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3 January 2017Big PharmaGeoff Hussey and Christopher Burnett

The pitfalls of second medical use patents

The latest judgment (October 13, 2016 handed down by the UK Court of Appeal in the long-running patent dispute between Warner-Lambert and Actavis aims to provide some guidance regarding the issue of infringement of second medical use claims in the UK. However, whether it achieves that aim is a point of debate.

The Court of Appeal was asked to consider issues of validity (insufficiency), amendment post-trial, and infringement of the patent in question, which was directed to the use of the drug pregabalin for pain, in particular neuropathic pain. Pregabalin as a drug itself is no longer patented and can also be used to treat epilepsy and generalised anxiety disorder.

The court concluded that the patent was invalid for being implausible across its breadth and was therefore insufficient. Consequently, the comments regarding infringement, made as the Court of Appeal recognised the importance of the issue generally, were made obiter. However, such is the significance of this case, these comments are likely to be regarded as an authoritative statement of the UK’s position on infringement of second medical use patents.

Swiss-type patent claims

So-called Swiss-type claims are second medical use claims protecting a new medical use of a known pharmaceutical composition. They are provided generally in the form of “use of a substance or composition X for the manufacture/preparation of a medicament for therapeutic application Y”. As of January 29, 2011 at the European Patent Office (EPO) and May 26, 2010 at the UK Intellectual Property Office (both following decision G2/08 of the EPO’s Enlarged Board of Appeal), the European Patent Convention and the UK Patents Act 1977 no longer permit Swiss-type claims. The particular form “compound X for the treatment of Y” for second medical use claims must now be used. There are still in force, however, many granted patents with Swiss-type claims.

In the UK, Swiss-type claims are treated as method claims, and direct infringement of these claims is considered under section 60(1)(c) of the UK Patents Act, which states that it is an infringement to “offer or dispose of any product obtained directly by means of [the claimed] process”. It should be noted that this is not the case in other jurisdictions—notably in Germany, Swiss-type claims are regarded as product claims.

Direct infringement

Actavis makes pregabalin and the question is whether the company manufactures it “for treating (neuropathic) pain”, as covered by the claims of the patent. It is established case law in the UK that the word “for” in such claims is interpreted as meaning “suitable and intended for” (Hospira v Genentech, 2014). There is no question that Actavis makes a drug that is suitable for treating pain, but is it intended for treating pain? While it is foreseeable that the drug could be prescribed or dispensed for pain, was there an intention that this should occur?

Following a previous Court of Appeal judgment (May 28, 2015) in this same Warner-Lambert v Actavis case, which considered the scope of second medical use claims, the test to apply is an objective one. Specifically, could it be objectively known or reasonably foreseen as a consequence of actions taken by the manufacturer that the drug would be used for the protected purpose?

Second medical use claims rely on the purpose of the use of the drug for their novelty. As a consequence of this, the Court of Appeal reaffirmed that to infringe, the manufacturer must only foresee whether there will be intentional use of the drug for the new medical indication. It clarified in its opinion that intentional use in this context is a reference to intentionally treating the new medical indication with the drug and not a reference to intentionally using the generic drug. An example of unintentional use would be where a drug is prescribed for a particular indication (say, epilepsy in the current case) but where a different issue (in this case, pain) is in fact treated, perhaps ‘accidentally’.

This leads to an important question of what actions, in practice, are sufficient to “negate” the existence of such an intention? In other words, what does a generic company need to do to prove that it does not intend its products to be used for the patented use?

Other courts

The Court of Appeal considered the position of the courts in many other jurisdictions and evaluated the position reached by them on this issue. This analysis clearly shows a wide divergence of approaches to infringement of second medical use throughout Europe.

On one extreme is the German approach, which looks for some outward manifestation of intention in the manufacture itself (which may include the packaging, but not advertising). The Court of Appeal called this the ‘only packaging will do’ approach. This was recognised as having obvious advantages of practicality, but that it may be unduly narrow and not give sufficient protection to the patentee.

Spain has adopted a slightly wider approach, in which an express authorisation for the new indication or some other act of encouragement for such use is looked for. The Madrid Court of Appeal has considered that it is necessary to show that the generic has applied, and received regulatory approval, for the patented indication or has done something else to strengthen use for that new indication.

“As there could be more than one party involved in the preparation of the drug, there could be acts of indirect infringement.”

At the other extreme the French courts look to what the generic manufacturer has done to prevent use for a patented indication and recognises that the manufacturer does not escape infringement merely by not encouraging the new use, but has a responsibility to show that it has taken steps to discourage such use. It has held that a so-called skinny label product with an email to doctors and pharmacists before launch stating that the product was not indicated for the patented use was sufficient to avoid infringement.

Having considered the range of approaches taken elsewhere, the Court of Appeal turned to what it regarded as the correct approach for the UK. It held that the absence of the patented indication from the product label (skinny label) alone cannot conceivably be sufficient to negate the intention. Therefore it rejected the German ‘only packaging will do’ approach.

The Court of Appeal concluded that the manufacturer can negate the relevant intention where it has taken all reasonable steps within its power to prevent the consequences occurring, ie, preventing its generic drug being prescribed or dispensed for the patented indication.

All reasonable steps

In the present case Actavis had taken the following steps in an attempt to avoid infringement:

i) It had written to more than 7,500 pharmacists informing them that the generic drug should not be prescribed for pain.

ii) It had written to every Clinical Commissioning Group in England, every Health Board in Wales and Scotland, and every Trust in Northern Ireland specifying that generic pregabalin should not be prescribed for pain.

iii) On launch it had emphasised in its promotional materials that its generic drug was not indicated for pain.

iv) It had provided its sales team with a brief to ensure that they all knew the generic drug should not be used for pain.

v) It had provided a script for its telemarketing team so they could communicate consistent information about the drug in response to customer enquiries.

vi) It had provided copies of its letters to prescribers and pharmacists, and subsequently National Health Service England guidance (to prescribe Warner-Lambert’s branded pregabalin for pain only), when contacted with queries about pregabalin.

Mr Justice Arnold in the High Court judgment of September 10, 2015 had concluded that these steps were sufficient insofar as there was held to be no infringement. However, the Court of Appeal made no reference to them and failed to complete the guidance by providing a view on whether these steps amounted to all reasonable steps.

Indirect infringement

A further point addressed by the Court of Appeal regarded indirect infringement of second medical use claims. Under section 60(2) of the UK Patents Act, a party infringes a patent in the UK when he or she “supplies or offers to supply … any of the means, relating to an essential element of the invention, for putting the invention into effect when s/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”.

It was considered by the Court of Appeal that a pharmacist could be part of the claimed preparation process by labelling the product before it is dispensed. Therefore, it was concluded that as there could be more than one party involved in the preparation of the drug, there could be acts of indirect infringement.

It is of some assistance to generics wishing to launch a drug that is subject to a second medical use patent that the Court of Appeal has set out that they should carry out all reasonable steps within their power to prevent their generic drug being prescribed or dispensed for the patented indication. However, quite what such steps are to be regarded as reasonable in these circumstances and whether the steps carried out by Actavis were sufficient, remains unknown. Therefore, it appears necessary and perhaps inevitable that further guidance from the court will be provided on this issue in an appropriate case.

Geoff Hussey is a partner at  AA Thornton & Co. He can be contacted at:

Christopher Burnett is an associate at AA Thornton & Co. He can be contacted at:

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