Kirin-Amgen Inc. et al. v. Hoechst Marion Roussel Ltd. et al., (2004) 331 N.R. 1 (HL)

• Case Date: October 21, 2004
• Jurisdiction: Canada (Federal)
• Citations: (2004), 331 N.R. 1 (HL)

Kirin-Amgen v. Hoechst Marion Roussel (2004), 331 N.R. 1 (HL)

MLB headnote and full text

Temp. Cite: [2004] N.R. TBEd. DE.051

Kirin-Amgen Inc. and others (appellants) v. Hoechst Marion Roussel Limited and others (respondents)

Kirin-Amgen Inc. and others (respondents) v. Hoechst Marion Roussel Limited and others (appellants) (conjoined appeals)

([2004] UKHL 46)

Indexed As: Kirin-Amgen Inc. et al. v. Hoechst Marion Roussel Ltd. et al.

House of Lords

London, England

Lord Hoffmann, Lord Hope of Craighead, Lord Rodger of Earlsferry, Lord Walker of Gestingthorpe and Lord Brown of Eaton-under-Heywood

October 21, 2004.

Summary:

Kirin-Amgen Inc. (Amgen) was the propri­etor of a European patent relating to the production of erythropoietin (EPO) by re­combinant DNA technology. Transkaryotic Therapies Inc. (TKT) (a U.S. company) de­veloped a method of making EPO using a pro­cess called "gene activation". The product was referred to as "GA-EPO". Hoechst Marion Roussel Ltd. (Hoechst), an English company, proposed to import GA-EPO into the United Kingdom. In three consolidated actions, Amgen claimed that GA-EPO in­fringed the claims of its patent in suit. TKT and Hoechst claimed a declaration of non-infringement and revocation of the patent. The trial judge held that one of the claims of the patent (claim 19) was invalid for insuf­ficiency but that another claim (claim 26) was valid and infringed. The Court of Ap­peal held that both claims were valid but that neither was infringed. Amgen appealed. TKT and Hoechst cross-appealed.

The House of Lords dismissed Amgen's ap­peal, allowed TKT and Hoechst's cross-ap­peal and revoked the patent.

Patents of Invention - Topic 5

General - Nature and purpose of grant of patent - The House of Lords (per Lord Hoff­mann) stated that "[a]n invention is a practical product or process, not infor­mation about the natural world. That seems to me to accord with the social contract between the state and the inventor which underlies patent law. The state gives the inventor a monopoly in return for an im­mediate disclosure of all the information necessary to enable performance of the in­vention. That disclosure is not only to en­able other people to perform the inven­tion after the patent has expired. If that were all, the inventor might as well be allowed to keep it secret during the life of the patent. It is also to enable anyone to make im­mediate use of the information for any pur­pose which does not infringe the claims. The specifications of valid and subsisting patents are an important source of information for further research, as is abundantly shown by a reading of the sources cited in the specification for the patent in suit. Of course a patentee may in some cases be able to frame his claim to a product or process so broadly that in prac­tice it will be impossible to use the infor­mation he has disclosed, even to develop important improvements, in a way which does not infringe. But it cannot be right to give him a monopoly of the use of the in­for­mation as such."

Patents of Invention - Topic 1026

The specification and claims - Construction of a patent - General - The House of Lords (per Lord Hoffmann) stated that "[c]on­struc­tion, whether of a patent or any other docu­ment, is of course not directly con­cerned with what the author meant to say. There is no window into the mind of the patentee or the author of any other doc­ument. Construction is objective in the sense that it is concerned with what a reasonable person to whom the utterance was addressed would have understood the author to be using the words to mean. No­tice, however, that it is not, as is some­times said, 'the meaning of the words the author used', but rather what the notional addressee would have understood the au­thor to mean by using those words. The meaning of words is a matter of conven­tion, governed by rules, which can be found in dictionaries and grammars. What the author would have been understood to mean by using those words is not simply a matter of rules. It is highly sensitive to the context of and background to the particular utterance. It depends not only upon the words the author has chosen but also upon the identity of the audience he is taken to have been addressing and the knowledge and assumptions which one attributes to that audience." - See paragraph 32.

Patents of Invention - Topic 1026

The specification and claims - Construction of a patent - General - The House of Lords (per Lord Hoffmann) stated that "'[p]ur­posive construction' does not mean that one is extending or going beyond the defi­ni­tion of the technical matter for which the patentee seeks protection in the claims. The question is always what the person skilled in the art would have understood the patentee to be using the language of the claim to mean. And for this purpose, the language he has chosen is usually of critical importance. The conventions of word meaning and syntax enable us to ex­press our meanings with great accuracy and subtlety and the skilled man will or­dinarily assume that the patentee has chosen his language accordingly. As a number of judges have pointed out, the specification is a unilateral document in words of the patentee's own choosing. Fur­thermore, the words will usually have been chosen upon skilled advice. The specifica­tion is not a document inter rus­ticos for which broad allowances must be made. On the other hand, it must be recog­nised that the pat­entee is trying to describe something which, at any rate in his opin­ion, is new; which has not existed before and of which there may be no generally accepted defin­ition. There will be occa­sions upon which it will be obvious to the skilled man that the patentee must in some respect have departed from conventional use of lan­guage or included in his descrip­tion of the invention some element which he did not mean to be essential. But one would not expect that to happen very often." - See paragraph 34.

