28 January 2015

Swiss Style Claims: Warner Lambert v Actavis

In Warner -Lambert Company, LLC v Actavis Group Plc EHF and Others [2015] EWHC 72 (Pat) (21 Jan 2015) Warner-Lambert LLC applied to Mr Justice Arnold for an interim injunction in the following terms:
"1, The Defendants: (a) shall make it a condition of any oral or written agreement entered into with a pharmacy for the supply of Lecaent that the pharmacy shall use reasonable endeavours not to supply or dispense Lecaent to patients who have been prescribed pregabalin for the treatment of pain, by making reasonable enquiries of a person presenting a prescription for 'pregabalin' as to whether the prescription is for pain and/or making reasonable checks of pharmacy records for the same; and (b) shall make it a condition of any oral or written agreement entered into with an intermediary (such as a distributor) for the supply of Lecaent that, in any onward supply of Lecaent by the intermediary, such intermediary must in turn make it a condition of any onward supply agreement for the supply of Lecaent that the receiving pharmacy shall use reasonable endeavours as specified in (a) above.
2. Insofar as the Defendants are to supply Lecaent to intermediaries (such as a distributor) they inform the Claimant's solicitors of the name of that intermediary prior to supply.
3. No later than the date of first supply of Lecaent to a pharmacy in the United Kingdom, the Defendants shall write a letter, in the form attached, to the superintendent pharmacist responsible for the pharmacy to which Lecaent is to be supplied.
4. Prior to launch of Lecaent in the United Kingdom the First, Second and Third Defendants and each of them shall ensure that each pack of Lecaent supplied to a pharmacist is accompanied by removable notification that is easily legible stating:
'This product is not authorised for the treatment of pain and must not be dispensed for such purposes.'
5. The Defendants shall notify in writing forthwith, and in any event before the date of first supply of Lecaent to a pharmacy in the United Kingdom, the NICE Medicines and Prescribing Centre of the Department of Health informing it that Lecaent should not be prescribed or dispensed for the treatment of pain.
6. No later than the date of first supply of Lecaent to a pharmacy in the United Kingdom, the Defendants shall write a letter, in the form attached, to all Clinical Commissioning Groups in the UK."
In order to understand the application it is necessary to know that Warner Lambert (which is now a subsidiary of Pfizer) holds a patent for a drug known as pregabalin as a method for treating pain and in particular neuropathic pain which it markets under the trade mark "Lyrica".  Pregabalin is a known substance that was already used for treating epilepsy and generalized anxiety disorder ("GAD"). The patent for pregabalin itself had expired in 2013. Protection for the drug had been extended until 2018 by a supplementary protection certificate but that SPC lapsed for non-payment of the prescribed fees.

The use of pregabalin for the treatment of pain is an example of a "Swiss style claim". In G 5/83 the Enlarged Board of Appeal of the European Patent Office held that a patent could be granted for a second or subsequent medical use if a specification claimed the use of a known substance that was already used for the treatment of one condition in the manufacture of a medicament for the treatment of another condition. Since the revision of the European Patent Convention by the Act revising the European Patent Convention of 29 Nov 2000 it has ceased to be necessary to draft claims for second and subsequent medical use in this way because art 54 (5) of the Convention now permits second and subsequent medical uses of known substances.

Actavis and its subsidiaries develop, manufacture and commercialize "high quality affordable generic and innovative branded pharmaceutical products for patients around the world." They propose to market a generic version of pregabalin for the treatment of epilepsy and GAD under the trade mark "Lecaent" at a lower price than Lyrica. 

The problem for Warner Lambert and the Pfizer group is that 83% of prescriptions are written generically and 95% of prescriptions do not state the condition for which the drug is prescribed. Unless they are made aware that pregabalin has been prescribed for the treatment of pain they are likely to deliver the generic preparation in response to a prescription rather than Lyrica.

Warner Lambert claim that the use of Lacaent for pain relief would infringe its patent. Actavis and another generic manufacturer have applied for revocation of the patent.   The trial of the infringement and revocation actions will be heard in the summer.  In the meantime Warner Lambert brought this application to oblige Actavis to take steps to preserve its sales of Lyrica for pain relief.

The questions that Mr Justice Arnold had to decide were as follows:
"whether, in such circumstances, the generic supplier will infringe the second medical use patent unless the supplier takes positive steps to prevent its generic version of the drug being dispensed for patients who have been prescribed the drug for the patented indication."
If the answer to that question was yes the judge then had to consider what steps if any the generic suppliers had to consider pending trial.

