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26 November 2015AmericasVaruni Paranavitane

Court reports: Warner-Lambert v Sandoz

Since the early 1980s, the European Patent Office has granted second medical use patents for new uses of known pharmaceutical products. Second medical use patents can cover a new indication, a new dosage regimen, or a new method of treatment. For example, Asp irin, possibly the world’s most commonly used drug, was first discovered for its analgesic properties; only subsequently were its anticoagulant properties discovered. The interpretation of second medical use claims, and consequently the approach to infringement of these claims by courts, varies from jurisdiction to jurisdiction and is a developing area of the law.

Warner-Lambert’s European patent number EP 0 934 016, covering the use of pregabalin for the treatment of pain, has been the subject of a multitude of patent disputes across Europe. Courts have to balance the patentee’s rights to exclude competitors from entering the market for its patent-protected indication against the legitimate rights of the generics companies to enter the market for all other indications which are not patent -protected.

One way in which generics companies seek to avoid infringement is by obtaining a marketing authorisation for all indications except the patent -protected indication ( so-called skinny labelling). This article considers two recent actions brought by Warner-Lambert against Sandoz’s pregabalin in England and France.

The English  decision

In October 2015, the English High Court ordered that interim injunctions that had been granted against Sandoz for dealing with a full -label pregabalin product falling under Warner-Lambert’s second medical use patent for pain be continued until trial, and that LloydsPharmacy (Lloyds) be joined under it.

Warner-Lambert’s compound patent for the active ingredient, pregabalin, expired in May 2013. Its second medical use patent  (‘016), for the treatment of pain, whose related product is marketed as Lyrica, is in force and will expire in July 2017. Pregabalin has also been authorised to treat epilepsy  and generalised anxiety disorder (GAD). Several generics companies have obtained marketing authorisations to supply pregabalin for only epilepsy and/or GAD , excluding the patent-protected pain indication.

Mylan and Actavis sought to revoke Warner-Lambert’s patent and in September the high court held that some of the patent claims were invalid due to being insufficient. However , Warner-Lambert has been granted permission to appeal against the decision. In these circumstances, under English law the patent is considered valid until it is declared invalid by a higher court.

Whil e other generics had launched their skinny -label pregabalin products, Sandoz decided to supply its pregab alin with a full label (therefore including the patent -protected indication for pain) in the UK. Sandoz supplied more than 100,000 packets—approximately three months’ supply—without providing any notice to Warner-Lambert.

In early October, Warner -Lambert applied for and obtained an urgent interim injunction against Sandozordering it to stop supplying or offering to supply the full-label pregabalin product. After the order was made Sandoz disclosed that its full -label pregabalin product had been sold on to Lloyds. In a further urgent interim application , Warner-Lambert requested that Lloyds notify all its pharmacies that the Sandoz full -label product should not be dispensed.

Warner-Lambert applied for a continuation of the interim injunctions granted against Sandoz and Lloyds in early October 2015 until trial. The court considered that there was a serious issue to be tried, that Warner-Lambert has a real prospect of success regarding the validity of its patent claims , and that Sandoz is dealing with pregabalin with a marketing authorisation including those indications protected by the patent.

The court also held that Warner-Lambert will suffer unquantifiable and irreparable harm between now and the judgment, and that if Sandoz is not injuncted, other generics are likely to follow with full -label pregabalin. The court held that granting the injunctions would create a l ower risk of irreparable harm than refusing them.

Warner-Lambert’s application for the injunction against Lloyds  was made primarily  based on section 37(1) of the Senior Courts Act 1981   and, in the alternative , on the basis of patent infringement. The high court held that Warner-Lambert’s reliance on “equitable protective jurisdiction” (that the entity with infringing goods in its possession or control must not aid the infringement by letting the goods get into the hands of those who may deal with them in a way which would infringe the proprietor’s rights, as described in Norwich Pharmacal v Customs & Excise Commissioners)could not apply, since there is no threat that Lloyds will pass on the Sandoz full -label pregabalin product except by dispensing it to patients.

The high court nevertheless granted the injunction on the basis of Warner-Lambert’s alternative case that Lloyds would infringe the patent by offering the full -label pregabalin product.

