Dr David Eyre

February 2023

In this decision the Hearing Officer noted that a marketing authorisation is focused on what a product is rather than what it does. Consequently, a change in how the authorised product is used does not alter the basis of the original marketing authorisation. Accordingly, and in line with existing case law, a further combination pharmaceutical therapy does not serve as sufficient basis for an SPC application.

Supplementary Protection Certificates

A supplementary protection certificate (SPC) is intended to compensate a patentee for delays in exploiting their patented product because of having to comply with regulatory requirements. However, the scope of protection of a supplementary protection certificate is narrower than the scope of the patent that it flows from. The intention of a SPC is to compensate the patentee for delays in launching their commercial product onto the market rather than extended the term of the patent over its whole claim scope.

Accordingly, the SPC regulation states (in Article 3 thereof) that the product that is to be protected by the SPC must (a) be protected by a basic patent in force; and (b) a valid marketing authorisation for that pharmaceutical product must have been granted.

This SPC application (SPC/GB15/046) was based on a marketing authorisation for the product safinamide (Xadago®). In addition, this SPC application was based on a granted patent that protects the combination of safinamide with levodopa and also a peripheral decarboxylase inhibitor (PDI). This pharmaceutical combination is for the treatment of Parkinson’s disease.

Pharmaceutical Products

Levodopa is administered therapeutically to treat Parkinson’s disease, The PDI is administered in order to inhibit the breakdown of the levodopa by carboxylase enzymes in the body while the levodopa is being transported through the bloodstream and across the blood-brain barrier in order to exert its therapeutic effect. The combination of safinamide and levodopa/PDI has been found to yield a synergistic effect in terms of improvement of Parkinson’s disease symptoms and a delay in disease progression.

Does the Marketing Authorisation Cover Pharmaceutical Combinations?

As noted above, the marketing authorisation for safinamide related to safinamide alone. However, the applicant for the SPC asserted that disclosures of combination therapies in the application for marketing authorisation constituted sufficient basis that the marketing authorisation also related to the combination of safinamide and levodopa.

In contrast, as noted at paragraph 4 of the Decision,

“Throughout the examination process, the Examiner dealing with this application has maintained the view that, if the product is taken to be the combination of safinamide and levodopa/PDI, then the application is contrary to Article 3(b) of the SPC Regulation, because the marketing authorisation on which the application is based is for safinamide only, and not the combination. Alternatively, if the product is taken to be a single compound, i.e., safinamide, then it is contrary to Article (a) of the SPC Regulation because the basic patent only protects the combination of safinamide with levodopa/PDI.”

(Decision BLO/1053/22, paragraph 4)

Thus, at paragraph 16 of the Decision the Examiner noted that there was only a single issue to be decided in the present case “does the present SPC application [provide] a valid authorisation to place the combination of active ingredients […] “safinamide for use in combination with levodopa/PDI” onto the market in the UK.”

In considering this point the Hearing Officer noted that the most relevant UK authority is Yeda Research and Development Company Limited vs Comptroller General of Patents [2010] EWHC 1733 (PAT) (“Yeda UK”). In the case of Yeda UK the UK Patents High Court heard an appeal from a decision of the UKIPO and confirmed the view of the Hearing Officer at the UKIPO that the medicinal product Erbitux and its single active ingredient cetuximab was clearly the subject matter of the marketing authorisation and although there were brief references in the marketing authorisation to the use of another therapeutically active compound in combination with cetuximab (i.e. irinotecan) these references were wholly insufficient to amount to a marketing authorisation for a product constituting cetuximab and irinotecan.

Furthermore, the Yeda UK judgement confirmed that there is a difference between what a medical product containing the product is, i.e., the subject of the marketing authorisation as a whole, and what the medicinal product containing the product is used for, which is the subject usually of the section of the marketing authorisation dealing with pharmaceutical particulars.

The Hearing Officer considered that the marketing authorisation focused on what the product is rather than what the product does and this is consistent with the fact that what the product does can change during the life of the marketing authorisation but the product itself does not.

However, in the light of the case cited during this hearing, how a medicinal product is used does not form part of the identification of the product itself. (Decision subsection 26).

Therefore, the Hearing Officer held that “the brief references to irinotecan in explaining how cetuximab is used are wholly insufficient to amount to a marketing authorisation of a product consisting of both cetuximab and irinotecan and, on this basis it was decided that the marketing authorisation was for only one active ingredient, safinamide.

Following this conclusion, the Hearing Officer Referred (in paragraphs 44 and 51 of the Decision to Yeda UK to further conclude that how a product is used does not form part of the identification of the product itself.

Conclusion

Accordingly, the Hearing Officer concluded that the marketing authorisation used as the basis for the SPC application related only to safinamide and not to the combination of safinamide and levodopa/PDI. Consequently there was no valid marketing authorisation for the combination therapy and the SPC was refused because the application did not comply with Article 3(b) of the Regulation.

In conclusion, this decision of the UKIPO refers to the leading UK case regarding Article 3 of the SPC regulation and confirms its decision and UKIPO practice regarding the identity of a product covered by a marketing authorisation eligible for supporting an SPC application. In short, while it is well known that pharmaceutical products can find alternative uses and applications, including combination therapies, these alternative uses cannot provide basis for an SPC even if the new use or application is covered by a further UK patent.

The full Decision is available for download from the UKIPO here.