House of Lords dismiss Amgen appeal in ground-breaking patent case

In one of the most eagerly-awaited decisions for many years in the patents field, the House of Lords on the 21 October 2004 gave judgment in the case of Kirin-Amgen ("Amgen") v Hoechst Marion Roussel and Transkaryotic Therapies ("TKT"). The House of Lords dismissed Amgen's appeal, confirming the Court of Appeal's finding of non-infringement. The House of Lords allowed TKT's cross-appeal, and has ordered the revocation of the patent on the grounds of lack of novelty and insufficiency.

The case follows quickly on the heels of the House of Lords' decision in Sabaf v MFI last week. Both decisions, and particularly the Amgen decision, have far-reaching implications for those involved in the biotechnology and other high-technology sectors. They also have significant implications for those involved in the protection and enforcement of patents.

Detailed comment and analysis on both decisions will follow. In the meantime, you should be aware of the following key aspects of the decisions:

• Construction – The "Protocol Questions" - the fundamental test in construing a patent is to give the patentee the full extent, but no 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. The "Protocol" (or "Improver") questions and "Catnic" principles are merely guidelines, more useful in some cases than in others, and may have no useful function in cases involving "rapidly-developing, high technology fields". The "Protocol" questions, because concise, practical and repeatedly cited, were considered to have taken on "a life of their own". They are likely to be used more sparingly in future cases - Lord Hoffmann notes that "patent lawyers may feel cast adrift on a sea of interpretive uncertainty".
• Construction – "Doctrine of Equivalents" - Lord Hoffmann also provides a detailed explanation of the English rules of construction, which are in line with the European Patent Convention, though significantly out-of-line with the rules applied in the United States. Lord Hoffmann expressed sympathy for patent litigants in the United States who, following the Festo litigation, now "pay dearly for results which are no more just or predictable than could be achieved by simply reading the claims". The House of Lords has confirmed that there is no "doctrine of equivalents" under English law. "Purpose of construction" does not entitle one to go beyond the technical matter for which the patentee seeks protection in the claims.
• Novelty – "Product by Process claims" – "Product by Process claims" will only be allowed in future in limited circumstances where the product is new, in the sense of being different from any existing product in the state of the art, but the difference cannot be described in chemical or physical terms. This represents a significant change in English law that is now in line with the law of other Member States and as applied by the EPO. Lord Hoffmann suggests that this change in practice is unlikely to be of great practical importance since a patentee can rely instead on a process claim and the application of Article 64(2) of the Patents Act 1977 (extending protection afforded by a process claim to a product directly made by that process).
• Sufficiency – The House of Lords did not feel the need to express concluded views on some of the issues of insufficiency raised. The decision does, however, usefully consider the practical application of the law in this area including the extent to which the skilled reader would make modifications to the disclosure made in the specification. Lord Hoffmann emphasized that, in order to consider the issue of sufficiency, it is necessary to decide the nature of the invention. On the facts, Amgen were considered to have caused difficulty for themselves, "having invented a perfectly good and ground-breaking process for making erythropoietin" by their attempts to try to patent the protein itself (erythropoietin) by reliance on "product by process claims" that failed.
• Obviousness – In Sabaf v MFI, the House of Lords overturned the Court of Appeal's decision and has re-established the "law of collocation". In particular, for a combination of two features, neither of which are original, to form the subject of a valid claim, they must interact with each other in an innovative and non-obvious way; the mere juxtaposition in a single product of two separate inventions does not constitute an inventive step.

To access these judgments click on the case below:

Amgen Case - This will open a PDF in a new window.

Sabaf Case - This will open a PDF in a new window.