Biogen Inc. v Medeva Plc

CourtHouse of Lords
JudgeLord Goff of Chieveley, Lord Browne-Wilkinson, Lord Mustill, Lord Slynn of Hadley, Lord Hoffmann
Judgment Date31 Oct 1996
JurisdictionEngland & Wales

[1996] UKHL J1031-1

House of Lords

Lord Goff of Chieveley

Lord Browne-Wilkinson

Lord Mustill

Lord Slynn of Hadley

Lord Hoffmann

Biogen Inc.
(Appellants)
and
Medeva Plc
(Respondents)
1

OPINIONS OF THE LORDS OF APPEAL FOR JUDGMENT IN THE CAUSE

Lord Goff of Chieveley

My Lords,

2

I have had the advantage of reading in draft the speech prepared by my noble and learned friend Lord Hoffmann. For the reasons he gives I would dismiss the appeal.

3

I wish to express the gratitude of the Appellate Committee to our two expert advisers, Professor D. Glover of the University of Dundee and Professor J. Neil of the University of Glasgow, who provided the Committee with invaluable assistance both before and during the hearing.

Lord Browne-Wilkinson

My Lords,

4

For the reasons given in the speech prepared by my noble and learned friend Lord Hoffmann I too would dismiss the appeal.

Lord Mustill
5

I have had the opportunity to read in draft the speech of my noble and learned friend Lord Hoffmann, and agree both with the conclusion that the appeal should be dismissed and with the reasons for that conclusion. In particular I am glad to adopt the proposed reconciliation of sections 14(5) and 72(1) of the Patents Act 1977, which eliminates a difficulty expressed by the Court of Appeal in Genentech Inc.'s Patent [1989] R.P.C. 147.

6

There is however one matter which I should mention: namely, the necessity or otherwise for a valid patent to concern an invention, as well as satisfying the conditions expressed in paragraphs ( a) to ( b) of Section 1(1) of the Act. This question was not contested before the House, although some reference was made to it in debate, for it was agreed (rightly in my opinion) that it has no bearing on the present appeal. My reason for referring to it is simply to make clear that in concurring with all your Lordships in the reasons for dismissing the appeal I should not be taken to accept, without full argument, that the need for an invention would always be academic, or that no such need is expressed by the words of section 1(1): nor indeed do I understand my noble and learned friend as advancing any conclusion to that effect. Certainly, in the great majority of cases, there will be no need to complicate the enquiry by looking outside the four conditions. The traditional law of patents is, however, in the course of adapting itself to new technologies, beyond contemplation when the foundations of that law were established. This process is not without strain, and I believe that in some instances a close conceptual analysis of the nature of patentability will not be a waste of time. Such a case was Genentech Inc.'s Patent where the claim was for a product already existing in nature, a subject far distant from the mechanical and chemical inventions to which so much of traditional patent law relates. There may well be others in the future.

7

My Lords, my purpose in adding this footnote to the speech of my noble and learned friend is not of course to express any opinion, one way or the other, on the correctness of the reasoning outlined at pp. 261-266 of the report of Genentech Inc.'s Patent. The intention is only to emphasise that when a dispute does arise on which this question may have a bearing it will merit study leading to a definitive answer.

Lord Slynn of Hadley

My Lords,

8

I have had the advantage of reading in draft the speech prepared by my noble and learned friend Lord Hoffmann. For the reasons he gives I too would dismiss the appeal.

Lord Hoffmann

My Lords,

9

1. Genetic Engineering.

10

In this appeal your Lordships' House has for the first time to consider the validity of a patent for products of genetic engineering. This is a technology which has developed only during the last 25 years, in consequence of the great advances which have been made in our knowledge of the genetic code contained in every living cell. The code is embodied in a molecule of deoxyribonucleic acid ("DNA") which directs the cell to make the proteins which the organism requires. Genetic engineering or "recombinant DNA technology" consists of altering the DNA of a suitable cell so that it produces a protein which in nature occurs in another organism. In this way it has been possible to manufacture products of great medical importance which could not have been made by orthodox chemical synthesis.

