In advance by fax
`
`
`
`
`Munich I Regional Court
`− 7th Civil Division −
`Prielmayerstraße 7
`80335 Munich
`
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`
`
`[Translation]
`
`
`Christine.Kanz@hoyngrokh.com
`Extension: +49 (211)550 22 320
`5084-17_ss180621_eng-kc/ck-SH
`22 June 2018
`
`
`
`Service between lawyers
`
`
`In the matter of
`
`
`Shire Viropharma Incorporated HOYNG ROKH MONEGIER
`
`Attorneys at Law Dr. Christine Kanz, Dr. Martin
`Köhler, Dr. Beatrix Metelski, Edna Althaus as well
`as all other lawyers of the partnership with limited
`professional liability
`
`rospatt osten pross
`
`
`
` v
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` e r s u s
`
`
`
`CSL Behring GmbH
`
`
` 7 O 9110/17 –
`
`
` –
`
`we would first of all like to explicitly point out that facts we have already disputed are
`
`not “undisputed” just because the defendant makes inflationary use of this term in its
`
`brief. A fact is not undisputed because the defendant refers to it as such.
`
`
`
`We respond as follows to the defendant's brief of 07 June 2018 (unless indicated oth-
`
`erwise, any references relate to this brief):
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`Page 1 of 48
`
`CSL EXHIBIT 1056
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`

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`- 2 -
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`
`
`I.
`
`The infringement
`
`
`
`1
`
`The submission stating that the defendant offers the attacked product of
`
`CSL Behring LLC is not a random submission but follows from the fact that
`
`the defendant manufactures and CSL Behring LLC sells the product in the
`
`USA. Even if CSL Behring LLC were to trigger the orders (see p. 2 at the
`
`top), it will not place orders "randomly" – some kind of indication of readi-
`
`ness and willingness to deliver will inevitably have preceded the order.
`
`In the "named patient compassionate use", as the defendant calls it, the two
`
`concepts of the "compassionate use program" are wrongly combined with
`
`the treatment of a patient on a "named-patient basis". The dispensation of a
`
`drug approved in another country to individual patients is not a “compas-
`
`sionate use” and, from a narrow perspective, also not a "named-patient-
`
`basis" treatment, but a dispensation according to Sec. 73 (3) AMG of a drug
`
`approved in the USA to patients in Germany (as “individual import”) (see no.
`
`33 RE). This possibility as such is of course known to the pharmaceutical
`
`entrepreneur and especially in rare diseases, where the few specialized
`
`doctors are also informed about approvals in other countries, such individual
`
`imports are common.
`
`This individual import is relevant because it shows that there is a possibility
`
`of a domestic use. Even if one were to accord purpose-related substance
`
`claims only a limited scope of protection (which, for the reasons set out in
`
`nos. 25 ff. RE and the expert opinion according to Exhibit K 31 is ruled out),
`
`this common possibility of a use of the product in Germany alone justifies
`
`the assumption of a direct patent infringement. The fact that this is done by
`
`prescription from a physician and dispensation through pharmacies is irrele-
`
`vant. The individual import is at any rate endorsed by pharmaceutical com-
`
`panies,
`
`
`
` 2
`
`
`
` 3
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`
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`
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`Page 2 of 48
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`
`4
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`
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`because it helps to tap new markets and prepare a later market entry.
`
`
`
`II.
`
`No right of prior use
`
`
`
`Not even in its most recent brief was the defendant able to demonstrate any
`
`acts of use, or arrangements to start a use any time soon.
`
`1.
`
`No prior use of the invention
`
`
`
`5
`
`Manufacturing a drug for experimental or approval purposes does not con-
`
`stitute a use of the invention. Since, at the priority date, only some, if at all,
`
`drugs were produced for the purpose of clinical studies, the defendant is not
`
`entitled to a right of prior use based on a use of the invention.
`
`
`
`a.
