Infringement - Annual Patents Review 2017

This is the Infringement chapter of Gordon Harris' Annual Patents Review 2017. For the other chapters of the review, please follow the links below or download the Annual Patents Review 2017 in full.

Introduction Infringement Validity Technical Matters and Procedure Competition Law, Settlement and Licensing Employee Inventor Compensation Summary and Conclusions 2. INFRINGEMENT

In previous years I have subdivided this section between "construction" and "infringement". It turns out I was right to do so, but probably not entirely for the right reasons. This year, instead of that subdivision, I am going to give over an entire section to what is probably the most significant patent decision for a decade, and certainly the most controversial. There really is no other place to start.

(a) Actavis v Lilly and following cases

Actavis sought a declaration of non-infringement from the English Patents Court regarding European patent number EP 1,313,508. Unusually, the declaratory relief sought was to cover not just the UK designation of the patent, but the French, Italian, Spanish and German designations too.

Following an early procedural spat, the Court of Appeal ruled that Eli Lilly had, in the course of correspondence, consented to service and thereby consented to the jurisdiction of the court over the claim. Lilly brought proceedings in Germany for threatened infringement of the German designation of the patent, where Actavis' jurisdictional challenge was unsuccessful. The dispute proceeded in Germany and Actavis discontinued the part of its claim in the English proceedings which concerned the German designation.

Actavis' proposed products involved pemetrexed compounds being used together with vitamin B12 for cancer treatment. However, rather than the "pemetrexed disodium" specified in the patent claims, the active ingredient in those products ("the Actavis products") was (a) pemetrexed diacid, (b) "pemetrexed ditromethamine" or (c) "pemetrexed dipotassium". Actavis admitted that like Eli Lilly's pemetrexed medicine, the proposed products would be reconstituted and diluted in saline solution (a source of sodium cations) before administration.

On 15 May 2014, Arnold J ruled that Actavis' proposed products did not infringe the patent either directly or indirectly. The Court of Appeal confirmed his conclusion in respect of direct infringement but overturned the judge's conclusion in respect of indirect infringement. Lilly appealed to the Supreme Court on the direct infringement issue; Actavis cross appealed on indirect infringement.

That is a fairly innocuous sounding backdrop for what followed. A few items had been batted around between the High Court and the Court of Appeal. Arnold J appeared to have nudged the door open for consideration of the file wrapper as an occasional aid to construction, but the Court of Appeal slammed that particular door shut.

By the time the case reached the Supreme Court, the key issue - the only one which could really change the outcome - was whether a patent could be infringed by an equivalent product or process, even if it did not strictly fall within the scope of the claims as written in the patent.

Background

Let us just step back and put this in some context. The notion of infringement by equivalents is not new. It has been established law in the USA and in Germany for many years. One of our founding cases on the doctrine of purposive construction, Improver v Remington1, was a graphic illustration of the contrasting approaches. In the UK, a slotted rubber tube was found not to infringe patent claims which specifically used the words 'helical spring'. Purposive construction could not reach that far. The German Courts reached the opposite conclusion. For them, the slotted rubber tube achieved the same ends by means sufficiently similar to amount to infringement. The key issue was the inventive concept.

Shortly after I embarked on these annual reviews, the issue of equivalents as against purposive construction raised its head. I do not propose to dwell on the history here to a great extent (I have already done that in my article "Actavis v Lilly - Should We Have Seen It Coming?"). Suffice to say there was some interesting judicial bi-play between a faction, led by Laddie J, which appeared to favour an open mind on the question, and an opposing faction, led by Aldous LJ, which rejected the whole notion.

The "Aldous faction" won the day with the definitive House of Lords judgment by Lord Hoffmann in Kirin-Amgen2. In a wide-ranging judgment which set out a clear guide to patent construction, Lord Hoffmann said ([41]):

There is often discussion about whether we have a European doctrine of equivalents and, if not, whether we should. It seems to me that both the doctrine of equivalents in the United States and the pith and marrow doctrine in the United Kingdom were born of despair. The courts felt unable to escape from interpretations which "unsparing logic" appeared to require and which prevented them from according the patentee the full extent of the monopoly which the person skilled in the art would reasonably have thought he was claiming.

