IIC https://doi.org/10.1007/s40319-018-0715-1 CASE NOTE

Comment on ‘‘Maxacalcitol II’’: Equivalent Infringement and File Wrapper Estoppel in Japan Hirotaka Nonaka

 Max Planck Institute for Innovation and Competition, Munich 2018

1 The Doctrine of Equivalents Under Japanese Law As the Supreme Court sets out in the beginning of its decision, the doctrine of equivalents aims at striking a balance between the proper protection for the invention’s contribution to the state of the art, and legal certainty to third parties. Among the five criteria set in the ‘‘Ball Spline Bearing’’ decision that courts should apply in order to determine equivalent infringement, there are three positive criteria (i–iii) to be proven by the patentee and two negative criteria (iv and v) to be proven by the alleged infringer.1 The Supreme Court in its decision deals with the fifth requirement, namely that there are no ‘‘special circumstances’’ where, for reasons of equity, a court should deny equivalent infringement. The ‘‘Ball Spline Bearing’’ decision in this connection mentions the ‘‘file wrapper estoppel’’ (where the patentee in the course of the application process disclaims certain features as not falling under the technical scope of the patented invention), but also ‘‘actions that could be objectively construed in that fashion,’’ and that would give rise to the estoppel of contradictory behaviour by the patentee. 1

Supreme Court, 24 February 1998, Hei 6 (o) No.1083 (Japan) – Ball Spline Bearing Case, Saiko¯ Saibansho Saibanrei Jo¯ho¯, http://www.courts.go.jp/app/hanrei_en/detail?id=374 (English translation) = 30 IIC p.433 (1999). See also IIC https://doi.org/10.1007/s40319-018-0714-2, footnote 2 for a list of the five criteria.

For a translation of the Maxacalcitol II decision into English by Hirotaka Nonaka, see this issue of IIC at https://doi.org/10.1007/s40319-018-0714-2. H. Nonaka (&) Attorney-at-Law, Tokyo, Japan e-mail: [email protected]

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2 Special Circumstances that Prevent an Application of the Equivalents Doctrine The courts have dealt with three types of situations where ‘‘special circumstances’’ were discussed. First, actual amendments of the claim during examination. In cases where an applicant has corrected or revised the claims, the Osaka District Court2 has given a limited interpretation of this estoppel and only excluded embodiments removed in order to avoid grounds for rejection, whereas the Tokyo District Court3 has tended to recognise corrections and revisions as intentional exclusions without considering their objective. Second, whether subject matter that was obvious at the time of the patent application, yet was not claimed, could still be claimed by way of equivalent infringement. This is controversial. One line of argument4 takes the view that if an applicant did not describe subject matter existing at the filling date in the claim, this could amount to an intentional exclusion from the claimed invention. Namely in a case where a normal patent drafter would have described the subject matter in the claim, the applicant who actually did not mention such subject matter should not be protected under the doctrine of equivalents with regard thereto.5 The opposite view6 opines that the mere fact that an applicant did not describe the subject matter existing at the filling date in the claim is not enough to be recognised as an intentional exclusion from the claimed invention. Some courts7 agreed with the latter view. The IP High Court in a decision of 25 September 20068 held that regardless of the fact that a feature relating to the allegedly infringing product could easily have been conceived of in light of publicly-known technology or the like at the time of application, the simple fact that a feature of that type

2

Osaka District Court, 27 May 1999, 1685 Hanrei Jiho¯ 103 and Osaka District Court, 23 May 2000, court website.

3

Tokyo District Court, 28 January 1999, 1664 Hanrei Jiho¯ 109 and Tokyo District Court, 30 June 30 1999, 1696 Hanrei Jiho¯ 149.

4

Ryoichi Mimura, ‘‘Saiko¯ saibansho hanrei kaisetsu minji ken’’ [Comments on Supreme Court Precedents in Civil Cases] 1998, p. 156; Seiji Ohno, ‘‘Kinto¯ron ni okeru honshitutekibubun oyobi isikitekizyogai’’ (‘‘The essential part and the intentional exclusion on the doctrine of equivalents’’), Chizai Kanri Vol. 54, No. 9, 1345 (2004); Ryu Takabayashi, Hyo¯jun Tokkyoho¯ (Standard Patent Law), 140, 2nd edn. (2005).

