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26 September 2023Big PharmaMuireann Bolger

‘A huge shame’: UPC denies access to pleadings and evidence in Sanofi v Amgen

An updated UPC rule requires a concrete and verifiable, legitimate reason for making available written pleadings and evidence | The wish from a natural person to form an opinion on the validity of a patent deemed insufficient reason for access | First decision marks latest twist in Amgen v Sanofi showdown.

A  Unified Patent Court (UPC) judge has refused access to written pleadings and evidence in two life sciences cases, prompting questions over whether the court is sufficiently transparent.

Judge-rapporteur  András Kupecz of the UPC’s Munich central division branch  denied an access request relating to a revocation action filed by Sanofi against an Amgen patent, European patent EP3666797 on September 20, citing the absence of a legitimate reason.

A day later, he rejected a similar application in another case—Astellas Institute for Regenerative Medicine v Healios KK, Riken & Osaka University—on the same grounds.

‘Not very transparent’

Commenting on LinkedIn,  Darren Smyth, partner at EIP,  decried the court’s decisions as a “huge shame”.

“The UPC is not a very transparent system. Party submissions are not automatically publicly available—they have to be requested,” he wrote.

“The first two such requests have been rejected. It seems that a real interest in access by the requester needs to be demonstrated. This is a huge shame (albeit that this does appear to be what the current rules of procedure envisage).”

Also commenting on the social media platform,  Paul England, senior counsel—knowledge, at Taylor Wessing,  observed that such moves were the result of last minute amendments made to  Rule 262.1(b) RoP just before the advent of the court.

“It is hard enough getting hold of orders and decisions in the UPC, but try getting hold of pleadings and evidence. The rules were changed shortly before the UPC came into force, requiring the latter to be kept from the public gaze unless an applicant can show a sufficiently concrete, legitimate reason to make them available,” he wrote.

According to this much-scrutinised rule, written pleadings and evidence should now only be made available to a member of the public upon “reasoned request to the registry”.

A reasoned request

In August, the initial request relating to Sanofi v Amgen was made on behalf of an anonymous third party who was interested in “the patent at issue and its legal validity (or lack thereof)”. Judge Kupecz subsequently rejected the request for access due to the application's “lack of concrete information”.

In an updated request, the applicant,  Daniel Wise, partner at Carpmaels & Ransford, no longer referred to one of his clients and made the request in his own name only.

But the judge rejected the request yet again, holding that the application lacked a “concrete, verifiable and legally relevant reason” for accessing the documents.

When doing so, the judge outlined how the rule makes a clear distinction between public access to decisions and orders, and written pleadings and evidence.

The first category shall be published whereas the latter shall be available only upon a reasoned request upon which the judge-rapporteur is to decide after consulting the parties, he added.

A ‘mere wish’ insufficient

Judge Kupecz further outlined how a “legitimate reason” is required for making written pleadings and evidence available to a member of the public. “Otherwise, this provision and the distinction made would seem to be moot and without substance,” he wrote.

He added that a mere “wish” from a natural person to form “an opinion” on the validity of a patent out of a “personal and a professional interest” cannot be accepted as a sufficiently concrete, legitimate reason to make available all pleadings and evidence in this case.

In these instances, the court failed to see why access to the written pleadings and evidence in this particular case “would be useful, let alone necessary” in order to fulfil a wish of forming an opinion on the validity of the patent.

“The applicant can study the patent and its (public) prosecution history as well as the prior art without access to what the parties to the proceedings have submitted,” wrote Judge Kupecz in his order.

“The fact that the application concerns a revocation action concerning a European patent which, as argued by the applicant, ‘confers rights on the patent proprietor(s)’.... does not make this assessment different. The general public can likewise inform themselves based on other sources than the pleadings and evidence filed in this action.”

In rejecting the application, the court additionally noted that—contrary to the position taken by the applicant—not solely the interests of the member of the public requesting access to pleadings and/or evidence and the parties have to be taken into account.

An ‘abuse of evidence’

Conversely, the interests of third parties may be at stake and/or an abuse of evidence may have to be prevented, argued Judge Kupecz.

A right to access to pleadings and evidence in the absence of a legitimate reason also does not automatically follow from a “general principle of publicity”, the court contended.

Judge Kupecz also pointed out that the general right to public access to the contents of a case file also cannot be based on European Union law or practice, noting that the  General Court of the Court of Justice of the European Union, states that: “No third party, private or public, may have access to the file in a case without the express authorisation of the President of the General Court, once the parties have been heard.”

Concluding that the rules and practices in relation to access to case files vary significantly among the member states of the EU, Judge Kupecz concluded that “no general right to public access can be deduced from the various national laws”.

The judge has granted leave to appeal in both cases.

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