He went on to elaborate further saying ([42]-[43]):

If literalism stands in the way of construing patent claims so as to give fair protection to the patentee, there are two things that you can do. One is to adhere to literalism in construing the claims and evolve a doctrine which supplements the claims by extending protection to equivalents. That is what the Americans have done. The other is to abandon literalism. That is what the House of Lords did in the Catnic case... The solution, said Lord Diplock, was to adopt a principle of construction which actually gave effect to what the person skilled in the art would have understood the patentee to be claiming.

In making that very definitive judgment, Lord Hoffmann brushed aside two particular issues. One was the then pending alteration to the Protocol on the Interpretation of Article 69 of the European Patent Convention, which added, as article 2, the words:

For the purpose of determining the extent of protection conferred by a European patent, due account shall be taken of any element which is equivalent to an element specified in the claims.

This had been recognised by the UK delegation to the diplomatic conference, which met in 2000 to discuss the amendment, as "a radical change to the legal position in the United Kingdom". However, in a special edition of the Official Journal in 2003, it was stated that the amendment was "purely clarificatory and editorial" because "patent practice in all the contracting states has long accepted that equivalents should be taken into account in determining the extent of protection". Lord Hoffmann went along with the view that the amendment changed nothing.

The second issue swept aside by Lord Hoffmann was the strongly reasoned judgment at first instance in the Kirin-Amgen case, by the then Mr Justice Neuberger3. The heart of his judgment is expressed in the following passage, in which he cast heretical doubt on the general applicability of the use of the "Improver Questions" (by then known as the "Protocol Questions"), saying ([615]):

It may be that the way in which these questions were expressed would seem to be a little narrow to those who practice in jurisdictions where there is a sharp demarcation between construction and infringement (for instance in Germany, where those issues are tried separately, indeed by different Courts). In a sense, by tying oneself down to construction, it might be said that one was concentrating more on form than on substance. I suspect that, free from the binding constituents of Catnic [1982] RPC 183, the questions might not have been expressed in terms of construction. After all, the claim in Improver [1990] FSR 183 referred to a "helical spring": as a matter of language, that could scarcely include a "rubber rod", as Hoffmann J recognised. Yet Catnic ... enabled him to conclude that a rubber rod could be within the claim. It may be that, shorn of authority, the question should be characterised as whether the rubber rod infringed the claim bearing in mind the technical contribution of the patent and not merely the words of the claim

He went on to say in the next passage ([616]):

While, particularly at first instance, it would be brave or worse to depart from the three questions, I do not find it entirely easy to accept that it can be right that, where there is no infringement on a literal construction, the Court is in every case to be forced into the straitjacket of answering the three specific questions in order to decide issues of construction or even issues of infringement

If I may allow myself a moment of smugness here, I reported that decision, back in 2001, and whilst noting that it was likely to be overturned (as indeed it was) I said:

Sooner or later the current Patents Court judges will start working their way through the ranks of the appellate courts and when they do, I do not think that we should assume that Improver is sacrosanct beyond review

Lord Neuberger's judgment in Actavis v Lilly

Turning now to the judgment of Lord Neuberger sixteen years later in Actavis v Lilly4, his Lordship stripped the matter back to first principles. He acknowledged the importance of the Protocol, as amended, saying ([54]):

... a problem of infringement is best approached by addressing two issues, each of which is to be considered through the eyes of the notional addressee of the patent in suit, i.e. the person skilled in the relevant art. Those issues are: (i) does the variant infringe any of the claims as a matter of normal interpretation; and, if not, (ii) does the variant nonetheless infringe because it varies from the invention in a way or ways which is or are immaterial? If the answer to either issue is "yes", there is an infringement; otherwise, there is not

In saying this, Lord Neuberger clarifies a point which has been the...