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Microsoft word - pregabalin 02 10 15.docx


Why is this important?
Increasingly, unmet medical needs are being met by "repurposing" of old medicines
for new diseases. Before such medicines may be used to treat patients for the new disease, expensive research including clinical trials must usually be performed. One mechanism to incentivise this research is to grant innovator companies exclusivity for the new indications through second medical use patents. Thus, there is a public policy argument for granting second medical use patents, and to ensuring that these patents are enforceable. On the other hand, generic versions of innovative drugs should be allowed on to the market for indications whose patent protection has expired. An optimal patent
system will strike a balance between allowing generics companies to market generic
drugs for non-patented indications whilst at the same time preventing use of generic
drugs for the patented indications. The outcome of the Warner-Lambert case will tell
us whether or not we have such a system in the UK.

Why is this difficult?

A generics company may try to avoid prescription of its drug for a patented
indication by use of a "skinny label", i.e. a label that mentions only the non-
patented indication and omits the patented indication. However, such a label may
not be effective at preventing use of the drug for the patented indication owing to
the way in which drugs are prescribed in the UK.

Doctors will often prescribe a drug by its International Non-proprietary Name (INN). The INN is common to the drugs produced by both the innovator and the generics company. The prescriptions are filled by the pharmacist, who may not know the indication for which the drug was prescribed. The pharmacist is incentivised to supply the cheapest versions of drugs and so will likely supply the generic version irrespective of the condition being treated. One solution would be to require doctors to prescribe a drug by the patent proprietor's brand name when it is prescribed for a patented use. The pharmacist will then provide the branded product to the patient. There is, however, a major practical obstacle to such a solution: even if guidance about the patent position could be provided to doctors, there is little that the patent proprietor could do if the doctor forgets or ignores the guidance.

Background to Warner-Lambert v Actavis

These cases concern the drug pregabalin. This drug was marketed by Warner-Lambert
under the tradename Lyrica for three indications, epilepsy, generalised anxiety
disorder and neuropathic pain. The patent protection for pregabalin per se expired in
October 2013. However, Warner-Lambert have a second medical use patent
containing Swiss claims covering one of the three indications, neuropathic pain. The most relevant of these claims are: 1. Use of [pregabalin] or a pharmaceutically acceptable salt thereof for the preparation of a pharmaceutical composition for treating pain. 2. Use according to claim 1 wherein the pain is neuropathic pain. Several generic companies, including Actavis, sought and obtained authorisations to market pregabalin for non-pain indications under a "skinny label" indicating only the anxiety and epilepsy indications. However, Warner-Lambert was concerned that, in the UK environment described above, Actavis' product Lecaent would be used for the pain indication. Warner-Lambert sued Actavis for infringement and Actavis counter-claimed for revocation. Specifically Warner-Lambert alleged infringement under section 60(1)(c) (direct infringement) and section 60(2) (indirect infringement) of the Patents Act. Section 60(1)(c) provides that: "(1) Subject to the provisions of this section, a person infringes a patent for an invention if, but only if, while the patent is in force, he does any of the following things in the United Kingdom in relation to the invention without the consent of the proprietor of the patent, that is to say - … (c) where the invention is a process, he disposes of, offers to dispose
of, uses or imports any product obtained directly by means of that
process or keeps any such product whether for disposal or otherwise."

It was common ground that Swiss style medical use claims are process claims (i.e. they include a manufacturing step) and not product claims. Actavis manufactured the PATENT ATTORNEYS • TRADE MARK ATTORNEYS

drug outside of the UK, so Warner-Lambert alleged that Actavis infringed by importing a product obtained by a patented process. Section 60(2) provides that:
"Subject to the following provisions of this section, a person (other than the
proprietor of the patent) also infringes a patent for an invention if, while
the patent is in force, he supplies or offers to supply in the United Kingdom
a person other than a licensee or other person entitled to work the invention
with any of the means, relating to an essential element of the invention,
for putting the invention into effect when he knows, or it is obvious to a
reasonable person
in the circumstances, that those means are suitable for

