Yeda Research and Development Company Ltd v Comptroller General of Patents
| Jurisdiction | England & Wales |
| Judge | THE HON MR JUSTICE LEWISON,Mr Justice Lewison |
| Judgment Date | 12 July 2010 |
| Neutral Citation | [2010] EWHC 1733 (Pat) |
| Docket Number | Case No: CH2010 APP 0137 |
| Court | Chancery Division (Patents Court) |
| Date | 12 July 2010 |
[2010] EWHC 1733 (Pat)
Before: The Hon Mr Justice Lewison
Case No: CH2010 APP 0137
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Tim Powell (instructed by Powell Gilbert LLP) for the Appellant
Thomas Mitcheson (instructed by Treasury Solicitors) for the Respondent
Hearing dates: 2 nd July 2010
Approved Judgment
I direct that pursuant to CPR PD 39A para 6.1 no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.
Mr Justice Lewison:
Yeda Research and Development Co Ltd (“Yeda”) appeals from the decision of Dr Lawrence Cullen, the Hearing Officer acting on behalf of the Comptroller General of Patents, dated 23 February 2010. The Hearing Officer refused two applications for supplementary protection certificates (an “SPC”) relating to EP 0 667 165 B1 (“the patent”).
The patent was filed in September 1989 and granted in 200It has now expired. The invention disclosed by the patent relates to the treatment of cancer. It explains [0011] that the primary goal in treating tumours is to kill the cells of the tumour. Two forms of agent are used. One is cytotoxic (i.e. it kills the cancer cells); the other is cytostatic (i.e. it stops them from replicating but does not kill them). Monoclonal antibodies are among the latter, and were known in the art. The problem with cytotoxic agents is that they are toxic to the patient (i.e. they kill healthy cells as well). What the patentee discovered [0018] was that:
“the combined treatment of one of the novel monoclonal antibodies with anti-neoplastic drugs … provides a more efficient treatment for inhibiting the growth of human cancer cells that express human EGF receptors and are mitogenically stimulated by human EGF than the use of the novel monoclonal antibody of the anti-neoplastic agent by itself. The combined treatment is advantageous because it combines two anti-cancer agents, each operating via different mechanisms of action to yield a cytotoxic effect to human tumor cells.”
In effect the combination of the two agents means that patients can be treated with lower doses of cytotoxic agents. The patent specification contains information both about the relevant antibodies and about their uses in combination with anti-neoplastic agents. The relevant claims reflect the disclosure in the specification. Claim 1 claims:
“A therapeutic composition comprising:
(a) a monoclonal antibody which inhibits the growth of human tumour cells by said antibody binding to the extra-cellular domain of the human EGF receptors of said tumor cells in an antigen-antibody complex, said tumor cells being characterized by their expression of human EGF receptors and mitogenic stimulation by human EGF; and
(b) an anti-neoplastic agent
wherein the antibody is not antibody 108 produced by hybridoma cell line ATCC HB 9764 or antibody 96 produced by hybridoma cell line ATCC HB 9763.”
It is clear from this claim that the invention resides in the combination of the two agents. Claim 2 claims:
“The therapeutic composition of claim 1 for separate administration of the components.”
Thus it is clear that the components of the combination may be separately administered. The only other claim I need mention is claim 6 which claims:
“Use of (a) a monoclonal antibody and (b) an anti-neoplastic agent, as defined in any one of claims 1 to 5, for the preparation of a therapeutic composition for treating cancer.”
The chosen monoclonal antibody (which has been approved for medical use) is cetuximab (known as Erbitux). The chosen anti-neoplastic agent is irinotecan. Following the usual clinical trials the appropriate regulatory authorities have approved the treatment. Precisely what they have approved is one of the issues on this appeal. The first approval came from the Swiss authorities. In December 2003 they issued a decision recording that:
“The application … for marketing authorisation of the preparation Erbitux, infusion solution, is approved.
The preparation Erbitux is approved for the indication/possible use in combination with Irinotecan for the treatment of patients with EGFR-expressing metastising colorectal carcinoma, when a cytotoxic therapy including Irinotecan has failed.”