`
`Commercial nature
`
`
`
`6
`
`Only acts of a commercial nature constitute a use of the invention within the
`
`meaning of Sec. 12 PatG. It is astonishing that the defendant places the
`
`question of the commercial nature at the centre in such a way, because
`
`both jurisdiction and the prevailing literature have clearly and for good rea-
`
`sons positioned themselves in such a way that the acts of use must be
`
`commercial. We submit as
`
`
`
`
`
`
`
`
`
`
`Exhibit K 59
`
`a further expert opinion of Professor Dr. Matthias Leistner, who also
`
`convincingly confirms this. In particular, he states in his opinion that the
`
`history of the law and especially the amendment of the Patent Act of 1981,
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`in no way suggest that the requirement of a commercial nature for the
`
`establishment of a prior use right should be abolished. Rather, it is the case
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`
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`Page 3 of 48
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`that the amendment has merely led to the dispute being brought up for
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`discussion once gain, the minority view that has positioned itself against the
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`commercial nature, but has been outdated since the mid-2000s.
`
`Furthermore, it is clear from the expert opinion that both the systematic and
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`teleological interpretation clearly speak in favour of a commercial nature. In
`
`particular, privileged acts under Sec. 11 Patent Act may not suffice to
`
`establish a right of prior use under Sec. 12 Patent Act.
`
`
`
`
`
`
`
` 7
`
`8
`
`The other aspects mentioned by the defendant on this question are not con-
`
`vincing, either. Especially Exhibit rop 36 is irrelevant in this context. These
`
`are not legally defined terms, but the BfArM only uses them to distinguish
`
`between investigator initiated trials (“IIT”) (by hospitals, universities or re-
`
`search institutes) and clinical trials initiated by pharmaceutical companies
`
`(see no. 76). There are no differences with regard to the requirements to be
`
`met by the study though. An IIT can also be used for commercial purposes
`
`later, and a pharmaceutical company can also carry out non-commercial
`
`clinical studies. The distinction in Exhibit rop 36 is therefore completely irrel-
`
`evant and does not work in the present context.
`
`The “Ethofumesat” decision (see p. 5) was issued under the old law and is
`
`therefore not relevant for this reason alone (see also expert opinion of Prof.
`
`Leistner, Exhibit K 59, p. 7 at top). Schulte/Rinken, PatG, 10th edition Sec.
`
`11 no. 11 also confirm this, who favour a privilege according to Sec. 11 No.
`
`2 PatG, i.e. who would not consider the acts as a patent infringement, and
`
`also refer to BGH GRUR 1996, 109 - Klinische Versuche in this respect (III
`
`3b aa):
`
`“aa) The decision of the Court applied to dated 21/02/1989- X ZR
`53/89 - Ethofumesat (BGHZ 107, BGHZ Vol. 107 page 46 =
`GRUR 1990, GRUR year 1990 page 997) and the principles de-
`veloped there regarding the admissibility of field tests do not con-
`tain any interpretation aid. According to those, someone who,
`during the term of a patent, has a crop treatment product contain-
`ing the protected substance tested by plant protection services or
`
`
`
`
` 9
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`
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`offices in domestic field tests in order to obtain the required proof
`for a marketing authorisation, infringes the patent. These princi-
`ples only concern the legal situation according to Sec. 6 PatG
`1968. They cannot simply be applied to the new legal situation
`which has arisen due to the introduction of Sec. 11 no. 2 PatG in-
`to the 1981 PatG.” (Emphasis added)
`
`b.
`
`Manufacture of product batches
`
`
`
`
`
`10
`
`It follows from the Bundle of Exhibits rop 37 that only 1186 units of CSL830/
`
`C1 Esterase Inhibitor 1500 U were produced at the priority date. The other
`
`units were not completed at that time.
