affidavit to the effect that she does not address the burden of making
discovery under Category 3, even though in her affidavit evidence she avers that the issues she has outlined bear on all the
categories of discovery (and this is borne out by a consideration of the substance of her evidence).
22. Finlay Geoghegan J. continues, at 17-20:
“I would also add that in general in considering the necessity of the discovery of relevant documents the nature and the
potential strength of the relevance is a consideration to be taken into account.
…
In relation to categories 2 and 3 I have formed the opposite view [i.e. the Court of Appeal will not allow discovery.] It
appears to me the trial judge was in error on the facts herein in concluding that the discovery of categories 2 and 3 is
necessary for the fair disposal of these proceedings. In reaching this conclusion I am fully conscious that on the facts of
Schneider I reached the opposite point of view in relation to the inventor’s notebooks on the facts therein and the trial
judge relied in part upon my decision in Schneider. However, as I have already indicated an applicant must establish
necessity having regard to the facts of the individual case. [Court Note: this has not been established in the within
application]. In Schneider the claim of obviousness was over two specified pieces of prior art and unlike this case also
over common general knowledge. I have no recollection now of the facts other than as recorded in my judgment, from
which it does not appear that the respondent in that case had made out any difficulty in providing the discovery sought
in terms of cost or numbers or documents nor based its objection upon confidentiality concerns.”
23. What one can see from the foregoing is that a key factor, from Finlay Geoghegan J.’s point of view, was proportionality.
24. Finlay Geoghegan J. continues:
“[I]t has been submitted in this appeal that in my reasoning in Schneider I was incorrect in accepting a submission in
that case…[that] ‘it will be of assistance to the defendant in cross-examining the plaintiff’s expert witnesses by
reference to what at least one person admittedly skilled in the art (i.e. the inventor) actually did.”
25. Finlay Geoghegan J. immediately moves on to correct the error in the foregoing, viz the notion that an inventor, being
an inventive person, could be the unimaginative skilled worker. Yet there is suggestion in the defendants’ affidavit
evidence that, inter alia, discovery of Category 3 “will also be of assistance to the Defendants in cross-examining the
Plaintiff’s expert witness(es) by reference to what at least one or more persons admittedly skilled in the art (i.e. the
inventors) actually did…”. That clearly just cannot be right.
26. Finlay Geoghegan J. continues, at 20:
“The principal differences on the facts in this application for discovery and those before me in Schneider are first the
objections grounded on the facts set out mainly in the affidavit of Mr. Jean-Christian Redel filed on behalf of Boehringer
concerning the cost, volume of documentation and multiple data sources which would have to be searched over long
periods and the complications of the confidentiality issues, particularly having regard to the fact that Teva is a generic
competitor and second the decision of Teva to pursue its similar claim in the UK without seeking disclosure or discovery
of any of the documents included in Categories 2 and 3. [Court Note: that is exactly the same position in the within
application, the sole distinction being that there are no confidentiality issues raised; however Ms Murphy has testified as
to the complications and the volume of documentation that has to be sought, which goes, of course, to proportionality].
Those facts are such that notwithstanding that the categories may contain relevant documents which may assist Teva
in giving instructions to its own experts or instructing counsel to cross examine experts from Boehringer I have
concluded that the trial judge was in error on the facts herein in concluding that discovery of the very significant volume
of documents potentially within Categories 2 and 3 is necessary for disposing fairly of the proceedings. The
proportionality between the potential advantage to Teva in obtaining these documents for use in these proceedings and
the probable cost and time involved in Boehringer making discovery and taking into account the position in the UK
proceedings is such that discovery of categories 2 and 3 is not necessary for the fair disposal of the proceedings. [Court
Note: this, it seems to the court, is a critical statement in explaining the approach of the Court of Appeal: (as here) there
is testimony as to the probable cost and time involved in making discovery and the position in the United Kingdom has
been taken into account (and in the within case, when one looks to the United Kingdom one finds that Category 3 was
not sought; what was sought was disclosure of material bearing on category 5)].”