Patents of Invention - Topic 1128

The specification and claims - The descrip­tion - Sufficiency of disclosure - Kirin-Amgen Inc. (Amgen) was the proprietor of a European patent relating to the produc­tion of erythropoietin (EPO) by recom­binant DNA technology - A company (TKT) developed a method of making EPO using a process called "gene activ­ation" - The product was referred to as "GA-EPO" - Amgen claimed that GA-EPO in­fringed the claims of its patent - Two of Amgen claims were for: a DNA sequence for use in securing the expression of EPO in a host cell (claim 1), EPO which was the product of the expression of an ex­o­genous DNA sequence (claim 19) and EPO which was the product of the expres­sion in a host cell of a DNA sequence according to claim 1 (claim 26) - TKT alleged that the specification was insuffi­cient to support claims 19 and 26 - The House of Lords (per Lord Hoffmann) stated that a patent could be revoked if the spec­ification did not disclose the invention clearly enough and completely enough for it to be per­formed by a person skilled in the art - Lord Hoffmann agreed with the trial judge that claim 19 was not sufficient­ly enabled and was invalid for insuffi­ciency - See para­graphs 102 to 131.

Patents of Invention - Topic 1136

The specification and claims - The descrip­tion - General - [See Patents of Invention - Topic 5 ].

Patents of Invention - Topic 1605

Grounds of invalidity - Anticipation - Par­ticular patents - Kirin-Amgen Inc. (Am­gen) was the proprietor of a European patent re­lating to the production of erythropoietin (EPO) by recombinant DNA technology - A company (TKT) developed a method of mak­ing EPO using a process called "gene activation" - The product was referred to as "GA-EPO" - Amgen claimed that GA-EPO infringed the claims of its patent - Two of Amgen claims were for: a DNA se­quence for use in securing the expression of EPO in a host cell (claim 1) and EPO which was the product of the expression in a host cell of a DNA sequence according to claim 1 (claim 26) - The House of Lords (per Lord Hoffmann) stated that claim 26 was to a product (EPO, a poly­peptide) - The question was whether it was new or the same as the EPO which was al­ready part of the state of the art - Lord Hoffmann declared claim 26 invalid on the ground of anticipation - See paragraphs 86 to 101.

Patents of Invention - Topic 2926

Infringement of patent - Acts not constitut­ing an infringement - Of particular patents - Kirin-Amgen Inc. (Amgen) was the pro­prietor of a European patent relating to the production of erythropoietin (EPO) by re­combinant DNA technology - An Ameri­can company (TKT) developed a method of making EPO using a process called "gene activation" - The product was re­ferred to as "GA-EPO" - An English com­pany (Hoechst), proposed to import GA-EPO into the United Kingdom - Amgen claimed that GA-EPO infringed the claims of its patent - Three of Amgen claims were for: a DNA sequence for use in securing the expression of EPO in a host cell (claim 1), EPO which was the product of the ex­pression of an exogenous DNA sequence (claim 19) and EPO which was the product of the expression in a host cell of a DNA sequence according to claim 1 (claim 26) -The House of Lords (per Lord Hoffmann) held that TKT and Hoechst did not in­fringe Amgen's claims - See paragraphs 53 to 85.

Cases Noticed:

Biogen Inc. v. Medeva plc, [1997] R.P.C. 1; 205 N.R. 257 (H.L.), refd to. [para. 4].

Catnic Components Ltd. v. Hill & Smith Ltd., [1982] R.P.C. 183 (H.L.), refd to. [paras. 18, 139].

British United Shoe Machinery Co. v. Fussell (A.) & Sons Ltd. (1908), 25 R.P.C. 631, refd to. [para. 20].

Electric and Musical Industries Ltd. v. Lissen Ltd. (1938), 56 R.P.C. 23 (H.L.), refd to. [para. 20].

Prenn v. Simmonds, [1971] 3 All E.R. 237; [1971] 1 W.L.R. 1381 (H.L.), refd to. [para. 30].

Reardon Smith Line v. Hansen-Tangen, [1976] 1 W.L.R. 989; [1976] 3 All E.R. 570 (H.L.), refd to. [para. 30].

Antaios Compania Naviera S.A. v. Salen Rederierna A.B., [1985] A.C. 191 (H.L.), refd to. [para. 31].

Mannai Investment Co. v. Eagle Star Life Assurance Co., [1997] A.C. 749; 215 N.R. 321 (H.L.), refd to. [para. 32].