`
`
`
`11
`
`
`
`
`
`
`
`Only the first and second “Certificate of IMP Release” in Bundle of Exhibits
`
`rop 37 shows a complete production. For easier understanding of the follow-
`
`ing explanations, we reproduce page 2 of Exhibit rop 37 below:
`
`On the top right, 23 June 2011 is stated as production date. But, as can be
`
`seen from the "Laufzeitrelevante Einsatzkomponenten” [components used
`
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`Page 5 of 48
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`relevant for the term] section, this date only relates to “SFP Berinert 1500,
`
`i.e. the semi-final Berinert 1500 product. We dispute that this was already
`
`lyophilized product filled into vials. Even if this were true, the manufacture of
`
`the products is not completed until the “release” listed further down, which
`
`for this batch was on 06 August 2012.
`
`The production of the next batch was completed on 29 March 2012:
`
`Yet the production of the subsequent batches of Bundle of Exhibits rop 37
`
`was not completed until after the priority date, as follows from the release
`
`dates shown below:
`
`
`
`
`
`12
`
`
`
`
`
`13
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`
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`Page 6 of 48
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`
`
`14
`
`
`
`
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`Moreover, the list only states that the batches produced are “CSL 830”. But
`
`in fact, based on “CSL 830”, the defendant also obtained an MA for the in-
`
`travenous product Berinert 1500. The clinical tests thus mainly served to ob-
`
`tain the MA for this product (see no. 34 of our surrejoinder).
`
`2.
`
`No arrangements to begin use
`
`
`
`15
`
`The defendants' submission to demonstrate a final decision of the manage-
`
`ment to market the allegedly previously used object in the near future is still
`
`inconclusive. This is also not surprising, because the submitted minutes
`
`show that there was no finished product at the priority date. Yet a company
`
`management will not make final and binding decisions on a mere idea or
`
`
`
`concept, but only on marketable products.
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`Page 7 of 48
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`16
`
`The defendant confuses the decision within the company to go ahead with a
`
`certain development project, with the decision to launch a product on the
`
`market. If every decision in favour of a development product were an “ar-
`
`rangement” within the meaning of Sec. 12 PatG, the right of prior use would
`
`be given a meaning it is not supposed to have.
`
`
`
`
`
`a.
`
`No use in the near future
`
`17
`
`What is noteworthy about the defendants' submission is what it does not
`
`contain. The defendant’s submission relating to the right of prior use ends
`
`with the priority date, and it does not show which further course the alleged-
`
`ly imminent commercial use took. The defendant itself has still not launched
`
`a product in Germany even more than five and a half years later.
`
`
`
`18
`
`
`
`19
`
`It acted very hesitantly before, but especially also after the priority date. Be-
`
`tween October 2015 (conclusion of Compact phase III) and 16 January
`
`2017 (filing of the application for EU marketing authorisation), as far as we
`
`can see, nothing happened. For this period, the defendant presented no fur-
`
`ther acts of use and no further arrangements. It is not comprehensible and
`
`has not been submitted by the defendant why it did not file the application
`
`for marketing authorisation in the EU directly upon receipt of the results of
`
`the COMPACT phase III study on 21 December 2015, or upon completion
`
`of the study report on 03 May 2016 (rejoinder, p. 37), respectively. The de-
`
`fendant filed this application in the EU relatively late, anyway, i.e. half a year
`
`after the application for marketing authorisation in the US.
`
`What is more in the present case is that the defendant has been observing
`
`its strongest competitor on the market, the plaintiff, and was therefore aware
`
`of the fact that the plaintiff was developing a comparable product (see e.g.
`
`p. 25 of the rejoinder). Therefore, the defendant also knew that the plaintiff
`
`had filed the patent which claims a priority date of 15 March 2013. Nonethe-
`
`less, it allowed a lot of time to pass without pressing ahead with the market
`
`entry.
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`Page 8 of 48
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`20
`
`Even half a year after obtaining the marketing authorisation, the defendant
`
`has still not placed BERINERT 2000® and BERINERT 3000® on the market
`
`in Germany, and is merely planning a possible market entry for January
`
`2019.
`
`
`
`21
`
`
`
`
`
`It thus becomes clear that a use was not in the least imminent at the priority
`
`date.
`
`
`
`b.
