Yeda Research and Development Company Ltd v Rhone-Poulenc Rorer International Holdings Inc. and Another
| Jurisdiction | UK Non-devolved |
| Judge | LORD HOFFMANN,LORD WALKER OF GESTINGTHORPE,LORD PHILLIPS OF WORTH MATRAVERS,LORD MANCE,LORD NEUBERGER OF ABBOTSBURY |
| Judgment Date | 24 October 2007 |
| Neutral Citation | [2007] UKHL 43 |
| Court | House of Lords |
| Date | 24 October 2007 |
and others
[2007] UKHL 43
Appellate Committee
Lord Hoffmann
Lord Phillips of Worth Matravers
Lord Walker of Gestingthorpe
Lord Mance
Lord Neuberger of Abbotsbury
HOUSE OF LORDS
Appellants:
Christopher Floyd QC
Tim Powell
Kathryn Pickard
(Instructed by Powell Gilbert LLP)
Respondents:
Rhone-Poulenc Rorer International Holdings Ltd
Peter Prescott QC
Daniel Alexander QC
Andrew Lykiardopoulos
(Instructed by Bird & Bird)
Imclone Systems Inc
Peter Prescott QC
Daniel Alexander QC
Andrew Lykiardopoulos
(Instructed by Milbank, Tweed, Hadley & McCloy)
Intervener
Comptroller General of Patents, Designs and Trade Marks
Michael Edenborough
(Instructed by Treasury Solicitor)
My Lords,
Twenty years ago some scientists in the Department of Chemical Immunology at the Weizmann Institute of Science in Israel were experimenting with forms of chemical treatment for cancer. They were trying to combine two different forms of treatment to obtain a synthesis which was more effective than either on its own. One was the use of monoclonal antibodies to bind to epidermal growth factor (EGF) receptors, which are often abundant on the surface of cancer cells. These antibodies are cytostatic, that is, they inhibit the growth of the cancer cells but do not kill them. The other treatment was the use of anti-neoplastic drugs which are cytotoxic, that is, they kill cancer cells. But their disadvantage is that they kill healthy cells as well. Their toxicity to healthy cells limits the doses in which they can be administered.
The Weizmann scientists say that their first idea was to try an antibody which was conjugated, that is, chemically coupled, to an anti-neoplastic drug. But they used as controls not only the antibody and the drug separately but also an unconjugated mixture of the two. And they found that the unconjugated combination gave much better results that the others.
The Weizmann scientists wrote up their results in the spring of 1988 in the form of an article for publication in a scientific journal. Before publication, they sent a draft to a Professor Schlessinger, who had previously worked at the Weizmann but was on sabbatical leave working for the Meloy Laboratories in Springfield, Virginia. (Meloy was afterwards taken over and became part of the group of which Rhone-Poulenc Rorer International Holdings Inc ("Rorer") is the holding company). Dr Schlessinger had supplied the Weizmann with two of the monoclonal antibodies used in their experiments, which he and his team had developed at Meloy but there is a dispute over whether anything in particular about these antibodies played a part in the synergistic effect which the Weizmann scientists say they discovered.
On 15 September 1988, after Dr Schlessinger had received the draft article but before it was published, Rorer applied for a US patent for the combination of antibody and drug. Dr Schlessinger and members of his team were named as the inventors. On 15 September 1989 they applied for a European patent, with the United Kingdom as one of the designated Contracting States. This was granted on 27 March 2002, taking priority from the date on which the application for the US patent was filed. The specification says that the applicant has "surprisingly discovered" that combined treatment with a monoclonal antibody and an anti-neoplastic drug provides a more efficient treatment than either agent on its own. Claim 1 is for a therapeutic composition comprising:
subject to the exclusion of two named antibodies.
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(a) a monocolonal 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
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(b) an anti-plastic agent
Yeda Research and Development Co Ltd ("Yeda") is an Israeli company which exploits inventions and technology developed at the Weizmann. They claim that Rorer did not make the discovery which forms the basis of the patent. They say it was made at the Weizmann, and Yeda, as assignee of the rights of the inventors, is entitled to have the patent transferred into its name.
