Intellectual Property: Landmark Patent decision In Biotech Case - What is the extent of protection conferred by a patent? In a recent Landmark case , Kirin-Amgen Inc and others v Hoechst Marion Roussel Ltd (HL) [2004], the House of Lords has finally laid down that the legal test regarding the proper construction of the claims of the patent.
This case concerned a claim for patent infringement by Amgen, a Californian pharmaceutical company, of its European patent relating to the production of erythropoietin (EPO) by recombinant DNA technology EPO. Amgen had made a significant advancement in the treatment of aneamia by developing a synthetic method of making EPO. Another US company, TKT, was marketing an EPO product under the name Dynepo. TKT made EPO using a process called 'gene activation'. This EPO product will be referred to as GA-EPO. Hoechst, a UK pharmaceutical company, was proposing to import GA-EPO into the United Kingdom. Amgen brought three consolidated actions for patent infringement claiming that GA-EPO infringed the claims of the patent in suit and TKT and Hoechst (together TKT), claimed a declaration of non-infringement and revocation of the patent on the grounds of invalidity. Amgen alleged that GA-EPO infringed claims 19 and 26 (see below) of its patent (TKT did not make any GA-EPO in the United Kingdom ).
The case was finally decided by the House of Lords and the Lords ruled that GA-EPO had not infringed Amgen's patent.
The Lords further ruled that not only had GA-EPO not infringed the patent, but that the patent was actually invalid because Amgen tried to patent the protein itself, which was not patentable.
Below is a summary of the case as it was decided by the High Court and the Court of Appeal.
First Instance
The relevant claims of Amgen's patent were (i) Claim 1 - A DNA sequence for use in securing the expression of EPO in a host cell; (ii) Claim 19 - EPO was the product of the expression of an exogenous DNA sequence according to claim 1; and (iii) Claim 26 - EPO which was the product of the expression in a host cell of a DNA sequence according to claim 1. On the question of whether GA-EPO infringed the patent, the judge in the first instance held the following:
Claim 19 - claim 19 was invalid for insufficiency
Claim 26 - claim 26 was valid and infringed. In deciding whether there has been infringement of a patent, the courts in the first instance had to decide whether the claims in the patent in suit had been infringed or whether the infringing product fell outside the claims .
Court of Appeal
On appeal to the Court of Appeal, the Court of Appeal held that both claims 19 and 26 were valid but that neither was infringed by GA-EPO. This led to both the claimant and defendant appealing to the House of Lords.
Kirin-Amgen Inc and others v Hoechst Marion Roussel Ltd and others; Hoechst Marion Roussel Ltd and others v Kirin-Amgen and others October [HL] 2004 The European patent related to the production of erythropoietin (EPO) by recombinant DNA technology EPO was a hormone made in the kidney which stimulated the production of red blood cells by the bone marrow. Erythropoietin is a genetically engineered form of a naturally-occurring protein known as EPO which boosts the body's production of red blood cells The discovery by Amgen of a method of making EPO artificially for use as a drug was a significant advance in the treatment of anaemia, particularly when associated with kidney failure. A Massachusetts corporation (TKT) had also developed a method of making EPO, which it marketed under the name Dynepo. It used a process called 'gene activation' and the product was referred to as GA-EPO. The English subsidiary (Hoechst) of a well-known multinational pharmaceutical company had been proposing to import GA-EPO into the United Kingdom. Infringement of a patent can only occur if the patent is protected in that country. In almost every case where there is a claim for infringement of a patent by a claimant, the defendant brings a claim for invalidity of that patent. In very basic terms, insufficiency means whether the patent provides sufficient details to enable a person skilled in the art to make it. A patent has a specification and the claims section. The specification describes the invention and the claims section sets out what the patent owner is claiming to be novel and inventive about its patent.
Appeal to the House of Lords
Amgen appealed against the decision that as a matter of construction, the TKT process was not within the claims and therefore had not infringed its patent. TKT appealed against its claim for revocation on the grounds of anticipation in the case of claim 26, i.e that the claim was obvious .
The chief question of construction was whether the person skilled in the art would understand 'host cell' to mean a cell which was host to the DNA sequence which coded for EPO. The alternative, put forward by Amgen, was that it could include a sequence which was endogenous to the cell, like the human EPO gene which expressed GA-EPO, as long as the cell was host to some exogenous DNA. In the TKT process, it was host to the control sequence and other machinery introduced by homologous recombination.
TKT's appeal against the rejection of its challenge to claim 26 on the ground of anticipation raised a point of principle about what counted as a new product. Claim 26 was to a product, namely a polypeptide which was the expression in a host cell of a DNA sequence in accordance with claim 1. Such a product was EPO and the question was whether it was new or the same as the EPO which was already part of the state of the art, namely the EPO which others had purified from urine.
Amgen's appeal was dismissed. TKT's appeal was allowed. Below are some extracts from the judge's decision which may assist you in understanding the basis on which the decision was reached.
Judges's Reasoning
TKT had not infringed any of the claims
The determination of the extent of protection conferred by a European patent was an examination in which there was only one compulsory question, namely that set by art 69 of the European Patent Convention and its Protocol. The European Patent Convention, art 69 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'.
The question is therefore what would a person skilled in the art have understood the patentee to have used the language of the claim to mean. Everything else, including the Protocol questions, was only guidance to a judge trying to answer that question. There was no point in going through the motions of answering the Protocol questions when one could not sensibly do so until the claim had been construed. In such a case, and the present was such a case, they simply provided a formal justification for a conclusion which had already been reached on other grounds. Further, new technology was another situation in which the Protocol questions might be unhelpful. In the instant case the man skilled in the art would not have understood the claim as sufficiently general to include gene activation. He would have understood it to be limited to the expression of an exogenous DNA sequence which coded for EPO.
Claim 26 was invalid on the ground of anticipation
It was important that the United Kingdom should apply the same law as the European Patent Office and other Member States when deciding what counted as new for the purposes of the European Patent Convention. Although that meant a change in a practice which had existed for many years, the difference was unlikely to be of great practical importance because a patentee could rely instead on the process claim and art 64(2) of the Convention. It would be most unfortunate if their Lordships were to uphold the validity of a patent, which would on identical facts have been revoked in opposition proceedings in the European Patent Office.
Claim 19 was invalid for insufficiency
Whether the specification was sufficient or not was highly sensitive to the nature of the invention. The first step was to identify the invention and decide what it claimed to enable the skilled man to do. Then one could ask whether the specification enabled him to do it. The invention in the instant case was a way of making EPO. The judge was entitled to reach the conclusions which he did and was right in law to conclude that the claim was not sufficiently enabled.
The test for obviousness is whether a person skilled in the art would have thought that the invention was an obvious one to make at the time of filing the patent application by Amgen State of the art - means any material in whatever form that was made available to the public prior to the patent application by Amgen
Comments
Under Article 69 of the European Patent Convention the description and drawings shall be used to interpret claims. This means that in drafting a patent you have to find the right balance between the risk of infringement of a patent in suit and the protection of your invention. At the end of the day, it boils down to whether your product would infringe a patent. Our advice to companies is when drafting your patents, look more closely now at the wording of a patent to determine if your invention falls within or outside of the patent claims
If you require further information contact us.
Email: Dr Rosanna Cooper
© RT COOPERS, 2004. This Briefing Note does not provide a comprehensive or complete statement of the law relating to the issues discussed nor does it constitute legal advice. It is intended only to highlight general issues. Specialist legal advice should always be sought in relation to particular circumstances.
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