Abraxis Bioscience LLC v The Comptroller-General of Patents
| Jurisdiction | England & Wales |
| Judge | Mr Justice Arnold |
| Judgment Date | 13 January 2017 |
| Neutral Citation | [2017] EWHC 14 (Pat) |
| Docket Number | Case No: CH/2016/000229 |
| Court | Chancery Division (Patents Court) |
| Date | 13 January 2017 |
[2017] EWHC 14 (Pat)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Rolls Building
Fetter Lane, London EC4A 1NL
Mr Justice Arnold
Case No: CH/2016/000229
Richard Meade QC and William Duncan (instructed by Carpmaels & Ransford LLP) for the Appellant
Brian Nicholson (instructed by the Treasury Solicitor) for the Respondent
Hearing dates: 20–21 December 2016
Contents
Topic Para
| Introduction | 1–5 |
| The Patent | 6–11 |
| The SPC Regulation | 12–14 |
| Interpretation of the SPC Regulation | 15–16 |
| Interpretation of Articles 1 (b) and 3 (d): the problems | 17–19 |
| Case law of the CJEU on Articles 1(b) and 3(d) | 20–51 |
| Pharmacia | 20–22 |
| MIT | 23–27 |
| Yissum | 28–31 |
| Neurim | 32–38 |
| GSK | 39–44 |
| Forsgren | 45–51 |
| Article 1(b) | 52–59 |
| Summary of Abraxis' contentions | 52–53 |
| Summary of the Comptroller's contentions | 54 |
| Analysis | 55–59 |
| Article 3(d) | 60–63 |
| Summary of Abraxis' contentions | 60 |
| Summary of the Comptroller's contentions | 61 |
| Analysis | 62–63 |
| Conclusion | 64 |
Introduction
This is an appeal by the Appellant ("Abraxis") against the decision of Dr Jim Houlihan, Deputy Director, acting for the Comptroller-General of Patents, dated 26 August 2016 (O/410/16) to refuse Abraxis' SPC Application No. GB/09/046 for a product described as "paclitaxel formulated as albumin bound nanoparticles" ("the Application") on the ground that it did not comply with Article 3(d) of European Parliament and Council Regulation 469/2009/EC of 6 May 2009 concerning the supplementary protection certificate for medicinal products (codified version) ("the SPC Regulation"). Abraxis calls the product paclitaxel formulated as albumin bound nanoparticles "nab-paclitaxel". For convenience I shall adopt that terminology, but I must make it clear that in doing so I am not intending to pre-judge the issues arising on this appeal. The importance of this point will become clear below.
Abraxis markets nab-paclitaxel under the trade mark Abraxane pursuant to marketing authorisation EU/1/07/428/001 ("the Abraxane MA"). The product is indicated for the treatment of metastatic breast cancer, metastatic adenocarcinoma of the pancreas and non-small cell lung cancer, used alone or together with other anti-cancer treatments. Prior to the date of the Abraxane MA, paclitaxel had been marketed by other parties under the trade marks Paxene and Taxol pursuant to earlier marketing authorisations. The details of the earlier marketing authorisations are immaterial for present purposes. Nab-paclitaxel is protected by European Patent (UK) No. 0 961 612 ("the Patent").
Abraxis contends that the active ingredient of the medicinal product authorised by the Abraxane MA is not paclitaxel, but nab-paclitaxel. It is common ground that, if this is correct, the Abraxane MA is the first marketing authorisation for nab-paclitaxel and that the Application complies with Article 3(d) of the SPC Regulation. The hearing officer held, however, that the active ingredient of the medicinal product authorised by the Abraxane MA is paclitaxel. It is common ground that the Abraxane MA is not the first marketing authorisation for paclitaxel. Accordingly, the hearing officer held that the Application did not comply with Article 3(d).
In the alternative, Abraxis contends that nab-paclitaxel is a new and inventive formulation of an old active ingredient, namely paclitaxel, and that Article 3(d) should be interpreted as permitting the grant of an SPC for a product which consists of a new and inventive formulation of an old active ingredient. The hearing officer held, however, that, although Article 3(d) permitted the grant of an SPC for a new and inventive therapeutic use of an old active ingredient, it did not permit the grant of an SPC for a new and inventive formulation of an old active ingredient.
