Patents - The First Case to Apply Eli Lilly v Actavis: Mylan v Yeda

Jane Lambert

Patents Court (Mr Justice Arnold): Generics (UK) Ltd (t/a Mylan) and another v Yeda Research And Development Company Ltd [2017] EWHC 2629 (Pat) (26 Oct 2017)

On Wednesday, 28 Feb 2018 I gave a talk to the C5 Pharma and Patent Litigation Conference at the Radisson Blu Hotel in Amsterdam. Mine was one of three talks on the topic Infringement under the Doctrine of Equivalents.  I discussed the law of England in the light of the Supreme Court's decision in Eli Lilly v Actavis UK Ltd and others [2017] UKSC 48, [2017] Bus LR 1731 while Paul Reeskamp and Philipp Cepl, who practise in the Netherlands and Germany, considered the topic in the light of the developing case law in their jurisdictions. I had previously written about the Supreme Court's judgment in The Supreme Court's Judgment in Eli Lilly v Actavis UK Ltd and Others: how to understand it and why it is important 13 July 2017.

Possibly because Lord Neuberger said that his approach to the construction of the patent claims complies with art 2 of the  Protocol on the Interpretation of Art 69 of the European Patent Convention which "squarely raises the principle of equivalents", it has been argued that the Supreme Court's judgment jettisons all the case law on claim construction since Catnic Components Ltd. v. Hill & Smith Ltd. [1982] RPC and substitutes in its place something like the US doctrine of equivalents. I have not been persuaded by that argument and believe that the Supreme Court did nothing more than reformulate principles that had previously been established.  I made that point in my presentation but was challenged by a member of the audience who did not explain in detail the reason for her disagreement and went on to pose a question to Paul and Philipp.

One reason why I believe that Eli Lilly does not radically change the law is that their lordships did not invoke the House of Lords’ Practice Statement of 26 July 1966 (Practice Statement (Judicial Precedent) [1966] 1 WLR 1234) which they are supposed to do when they wish to depart from a previous line of decisions. A second reason is that the courts would have to invent a limiting doctrine such as file wrapper estoppel were they ever to free the interpretation of claims from the principles that they had developed in Catnic and subsequent cases and they have expressly chosen not to do so.  Yet another reason for my view is that the Supreme Court's judgment has been considered and applied by Mr Justice Arnold in Generics (UK) Ltd (t/a Mylan) and another v Yeda Research and Development Company Ltd  [2017] EWHC 2629 (Pat) and he does not seem to believe that there has been radical change.

In that case, Mylan and Synthon BV sought the revocation of European patent 2 949 335 entitled "Low frequency glatiramer acetate therapy" which had been granted to Yeda Research and Development Co. Ltd. and licensed exclusively to Teva Pharmaceutical Industries Ltd for anticipation, obviousness and insufficiency. Yeda and Teva counterclaimed for threatened infringement of their patent. Mr Justice Arnold explained at paragraph [6] of his judgment:

"The reason for the current litigation is not hard to find. Teva markets GA [Glatiramer acetate] under the trade mark Copaxone. Worldwide sales of Copaxone in the year ending 31 December 2016 were about $4.2 billion, representing nearly a fifth of Teva's worldwide sales and a significantly higher percentage of its profits. Since GA has been authorised for administration in accordance with the 40 mg TIW regimen, a large proportion of prescriptions of GA has been written for that regimen. The Claimants have previously introduced a 20 mg GA generic product. Now they wish to clear the way for the launch of a 40 mg GA generic product for which they obtained a marketing authorisation on 5 October 2017 ("the Claimants' Product"). There is no dispute that, if the Patent is valid, the Claimants' intended acts in relation to the Claimants' Product would infringe it."