The French  decision

The Paris District Court held that Sandoz’s launch of pregabalin in France with the skinny label was not patent infringement and refused Warner-Lambert’s application for an urgent injunction.

Warner-Lambert carried out a test purchase in early October and found that despite the skinny label the pharmacist dispensed generic pregabalin without checking which indication the patient was being treated for, leading to the possibility that generic pregabalin could be dispensed to a patient for the treatment of pain. Warner-Lambert also claimed that Sandoz had advertised that its prospective market for pregabalin was worth around €144 million  ($158 million). Warner -Lambert claimed that this exceeded the market share available for the GAD and epilepsy indications.

"While other generics had launched their skinny-label pregabalin products, Sandoz decided to supply its pregabalin with a full label (therefore including the patent-protected indication for pain) in the UK."

Warner-Lambert claimed that as the prescriptions for the treatment of pain represented 88% of the total sales of Lyrica, and that the use for epilepsy and GAD represented only 1% of Lyrica sales, Sandoz’s announcement that its prospective market was worth €144 million, combined with the figures of market share obtained by Sandoz’s pregabalin, meant that direct infringement must have been committed.

Sandoz responded that because this is a process patent, there cannot be direct infringement as the claim was made against the distributor, not the manufacturer.

The court’s interpretation of the French Intellectual Property Code only permits enforcement of process claims against manufacturers. Where the claim is made for infringement of a product of a process, the court needed to establish whether Sandoz’s offer for sale of pregabalin that had been manufactured outside France was an infringement.

Sandoz claimed that it had sent out an information notice to doctors and pharmacists stating that its generic pregabalin has been approved for GAD and epilepsy , and that it is not approved for the treatment of pain, which is protected by Warner-Lambert’s patent.

The court held that as a result of this notification to doctors and pharmacists that theproduct was not approved for the pain indication, Sandoz ha d not directly infringed the patent.

In contrast, the English courts held that the skilled person will understand the claim to be interpreted beyond making pregabalin, but as making pregabalin for patients to whom it will be intentionally administered for treating pain.

As an alternative, Warner-Lambert claimed that by Sandoz  putting its generic pregabalin on the market where it knows that its product is likely to be used in the treatment of pain , this constitutes indirect patent infringement.

Warner-Lambert relied on article L. 613-4 of the French Intellectual Property Code , which prohibits the supply of means pertaining to a fundamental aspect of a patent ed invention to an unlicensed person where (1) the means are a readily commercially available product ; and (2) there is no infringement unless the supplier incites the buyer to infringe.

The French court held that as Warner-Lambert failed to state on which ground of indirect infringement it was relying, (1) of the French code above could not apply   since Sandoz ha d not supplied any third party in France the means to exploit the protected process in France.

Further, the court held that (2) of the French code applies since medicaments are “readily commercially available” and there was no evidence that Sandoz incited doctors or pharmacists to prescribe and dispense  Sandoz’s pregabalin product for the patent -protected indication. The court awarded €100 ,000 to Sandoz and denied Warner-Lambert’s application for the injunction.

The requirement of the French code for active “incitement to infringe” means that the French interpretation of indirect infringement will always be narrower than the English equivalent. The English courts have taken the approach that the mental element of indirect infringement of the equivalent claim is that the manufacturer knows or can reasonably foresee the ultimate intentional use for pain, which is a lower hurdle for the patentee to pass in comparison to the French court’s approach.

An alys  is

It is interesting that Sandoz took the brave stance of launching full -label pregabalin in the UK knowing very well that there was a high risk of being injuncted on the basis of patent infringement. Its argument that some pharmacies in the UK, including Lloyds , are not willing to stock and dispense skinny -label generic pregab alin, but are willing to stock full -label pregabalin, did not wash well with the English court despite evidence from Lloyds outlining reasons why it does not stock pharmaceutical products with skinny labels.

Sandoz was clearly keen to be the first generic on the mark et for all authorised indications if and when the claims of the patent were declared invalid and the patent ordered to be revoked, but the court was not prepared to overlook Warner-Lambert’s residual patent rights in such circumstances.

Varuni Paranavitane is an associate at  Osborne Clarke. She can be contacted at:

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