putting, and are intended to put, the invention into effect in the United Kingdom." On 10 September 2015, the High Court Judge, Mr Justice Arnold, issued a massive
(727 paragraph) judgment1. He found the patent to be partially invalid on the
ground of insufficiency. He also found that the patent was not infringed and that
Warner-Lambert had made groundless threats.
Prior to this full-trial judgment of Arnold J, the patent had been the subject of
extensive interim proceedings including an interim judgment of the Court of Appeal.
The Court of Appeal had commented on the question of infringement in deciding not
to grant interim relief to Warner-Lambert, so Arnold J had those comments in hand
at the time he issued his judgment. We will comment below on the Court of
Appeal's judgment before returning to Arnold J's judgment. The interim proceedings
are summarised in an Annex to this Briefing Note.
The Court of Appeal judgment relating to the interim injunction

Direct infringement
The Court of Appeal considered two possible tests for infringement:
A "subjective intention" test, according to which there is infringement only if the manufacturer actually intends its drug to be used for the patented A "foreseeability" test, a less stringent test according to which there is infringement if it is foreseeable to the manufacturer that the drug will intentionally be used downstream for the patented indication. The Court concluded that the appropriate test is the "foreseeability" test and that, under that test, Warner-Lambert had an arguable case for direct infringement. PATENT ATTORNEYS • TRADE MARK ATTORNEYS

Indirect infringement Warner-Lambert's case for indirect infringement has a potential strength that section 60(2) of the Patents Act as set forth above specifies a statutory mental element that is more akin to the foreseeability test than to the subjective intention test; the section requires that it would be "obvious to a reasonable person in the circumstances" that the supplied means are suitable for putting, and are intended to put, the invention into effect in the United Kingdom. The Court of Appeal decided that Warner-Lambert's case for indirect infringement had enough merit to proceed to full trial, but noted that there was a weakness with the case. The weakness derives from the fact that the invention as defined by the Swiss style claims is a manufacturing process and that indirect infringement therefore arguably requires a person to be supplying a manufacturer. Actavis were not supplying a manufacturer, but rather were themselves the manufacturer. Potential remedies The Court of Appeal commented that: "On the assumption that infringement is shown at trial, it does not follow that unqualified relief will follow as of right. Those are issues for the trial or any enquiry which follows." This comment in the context of the rest of judgment suggests that the Court of Appeal had in mind that a potential way to resolve the dispute would be to find that Actavis infringed the patent but to frame an injunction and/or damages in such a way as to strike a balance between allowing Actavis to market its drug for the non-patented indications whilst giving Warner-Lambert some value for its patent. However, it is fiendishly difficult to imagine what remedies might achieve this balance, and the Court did not indicate what form an injunction or damages might take. For the practical reasons explained above, it is hard to see how to frame an injunction that stops the generic drug from reaching patents who have pain. It is also not clear that damages would work, not least because, if Warner-Lambert sells Lyrica for the patented indication at a higher price than the generic drugs, any damages may exceed the generics companies' profits and thereby effectively exclude them from the market for all indications.
The decision of the High Court (Arnold J) at full trial

Direct infringement

Arnold J followed the "foreseeability" test for infringement put forward by the Court
of Appeal, despite questioning it correctness. However, in applying this test, he
reached a conclusion that the Court of Appeal may not have expected; he found that there was no infringement. Arnold J reasoned that, whilst foreseeability may be all that is required on the part of the manufacturer, there still has to be actual intention to use the drug for the patented indication by a user, i.e. the doctor, the pharmacist or the patient. He PATENT ATTORNEYS • TRADE MARK ATTORNEYS