5

Seiji Ohno, ibid, p. 1351; Ryoichi Mimura, ‘‘Zadankai tokkyo claim kaishaku no ronten wo megutte’’ (‘‘Symposium; Issues on claim interpretation’’), p. 87 (2003).

6

Ryuichi Shitara, ‘‘Kure¯mu kaisyakusyuhou no suii to tenbou’’ (‘‘Transition and prospects on claim interpretation’’), Kinyu shoji hanrei No. 1236, 56 (2006); Shuhei Shiotsuki, ‘‘Gijutsu hani to Kinto¯’’ (‘‘The scope of claim and the doctrine of equivalents’’), in: Chitekizaisanho¯ gendaishakai;Makino Toshiaki hanji taikankinen (IP law and modern society; Commemorative Issue on Judge Toshiaki Makino’s retirement),106 (1994); Yotaro¯ Nunoi, ‘‘Kinto¯ron no tekiyo¯ yo¯ken’’ (‘‘Requirements for the application of the doctrine of equivalents’’), Chizai Kanri Vol. 55, No. 13, 2023 (2005).

7

Nagoya District Court, 10 February 2003, 1880 Hanrei jiho 95, and Intellectual Property High Court, 25 September 2006, 2005 (Ne) 10045.

8

AIPPI Vol. 52, No. 7, 454.

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Comment on ‘‘Maxacalcitol II’’: Equivalent Infringement…

was not included in the claims does not constitute the intentional exclusion of that structure relating to the Subject Product from the claims. In the current case, both the first and second instance court held that an applicant does not already intentionally exclude an embodiment from protection that could have been easily conceived at the filling date of the claim. In this respect, the IP High Court judgment required the ‘‘applicant’s recognition’’ for affirming ‘‘special circumstances’’. The Supreme Court took a slightly narrower stance and required an ‘‘indication’’ by the applicant. This should be interpreted as a positive action by the applicant rather than simply the ‘‘applicant’s recognition’’. In this case, the transisomer of a vitamin D derivative (the defendant’s starting product) was neither described in the claim nor the description. Accordingly, the Supreme Court held that there was no ‘‘indication by the applicant’’, and affirmed that there was no bar to applying of the doctrine of equivalents. While future cases will certainly give more guidance to what should be considered as an ‘‘indication by the applicant’’, it is important to note that the Supreme Court rejects both Mimura’s theory that an oversight could be enough to allow the estoppel under the fifth requirement (‘‘could have been aware of the alternative at the time of application’’), and the view taken by some courts that a recognition of the alternative was enough (‘‘had not included the alternative although being aware of it’’). Third, whether special circumstances could be affirmed where the applicant actually disclosed several alternatives in the patent description, yet claimed only some of them and then ascertained equivalent infringement also against those alternatives not claimed. There was one precedent that affirmed a conscious exclusion in a case in which an alternative was disclosed in a drawing of the description, yet had not been stated in the claims.9 For this situation, the Supreme Court in the current decision is very clear (although strictly speaking in an obiter dictum): For reasons of equity and the estoppel of contradictory behaviour of the patentee, the latter should not be able to claim these alternatives.

3 Comparative Remarks It is worthwhile to compare the Japanese Supreme Court case with decisions from the UK and Germany. In the UK, the Supreme Court recently dealt with the alleged equivalent infringement of a patent that claimed the use of pemetrexed disodium in the manufacture of a medicament for use in combination with vitamin B12 for the treatment of cancer.10 The defendants for their products had exchanged pemetrexed disodium with pemetrexed diacid, pemetrexed ditromethamine or pemetrexed dipotassium. According to the description of the patent, ‘‘[t]he current invention concerns the discovery that administration of a methylmalonic acid lowering agent such as vitamin B12 or a 9 10

Tokyo District Court 29 June 1999, 1686 Hanrei Jiho¯ 111. UK Supreme Court, Actavis et al. v. Eli Lilly et al., decision of 12 July 2017, (2017) UKSC 48.

