PI request against Edwards’ TMVr device PASCAL granted based on EP’850

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Case No. S2019_002 | Decision of 15 August 2019 | ‘PASCAL’

DISCLOSURE NOTICE

Hepp Wenger Ryffel is involved in this case on behalf of the plaintiffs.

This infringement case is about EP 1 624 810 B1 and EP 1 408 850 B1; see EPO Register (here and here) and Swissreg (here and here) for further bibliographic information. Plaintiffs (Abbott et al.) asserted that defendants  (Edwards et al.) are infringing the Swiss parts of EP’810 and EP’850 with their PASCAL Transcatheter Mitral Valve repair (TMVr) device.

See Edward’s PASCAL website for further information on this product.

For comparison, plaintiffs’ own product is MitraClip:

See Abbott’s MitraClip website for further information on this product.

The main hearing had taken place on 3 July 2019.

The decision holds that PASCAL infringes claim 1 of EP’850 (¶¶ 62-70), and that this claim is valid over the prior art referred to by defendants as a plea in defense, i.e. US 3,874,388 (E5), WO 96/32882 A1 (E6) and CN 1 142 351 A (E7); ¶¶ 48-61. Preliminary injunctive relief was thus granted, based on EP’850.

As to EP’810, the decision holds that claim 1 is not infringed; ¶¶ 31-34.

Not easily reparable harm

Defendants contested that MitraClip itself is covered by the patents in suit; plaintiffs disagreed. The decision holds that this is irrelevant in any event. The irreparable harm of plaintiffs 1 and 3 depends on whether their own product is competing, since experience has shown that this leads to a loss of turnover, the extent of which is difficult to prove. Mere reference to potential financial compensation does not eliminate the irreparable harm; ¶ 77.

Proportionality

Precautionary measures must be proportionate in the sense that the content of the ordered measure must be suitable to avert the asserted disadvantage and must not go further than is absolutely necessary to avert the disadvantage (‘proportionality in the narrower sense’). Whether the adoption of precautionary measures may also be made dependent on the fact that the precautionary measure applied for does not encroach disproportionately heavily on the legal sphere of the defendant (‘proportionality in the broader sense’) is controversial.

In the present case, the FPC could leave this issue undecided because the defendants did not claim that the precautionary measure applied for has a disproportionate impact on their legal sphere, but that it is in the public interest that the marketing of the PASCAL device in Switzerland should not be prohibited as a precautionary measure.

The decision holds that — while it is controversial whether the adoption of a precautionary measure can be refused if it disproportionately affects the interests of the defendant — it is clear that public interests are not to be taken into account when it comes to weighing of interests: The PatA provides for a system of compulsory licences which, in principle, closes the gap in order to protect public interests from being jeopardised by the enforcement of patents. In particular, Art. 40 PatA provides for a compulsory licence in the public interest. In passing, the decision notes that it has not yet been decided in Switzerland whether the claim to a compulsory license can also be invoked in summary proceedings. Note that this has been answered in the affirmative in Germany recently; BGH X ZB 2/17 — Raltegravir.

Anyway, defendants did not claim that they should be granted a compulsory license in order to protect public interests. In particular, defendants had not submitted a license offer to the patentee at reasonable market conditions which the patentee has not accepted within a reasonable period (cf. Art. 40 in conjunction with Art. 40e (1) PatA). Accordingly, the objection that the requested measures were disproportionate has been rejected.

These considerations in ¶¶ 80-82 are what the FPC referred to in the following Tweet:

An appeal is currently pending at the Supreme Court.

Reported by Martin WILMING

BIBLIOGRAPHY

Case No. S2019_002 | Decision of 15 August 2019 | ‘PASCAL’

(1) Evalve, Inc.
(2) Abbott Cardiovascular Systems, Inc.
(3) Abbott Medical (Schweiz) AG
./.
(1) Edwards Lifesciences AG
(2) Edwards Lifesciences Technology Sàrl
(3) Edwards Lifesciences IPRM AG
(4) Mitral Valve Technologies Sàrl

Panel of Judges:

  • Dr. Mark SCHWEIZER
  • André ROLAND
  • Dr. Michael STÖRZBACH

Judge-rapporteur:

  • André ROLAND

Court Clerk:

  • Agnieszka TABERSKA

Representative(s) of Plaintiff:

Representative(s) of Defendant:

DECISION IN FULL

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ANNOUNCEMENT OF THE HEARING

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EP 1 624 810 B1

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EP 1 408 850 B1

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A creative approach to compulsory licenses — or just PR?

I stumbled upon an open letter of Public Eye to Alain Berset, head of the Federal Department of Home Affairs. Public Eye pushes for a

[…] public non-commercial use (compulsory) licence on patents related to the breast cancer medicine pertuzumab sold by Roche under the brand name Perjeta®.

Roche logo

Perjeta® is approved in combination with Herceptin and chemotherapy for the neoadjuvant (pre-surgery) treatment of people with HER2-positive, locally advanced, inflammatory, or early stage breast cancer and as a first-line treatment of advanced HER2-positive breast cancer.

Roche has recently been criticised for the price regime; SRF Rundschau, 30 January 2019.

Public Eye logo

In addition to a cover letter, Public Eye also served Mr Berset with a turnkey draft request to be filed with the Federal Patent Court, for a compulsory license to be granted.

Well, I have my doubts that this request will actually find its way to the FPC. But even if it did, I frankly do not see how the FPC could allow it.

Art. 40 PatA regulates licenses in the interest of the public, as follows:

Where public interest so dictates, the person to whom the proprietor of the patent has, without sufficient reason, refused to grant the licence requested, may apply to the court for the grant of a licence to use the invention.

I have no reason to assume that the Federal Council had ever requested a license from Roche. Thus, Public Eye relies on Art. 40e(1) PatA, which holds (emphasis added):

The licences […] are granted only if efforts by the applicant to obtain a contractual licence on appropriate market terms within a reasonable period of time have been unsuccessful; […]. Such efforts are not required […] in cases of public non-commercial use.

Frankly, I cannot see how such public non-commercial use of a biosimilar to Perjeta® should work. The Federal Council itself would surely not start production and marketing of biosimilars. The draft request is vague about the actual licensee. In fact, Public Eye suggests in ¶3.3.2 that the Federal Council would

[…] rely on an established third-party manufacturer, with recognised production capacities and which applies proven quality compliance mechanisms, to manufacture and deliver the biosimilar product in Switzerland.

Further, Public Eye notes that

[…] grant of a compulsory license in Switzerland would induce them to accelerate the development of a pertuzumab biosimilar.

That may well be the case. But any such third-party manufacturer would need to somehow be covered by the compulsory license. Maybe, as a sub-licensee of the Federal Council, or under a ‘have-made’ right of the Federal Council? But even then, I do not readily see how the obviously commercial conduct of such a third-party manufacturer could be interpreted as public non-commercial use referred to in Art. 40e(1) PatA. To me, this has the notion of an attempt to circumvent the requirement that the law imposes on normal market player to at least attempt to negotiate a license.

But still, compulsory licenses are a hot topic in recent times. The Raltegravir / Isentress® case in Germany is a prime example. With decision X ZB 2/17 of 11 July 2017, the German Federal Supreme Court had approved the grant of a compulsory license in the interest of the public — after unsuccessful efforts to obtain a license. That’s the key difference, in my perception.

Reported by Martin WILMING

COVER LETTER

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DRAFT REQUEST

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