`
`No decision to begin use
`
`aa.
`
`No decision documented
`
`22
`
`The defendant was not able to prove that a decision had already been taken
`
`at the priority date. Apparently, such a decision was not taken during the
`
`meetings referred to by the defendant either, in which the relevant decision-
`
`makers were not present anyway; in particular, the concrete decision to en-
`
`ter the market was not documented in any of the meeting minutes.
`
`
`
`bb.
`
`No decision made by decision-makers
`
`
`
`23
`
`The defendant neither submitted in any comprehensible manner who was
`
`authorised to make decisions in this matter, nor that this person or group of
`
`persons actually made the relevant decision.
`
`
`
`24
`
`First of all, the defendant's statements on the function of the members of the
`
`PPC and PRC mentioned partly contradict those in the annual report sub-
`
`mitted as evidence according to Exhibit rop 40. For example, the defendant
`
`alleges that Peter Turner was the President of the global CLS Behring
`
`group, whereas in the annual report he is only mentioned as an Executive
`
`Director. Paul Perrault, who according to the defendant was Executive Vice
`
`President Research & Development at the time, was the President of CSL
`
`Behring according to the annual report. Moreover, many of the persons re-
`
`ferred to are not mentioned in the annual report at all. We therefore dispute,
`
`on the basis of a lack of knowledge, that the persons referred to even exer-
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`Page 9 of 48
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`
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`25
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`
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`26
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`
`
`27
`
`
`
`28
`
`
`
`29
`
`
`cised the functions indicated.
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`Furthermore, the decision-making process outlined by the defendant is con-
`
`tradictory in itself and remains entirely unclear, also in respect of who was
`
`authorised to make decisions.
`
`For instance, the defendant claims that decisions are "taken by the global
`
`directors of the relevant functions and then implemented locally". Instead of
`
`then naming the specific global director or directors of the relevant function,
`
`the defendant merely makes the sweeping claim that the PPC and PRC is
`
`"staffed by high-ranking representatives" and names a few of them. At this
`
`point, the question arises whether decisions are actually made by specific
`
`directors or by entire committees whose members are apparently persons
`
`with entirely different functions.
`
`The defendant then reports on alleged decisions supposedly taken by the
`
`PPC and the PRC, but still refuses to determine which one of the two com-
`
`mittees allegedly took the decision.
`
`The defendant then claims that Mr. Peter Turner as the Managing Director
`
`having the sole power of representation for CSL Behring Verwaltungs
`
`GmbH, which in turn was allegedly the sole general partner of the defend-
`
`ant's sole shareholder, had authority to instruct the defendant. It must be
`
`noted in this regard that the circumstance that Mr. Turner was the managing
`
`director of the sole general partner of the defendant's shareholder does not
`
`prove that he had authority to issue instructions in the present case, be-
`
`cause the shareholders' agreement or a corporate resolution might also
`
`stipulate otherwise. We therefore dispute this due to a lack of knowledge.
`
`However, this entire submission raises the question of who allegedly took
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`Page 10 of 48
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`
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`the relevant marketing decision: Mr. Martin as one of the defendant's man-
`
`aging directors at the time, who according to an excerpt from the commer-
`
`cial register did not even have the sole power of representation at that point
`
`in time; Mr. Turner as the managing director of the sole general partner of
`
`the defendant's shareholder, who may not have had authority to instruct; the
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`PRC, of which both were members; the PPC, of which according to rop 13
`
`at least Mr. Martin was not a member; or, after all, "the global directors of
`
`the relevant functions", whoever they may have been in the specific case.
`
`
`
`30
`
`
`
`The question regarding the relevant decision-makers thus still remains un-
`
`answered.
`
`cc.
