Source: https://www.patentlitigation.ch/tag/doctrine-of-equivalents/
Timestamp: 2019-04-22 14:11:33+00:00

Document:
As reported earlier on this Blog here, the Supreme Court had remitted the case to the FPC with the order to dismiss the suit with respect to the requested declaratory judgment of non-infringement for the diacid, and to also assess the two other salts that had initially been at stake in first instance proceedings.
Well, the first part is a no-brainer. The FPC is bound to the legal assessment of the Supreme Court, and it thus dismissed the suit with respect to the diacid.
As to the two other salts, i.e. pemetrexed dipotassium and pemetrexed ditromethamine, the FPC briefly assessed infringement under the doctrine of equivalents.
The first question to be answered in the assessment of infringement under the DoE is whether the replaced feature and the replacing feature have the same objective function. The decision holds that it is only the cation that is different, and that the dianion is the same in any event. Further, it is held that both the dipotassium and the ditromethamine salt will be dissociated under physiological conditions, and everything suggests that the mode of action is determined by the dianion.
Pemetrexeddikalium unterscheidet sich von Pemetrexeddinatrium bzw. Pemetrexeddisäure lediglich durch das Kation. Das Dianion ist in allen Fällen identisch. Pemetrexeddikalium liegt bei physiologischem pH dissoziiert in Kation und Dianion vor. Es spricht alles dafür, dass die Wirkungsweise durch das Pemetrexed-Dianion gegeben ist.
Aus diesen Gründen ist eine Gleichwirkung für Pemetrexeddikalium gegeben ist.
One may like or dislike the outcome as it is. Be this as it may. What is troubling me is that this reasoning is only focused on the mode of action of the dianion. Note that the dianion neither is the replaced feature nor the replacing feature. Does this reasoning actually address the first question of the FPC’s questionnaire for the assessment under the DoE at all?
Is there a need to rephrase the first question? Time will show, I guess.
The FPC answered the second and third question in the affirmative, too. It did so by mere reference to the considerations of the Supreme Court.
In sum, all three pemetrexed forms (diacid, dipotassium and ditromethamine) are held to infringe the patent in suit.
The patent in suit is Lilly‘s EP 1 313 508 B1; see the EPO Register and Swissreg for further details. EP’508 is heavily litigated in many countries. The present decision in Switzerland concerns Lilly’s request for interim injunctive relief in summary proceedings. Main proceedings are still pending (O2105_004).
12. A product containing pemetrexed disodium, vitamin B 12 or a pharmaceutical derivative thereof said pharmaceutical derivative of vitamin B12 being hydroxocobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-chlorocobalamin perchlorate, azidocobalamin, chlorocobalamin or cobalamin, and, optionally, a folic binding protein binding agent selected from the group consisting of folic acid, (6R)-5-methyl-5,6,7,8-tetrahydrofolic acid and (6R)-5-formyl-5,6,7,8-tetrahydrofolic acid, or a physiologically available salt or ester thereof, as a combined preparation for the simultaneous, separate or sequential use in inhibiting tumor growth.
Pemetrexed disodium (see structural formula below) is marketed by Lilly under the trademark Alimta®. Stakes are high for Lilly: Alimta® generated a worldwide revenue of $2,493 million in 2015; see Lilly’s Annual Report 2015, p F31. The drug is used as a cancer medication that interferes with the growth and spread of cancer cells in the body; see drugs.com for further information.
Literal infringement was not an issue. The present decision is all about the question of whether or not the use of pemetrexed diacid might constitute an infringement under the Doctrine of Equivalents (DoE).
Note that the wording of the claim had been narrowed down during prosecution in order to overcome the examiner’s objections and to proceed to grant: The broad term antifolate had been more precisely defined as pemetrexed in first place, and finally even further as pemetrexed disodium. The FPC thus assessed whether the DoE is applicable at all to the feature pemetrexed disodium. The FPC notes that the patentee is bound by limitations he had accepted during prosecution in order to obtain the patent, and that he is therefore prevented under principles of good faith (Art. 2 CC) to circumvent this limitation by asserting equivalence. The FPC refers to a decision HG060066 of the Commercial Court Zurich in this respect. This is not to be confused with the Prosecution History Estoppel known in the U.S. — it rather highlights that the prosecution history is not just irrelevant.
