Kirin-Amgen v Hoechst Marion Roussel
Encyclopedia
Kirin-Amgen, Inc. v Hoechst Marion Roussel Ltd. is a decision by the House of Lords
of England and Wales. The judgment was issued on 21 October 2004 and relates to the scope to be accorded to patent claims, including the doctrine of equivalents
. The case and subsequent judgment affirmed principles from a prior case, Catnic Components Ltd. v. Hill & Smith Ltd.
The issue was whether the claims of a European patent granted to Kirin-Amgen, Inc. were infringed by Transkaryotic Therapies Inc. and Hoechst Marion Roussel Ltd in a situation where there was a remarkable similarity between the technologies employed by the two parties for producing the hormone erythropoietin. Infringement was not found due to the language used in the claims of the Amgen patent.
The reasoning in the judgment has presently formed a basis for the current practice of the UK Intellectual Property Office, and other countries that take great consideration of the legal implications of British case law, when assessing whether a patent has been infringed by a device or process which is equivalent to the patented invention. (See also Doctrine of equivalents
.)
("Amgen"), a Californian pharmaceutical company
, was the proprietor of relating to the production of the glycoprotein hormone
erythropoietin (EPO)
by recombinant DNA technology
. Amgen sued Transkaryotic Therapies, Inc. ("TKT") for patent infringement
. TKT, a Massachusetts corporation, had also developed a method of making EPO using a process of gene activation. Hoechst Marion Roussel Ltd ("Hoechst") was sued for proposing to import TKT’s EPO into the United Kingdom. EPO, a previously known glycoprotein hormone, is made in the kidney
and stimulates the production of red blood cells by the bone marrow
.
of the amino acid
residues in the EPO gene
which coded for human EPO and its leader sequence. The Amgen patent addressed introducing this newly characterised gene into another organism (a self-replicating unicellular organism such as bacteria, yeast or mammalian cells in culture
). The result was that the existing machinery for gene expression in the transfected
microbial host cells operated to construct the desired product, EPO. The Amgen technique described using exogenous DNA
as a template for transcription of mRNA
which is then translated into a continuous sequence of amino acid residues within the transformed microbial host cells.
In TKT's gene activation method, the EPO is expressed in a human cell by an endogenous gene that is naturally present but typically dormant, or by cells derived by replication from such a cell. The TKT technique involved introducing the necessary control sequence into the DNA within a human cell upstream from the latent EPO gene. This different exogenous control sequence DNA had to be inserted into the human DNA at exactly the right point upstream of the EPO gene to enable it to activate or "switch-on" the inherent EPO gene in a human cell, which would not ordinarily express the EPO glycoprotein.
The essential difference between Amgen's EPO and TKT's EPO (which are chemically identical) is that the former is made by an exogenous DNA sequence coding for EPO that had been introduced into an host cell; and the latter is made by an endogenous DNA sequence coding for EPO in a human cell into which an exogenous promoter sequence has been inserted. However, the technique of inserting a promoter sequence to transform microbial host cells to construct a desired product was not generally known at the time that the Amgen patent application was published, and was not addressed in the Amgen patent specification or claims.
The key Amgen claims in issue can be summarised as:
Only claims 19 and 26 were alleged to have been infringed because TKT did not make any of its EPO in the UK. The alleged infringement was by importation. Claim 26 cannot be understood without interpretation of claim 1.
Claims 2, 3, 5, 6 and 7 were all dependent on claim 1 in the sense that if the TKT method did not involve using a "DNA sequence for use in securing expression (of EPO) in a…host cell" within the meaning of Claim 1, then TKT would not infringe any of the other claims either.
("EPC") in the UK, the extent of protection conferred by a patent was governed by the common law, the terms of the royal grant and general principles of construction of documents. Lord Diplock expounded his new principles of "purposive construction" in the leading case of Catnic Components Ltd. v. Hill & Smith Ltd.