`
`No supply issues of plaintiff
`
`
`
`31
`
`As already stated above (no. 30 et seq.), the absence of a concrete decision
`
`at the priority date is also obvious from the fact that even more than five
`
`years after the priority date the defendant still has not launched the infring-
`
`ing embodiment in Germany. A market entry at least requires a marketing
`
`authorization which the defendant only applied for in January 2017, and
`
`which was granted for Europe in January 2018. Even if the failure to enter
`
`the market should be connected to a supply bottleneck of less than three
`
`months in autumn 2017, which we dispute (cf. surrejoinder, no. 117), the
`
`question remains why the defendant did not apply for the MA and launch the
`
`infringing embodiment on the German market before January 2017, if the
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`market entry was supposedly imminent already in March 2013.
`
`The plaintiff has not had any delivery problems since 05 October 2017. As
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`stated by the defendant itself (p. 22, middle), it directly follows from Exhibit
`
`rop 42 submitted by it that Cinryze® is currently available in the US. We
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`submit as
`
`Exhibit K 60
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`a communication by the European Medicines Agency (EMA) dated 19 Oc-
`
`
`
`
`32
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`Page 11 of 48
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`
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`tober 2017. The document bears the watermark “Shortage resolved”, and
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`the update of 19 October 2017 reads:
`
`"The shortage affecting Cinryze has been resolved and the below
`information and recommendations which were issued during the
`shortage no longer apply."
`
`German translation:
`
`
`"Der Engpass bei Cinryze wurde gelöst und die untenstehenden,
`während des Engpasses ausgegebenen Informationen und Emp-
`fehlungen gelten nicht mehr."
`
`
`33
`
`The letters submitted as Exhibits rop 43 and rop 44 do not demonstrate a
`
`delivery problem, either. On the contrary, Exhibit rop 43 states that the
`
`short-term delivery problems have been resolved. The cause at the time
`
`was not within the plaintiff's sphere, but that of a third-party supplier. The
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`“supply outlook” for 2018 which is also mentioned concerns an entirely dif-
`
`ferent question, namely the production capacities as such; these may occa-
`
`sionally lead to a situation for both the plaintiff and the defendant in which
`
`no new patients can be supplied.
`
`
`
`34
`
`
`
`
`
`
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`We dispute that the defendant was asked by the US Food and Drug Admin-
`
`istration to somehow compensate for short-term delivery bottlenecks at the
`
`plaintiff’s. The letter from which the defendant quotes in this context is not
`
`addressed to the FDA, but, see
`
`Exhibit K 61
`
`to “Healthcare Professionals”, i.e. physicians. This letter does not state in
`
`any way that the defendant somehow stands in for short-term delivery bot-
`
`tlenecks of the plaintiff. The letter solely relates to HAEGARDA® itself. It
`
`points out that in October 2017 - i.e. shortly after the product launch in the
`
`US - patients interested in HAEGARDA® were put on a waiting list, because
`
`it was not possible to cater for still more patients. The reason for this is also
`
`given:
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`Page 12 of 48
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`
`35
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`"Since then we have successfully enhanced our manufacturing
`plan to provide more HAEGARDA than originally forecasted,
`which will help us to supply an even greater number of HAE pa-
`tients."
`
`German translation:
`
`
`
`"Seitdem haben wir unseren Herstellungsplan erfolgreich erwei-
`tert, um mehr HAEGARDA zur Verfügung zu stellen als ursprüng-
`lich geplant, was uns dabei helfen wird, noch mehr Patienten zu
`versorgen."
`
`Like Exhibits rop 43 and rop 44, this therefore simply related to the defend-
`
`ant’s production capacities, and not to “emergency relief” for the plaintiff, or
`
`bottlenecks for donor blood or the likes. The defendant simply does not
`
`have the production capacities it needs, and that it would additionally need,
`
`especially for the European market. This is the reason why it did not decide
`
`to launch the attacked products on the German market now or at an earlier
`
`time in the past; this is also what the defendant concedes (p. 23, bottom).
`
`But this means, there cannot have been a final decision of the management
`
`in 2013 already to put the attacked products on the German market, seeing
`
`that the defendant does not even have the required production capacities
`
`for this now.
`
`
`
`c.
