Intellectual Property Rights

Kirin-Amgen Inc. v. Hoechst Marion Roussel Ltd.

[2004] UKHL 46

Facts

Amgen owned a European patent concerning the production of erythropoietin, or EPO, through recombinant-DNA technology.
EPO is a hormone that stimulates red-blood-cell production and is used to treat anaemia.
Amgen’s method involved:
identifying the human EPO gene;
introducing an external or exogenous DNA sequence into a host cell;
causing that host cell to produce EPO.
Transkaryotic Therapies developed a different method known as gene activation.
Instead of inserting the EPO coding sequence into the cell, it activated the cell’s naturally existing human EPO gene by inserting a regulatory sequence.
Hoechst proposed importing the resulting product, GA-EPO, into the United Kingdom.
Amgen alleged infringement.
TKT and Hoechst denied infringement and challenged the patent’s validity.

How patent claims should be interpreted under Article 69 of the European Patent Convention.
Whether TKT’s gene-activation process fell within Amgen’s claims.
Whether protection could extend beyond the language of the claims through a separate doctrine of equivalents.
Whether important product claims were invalid for insufficiency or lack of novelty.

The extent of patent protection is determined primarily by the claims, interpreted with the assistance of the description and drawings.
Claims are given a purposive construction:
the court asks what a skilled reader would understand the patentee to be claiming;
the language is not interpreted with narrow verbal literalism;
but the monopoly cannot simply be extended beyond the claims.
The Improver or Protocol questions may assist interpretation but are not independent statutory rules.
Under the United Kingdom approach then applied, there was no free-standing doctrine allowing protection outside the properly interpreted claims.
A patent must also disclose the invention sufficiently across the full width of the claim.
A product is not new merely because it is produced through a new process where the resulting product is materially identical to an existing product.

The patent repeatedly described production of EPO through expression of an exogenous DNA sequence introduced into a host cell.
A skilled reader would understand the claims in that technical context.
TKT’s process did not insert the EPO coding sequence into the cell.
It activated the endogenous EPO gene already present in the human cell.
Although both methods produced chemically equivalent EPO, they used materially different genetic mechanisms.
The Court refused to widen Amgen’s claims merely because TKT had achieved the same broad result.
Amgen had made a major scientific contribution, but patent protection depended upon what it had actually claimed.
The House of Lords also considered claim validity.
Claim 19 attempted to define recombinant EPO partly by comparing its molecular weight with urinary EPO.
Evidence showed wide variations in both recombinant and urinary EPO, making it extremely difficult for a skilled person to determine whether a product fell within the claim.
The claim therefore failed the requirement of sufficient disclosure and certainty.
Claim 26 defined EPO partly by the process through which it was made.
The Court found that the resulting EPO was not necessarily different from previously known urinary EPO.
A previously known product did not become novel merely because it was later made by a recombinant process.
Claim 26 was therefore anticipated.

TKT’s gene-activation process did not infringe Amgen’s properly construed claims.
The House of Lords dismissed Amgen’s appeal and allowed TKT’s cross-appeal.
The patent was revoked because claim 19 was insufficient and claim 26 lacked novelty.
Use this case for: patent protection is determined through purposive construction of the claims, and a major inventive contribution cannot justify extending the monopoly beyond what the claims reasonably cover.(