A doctor who prescribes pregabalin by its INN for pain does not have the relevant intention because he does not specifically intend a generic drug to be used. Statistically, sales of the patent proprietor's Lyrica are highest, so the likelihood is that Lyrica will be prescribed. The intention of the pharmacist was assessed under two possible scenarios. In the first scenario, pregabalin is prescribed by its INN and the pharmacist does not know the indication for which pregabalin has been prescribed. In this scenario, even if the pharmacist supplies Lecaent, Arnold J considered that the pharmacist did not have the required intention. In the second scenario, pregabalin is prescribed by either its tradename Lyrica or the INN, and the pharmacist knows that the pregabalin will be used to treat pain. In this scenario, if the pharmacist supplies Lecaent he does have the required intent. However, Arnold J felt that the occurrence of this second scenario was de minimis. Arnold J did not credit the patient with intentionally taking Lecaent to treat pain. He noted that "in general the patient intends to take whatever drug the doctor has prescribed for whatever condition the doctor has prescribed it for. Usually the patient will not have any medical knowledge about the efficacy of that drug for that condition. Moreover, the patient will rely on the pharmacists to dispense the correct drug, and in general the patient will not have any choice as to the source of that drug." Thus, overall, Arnold J decided that the instances of infringement were de minimis and, therefore, that Actavis did not directly infringe the patent. Indirect infringement Indirect infringement was not argued at great length during the full trial proceedings. However, Arnold J decided that there was no indirect infringement owing to the weakness mentioned above. Threats Things then got even worse for Warner-Lambert; it was found that they had issued groundless threats under Section 70(1) of the Patents Act. Section 70(1) provides that: "Where a person (whether or not the proprietor of, or entitled to any right in, a patent) by circulars, advertisements or otherwise threatens another person with proceedings for any infringement of a patent, a person aggrieved by the threats (whether or not he is person to whom the threats are made) may, subject to subsection (4) below, bring proceedings in the court against the person making the threats, claiming any relief mentioned in subsection (3) below." PATENT ATTORNEYS • TRADE MARK ATTORNEYS

Section 70(2) provides that the claimant is entitled to relief if he proves the threats were made and he was a person aggrieved by them. Section 70(5) provides that certain types of communication do not constitute threats for the purposes of the section, and in particular a communication which "merely (a) provides factual information about the patent". Warner-Lambert had written to a number of medical organisations bringing their attention to the patent. Arnold J found that some of these letters were threats and that, in some cases, Actavis had been aggrieved. Particular causes of concern for Arnold J were letters which "were very clear and explicit in stating Pfizer's position that pharmacists are infringing the patent", which referred to the "potential liability" of pharmacists, which noted "that patentees have occasionally asserted patent infringement against pharmacists" and which emphasised that it was a "legal matter". As for whether Actavis were aggrieved, evidence was put forward to suggest that pharmacists had been discouraged from stocking Lecaent over fear of legal reprisals. Arnold J noted in relation to one particular communication from Warner-Lambert that "the email was calculated to have a chilling effect on the willingness of pharmacists to stock and dispense generic pregabalin, and in particular Actavis' product when it was launched".

Arnold J's judgment appears to be good news for generics companies and bad news
for innovators in the field of drug repurposing. There are, however, at least three
reasons for innovators to retain optimism.
Firstly, Arnold J's judgment on infringement may well not be what the Court of
Appeal expected and so may well be overturned by the Court of Appeal (and may
then go on to the Supreme Court). If the findings on infringement and validity are
overturned, there may have to be some creative work to frame an injunction and/or
damages in such a way as to strike a balance between allowing Actavis to market its
drug for the non-patented indications whilst giving Warner-Lambert some value for
its patent.
Secondly, Actavis had taken steps to limit use of their generic drug for treating pain,
including the use of a skinny label that omitted the pain indication. Assuming that
these steps were at least partially effective, the patent provided value to Warner-
Lambert. If Actavis had not taken the steps, they may well have been found to
infringe the patent.
Thirdly, this case related to Swiss claims, and both the Court of Appeal and the High
Court made it clear that their judgments do not apply to a new style of claim that
has been permitted since EPC 2000 came into force, namely "compound X for use in a method of treating disease Y". Warner-Lambert's case for indirect infringement may have been stronger if EPC 2000 claims were available to them. Since there is no step of manufacturing a medicament in an EPC 2000 claim, there may be a better argument that a party downstream of the generic manufacturer is "putting the invention into effect". However, Arnold J's most recent judgment suggests that no- PATENT ATTORNEYS • TRADE MARK ATTORNEYS