27. Finlay Geoghegan J. continues, at 20-21:
“I have formed a similar view in relation to category 4. Whilst I recognise that this category is of a more limited
category of documents, nevertheless as Mr. Redel’s affidavit discloses identifying the existence of such documents over
a nine-year period from multiple sources having regard to the facts set out would also involve significant time and
money. Certain of the documents whilst relevant may be the subject of privilege. That is a lesser consideration… [than]
others. I have reached the conclusion that on the particular facts herein, that category 4 is not necessary for the fair
disposal of the proceedings. Even assuming Teva might ultimately have had disclosed to them (if the discovery order
were upheld) relevant documents which are not privileged and which refer to an issue of validity of the 220 Patent which
may have assisted in instructing experts or instructing counsel for the purposes of cross-examination I do not consider
on the facts herein such discovery is proportionate or necessary. Again, in reaching this conclusion I have taken into
account the fact that Teva proceeded in the UK, without claiming any unfairness without such documents. It is also
relevant that both parties belong to major pharmaceutical groups with multiple resources available to obtain expert
scientific and legal advice and hence Teva is in a position to independently obtain leading advice, both scientific and legal
as to the validity of the 220 Patent and it is not necessary for the fair disposal of these proceedings that they be
permitted to view any such non-privileged advice obtained by Boehringer in the course of the nine-year period referred
to in the High Court order. [Court Note: the within case sits ‘four square’ with Boehringer in this regard. This is a case
where the disputed categories other than Category 5 were not sought in the United Kingdom and it does not appear that
there was any disadvantage perceived to arise in the United Kingdom that matters proceeded so.]
28. Leave to appeal the judgment of the Court of Appeal to the Supreme Court was refused by way of determination of 5th May,
2016, with, inter alia, the following observations being made by the Supreme Court:
“1.This determination relates to an interlocutory application for discovery of documents….[T]he case should be
determined in accordance with the pleadings in the case and any discovery order should be strictly limited to what is
relevant to the issues pleaded, provided same is relevant and necessary for the disposal of the case, and the order
made is not disproportionately burdensome to either side.
2.What is at issue is a claim by Teva that the patent granted is invalid due to, firstly, lack of sufficiency and/or
plausibility in the patent and, secondly, that 3 pieces of prior art which are specifically pleaded mean that the patent
was obvious to those skilled in the area and, thus, did not constitute an inventive step. The 3 pieces of prior art [are
cited]….Obviousness over common general art was not pleaded.
3.There needs to be a refocusing in this case on issues which concern, firstly, the interpretation of the patent itself and
what it teaches [i.e. the first step in the Windsurfing test] and, secondly, what level of knowledge the team considering
the pleaded prior art would have had as to the state of science at the time of the patent and whether an inventive step
was required in order to arrive at what is alleged by Teva to have been obvious, and therefore not patentable. Where
patent cases are focused in this way, lengthy discovery applications, lengthy submissions and the exchange of vast
quantities of documentation become unnecessary. Furthermore, the issues in the case will be addressed within a limited
timescale by the court of trial and expert witnesses will not be called repetitively on each side….
6. Turning then to the issues on this application, Cregan J. in the High Court originally ordered 5 categories of
discovery….
8. The Court of Appeal upheld the order of the High Court in relation to category 1. In relation to categories 2 and 3,
while partly claimed by one side to have been influenced by the decision of Arnold J of the High Court of England and
Wales, a different view was taken [by the Court of Appeal]…in relation to category 4. At paragraph 43 Finlay Geoghegan
J stated:
43. In relation to categories 2 and 3 I have formed the opposite view. It appears to me that the trial judge was in
error on the facts herein in concluding that the discovery of categories 2 and 3 was necessary for the fair disposal
of these proceedings. In reaching this conclusion I am fully conscious that on the facts of Schneider I reached the
opposite point of view….However, as I have already indicated an applicant must establish necessity having regard
to the facts of the individual case. In Schneider the claim of obviousness was over two specified pieces of prior art
and unlike this case also over common general knowledge. I have no recollection now of the facts other than as
recorded in my judgment, from which it does not appear that the respondent in that case had made out any
difficulty in providing the discovery sought in terms of cost or numbers or documents nor based its objection upon
confidentiality concerns. It was a case where there was a claim for infringement with a counterclaim of invalidity.
