Case No. S2023_006 | Judgment of 25 July 2023 | ‘Rivaroxaban / Acino’
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WHAT YOU NEED TO KNOW
Bayer’s Swiss SPC on rivaroxaban expires on 17 June 2024. Acino’s out-licensing offer (a service package that includes all regulatory / approval work and manufacturing / packaging) for rivaroxaban does not constitute an imminent threat of market entry of a potential licensee. Bayer’s request for an ex parte PI was accordingly dismissed. Acino has nevertheless taken rivaroxaban off its list of compounds available for out-licensing, for the time being. |
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This case is about rivaroxaban, a prescription blood thinner. It is used to treat deep vein thrombosis (DVT) and pulmonary embolism (PE). It’s a pretty interesting small molecule that acts as an anticoagulant; it has been the first orally active direct factor Xa inhibitor.
You may grab und turn it in the illustration below to get an idea of its structure in 3D:
Rivaroxaban is marketed by Bayer as Xarelto®. It is only in the U.S. that Bayer has out-licensed the drug to a subsidiary of Johnson & Johnson. Direct sales and license income from J&J make Xarelto® Bayer’s best-selling drug, by far. But sales are declining:
Patents and competition
The basic compound patent EP 1 526 132 B1 has lapsed in December 2022, but the Swiss SPC C01261606/01 is still in force until 17 June 2024. EP 132 and the corresponding SPC were apparently not challenged by now; validity of the corresponding US 7,157,456 B2 has been confirmed in inter partes proceedings. Accordingly, Bayer’s Xarelto® is currently the only rivaroxaban containing pharmaceutical listed in Compendium. However, quite some competitors have already obtained their MAs for rivaroxaban (Nobel, Sandoz, Spirig and Mepha):
Note that Bayer has yet another patent on a dosage regime of ribaroxaban; EP 1 845 961 B1 still runs until until January 2026 (see Swissreg). EP 961 has been maintained in EPO proceedings lately, but is under fire in national proceedings.
acino’s out-licensing offer
Bayer had noted that Acino was promoting rivaroxaban on their website as a new product that was available for out-licensing. Acino’s service of out-licensing apparently comprises the development and subsequent licensing of an entire medicinal product dossier. In addition to the production and delivery of the pre-packaged pharmaceutical, Acino also obtains all necessary authorisations, approvals, etc. The out-licensed products are manufactured in the Basel region. The out-licensing offer comes along with the following footer:
Products which are subject to patent protection are offered with respect of the prevailing patent laws. No sales, prior to the expiry date of valid patents, are foreseen to countries where patents are in force.
Further, Acino has filed its MA request with Swissmedic on 21 June 2023.
Earlier this year, i.e., on 10 June 2023, Acino’s website had indeed listed rivaroxaban as one of the products available for out-licensing:
As per today, rivaroxaban is not listed on that website anymore. Likewise, Acino’s out-licensing brochure of April 2023 mentioned rivaroxaban, while the current version of July 2023 does not.
What’s been decided
The judgment holds that Acino does not (yet) offer any pharmaceuticals containing rivaroxaban, and that it is not credible that market entry is imminent. In practice, not even the granting of a MA by Swissmedic indicates imminent market entry since the MA only gives the right to market the respective pharmaceutical, but there is no corresponding obligation to do so. It is quite possible, and indeed common, to apply for a MA before the final clarification of the IP situation, so that the sale can start promptly after clarification of the IP situation.
Specifically, Bayer could not show any concrete evidence that potential customers of Acino’s out-licensing programme would not respect Bayer’s patents. The abstract threat that a holder of a MA will enter the market before the expiry of the term of protection of relevant IP rights always exists, but this is not sufficient to establish a credible threat of actual infringement.
Accordingly, the President acting as single judge dismissed Bayer’s request for an ex parte PI.
✍ MW
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BIBLIOGRAPHY
Case No. S2023_006 | Judgment of 25 July 2023 | ‘Rivaroxaban / Acino’
Bayer Intellectual Property GmbH
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Acino International AG
Acino Pharma AG
Single Judge:
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- Dr. Mark SCHWEIZER
- Court Clerk:
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- Dr. Lukas ABEGG
Representative(s) of Plaintiff:
Representative(s) of Defendant:
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- Barbara ABEGG (Lenz & Staehelin)
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