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pharmaceutical derivative thereof, in combination with an antifolate drug such as pemetrexed disodium reduces the toxicity of the said antifolate drug.’’ The court of first instance had ascertained that, ‘‘The only form of pemetrexed which had been shown to be effective and safe to any extent was pemetrexed disodium, which was manufactured by Lilly under the trade mark Alimta.’’ It was not least for this reason that the EPO examiner had insisted that ‘‘antifolate’’ (original filing) was changed not only to ‘‘pemetrexed’’ (first amendment), but rather to ‘‘pemetrexed sodium’’, as only this found a proper basis in the application. In a major deviation from previous case law,11 and in referring to an article by Hugh Laddie published in this journal,12 the Supreme Court affirmed an equivalent infringement. In this context, especially two passages of the decision merit attention. The first concerns the relationship between disclosure in the description, and claimed subject matter (third scenario as above): 72. More specifically, I do not agree with the Court of Appeal’s view that, because the specification referred to ‘‘anti-folates’’ and ‘‘anti-folate drugs’’, the fact that the claims were limited to pemetrexed disodium means that the drafter of the Patent would have been understood to intend that the other pemetrexed compounds would not infringe… 73. Further, … I would have thought that if the specification had not referred to anti-folates but had only referred to pemetrexed disodium, that would have been a more powerful indication that the patentee was intending to limit himself to pemetrexed disodium. The very fact that the specification teaches that there are other anti-folate drugs which have a similar effect to pemetrexed disodium … highlights (that no) ‘‘rational patentee should want to place so narrow a limitation on his invention’’ as to limit the scope of protection afforded by the Patent to pemetrexed disodium …’’. The second concerns the legal implication of the above claim limitation during examination. After having observed that the courts in Germany and the Netherlands generally discourage the use of the patent office file in the interpretation of claims, Lord Neuberger observes that: 87. It is appropriate for the UK courts to adopt a sceptical, but not absolutist, attitude to a suggestion that the contents of the prosecution file of a patent should be referred to when considering a question of interpretation or infringement, along substantially the same lines as the German and Dutch courts. … 89. It seems to me clear that the reason why the examiner considered that the claims in the patent should be limited to pemetrexed disodium was because the teaching in the specification did not expressly extend to any other anti-folates … I do not consider that that consideration can have any bearing on the question whether any pemetrexed salts other than pemetrexed disodium should be within the scope of the patent pursuant to the doctrine of equivalents. 11 UK House of Lords, Kirin Amgen v. Hoechst Marion Roussel, (2005) RPC 9; UK High Court, Improver Corp. v. Remington Consumer Products (1990) FSR 181. 12

Hugh Laddie, ‘‘Kirin-Amgen, The End of Equivalents in England?’’, IIC 40(1):3–38 (2009).

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This is certainly a different approach from the one taken by Japanese case law. In Germany, the third scenario as mentioned above has been subject to a vivid controversy. Here, two German Federal Supreme Court cases, Okklusionsvorrichtung (Occlusion Device)13 and Diglycidverbindung (Manufacture of a Reagent)14 dealt with a scenario where the patentee in the description had disclosed several ways of implementing the invention, yet claimed only one of them. The defendant had carried out the invention according to one of the ways that was cited in the description, yet not claimed. This scenario is different from the Macacalcitol scenario where the patentee could have foreseen the allegedly infringing alternative, yet did not claim it (above scenario two). It is pretty clear that in the Maxacalcitol scenario, the German courts would have found for an equivalent infringement, while this was less clear in the third scenario. Both in ‘‘Okklusionsvorrichtung’’ and in ‘‘Diglycidverbindung’’, the Du¨sseldorf courts as infringement courts of first and second instance had found in favour of the plaintiff, and in both cases were overturned by the Federal Supreme Court. The headnotes in ‘‘Okklusionsvorrichtung’’ read as follows: –

–

In the event of contradictions between the patent claims and the description, the elements of the description that are not reflected in the patent claims are, as a matter of principle, not included in the protection afforded by the patent. The description is only to be taken into account to the extent that it can be read as an explanation of the subject matter of the patent claim. If the description discloses a number of ways in which a specific technical effect can be achieved, but only one of these ways is included in the patent claim, the use of one of the other ways does not, as a rule, constitute an infringement of the patent with equivalent means. In the following decision ‘‘Diglycidverbindung’’, the Court further specified this: Where a patent offers several possibilities of how to achieve a certain technical effect, and where only one of these possibilities is actually claimed, an infringement by equivalents can only be affirmed when the modified solution in its specific effects is congruent with the specific effects of the solution that has actually been claimed and in the same way differs from the solution that has been disclosed in the description, but not in the claims.