`
`No finished product
`
`
`
`36
`
`There was not even a finished product in March 2013. The question of
`
`whether the defendant produced some test substance having the features of
`
`claim 1 is irrelevant in this regard. To make arrangements for an actual use,
`
`holding a finished product in one's hands is essential, i.e. also in regard to
`
`dosage, packaging, etc. Without such a finished product, even the company
`
`management can at best decide to run or continue a development pro-
`
`gramme, but not make a firm and final – and, especially, concrete – decision
`
`
`
`to enter the market.
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`37
`
`For the changes during the course of the clinical trials, we refer to our ob-
`
`servations in nos. 54, 65 and 178 of the surrejoinder as an example, con-
`
`cerning the very different dosages. The most striking difference is that the
`
`clinical tests were performed with dosages independent of body weight, see
`
`the information on the COMPACT study in Zuraw et al., Exhibit rop 27, E3,
`
`p. 1321, while the attacked embodiment is based on body weight. The de-
`
`fendant has not submitted any documents showing when and for which rea-
`
`son this change was made, and how complicated this was or was not. But in
`
`the end, this is not relevant.
`
`The screenshot submitted as Exhibit rop 39 is not convincing, either. It is not
`
`even clear for which product this overview was created. The document
`
`bears no date, and it is not recognisable who it originates with and when it
`
`was created. We deny on the basis of a lack of knowledge that the work
`
`was actually carried out in this manner. The defendant first claims that this
`
`work is the prerequisite for beginning clinical studies. But in the last para-
`
`graph on p. 16 it says that the “conformance slots” were needed for the later
`
`marketing authorisation. The defendant also mentions and “old” and a “new”
`
`process, without explaining how these differ. We dispute that differences ex-
`
`isted, due to lack of knowledge. At the hearing on 30 November 2017, the
`
`defendant still alleged that the attacked products were practically obtained
`
`from the same lyophilisate as Berinert. We also dispute based on a lack of
`
`knowledge that new equipment for the production of the products attacked
`
`now was already purchased in 2011.
`
`No other indications of an impending market entry
`
`d.
`
`
`
`38
`
`
`
`
`
`39
`
`We have already explained in detail and offered evidence of the fact that
`
`there were no increased expectations of success of the attacked embodi-
`
`ments, which would have made a preceding management decision − which
`
`
`
`is also not proven − plausible (no. 109 of the surrejoinder). The defendant
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`
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`
`
`did not oppose this. Even if the defendant does not get tired of claiming the
`
`opposite, phase I studies were necessary, too, and not only phase II and III
`
`studies. The COMPACT study is explicitly referred to as a phase I and II
`
`study (no. 101 of the surrejoinder).
`
`40
`
`The computation of a “business case” does not prove a decision in favour of
`
`a market entry, either. Such a business case is always necessary when
`
`money is to be earmarked for a development project in the first place.
`
`
`
`41
`
`
`
`
`
`We dispute that the public could assess clinical trials at an advanced stage
`
`as an indication of an imminent market entry (p. 14, penultimate paragraph).
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`Before the priority date, the clinical trials were not “advanced” yet; they were
`
`not even in phase III. A successfully concluded phase III, however, is the
`
`requirement for applying for a marketing authorisation and thus also for the
`
`decision to place a product on the market.
`
`3.
`
`Forfeiture
`
`42
`
`Since the defendant, as stated above, has not launched a product in Ger-
`
`many even more than five and a half years later, and has behaved very hes-
`
`itantly since the priority date, we raise the
`
`
`
`
`
`objection of forfeiture.
`
`43
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`It is inequitable to still accord the defendant a right of prior use after such a
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`long period in which no use took place.
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`
`
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`Page 15 of 48
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`III.
`
`No stay of the proceedings
`
`
`
`44
`
`A stay of the proceedings is not justified. There is no likelihood whatsoever,
`
`neither based on the informed consent form nor on the other documents cit-
`
`ed in the grant proceedings, that the patent in suit could be revoked.
`
`
`
`1.
