Our client is a chemicals manufacturer which supplied precursors and API’s to a wide range of pharmaceutical companies, both major R&D-based and generic manufacturers. It had a successful process for manufacturing an API that was the basis of a major product, and a plant where it was scheduled to occupy a large proportion of manufacturing capacity. A number of generic manufacturers had marketing authorisations for products based upon it’s API in the process of being granted in the UK and other countries in Europe. However, the particular form of the API was subject to a patent owned by the original approval holder. Our client’s objectives were:
i. to be able to assure its generics customers that they would not be prevented from launching products by the imposition of an interim injunction;
ii. to ensure that it was not itself prevented from manufacturing by the imposition of an interim injunction; and
iii. to obtain a judgment that would be highly persuasive in all jurisdictions.
Although our client is incorporated in Germany, its relevant manufacturing plant was in the UK. This, and the fact that there were pending marketing authorisations in the UK, were reasons for proceedings being brought in the English Patents Court. It also wanted to take action in England because (contrary to some beliefs) the English Patents Court can be one of the quickest in the world to achieve a first instance decision, and because its decisions, recognised as being the result of particularly thorough investigations, are highly persuasive in actions brought subsequently in other jurisdictions. In fact, it had already succeeded in revoking the equivalent German patent, and, whilst it did not feel that this would give it any advantage in actions elsewhere, it did mean that product manufactured in the UK could be exported to Germany for storage whilst the situation was resolved in the English Court, with relatively little risk of any injunction in the UK to stop the manufacture.
We advised that launching a product without first “clearing the undergrowth” of UK patents that might be infringed would result in a high probability of an interim injunction being granted in the UK, particularly for the launch of a first generic product.
Some months before the expected grant of the first marketing authorisation in the UK, we commenced proceedings for revocation of the UK patent. The patent owner did not attempt to counterclaim for infringement. We succeeded in arranging for the action to be heard as an expedited action, with a trial fixed for three and a half month’s time. We needed to generate a substantial amount of evidence within that short time, including significant experimental evidence backed up by expert reports. The fields of expertise needed were synthetic organic chemistry and x-ray crystallography. We already knew an ideally suited synthetic organic chemist, and through the chemists in our team we had a number of contacts in the field of solid state science, which quickly led us to a crystallographer with ideally suited expertise. Although the latter expert had no experience of acting as an expert witness, we were able to work with him to assist him in understanding what was required, how to prepare a report, and how to deliver his evidence.
All of the product claims were revoked following the trial, and all that remained was one claim for a process that our client did not use. It was delighted that it achieved its objective of clearing the UK undergrowth, leaving it free to manufacture the API and for customers to sell products based upon it. Furthermore this had been achieved within a remarkably short time, and the resulting judgment would help persuade other courts. As a bonus, not only were our client’s legal costs little different from those it had incurred in Germany (where there had been separate invalidity and infringement actions), but it recovered a substantial proportion of its costs from the patent owner.