A marketing authorisation granted by the Swiss regulators is, so I was told, recognised in Liechtenstein although not in other member states of the European Union. This authorisation enabled Erbitux to be placed on the market in Liechtenstein, subject to the limitations of the approval. In order to be able to market more widely in the EU a further approval was necessary. This was granted by the European Commission on 26 June 2004 following an evaluation by the European Agency for the Evaluation of Medicinal Products. The Commission decision begins by saying that it is “granting marketing authorisation for the medicinal product for human use “Erbitux – cetuximab”. The decision recites that “the medicinal product Erbitux – cetuximab complies” with certain regulatory requirements. Article 1 states:
“The marketing authorization … is hereby granted in respect of the medicinal product, “Erbitux – cetuximab” whose characteristics are summarized in Annex 1 hereto. This medicinal product shall be entered in the Community Register of Medicinal Products under the numbers:
EU/1/04/281/001 Erbitux-2 mg/ml-Solution for infusion-Intravenous use-Vial (glass) 50 ml-1 vial”
Annex 1 names the medicinal product as “Erbitux-2 mg/ml-solution for infusion”. It said that each ml contained 2 mg of cetuximab and that cetuximab was a chimeric monoclonal antibody produced by recombinant DNA technology. It went on to say that Erbitux was a colourless solution that might contain particles. Under clinical particulars it said:
“Erbitux in combination with irinotecan is indicated for the treatment of patients with epidermal growth factor (EGFR) expressing metastatic colorectal cancer after failure of irinotecan including cytotoxic therapy.”
It went on to describe the dosage of Erbitux and said that:
“For the dosage of concomitant irinotecan, refer to the product information for this medicinal product. … However, recommendations for dose modifications of irinotecan according to the product information for this medicinal product must be followed.”
Section 5 of Annex 1 contains details of the pharmacological properties of cetuximab. Although it says that cetuximab was investigated in combination with irinotecan in two clinical studies, it says nothing else about irinotecan.
Based on this marketing authorisation and the patent, the patentee applied for SPCs. Jacob J explained the background to SPCs in Draco's Application [1996] RPC 417, 436:
“I now turn to the supplementary protection certificate (SPC) scheme under which the appeal arises. Because of the drug regulatory scheme it was recognised by the Member States of the European Community that research in the drug field was not getting its proper reward. Although the term of a patent is 20 years, it was taking so long to get through the necessary procedures leading to authorisation to sell a drug that the practical period of protection was often too short. So Council Regulation No. 1768/92 concerning the creation of an SPC scheme for medicinal products was enacted. The basic idea is that where a patentee of a medicine has lost time in obtaining his authorisation, he may gain a further period of protection by the grant of an SPC. The period (subject to a maximum of 5 years) of an SPC is the time between grant of the basic patent and first authorisation to sell (“place the product on the market”) less five years.”
The recitals to the regulation further explain its purpose. Among the recitals, recital (10) is significant:
“All the interests at stake, including those of public health, in a sector as complex and sensitive as the pharmaceutical sector should nevertheless be taken into account. For this purpose, the certificate cannot be granted for a period exceeding five years. The protection granted should furthermore be strictly confined to the product which obtained authorisation to be placed on the market as a medicinal product.”
Article 1 of the regulation contains the following relevant definitions:
“For the purposes of this Regulation:
(a) “medicinal product” means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;
(b) “product” means the active ingredient or combination of active ingredients of a medicinal product;
(c) “basic patent” means a patent which protects a product as defined in (b) as such, a process to obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for grant of a certificate;
(d) “certificate” means the supplementary protection certificate.”
Article 3 sets out the conditions that must be fulfilled in order to obtain an SPC:
“A certificate shall be granted if, in the Member State in which the application referred to in article 7 is submitted and at the date of that application:
(a) the product is protected by a basic patent in force;
(b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate;
(c) the product has not already been the subject of a certificate;
(d) the authorization referred to in...
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