The biggest customer for pregabalin in the UK is, of course, the National Health Service.  Mr Justice Arnold noted at paragraph [1] of his judgment that:
"This case arises out of a collision between the policy of incentivising important medical research by granting second medical use patents on the one hand and other policies and practices which form part of the United Kingdom's healthcare systems (and in particular the English and Welsh systems) on the other hand."
He added at paragraph [4]:
"This question is complicated by the involvement of third parties who are not under either party's control: not just prescribing doctors and pharmacists, but also healthcare organisations such as Clinical Commissioning Groups ("CCGs") (in England) and Health Boards (in Wales), regulators such as the Medicines and Healthcare Products Regulatory Agency ("MHRA") and the National Institute for Heath and Care Excellence ("NICE"), NHS England and NHS Wales, and the Department of Health itself. It is further complicated by the fact that the patentee has itself taken, and is continuing to take, steps to prevent the generic version being dispensed for patients who have been prescribed the drug for the patented indication. It is still further complicated by the behaviour of patients, many of whom do not take their own prescriptions to the pharmacy, some of whom may not remember what they have been prescribed pregabalin for and a few of whom may mislead their doctors for ulterior reasons."
Warner Lambert sought to join the Highland Health Board as a defendant because it had published an article in The Pink One that was said to encourage doctors to prescribe, and pharmacists to dispense. generic pregabalin for all indications regardless of the patent position.  Mr Justice Arnold did not make a ruling on that issue because the parties were negotiating a settlement and seemed close to agreement.

Because the relief that Warner Lambert sought was intended not to affect Actavis' own conduct so much as the conduct of third parties who were not before the court there was no precedent for the application. Actavis opposed it on the ground that Warner-Lambert's infringement claim had no real prospect of success, and that the balance of the risk of injustice favoured refusal of the relief sought. The defendant group also argued that the relief sought was contrary to competition law.

The judge applied the principles set out by Lord Diplock in American Cyanamid Co (No 1) v Ethicon Ltd [1977] FSR 593, [1975] AC 396, [1975] 1 All ER 504, [1975] 2 WLR 316, [1975] UKHL 1 (5 Feb 1975) with particular care.

His Lordship considered first whether there was a serious issue to be tried and decided that there was not. Swiss style claims are process claims so if any action lay against Actavis it would be under s.60 (1) (c) of the Patents Act 1977 that is to say disposing of, offering to dispose of, using or importing any product obtained directly by means of that process or keeping any such product whether for disposal or otherwise. There was no dispute that Actavis's pregabalin was derived from the patented process. The argument was whether such manufacture was for the purpose of treating neuropathic and other pain.  There was no doubt that such pregabalin was suitable for treating pain but it was denied that that was Actavis's intention.  Warner Lambert submitted that it was enough to show that Actavis knew that such use was likely.  The judge accepted at paragraph [108] that:
"there are circumstances in which an intermediary who knows that goods in his possession will, if disposed of by another, infringe an intellectual property right or who knows that his services are being used by third parties to infringe an intellectual property right, can come under a duty to take positive steps to prevent or reduce such infringement. As counsel for Actavis pointed out, however, such duties arise in circumstances where the person in question knows of infringement by another. This does not assist Warner-Lambert to establish that Actavis will infringe unless it is shown that others will infringe; but that is not the case. Furthermore, Warner-Lambert does not rely upon any extra-statutory duty upon Actavis, but only upon section 60(1)(c)."
There was authority from a number of European jurisdictions that supported the proposition that subjective intent is required to which Warner Lambert had no cogent answer.  Accordingly. his Lordship held at [111] that "the word 'for' in Swiss form claims imports a requirement of subjective intention on the part of the manufacturer that the medicament or pharmaceutical composition will be used for treating the specified condition."

The judge  next considered whether Warner Lambert would suffer unquantifiable and irreparable harm between the application and trial if relief were refused and held that it would not. Actavis was already allowed to supply pregabalin to treat epilepsy and GAD and it had taken steps to prevent the use of its product for relieving pain. It could not be held responsible for the actions of doctors and patients. Warner Lambert might lose some revenue as a result of competition with generic pregabalin but that was inevitable. There was no reason to suppose that its losses for the use of generic pregabalin for pain relief would be substantial.

On the other hand the judge decided that Actavis would suffer substantial unquantifiable loss if the injunction were granted because Actavis's entry into the market would be delayed and pharmacists would be deterred from supplying pregabalin for any purpose by the proposed label. He concluded at paragraph [137]:
"granting the relief sought by Warner-Lambert would create a greater risk of injustice than refusing it. In my view, wrongly granting the relief is more likely to cause Actavis substantial unquantifiable harm than wrongly refusing it is likely to cause Warner-Lambert substantial unquantifiable harm. Taking into account the other factors considered above, including the likely efficacy of the measure, I consider that the balance is firmly tipped against ordering Actavis to put a notice on its packaging."
He therefore dismissed the application at paragraph [139] on the grounds that:
"i) there is no serious issue to be tried with regard to Warner-Lambert's claim that Actavis will infringe the Patent by marketing Lecaent; and
ii) even if there was a serious issue to be tried, the balance of the risk of injustice would favour refusal of the relief sought by Warner-Lambert."
Even though this was an interlocutory decision it is an important judgment and one to be welcomed. Had it gone the other way it would have been much more difficult for generic manufacturers to enter the market for drugs for permitted medical uses where there was a patent for second or subsequent medical uses and the NHS would have to pay more for its medicines. The judgment may have wider significance since it considered the conditions for liability under s.60 (1) (c), Finally, as American Cyanamid approaches its 40th anniversary the judgment shows that Lord Diplock's principles are in rude health and capable of development and extension.

Should anyone wish to discuss this case, patents or interim injunction applications in general, he or she should call me on 020 7404 5252 during office hours or use my contact form.

      1 comment:

      Anonymous said...


      That's a very one-sided view without an appreciation of the issues.