UK High Court Clarifies Scope of SPC Waiver Notification Requirements

A recent judgment of the U.K. High Court (Patents Court) has clarified the scope of the notification requirements for the supplementary protection certificate (SPC) manufacturing waiver in the U.K. The High Court’s ruling arose out of Regeneron Pharmaceuticals, Inc., and Bayer Plc’s (“claimants”) efforts to enjoin Alvotech Hf and Fisher Clinical Services U.K. Limited (“defendants”) from manufacturing and marketing AVT06, a biosimilar of Eylea® (aflibercept), prior to the expiration of the SPC covering Eylea®.¹ The High Court denied the injunction request, finding that the defendants’ activities were permitted by the SPC manufacturing waiver.

The SPC manufacturing waiver set forth in Article 5 of the SPC Regulation provides two exceptions to infringement in the U.K. by “makers” of medicinal products covered by an SPC — (1) making products for export outside the U.K. and the EU; and (2) making and storing products during the last six months of the SPC for sales in the U.K. and EU after the SPC expires. The purpose of this manufacturing waiver is to allow EU companies to better compete with companies in non-EU countries without SPC protection. For example, manufacturers in non-EU countries without SPC protection could make and export a drug to another country without SPC protection. But, before the waiver, EU manufacturers could not do so without infringing the SPC.

To qualify for these two exceptions, the maker must, at least three months in advance of manufacture, provide the SPC owner with certain information, including “the reference number of the marketing authorization . . . in each country of export, as soon as it is publicly available.” The purpose of this notification requirement is to allow the SPC owner to make an initial, but not definitive, assessment of whether the maker is acting within the limits of the waiver.

The defendants provided two notifications to the claimants within the three-month period. These notifications did not include the marketing authorization (MA) reference numbers for Japan (the intended country of export) because these numbers had not been granted. The defendants sent these MA numbers to the claimants once they were granted.

The claimants argued that both notifications were invalid (and thus did not qualify for the waiver) because they failed to provide the MA numbers. Under the claimants’ interpretation of the SPC Regulation, a notification cannot be valid until there is a granted MA number for the export country and that the three-month period does not begin to run until the MA numbers are given.

The defendants, on the other hand, argued that a valid notification can be given prior to the grant of the MA numbers and that the MA numbers can be given without restarting the three-month period.

The High Court agreed with the defendants’ interpretation. The court reasoned that the text of Article 5 requires the maker provide the MA number “as soon as it is publicly available.” The court also relied on the legislative purpose of the regulation. EU/U.K. makers would be disadvantaged if they could only obtain a waiver three months after they had a MA number, because competing makers in non-EU/U.K. countries without SPC protection could start manufacturing without an MA.

Takeaways for SPC owners and biosimilar manufacturers

Following this decision, a party seeking an SPC export waiver in the U.K. can give a valid notification prior to having an MA in the export country so long as they provide the MA number once it becomes publicly available.

In light of the High Court’s decision, there is increased importance on SPC owners to be aware of the timelines associated with their SPCs. Biosimilar manufacturers must provide waiver notice to the SPC owner three months prior to the start of manufacturing. SPC owners should be prepared to respond to an SPC waiver immediately and have a plan in place to request and obtain sufficient information from the biosimilar manufacturer to determine whether the manufacturer’s actions are within the limits of the waiver. The High Court made clear that the disclosures required by Article 5 are not expected to be sufficient on their own for an SPC owner to definitively determine whether a biosimilar manufacturer is acting beyond the limits of an SPC waiver or engaging in acts of infringement. Because the Article 5 notice disclosures will likely not be sufficient to definitively determine whether there is infringement, the SPC owner should immediately request additional information from the biosimilar manufacturer that will allow it to make a reasonable assessment of infringement or violation of the SPC waiver. For example, the SPC owner should request confidential documents and negotiate a plan to maintain the confidentiality of the documents with the biosimilar manufacturer. While there is no legal requirement for the biosimilar manufacturer to provide the requested confidential information, the High Court’s decision emphasized that courts may view a manufacturer’s failure to do so unfavorably should the matter proceed to litigation. SPC owners should also be diligent in monitoring regulatory filing in non-U.K./EU territories for indications that a biosimilar manufacturer has intent to market in those territories upon expiry of the SPC and to determine whether a waiver notice remains compliant with the requirements of Article 5.

For biosimilar manufacturers, manufacturing scale-up activities won’t be delayed while the issuance of an MA number is pending so long as the other notice requirements of Article 5 are met. Biosimilar manufacturers should be aware, however, that while an initial SPC waiver notice may not require an MA number, the manufacturer may need to provide some evidence that the market authorization process in the non-EU territory is pending. Biosimilar manufacturers should also be prepared to receive a request for additional information, including confidential documents, from the SPC owner after serving notice. Biosimilar manufacturers should consider collecting documents showing pending market authorization prior to sending a waiver notice to the SPC owner. Biosimilar manufacturers should also keep in mind that they may be obligated to produce these documents as part of the discovery process if the waiver issue is litigated. Biosimilar manufacturers should have protocols in place to immediately update wavier notices once an MA number has issued in the non-EU territory to maintain compliance with the requirements of Article 5.