Are rights re-established once and for all?

Case No. O2017_016 ¦ Main Hearing of 25 April 2018

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I have attended the hearing in this matter earlier today. Infringement of the Swiss SPC C00716606/01 concerning sevelamer is at stake; the basic patent is EP 0 716 606 B1 of Genzyme Corporation. Interim injunctive relief had been granted in earlier proceedings S2016_009; see this Blog here.

Notably, infringement per se is undisputed, as well as validity of the basic patent. However, the defendant (only) alleges that the SPC is invalid because the Office wrongfully granted re-establishment of rights (Art. 47 PatA) with respect to the time limit for filing the SPC application under Art. 140f PatA.

The parties had been summoned to the main hearing after a single exchange of briefs; plaintiff’s reply and defendant’s rejoinder were pleaded in the hearing. Since the only question at stake is a legal one, this worked out smoothly. It was also noted that no expert opinion of the judge-rapporteur will be established.

Now, can the SPC still be challenged for wrongful reinstatement in the present civil proceedings?

Undisputedly, wrongful reinstatement is not explicitly listed as a ground for nullity in Art. 140k PatA. However, the parties dissent on whether or not the list is exhaustive.

Defendant essentially argued that the Swiss legislator voluntarily aligned the Swiss law with the respective EU regulation, and that also further developments of the EU law need to be taken into account; BGE 129 III 135, ¶6. In the view of the defendant, the ECJ in all its decisions on SPCs essentially declared SPCs invalid whenever its grant had not been objectively justified — irrespective of whether or not the ground was explicitly listed in Art. 15 of Regulation (EC) 469/2009.

Plaintiff disagreed; the ECJ never introduced additional grounds of nullity but rather only interpreted the grounds that are explicitly mentioned. Further, the nullity grounds referred to in Art. 140k(1) lit a PatA explicitly only refer to Art. 146(1). However, the time limit for filing the SPC request is defined in Art. 146(2). The plaintiff noted that this focus only on paragraph 1 underlines the legislator’s intent to not include paragraph 2 into the list of grounds for nullity. Plaintiff further argued that any interested third party could well have appealed the decision of reinstatement (Art. 48 ff APA in the version of 09 December 2003), together with the decision of grant of the SPC – but the defendant failed to do so. See also the summary judgment in ¶3.5 in this respect. The decision on reinstatement is thus formally final, and the defendant has to live with it. Plaintiff further referred to BGE 90 I 186 (¶3) which held that re-establishment of rights according to Art. 47 PatA only concerns the relationship of the patentee to the Office; the effects on third parties are regulated exhaustively (sic!) by Article 48 PatA with the prior user right for bona fide third parties.

The later the day, the more pronounced the arguments: The parties reproached each other for having not been able to refer to a prior decision on precisely this issue to their favour. On the funny side, plaintiff noted that this is only because so far just no one has come up with this absurd idea.

So sad

The parties were then asked by the presiding judge whether they were interested in settlement discussions. Unfortunately, I cannot tell what the answer was because it was requested that the public be excluded before the question is answered, and this request was granted.

UPDATE 05 May 2018:

I meanwhile obtained the request and the grant of reinstatement.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. O2017_016 ¦ Main Hearing of 25 April 2018

  1. Genzyme Corporation
  2. Sanofi-Aventis (Suisse) SA

./.

Salmon Pharma GmbH

Composition of the Board of the FPC:

  • Dr. Ralph SCHLOSSER
  • Dr. Tobias BREMI
  • Prof. Dr. Daniel KRAUS
  • Dr. Andreas SCHÖLLHORN SAVARY
  • Dr. Stefan KOHLER

Court Clerk:

  • Susanne ANDERHALDEN

Representative(s) of Requester:

Representative(s) of Respondent:

  • Dr. Robert BRINER (CMS)

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