The High Court has handed down its decision in the latest patent dispute relating to glatiramer acetate (GA), the immunomodulator drug marketed by Teva under the brand name Copaxone for the treatment of multiple sclerosis (MS) . The Claimants, Mylan and Synthon, successfully sought revocation of Yeda’s patent (of which Teva is the exclusive licensee) concerning a dosage regimen for GA. This is the third case relating to GA since 2012; a fourth, in relation to preparation processes, is already listed for early 2018.
While the case is in many respects a typical pharmaceutical patent case, with the patent being revoked on grounds of obviousness (and insufficiency), of particular interest is that the Court considers the implications of two recent developments in English patent law: first, the doctrine of equivalents, following the recent Supreme Court decision in Actavis v Lilly; and second, the re-emergence of Arrow declarations in FKB v AbbVie.
In respect of the doctrine of equivalents, there has been considerable commentary following the Supreme Court’s decision in respect of how the doctrine will impact on novelty, in particular whether finding an equivalent in the prior art would anticipate a patent. The answer which Arnold J reached, albeit briefly (and in obiter), is that the doctrine does not apply (though if it did the patent would be anticipated, illustrating the potency such an attack might have).
Arnold J also considered Arrow declarations, declining to grant them on the basis that in this case they would provide no useful purpose beyond that provided by the reasoned judgement on the validity of the patent.
Novelty and equivalents
The case is the first substantive decision from the High Court to consider the question of equivalents since the Supreme Court’s decision in Actavis. However, this case considered the doctrine under a significantly different guise, namely novelty. This immediately created the converse scenario to Actavis in that the patentee was arguing for a narrow construction to avoid invalidity rather than a broad construction to increase the scope of protection (as in Actavis).
Since the House of Lords decision in Synthon, it has been settled law that a claim should be interpreted in the same manner, and have the same scope, for the purposes of considering novelty and infringement. As remarked by Arnold J, the Supreme Court in Actavis did not mention the impact of its decision on novelty. Of course, this was simply because novelty (or indeed any heading of validity) was not in suit.
The prior art in the present case disclosed a dosage regimen which on its face differed from that claimed in the patent:
While different on their face, over a seven day period the regimens can be identical and even over a longer period they would be identical every other week.
The question to be considered was whether the prior art regimen anticipated the patent on the basis that if it was performed it would infringe the patent. Significantly, the Court was asked to address the impact of the new two-part test for infringement set out by the Supreme Court in Actavis:
(1) does the variant infringe any of the claims as a matter of normal interpretation; and, if not,
(2) does the variant nonetheless infringe because it varies from the invention in a way or ways which is or are immaterial? [the doctrine of equivalents].
Assessment of part one
Concerning the first part of the test, there had been some discussion following the decision about whether Lord Neuberger intended by the phrase "normal" interpretation to change the way in which patent claims are construed (ie prior to coming to the question of equivalents). Arnold J ruled that this was not Lord Neuberger’s intention; "normal" interpretation was still to be given a purposive construction and the patent was still to be interpreted through the eyes of the person skilled in the art. He referred to this for the rest of the decision as "proper interpretation".
Following this test, Arnold J found that the prior art dosage did not infringe as a matter of proper construction. He found that the skilled person would regard the regimens as distinct. Furthermore, the regimens result in the administration of different quantities of GA over any period longer than one week. The patented regimen also has advantages that the prior art does not have (eg enabling fixed-day administration and injection-free weekends).
Assessment of part two
The key issue to decide in respect of Part Two was whether this part of the test, the doctrine of equivalents, can be taken into account when assessing novelty at all as a matter of principle.
The Claimants argued that the law remained the same; a claim lacked novelty if the prior publication disclosed subject-matter which, if performed, would necessarily infringe the claim. Such infringement would now include infringement by equivalence. To decide otherwise risked potential situations where performing the prior art could lead to you infringing the claims of a later patent, and would be a radical departure from English patent law.