`
`Novelty in view of the informed consent form (ICF)
`
`
`
`45
`
`The informed consent form is not a prior art document, in particular because
`
`the patients are not part of the public. Additionally, the informed consent
`
`form discloses neither the therapeutic effect, nor is it a disclosure that can
`
`be carried out without undue experimentation.
`
`
`
`46
`
`
`
`
`
`The defendant is now only referring to the written informed consent form as
`
`prior art, see explicitly on p. 25, no. 2.1, and not to an alleged passing of in-
`
`formation from patients to third parties. We do not (any longer) understand
`
`the reference at the top of p. 29 that allegedly, family members are free to
`
`speak about the study, to assert that the contents of the informed consent
`
`form were made available orally. Thus we are limiting our following state-
`
`ments merely to the aspect of making the informed consent form available
`
`to the patients themselves in written form.
`
`a.
`
`Standard for a stay of proceedings
`
`47
`
`In any case, the fact remains that the ICF was not presented to the EPO
`
`during prosecution although the defendant could have done so. Submitting
`
`this alleged prior art would, in any case, not have been "futile" (see p. 25,
`
`top) but of course at that stage of the proceedings the defendant would also
`
`have had to prove that the ICF was allegedly a prior art document. The evi-
`
`dence requirements are no different now than they would have been in the
`
`
`
`procedure for grant.
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`Page 16 of 48
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`- 17 -
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`48
`
`The defendant’s quote on the bottom of p. 24 is erroneous on two counts.
`
`On the one hand, the defendant itself had established that it is not basing its
`
`assertion on a “use”, but is asserting the informed consent form as a written
`
`prior art document (p. 39 l., 2nd paragraph). On the other hand, the quote
`
`only reveals something obvious: when the facts are disputed, proof must be
`
`brought forward. This applies in the grant proceedings as well as the oppo-
`
`sition proceedings.
`
`
`
`49
`
`
`
`
`
` In any case, the holding back of an allegedly anticipatory document in the
`
`grant proceedings is enough to justify a stricter standard for the stay of pro-
`
`ceedings (no. 124 surrejoinder).
`
`b.
`
`Evidence requirement “up to the hilt”
`
`
`
`50
`
`In the opposition proceedings, the defendant merely submitted the written
`
`statements of Dr. Martinez Saguer, Dr. Craig, Mrs. Herget and Mrs. Nolte,
`
`on which we have already commented (no. 183 ff. surrejoinder).
`
`
`
`
`
`
`
`51
`
`Even if the defendant now limits itself to the informed consent form as writ-
`
`ten prior art document, the “up to the hilt” standard of proof (see no. 151
`
`surrejoinder) applies, because all pieces of evidence regarding the alleged
`
`handing out and explanation of the informed consent form are in the de-
`
`fendant’s sphere. We refer to T 2451/13, no. 3.2.6:
`
`
`
`
`
`"The board agrees with the appellant that the standard "up to the
`hilt" also applies to the present case. Document D16 originates
`from a company (Gerber) which is now a subsidiary of the re-
`spondent. Therefore, all the evidence about the publication date
`of D 16 is essentially in the hands of the respondent. It thus has
`to be examined whether the respondent has proven beyond rea-
`sonable doubt that D16 was available to the public before the pri-
`ority date of the patent."
`
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`- 18 -
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`German translation:
`
`
`"Die Kammer stimmt der Beschwerdeführerin zu, dass der „up to
`the hilt“-Standard auch im vorliegenden Fall gilt. Das Dokument
`D16 stammt von einem Unternehmen (Gerber), welches heute
`eine Tochtergesellschaft der Beschwerdegegnerin ist. Sämtliche
`Beweismittel bezüglich des Veröffentlichungsdatums von D16
`liegen damit in den Händen der Beschwerdegegnerin. Es ist also
`zu prüfen, ob die Beschwerdegegnerin ohne vernünftigen Zweifel
`dargelegt hat, dass die D16 der Öffentlichkeit vor dem Prioritäts-
`tag des Patents zugänglich war."