11

2. The patent in suit.

12

The principal claim of the patent in suit is for an artificially constructed molecule of DNA carrying a genetic code which, when introduced into a suitable host cell, will cause that cell to make antigens of the virus hepatitis B ("HBV"). I shall have to describe in much greater detail what antigens are and how the invention enables them to be made. Suffice it for the moment to say that HBV is a widespread human virus, often causing fatal diseases of the liver, and that its antigens can be used both to test for whether someone has the virus and to make a vaccine which can give immunity against infection.

13

3. Biogen and Professor Murray.

14

The patent is based upon experimental work done in 1978 by Professor Sir Kenneth Murray of Edinburgh University. Recombinant DNA technology was then in its promising infancy. In February 1978 Professor Murray and a number of other molecular biologists of international repute, together with financial backers, met in Geneva and decided to found Biogen Inc, the patentee company ("Biogen"), for the purpose of exploiting the technology for commercial purposes. One of the first projects upon which they agreed was to try to make the antigens of HBV. Professor Murray began work in the spring of that year and in November reported that he had produced two of the known HBV antigens in colonies of cultured bacteria.

15

4. History of the proceedings and legal issues.

16

On 22 December 1978 Biogen filed a U.K. patent application describing what Professor Murray had done. This application, known in the proceedings as "Biogen 1" forms the basis of a claim to priority in respect of a later application filed with the European Patent Office ("EPO") in Munich on 21 December 1979. The European Patent was granted on 11 July 1990 and opposition proceedings were dismissed on appeal by the EPO on 28 July 1994.

17

Meanwhile, in 1992 Biogen began infringement proceedings against the respondent, Medeva pic, which was proposing to market what it described as a third-generation hepatitis B vaccine made by recombinant DNA technology in colonies of mammalian cells. Medeva counterclaimed for revocation. It alleged that the patent was invalid on a number of grounds. I shall briefly mention those which are still relied upon without at this stage making any comment or doing more than to refer to the sections of the Patents Act 1977 on which the objections are based. They are, first, that the claimed invention was obvious (sections l(1)(b) and 3), both at the date of application for the patent in suit and at the date of Biogen 1. Secondly, that Biogen was not entitled to the priority date of Biogen 1 because it did not "support" the invention claimed in the patent (section 5(2)( a)). Thirdly, that the claimed invention was not an invention (section 1(1)), and fourthly, that the description in the specification was insufficient (section 72(1)( c)). Biogen concedes that the claimed invention was obvious at the date when the application for the European patent was filed but not that it was on the date of Biogen 1.

18

Aldous J. held that the claims in the patent were supported by the matter disclosed in Biogen 1 and that it was accordingly entitled to the earlier priority date. He dismissed all the objections and held the patent valid and infringed. The Court of Appeal (Nourse, Peter Gibson and Hobhouse L.JJ.) allowed an appeal. Hobhouse L.J. gave the judgment of the court. He held that Biogen 1 did not support the claimed invention and that in any case it was obvious at the earlier date. He would have been inclined, but for Medeva's counsel's lack of enthusiasm for the point, to hold that it was not an invention at all. He also held the description in the specification to be insufficient. From this comprehensive reverse Biogen appeals to your Lordships' House.

19

5. The state of the art in 1978.

20

In this appeal much turns upon identifying the inventive step, if any, in what Professor Murray did. There is no doubt that he was the first person to make HBV antigens by recombinant DNA technology. It does not however follow that he was inventive. The technology was developing very fast and recent developments might have made its use for that purpose obvious. Even if it was not, it does not follow that "making HBV antigens by recombinant DNA technology" would be the right way to describe his inventive step. Whenever anything inventive is done for the first time it is the result of the addition of a new idea to the existing stock of knowledge. Sometimes, it is the idea of using established techniques to do something which no one had previously thought of doing. In that case, the inventive idea will be doing the new thing. Sometimes, it is finding a way of doing something which people had wanted to do but could not think how. The inventive idea would be the way of achieving the goal. In yet other cases, many people may have a general idea of how they might achieve a goal but not know how to solve a particular problem which stands in their way. If someone devises a way of solving the problem, his inventive step will be that solution, but not the goal itself or the general method of achieving it. To discover precisely what constituted the inventive step, one must therefore examine the state of the art of molecular biology in 1978. Would it have been a new idea to think of making HBV antigens at all? Or would that have been a goal which people had thought about but did not know how to achieve ? If the latter, would it have...

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