Baxter Healthcare Corp & Anor v Abbott Laboratories & Anor

In a declaration of non-infringement concerning a manufacturing process, the court may require the product and process description to address material features of the process which may affect infringement. Where the parties proceed on the footing that the product actually manufactured is relevant, potential impurities and stabilising agents may fall within the scope of the dispute. A party seeking to rely on a newly identified possibility must raise it explicitly and without undue delay. If an issue is raised late and causes an adjournment, the party responsible may be ordered to pay the costs thrown away.

Baxter Healthcare Corporation and Baxter Healthcare Limited sought declarations of non-infringement and revocation concerning a patent for fluoroether compositions and methods of inhibiting their degradation in the presence of a Lewis acid. The defendants, Abbott Laboratories and Central Glass Company Limited, applied for further specification of the Product and Process Description.

The dispute concerned whether water, the epoxyphenolic resin lining the product containers, or possible amine impurities arising during manufacture could act as Lewis acid inhibitors within the patent claims. The immediate issues were whether the late suggestion of fluorinated amines should be investigated and how far that issue could be raised at trial.

1. The proceedings were unusual because the parties proceeded on the footing that what Baxter actually did in manufacturing, formulating and packaging sevoflurane was relevant to the declaration sought. The Product and Process Description therefore had to identify material aspects of the process and product bearing on possible infringement.
2. The manufacturing information showed that di-isopropylethylamine was used in the reaction mixture. That created a possible route by which amine impurities, including a fluorinated amine, might survive the washing process and act as Lewis acid inhibitors. The possibility should have been identified earlier because the relevant regulatory filing had been disclosed and available for inspection.
3. The late emergence of the issue was not attributable to Baxter’s failure to disclose a supporting chemical development report. That report was needed to identify the particular route, but not to establish the possibility that amines might be present. Baxter was accordingly entitled to investigate whether the impurities were present at a level requiring amendment of the product description.
4. At trial, the only fluorinated amine then identifiable was the product of Route 2. That was the only possibility to be considered. If Abbott wished to raise other possibilities, it had to do so explicitly.
5. The late issue required the trial to be put off. Abbott was ordered to pay the costs thrown away by the adjournment.