Für die Beurteilung der Bedeutung dieser von der Patentinhaberin im Laufe des Erteilungsverfahrens vorgenommenen Einschränkung ist davon auszugehen, dass die Schweiz, wie andere Europäische Länder auch, keine Prosecution History Estoppel, wie sie in USA angewandt wird, kennt. Das heisst aber keineswegs, dass die Erteilungsgeschichte in der Schweiz völlig ausser Acht gelassen werden kann.
The FPC consequently held that the request for interim injunctive relief had to be dismissed for this reason alone.
For the sake of completeness, the FPC additionally assessed infringement under the DoE. The FPC’s 3-step questionnaire has recently been approved by the Supreme Court.
The first question to be answered is whether the replaced features have the same objective function. The FPC essentially relied on the fact that the attacked embodiment is a Swissmedic approved generic version of Alimta®, ie the pemetrexed disodium containing product. The same objective function was thus held to be given.
The second question asks whether the replaced features and their same objective function are made obvious to the skilled person by the teaching of the patent. See also the clarifying headnote of O2014_002 on how the FPC expects this question to be addressed. The FPC held that the skilled person knows that pemetrexed diacid would be at least partially deprotonated under physiological conditions, and that both pemetrexed diacid and pemetrexed disodium will result in the same pemetrexed dianion. Concluding, the skilled person would thus have expected the diacid to have the same effect (based on the anion). The FPC expressly dissents with the judgement of the England and Wales Court of Appeal ( EWCA Civ 555, #71) in this respect.
The terms “antifolate” and “antifolate drug” generally refer to a chemical compound which inhibits at least one key folate-requiring enzyme of the thymidine or purine biosynthetic pathways, preferably thymidylate synthase (“TS”), dihydrofolate reductase (“DHFR”), or glycinamide ribonucleotide formyltransferase (“GARFT”), by competing with reduced folates for binding sites of these enzymes. The “antifolate” or “antifolate drug” for use in this invention is Pemetrexed Disodium (ALIMTA®), as manufactured by Eli Lilly & Co.
The FPC thus answered the third question in the negative, expressly consenting with the judgement of the England and Wales Court of Appeal ( EWCA Civ 555, #72) in this respect. The FPC also sides with the German Federal Supreme Court’s decision X ZR 29/15 in parallel proceedings in that the present matter is not an abandonment in the sense of X ZR 16/09 – Okklusionsvorrichtung. In Okklusionvorrichtung the replacing feature had been explicitly mentioned in the specification; not so in the present matter. However, the FPC notes that this does not automatically mean that a contrario the third question is to be answered in the affirmative.
Der BGH fokussiert sich bei der Beurteilung der dritten Äquivalenzfrage allerdings sehr auf diese Frage des Verzichts. Dem kann nicht gefolgt werden. Die Tatsache, dass kein Verzicht gemäss Okklusionsvorrichtung vorliegt, bedeutet keineswegs automatisch im Umkehrschluss, dass die 3. Äquivalenz-Frage zu bejahen ist. Das greift zu kurz.
The FPC thus dismissed Lilly’s request for interim injunctive relief in summary proceedings. Main proceedings are still pending (O2015_004).
A comprehensive summary on the current status of proceedings relating to Lilly’s Alimta® can be derived from Lilly’s Form 10-Q (3/2016); see p 24-25.
If you are interested in the fulltext decisions, there is a long series of decisions to read from the UK, ie  EWHC 3316 (Pat),  EWCA Civ 517,  EWHC 1511 (Pat),  EWCA Civ 555 and  EWHC 234 (Pat).
