Düsseldorf UPC Ruling Clarifies "Imminent Infringement" Standards for Biosimilars
核心洞察
The Düsseldorf Local Division of the Unified Patent Court (搜索) has issued a significant ruling that establishes clearer standards for determining "imminent infringement" in pharmaceutical patent cases.
In the Novartis/Genentech v. Celltrion case, the court ruled that obtaining marketing authorization and promoting a biosimilar at conferences are insufficient to constitute imminent infringement without completed pricing negotiations.
The decision provides important guidance for pharmaceutical companies, indicating that patent holders must demonstrate that all pre-launch preparations have been completed before claiming imminent infringement.
On September 6, 2024, the Düsseldorf Local Division of the Unified Patent Court (搜索) (UPC) issued a landmark order that provides crucial guidance on how "imminent infringement" of patented medicinal products should be assessed under UPC rules. The case involved Novartis and Genentech seeking an interim injunction against Celltrion over a biosimilar to Novartis's XOLAIR product.
The ruling establishes important precedent for pharmaceutical companies navigating the complex landscape of patent protection for original drugs against generic and biosimilar competitors in the European market.
Key Elements of the Düsseldorf UPC Ruling
The court's order (UPC_CFI_165/2024) clarifies that for a patent infringement to be considered "imminent" under Article 62(1) of the Unified Patent Court (搜索) Agreement (UPCA), there must be concrete evidence that the potential infringer has completed all necessary preparations for market entry.
In this specific case, Celltrion had already obtained marketing authorization from the European Medicines Agency for its biosimilar product OMLYCLO, promoted it at specialist conferences, and initiated preliminary business contacts with potential buyers. The company had also publicly announced plans to launch in Europe and had commenced invalidity proceedings against the patent in question.
Despite these activities, the Düsseldorf court determined that these actions were insufficient to constitute "imminent infringement." The court emphasized that price negotiations with health authorities and the establishment of reimbursement conditions had not yet been finalized, meaning Celltrion was not in a position to promptly supply the medicine.
"A situation of imminent infringement must be characterized by certain circumstances which indicate that the infringement has not yet occurred, but that the potential infringer has already created the conditions for it to occur," the court stated in its ruling. "The infringement is ready to happen, as all preparations for it have been successfully completed."
Implications for Pharmaceutical Patent Enforcement
This ruling significantly impacts how pharmaceutical companies can enforce their patents against potential biosimilar and generic competitors. It suggests that patent holders must wait until a competitor has completed all regulatory and commercial preparations before seeking preliminary injunctions based on imminent infringement claims.
The decision aligns with established national case law in several European Union states, including Italy, which holds that simply obtaining marketing authorization for a generic or biosimilar medicine does not in itself constitute an infringement of the original medicine's patent.
For biosimilar manufacturers, the ruling provides some clarity on the activities they can undertake without triggering immediate patent enforcement actions. Companies can proceed with obtaining marketing authorizations, conducting preliminary promotional activities, and even initiating some business contacts without necessarily facing successful preliminary injunction requests.
Additional Legal Clarifications
The Düsseldorf ruling also addressed several procedural matters that provide further guidance for UPC proceedings:
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In cases with multiple defendants, where one defendant resides within the territory of the Local Division, that division is competent to hear the case under Article 33(1)(b) UPCA, regardless of whether other defendants are located inside or outside the Contracting Member States.
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Companies within the same group engaged in related commercial activities aimed at the same purpose (such as R&D, manufacturing, and distribution of the same products) can be considered to have "a commercial relationship" and may be cumulatively liable.
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The court declined to stay proceedings in favor of parallel Dutch proceedings, noting that stays are incompatible with the urgent nature of provisional measures.
Market Impact and Industry Response
The pharmaceutical industry has been closely watching this case as one of the early significant rulings from the UPC, which began operations in June 2023. The decision provides important guidance on how the new court system will handle the delicate balance between patent protection and market competition in the pharmaceutical sector.
For innovator companies, the ruling suggests a potentially higher threshold for obtaining preliminary injunctions against biosimilar competitors. Patent holders may need to wait until competitors are further along in their launch preparations before taking legal action.
For biosimilar and generic manufacturers, the decision offers some reassurance that early preparatory steps toward market entry won't necessarily trigger immediate legal consequences, potentially allowing for more efficient planning of market entry strategies.
As the UPC continues to develop its jurisprudence, this ruling represents an important step in establishing predictable standards for pharmaceutical patent enforcement across participating European jurisdictions.