Does the doctrine of equivalents apply to novelty?
Patent practitioners have been speculating in recent weeks about what the Actavis v Eli Lilly Supreme Court judgment means in practice and how that decision might be applied. One issue is how far the doctrine of equivalents articulated by the Supreme Court extends - does it apply when novelty is being assessed? This is one of a number of interesting issues addressed in the recent decision of Generics (U.K.) Limited and others v Yeda Research and Development Company Limited and others [2017] EWHC 2629 (Pat) - the first application of Actavis v Eli Lilly in the Patents Court. The answer on novelty, according to Arnold J., is that the doctrine of equivalence does not apply. This marks a significant departure from the previous position that a patent claim be interpreted in the same manner for the purposes of validity and infringement.
Background
The Claimants, Mylan and Synthon, sought revocation of European Patent (UK) No. 2 949 335 entitled "Low frequency glatiramer acetate therapy". Yeda is the registered proprietor of the Patent and Teva is the exclusive licensee. The Patent is directed to a dosage regimen for the administration of glatiramer acetate (GA) for the treatment of relapsing forms of multiple sclerosis consisting of three subcutaneous injections of 40 mg GA every seven days with at least one day between each injection.
Teva markets GA 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. The Claimants have previously introduced a 20 mg GA generic product, and here they sought 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. There was no dispute that, if the Patent is valid, the Claimants' intended acts in relation to their product would infringe it.
Application of the doctrine of equivalents
Before the recent Supreme Court decision in Actavis v Eli Lilly, it was settled law that the claim should be interpreted in the same manner for considering the purposes of novelty and infringement. One issue upon which the Supreme Court judgment is silent is whether the doctrine of equivalents has any impact on the law of novelty (the Supreme Court's 3-step formulation is replicated at the end of this post for ease of reference). Arnold J. explained that he would not consider this matter at length, given that he held the Patent invalid for obviousness in any event.
The Claimants submitted that it remained the law that a claim lacked novelty if the prior publication disclosed subject-matter which, if performed, would necessarily infringe the claim. Even if the subject-matter would not fall within the claim on its proper interpretation, it was sufficient that the subject-matter would infringe the claim applying the doctrine of equivalents. Otherwise, a claim could be infringed by a person who did exactly what the prior publication taught, yet the claim would be novel over that prior publication, and that would be a radical departure from English patent law as it had previously been understood for many decades.
The Defendants maintained that a 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. This was because: (1) in Synthon v SKB (which is authority for the proposition that what infringes must constitute disclosure) - the House of Lords had not been considering the question of anticipation by equivalents, because at that time it was not possible to infringe by virtue of a doctrine of equivalents if the alleged infringement fell outside the claim on its proper interpretation; (2) it is established in the jurisprudence of the Boards of Appeal of the EPO that a claim is not deprived of novelty by an obvious equivalent of a feature in a prior publication; and (3) the decision of the Supreme Court was based on Article 2 of the Protocol on the Interpretation of Article 69 of the European Patent Convention, which is concerned with the extent of protection conferred by a European patent or patent application (i.e. infringement, not validity).
The judge concluded without further elaboration that the Defendants' position is correct, i.e. the doctrine of equivalents has no application in the law of novelty. However, in case he was wrong, the judge went on to consider whether the patent would have lacked novelty on the basis of a doctrine of equivalents, and concluded that the claims would have indeed been anticipated by the "Pinchasi" prior art cited by the Claimants (see paragraphs 167 - 173 for further details of that analysis).
Availability of Arrow declarations?
In addition to their application for revocation of the Patent, the Claimants sought an Arrow declaration (following recent confirmation from the Court of Appeal that there is jurisdiction to grant such relief - see previous IPKat posts here and here). By way of background, the Patent stems from a divisional of European Patent 2 405 749 ('749). On 2 February 2017 Teva withdrew the text of '749 before a Technical Board of Appeal could rule upon its validity in the light of (among other citations) Pinchasi. There was no dispute that Teva has filed two further pending divisional applications which cover the 40 mg TIW regimen for administration of GA, namely European Patent Applications Nos. 2 630 962 ("962A") and 3 199 172 ("172A"). The declaration sought by the Claimants was as follows:
"A declaration that the use of the Claimants' Product for treating a patient suffering from relapsing forms of MS wherein the Claimants' Product comprises glatiramer acetate for administration 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 would have lacked novelty and/or been obvious as at 20 August 2009 insofar as the dosing regimen is concerned."
Applying the principles laid down by the Court of Appeal in FKB v Abbvie, Arnold J. declined to grant an Arrow declaration, principally because it would have no greater persuasive value than the reasoned judgment of the Court on the validity of the Patent (see paras 205-212 for further details).
