EP 1 200 092 held invalid

Case No. O2015_007 ¦ Decision of 17 February 2016 ¦ “Gutheissung Nichtigkeitsklage; Zweifel an gültigem Prioritätsanspruch; mangelnde Neuheit”

Note that Hepp Wenger Ryffel is involved in this matter on behalf of the plaintiff. An appeal is pending at the Supreme Court. The following is only a summary of the technical background and the reasons of the decision as such. A more detailed comment on the merits of the case will follow when the decision has become final.

This decision concerns a nullity suit of Actelion Pharmaceuticals Ltd against the Swiss part of EP 1 200 092 B1, a patent granted on a Euro-PCT application based on WO 2001/08688. According to paragraph [0007] of EP’092, the alleged invention provides particulate preparations of a free drug form of a β-carboline compound having specific and defined particle size characteristics. The defined particle size is said to permit a uniform formulation of stable pharmaceutical compositions. Accordingly, claim 1 of EP’092 reads as follows:

1. A free drug particulate form of a compound having a formula

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and pharmaceutically acceptable salts and solvates thereof in which the compound is present as solid particles not intimately embedded in a polymeric co-precipitate, wherein at least 90% of the particles have a particle size of less than about 40 microns.

See Swissreg and the European patent register for any further bibliographic details on the patent in suit.

The active ingredient (AI) is tadalafil, a phosphodiesterase type 5 (PDE5) inhibitor. Other well-known PDE5 inhibitors include sildenafil (e.g. Pfizer‘s Viagra®) and vardenafil (e.g. Bayer‘s and GSK‘s Levitra®).

Cialis®
Lilly’s Cialis®

The corresponding U.S. patent 6,821,975 in this patent family is listed in the FDA’s Orange Book for Lilly’s drug Cialis® for treatment of erectile dysfunction. But this is not the only indication: The very same substance is also used in the treatment of pulmonary arterial hypertension, marketed under the tradename Adcirca®.

The filing date of EP’092 is 01 August 2000, and priority of US 60/147,048 of 03 August 1999 is claimed. However, it has been set forth in the writ that the priority is apparently not validly claimed. Further, it has been argued that both WO 01/08686 A1 and WO 01/08687 A1 with filing dates of 26 April 2000 are novelty-destroying for the patent in suit under Art. 54(3) EPC. Further, and irrespective of the validity of the priority claim, it was argued that EP 1 120 120 A1 is novelty-destroying and, alternatively, that the claimed subject-matter is not inventive over either one of WO 95/19978 A1, WO 97/03675 A1 or WO 96/38131 A1. It was also argued for a lack of sufficiency of disclosure.

The patentee did not take up the fight. No domicile for service in Switzerland was named and no answer to the writ was filed. The FPC publicly notified the defendant in the Swiss Official Gazette of Commerce (SOGC) of the extended time limit for the answer, the costs, and the decision itself.

On the merits of the case, the FPC only dealt with the plaintiff’s nullity arguments to the extent necessary to come to a decision. No interim assessment of a reporting judge was obtained since the relevant subject-matter only required some general technical understanding (BGE 4A 52/2008, r. 3.4; Art. 183(3) CPC, Art. 37(3) PatCA).

The priority issue was decisive. The priority application US 60/147,048 named five inventors, i.e. Neil R. Anderson (1), Sandra J. Zeckel (2), Martha A. Kral (3), Gregory L. Stevenson (4) and Kerry J. Hartauer (5). The PCT application WO 2001/08688 was filed in the name of Lilly ICOS LLC, but inventor (2) was not named anymore. No assignment information from any inventor to Lilly ICOS LLC is on file at all in the publicly accessible WIPO and EPO dockets. To the contrary, the USPTO records explicitly hold that no assignment information is available. Not even an informal assignment could be presumed for inventor (2) who is missing on the PCT application. The FPC thus had severe doubts as to the validity of the priority claim of Lilly ICOS LLC. Since the burden of proof lies with the defendant in legal proceedings (Art. 20 PatA), and no evidence in this respect has been on file, the FPC held that the priority claim was invalid. The effective date of the claimed subject-matter was thus only 01 August 2000, i.e. the filing date of the PCT application. With the priority claim being invalid, the rest of the story is quickly told: WO 01/08686 A1 with a filing date of 26 April 2000 was held novelty-destroying for all independent claims, and EP’092 was thus held invalid.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2015_007 ¦ Decision of 17 February 2016 ¦ “Gutheissung Nichtigkeitsklage; Zweifel an gültigem Prioritätsanspruch; mangelnde Neuheit”

Actelion Pharmaceuticals Ltd ./. Icos Corporation

Board of Judges:

  • Dr. Dieter BRÄNDLE
  • Dr. Barbara HERREN
  • Dr. Martin SPERRLE

Court Clerk:

  • Susanne ANDERHALDEN

Reporting Judge:

  • n/a

Representative(s) of Plaintiff:

Representative(s) of Defendant:

  • n/a

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6 Replies to “EP 1 200 092 held invalid”

    1. It’s hard to recognise any sleeky strategy in not filing any reply. I’d rather guess that it’s been unintentional. What a disastrous oversight, if that indeed turns out to be true!

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