`
`
`52
`
`The affidavits submitted by defendant are not sufficient to meet this "up to
`
`the hilt" standard, so that the defendant has not yet complied with these re-
`
`quirements in the opposition proceedings. It is also more than unlikely that
`
`the defendant will still do so. The opposition deadline has passed, meaning
`
`that new pieces of evidence are not admissible so easily.
`
`
`
`53
`
`
`
`c.
`
`Informed consent form is not prior art
`
`
`
`The informed consent form was not made accessible to the public.
`
`aa.
`
`Case law of the Boards of Appeal
`
`
`
`54
`
`The defendant only describes the established case law of the Board of Ap-
`
`peal regarding written prior art in an incomplete and thus a misleading man-
`
`ner. What is relevant is not the access of just any single person, but of a
`
`person who represents the public and understands the content of the docu-
`
`ment. The explanations of no. 143-150 surrejoinder are thus precisely accu-
`
`rate. To facilitate the work of the Court, we submit as
`
`
`
`
`
`Exhibit K 62
`
`
`
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`chapter C. 3 of the case law of the Boards of Appeal of the EPO of July
`
`2016 and summarize the relevant aspects here:
`
` where publications and other written documents are concerned, ac-
`
`cording to para. 3.2.1 a), the public must have been able to gain
`
`knowledge of the content of the document without any obligation of
`
`confidentiality restricting the use or dissemination of such knowledge;
`
`
`
`regarding the concept of the “public”, section 3.3 (p.102) states:
`
`“The boards considered the concept of "the public" in
`several decisions. According to their case law, infor-
`mation is generally to be regarded as having been
`made public if even just one single member of the pub-
`lic is in a position to gain access to this information
`and understand it, and if there is no obligation to main-
`tain secrecy (T 1081/01, T 229/06, T 1510/06, T
`1309/07, T 2/09, T 834/09, T 1168/09).” (Emphasis
`added)
`
`
`
`
`
`
`
` with respect to making the information available to a limited circle of
`
`people, section 3.3.3, 4th paragraph states that if, at the time of re-
`
`ceipt of the information, the recipient was in some special relationship
`
`to the donor of the information, he could not be treated as a member
`
`of the public, and the information could not be regarded as published
`
`for the purpose of Art. 54 EPC 1973.
`
`This means that the informed consent form is only part of the written prior
`
`art, if
`
`
`
`at least one single patient was actually given the informed con-
`
`sent form; and
`
`
`
`
`
`
`55
`
`
`
`
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`Page 19 of 48
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`- 20 -
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`this patient can understand said information; and
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`the patient is not subject to an (explicit or implicit) confidentiality
`
`agreement and is not in a special relationship with the provider of
`
`the information, i.e. does not represent the public.
`
`
`
`
`
` 
`
`
`
`These principles can also be found in the decision T 239/16 cited by the
`
`defendant as follows:
`
`It was undisputed that there was no explicit confidentiality agreement be-
`
`tween the study’s sponsor and these patients, no more than an obligation to
`
`confidentiality under national law. Following this, the question was whether
`
`the patients could be seen as exempt from being seen as part of the public
`
`due to a special situation or relationship between the sponsor and the pa-
`
`tients.
`
`In particular, the Board of Appeal considered the affidavit of a principal clini-
`
`cal investigator of the study. This principal investigator stated that he told his
`
`patients to openly discuss the treatment with anybody, including their fami-
`
`lies and their family physician before they signed the declaration of consent
`
`regarding this treatment. Additionally, he stated that he had encouraged his
`
`patients to do so.
`
`The patent proprietor did not dispute the content of the affidavit, and the
`
`Board of Appeal deemed it trustworthy. Thus the Board of Appeal assumed
`
`that the patients were explicitly encouraged to discuss the content with “an-
`
`yone”. In this context, the Board of Appeal understood the term “anyone” to
`
`include persons who were not in a special relationship with the patient or the
`
`study’s sponsor.
`
`Thus the decision is based sol