13

German Federal Supreme Court, 10 May 2011, 2001 GRUR p. 701 – ‘‘Okklusionsvorrichtung’’.

14

German Federal Supreme Court, 13 September 2011, 2012 GRUR p. 45 – ‘‘Diglycidverbindung’’.

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These decisions were critically commented by Ku¨hnen, a presiding judge of the Du¨sseldorf Court of Appeal15 and a subsequent decision of the Du¨sseldorf District Court (‘‘Borreliosekarte’’)16 refused to follow them. In ‘‘Borreliosekarte’’, the patent concerned a so-called ‘‘tick card’’ meant to remove ticks from the skin:

The claim was limited to a card that envisages ‘‘a corner area designed with a slit for use in removing a tick’’. The description, however, also considers other locations for the slit: [0017] The disclosed slit or cut-out 36, which may end up in a circular hole, may alternatively, or as a supplement, also be provided at a short side of the card. The ‘‘BorreliaCard’’ will hereby act as a pre-stressed spring which by itself, after placing under and around the tick, will provide a certain pulling or elevation action on the tick so that it, including mouth parts, will be pulled or lifted off the skin. The defendant had made use of exactly the embodiment envisaged in paragraph 17 and sold cards with a slit in the middle of the short side of the card, in other words an embodiment that was disclosed, but not claimed. The Du¨sseldorf District Court found the defendant’s embodiment to infringe by equivalent means: Even considering that a guidance according to the patent claim requires not only that the patent claim in all its features is the starting point [for determining infringement], but also the relevant basis for the considerations of the person skilled in the art …, equivalence can be affirmed according to the previous considerations. This is even so against the background of recent case of law of the Federal Supreme Court on the question of equivalents where the 15

Thomas Ku¨hnen, ‘‘Die Reichweite des Verzichtsgedankens in der BGH-Rechtsprechung zum ¨ quivalenzschutz’’, 2013 GRUR p. 1086. Ku¨hnen takes the view that equivalent infringement should A only be denied where the patentee was forced to limit the claim by objections of prior art rather than out of his own volition. 16

Du¨sseldorf District Court, 15 September 2011, Case 4b O 216/08 – ‘‘Borreliosekarte’’ (unpublished).

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patent claim has made a limiting selection (Federal Supreme Court, 10 May 2011 – ‘‘Occlusion Device’’). According to this decision, the following applies: Where a description offers several possibilities of how a certain technical effect can be achieved, and only one of these possibilities has actually been claimed, the use of the other alternatives generally does not qualify as an infringement by equivalents. However, in the case at issue and in light of paragraph [17], competitors could not in good faith take the view that positioning the slit outside of the corner of the card, and even in the middle between two corner areas, would not amount to an infringement of the patent at issue. Especially due to the advantages disclosed in the above-cited passage, a good-faith reading of the above-mentioned passage does not give reason to the view that the patentee did not wish to claim protection for cards with slits outside the corner areas. The Federal Supreme Court revoked the patent and for this reason did not take a position on the infringement question. Yet it is clear that the decision of the Du¨sseldorf District Court argues infringement based on the patentee’s contribution to the state of the art rather than, as was mandated by the Federal Supreme Court decisions, the wording of the claim and the patentee’s choice not to claim all embodiments that were disclosed.

4 Analysis Both the Japanese and the German Supreme Courts applied very similar standards in what they considered should exclude an equivalent infringement. They thereby disagreed with more extreme opinions on both ends of the spectrum: Mimura17 would have already excluded equivalent infringement for alternatives the patentee could have foreseen, but did not claim. This is problematic because it essentially leaves no room for equivalent infringement: Either the patentee could have foreseen the alternative at the filing date and subsequently cannot claim it as an equivalent, or the patentee could not have foreseen it, in which case it is an inventive rather than an equivalent alternative. On the other end, Ku¨hnen18 and the Du¨sseldorf courts19 would have affirmed an equivalent infringement even for an alternative that was mentioned in the description, but was not claimed. This is certainly consistent with the notion that a patentee should receive protection commensurate to the contribution to the state of the art, yet this is difficult to reconcile with the principle that the claims determining the scope of protection are consciously drafted by the patentee and should also give third parties certainty about those features or embodiments that are not claimed and therefore free for all to use. From the passages cited above, it appears that also the UK Supreme Court would now rather 17 Ryoichi Mimura, ‘‘Saiko¯ saibansho hanrei kaisetsu minji ken’’ [Comments on Supreme Court Precedents in Civil Cases] 1998, p. 156. 18 Thomas Ku¨hnen, ‘‘Die Reichweite des Verzichtsgedankens in der BGH-Rechtsprechung zum ¨ quivalenzschutz’’, 2013 GRUR p. 1086. A 19