….11…..It is pleaded that discovery has been ‘equated with admissibility’ in the judgment of the Court of Appeal, where
the assertion is that discovery has nothing to do with admissibility in evidence. Another complaint is that what has been
set by the Court of Appeal is ‘a proportionality test with an unduly low threshold’ enabling the burden of discovery to be
pleaded by an opponent in order to defeat ‘the interests of justice’. Finally, the Court of Appeal is said to have fallen into
error in a manner which impacts generally on the public interest in refusing discovery in relation to issues of
confidentiality.
….12….If, as is clear, the issue is whether an inventive step was taken by the team considering the eventually patented
product, the entire focus of litigation should be on the nature of the prior art and whether the step or steps leading to
what was patented could properly be analysed as being inventive. Of course, the patenting of medicines is an important
issue for society generally. The invention of medicines is also important as is the relevant legislation which seeks to
define a proper balance between the needs of society and a proper reward for innovative research and development.
Something to do with patent registration of medicinal products does not of itself make the case of one of general public
importance.”
29. Reasonable people might perhaps reasonably differ in their views as to the approach adopted by the Court of Appeal in Boehringer
and whether there was merit to the substance of the appeal advanced before the Supreme Court (to the extent that the substance
of same is known). However, the court does not get to entertain such views or engage in such debate. It is bound and accepts itself
to be bound by the decision of the Court of Appeal, which decision in any event enjoys a degree of endorsement from the Supreme
Court insofar as no issues of public importance were perceived to arise from the decision of the Court of Appeal, the Supreme Court
urging a refocusing by the parties in Boehringer on the central issues at play (what might be styled ‘the Windsurfing issues’).
30. Turning then from the lengthy but worthwhile consideration of the decision of the Court of Appeal undertaken in the preceding
pages and returning once more to the text of Category 3, as set out in the table previously above, there are a few points which it
seems to the court are worthy of note:
(1) this is a remarkable request for a 14-year period of documentation which was not sought in the United Kingdom.
(2) the priority date of the 304 Patent is 15th November, 2005. This being so, it is not clear why documentation is being
sought for a remarkable eight years after the priority date. Of course, discovery for some period after a priority date can
satisfy the criteria for discovery but eight years is a strikingly long period.
(3) the court’s attention has been drawn to certain e-mail correspondence in the United States between or for the
parties (an e-mail of 25.01.2017 from Mr R Cerwinski to Mr G Frischling (others copied); and an e-mail of 27.01.2017 from
Mr G Frischling to Mr R Cerwinski (others copied)) as in effect pointing to the Category 3 documentation having been, to
use a colloquialism, ‘ready to roll’ in the United States, the point being that the Category 3 documentation should
therefore be readily discoverable in this jurisdiction (i.e. assuming relevance and necessity being satisfied, it should be
readily capable of production and so, at least in that (limited) sense, discovery would be proportionate. However, there
are a couple of problems with this logic. First, the e-mail correspondence, on examination, does not point to the Category
3 documentation as being ‘ready to roll’. Second, as counsel for the plaintiffs noted in his submissions at hearing, in fact
this line of contention rather backfires on the defendants because what becomes apparent from a consideration of the
evidence before the court is that the defendants when it came to what, for ease of reference, might be described as the
Category 3 realm, was satisfied to accept a much narrower disclosure in the United States in this regard. In fact, the
defendants remain willing to give United States-style disclosure on this basis, should that be asked for, in respect of both
patents, subject to slight variation as to dates. But, for reasons best known to them, this is not acceptable to the
defendants; they want discovery of all of the Category 3 documentation and for the reasons identified in the within
judgment that is something to which they are not entitled as a matter of law.
(4) the defendants face real difficulties when it comes to establishing the relevance of Category 3. The first affidavit of
Mr. Kelly struggles to justify, save by reference to its possible role as secondary evidence, what the utility of the
Category 3 documentation will be. Thus Mr Kelly avers, inter alia, that:
– “they may lead to a line of inquiry in that they will disclose the actual experiments and other steps taken by the
inventors”, but this was viewed by Finlay Geoghegan J. in Boehringer as being of secondary significance.
– “[s]uch documents may also address the issue of added matter and/or insufficiency”. In this last regard the
court struggles to see how what the inventors actually did has anything to do with added matter. Added matter is
seeing whether there is something new in the patent as granted as compared to the patent application. It is a
comparative exercise between the two that has nothing to do with what the inventor did. As to “insufficiency” that
is the allegation that the patent does not disclose the invention so that it can be practised. But again what the
inventor did has nothing to do with that question. That is a question of expert evidence on the point ‘does this or
does this not tell me how I am going to perform the invention?’