, in respect of a patent granted before 1977. After the UK Patents Act 1977 the extent of protection conferred by a UK-EPC patent was governed by specific EPC provisions. Article 84 of the EPC specifies the role of the claims in an application to the European Patent Office for a European patent as follows:
Article 69 of the EPC, which applies to infringement proceedings for a European patent in the domestic courts of all EPC Contracting States provides:
And a further "Protocol on the Interpretation of Article 69" reads as follows:
Before the EPC came into effect, and until the House of Lords decision in Catnic, the words and grammar of a patent claim, in the absence of ambiguity, were to be given their natural and ordinary meaning. That is to say, they were to be given the meanings assigned to the words by a dictionary and to the syntax by a grammar. This meaning was to be adopted regardless of the context or background against which the words were used, unless the words used were "ambiguous"; i.e., capable of having more than one meaning. The previous law was declared by Lord Porter in Electric & Musical Industries Ltd v Lissen Ltd (1938) 56 RPC 23, 57 as follows:
Lord Diplock changed this principle in the House of Lords decision in Catnic Components Ltd v Hill & Smith Ltd [1982] RPC 183, 243 when he said that the new British approach to contract interpretation should also be applied to the construction of patent claims. He summarises this as: "A patent specification should be given a purposive construction rather than a purely literal one", where "purposive construction" means understanding language in accordance with what a reasonable person would understand the author to be using the words to mean.
"Purposive construction" as applied to patent claims does not mean 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. There is no presumption about the width of the claims. A patent may, for one reason or another, claim less than it teaches or enables.
By way of contrast, the effect of the doctrine of equivalents
under United States law is to extend protection to something outside the claims which performs substantially the same function in substantially the same way to obtain the same result.
Lord Diplock preferred to adopt a principle of construction which actually gave effect to what the person skilled in the art would have understood the patentee to be claiming. Subsequently, Article 69 of the EPC has confirmed that there can be no patent protection under UK law which extends protection outside the scope of the claims, so interpreted.
The Protocol requires a UK court, in interpreting patent claims, to reconcile the objectives of giving a Patentee the full extent of the monopoly which the person skilled in the art would think he was intending to claim, without giving the patentee more than the full extent of the monopoly which the person skilled in the art would think that he was intending to claim. In other words, a Patentee is to be bound by his claims, properly understood. This means giving the patentee the full extent, but not more than the full extent, of the monopoly which a reasonable person skilled in the art, reading the claims in context, would think he was intending to claim.
A corresponding United States decision which may represent the beginning of a similar tendency is Phillips v. AWH (CAFC 2005, en banc), 415 F.3d 1303 (Fed. Cir. 2005), cert. denied, 126 S. Ct. 1332 (2006). The principal question in that case was the extent to which a court should resort to the patent specification in seeking to ascertain the proper scope of its claims. The conclusion was that claims should definitely be read in the context of the specification. In passing, the court cited Bates v Coe 98 US 31, 38 (1878), but otherwise does not focus on the intent of a Patentee, as discernible from a patent specification.
For UK-EPC patents, while Article 69 prevents equivalence from extending protection outside the claims, equivalence can be an important part of the background of facts known to the skilled person which would affect what he understood the claims to mean. This is also expressly provided by the new Article 2 added to the Protocol by the Munich Act revising the EPC, dated 29 November 2000 (but which has not yet come into force):
The principles that Lord Diplock offered in the Catnic case were summarized by Lord Hoffmann in Improver Corporation v Remington Consumer Products Ltd
[1990] FSR 181, 189 in terms of the three Improver principles or test procedures. Lord Hoffmann in that same decision observed that a patentee may have intended a word or phrase to have not a literal but rather a figurative meaning, the figure being a form of synecdoche
- (a form of the metaphor
in which the part mentioned signifies the whole); or metonymy
(a form of metaphor denoting the relation between two objects. Metonymy is to synecdoche what a metaphor is to a simile
).
