Warner-Lambert v Sandoz and Lloyds Pharmacy, High Court

The High Court has granted interim injunctions preventing Sandoz from trading in full label generic pregabalin and Lloyds Pharmacy from dispensing such product.

Background

The case concerns the pharmaceutical product, pregabalin, marketed by Pfizer under the brand name, Lyrica. Warner-Lambert, which is part of the Pfizer group, is the owner of the relevant patent. Lyrica is a very important product for Pfizer. In 2013 Lyrica had global sales of US$4.6 billion. The patent claims the use of pregabalin for the preparation of a pharmaceutical composition for treating pain and neuropathic pain. In addition to those patented indications, the marketing authorisation for Lyrica includes indications for generalised anxiety disorder and epilepsy.

In separate proceedings involving Mylan and Actavis, but not Sandoz, the High Court ruled that (1) certain key claims of the patent were invalid and (2), even if the relevant claims were valid, they were not infringed by Mylan’s and Actavis’s skinny label products (i.e. labels not including the patented indication). Both the validity and infringement findings are the subject of appeals to the Court of Appeal.

Sandoz’s launch of a full label product

Since February 2015, a number of companies, including Sandoz, have been selling generic pregabalin products with skinny labels. However, on 1 October 2015, Sandoz launched a full label pregabalin product when it sold product to AAH, who in turn supplied Lloyds Pharmacy. The reason for the launch was that certain pharmacies were unwilling to stock and dispense a skinny label pregabalin product, but were prepared to take a full label product. Warner-Lambert almost immediately obtained an ‘emergency’ interim injunction preventing any trade in the relevant product, pending the recent ‘full’ interim injunction hearing.

The High Court’s decision

The Court granted an interim injunction restraining Sandoz from dealing in its full label pregabalin product and an interim injunction preventing Lloyds from dispensing such product in its possession, pending the full trial on infringement, due to be heard on in March 2016.

The Court applied the test of adopting whichever course (granting or not granting the injunction) would cause the least irremediable harm to one party or the other. The Court accepted there was a real likelihood that, if an interim injunction were refused, other generic companies would follow Sandoz onto the market and launch their own full label products. Unsurprisingly, the Court (1) ruled that such a period of generic competition would likely lead to an irretrievable downward price spiral in the price of Lyrica and (2) attributed weight to Sandoz’s failure to ‘clear the way’ by seeking a declaration of non-infringement.

Sandoz and Lloyds applied for cross-undertakings in damages retrospectively from the date of an earlier order of the Court granted in favour of Warner-Lambert against NHS England. However, the Court ruled that Sandoz and Lloyds should only benefit from the cross-undertaking prospectively. They could have applied at the relevant time, as a number of generic companies did, but had chosen not to do so.

Comment

Tom Cahill, a Solicitor at Matthew Arnold & Baldwin LLP, comments: “Given the Court’s historical willingness to grant interim injunctions in pharma cases, the main decision was not at all surprising. However, the ruling on the cross-undertaking issue is worth noting. It underlines the importance for generic companies to consider the timing of any relevant application.”

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