Du¨sseldorf District Court, 15 September 2011, Case 4b O 216/08 – ‘‘Borreliosekarte’’ (unpublished).

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side with the Du¨sseldorf courts than the German Supreme Court: Paragraph 73 of the Actavis decision indicates that the broad mention of anti-folates and the limitation of the claim to pemetrexed disodium is no bar for the patentee to subsequently claim anti-folates beyond the one specifically claimed. The case is different from Okklusionsvorrichtung in that the examiner of the Eli Lilly patent thought that there was no support for a broader claim20 (a view that is backed up by the findings of the Actavis first instance decision, but that Lord Neuberger thought was wrong). So the limitation was brought about by an objection of insufficient disclosure rather than an objection of prior art or the patentee’s own volition. For this reason, the applicant of the Eli Lilly patent did not describe subject matter that did exist at the filing date of the invention, because the description in this breadth was non-enabling. Seen this way, it is interesting to ask whether Eli Lilly’s claim of equivalent infringement under the Japanese doctrine of equivalents would have fallen at the hurdle of the fifth requirement. Also in Japan, there was discussion as to whether the reasons for a claim limitation could play a role in affirming or denying equivalent infringement. After the Ball Spline Bearing case of the Supreme Court in 1998,21 the lower courts were split on this issue. Some denied equivalent infringement without taking into account the reasons why the limitations were made,22 others considered the grounds of the limitation in applying equivalent infringement.23 By now, academic writings and more recent decisions seem to agree that equivalent infringement cannot be claimed over subject matter that was renounced during examination no matter the reason.24 On the other hand, the fact that the chemical compounds used by Actavis were not obvious (and even inventive) alternatives at the filing date does not necessarily preclude equivalent infringement, as in Japan, the date for determining obvious interchangeability is the date of infringement rather than the filing date. It is finally interesting to note that the carefully balanced position of the Japanese Supreme Court whereby the patentee’s mere silence cannot be taken as a renouncement is echoed in Ku¨hnen’s article where he writes: Denying that patent protection has been renounced as unmentioned, but obvious alternatives are consistent with the approach under general civil law to which patent law also belongs. There, it is understood that the renunciation of a subjective right (e.g. a claim under the law of obligations, a right that can be exercised or an estoppel) is possible even implicitly and by mere silence. 20 Perhaps it would have been wise for the examiner of Eli Lilly’s patent to insist on an adaptation of the description, too, in order to have the broader mention of anti-folates deleted and exchanged by what the examiner thought was the inventive contribution, namely pemetrexed disodium. 21

Supra note 1.

22

Intellectual Property High Court, 24 December 2015 (2015 (Ne) 10031); Tokyo District Court, 23 April 2010 (2008 (Wa) 18566); Tokyo District Court, 22 January 2008 (2007 (Wa) 11981); Osaka District Court, 21 December 2006 (2004 (Wa) 3640); Tokyo District Court, 30 June 1999 (1696 Hanrei Jiho¯ 149). 23

Intellectual Property High Court, 25 April 2013 (2012 (Ne) 10080); Osaka District Court, 3 October 2002 (2000 (Wa) 10170); Osaka District Court, 23 May 2000 (1995 (Wa) 1110); Osaka District Court, 27 May 1999 (1685 Hanrei Jiho¯ 103). 24

Tetsu Iwatsubo, in: Shin Chukai Tokkyoho¯ (New Commentary on Patent law) 2nd edn., p. 1278, second volume (2017).

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This, however, requires an intention to renounce by the person entitled to this position.25

25 Thomas Ku¨hnen, Die Reichweite des Verzichtsgedankens in der BGH-Rechtsprechung zum ¨ quivalenzschutz, 2013 GRUR p. 1089. A

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