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NL – Fresenius Kabi, Teva v. Eli Lilli / Alimta® – Appeal

14 May 2018

Fresenius Kabi Nederland B.V. v. Eli Lilli & Company, Court of Appeal, The Hague, 8 May 2018, Case no. ECLI:NL:GHDHA:2018:1105
Teva Nederland B.V. v. Eli Lilli & Company, Court of Appeal, The Hague, 8 May 2018, Case no. ECLI:NL:GHDHA:2018:1106

Eli Lilly (”Lilly”) is the holder of the European patent EP 1 313 508 B1 (“EP ‘508”) entitled “Combination containing an antifolate and methylmalonic acid lowering agent”. The patent was filed on 15 June 2001.

EP ‘508 primarily claims the use of pemetrexed disodium in the manufacture of a medicament for use in combination therapy for inhibiting tumor growth, wherein said medicament is to be administered in combination with vitamin B12. Lilly markets the medicine Alimta which is protected by EP ‘508. Both Fresenius and Teva offer a generic drug with pemetrexed diacid as the active ingredient, which is prescribed in combination with a vitamin supplement consisting of folic acid and vitamin B12.

Lilly sued Fresenius and Teva in two separate preliminary relief proceedings. In first instance the PI judge granted an injunction in both cases (see: here). Both Fresenius and Teva filed an appeal. The Court of Appeal decided to uphold the judgments in both cases.

Other proceedings in Europe (update)
Since the Dutch first instance decisions there have been several foreign decisions dealing with the question of infringement of EP ‘508. The Swiss Bundesgerichthof has overruled a finding of the Bundespatentgericht that Actavis’ generic Amtiris product did not infringe EP ‘508. An Austrian court has now granted an injunction in inter partes proceedings after having declined an injunction ex parte at an earlier stage. Danish and Swedish courts have now also decided that generic products with non-disodium salt forms infringe EP ‘508. In Italy an appeal is pending against a first instance finding of non-infringement.

Dutch proceedings
The Court of Appeal starts off by confirming that a different reference date should be taken into account when it comes to determining the scope of protection of a patent on the one hand and when it comes to determining whether or not a product or method falls within that scope of protection on the other (the question of infringement).

With regard to determining the scope of protection the relevant moment for assessing the knowledge of the skilled person is the application (or priority) date. Other relevant aspects to determine the scope of protection are the inventive concept underlying the wording of the claims, the legal certainty for third parties and specific circumstances such as the degree of innovation brought by the invention. Only in evaluating whether a product or process infringes the patent (the second question) the knowledge of the skilled person at the time of infringement can be of significance, in particular where it concerns equivalence.

The Court of Appeal follows Fresenius and Teva in their definition of the skilled person being a team consisting of an oncologist and a chemist or formulation expert. In line with the first instance decision, the Court of Appeal considers that the skilled person reading the patent would understand that the inventive concept of EP ‘508 is directed to reducing the adverse effects of pemetrexed by administrating pemetrexed in combination with vitamin B12.

Fresenius and Teva agree that in some cases the inventive concept can break through the limited wording of the claims. They are however of the opinion that this cannot be the case when third parties can legitimately rely on a deliberate choice of the patentee for a narrow claim (referring to The Supreme Court 5 February 2016 in Bayer/Sandoz, ECLI:NL:HR:2016:196 and the conclusion of Attorney-General Van Peursem of 30 October 2015, ECLI:NL:PHR:2015:2200).

The Court of Appeal considers that the deliberate choice criterium as formulated in the Bayer/Sandoz case is a choice which is grounded on a technical reason (whether or not that technical reason has something to do with the inventive concept does not matter). According to the Court of Appeal Lilly’s decision to claim pemetrexed disodium in EP ‘508 was not based on such a technical reason and is therefore not to be considered a deliberate choice.

At the priority date pemetrexed and the implications of its anion as well as the influence of the form of administration on the working of the medicine was common general knowledge to the skilled person. Salt-screening is a routine activity and EP ‘508 does not disclose anything in relation to which salt forms are most suitable. EP ‘508 only discloses that pemetrexed disodium (which form was already publicly available) is one of the suitable forms. Pemetrexed disodium has been specifically mentioned in EP ‘508 not because of its (different) technical effect but because it was generally known to be a suitable form of salt at the time EP ‘508 was filed. The skilled person reading the patent would understand that Lilly did not deliberately choose to limit the scope of protection of EP ‘508 to pemetrexed disodium.

When considering Article 123(2) EPC the EPO does not allow equivalent measures to be regarded as being implicitly disclosed in the application as filed. Equivalent measures however are to be taken into account in determining the scope of protection. Article 69 EPC and Article 2 of the Protocol (explicitly) require this. The strict assessment by the EPO in relation to the requirements of Article 123(2) EPC where equivalents are not considered to be part of a patent’s disclosure and the equivalent elements being taken into account in determining the scope of protection results in a fair balance between a fair protection for the patentee and reasonable legal certainty for third parties. The fact that Lilly did not oppose against the decision of the Examiner not to grant a broader claim does not affect any of the above.

Taking into account all aspects relevant for determining the scope of protection the Court of Appeal concludes that notwithstanding the narrow wording of the claims of EP ‘508 the inventive concept underlying the claimed invention justifies that other forms of pemetrexed which release the active ingredient pemetrexed (anion) after dissolving the salt fall under the scope of protection as well.

Teva and Fresenius had argued that according to Dutch Supreme Court case law a patentee cannot rely on equivalence, unless the equivalent measures regard embodiments which were not yet foreseeable on the priority date. The Court of Appeal finds that it was not foreseeable on the priority date that pemetrexed diacid (like disodium) would be suitable for the use of the inventive concept – although it was known that it could be suitable – the argument of Fresenius and Teva that the doctrine of equivalence could not be applied in this case is therefore not followed by the Court of Appeal.

The Court of Appeal also does not agree with the reasoning of Fresenius and Teva that if the skilled person would consider other salt forms of pemetrexed to be covered by the claims, such forms should have been claimed by Lilly in order for such salt forms to be protected. According to the Court of Appeal such rule cannot be extracted from the case law of the Supreme Court (Abbott/Medinol and AGA/Occlutech) and such rule would also contradict Article 2 of the Protocol.

The Court of Appeal finds that a broad protection in this case is not contrary to legal certainty as it was clear for the skilled person in light of the inventive concept that the patentee was seeking such broad protection, while the skilled person did also not see a technical reason why the patentee nevertheless opted for a more limited protection (no deliberate choice). The Court of Appeal confirms the judgments of the of the PI judge in first instance.

A copy of the Fresenius judgment can be found here.
A copy of the Teva judgment can be found here.

Headnote: Mattie de Koning and Daisy Termeulen, Simmons & Simmons LLP