Confirmed in main proceedings re Pemetrexed: The counterion matters!

Case No. O2015_004 ¦ Decision of 09 March 2017 ¦ “Pemetrexed: Feststellungsklage auf Nichtverletzung gutgeheissen, Bindung an Einschränkung im Erteilungsverfahren”

Please note that Hepp Wenger Ryffel is involved in this matter on behalf of the plaintiff.

The patent in suit is Lilly‘s EP 1 313 508 B1 which is litigated in various countries; see the EPO Register and Swissreg for further details. It’s all about a generic version of Lilly’s Alimta®, ie Actavis’ Amtiris®. While the claims of Lilly’s EP’508 specifically require pemetrexed disodium, Amtiris® comprises pemetrexed diacid.

The independent claims of EP’508 read as follows (emphasis added):

1.   Use of pemetrexed disodium in the manufacture of a medicament for use in combination therapy for inhibiting tumor growth in mammals wherein said medicament is to be administered in combination with vitamin B12 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.

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.

Protection of pemetrexed diacid and the pharmaceutically acceptable salts thereof by the basic patent EP 432 677 B1 and a subsequent SPC has lapsed in December 2015.

The FPC had already dismissed Lilly’s request for interim injunctive relief in corresponding summary proceedings S2016_004; see this Blog here. In a nutshell, it had been 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 (DoE) since the skilled person would have understood the wording pemetrexed disodium as a strict limitation, in view of the claims and in further consideration of the specification.

The present decision now is a declaratory judgement of non-infringement in main proceedings. The reasons are essentially along the line of arguments as set forth already in summary proceedings S2016_004. But still, there are some interesting aspects beyond that:

1.   Three- vs. five-member panel of judges

As a general rule, the FPC makes its decisions as a three-member panel. However, the FPC can make its decisions as a five-member panel on the order of the President where this is in the interest of the further development of the law; Art. 21(2) PatCA.

The defendant requested that the panel of judges be extended to five members, in view of the critical legal questions at stake (equivalence; abandonment of subject-matter during prosecution and its interplay with claim construction in after-grant proceedings).

First, the FPC held that this request is belated. It has only been filed when the parties had already been served with the expert opinion of the judge-rapporteur — which has been unfavorable for the defendant. In the FPC’s view, this might well be the actual motivation of the request, not the complexity of the legal questions at stake.

Im Übrigen gibt die Tatsache, dass der Antrag der Beklagten erst auf den Erhalt des für sie negativ ausgefallenen Fachrichtervotums erfolgte, Anlass zur Frage, ob nicht eher dies — und nicht die Rechtsfragen — Anlass für den Antrag war.

On the merits, the FPC further holds that this is no case of special interest for the further development of the law. Appearance of bias due to prior involvement of the same panel of judges in corresponding summary proceedings cannot be an issue, either; Art. 47(2) lit. d CPC.

2.   The ‘core of the invention’

The defendants argued that it was only the combination with vitamin B12 that made pemetrexed reasonably usable in anti-cancer therapy, since pemetrexed alone had been too toxic. This purportedly is the ‘core of the invention’. Even though the Supreme has recently used the term ‘core of the invention’ — yet only with a reference to literature from 1985 — the FPC clearly holds that the concept of a ‘core of the invention’ (resembling the outdated concept of a ‘general gist of the invention’ / ‘allgemeiner Erfindungsgedanke’) is neither necessary nor useful at all in the assessment of infringement. There is either literal infringement or infringement under the DoE, the latter being assessed with the three-step questionnaire.

Für Überlegungen zum Kern der Erfindung bleibt da weder Raum noch Bedarf.

3.   Abandonment of subject-matter

The wording of the claims had been narrowed down during prosecution in order to overcome the examiner’s objections re novelty, and to proceed to grant: The broad term antifolate had been amended in the claims to pemetrexed in first place, and finally to pemetrexed disodium.

This limitation is also reflected in the description. The definition in paragraph [0022] of EP’508 had only been introduced during prosecution:

Amended description during prosecution (mark-up)

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 the limitation that 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 notes that an admissible intermediate generalisation of the term antifolate is missing in the application as filed (the FPC refers to this as the onion-shell principle); the patentee has to face the consequences thereof, not the public. 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.

4.   No infringement under the Doctrine of Equivalents

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 ([2015] EWCA Civ 555, #71) in this respect.

Finally, the third question asks whether it is evident for the skilled person that the replaced feature has the same effect, starting from the teaching of the patent in suit. Would the skilled person have understood the wording pemetrexed disodium as a strict limitation? The FPC notes that other components are defined more broadly in the claims, ie vitamin B12 or a pharmaceutical derivative thereof. Not so for pemetrexed disodium. The skilled person would thus have understood this as an intentional limitation, in further view of the specification.

The FPC thus answered the third question in the negative, expressly consenting with the judgement of the England and Wales Court of Appeal ([2015] 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 16/09Okklusionsvorrichtung. 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.

It is highly likely that this decision will be appealed to the Supreme Court.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2015_004 ¦ Decision of 09 March 2017 ¦ “Pemetrexed: Feststellungsklage auf Nichtverletzung gutgeheissen, Bindung an Einschränkung im Erteilungsverfahren”

Actavis Switzerland AG

./.

(1) Eli Lilly and Company
(2) Eli Lilly (Suisse) SA

Composition of the Board of the FPC:

  • Dr. Dieter BRÄNDLE
  • Dr. Roland DUX
  • Prisca VON BALLMOOS

Reporting Judge:

  • Dr. Roland DUX

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

DECISION IN FULL

Download (PDF, 498KB)

WHAT’S GOING ON ELSEWHERE

A comprehensive summary on the current status of proceedings relating to Lilly’s Alimta® can be derived from Lilly’s Form 10-K (Annual Report); see p 93-94.

If you are interested in the fulltext decisions, there is a long series of decisions to read from the UK, ie [2012] EWHC 3316 (Pat), [2013] EWCA Civ 517, [2014] EWHC 1511 (Pat), [2015] EWCA Civ 555 and [2016] 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.

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5 Replies to “Confirmed in main proceedings re Pemetrexed: The counterion matters!”

  1. Fresenius Kabi ./. Lilly at the Court of Milan in a related matter: Declaration of non-infringement granted for pemetrexed diacid in combination with tromethamine. My Italian is not too good, but the reasons apparently resemble the gist of the FPC’s decision. See the decision here and brief comments on EPLAW Blog and IP Kat here and here.

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