As to Germany, there is the most recent decision X ZR 29/15 of the Federal Supreme Court. Please find the whole course of proceedings through the various instances in Germany here. Interim injunctive relief has been granted by the Regional Court Munich I in matters 21 O 22243/15 and 21 O 5583/16.
The FPC dismissed Lilly’s request for interim injunctive relief in summary proceedings concerning a generic version of Lilly’s Alimta®, ie Actavis’ Amtiris®. While the claims of Lilly’s EP 1 313 508 B1 specifically require pemetrexed disodium, Amtiris® comprises pemetrexed diacid. The FPC held that limitation from antifolate to pemetrexed disodium during prosecution constitutes an abandonment of subject-matter. But even if it would not be considered an abandonment, the FPC denied an infringement under the Doctrine of Equivalents since the skilled person would have understood the wording pemetrexed disodium as a strict limitation, in view of the claims in view of the specification. Main proceedings are still pending (O2015_004).
I have reported on the main hearing before the FPC on this Blog here. For a brief review of the underlying decision O2014_002 of the FPC, see this Blog here.
Long awaited, now here it is: The first decision of the Supreme Court on the Doctrine of Equivalents since ages; see fulltext below. You hoped for a ready-mix for assessment of equivalency? I’m sorry, there is none.
But let’s have a look at the very basic facts first.
The technology is not difficult to understand: The strip (6) and the ‘component with a complementary surface’ — actually, yet another strip — are arranged in a way as to allow fluid passing through the valve in the one direction of the valve. The valve closes when the fluid has passed, to prevent unpleasant odor from rising up. Flattened tubes instead of separate strips had been known in the prior art for the same purpose; see D1, US 3 835 857).
actually mean? There is no explicit definition of “separate” in the patent. Actually, the word as such was not even used in the application as filed at all. It had been introduced during prosecution, based on the overall specification and figures which all show (completely) separate strips; see figures 1 and 2, above.
On the other hand, the two strips are interconnected by lateral connectors in the attacked embodiment. Noteworthy, this configuration is protected by EP 2 553 299 B1 of the defendant (embedded below; EP’299 explicitly acknowledges the patent in suit as closest prior art in para. -).
Die Ausführungsbeispiele weisen auf dieses Verständnis eindeutig hin, ohne dass Anhaltspunkte für ein weiteres Verständnis von ‘separate’ in dem Sinne bestehen würden, dass das Ausführungsbeispiel mit den losen Enden nur als eine – wie die Beschwerdeführerin behauptet, bevorzugte – Ausführung erschiene.
Almost no decision on equivalency is uncontroversial, and people mostly have a very firm opinion pro or contra infringement under the Doctrine of Equivalents. So do I. But I feel there are plausible arguments for both views in the present matter, and I won’t take position for either side. No use crying over spilt milk anyway; this case has been finally decided now.
But let’s have a closer look at what can be learned about how the Supreme Court nowadays assesses infringement under the Doctrine of Equivalents on the basis of the three-step questionnaire as defined by the FPC (see S2013_001).
[…] component and the strip (6) are separate for a sufficient length to allow for a sealing effect when a fluid has passed.
The first question is a no-brainer here: Fulfilment of the same function has been beyond dispute.
It is to be determined whether, once the features are replaced, the same effect is evident for the person of skill in the art when objectively assessed in consideration of the teaching of the patent.
Zu beurteilen ist, ob, wenn die Merkmale ausgetauscht sind, die Gleichwirkung für den Fachmann bei objektiver Betrachtung unter Berücksichtigung der Lehre des Patents offensichtlich ist.
According to the hn in light of the reasons, this test compares two already given situations (one with the replaced/claimed feature and another one with the replacing feature) and only then asks whether the same effect is evident. As I have outlined earlier, this really makes a big difference.
[…], whether the skilled person who intends to add a fixation at the lower end of the strips instead of the loose ends will readily understand that the strips have to be separate at a length which is sufficient to achieve the effect which the patent intends to achieve.