– “such documents…may be used to assist the Plaintiffs in briefing its own expert witness(es) and providing the
Plaintiffs’ legal team with relevant documents for the purpose of cross-examining the Defendants’ expert
witness(es)”. But briefing and cross-examining by reference to what the inventors actually did is, as explained in
Boehringer, only of secondary significance because an inventor (being inventive) cannot equate to an unimaginative
skilled worker. As to the cross-examination point, that was rejected by Finlay Geoghegan J. in Boehringer, her point
being that to cross-examine somebody by reference to what the inventor did does not really progress the issues
very much because, again, an inventor (being inventive) cannot equate to an unimaginative skilled worker.
(5) it does not follow inevitably that because there was a form of discovery in the United States that this has the effect
of reducing the burden of what is now sought because there is not a mirroring between what was then sought and what
is now sought.
(6) the court does not accept the proposition averred to by Mr Kelly in his affidavit evidence that the issue of
proportionality falls to be gauged by reference to the profitability of the relevant product, rather than the probity of the
evidence. So, for example, he avers that “The Second-Named Defendant (F Hoffman-La Roche AG) made approximately
€22 million from sales of rituximab was worth in excess of €200 million a year. Whenever proportionality is raised as a
reason to refuse to make discovery, it is important to bear in mind what the cost of discovery is proportional to.” That,
with respect, is not a correct understanding of the proportionality test. The proportionality test requires a court to look
at the burden of making discovery and to assess whether it is proportionate to the probative or likely probative value of
the documentation sought. In a nutshell, proportionality in this regard checks for ‘probative versus burden’, not
‘profitability versus burden’.
(7) when it comes to the evidence as to disproportionate burden, the court notes, in particular, the following averments
of Ms Murphy, a solicitor acting for the plaintiffs in the within proceedings:
“Category 3 as drafted is far broader than the reasons proffered in support of the discovery. Firstly, it spans a
period of 14 years, which in itself represents an extremely heavy burden in terms of searching for documents. As
such, it seeks discovery of documentation created five years before the priority date. Further, it seeks
documentation for circa. 8 years after the filing date”,
and also
“I am instructed [as to] the following regarding the third-named Plaintiff (‘Genentech’). I am instructed that the
following are very rough estimates.
I am instructed that Genentech stores many documents in a form of off-site storage called
DataSafe.
When a DataSafe search was carried out solely in respect of the individuals whose names appear in
the Defendants’ discovery requests, approximately 1,448 potentially relevant documents were
identified, involving potentially millions of pages of documents.
The documents stored with DataSafe do not include other documents held in other forms of storage
that could potentially be implicated, for example documents held by Genentech employees and former
employees.
Regarding the time it would typically take to review this amount of material, Genentech has made a
conservative estimate of 4,000 hours. This does not include the number of hours that would be
required to search and review documentation held by Biogen and La Roche.
Regarding the typical cost of reviewing this amount of material, Genentech’s current conservative
estimate is $200,000 USD assuming contract attorneys were used. This would increase substantially if
Genentech’s standard outside counsel were used.
…Furthermore, I am instructed the following regarding the first-named Plaintiff (‘Biogen’):
Former Idec employees, Drs White, Grillo-Lopez, and Totoritis all left the company more than a
decade ago. The San Diego facility where they worked was shut down in 2011….
Biogen has a collection of archival materials from the San Diego site in the form of computer back-
up tapes. These tapes are maintained off-site by a records management service called Iron Mountain.
There are 12,676 computer tapes in this archive, going back to 1999. Biogen does not have the
internal capability to read these old tapes, and Biogen’s understanding is that the tapes are likely in a
variety of different formats, increasing the burden of reading them all. A discovery vendor would likely
need four or five different types of systems to read the tapes.
Biogen often has no record of what is on a given tape. Thus, for many of these thousands of tapes,
to determine what is on it would likely require loading and reviewing it. This would dramatically
increase the burden of reviewing the archives. In particular, Biogen has no reliable information about
the contents of any tapes from before 2005.
