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You are here: BAILII >> Databases >> United Kingdom House of Lords Decisions >> Biogen Inc v. Medeva Plc [1996] UKHL 18 (31 October 1996) URL: https://www.bailii.org/uk/cases/UKHL/1996/18.html Cite as: [1996] UKHL 18, [1997] RPC 1, (1997) 38 BMLR 149 |
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[1996] UKHL 18
BIOGEN INC. | (APPELLANTS) |
MEDEVA PLC | (RESPONDENTS) |
ON 31ST OCTOBER 1996
Lord Goff of Chieveley
Lord Browne-Wilkinson
Lord Mustill
Lord Slynn of Hadley
Lord Hoffmann
LORD GOFF OF CHIEVELEY
My Lords,
LORD BROWNE-WILKINSON
My Lords,
LORD MUSTILL
LORD SLYNN OF HADLEY
My Lords,
LORD HOFFMANN
My Lords,
1. Genetic Engineering.
2. The patent in suit.
3. Biogen and Professor Murray.
4. History of the proceedings and legal issues.
5. The state of the art in 1978.
(a) HBV in 1978.
(b) Recombinant DNA technology in 1978.
6. Biogen 1: Professor Murray's success.
"To be useful in the process a restriction enzyme should not cleave the HBV DNA within an essential part of the gene for antigenic specificity"
1. A recombinant DNA molecule characterized by a DNA sequence coding for a polypeptide or a fragment thereof displaying HBV antigen specificity, said DNA sequence being operatively linked to an expression control sequence in the recombinant DNA molecule and being expressed to produce a polypeptide displaying HBV antigen specificity when a suitable host cell transformed with said recombinant DNA molecule is cultured, the transformed host cell not producing any human serum proteins and any primate serum proteins other than the polypeptide displaying HBV antigen specificity.
2. The recombinant DNA molecule according to claim 1, characterized in that the polypeptide displaying HBV antigen specificity also displays HBV antigenicity.
3. The recombinant DNA molecule according to claim 1 or 2, characterized in that the DNA sequence codes for a polypeptide or a fragment thereof displaying the HBV antigen specificity of a hepatitis B virus core antigen.
4. The recombinant DNA molecule according to claim 1 or 2, characterized in that the DNA sequence codes for a polypeptide or a fragment thereof displaying the HBV antigen specificity of a hepatitis B virus surface antigen.
Claim 6 (as amended) is to:
6. A polypeptide free of any human serum proteins and any primate serum proteins which displays HBV antigen specificity, said polypeptide being produced by a host cell transformed with a recombinant DNA molecule according to claim 1 or 2.
Claims 7 and 8 are to polypeptides displaying respectively HBcAg and HBsAg specificity, produced by host cells transformed in accordance with claims 1, 2 or 3 or 1, 2 or 4 respectively.
8. Patentable Inventions.
1(1) A patent may be granted only for an invention in respect of which the following conditions are satisfied, that is to say -
(a) the invention is new;
(b) it involves an inventive step;
(c) it is capable of industrial application;
(d) the grant of a patent for it is not excluded by subsections (2) and (3) below;
and references in this Act to a patentable invention shall be construed accordingly.
9. What is an invention ?
"You cannot invent water, although you certainly can invent ways in which it may be distilled or synthesised."
This is obviously right and in such a case it may seem pedantic to say that water fails the condition in paragraph (a) of section 1(1) because it is not new. Unfortunately, most cases which come before the courts are more difficult. Judges would therefore be well advised to put on one side their intuitive sense of what constitutes an invention until they have considered the questions of novelty, inventiveness and so forth. In the present case, I think that Medeva's counsel was right to resist the invitation of the Court of Appeal to make submissions on whether the claims constituted an invention.
10. Inventive Step
"An invention shall be taken to involve an inventive step if it is not obvious to a person skilled in the art, having regard to any matter which forms part of the state of the art by virtue only of section 2(2) above . . ."