The Catnic decision established the "Catnic principle": the principle of purposive construction, but it also provided guidelines for applying that principle to equivalents. Those principles are encapsulated in the Protocol questions. However, the principle of purposive construction is the bedrock of patent construction, universally applicable. The guidelines are only guidelines, more useful in some cases than in others.
:
and simply replicate the pre-existing genes already present in the TKT cells. The TKT process works by a technique not generally known at the time when the Amgen patent application was published.
A claim may, upon its proper construction, cover products or processes which involve the use of technology unknown at the time the claim was drafted. The question is whether the person skilled in the art would understand the description in a way which was sufficiently general to include the new technology.
Lord Hoffmann concluded that that TKT did not infringe any of the claims and dismissed Amgen's appeal. The other lords all agreed.
Additionally, if a claim is intended to cover products or processes which involve the use of technology unknown at the time the claim was drafted, then the patent specification and claims based thereon should be drafted so that a person skilled in the art would understand the description in a way which was sufficiently general to include the new technology.
House of Lords
The House of Lords is the upper house of the Parliament of the United Kingdom. Like the House of Commons, it meets in the Palace of Westminster....
of England and Wales. The judgment was issued on 21 October 2004 and relates to the scope to be accorded to patent claims, including the doctrine of equivalents
Doctrine of equivalents
The doctrine of equivalents is a legal rule in most of the world's patent systems that allows a court to hold a party liable for patent infringement even though the infringing device or process does not fall within the literal scope of a patent claim, but nevertheless is equivalent to the claimed...
. The case and subsequent judgment affirmed principles from a prior case, Catnic Components Ltd. v. Hill & Smith Ltd.
Catnic Components Ltd. v. Hill & Smith Ltd.
Catnic Components Ltd. v. Hill & Smith Ltd. R.P.C. 183 is a leading House of Lords decision on the nature of a patent and in particular the methods of claim construction.-Background:...
The issue was whether the claims of a European patent granted to Kirin-Amgen, Inc. were infringed by Transkaryotic Therapies Inc. and Hoechst Marion Roussel Ltd in a situation where there was a remarkable similarity between the technologies employed by the two parties for producing the hormone erythropoietin. Infringement was not found due to the language used in the claims of the Amgen patent.
The reasoning in the judgment has presently formed a basis for the current practice of the UK Intellectual Property Office, and other countries that take great consideration of the legal implications of British case law, when assessing whether a patent has been infringed by a device or process which is equivalent to the patented invention. (See also Doctrine of equivalents
Doctrine of equivalents
The doctrine of equivalents is a legal rule in most of the world's patent systems that allows a court to hold a party liable for patent infringement even though the infringing device or process does not fall within the literal scope of a patent claim, but nevertheless is equivalent to the claimed...
.)
Background
Kirin-Amgen, Inc.Kirin-Amgen, Inc.
Kirin-Amgen, Inc. is a biotechnology joint venture between Kirin Brewery Company, Ltd. and Amgen. It is based in Thousand Oaks, California, USA.-See also:...
("Amgen"), a Californian pharmaceutical company
Pharmaceutical company
The pharmaceutical industry develops, produces, and markets drugs licensed for use as medications. Pharmaceutical companies are allowed to deal in generic and/or brand medications and medical devices...
, was the proprietor of relating to the production of the glycoprotein hormone
Glycoprotein
Glycoproteins are proteins that contain oligosaccharide chains covalently attached to polypeptide side-chains. The carbohydrate is attached to the protein in a cotranslational or posttranslational modification. This process is known as glycosylation. In proteins that have segments extending...
erythropoietin (EPO)
Erythropoietin
Erythropoietin, or its alternatives erythropoetin or erthropoyetin or EPO, is a glycoprotein hormone that controls erythropoiesis, or red blood cell production...
by recombinant DNA technology
Recombinant DNA
Recombinant DNA molecules are DNA sequences that result from the use of laboratory methods to bring together genetic material from multiple sources, creating sequences that would not otherwise be found in biological organisms...
