Les Laboratoires Servier & Anor v Apotex Inc & Ors

A crystalline-form patent claim defined by powder X-ray diffraction data must be construed through the eyes of the skilled reader. Where the stated measurements inherently lack absolute precision, the claim covers an essentially similar overall diffraction pattern rather than requiring an exact match for every peak.

A claim lacks novelty where the claimed product is the overwhelming and inevitable result of performing the prior-art process. A merely theoretical possibility that an unidentified alternative crystalline form might exist does not prevent that conclusion. A process claim is also obvious where its cooling regime is an obvious implementation of the prior-art instruction to cool, filter and dry.

Servier appealed against Pumfrey J’s decision concerning a patent for the alpha crystalline form of the tert-butylamine salt of perindopril, a process for making it, and pharmaceutical compositions containing it. The judge held the patent invalid for lack of novelty and obviousness, although Apotex’s product would have infringed had the patent been valid.

The appeal concerned whether the earlier patent process inevitably produced the claimed alpha form, having regard to powder X-ray diffraction results, and whether the specified cooling regime was obvious. An earlier application to continue an interim injunction pending appeal had been refused by this court: [2007] EWCA Civ 783.

Disposition

1. Appeal dismissed. Jacob LJ gave the leading judgment. Lloyd LJ and the Lord Chief Justice agreed. The court upheld the finding that the patent was invalid for both lack of novelty and obviousness.
2. The skilled reader would understand the powder X-ray diffraction table as inherently imprecise. It recorded computer-generated measurements affected by overlapping peaks, smoothing and subjective assessment. The claim therefore did not require exact correspondence with every listed value. It covered a materially similar overall pattern of peak positions and relative intensities.
3. The experiments performed according to the earlier patent process all produced the claimed alpha form, including material showing a slight crystal distortion. The beta and gamma forms had very different patterns. The remote possibility of a further, undiscovered form with a nearly identical pattern did not prevent the product of the prior art being treated as inevitable. Applying the novelty test stated in Synthon’s v SKB, [2006] 1 All ER 685, the court held that claim 1 lacked novelty.
4. The process claim was independently obvious. The evidence established that the claimed linear cooling regime was an obvious way to implement the earlier instruction to cool, filter and dry. The proposed amendment, which added cooling parameters without demonstrated technical significance, did not save the claim.
5. Jacob LJ additionally observed that, if the taught cooling process did not reliably produce the asserted form, the process claim would be insufficient under Article 83 of the European Patent Convention. That was alternative reasoning because the court found that the process did produce the alpha form. The Lord Chief Justice further observed that there had been no real prospect of disturbing the decisive factual finding, so permission to appeal should not have been granted under the Pozzoli test.

• Court of Appeal (Civil Division): Dismissed Servier’s appeal and affirmed that the patent was invalid for lack of novelty and obviousness: [2008] EWCA Civ 445.
• Court of Appeal (Civil Division): Before the merits appeal, refused to continue an interim injunction pending appeal: [2007] EWCA Civ 783.
• High Court, Chancery Division, Patents Court: Pumfrey J held the patent invalid for lack of novelty and obviousness, while finding conditional infringement if it had been valid.