Section 2(2) defines the state of the art:
"The state of the art in the case of an invention shall be taken to comprise all matter (whether a product, a process, information about either or anything else) which has at any time before the priority date of that invention been made available to the public (whether in the United Kingdom or elsewhere) by written or oral description, by use or in any other way."
"The first is to identify the inventive concept embodied in the patent in suit. Thereafter, the court has to assume the mantle of the normally skilled but unimaginative addressee in the art at the priority date and impute to him what was, at that date, common general knowledge in the art in question. The third step is to identify what, if any, differences exist between the matter cited as being "known or used" and the alleged invention. Finally, the court has to ask itself whether, viewed without any knowledge of the alleged invention, those differences constitute steps which would have been obvious to the skilled man or whether they require any degree of invention."
"It is accepted that once a decision [had] been made to try expression of the HBV genome, the technique set out in Villa-Komaroff would have been sufficient to enable it to be carried out. Thus the difference between the prior art and the inventive concept is the idea or decision to express a polypeptide displaying HBV antigen specificity in a suitable host."
Again, I think that this is not a sufficiently specific way of stating the inventive concept. The general idea of expressing the gene for a polypeptide displaying HBV antigen specificity in a suitable host was, as I have said, fairly widely entertained. The inventive concept was the notion that Professor Murray's method of achieving the goal - creating large fragments of genomic DNA, ligating them to pBR322 and introducing the hybrid molecule into E. coli - would work.
"it was not until the sequence had been obtained, with the knowledge that introns would not be a problem, that the skilled man would seriously consider expression of HBV antigens."
The judge accepted this submission and held that Strategy B would not have been obvious in 1978. He said:
"In the present case, there is no evidence to suggest that anyone, other than Biogen, contemplated expression of the HBV antigen in December 1978, despite the fact that the skilled man must have read the Villa-Komaroff paper and there was an incentive to do so. The reason may well be that stated in the patent, namely the skilled man was put off by introns."
He also rejected the argument that Strategy A was an obvious way of making the antigens. The evidence showed only that sequencing might show that there were no introns and that the gene could be expressed in bacteria but there was no ground for assuming that it would.
11. Priority date
5(1) For the purposes of this Act the priority date of an invention to which an application for a patent relates and also of any matter (whether or not the same as the invention) contained in any such application is, except as provided by the following provisions of this Act, the date of filing the application.
(2) If in or in connection with an application for a patent (the application in suit) a declaration is made, whether by the applicant or any predecessor in title of his, complying with the relevant requirements of rules and specifying one or more earlier relevant applications for the purposes of this section made by the applicant or a predecessor in title of his and each having a date of filing during the period of twelve months immediately preceding the date of filing the application in suit, then -
(a) if an invention to which the application in suit relates is supported by matter disclosed in the earlier relevant application or applications, the priority date of that invention shall instead of being the date of filing the application in suit be the date of filing the relevant application in which that matter was disclosed or, if it was disclosed in more than one relevant application, the earliest of them;
"The specification of an application shall disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the art."
This is plainly a requirement of an "enabling disclosure." In addition, subsection (5)(c) says that the claim or claims shall be "supported by the description." It was by reference to subsection (3) that Lord Oliver of Aylmerton, who gave the leading speech in Asahi, reasoned, at p. 536 that a description would not "support" the claims for the purpose of subsection (5)(c) unless it contained sufficient material to enable the specification to constitute the enabling disclosure which subsection (3) required: "the Act can hardly have contemplated a complete application for a patent lacking some of the material necessary to sustain the claims made." By parity of reasoning, he said that "support" must have the same meaning in section 5(2)(a).
"the specification of the patent does not disclose the invention clearly enough and completely enough for it to be performed by a person skilled in the art."
This is entirely in accordance with what one would expect. The requirement of an enabling disclosure in a patent application is a matter of substance and not form. Its absence should therefore be a ground not only for refusal of the application but also for revocation of the patent after grant. Similarly, the same concept is involved in the question of whether the patent is entitled to priority from an earlier application. This is not to say that the question in each case is the same. The purposes for which the question is being asked are different. But the underlying concept is the same.
