Factual and Procedural Background
This appeal concerns the refusal by the Deputy Director acting for the Comptroller-General of Patents to grant a Supplementary Protection Certificate (SPC) application filed by the Appellant ("Abraxis") for a product described as "paclitaxel formulated as albumin bound nanoparticles" ("nab-paclitaxel"). The refusal was based on the ground that the application did not comply with Article 3(d) of the SPC Regulation, which requires that the marketing authorisation relied upon be the first authorisation to place the product on the market as a medicinal product.
Abraxis markets nab-paclitaxel under the trade mark Abraxane pursuant to a marketing authorisation ("Abraxane MA"). The product is indicated for treatment of various cancers. Prior marketing authorisations existed for paclitaxel under other trade marks, but not for nab-paclitaxel. The product is protected by a European patent ("the Patent").
Abraxis contends that nab-paclitaxel is a distinct active ingredient from paclitaxel, making Abraxane MA the first authorisation for this product and thus compliant with Article 3(d). Alternatively, Abraxis argues that nab-paclitaxel is a new and inventive formulation of paclitaxel and that Article 3(d) should allow an SPC for such new formulations. The hearing officer rejected both contentions, holding that paclitaxel is the active ingredient and that the Abraxane MA is not the first authorisation for paclitaxel, and that Article 3(d) does not allow SPCs for new formulations of old active ingredients.
Abraxis sought a referral to the Court of Justice of the European Union (CJEU) for interpretation of Articles 1(b) and 3(d) of the SPC Regulation, citing inconsistent decisions across EU Member States. The Comptroller opposed the referral, arguing the questions are clear.
Legal Issues Presented
- Whether "nab-paclitaxel" constitutes a distinct active ingredient or a combination of active ingredients within the meaning of Article 1(b) of the SPC Regulation.
- Whether Article 3(d) of the SPC Regulation permits the grant of an SPC when the marketing authorisation relied upon is for a new and inventive formulation of an old active ingredient, rather than the first authorisation for that active ingredient.
- Whether a reference to the Court of Justice of the European Union is necessary to clarify the interpretation of Articles 1(b) and 3(d) of the SPC Regulation in this context.
Arguments of the Parties
Appellant's Arguments
- Nab-paclitaxel should be regarded as a single active ingredient distinct from paclitaxel due to the tight binding of paclitaxel to albumin, which has significant therapeutic consequences.
- Accordingly, the Abraxane MA is the first marketing authorisation for nab-paclitaxel, satisfying Article 3(d) of the SPC Regulation.
- Support for this position is drawn from UK Intellectual Property Office practice granting SPCs for pro-drugs and PEGylated proteins, which are chemically modified active ingredients.
- A teleological interpretation of Article 1(b) supports rewarding innovative research and compensating patentees for delays in obtaining marketing authorisations.
- Abraxis acknowledges uncertainty in whether Article 1(b) should be interpreted to treat nab-paclitaxel as a single active ingredient.
Respondent's (Comptroller's) Arguments
- The hearing officer found as a fact that nab-paclitaxel is not a single active ingredient but a combination of paclitaxel (active ingredient) and albumin (non-active carrier), consistent with the product information and marketing authorisation documents.
- The Abraxane MA and its supporting documents identify the active substance as paclitaxel formulated with albumin, not as a new active ingredient.
- Nab-paclitaxel differs from pro-drugs and PEGylated proteins, which constitute chemically distinct molecules and different active ingredients.
- The legal position is clear and does not warrant a referral to the CJEU.
Table of Precedents Cited
| Precedent |
Rule or Principle Cited For |
Application by the Court |
| Case C-31/03 Pharmacia Italia SpA [2004] ECR I-10001 |
Clarified that the decisive factor for SPC grant is the product's first marketing authorisation regardless of human or veterinary use; one certificate per product. |
Supported strict interpretation of "first authorisation" and uniform application across Member States. |
| Case C-431/04 Massachusetts Institute of Technology [2006] ECR I-4089 |
Active ingredient excludes substances without therapeutic effect; combination of active ingredient with excipient not regarded as combination of active ingredients. |
Confirmed narrow interpretation of "active ingredient" excluding excipients even if they influence efficacy. |
| Case C-202/05 Yissum Research and Development Company v Comptroller-General of Patents [2007] ECR I-2839 |
Therapeutic use does not form part of the definition of "product" under Article 1(b). |
Confirmed strict interpretation excluding therapeutic use from product definition. |
| Case C-130/11 Neurim Pharmaceuticals Ltd v Comptroller-General of Patents [EU:C:2012:489] |
Article 3(d) interpreted to allow SPCs for new therapeutic uses of known active ingredients despite earlier marketing authorisations. |
Allowed SPC for second medical use; distinction between product and use. |
| Case C-210/13 Glaxosmithkline Biologicals SA v Comptroller-General of Patents [EU:C:2013:762] |
Adjuvants without therapeutic effect are not active ingredients; combinations with adjuvants do not constitute combination of active ingredients. |
Reinforced narrow interpretation of active ingredient excluding adjuvants. |
| Case C-631/13 Forsgren v Austrian Patent Office [EU:C:2015:13] |
Active ingredient may be covalently bound to others and still qualify if it produces pharmacological effect; carrier proteins must produce effect to qualify as active ingredient. |
Clarified that active ingredient status depends on pharmacological effect, not binding status. |
Court's Reasoning and Analysis
The court began by considering the definition of "active ingredient" under Article 1(b) of the SPC Regulation, relying on established CJEU case law which interprets the term narrowly to exclude substances without a pharmacological, immunological, or metabolic effect of their own. The court noted that albumin functions as a carrier and does not have such an effect, thus nab-paclitaxel is not a single active ingredient but a combination of paclitaxel (active ingredient) and albumin (non-active carrier).
The court accepted the hearing officer's factual findings, which were unchallenged by the appellant, that paclitaxel is the active ingredient and albumin is a carrier not covalently bonded to paclitaxel. The court also considered the marketing authorisation documents (SmPC and EPAR), which identified paclitaxel as the active ingredient and described nab-paclitaxel as a formulation of paclitaxel.
Regarding Article 3(d), the court acknowledged the uncertainty arising from the CJEU's Neurim decision, which permits SPCs for new therapeutic uses of known active ingredients despite earlier marketing authorisations. However, the court distinguished this from new formulations of old active ingredients, noting that prior case law (MIT, GSK, Forsgren) indicates SPCs are not available for new formulations without new therapeutic uses.
The court emphasized the need for clear, predictable, and uniform rules in the SPC system to balance the interests of patentees and other stakeholders. It reasoned that allowing SPCs for new formulations under Article 3(d) would introduce uncertainty and inconsistency, contrary to the Regulation's objectives and the explanatory memorandum's indications.
Consequently, the court concluded that Article 1(b) excludes nab-paclitaxel as a single active ingredient and that Article 3(d) should not be interpreted to permit SPCs for new formulations of old active ingredients. However, due to the lack of definitive CJEU authority on Article 3(d) in this context, the court decided to refer a question to the CJEU for clarification regarding the interpretation of Article 3(d) concerning new formulations.
Holding and Implications
REFERRAL TO THE COURT OF JUSTICE OF THE EUROPEAN UNION
The court held that nab-paclitaxel is not a distinct active ingredient within the meaning of Article 1(b) of the SPC Regulation and that the marketing authorisation relied upon is not the first authorisation for the active ingredient paclitaxel. Therefore, the SPC application does not comply with Article 3(d) of the SPC Regulation.
However, recognizing uncertainty in the interpretation of Article 3(d) as it applies to new formulations of old active ingredients, the court referred a question to the CJEU seeking authoritative guidance on whether Article 3(d) permits the grant of an SPC in such circumstances.
The direct effect of this decision is that the appellant's SPC application is refused on the current interpretation. No new precedent altering the established interpretation of Article 1(b) is set. The referral aims to clarify the scope of Article 3(d) for future cases involving new formulations.