Kirin-Amgen Inc v Hoechst Marion Roussel Ltd

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Kirin-Amgen, Inc. v Hoechst Marion Roussel Ltd
Full case nameKirin-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)
Citation(s)[2004] UKHL 46
Transcript(s) HL judgment COA judgment
Court membership
Judge(s) sitting Lord Hoffmann, Lord Hope of Craighead, Lord Rodger of Earlsferry, Lord Walker of Gestingthorpe, Lord Brown of Eaton-under-Heywood

Kirin-Amgen, Inc. v Hoechst Marion Roussel Ltd. [1] 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.

Contents

The issue was whether the claims of a European patent granted to Kirin-Amgen, Inc. were infringed by Transkaryotic Therapies Inc. ("TKT") 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 under the doctrine of equivalents.

Background

Kirin-Amgen, Inc. ("Amgen"), a Californian pharmaceutical company, was the proprietor of EP 0148605   relating to the production of the glycoprotein hormone erythropoietin (EPO) by recombinant DNA technology. Amgen sued Transkaryotic Therapies, Inc. 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.

Kirin-Amgen's invention versus TKT's invention

The Amgen team succeeded for the first time in establishing the correct sequence 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.

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:

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:

1. A DNA sequence for use in securing expression in a procaryotic or eucaryotic host cell of a polypeptide product having at least part of the primary structural [conformation] of that of erythropoietin to allow possession of the biological property of causing bone marrow cells to increase production of reticulocytes and red blood cells and to increase haemoglobin synthesis or iron uptake, said DNA sequence selected from the group consisting of:

(a) the DNA sequences set out in Tables V and VI or their complementary strands; (b) DNA sequences which hybridize under stringent conditions to the protein-coding regions of the DNA sequences defined in (a) or fragments thereof; and (c) DNA sequences which, but for the degeneracy of the genetic code, would hybridize to the DNA sequences defined in (a) and (b).

19. A recombinant polypeptide having part or all of the primary structural conformation of human or monkey erythropoietin as set forth in Table VI or Table V or any allelic variant or derivative thereof possessing the biological property of causing bone marrow cells to increase production of reticulocytes and red blood cells to increase haemoglobin synthesis or iron uptake and characterised by being the product of eucaryotic expression of an exogenous DNA sequence and which has a higher molecular weight by SDS-PAGE from erythropoietin isolated from urinary sources.

26. A polypeptide product of the expression in a eucaryotic host cell of a DNA sequence according to any of claims 1, 2, 3, 5, 6 and 7.

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 Convention ("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: [2]

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: [3]

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: [4]

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 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 (which entered into force on 13 December 2007):

(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 [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.

Opinion of the court

Composition of the court

The case was heard by five sitting Lords of Appeal in Ordinary:

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 division 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 TKT did not infringe any of the claims and dismissed Amgen's appeal. The other lords all agreed.

Consequences

This case affirmed that: "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." (Paragraph 32 of the judgement)

It is a common misunderstanding that the words of the claims should be understood as what the author used them to mean. This is not the case. Rather, the claims should be understood as what a skilled person (at the date of filing of the application) would have understood the author to be using the words to mean.

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

Related Research Articles

The patentability of software, computer programs and computer-implemented inventions under the European Patent Convention (EPC) is the extent to which subject matter in these fields is patentable under the Convention on the Grant of European Patents of October 5, 1973. The subject also includes the question of whether European patents granted by the European Patent Office (EPO) in these fields (sometimes called "software patents") are regarded as valid by national courts.

<span class="mw-page-title-main">European Patent Convention</span> International patent treaty

The European Patent Convention (EPC), also known as the Convention on the Grant of European Patents of 5 October 1973, is a multilateral treaty instituting the European Patent Organisation and providing an autonomous legal system according to which European patents are granted. The term European patent is used to refer to patents granted under the European Patent Convention. However, a European patent is not a unitary right, but a group of essentially independent nationally enforceable, nationally revocable patents, subject to central revocation or narrowing as a group pursuant to two types of unified, post-grant procedures: a time-limited opposition procedure, which can be initiated by any person except the patent proprietor, and limitation and revocation procedures, which can be initiated by the patent proprietor only.

<span class="mw-page-title-main">Patent infringement</span> Breach of the rights conferred by a patent

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 selling the patented invention. In many countries, a use is required to be commercial to constitute patent infringement.

In a patent or patent application, the claims define in technical terms the extent, i.e. the scope, of the protection conferred by a patent, or the protection sought in a patent application. In other words, the purpose of the claims is to define which subject-matter is protected by the patent. This is termed as the "notice function" of a patent claim—to warn others of what they must not do if they are to avoid infringement liability. The claims are of paramount importance in both prosecution and litigation.

A person having ordinary skill in the art, a person of (ordinary) skill in the art, a person skilled in the art, a skilled addressee or simply a skilled person is a legal fiction found in many patent laws throughout the world. This hypothetical person is considered to have the normal skills and knowledge in a particular technical field, without being a genius. This measure mainly serves as a reference for determining, or at least evaluating, whether an invention is non-obvious or not, or involves an inventive step or not. If it would have been obvious for this fictional person to come up with the invention while starting from the prior art, then the particular invention is considered not patentable.