The Patents Act 1977 contains procedural machinery for determining disputes over who is entitled to a patent. Section 8 deals with the case in which the dispute arises before or during the application stage, before the patent has been granted. By section 8(1)(a), any person may refer to the comptroller the question of whether he is entitled to be granted (alone or with any other persons) a patent for that invention. The comptroller must determine the question and "may make such order as he thinks fit to give effect to the determination". Section 8(2) provides for a variety of orders which the comptroller can make once an application has been made, such as ordering that the application shall proceed in the name of the person claiming to be entitled instead of the person who made the application.
Section 37 deals with the case in which the dispute arises when the patent has already been granted and is the provision relevant to these proceedings:
(1) After a patent has been granted for an invention any person having or claiming a proprietary interest in or under the patent may refer to the Comptroller the question—
(2) Without prejudice to the generality of subsection (1) above, an order under that subsection may contain provision—
…
(4) Where the Comptroller finds on a reference under this section that the patent was granted to a person not entitled to be granted that patent (whether alone or with other persons) and on application made under section 72 below makes an order on that ground for the conditional or unconditional revocation of the patent, the Comptroller may order that the person by whom the application was made or his successor in title may, subject to section 76 below, make a new application for a patent—
(5) On any such reference no order shall be made under this section transferring the patent to which the reference relates on the ground that the patent was granted to a person not so entitled, and no order shall be made under subsection (4) above on that ground, if the reference was made after the end of the period of two years beginning with the date of the grant, unless it is shown that any person registered as a proprietor of the patent knew at the time of the grant or, as the case may be, of the transfer of the patent to him that he was not entitled to the patent.
…
(8) If it appears to the Comptroller on a reference under this section that the question referred to him would more properly be determined by the Court, he may decline to deal with it and, without prejudice to the Court's jurisdiction to determine any such question and make a declaration, or any declaratory jurisdiction of the Court in Scotland, the Court shall have jurisdiction to do so.
(9) The Court shall not in the exercise of any such declaratory jurisdiction determine a question whether a patent was granted to a person not entitled to be granted the patent if the proceedings in which the jurisdiction is invoked were commenced after the end of the period of two years beginning with the date of the grant of the patent, unless it is shown that any person registered as a proprietor of the patent knew at the time of the grant or, as the case may be, of the transfer of the patent to him that he was not entitled to the patent.
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(a) who is or are the true proprietor or proprietors of the patent,
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(b) whether the patent should have been granted to the person or persons to whom it was granted, or
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(c) whether any right in or under the patent should be transferred or granted to any other person or persons; and the Comptroller shall determine the question and make such order as he thinks fit to give effect to the determination.
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(a) directing that the person by whom the reference is made under that subsection shall be included (whether or not to the exclusion of any other person) among the persons registered as proprietors of the patent;
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(b) directing the registration of a transaction, instrument or event by virtue of which that person has acquired any right in or under the patent;
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(c) granting any licence or other right in or under the patent;
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(d) directing the proprietor of the patent or any person having any right in or under the patent to do anything specified in the order as necessary to carry out the other provisions of the order.
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(a) in the case of unconditional revocation, for the whole of the matter comprised in the specification of that patent; and
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(b) in the case of conditional revocation, for the matter which in the opinion of the Comptroller should be excluded from that specification by amendment under section 75 below; and where such new application is made, it shall be treated as having been filed on the date of filing the application for the patent to which the reference relates.
It will be noticed that although subsection (1) lists three questions which may be referred to the Comptroller, the only substantive question is (a): who is or are the "true proprietor or proprietors"? Question (b) is a corollary of (a): if the patent has been granted to A but B is the true proprietor, then it should have been granted to B instead of A. And question (c) is concerned with the remedies which the Comptroller may grant pursuant to a finding that the person to whom the patent was granted was not the true proprietor, or not the only true proprietor.
Rule 54(1) of the Patents Rules 1955 provides that a reference under section 37(1) must...
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