How new requirements for evidence of medicinal product availability in reimbursement proceedings affect launch-at-risk strategies
Published on 17th Jun 2024
Recently, a communication has been published in the Refund List Management System (Polish: System Obsługi List Refundacyjnych), a web portal through which market authorization holders submit their applications for medicine reimbursements in Poland, that an applicant's declaration on market availability of a medicinal product is now enough in lieu of invoices. This may affect Polish pending „launch-atrisk” patent disputes.
Who is affected?
Although the change appears to be technical, in practice it affects the market position of patent or supplementary protection certificate (SPC) holders who own rights to patented medicinal products as well as market authorization holders for follow-up medicinal products (generic, biosimilar, hybrids), especially in the context of the so-called launch-at-risk and patent enforcement strategies.
What has changed?
• The Polish medicine reimbursement rules requi re that an applicant enclose evidence of medicinal product availability on the market (Polish: dowód dostępności).to the reimbursement application.
• In the past, the Polish Ministry of Health required an applicant to support a reimbursement application for a follow-on product with a copy of a sales invoice for the product in question to a wholesaler located in Poland.
• It has been debated whether the submittal of a reimbursement application accompanied by a copy of a sales invoice for the product in question to a wholesaler in Poland during the patent- or SPC related- exclusivity period is subject to the regulatory review exemption and therefore is free of patent / SPC infringement.
• As of the end of April, an applicant's sole declaration on product availability on the market is considered sufficient to meet the requirements imposed by the Polish reimbursement laws. The declaration must be signed by an authorized representative of the applicant. Relevance to launch-at-risk strategies
• As known, selling or offering of medicinal products during the patent- or SPC-exclusivity period violates the patent or SPC rights, respectively. As a result, in the past, submitting a reimbursement application accompanied by evidence of medicinal product availability triggered the filing of a preliminary injunction request by patentees or SPC holders.
• Although filing of a reimbursement application alone is now considered as an administrative act only, falling outside the scope of the patent or SPC exclusivity (and thus patent-free), the subsequent steps in the reimbursement procedure may still result in requests for preliminary injunctions.
• If a reimbursement application is accepted, a medicine will be included in the list of reimbursed medicines. According to Polish case law, that list in practice has also an advertising function, due to general restrictions on advertising medicinal products.
• In the past some courts ruled that that kind of offering of the infringing products constituted patent infringement. The fact that reimbursed medicines are also subject to the obligation of having their continuity and volume of supplies assured may be argued as a situation of imminent patent infringement, and in practice this may also trigger the request for a preliminary injunction.
Other possible changes to reimbursement proceedings
We believe that the amendments do not reduce the controversies surrounding the reimbursement proceedings as a reason for filing a preliminary injunction request. The major points of the current debate are whether it is advisable:
• to explicitly confirm that the regulatory review exemption in Poland applies to reimbursement submissions
• to indicate that evidence of market availability of a medicine should be provided by the end of the reimbursement proceedings; or
• to waive this requirement, but at the same time allow relevant authorities to check the market availability of a medicinal product (e.g., via an electronic system) once the proceedings are over.
