Kirin Amgen Inc and Ors v Hoechst Marion Roussel Ltd & Ors

A claim containing a process feature must be construed according to the monopoly it defines. A product claim may be limited to products made by a specified process, and that limitation may contribute novelty.

For infringement under the Protocol on Interpretation, the variant must be compared with the invention at the level of generality used in the claim. An endogenous gene activated by an introduced construct was materially different from an isolated exogenous DNA sequence suitable for expression in a host cell.

Insufficiency concerns enablement, not clarity, conciseness or support. A specification disclosing a principle capable of general application may support correspondingly general claims. The patent was valid but not infringed.

These conjoined appeals arose from three sets of proceedings concerning European Patent UK No 0148605, relating to recombinant production of erythropoietin. Neuberger J held that claims 19 to 25 were invalid for insufficiency, that other claims were valid, and that Transkaryotic Therapies Inc and Hoechst Marion Roussel Ltd infringed claim 26.

The appellants challenged validity and infringement. Amgen challenged the finding concerning claim 19 and appealed decisions refusing amendment of the pleadings. The appeals also concerned amendment of the patent and relief under the Patents Act 1977. The central questions were the construction of product claims containing process limitations, infringement by gene-activation technology, insufficiency, and the effect of errors in the specification.

1. Construction of claims. The words in claim 26 limited it to polypeptide products resulting from expression of a claim 1 DNA sequence. A product made by another process was outside the claim. The same construction applied to claim 19. A product-by-process limitation could contribute novelty, consistently with article 64(2) EPC and section 60(1)(c) of the Patents Act 1977.
2. Infringement. TKT’s process activated endogenous EPO coding sequences by inserting an exogenous promoter construct. The relevant DNA was not an isolated exogenous sequence suitable for use in a host cell. Applying the Protocol questions, the variant had a material effect on how the claimed invention worked. The court also held that, in 1984, the skilled person would not have regarded the variant as obviously working in the same way. The claim therefore did not extend to TKT’s product. Claims 19 and 26 were not infringed.
3. Validity and insufficiency. The novelty attack failed because claim 26 did not cover urinary EPO. Section 72(1)(c) provided one ground of insufficiency: the specification had to enable the invention to be performed across the full extent of the monopoly. It was not necessary to enable every individual analogue where the specification disclosed a principle capable of general application. The attacks on claims 1 and 26 failed.
4. Claim 19. The variability of urinary EPO samples created a clarity problem, but the SDS-PAGE test could be performed without undue effort. Lack of clarity was not converted into insufficiency under section 72(1)(c). Claims 19 and 20 were valid.
5. Other orders. The order concerning amendment was varied so that amendment was directed and stayed pending appeal, and the direction to amend the invalid claims was set aside. The refusal to permit amendment to plead infringement of claim 1 was upheld. The findings that the specification was framed in good faith and with reasonable skill and knowledge were upheld.

• Court of Appeal (Civil Division): appeals from orders and judgments of Neuberger J in the Chancery Division. The court held the patent valid but not infringed, varied the amendment order, upheld the refusal to amend the pleading concerning claim 1, and upheld the findings under section 63 of the Patents Act 1977.