Abraxis' contentions raise questions to the proper interpretation of Articles 1(b) and 3(d) of the SPC Regulation. Abraxis submits that the answers to the questions are not clear, and therefore the questions should be referred to the Court of Justice of the European Union. In support of this submission, Abraxis relies on the fact that SPCs have been granted for nab-paclitaxel in nine EU Member States (Austria, Denmark, Finland, France, Greece, Italy, Luxembourg, Portugal and Spain), refused in two Member States (Sweden and the UK) and are the subject of pending applications in a further three Member States (Germany, the Netherlands and Ireland) and also in Switzerland. The Respondent ("the Comptroller") submits that the answers to the questions are clear, and accordingly no reference is necessary.
The Patent
The Patent is entitled "Protein stabilized pharmacologically active agents and their use". It is not necessary for present purposes to describe the Patent in any detail. It is sufficient to set out claims 1, 32 and 33, which are in the following terms:
"1. A composition comprising particles of a solid or liquid, substantially water insoluble pharmacologically active agent, coated with protein, wherein the average diameter of said particles is less than 200 nm, wherein said protein coating has free protein associated therewith, and wherein a portion of said pharmacologically active agent is contained within said protein coating and a portion of said pharmacologically active agent is associated with said free protein.
32. A composition according to any one of claims 1 to 22 for use in eliminating cancer cells, wherein said composition is cremaphor free and said pharmacologically active agent is an antineoplastic.
33. A composition according to claim 32, wherein said antineoplastic is paclitaxel and said protein is albumin."
It can be seen from this that claim 33 covers a composition comprising particles of a pharmacologically active agent, namely paclitaxel, coated with a protein, namely, albumin, in which the average diameter of the particles is less than 200 nm and part of the paclitaxel is contained within the albumin coating and part is associated with free albumin associated with the coating.
Nab-paclitaxel
The hearing officer made the following findings about nab-paclitaxel. Nab-paclitaxel comprises nanoparticles of paclitaxel coated with albumin. This coating has further free albumin associated with it. Some paclitaxel is contained within the albumin coating, and some is associated with the free albumin. Albumin and paclitaxel are tightly bound together in the particles, and this interaction is stronger than that between free albumin and paclitaxel, but it does not consist of a covalent bond. (Although the hearing officer was not explicit as to the nature of the interaction, my understanding is that it is a hydrophobic interaction.) The binding is sufficiently tight that the albumin and paclitaxel are transported across the cell membrane as a single unit.
The hearing officer concluded at [154] that nab-paclitaxel consists of an active ingredient, namely paclitaxel, together with a carrier, namely albumin, which "enables paclitaxel to be effective in exerting its own cytotoxic effects on tumours".
Nab-paclitaxel behaves materially differently to paclitaxel in a number of ways which the hearing officer summarised at [183] as follows:
"(i) nab-paclitaxel displays more effectiveness than paclitaxel in treating some tumours either alone or in combination with other anti-cancer agents; (ii) … nab-paclitaxel offers advantages over conventional cremaphor-based formulations of paclitaxel in terms of patient tolerability; (iii) … nab-paclitaxel depletes the tumour microenvironment and kills cells other than cancer cells within it; (iv) … nab-paclitaxel is better than paclitaxel in killing tumour cells in vitro; (v) … nab-paclitaxel is transported particularly effectively to tumour locations and … (vi) nab-paclitaxel remains intact inside the cell."
Abraxane
There is no dispute that Abraxane required prolonged and expensive research to develop, with the consequence that it took a significant period of time for Abraxis to obtain the Abraxane MA following the filing of the application for the Patent.
The SPC Regulation
The SPC Regulation enables the proprietor of a patent for a medicinal product to obtain an SPC which extends the duration of the patent with respect to that product so as to compensate the proprietor for the effective loss of patent term caused by the need to obtain a marketing authorisation before the product can be marketed.
The SPC Regulation includes the following recitals:
"[3] Medicinal products, especially those that are the result of long, costly research will not continue to be developed in the Community and in Europe unless they are covered by favourable rules that provide for sufficient protection to encourage such research.
[4] At the moment the period that elapses between the filing of an application for a patent for a new medicinal product and authorisation to place the medicinal product on the market makes the period of effective protection under the patent insufficient to cover the investment put into the research.
[5] This situation leads to a lack of protection which penalises pharmaceutical research.
[6] There exists a risk of research centres situated in the Member States relocating to countries that offer greater protection.
[7] A uniform solution at Community level should be provided for, thereby preventing the heterogeneous development of national laws leading to further disparities which would be likely to create obstacles to the free movement of medicinal products within the Community and thus directly affect the establishment and the functioning of the internal market.
[8] Therefore, the creation of a...
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