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The inventive step and non-obviousness reflect a general patentability requirement present in most patent laws, according to which an invention should be sufficiently inventive—i.e., non-obvious—in order to be patented. In other words, "[the] nonobviousness principle asks whether the invention is an adequate distance beyond or above the state of the art".

Prosecution history estoppel, also known as file-wrapper estoppel, is a term used to indicate that a person who has filed a patent application, and then makes narrowing amendments to the application to accommodate the patent law, may be precluded from invoking the doctrine of equivalents to broaden the scope of their claims to cover subject matter ceded by the amendments. Although primarily a U.S. term, questions of whether, or the extent to which the prosecution history should be relevant for determining the extent of protection of a patent also arise outside the U.S.

Sufficiency of disclosure or enablement is a patent law requirement that a patent application disclose a claimed invention in sufficient detail so that the person skilled in the art could carry out that claimed invention. The requirement is fundamental to patent law: a monopoly is granted for a given period of time in exchange for a disclosure to the public how to make or practice the invention.

European patent law covers a range of legislations including national patent laws, the Strasbourg Convention of 1963, the European Patent Convention of 1973, and a number of European Union directives and regulations. For some states in Eastern Europe, the Eurasian Patent Convention applies.

Catnic Components Ltd. v. Hill & Smith Ltd. [1982] 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.

<i>Free World Trust v Électro Santé Inc</i> Supreme Court of Canada case

Free World Trust v Électro Santé Inc, [2000] 2 S.C.R. 1024, 2000 SCC 66, is a leading Supreme Court of Canada decision on patents, namely claim construction and the necessity to identify essential elements and non-essential elements. Along with the related decision, Camco v. Whirlpool (2001), 9 C.P.R. (4th) 129 (SCC), the Supreme Court of Canada rejected the doctrine of equivalents applied in the United States and adopted the doctrine of purposive construction, as originally applied by the United Kingdom House of Lords in Catnic v. Hill & Smith. This was a landmark decision as it resolved the uncertainty in Canadian case law between the two doctrines.

A patent application is a request pending at a patent office for the grant of a patent for an invention described in the patent specification and a set of one or more claims stated in a formal document, including necessary official forms and related correspondence. It is the combination of the document and its processing within the administrative and legal framework of the patent office.

Fu-Kuen Lin is a mycological physiologist, nephrologist and hematologist.

This is a list of legal terms relating to patents and patent law. A patent is not a right to practice or use the invention claimed therein, but a territorial right to exclude others from commercially exploiting the invention, granted to an inventor or their successor in rights in exchange to a public disclosure of the invention.

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.

European patents are granted by the European Patent Office (EPO) under the legal provisions of the European Patent Convention (EPC). However, European patents are enforced at a national level, i.e. on a per-country basis, or, since June 1, 2023, before the Unified Patent Court (UPC). Under Article 64(3) EPC, "any infringement of a European patent shall be dealt with by national law," with the European Patent Office having no legal competence to deal with and to decide on patent infringements in the Contracting States to the EPC. A few, limited aspects relating to the infringement of European patents are however prescribed in the EPC.

Article 84 of the European Patent Convention (EPC) specifies that the "matter" for which patent protection is sought in an application - the purported invention - shall be stated ("defined") in the claims. This legal provision also requires that the claims must be clear and concise, and supported by the description. The function, form and content of the claims are defined by Article 84 supplemented by Rule 43 EPC.

Article 123 of the European Patent Convention (EPC) relates to the amendments under the EPC, i.e. the amendments to a European patent application or patent, and notably the conditions under which they are allowable. In particular, Article 123(2) EPC prohibits adding subject-matter going beyond the content of the application as filed, while Article 123(3) EPC prohibits an extension of the scope of protection by amendment after grant. In addition, Rule 80 EPC limits the types of amendments that can be done during opposition proceedings before the European Patent Office (EPO), and Rule 139 EPC relates to the correction of errors in documents filed with the EPO.

<span class="mw-page-title-main">Patent infringement in Canadian law</span>

Once an invention is patented in Canada, exclusive rights are granted to the patent holder as defined by s.42 of the Patent Act. Any interference with the patent holder's "full enjoyment of the monopoly granted by the patent" is considered a patent infringement. Making, constructing, using, or selling a patented invention without the patent holder's permission can constitute infringement. Possession of a patented object, use of a patented object in a process, and inducement or procurement of an infringement may also, in some cases, count as infringement.

References

  1. ↑ Kirin-Amgen, Inc. v Hoechst Marion Roussel Ltd. [2004] UKHL 46 (21 October 2004)
  2. ↑ Article 84 EPC
  3. ↑ Article 69 EPC
  4. ↑ Protocol on the Interpretation of Article 69 , MR/13/00 dated 20 November 2000, submitted by the United Kingdom delegation.
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