one intended the generic drug to be used for pain, and he may have found non-infringement of EPC 2000 claims on the basis that they require someone somewhere in the chain to have intent. Overall, Arnold J's judgment suggests that, if a generics company which markets a drug for a non-patented indication takes steps to avoid use of the drug for a patented indication, the company may well not infringe the patent even if some of the drug ends up being used for the patented indication. As always, much will depend on the facts of any given case. We await the Court of Appeal's judgment with interest. If, in the meantime, you have any questions or comments, please contact your usual J A Kemp contact, Lucy Whetton via or Patrick Campbell via 02 October 2015 J A Kemp 14 South Square Gray's Inn London WC1R 5JJ UK +44 20 3077 8600 PATENT ATTORNEYS • TRADE MARK ATTORNEYS Annex

Summary of the Interim Proceedings

Case Background/facts
Warner-Lambert sought an Direct infringement Lambert 1 interim injunction to
reduce/prevent sales of The word "for" imports a Lecaent for treating pain. The requirement of subjective intent injunction consisted of a on the behalf of the manufacturer. number of steps that Actavis Actavis had taken steps to avoid its should take. Most of these product being prescribed for pain, steps were agreeable to so the relevant intent is not Actavis, but two proposed steps present and there is no were at issue: (1) Warner-Lambert wanted Actavis to make it a Indirect infringement requirement of any agreement entered into with pharmacies In order to allege indirect that the pharmacy would not infringement, Warner-Lambert prescribe Lecaent for pain; and would need to prove that Actavis (2) Warner-Lambert wanted was supplying a second party with Actavis to add warning labels means essential for "putting the to boxes of Lecaent informing invention into effect". Thus, doctors/pharmacists that the Warner-Lambert needs to prove drug should not be prescribed that someone other than Actavis is performing the invention. A Swiss claim is directed to a step of manufacturing a medicament and no-one other than Actavis is performing such a manufacture step. Therefore, there is no indirect infringement. Relief On the balance of convenience, no relief is granted. The damage to Warner-Lambert caused by Actavis is relatively low. In addition, the relief requested by Warner-Lambert is likely to harm Actavis as it will likely deter pharmacists from stocking Lecaent for any indication and a change in Actavis' labelling policy may contradict regulatory requirements. The best solution is to prescribe Lyrica for pain using its tradename. PATENT ATTORNEYS • TRADE MARK ATTORNEYS Actavis applied to strike out Arnold J concludes that the case on Lambert 2 the infringement case and
infringement is weak. However, he Warner-Lambert applied to notes that this is a developing area amend its particulars of case of case law. Arnold J recognised he to plead subjective intent could be wrong regarding "subjective intent" and decides not to strike out the infringement case. Warner-Lambert appealed the "Subjective intent" is not required. decision relating to the interim Floyd LJ proposes a injunction. The Court of "foreseeability" test, i.e. is it Appeal considered foreseeable on the manufacturer's part that the drug will be used for the patented use? Floyd LJ notes that the relief available must be considered carefully. Warner-Lambert has an arguable case for infringement. The case returns to the first An injunction against the NHS was Lambert 3 instance where Warner-
granted, but a large cross- Lambert applied for a further undertaking was put in place. The injunction against the NHS. NHS must write to various organisations requiring that pregabalin is prescribed by the brand-name Lyrica for the treatment of pain. PATENT ATTORNEYS • TRADE MARK ATTORNEYS


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