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Timestamp: 2020-07-06 11:26:04
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Infringement Archives | Page 2 of 7 | FPC Review
Posted on March 23, 2017 July 6, 2017
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.
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.
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.
4. No infringement under the Doctrine of Equivalents
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.
It is highly likely that this decision will be appealed to the Supreme Court.
Alfred FRUEH (Schellenberg Wittmer)
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.
Posted on December 22, 2016 July 6, 2017
Case No. 4A_427/2016 (Supreme Court) ¦ Decision of 28 November 2016 ¦ “Patent; novelty-destroying publication”
For a review of the FPC’s underlying decision O2012_043 of 10 June 2016, please see this Blog here. In brief, Bombardier alleged infringement of EP 1 963 157 B1 (see EPO Register and Swissreg for bibliographic details). Stadler’s electric double-deck trains RABe 511 KISS were at stake, more specifically the pairwise arrangement of transformer units and power converter units at the wheel units of the train. The defendants of the Stadler group of companies essentially argued for nullity as a plea in defense and alleged a prior user right; Art. 35 PatA.
The FPC held that EP’157 is not novel over documents which had been sent by ABB to both Siemens and Stadler in parallel, in an informal reply to a request for an offer from Siemens. The mere fact that ABB deliberately distributed the documents not only to Siemens but also to yet another third party (the defendant) made clear that ABB had no interest in any confidentiality. The alleged prior user right had been acknowledged in the interim assessment (Art. 35 PatA), but could be left undecided in view of the lack of novelty of the patent in suit.
For further details on the background of the case and the actual subject-matter at stake, please see the report from the main hearing on this Blog here.
The Supreme Court now had a second look at it:
The plainfiff’s appeal was all about whether or not the exchange of the novelty-destroying documents had been subject to implied confidentiality between ABB, Siemens and Stadler. Towards this end, the plaintiff had requested before the FPC that a witness be heard with respect to the (existence of a) development cooperation between ABB, Siemens and Stadler. However, the witness had not been heard. On appeal, the plaintiff alleged a violation of his right to be heard. The Supreme Court holds that even if a development cooperation had existed, this would not have been sufficient to conclude that an implied confidentiality had existed with respect to the relevant documents at stake.
Die Vorinstanz hat die von der Beschwerdeführerin behauptete Zusammenarbeit zwischen den Beschwerdegegnerinnen, Siemens und ABB im Ergebnis zutreffend als nicht hinreichend für den Schluss angesehen, dass die beanspruchte Lehre durch die Korrespondenz vom April/Mai 2003 (wegen vereinbarter Geheimhaltung) nicht neuheitsschädlich vorweggenommen ist.
The Supreme Court thus held that hearing of the witness would not have been of any legal relevance (BGE 133 III 295, r 7.1; 4A_607/2014, r 2.2; 4A_452/2013, r 3.1). Consequently, the plaintiff’s right to be heard was not violated by not hearing the witness (Art. 29(2) FC, Art. 8 CC, Art. 152 CPC).
Marc METZGER (Staiger Schwald)