BREAKING: Non-enabling disclosure as closest prior art

Supreme Court
Case No. 4A_541/2017 | Decision of 08 May 2018 | ‘Appeal against decision O2015_011 of 29 August 2017

As to the background of this decision, I suggest to first have a look at the review of the first instance judgment on this Blog here.

In (very) brief, AstraZeneca’s EP(CH) 2 266 573 B1 had been revoked for lack of inventive step over Howell in view of McLeskey. The parties heavily dissented on whether or not Howell contained an enabling disclosure or not. The FPC held that it did, and that the objective technical problem to be solved in accordance with the problem-and-solution approach was only to provide an alternative formulation for sustained release.

AZ appealed and essentially argued that the FPC erroneously assumed a (concrete) pharmaceutical formulation in Howell, thus incorrectly defined the distinguishing features and the (objective) technical problem, and then wrongly concluded for lack of inventive step.

The Supreme Court indeed agreed and remitted the case for re-assessment of inventive step on the basis of an ‘objectively correct’ definition of the problem to be solved; see ¶2.3.5. Further, the Supreme Court notes in ¶2.3.3 that a correct definition is:

Provision of a castor oil-based formulation (i.e. a formulation consisting of castor oil and known suitable solvents and adjuvants in a certain composition and amount) for the administration of up to 250 mg fulvestrant for the treatment of breast cancer, which is well tolerated, has a uniform release profile and achieves the therapeutically decisive concentration of fulvestrant in the blood plasma over a longer period of time.

It is rare (to say the least) that the Supreme Court re-defines the objective technical problem to be solved in the assessment of inventive step. It did so here because the FPC got the meaning of an enabling disclosure wrong:

[…] weil [die Vorinstanz] von einem unzutreffenden Begriff der Ausführbarkeit der Lehre ausgegangen ist […]

What the heck …?!

Really? The FPC got such a fundamental point of law just wrong!?

This demands for a closer look!

The Supreme Court holds that the FPC failed to recognize the concept of feasibility or sufficient disclosure with the conclusion that ‘the technical teaching of [Howell] could basically be reworked.’ For a technical teaching consists not only of the problem but also of the solution.

Die Vorinstanz hat den Begriff der Ausführbarkeit oder der hinreichenden Offenbarung verkannt mit dem Schluss, dass ‘die Lehre [in Howell] grundsätzlich nacharbeitbar war’. Denn eine technische Lehre besteht nicht nur aus dem Problem, sondern auch aus der Lösung.

However, Howell only suggests that there was a compatible and pharmaceutically effective depot formulation available — but the actual composition of this formulation is not disclosed.

Further, the Supreme Court holds that the FPC did not expand on which concrete formulation the skilled person(s) would have found on the basis of the information in Howell without undue burden and without involvement of an inventive step. The general knowledge that steroids such as fulvestrant can be dissolved in castor oil with certain excipients and solvents in such a way that compatible injections can be produced is not sufficient for the feasibility of a technical teaching, in the Supreme Courts’ view.

In sum, the Supreme Court thus holds that the FPC applied an incorrect legal concept of feasibility with the assumption that no concrete technical formulation was required in order to affirm that there well is a technical teaching in Howell; ¶2.2.4.

Die Beschwerdeführerin rügt im Ergebnis zu Recht, dass die Vorinstanz von einem unzutreffenden Rechtsbegriff der Ausführbarkeit ausgegangen ist mit der Annahme, es bedürfe keiner konkreten technischen Formulierung, um die Offenbarung der technischen Lehre — d.h. hier der in [Howell] beschriebenen Depot-Formulierung — bejahen zu können. […] Die Vorinstanz hat die Offenbarung einer technischen Lehre durch [Howell] zu Unrecht bejaht.

Further down the road, the Supreme Court concluded that the FPC failed in the identification of the differentiating features. It just could not do it correctly because there is no specific disclosure in Howell.

But still, Howell undoubtedly is pre-published. Now, what to do with it?

The FPC had left it undecided whether or not a non-enabling disclosure is ‘prior art’ under Art. 54(2) EPC. But the Supreme Court took over — and answered even more than that. The Supreme Court holds that Howell belongs to the state of the art (contrary to what the EPO typically does, i.e. to just ignore it in toto; see Guidelines, G-IV, 2). But, in the Supreme Court’s view, such a piece of prior art cannot be assessed with the problem-and-solution approach because the objective technical problem is then just to find a working solution to what is insufficiently disclosed therein, and there is an inherent motivation to search for that solution; ¶2.3.2.

Der Beschwerdegegnerin ist zwar zuzustimmen, dass die Information von [Howell], in der das Problem formuliert und Ansätze für die Lösung mitgeteilt werden, zum Stand der Technik gehört. Wird jedoch ein Dokument als ‘nächstliegender Stand der Technik’ beigezogen, das keine technische Lösung offenbart, […]  wird der ‘Aufgabe-Lösungs-Ansatz’ verlassen. Denn die objektive technische Aufgabe ergibt sich unmittelbar aus [Howell], wenn darin dem fachkundigen Adressaten mitgeteilt wird, dass es eine Lösung für das Problem gibt […]. […] Eines Vergleichs von Merkmalen zur Ermittlung der objektiven technischen Aufgabe bedarf es in diesem Fall nicht. […] Aufgrund der Information in Howell, dass es eine Formulierung [gibt], wird das Fachteam jedenfalls dazu motiviert, geeignete Depotformulierungen zu suchen.

Frankly, it is now me who is not (yet) enabled to fully grasp the implications of this decision. Time will tell, as always.

Reported by Martin WILMING

BIBLIOGRAPHY

Supreme Court
Case No. 4A_541/2017 | Decision of 08 May 2018 | ‘Appeal against decision O2015_011 of 29 August 2017

AstraZeneca AB
./.
Actavis Switzerland AG

Panel of Judges:

  • Dr. Christina KISS
    • Dr. Kathrin KLETT
    • Dr. Fabienne HOHL
    • Dr. Martha NIQUILLE
    • Marie-Chantal MAY CANELLAS

Court Clerk:

  •  Dr. Matthias LEEMANN

Representative(s) of Appellant / Defendant:

  • Dr. Michael RITSCHER (MLL)
  • Dr. Kilian SCHÄRLI (MLL)

Representative(s) of Respondent / Plaintiff:

SUPREME COURT DECISION

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FIRST INSTANCE DECISION

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PATENT IN SUIT

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