Physical deterioration of tapes would further impact a search like this. For tapes older than five
years (which these are), it is likely that tape content will be lost or very difficult to access. For tapes
going as far back as 1999, it is likely that most of the tape content will have deteriorated.
Biogen estimates that the vendor process with regard to these tapes would cost at least hundreds
of thousands of US dollars even assuming that none of the tapes are encrypted. If tapes are
encrypted, as seems likely, that would cost an additional US$100 per tape. This same process would
take approximately four months.
In my firm’s letter of 19 January 2018, it was further noted that this request as it standards refers
to ‘any communications’ between anyone at either Biogen Inc., F Hoffman La-Roche and Genentech
Inc., three large companies, and any of five separate individuals, relating to a study that was run over
two decades ago, since which we are instructed a variety of corporate transactions and records-
disrupting events have occurred.
By way of example:
– Roche Holdings Ltd acquired a majority holding in Genentech in 1990.
– The partnership between Genentech and Idec Pharmaceuticals Inc to market Rituximab was in
1997.
– [in] 2003 Biogen Inc merged with Idec Pharmaceuticals Inc to become Biogen Idec Inc
(subsequently reverted to Biogen Inc)
– [in] 2009 Roche and Genentech merged….
I am instructed that Roche has been engaged in numerous acquisitions over the years also in the pharmaceutical
business. The storage of files belonging to the patent department has been transferred in 2014 to an outside
vendor. This makes it difficult to locate files not being part of a specific case folder. The pharmaceutical research
and development at Welwyn Garden City has been closed in 2001. Numerous documents have been transferred to
the Basel storage facilities and are burdensome to be tracked down. In addition, there has been quite some
change with regard to the employees (retirement, change of workplace or change of employer). The patent files
handled in Basel basically reflect a part of the documents at Genentech. The majority (roughly 40 folders) are
related to ongoing invalidity actions and worldwide litigation….
For the avoidance of doubt, the significant practical difficulties arising in respect of Category 15(i) also arise
generally in respect of all the categories of discovery remaining in dispute.”
(ii) Category 4.
31. The detail of Category 4 has been identified previously above. The same points arise to be made, mutatis mutandis, concerning
Category 4 as have been made by the court in respect of Category 3, save to note that the documentation in this category is being
sought in respect of a 22-year period.
(iii) Category 5.
32. The detail of Category 5 has been identified previously above. The same reasons are offered for this category as was offered for
the previous categories, with the additional averment that Category 5 had been deemed by the plaintiffs to be relevant to the issues
in the UK proceedings. A number of points might usefully be made in this regard:
– first, the court notes Ms Murphy’s averments in this regard, as referenced previously above, viz:
“In the Grounding Affidavit, the Defendants assert that it is noteworthy that the Plaintiffs have refused to make
discovery of the Defendants’ requested category 5 despite the same category in relevant proceedings in the UK
(‘UK proceedings’) forming the subject-matter of the UK Disclosure report….
I have been informed by Mr Aaron Hayward, Senior Associate of Herbert Smith Freehills LLP (who were directly
involved in the UK proceedings) that it is correct that the Plaintiffs initially agreed to provide standard disclosure in
the UK proceedings confined to the 4-year window (2 years either side of the priority date). However, three
significant points bear emphasis in this regard….
First, we are instructed that standard disclosure is subject always to proportionality and reasonableness of search
based on the factors set out in the Civil Procedure Rules (CPR 31.7(2)), including the nature and complexity of the
proceedings, the ease and expense of retrieval of any particular document and the significance of any document
that is likely to be located during the search. As such, at its height, the Plaintiffs agreed only to conduct a
reasonable and proportionate search for such documents and to disclose what was identified. It was never the
case that the Plaintiffs agreed to disclose all such documents. The initial agreement was only to conduct a
reasonable and proportionate search for such documents and disclose what was identified….