The Defendants submitted that the law was now that a claim would lack novelty over the prior art if the prior art disclosed subject-matter which, if performed, would fall within the claim on proper interpretation only (Part One of the test). The Defendants made their arguments under three points:
- the principle relied on in Synthon could only have taken into account proper interpretation and not equivalence since the House of Lords could not have been considering equivalents given the law at the time did not include them
- the jurisprudence of the EPO Board of Appeal was that a claim is not deprived of novelty by an equivalent in a prior publication, and
- the decision in Actavis was based on Article 2 of the Protocol on the Interpretation of Article 69 of the EPC which is concerned with the extent of protection conferred by a patent, ie infringement, and not validity.
Arnold J concluded that the Defendants were right.
On this basis, Actavis has, to an extent, severed the link between claim interpretation and scope for novelty and infringement, and the doctrine of equivalents is confined to considerations of infringement. Despite having provided a view, the judge remarked that ultimately it is likely the Supreme Court will have to provide a definitive answer.
Further, in case he was wrong, Arnold J went on to consider if the patent would have lacked novelty on the basis of the doctrine of equivalents being applied to the prior art; and he held that it would. In doing so, he addressed the new three-stage test for infringement by equivalence, adopting the amended (or improved) version of the Improver or Protocol questions:
(i) notwithstanding that it is not within the literal meaning of the relevant claim(s) of the patent, does the variant achieve substantially the same result in substantially the same way as the invention, ie the inventive concept revealed by the patent?
(ii) would it be obvious to the person skilled in the art, reading the patent at the priority date, but knowing that the variant achieves substantially the same result as the invention, that it does so in substantially the same way as the invention?, and
(iii) would such a reader of the patent have concluded that the patentee nonetheless intended that strict compliance with the literal meaning of the relevant claim(s) of the patent was an essential requirement of the invention?
On question (i) Arnold J decided that, where there was no evidence to show conclusively that the variants achieved substantially the same result, it would be a matter to determine on the balance of probabilities. In this case, with no clinical trial to show that the results would be substantially the same, he relied on the expert evidence to find that this was the case and that the answer to question (i) (and question (ii) would) be "yes".
In considering question (iii), Arnold J appears to have applied a high threshold, looking to identify something written into the specification to suggest to the skilled reader that strict compliance with the literal meaning of this feature of claim 1 was required. He said he found nothing. The Defendants argued that the skilled reader would understand strict compliance was required on the basis that it would avoid the prior art and to convey the benefits of the patented regimen over the prior art. Arnold J rejected both of these submissions. On the former, he commented that in the absence of an express reference in the patent to the prior art in question, the skilled reader would not understand that the claim was intended to avoid it.
In addition to challenging the validity of the patent, the Claimants also sought an Arrow declaration that the use of their product (which was identical to the patented regime) would have lacked novelty and/or been obvious at the priority date. This was in part because it was acknowledged by the parties that further divisional applications covering the regimen in the disputed patent had been applied for and were pending.
Arnold J considering the principles applied in AbbVie both by the Court of Appeal and decisions by Carr J in the High Court. In particular, he found that:
- a finding of lack of novelty and/or obviousness is a necessary, but not sufficient, foundation for the grant of a declaration
- simply identifying pending divisionals is not sufficient justification on its own for the grant of a declaration and the court must exercise its discretion
- there was no attempt to inappropriately shield the patent from scrutiny in the UK, and that a stated intention to defend a patent portfolio is not, by itself, an issue, and
- where a court will be providing a reasoned judgment on the validity of the patent, an Arrow declaration is likely to provide no greater persuasive value or additional commercial certainty.
Overall, the final point appears to have been particularly fatal to the grant of declaration in this case.
In respect of the doctrine of equivalents, a significant aspect of this decision is that the ripples from the Actavis decision seem to have fallen short of impacting upon novelty (at least for now). The case nonetheless illustrates the potency that such a novelty attack might have and so it is very likely that this will continue to be tested by parties seeking to revoke a patent.
As for Arrow declarations, the gap in such relief being considered by the UK Courts was previously ten years; between the original Arrow decision and FKB earlier this year. It will be interesting to see if this case marks the onset of more attempts to seek such relief. It remains to be seen what proportion of such attempts will be successful.
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