EU & Competition news



Eli Lilly & Co Ltd v. Neopharma Ltd and another



10 September 2008

Hearing Date: 6 March 2008

Court: Chancery Division, Patents Court

The claimant was the registered proprietor of a patent covering the compound olanzapine, which the claimant manufactured and marketed throughout the United Kingdom and the rest of Europe as Zyprexa. Olanzapine was an anti-psychotic drug used for the treatment of schizophrenia, bipolar disorder and acute mania. By 2006, annual worldwide sales were approximately £2.2bn. The revenue generated for the claimant in the UK was £140m, which accounted for approximately 50 per cent of the claimant’s revenue in the EU. The first defendant was a non-trading British company and was the holder of a variety of EU marketing authorisations. The major marketing authorisation was the Olanzapine Neopharma authorisation. The exclusive distributor of the product in the UK was the second defendant. The two defendants had the same address and had a commercial relationship, but were under different ownership. The second defendant was a privately owned UK-based company that marketed generic pharmaceuticals in the domestic market through its own distribution outlets and in major EU markets through selected major national generic companies. It also had a strategic alliance with Cipla Ltd, the largest pharmaceutical company on the domestic Indian market. It filed a revocation action against the corresponding patent in Germany in May 2006, resulting in the revocation of that patent. The decision was under appeal at all material times. Two other companies both launched revocation actions against the patent in 2007, the hearing of which was scheduled for July 2008. Neither of the defendants in the English case was involved in those proceedings. Various other actions in respect of equivalent patents had also been filed in other countries. In November 2007, the claimant wrote to the first defendant asking for information including “full details of when (by individual country) you intend to launch Olanzapine Neopharma in Europe”. It asked for an undertaking not to take any steps to market Olanzapine Neopharma in any European country where the patent or national equivalent remained in force. The defendants asked for information about the portfolio of patents in Europe and asked for a cross-undertaking in damages for losses incurred in respect of jurisdictions where the patent was revoked. The claimant in turn required that the defendants provide evidence to show that, absent the patent rights, they would proceed with the marketing of Olanzapine Neopharma. The defendants declined to provide details of any recipient of Olanzapine Neopharma tablets or of any of the quantities involved, stating that that information was highly confidential to its business. By an application notice of February 2008, the claimant sought an interim injunction to restrain the first defendant from infringing the patent and also an order that the first defendant disclose the names and addresses of all persons to whom it had supplied Olanzapine Neopharma and any other products containing olanzapine, and the dates and quantities of each supply. The second defendant was later joined by consent. Both defendants gave undertakings substantially in the form requested for the injunctive relief, with the claimant giving the usual cross-undertaking in damages. The defendants resisted the disclosure action.

The defendants accepted that the court had power to order disclosure of customer names, but maintained that it should be cautious in making such an order where, as in this case, it would not help the claimant establish its pleaded case on liability. It was accepted both that there was an arguable case of patent infringement and an arguable defence based on the alleged invalidity of the patent. Both sides claimed that they would suffer irreparable damage.

The court ruled:

The court had power to order disclosure of the names of customers where those customers were arguably wrong-doers, the order was necessary to enable action to be taken against the wrong-doers and the defendant was mixed up in all the wrong-doing and was in a position to give the necessary information. Even if those requirements were met the court retained a discretion as to whether to order disclosure. The question had to be approached in a similar fashion to considering the grant of an interim injunction.

In the instant case, the requirements for making the order were all met and the balance of convenience was in favour of granting the order for disclosure. The fact that the defendants gave undertakings when proceedings were issued was relevant: it had to amount to an acceptance at that stage that the balance of convenience was in the claimant’s favour. In any event, the damage that the defendants claimed they would suffer if ordered to give disclosure would not be as great as they alleged. In all the circumstances, it was right to make the order sought.

This material first published by the LexisNexis Butterworths. All rights reserved.





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