AZ’s Faslodex®: EP(CH) 2 266 573 and EP(CH) 1 250 138 revoked

Case No. O2015_011 ¦ Decision of 29 August 2017 ¦ “Gutheissung Nichtigkeitsklage”

Case No. O2015_012 ¦ Decision of 29 August 2017 ¦ “Gutheissung Nichtigkeitsklage; Nichtzulassung verspäteter Einschränkung”

We have reported on the combined main hearing in these nullity cases on this Blog here. In brief:

As could be expected after the main hearing, assessement of inventive step in view of McLeskey and Howell was key. The panel of judges essentially followed the expert opinion of the judge-rapporteur and denied patentability for lack of an inventive step in both cases. Besides the (always) very case-specific assessment of inventive step, I feel that some other aspects of these decisions are of more general interest.

  1. Partial priorities / ‘self-collision’

Plaintiff argued that the divisional application EP 1 669 073 A2 is novelty-destroying for its parent, EP’138. With reference to the decision G 1/15 of the Enlarged Board of Appeal (EPO), the FPC did not buy the self-collision argument.

No more poison!

In principle, the claims at stake could well be split into parts that did / did not enjoy priority (‘generic or’-claims) – even though that might well be a challenging task. However, since there was no intervening prior art on file, there was no need to go through that academic exercise. Partial priority was acknowledged, ruling out any self-collision issue.

Es scheint aber insbesondere im Hinblick auf die Entscheidung G 1/15 angebracht, im vorliegenden Fall Teilprioritäten grundsätzlich anzuerkennen und zwar selbst dann, wenn keine explizite Aufteilung der Patentansprüche in die Prioritäten gültig beanspruchende bzw. nicht gültig beanspruchende Teilbereiche vorliegt.

The ‘self-collision genie’ is pushed back in the bottle.

  1. Prior public use / clinical studies

It was beyond dispute that Faslodex® had been in phase-III clinical study in 1998, well before the earliest priority date. The decisions refer to the study as 9338IL/0020, but this appears to be a typo. I trust it should read 9238IL/0020; see EMA ‘Assessment Report for Faslodex’ of 2010, at the bottom of p 29.

Plaintiff argued that clinical studies would generally make the pharmaceuticals publicly available, in the absence of any proof to the contrary. It was referred to T 0007/07 in this respect. Further, it was argued that the patients must have been informed about the exact formulation; and even if this had not been the case, the formulation could have been identified / analysed with ease.

The FPC did not agree. In the case at hand, two ‘Clinical Trial Agreements’ from this study contained confidentiality clauses, and the ‘Written Informed Consent Form’ apparently did not reveal details as to the exact formulation. Finally, the patients got a monthly injection into the gluteal muscle. This is unlikely being done by the patient herself, and thus it is unlikely that the patient ever had access to the pharmaceutical for further investigation of the formulation.

Under the given circumstances, the clinical study was thus held to not constitute a public prior use. Novelty was acknowledged.

  1. Insufficient disclosure to be considered as prior art?

Howell discloses a dosage of 250 mg fulvestrant and mentions an injection volume of 5 ml. Plaintiff argued the this results in a solution with a concentration of 50 mg/ml. Defendant disagreed: The solubility of fulvestrant would be too low to obtain a solution in castor oil. Rather, a dispersion would be obtained. Further additives would be necessary to obtain a solution with such a high concentration of fulvestrant. But there is no indication of any such additives in Howell. Defendant thus argued that Howell must not be considered as prior art, for lack of an enabling disclosure.

This argument is in line with the EPO Guidelines (G-IV, 2) and some BoA decisions referred to therein:

Subject-matter can only be regarded as having been made available to the public, and therefore as comprised in the state of the art pursuant to Art. 54(1), if the information given to the skilled person is sufficient to enable him, at the relevant date (see G‑VI, 3), to practise the technical teaching which is the subject of the disclosure, taking into account also the general knowledge at that time in the field to be expected of him (see T 26/85T 206/83 and T 491/99).

Where a prior art document discloses subject-matter which is relevant to the novelty and/or inventive step of the claimed invention, the disclosure of that document must be such that the skilled person can reproduce that subject-matter using common general knowledge (see G‑VII, 3.1).

This appears to be a sensible approach at first sight. But is it really in line with the definition of ‘the state of the art’ codified in Art. 54(2) EPC?

The state of the art shall be held to comprise everything made available to the public by means of a written or oral description, by use, or in any other way, before the date of filing of the European patent application.

Frankly, I am not conviced. What is published, is just out there as-is. What the skilled person actually can do based on a specific publication at a given point in time, that’s a different story to me.  Anyway, the FPC did not need to decide on this issue; but I catch the notion between the lines that it is not carved in stone that the FPC would follow the EPO’s approach.

Lässt man die Praxis des EPA unberücksichtigt, ist die D15 vollumfänglich dem Stand der Technik zuzurechnen. […] Ob der erwähnten Praxis des EPA zu folgen ist, kann deshalb hier offen bleiben.

In the case at hand, the  FPC held that Howell did contain an enabling disclosure for the skilled person, and it was considered as prior art.

  1. Belated limitation not admitted into the proceedings

Defendant limited one of his auxiliary requests in O2015_012 with an additional feature (marked-up below) as follows:

Use of fulvestrant in the preparation of a pharmaceutical formulation for the treatment of breast cancer by intra-muscular administration to human patients, […] wherein […] the formulation is adapted for attaining a therapeutically significant blood plasma fulvestrant concentration of at least 8.5 ng ml-1 for at least two weeks.

Defendant argued that this further limitation was a partial acknowledgment of the complaint which is possible at any stage of the proceedings; Art. 241 CPC. The FPC did not agree.  The further limitation only concerned an auxiliary request, i.e. it only came into play when the court had already decided on the main requests of the defendant: Denial of the complaint, without any amendments to the claims. At that stage, there is no room anymore for a partical acknowledgment of the complaint. The FPC held that the defendant in fact present the court with new facts to be considered as an auxiliary measure. This is possible in general, but only within the time limits for submission of novae; Art. 229 CPC. Consequently, the newly drafted auxiliary request was not admitted into the proceedings.

UPDATE October 17, 2017:

The patentee has lodged an appeal to the Supreme Court in both cases.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2015_011 ¦ Decision of 29 August 2017 ¦ “Gutheissung Nichtigkeitsklage”

Case No. O2015_012 ¦ Decision of 29 August 2017 ¦ “Gutheissung Nichtigkeitsklage; Nichtzulassung verspäteter Einschränkung”

Actavis Switzerland AG ./. AstraZeneca AB

Composition of the Board of the FPC:

  • Dr. Dieter BRÄNDLE
  • Dr. Hannes SPILLMANN
  • Dr. Daniel ALDER
  • Dr. Hanny KJELLSAA-BERGER
  • Dr. Prisca VON BALLMOOS

Judge-rapporteur:

  • Dr. Hannes SPILLMANN

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Plaintiff:

Representative(s) of Defendant:

  • Dr. Michael RITSCHER (MLL)
  • Dr. Mark SCHWEIZER (MLL)
  • Dr. Kilian SCHÄRLI (MLL)
  • Dr. Thorsten BAUSCH (Hoffmann Eitle), assisting in patent matters

DECISION O2015_011

Download (PDF, 470KB)

THE ‘573 PATENT IN SUIT IN O2015_011

Download (PDF, 674KB)

DECISION O2015_012

Download (PDF, 612KB)

THE ‘138 PATENT IN SUIT IN O2015_012

Download (PDF, 1.04MB)

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