Guidance on multiple expert witnesses
The Court also provided stern guidance for litigants who rely upon duplicative expert evidence in patent cases. It was common ground between the parties at the CMC that there was potentially a need for expert evidence in the fields of (i) clinical treatment of MS, (ii) neurology and (iii) statistical analysis of clinical trials. The Claimants put forward one expert to cover all three issues, while the Defendants called two expert witnesses, whose reports "substantially duplicated each other. The duplication was made manifest, rather than avoided, by the fact each expert repeatedly stated that he agreed with passages in the other expert's reports." The judge noted that "where parties adduce evidence from more than one expert, the evidence of the respective experts should be clearly delineated. Parties who flout the guidance which the courts have repeatedly given can expect to be heavily sanctioned in costs. " (para 83)
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Actavis v Eli Lilly questions (para 66 of Supreme Court judgment):
"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?
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?"
Background
The Claimants, Mylan and Synthon, sought revocation of European Patent (UK) No. 2 949 335 entitled "Low frequency glatiramer acetate therapy". Yeda is the registered proprietor of the Patent and Teva is the exclusive licensee. The Patent is directed to a dosage regimen for the administration of glatiramer acetate (GA) for the treatment of relapsing forms of multiple sclerosis consisting of three subcutaneous injections of 40 mg GA every seven days with at least one day between each injection.
Application of the doctrine of equivalents
Before the recent Supreme Court decision in Actavis v Eli Lilly, it was settled law that the claim should be interpreted in the same manner for considering the purposes of novelty and infringement. One issue upon which the Supreme Court judgment is silent is whether the doctrine of equivalents has any impact on the law of novelty (the Supreme Court's 3-step formulation is replicated at the end of this post for ease of reference). Arnold J. explained that he would not consider this matter at length, given that he held the Patent invalid for obviousness in any event.
The Claimants submitted that it remained the law that a claim lacked novelty if the prior publication disclosed subject-matter which, if performed, would necessarily infringe the claim. Even if the subject-matter would not fall within the claim on its proper interpretation, it was sufficient that the subject-matter would infringe the claim applying the doctrine of equivalents. Otherwise, a claim could be infringed by a person who did exactly what the prior publication taught, yet the claim would be novel over that prior publication, and that would be a radical departure from English patent law as it had previously been understood for many decades.
The Defendants maintained that a 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. This was because: (1) in Synthon v SKB (which is authority for the proposition that what infringes must constitute disclosure) - the House of Lords had not been considering the question of anticipation by equivalents, because at that time it was not possible to infringe by virtue of a doctrine of equivalents if the alleged infringement fell outside the claim on its proper interpretation; (2) it is established in the jurisprudence of the Boards of Appeal of the EPO that a claim is not deprived of novelty by an obvious equivalent of a feature in a prior publication; and (3) the decision of the Supreme Court was based on Article 2 of the Protocol on the Interpretation of Article 69 of the European Patent Convention, which is concerned with the extent of protection conferred by a European patent or patent application (i.e. infringement, not validity).
The judge concluded without further elaboration that the Defendants' position is correct, i.e. the doctrine of equivalents has no application in the law of novelty. However, in case he was wrong, the judge went on to consider whether the patent would have lacked novelty on the basis of a doctrine of equivalents, and concluded that the claims would have indeed been anticipated by the "Pinchasi" prior art cited by the Claimants (see paragraphs 167 - 173 for further details of that analysis).
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Availability of Arrow declarations?
In addition to their application for revocation of the Patent, the Claimants sought an Arrow declaration (following recent confirmation from the Court of Appeal that there is jurisdiction to grant such relief - see previous IPKat posts here and here). By way of background, the Patent stems from a divisional of European Patent 2 405 749 ('749). On 2 February 2017 Teva withdrew the text of '749 before a Technical Board of Appeal could rule upon its validity in the light of (among other citations) Pinchasi. There was no dispute that Teva has filed two further pending divisional applications which cover the 40 mg TIW regimen for administration of GA, namely European Patent Applications Nos. 2 630 962 ("962A") and 3 199 172 ("172A"). The declaration sought by the Claimants was as follows:
"A declaration that the use of the Claimants' Product for treating a patient suffering from relapsing forms of MS wherein the Claimants' Product comprises glatiramer acetate for administration 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 would have lacked novelty and/or been obvious as at 20 August 2009 insofar as the dosing regimen is concerned."
Applying the principles laid down by the Court of Appeal in FKB v Abbvie, Arnold J. declined to grant an Arrow declaration, principally because it would have no greater persuasive value than the reasoned judgment of the Court on the validity of the Patent (see paras 205-212 for further details).
Guidance on multiple expert witnesses
The Court also provided stern guidance for litigants who rely upon duplicative expert evidence in patent cases. It was common ground between the parties at the CMC that there was potentially a need for expert evidence in the fields of (i) clinical treatment of MS, (ii) neurology and (iii) statistical analysis of clinical trials. The Claimants put forward one expert to cover all three issues, while the Defendants called two expert witnesses, whose reports "substantially duplicated each other. The duplication was made manifest, rather than avoided, by the fact each expert repeatedly stated that he agreed with passages in the other expert's reports." The judge noted that "where parties adduce evidence from more than one expert, the evidence of the respective experts should be clearly delineated. Parties who flout the guidance which the courts have repeatedly given can expect to be heavily sanctioned in costs. " (para 83)
***************************************************************
Actavis v Eli Lilly questions (para 66 of Supreme Court judgment):
"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?
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?"
