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Monday, 9 November 2015

When litigants must be responsible -- and what happens when they're not: Lyrica pregabalin injunction is continued

Lyrica returns to court. Warner-Lambert Co LLC v Sandoz GmbH, Sandoz Ltd and Lloyds Pharmcacy Ltd [2015] EWHC 3153 (Pat) is the latest in a series of decisions in the ongoing patent infringement dispute over pregabalin, a generic version of Lyrica. It's another Patents Court, England and Wales, ruling of Mr Justice Arnold, dating back to last Wednesday. The history of the litigation can be gleaned by reading a whole host of Katposts here.

In short, in these proceedings pegabalin patent-owner Warner Lambert applied to continue interim injunctions restraining (i) the first and second defendants (both Sandozgeneric drug companies) from infringing its patent by dealing in a full label generic pregabalin product; (ii) retail pharmacy chain Lloyds from dispensing quantities of that product in its possession.

The patent concerned the second medical use of pregabalin for the treatment of pain.  Warner Lambert supplied its "Lyrica" branded patent through another pharmaceutical company which held a full marketing authorisation to use Lyrica in the treatment of epilepsy, generalised anxiety disorder and neuropathic pain. A number of generic companies had a "skinny label" marketing authorisation to supply pregabalin only for epilepsy or anxiety, and National Health Service guidance provided that, if a pharmacist had reason to believe that a prescription was for treating pain, Lyrica was to be dispensed; if it was not prescribed for that purpose, generic pregabalin could be dispensed.

Pregabalin: once a
painkiller, now a pain?
The Sandoz companies launched their own full-label generic pregabalin product, without giving Warner Lambert prior notice of their intention to do so, and sold over 100,000 packs to of their product to Lloyds.  Having commenced proceedings against the Sandoz companies, Warner Lambert obtained an urgent interim injunction to stop them supplying full-label generic pregabalin, and to stop Lloyds, which was later added as a party, from dispensing that product. Now Warner Lambert applied to continue those injunctions either until trial or until a further order.

Mr Justice Arnold granted the injunction.  In his view:

* If Sandoz had given proper notice of their intention to launch their generic product, the whole matter could have been resolved in an orderly manner. However, by taking the course they had, they had made it as difficult as possible for that to take place. The Patents Court, which expected litigants to behave responsibly to enable patent disputes to be resolved in an orderly manner, would not hesitate to use its powers to grant urgent interim relief to ensure that parties who tried to steal a march on others did not benefit from such conduct.

* In determining an application for interim relief, the court should adopt whichever course seemed likely to cause the least irremediable prejudice to one party or the other.

* A patent owner that marketed a patented drug would suffer unquantifiable loss if a generic supplier wrongly entered the market pending trial, because it would be difficult to calculate the profits it had lost --  and it would suffer irreparable harm because the generic competition would lead to price depression which would be difficult to reverse.

* When a generic supplier intended to market a product covered by a patent, it was appropriate for it to "clear the path" for the launch of its product sufficiently far in advance of the launch to enable the patent's validity or non-infringement to be determined before the launch date. On this basis, Sandoz should have cleared the path for their launch of full-label generic pregabalin by seeking a declaration of non-infringement, which they didn't.

* If the interim injunction were continued, this would create a lower risk of irremediable harm than if it were refused. What's more, it would preserve the status quo, this being the absence in the market of full-label generic pregabalin products. In contrast, if no injunction was granted, the arrival of full-label generic pregabalin on the market would make it significantly more difficult for the court to ensure appropriate compensation of those parties who ultimately merited it.

* Lloyds could in any event claim reimbursement of their outlay from Sandoz and would be able to return the goods: the worst that could happen to Lloyds is that it would lose the profit margin on sales of the packs it had received, and this was totally quantifiable. Nor was Lloyds prevented from buying and dispensing skinny-label generic pregabalin products under the NHS guidance.

This all seems very sensible to this Kat, who feels that businesses do indeed have a duty to behave responsibly not only once a dispute arises but before it does so, in order to minimise the risk of their conduct ending up in court.  He eagerly awaits the next instalment ...

2 comments:

ActivistInventor said...

I am surprised that businesses have a duty to get a declaration of non-infringement from the Court before launching a product, in whatever space. Whatever happened to the idea that Courts were the last resort, to be invoked when all other mechanisms, including ADR etc, had failed?

Anonymous said...

So don't get a declaration, but don't complain about the injunction.

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