Second, it became apparent in the UK proceedings that even standard disclosure would be extremely onerous and
disproportionate. In this regard, I am further instructed by Mr Hayward that, during the course of the UK
proceedings, the Plaintiff’s advisors became aware that Biogen/Genentech had collated documents onto a database
in or about 2011 (the ‘US Database’) in the context of US infringement proceedings brought by Biogen/Genentech
against GSK. In the said proceedings Biogen/Genentech against GSK. In the said proceedings Biogen/Genentech had
alleged that GSK’s Arzerra product infringed its US 7 682 612 Patent (US equivalent of EP 1 616 572). The US
Database was at that time managed by DLA Piper (though has since been migrated to Deloitte). We are instructed
by Mr Hayward that it was initially hoped that the US Database would provide a short cut to the disclosure process
in the UK. However, the US Database contained a vast amount (1.3 TB) of material and it was not possible to
ascertain what documents were collared into the database(or how the documents had been identified). DLA Piper
had indicated to Herbert Smith Freehills LLP that they thought the documents recording that process had since
been destroyed. Given this development we are instructed that this option was put on hold in favour of exploring
other options, including a targeted search of source documents, rather than using the US database, significantly
curtailed disclosure or no disclosure at all….
[W]e are instructed that at the Case Management Conference that took place in the UK proceedings on 25
February 2016, Mr Justice Carr [of the High Court of England and Wales] expressed doubts as to the relevance of
standard disclosure at all. In particular, he expressed the view that the Plaintiff’s solicitors in the UK proceedings
were ‘…very, very obliging souls’ for agreeing to make standard disclosure. He went on to state:
‘I have already expressed my concern about this potentially vast exercise, which may well produce
virtually nothing of any relevance. I appreciate it was your proposal that was then agreed that there
should then be standard disclosure. If that is what the parties have agreed, fair enough, but you might
reconsider it.’
[Court Note: Like comments were made by Arnold J. in Boehringer and the Court of Appeal had regard to
this fact in that case.]
…Third, the UK proceedings were ultimately compromised and document production did not eventually occur….
In the circumstances, the Plaintiffs are of the view that the Defendants’ attempts to draw parallels between the
UK disclosure process and the Irish discovery request are misleading. Whilst we are instructed that the Plaintiffs
did agree to make standard disclosure at a point in time, the order for standard disclosure itself imparts a
proportionality and reasonableness test in terms of the searches to be conducted. Consequently the Plaintiffs in
the UK proceedings agreed only to conduct a reasonable and proportionate search for such documents and
disclose what was identified. Moreover, as outlined above, it subsequently transpired that standard disclosure
would be unworkable and the English High Court questioned the ‘potentially vast’ disclosure request, which it noted
might produce ‘virtually nothing of any relevance’.”
– second, the court notes the following details that feature under the heading “Disclosure” in the third witness statement
delivered by Mr Moore, a solicitor acting for the plaintiffs in the (compromised) corresponding UK proceedings:
“I understand from my colleagues that the following was confirmed [in a telephone call between the parties]…on 17
February 2016:
(a) Both sides agree to standard disclosure;
(b) There are vast amounts of documents on a US database which may or may not be relevant;
(c) Given (ii), my firm may work with Biogen to do a targeted search of source documents, rather
than utilising the US database; and
(d) If so, the estimated costs of disclosure may be less than the initial cost estimate provided in the
disclosure report; however
(e) at this stage, we are not ruling out that a keyword search of the US database may be the
preferable, along with a potentially significant document review exercise in relation to the results….
Standard disclosure is subject always to proportionality and reasonable of search…based in the factors
set out in CPR 31.7(2). [ It is useful to quote both CPR 31.(7)(1) and (2):
“(1) When giving standard disclosure, a party is required to make a reasonable search for documents
falling within rule 31.6(b) or (c) [i.e. documents which (per rule 31.(6)(b)) (i) adversely affect his own
case, (ii) adversely affect another party’s case, or (iii) support another party’s case, and (per rule 31(6)
(c)) (iv) documents which he is required to disclose by a relevant practice direction].
(2) The factors relevant in deciding the reasonableness of a search include the following:
(a) the number of documents involved;
(b) the nature and complexity of the proceedings;
(c) the ease and expense of retrieval of any particular document; and
(d) the significance of any document which is likely to be located during the search.”]
Included in those factors are the nature and complexity of the proceedings, the ease and expense of
retrieval of any particular documents and the significance of any document that is likely to be located
during the search….
If the only way to find certain categories of potentially relevant documents is to search the US
database, it may well be a substantial exercise that cannot be conducted by the deadline requested by
Celltrion for a September trial date….