The patented invention was "an effective low frequency dosage regimen of GA administration to patients suffering from a relapsing form of multiple sclerosis, including patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis". The patent had only four claims of which the first and third were independently asserted:

"1,   Glatiramer acetate for use in a regimen of three subcutaneous injections of a 40mg dose of glatiramer acetate every seven days with at least one day between each subcutaneous injection for use in treating a patient who is suffering from a relapsing form of multiple sclerosis or who has experienced a first clinical episode and is at high risk of developing clinically definite multiple sclerosis and wherein the pharmaceutical composition further comprises mannitol
3.  Glatiramer acetate for use according to claim 1, wherein the tolerability of glatiramer acetate treatment in the human patient is increased by reducing the frequency of an immediate post injection reaction or an injection site reaction.
In order to decide whether those claims had been anticipated, his lordship had to construe them in accordance with the Supreme Court's judgment in Eli Lilly.  Clearly, he had to take account of paragraph [54] of Lord Neuberger's judgment:

"In my view, notwithstanding what Lord Diplock said in Catnic [1982] RPC 183, 242, 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, ie 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. Such an approach complies with article 2 of the Protocol, as issue (ii) squarely raises the principle of equivalents, but limits its ambit to those variants which contain immaterial variations from the invention. It is also apparent that the two issues comply with article 1 of the Protocol in that they involve balancing the competing interests of the patentee and of clarity, just as much as they seek to balance the encouragement of inventions and their disclosure with the need for a competitive market. In my view, issue (i) self-evidently raises a question of interpretation, whereas issue (ii) raises a question which would normally have to be answered by reference to the facts and expert evidence."

The problem for Mr Justice Arnold lay in deciding what exactly Lord Neuberger intended by his reference to art 2 of the Protocol and the "principle of equivalents". Counsel for Mylan and Synthon submitted that 

"it remained the law that a patent claim should be given a purposive construction. In support of this submission, he relied upon the following paragraphs of Lord Neuberger's judgment: [22], where he said that "a patent is to be interpreted on the basis that it is addressed to a person or group of persons who is or are likely to have a practical interest in the claimed invention"; [54], where he said that both the issues of (i) "normal interpretation" and (ii) infringement by immaterial variants should be "considered through the eyes of a notional addressee" of the patent; and [56], where he referred to issue (ii) involving 'not merely identifying what the words of a claim would mean in their context to the notional addressee,'"

Those representing Yeda and Teva argued that "a patent claim should be interpreted literally – by which counsel explained that he meant in the same manner as a clause in a commercial contract – and without regard to the patentee's purpose. In support of this submission, he relied upon the following paragraphs of the judgment of Lord Neuberger (with whom the other members of the panel agreed): [54], where Lord Neuberger referred to "normal interpretation" of claims; [58], where he said that "the applicable principles" for "interpreting documents" were those summarised by Lord Hodge in Wood v Capita Insurance Services Ltd [2017] UKSC 24, [2017] 2 WLR 109 at [8]-[15]; and [66(i)], where he referred to "the literal meaning of the relevant claim(s)".

At paragraph [138] Mr Justice Arnold agreed with the claimants:

"In my judgment counsel for the Claimants is correct. As has often been pointed out, patents differ from commercial contracts in two key ways. First, a contract is (at least in principle) a bilateral statement agreed between the contracting parties, whereas a patent is a unilateral statement made by the patentee and addressed to the class of persons represented by the person skilled in the art. Secondly, whereas a contract is a document containing promises by the contracting parties to each other (in some cases for the benefit also of third parties), a patent is a document which describes and claims an invention for the purposes of establishing a legal monopoly with regard to that invention. One cannot rationally interpret a patent claim without taking these matters into account. Moreover, I do not consider that Lord Neuberger can have meant anything different, even though he appears to have eschewed the expression "purposive construction" when describing the correct approach. On the contrary, in the passages relied upon by counsel for the Claimants, he expressly stated that a patent was to be interpreted through the eyes of the person skilled in the art and that the exercise involved interpreting the words of the claim in context. The context must include the very purpose for which the document exists, namely to describe and claim an invention."

As his lordship had already observed at [134], that was broadly the position before Eli Lilly:

"Prior to 12 July 2017 it was settled law that patent claims were to be interpreted in accordance with the principles established by the House of Lords in Catnic Components Ltd v Hill & Smith Ltd [1982] RPC 183 and Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2004] UKHL 46, [2005] RPC 9 and a multitude of decisions of the Court of Appeal applying those principles. In the briefest summary, the ultimate question was what the person skilled in the art would have understood the patentee to have used the language of the claim to mean. This involved giving the claim a purposive construction, that is to say, interpreting it having regard to the fact that the patentee's purpose was to describe and claim an invention."