. Amgen sued Transkaryotic Therapies, Inc. ("TKT") for patent infringement
Patent infringement
Patent infringement is the commission of a prohibited act with respect to a patented invention without permission from the patent holder. Permission may typically be granted in the form of a license. The definition of patent infringement may vary by jurisdiction, but it typically includes using or...
. TKT, a Massachusetts corporation, had also developed a method of making EPO using a process of gene activation. Hoechst Marion Roussel Ltd ("Hoechst") was sued for proposing to import TKT’s EPO into the United Kingdom. EPO, a previously known glycoprotein hormone, is made in the kidney
Kidney
The kidneys, organs with several functions, serve essential regulatory roles in most animals, including vertebrates and some invertebrates. They are essential in the urinary system and also serve homeostatic functions such as the regulation of electrolytes, maintenance of acid–base balance, and...
and stimulates the production of red blood cells by the bone marrow
Bone marrow
Bone marrow is the flexible tissue found in the interior of bones. In humans, bone marrow in large bones produces new blood cells. On average, bone marrow constitutes 4% of the total body mass of humans; in adults weighing 65 kg , bone marrow accounts for approximately 2.6 kg...
.
Kirin-Amgen’s invention versus TKT’s invention
The Amgen team succeeded for the first time in establishing the correct sequenceDNA sequence
The sequence or primary structure of a nucleic acid is the composition of atoms that make up the nucleic acid and the chemical bonds that bond those atoms. Because nucleic acids, such as DNA and RNA, are unbranched polymers, this specification is equivalent to specifying the sequence of...
of the amino acid
Amino acid
Amino acids are molecules containing an amine group, a carboxylic acid group and a side-chain that varies between different amino acids. The key elements of an amino acid are carbon, hydrogen, oxygen, and nitrogen...
residues in the EPO gene
Gene
A gene is a molecular unit of heredity of a living organism. It is a name given to some stretches of DNA and RNA that code for a type of protein or for an RNA chain that has a function in the organism. Living beings depend on genes, as they specify all proteins and functional RNA chains...
which coded for human EPO and its leader sequence. The Amgen patent addressed introducing this newly characterised gene into another organism (a self-replicating unicellular organism such as bacteria, yeast or mammalian cells in culture
Microbiological culture
A microbiological culture, or microbial culture, is a method of multiplying microbial organisms by letting them reproduce in predetermined culture media under controlled laboratory conditions. Microbial cultures are used to determine the type of organism, its abundance in the sample being tested,...
). The result was that the existing machinery for gene expression in the transfected
Transfection
Transfection is the process of deliberately introducing nucleic acids into cells. The term is used notably for non-viral methods in eukaryotic cells...
microbial host cells operated to construct the desired product, EPO. The Amgen technique described using exogenous DNA
Exogenous DNA
Exogenous DNA refers to any deoxyribonucleic acid that originates outside of the organism of concern or study.The introduction of exogenous DNA into a cell is called...
as a template for transcription of mRNA
Messenger RNA
Messenger RNA is a molecule of RNA encoding a chemical "blueprint" for a protein product. mRNA is transcribed from a DNA template, and carries coding information to the sites of protein synthesis: the ribosomes. Here, the nucleic acid polymer is translated into a polymer of amino acids: a protein...
which is then translated into a continuous sequence of amino acid residues within the transformed microbial host cells.
In TKT's gene activation method, the EPO is expressed in a human cell by an endogenous gene that is naturally present but typically dormant, or by cells derived by replication from such a cell. The TKT technique involved introducing the necessary control sequence into the DNA within a human cell upstream from the latent EPO gene. This different exogenous control sequence DNA had to be inserted into the human DNA at exactly the right point upstream of the EPO gene to enable it to activate or "switch-on" the inherent EPO gene in a human cell, which would not ordinarily express the EPO glycoprotein.