Additionally, it is currently not clear to me that disclosure will be at all probative in this action. For
example, unpublished materials available to my client in the relevant disclosure window relating to
clinical trials are unlikely to have been available to the skilled person, and are therefore not probative
to the analysis of the skilled person’s knowledge or attitude at the priority date….”
– third, it is for the defendants (as applicants in the within application) to identify the relevance of the
Category 5 documentation; however, all they have been able to do is point towards the UK disclosure
report. There is no explanation in the affidavit evidence before the court as to the significance of the
documentation. And the Category 5 documentation would actually be somewhat wider than was sought
in the United Kingdom because it is not subject to a reasonable search restriction at all.
33. It seems to the court that:
(i) the plaintiffs cannot get around the fact that what might be styled a ‘substantial chunk’ of what, in the within
proceedings, is the Category 5 documentation, was acknowledged (or effectively acknowledged) by the plaintiffs in
England and Wales proceedings to be relevant (albeit that this acknowledgement came in the context of the
proportionality and reasonableness test which applied to the searches that fell to be conducted in that jurisdiction);
(ii) the defendants, on whom the burden falls in this regard, have failed to establish the relevance of the Category 5
documentation beyond the (narrower) Category 5-like documentation that would have been provided in England and
Wales.
34. The foregoing being so: (a) the court will order discovery of the Category 5 documentation; but (b) to ensure that the
requirements of relevance, necessity and proportionality are satisfied, will order that the plaintiffs conduct only the reasonable search
of the type contemplated by rule 31.7 of the Civil Procedure Rules of England and Wales.
(iv) Categories 6 and 7.
35. The detail of Categories 6 and 7 has been identified previously above. Both categories are in similar terms. Both categories were
refused in Boehringer. Both raise the same issues of proportionality and in this regard, like points arise to be made, mutatis mutandis,
as have been made in respect of Category 3 above.
(v) Category 8.
36. The detail of Category 8 has been identified previously above. This category was rejected in Boehringer because of its scale (an
aspect of matters which is equally applicable here), and the improbability of it containing anything of assistance given that all of it
was likely to be
privileged. [ The court’s attention has been drawn in this regard to s.94 of the Patents Act 1992, as amended, which provides as
follows:
“(1) A communication to which this section applies shall be privileged from disclosure in any proceeding (including a
proceeding before the Controller or competent authority under the European Patent Convention or the Treaty) to the
same extent as a communication between client and solicitor is privileged in any proceeding before a court in the State.
(2) This section applies to a communication— (a) between a person, or person acting on his behalf and a solicitor or
patent agent, or person acting on his behalf, or (b) for the purpose of obtaining, or in response to a request for,
information which a person is seeking for the purpose of instructing a solicitor or patent agent in relation to any matter
concerning the protection of an invention, patent, or technical information or any matter involving passing off.
(3) In this section ‘patent agent’ means (a) a person registered as a patent agent in the register of patent agents, (b) a
company or partnership lawfully practicing as a patent agent in the State (c) a person to whom section 106(3) applies, or
(d) a person or partnership who satisfies the condition mentioned in subsection (1) or (3) of section 125.”]
(vi) Category 15(i).
37. The detail of Category 15(i) has been identified previously above. The court notes that an offer has been made by the plaintiffs in
respect of this category, that offer being to make discovery of what was offered and accepted in the United States. However, there
has been no explanation as to why this offer is not sufficient. The category is sought on the basis that the defendants wish to
enquire what is the O’Brien study connection to the 313 Patent. The plaintiffs point to the fact that if it is to be granted as sought it
would involve a disproportionate exercise. To satisfy the requirements of relevance, necessity and proportionality, the court will order
discovery on the terms offered by the defendants.
VII
Conclusion
38. For the reasons identified above:
(i) the court respectfully refuses to make an order of discovery in respect of Categories 3, 4, 6, 7 and 8;
(ii) (a) the court will order discovery of the Category 5 documentation; but (b) to ensure that the requirements of
relevance, necessity and proportionality are satisfied, will order that the plaintiffs conduct only a reasonable search of the
type contemplated by rule 31.7 of the United Kingdom’s Civil Procedure Rules; and
(iii) the court will order discovery of Category 15(i) on the terms offered by the defendants.