The learned judge then proceeded to give a purposive construction to claim 1 as there was a dispute as to what was meant by the words "for use in treating a patient who is suffering from a relapsing form of [MS]". Mylan and Synthon argued that the wording merely required the 40 mg TIW regimen to be suitable for treating such a patient, that is to say, that it had some degree of efficacy while Yeda and Teva said that it required the 40 mg TIW regimen to reduce the annualized relapse rate by about 30%, that is to say, to be essentially equivalent in efficacy to the 20 mg QD regimen. The judge sided with the claimants for the reasons that he set out in paragraphs [141] to [143] of his judgment:

"[141] ................... The Defendants' construction involves reading in words which are not present in the claim. The Defendants rely upon the facts that the primary endpoint defined in the specification at [0109] is a 30% reduction in relapse rate compared to placebo and that the skilled person would be well aware that the 20 mg QD regimen achieved a 30% reduction. As the Claimants point out, however, that is merely the hoped-for outcome of the proposed Phase III trial. Moreover, the specification expressly teaches the skilled reader at [0078] that the example is non-limiting. There is nothing in the specification to suggest that the patentee intended to limit the claim to a regimen which achieved a 30% reduction. As the skilled reader would appreciate, a regimen which achieved a reduction of, say, 20% compared to placebo might well be of value, particularly if it had advantages in terms of tolerability.
[142] Furthermore, another difficulty with the Defendants' interpretation is that the claim extends to treatment of CIS. What is the comparator then? A reduction in annualised relapse rate does not make sense in that case. If the risk of progression is the comparator, the PreCISe trial demonstrated that 20 mg GA QD reduced the risk of developing clinically definite MS by 45%.
[143] Finally, the claim is not limited to a concentration of 40 mg/ml, but extends to other concentrations, in particular 40 mg/0.75 ml. It was Prof Zajicek's evidence that the skilled person would not know what the efficacy of a different concentration might be. Moreover, counsel for the Defendants put an FDA document (dated 3 January 2011, but not suggested to represent a different approach to that which would have been taken in August 2009) to Dr Green in cross-examination indicating that it was necessary to be cautious about "the possible impact of a higher concentration/lower volume formulation on the safety and efficacy of the product".

It is respectfully submitted that Mr Justice Arnold would have delivered an identical judgment in respect of that point had Eli Lilly never been decided.

A point that had not been considered by the Supreme Court was the effect of their lordships' judgment on applications for the revocation of claims for lack of novelty.  At paragraph [159] Mr Justice Arnold said:

"Prior to 12 July 2017 it was settled law that the claim should be interpreted in the same manner, and had the same scope, for the purposes of considering both novelty and infringement: see Terrell on the Law of Patents (18th ed, 2016) at §§9-12 to 9-19 and the authorities cited, many of which emphasise the importance of ensuring that the patentee cannot maintain a broad scope of claim for the purposes of infringement, but a narrow one for the purposes of validity."

He noted that the Supreme Court had held that a claim could be infringed on the basis of a doctrine of equivalents even though the allegedly infringing act did not fall within the claim on its strictly literal interpretation.  As he had decided that the disputed claims were invalid for obviousness he did not consider the question at length but agreed with the defendants' contention that:

"it was no longer the law that a claim lacked novelty if the prior publication disclosed subject-matter which, if performed, would necessarily infringe the claim. Rather, the claim would only lack novelty if the prior publication disclosed subject-matter which fell within the claim on its proper interpretation. It was not sufficient that the subject-matter would infringe the claim applying the doctrine of equivalents."

There is, of course, a lot more to Mylan v Yeda than claim construction and anticipation. The judge said some interesting things about obviousness, insufficiency and the discretion of the courts to make Arrow declarations but these will have to wait for another day. Should anyone wish to discuss this post, he or she should call me on 020 7404 5252 during office hours or send me a message through my contact form. 

Finally, I did not spend all my time in Amsterdam talking about patent litigation. I attended a splendid performance of Don Quixote by the Dutch National Ballet and was introduced to a great restaurant near the Music Theatre called "Heavenly Mud". Readers will find the details in A Day of Superlatives - Dutch National Ballet's Don Quixote 1 March 2018 in Terpsichore.


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