The essential difference between Amgen's EPO and TKT's EPO (which are chemically identical) is that the former is made by an exogenous DNA sequence coding for EPO that had been introduced into an host cell; and the latter is made by an endogenous DNA sequence coding for EPO in a human cell into which an exogenous promoter sequence has been inserted. However, the technique of inserting a promoter sequence to transform microbial host cells to construct a desired product was not generally known at the time that the Amgen patent application was published, and was not addressed in the Amgen patent specification or claims.
Infringement
The principal issue in the case was whether TKT's EPO fell outside the claims of Amgen's patent suit because of the difference in the way it was made.The key Amgen claims in issue can be summarised as:
- (1) a DNA sequence for use in securing the expression of EPO in a host cell,
- (19) EPO which is characterised by being the product of eucaryoticEukaryoteA eukaryote is an organism whose cells contain complex structures enclosed within membranes. Eukaryotes may more formally be referred to as the taxon Eukarya or Eukaryota. The defining membrane-bound structure that sets eukaryotic cells apart from prokaryotic cells is the nucleus, or nuclear...
expression of an exogenous DNA sequence with further characteristics that made it different from pre-existing EPO, and - (26) EPO which is the product of the expression in a host cell of a DNA sequence according to claim 1.
Only claims 19 and 26 were alleged to have been infringed because TKT did not make any of its EPO in the UK. The alleged infringement was by importation. Claim 26 cannot be understood without interpretation of claim 1.
Amgen’s claims
Amgen's asserted Claims were expressly as follows:Claims 2, 3, 5, 6 and 7 were all dependent on claim 1 in the sense that if the TKT method did not involve using a "DNA sequence for use in securing expression (of EPO) in a…host cell" within the meaning of Claim 1, then TKT would not infringe any of the other claims either.
The law
Prior to the UK Patents Act 1977, which gave effect to the European Patent ConventionEuropean Patent Convention
The Convention on the Grant of European Patents of 5 October 1973, commonly known as the European Patent Convention , is a multilateral treaty instituting the European Patent Organisation and providing an autonomous legal system according to which European patents are granted...
("EPC") in the UK, the extent of protection conferred by a patent was governed by the common law, the terms of the royal grant and general principles of construction of documents. Lord Diplock expounded his new principles of "purposive construction" in the leading case of Catnic Components Ltd. v. Hill & Smith Ltd.
Catnic Components Ltd. v. Hill & Smith Ltd.
Catnic Components Ltd. v. Hill & Smith Ltd. R.P.C. 183 is a leading House of Lords decision on the nature of a patent and in particular the methods of claim construction.-Background:...
, in respect of a patent granted before 1977. After the UK Patents Act 1977 the extent of protection conferred by a UK-EPC patent was governed by specific EPC provisions. Article 84 of the EPC specifies the role of the claims in an application to the European Patent Office for a European patent as follows:
The claims shall define the matter for which protection is sought. They shall be clear and concise and be supported by the description.
Article 69 of the EPC, which applies to infringement proceedings for a European patent in the domestic courts of all EPC Contracting States provides:
The extent of the protection conferred by a European patent or a European patent application shall be determined by the terms of the claims. Nevertheless, the description and drawings shall be used to interpret the claims.
And a further "Protocol on the Interpretation of Article 69" reads as follows:
Article 69 should not be interpreted in the sense that the extent of the protection conferred by a European patent is to be understood as that defined by the strict, literal meaning of the wording used in the claims, the description and drawings being employed only for the purpose of resolving an ambiguity found in the claims. Neither should it be interpreted in the sense that the claims serve only as a guideline and that the actual protection conferred may extend to what, from a consideration of the description and drawings by a person skilled in the art, the patentee has contemplated. On the contrary, it is to be interpreted as defining a position between these extremes which combines a fair protection for the patentee with a reasonable degree of certainty for third parties.