Investors Compensation Scheme Ltd. v. West Bromwich Building Society, [1998] 1 W.L.R. 896 (H.L.), refd to. [para. 32].

Rockwater Ltd. v. Technip France SA, [2004] E.W.C.A. Civ. 381, refd to. [para. 33].

Clark v. Adie (1877), 2 App. Cas. 315, refd to. [para. 36].

Van Der Lely (C.) N.V. v. Bamfords Ltd., [1963] R.P.C. 61 (H.L.), refd to. [para. 36].

Graver Tank & Manufacturing Co. et al. v. Linde Air Products Co. (1950), 339 U.S. 605, refd to. [para. 37].

Royal Typewriter Co. v. Remington Rand Inc., 168 F.(2d) 691 (C.A. 2nd Conn.), refd to. [para. 38].

Warner-Jenkinson Co. v. Hilton Davis Chemical Co. (1997), 520 U.S. 17 (Sup. Ct.), refd to. [para. 39].

Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co. (2000), 234 F3d 558, refd to. [para. 39].

Improver Corp. v. Remington Consumer Products Ltd., [1989] R.P.C. 69 (C.A.), refd to. [para. 45].

Southco Inc. v. Dzus Fastener Europe Ltd., [1992] R.P.C. 299, refd to. [para. 45].

PLG Research Ltd. v. Ardon International Ltd., [1995] R.P.C. 287, refd to. [para. 45].

Assidoman Multipack Ltd. v. Mead Corp., [1995] R.P.C. 321, refd to. [para. 46].

Improver Corp. v. Remington Consumer Products Ltd., [1990] F.S.R. 181, refd to. [paras. 51, 138].

Wheatly v. Drillsafe Ltd., [2001] R.P.C. 133 (C.A.), refd to. [paras. 52, 138].

Batteriekastenschnur, Re, [1989] G.R.U.R. 903, refd to. [para. 73].

Ciba-Geigy/Ot/Optics, Re, [1995] Neder­landse Jurisprudentie 39, refd to. [para. 73].

BAYER/Plant growth regulating agent, Re, [1990] E.P.O.R. 257, refd to. [para. 73].

Kunstoffrohrteil, Re, [2002] G.R.U.R. 511, refd to. [para. 75].

Schneidemesser 1, Re, [2003] E.N.P.R. 12, refd to. [para. 75].

American Home Products Corp. v. Novar­tis Pharmaceuticals UK Ltd., [2001] R.P.C. 159, refd to. [para. 75].

Genentech Inc.'s Patent, Re, [1989] R.P.C. 147 (C.A.), refd to. [para. 76].

Genentech Inc.'s Patent, Re, [1987] R.P.C. 553, refd to. [para. 76].

R. v. United Kingdom (Secretary of State for Health); Ex parte Quintavalle, [2003] 2 A.C. 687; 307 N.R. 325 (H.L.), refd to. [para. 80].

International Flavors & Fragrances Inc., [1984] O.J. E.P.O. 309, refd to. [para. 90].

Merrell Dow Pharmaceuticals Inc. et al. v. Norton (H.N.) & Co. et al., [1996] R.P.C. 76; 189 N.R. 364 (H.L.), refd to. [para. 101].

Genentech I/Polypeptide expression (T 292/85), [1989] O.J. E.P.O. 275, refd to. [para. 112].

Amgen Inc. v. Chugai Pharmaceutical Co. (1991), 18 U.S.P.Q.(2nd) 1016 (Fed. Cir. C.A.), refd to. [para. 120].

British Thomson-Houston Co. v. Corona Lamp Works Ltd. (1922), 39 R.P.C. 49, refd to. [para. 128].

Authors and Works Noticed:

Brinkhof, Jan, Is there a European Doc­trine of Equivalence? (2002), 33 I.I.C. 911, p. 915 [para. 22, 72].

Miyake, Kung and Goldwasser, Purifica­tion of Human Erythropoietin (1977), 252 J. Biol. Chem. 252, No. 15, pp. 5558 to 5564 [para. 5].

Sue and Sytkowski, Site-specific Anti­bod­ies to Human Erythropoietin Directed To­ward the NH2-terminal Region (1983), 80 Prod. Natl. Acad. Sci. U.S.A. 3651, pp. 3652 to 3655 [para. 5].

Counsel:

Not disclosed.

Agents:

Not disclosed.

This appeal and cross-appeal were heard before Lord Hoffmann, Lord Hope of Craig­head, Lord Rodger of Earlsferry, Lord Walk­er of Gestingthorpe and Lord Brown of Eaton-under Heywood of the House of Lords. The decision of the House was given on October 21, 2004, when the following speeches were delivered:

Lord Hoffmann - see paragraphs 1 to 133;

Lord Hope of Craighead - see paragraphs 134 to 135;

Lord Rodger of Earlsferry - see para­graph 136;

Lord Walker of Gestingthorpe - see para­graphs 137 to 139;

Lord Brown of Eaton-Under Heywood - see paragraph 140.