[…], ob der Fachmann, der statt der losen Enden der Streifen am unteren Ende der Streifen eine Befestigung anbringen will, ohne weiteres erkennt, dass die Streifen auf einer hinreichenden Länge getrennt werden müssen, um die mit dem Patent angestrebte Wirkung zu erreichen.
I don’t think that this is what the FPC had in mind when drafting the hn and r. 6.5.2.4. In the assessment of the FPC, there is no need at all for a skilled person intending to add a fixation. The skilled person rather only compares two given scenarios, i.e. the claimed solution and the attacked embodiment. If the same effect of these two embodiments is evident, the question is to be answered in the affirmative. Else, it’s not. Frankly speaking, I just cannot say whether the Supreme Court is supportive of this approach or not.
Thus, it is not apparent for the skilled person in view of the claim construction that the claimed subject-matter (separately) could equivalently be replaced with a modification of this feature (lateral connectors).
So ist in diesem Fall für den Fachmann bei Orientierung am ausgelegten Anspruchswortlaut auch nicht erkennbar, dass die anspruchsgemässe Lehre (separat) mit einer Abwandlung des betroffenen Merkmals (Verbindungsstege) gleichwertig realisiert werden kann.
Actually, a complete separation […] with loose ends is not required by the wording of the claim as such.
Eine vollständige Trennung […] mit losen Enden wird vom Anspruchswortlaut für sich genommen gerade nicht verlangt.
If that was indeed the case, then why is there no literal infringement?
Thus, the loose end of the strips can equally be replaced by a fixation.
Danach lässt sich das lose Ende der Streifen gleichwertig durch eine Befestigung ersetzen.
In my perception, the great achievement of the third question reaches far beyond that. It had been intended to be all about providing a reasonable degree of legal certainty for third parties, i.e. to reasonably confine the potential scope under the Doctrine of Equivalents. Therefore, it essentially asks whether the skilled person would really have considered the replacing feature as an equivalent, with due consideration of the claim and the description — not merely whether it objectively is an equivalent replacement.
Subsequent inventions are directly covered by the scope of the prior teaching if this prior teaching is fully embodied while providing for an improved, non-obvious variant; and inventions which make use of the core of the inventions that has been patented earlier (ALOIS TROLLER, Immaterialgüterrecht, Bd. II, 3. Aufl. 1985, S. 891). Art. 36(1) PatA provides for a non-exclusive license in such cases (cf decision 4C.502/1997 of April 20, 1998, r. 5b).
Vom Schutzbereich der älteren Lehre direkt umfasst sind spätere Erfindungen, wenn sie die ältere Lehre vollständig anwenden, aber eine verbesserte, nicht naheliegende Ausführung lehren, und ebenso Erfindungen, bei deren Anwendung der Kern der früher patentierten Erfindung mitverwendet wird (ALOIS TROLLER, Immaterialgüterrecht, Bd. II, 3. Aufl. 1985, S. 891). Dafür sieht Art. 36 Abs. 1 PatG eine nicht ausschliessliche Lizenz vor (vgl. Urteil 4C.502/1997 vom 20. April 1998 E. 5b).
Reference to Art. 36(1) PatA looks like an easy way out, but the right to be granted a non-exclusive license is explicitly only given by law if the invention represents an important technical advance of considerable economic significance in relation to the invention that is the subject-matter of the prior patent. It will not necessarily be easy to meet this precondition.
I hope we will see further decisions of the Supreme Court in the near future which provide some more guidance on the actual interpretation of the second question and how the reasonable degree of legal certainty for third parties is to be safeguarded when answering the third question. Addressing infringement under the Doctrine of Equivalents with a set of three questions that somehow resemble the questionnaires used in the U.K. and Germany surely is an achievement of harmonization. But I do not yet see much harmony in how the questions are interpreted and answered.
The good news from the first decision of the Supreme Court on the Doctrine of Equivalents since ages: The third question of the FPC’s questionnaire is approved. The sad news: There is little to no guidance in the decision with respect to how the second and the third question are to be interpreted. In particular, it still remains unclear how the reasonable degree of legal certainty for third parties is to be safeguarded when answering the third question.
For a brief review of the underlying decision O2014_002 of the FPC, see this Blog here. The decision of the Supreme Court has been published today.
An important take-away message is: The third question (which has been applied by the FPC for the first time in S2013_001, somewhat similar to Schneidmesser in Germany and Improver in the UK) has now been approved by the Supreme Court. Welcome!
On the merits of the case, the Supreme Court overruled the FPC’s decision on equivalence. It will take me a few days to digest the decision and to put it into perspective. Asking three questions is a first step; the devil surely is in the detail of the answers. Stay tuned.
Art. 109 PatA; Art. 69 EPC; Protocol on the Interpretation of Article 69 EPC of 05 October 1973 as revised by the Act revising the EPC of 29 November 2000; Art. 66 para. 1 lit. a PatA: imitation (equivalence), accessibility.
The decision is a booklet of 82 pages and it will take me some more time to finish a post on all aspects of the decision. The main hearing took place on 14 September 2015; see this Blog here for some background information on the subject-matter at stake. But the highlight for sure is the headnote which is meant to clarify an important issue in the assessment of equivalence, i.e. the second question relating to accessibility (Auffindbarkeit). So I bring forward this part of the story.
Werden die ersetzten Merkmale und deren objektiv gleiche Funktion dem Fachmann durch die Lehre des Patentes nahe gelegt?
Are the replaced features and their objectively same function rendered obvious by the teaching of the patent to the person of skill in the art?
Starting from the teaching of the patent in suit, is it evident for the skilled person that the replaced feature has the same effect?
Ist bei ausgetauschten Merkmalen die Gleichwirkung für den Fachmann bei objektiver Betrachtung ausgehend von der Lehre des Patents offensichtlich?
Was the person skilled in the art enabled by his expertise to find the modified means as having the same effect?
Haben seine Fachkenntnisse den Fachmann befähigt, die abgewandelten Mittel als gleichwirkend aufzufinden?
This question is all about excluding those cases in which an inventive step was necessary to find the modified means as having the same effect. If that is the case, i.e. if the means having the same effect were not obvious to the person skilled in the art, they are outside the scope of the patent (BGH Oct. 24, 1986, Case No. X ZR 45/85, (Befestigungsvorrichtung [Fixing Device])). Because what the person skilled in the art is not able to find and to do based on the patent and helped by his or her knowledge in the art, is not to be granted to the patentee (BGH May 15, 1975, Case No. X ZR 35/72, (Ski-Absatzbefestigung [Ski Heel Attachment])). Else, the fundamental bargain underlying most patent regimes is violated — i.e. that a patent is an exclusive right granted for a limited period in exchange for certain technical teaching made available by the patentee to the public, by publication of the patent.
But let’s again have a look at the reasons of the decision S2013_001, r. 17.2: In light of various Supreme Court decisions (BGE 97 II 85, r. 1; BGE 125 III 29, r. 3b; BGE 115 II 490, r. 2a), it was held that it has to be asked whether the replacing means are rendered obvious by the teaching of the patent for the person of routine skill in art, “henceforth referred to as the second question” (“nachstehend als zweite Frage bezeichnet”). In the next paragraph, the second Schneidmesser question is recited and it was held, that this question equates with the aforementioned second question (“entspricht obiger zweiter Frage”). This is why I felt that the Swiss approach to the second question actually resembles Schneidmesser. With the reasons of the present decision at hand, I doubt that this is the case.
I remain keen to learn how the Urinal question will henceforth be applied in practice.

References: EWCA 
 EWCA 
 EWCA 
 EWCA 
 Art. 36
 Art. 36
 Art. 36

Art. 109
 Art. 69
 Art. 66