Before the EPC came into effect, and until the House of Lords decision in Catnic, the words and grammar of a patent claim, in the absence of ambiguity, were to be given their natural and ordinary meaning. That is to say, they were to be given the meanings assigned to the words by a dictionary and to the syntax by a grammar. This meaning was to be adopted regardless of the context or background against which the words were used, unless the words used were "ambiguous"; i.e., capable of having more than one meaning. The previous law was declared by Lord Porter in Electric & Musical Industries Ltd v Lissen Ltd (1938) 56 RPC 23, 57 as follows:
If the Claims have a plain meaning in themselves, then advantage cannot be taken of the language used in the body of the Specification to make them mean something different.
Lord Diplock changed this principle in the House of Lords decision in Catnic Components Ltd v Hill & Smith Ltd [1982] RPC 183, 243 when he said that the new British approach to contract interpretation should also be applied to the construction of patent claims. He summarises this as: "A patent specification should be given a purposive construction rather than a purely literal one", where "purposive construction" means understanding language in accordance with what a reasonable person would understand the author to be using the words to mean.
"Purposive construction" as applied to patent claims does not mean 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. There is no presumption about the width of the claims. A patent may, for one reason or another, claim less than it teaches or enables.
By way of contrast, the effect of the doctrine of equivalents
Doctrine of equivalents
The doctrine of equivalents is a legal rule in most of the world's patent systems that allows a court to hold a party liable for patent infringement even though the infringing device or process does not fall within the literal scope of a patent claim, but nevertheless is equivalent to the claimed...
under United States law is to extend protection to something outside the claims which performs substantially the same function in substantially the same way to obtain the same result.
Lord Diplock preferred to adopt a principle of construction which actually gave effect to what the person skilled in the art would have understood the patentee to be claiming. Subsequently, Article 69 of the EPC has confirmed that there can be no patent protection under UK law which extends protection outside the scope of the claims, so interpreted.
The Protocol requires a UK court, in interpreting patent claims, to reconcile the objectives of giving a Patentee the full extent of the monopoly which the person skilled in the art would think he was intending to claim, without giving the patentee more than the full extent of the monopoly which the person skilled in the art would think that he was intending to claim. In other words, a Patentee is to be bound by his claims, properly understood. This means giving the patentee the full extent, but not more than the full extent, of the monopoly which a reasonable person skilled in the art, reading the claims in context, would think he was intending to claim.
A corresponding United States decision which may represent the beginning of a similar tendency is Phillips v. AWH (CAFC 2005, en banc), 415 F.3d 1303 (Fed. Cir. 2005), cert. denied, 126 S. Ct. 1332 (2006). The principal question in that case was the extent to which a court should resort to the patent specification in seeking to ascertain the proper scope of its claims. The conclusion was that claims should definitely be read in the context of the specification. In passing, the court cited Bates v Coe 98 US 31, 38 (1878), but otherwise does not focus on the intent of a Patentee, as discernible from a patent specification.
[I]n case of doubt or ambiguity it is proper in all cases to refer back to the descriptive portions of the specification to aid in solving the doubt or in ascertaining that true intent and meaning of the language employed in the claims.
For UK-EPC patents, while Article 69 prevents equivalence from extending protection outside the claims, equivalence can be an important part of the background of facts known to the skilled person which would affect what he understood the claims to mean. This is also expressly provided by the new Article 2 added to the Protocol by the Munich Act revising the EPC, dated 29 November 2000 (but which has not yet come into force):
(2) For the purpose of determining the extent of protection conferred by a European patent, due account shall be taken of any element which is equivalent to an element specified in the claims.
The principles that Lord Diplock offered in the Catnic case were summarized by Lord Hoffmann in Improver Corporation v Remington Consumer Products Ltd
Improver v Remington
Improver Corporation v Remington Consumer Product Limited [1990] F.S.R. 181 is a leading United Kingdom case on patent infringement, particularly in relation to how to establish what specifically a patent covers.-The Catnic Decision:...
[1990] FSR 181, 189 in terms of the three Improver principles or test procedures. Lord Hoffmann in that same decision observed that a patentee may have intended a word or phrase to have not a literal but rather a figurative meaning, the figure being a form of synecdoche
Synecdoche
Synecdoche , meaning "simultaneous understanding") is a figure of speech in which a term is used in one of the following ways:* Part of something is used to refer to the whole thing , or...