"What is also important in the present case is the irrelevancy of the particular choice of a variant within the functional terms 'bacteria,' 'regulon' or 'plasmid.' It is not just that some result within the range of polypeptides is obtained in each case but it is the same polypeptide which is expressed, independent of the choice of these means. . . . Unless variants of components are also embraced in the claims, which are, now or later on, equally suitable to achieve the same effect in a manner which could not have been envisaged without the invention, the protection provided by the patent would be ineffectual . . . The character of the invention this time is one of general methodology which is fully applicable with any starting material, and is, as it was already stated, also independent from the known, trivial, or inventive character of the end-products."
In other words, the applicants had invented a general principle for enabling plasmids to control the expression of polypeptides in bacteria and there was no reason to believe that it would not work equally well with any plasmid, bacterium or polypeptide. The patent was therefore granted in general terms.
"Furthermore, Article 84 EPC also requires that the claims must be supported by the description, in other words, it is the definition of the invention in the claims that needs support. In the Board's judgment, this requirement reflects the general legal principle that the extent of the patent monopoly, as defined by the claims, should correspond to the technical contribution to the art in order for it to be supported, or justified."
12. Support for the claims
"Upon the evidence, I conclude that Biogen did express and demonstrate expression of the surface antigen using the techniques described in the specification."
The disclosure was therefore sufficient in respect of both inventions.
"The outcome of this evidence is that whatever results the plaintiff obtained in 1978 did not amount to evidence justifying a claim to have produced a recombinant DNA molecule which enabled the expression of HBsAg in E. coli (or any other host)."
"Before Morse's invention, the scientific community saw the possibility of achieving communication by the 'galvanic' current but did not know any means of achieving that result. Morse discovered one means and attempted to claim all others."
"... [T]he problem was simply how to do automatically what could already be done by the skill of the workman. On the other hand, the principle which the inventor applies for the solution of the problem is the capacity of a cam to vary the relative positions of two parts of a machine while the machine is running. Assuming this principle to be new, it might be possible for the inventor, having shown one method of applying it to the solution of the problem, to protect himself during the life of his Patent from any other method of applying it for the same purpose, but I do not think that the novelty of the principle applied would enable him to make a valid claim for all means of solving the problem whether the same or a different principle were applied to its solution."
13. The EPO decision.
14. Sufficiency
Upon Report from the Appellate Committee to whom was referred the Cause Biogen Inc. against Medeva plc, That the Committee had heard Counsel as well on the 29th and 30th days of April as on the 1st, 2nd, 7th, 9th, 13th, 14th, 15th, 16th, 20th, 21st, 22nd and 23rd days of May last upon the Petition and Appeal of Biogen Inc., of 14 Cambridge Center, Cambridge, Massachusetts, United States of America, praying that the matter of the Order set forth in the Schedule thereto, namely an Order of Her Majesty's Court of Appeal of the 3rd day of November 1994, might be reviewed before Her Majesty the Queen in Her Court of Parliament and that the said Order might be reversed, varied or altered or that the Petitioners might have such other relief in the premises as to Her Majesty the Queen in Her Court of Parliament might seem meet; as upon the case of Medeva plc lodged in answer to the said Appeal; and due consideration had this day of what was offered on either side in this Cause:
It is Ordered and Adjudged, by the Lords Spiritual and Temporal in the Court of Parliament of Her Majesty the Queen assembled, That the said Order of Her Majesty's Court of Appeal of the 3rd day of November 1994 complained of in the said Appeal be, and the same is hereby, Affirmed and that the said Petition and Appeal be, and the same is hereby, dismissed this House: And it is further Ordered, That the Appellants do pay or cause to be paid to the said Respondents the Costs incurred by them in respect of the said Appeal to this House, the amount thereof to be certified by the Clerk of the Parliaments if not agreed between the parties: And it is also further Ordered, That the fees and expenses payable to the Specialist Advisers appointed under Standing Order XIV be paid by both parties in equal shares.
Cler: Parliamentor: