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The House of Lords rejects product-by-process claims

The House of Lords rejects product-by-process claims

05/11/04

In a recent decision, the House of Lords unanimously revoked Kirin-Amgen’s (Amgen) patent for making erythropoietin (EPO) on the grounds that the claims were insufficient and not new. The decision is a victory for Transkaryotic Therapeutics (TT), which produces a rival product.

Amgen’s invention of a means of artificially producing EPO using recombinant DNA technology was one of the first big breakthroughs in life science. The product, which is called Epogen, is used in treating anaemia.

TT later developed an alternative method of making EPO, using a process known as gene activation. Amgen sued TT for infringement in both the US and UK.

The House of Lords ruled that the patent is invalid because the protein sequence on which the method of manufacture was based was already known. Lord Justice Hoffmann wrote: “Amgen have got themselves into difficulties because, having invented a perfectly good and ground-breaking process for making EPO and its analogues, they were determined to try to patent the protein itself, notwithstanding that, even when isolated, it was not new.” LJ Hoffmann went further by rejecting the traditional UK practice of granting product-by-process claims where the product is already known as being incompatible with European Patent Office practice*.

The House of Lords ruling means that Amgen’s European patent is revoked in the UK but remains valid in the rest of Europe where, so far, the protein itself is considered new. TT however, do not expect any further European litigation believing that the decision sets a non-binding precedent for the other European countries.

The House of Lords decision comes a week after a ruling in a parallel dispute in the US. Judge Young of the district court of Massachusetts upheld the principal claims of Amgen’s US patents and found them to be infringed by TT. The patent claims at issue in the US are not directly comparable to those in the European patent.

The US litigation is set to continue, after TT vowed to appeal the decision to the Federal Circuit.

* The European Patent Convention provides protection for products directly obtained by a patented process under Article 64 (2) EPC. The European Patent Office only permits product-by-process claims where the product itself is novel.