- (a form of the metaphor
Metaphor
A metaphor is a literary figure of speech that uses an image, story or tangible thing to represent a less tangible thing or some intangible quality or idea; e.g., "Her eyes were glistening jewels." Metaphor may also be used for any rhetorical figures of speech that achieve their effects via...
in which the part mentioned signifies the whole); or metonymy
Metonymy
Metonymy is a figure of speech used in rhetoric in which a thing or concept is not called by its own name, but by the name of something intimately associated with that thing or concept...
(a form of metaphor denoting the relation between two objects. Metonymy is to synecdoche what a metaphor is to a simile
Simile
A simile is a figure of speech that directly compares two different things, usually by employing the words "like", "as". Even though both similes and metaphors are forms of comparison, similes indirectly compare the two ideas and allow them to remain distinct in spite of their similarities, whereas...
).
The Catnic decision established the "Catnic principle": the principle of purposive construction, but it also provided guidelines for applying that principle to equivalents. Those principles are encapsulated in the Protocol questions. However, the principle of purposive construction is the bedrock of patent construction, universally applicable. The guidelines are only guidelines, more useful in some cases than in others.
Composition of the court
The case was heard by five sitting Lords of Appeal in OrdinaryLord of Appeal in Ordinary
Lords of Appeal in Ordinary, commonly known as Law Lords, were appointed under the Appellate Jurisdiction Act 1876 to the House of Lords of the United Kingdom in order to exercise its judicial functions, which included acting as the highest court of appeal for most domestic matters...
:
- Lord Hoffmann
- Lord Hope of Craighead
- Lord Rodger of Earlsferry
- Lord Walker of Gestingthorpe, and
- Lord Brown of Eaton-under-Heywood
The Amgen decision on its facts
Interpreting the claims of the Amgen patent in the context of its specification, the claims are concerned with the expression of EPO by a gene which is exogenous to the cell. But the genes which express EPO in cells by the TKT process are not exogenous. They come into existence when the cell is formed by divisionCell division
Cell division is the process by which a parent cell divides into two or more daughter cells . Cell division is usually a small segment of a larger cell cycle. This type of cell division in eukaryotes is known as mitosis, and leaves the daughter cell capable of dividing again. The corresponding sort...
and simply replicate the pre-existing genes already present in the TKT cells. The TKT process works by a technique not generally known at the time when the Amgen patent application was published.
A claim may, upon its proper construction, cover products or processes which involve the use of technology unknown at the time the claim was drafted. The question is whether the person skilled in the art would understand the description in a way which was sufficiently general to include the new technology.
Lord Hoffmann concluded that that TKT did not infringe any of the claims and dismissed Amgen's appeal. The other lords all agreed.
Consequences
This case affirmed, without doubt, the Catnic principle: the words of a patent claim are to be understood in the sense that the author of the patent document apparently intended them to mean. The claims, so understood, delimit the boundaries of the patent monopoly.Additionally, if a claim is intended to cover products or processes which involve the use of technology unknown at the time the claim was drafted, then the patent specification and claims based thereon should be drafted so that a person skilled in the art would understand the description in a way which was sufficiently general to include the new technology.
See also
- Doctrine of equivalentsDoctrine of equivalentsThe doctrine of equivalents is a legal rule in most of the world's patent systems that allows a court to hold a party liable for patent infringement even though the infringing device or process does not fall within the literal scope of a patent claim, but nevertheless is equivalent to the claimed...
- Improver v. Remington
- Catnic Components Ltd. v. Hill & Smith Ltd.Catnic Components Ltd. v. Hill & Smith Ltd.Catnic Components Ltd. v. Hill & Smith Ltd. R.P.C. 183 is a leading House of Lords decision on the nature of a patent and in particular the methods of claim construction.-Background:...