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)
***************************************************************
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?"
Does the doctrine of equivalents apply to novelty?
Reviewed by Eibhlin Vardy
on
Tuesday, October 31, 2017
Rating:
Reviewed by Eibhlin Vardy
on
Tuesday, October 31, 2017
Rating:
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Posts
I'm having difficulty following the Claimant's argument, as set out in the para above that begins "The Claimants submitted that it remained the law that....."
ReplyDeleteI suspect the logic is faulty. Somehow, the tail is wagging the dog. You know, like, "All dogs have tails. That animal has a tail. Therefore that animal is a dog."
Then again, I have yet to drink my strong morning coffee. Am I missing something?
I wonder whether the novelty assessment was even done correctly. I have already written a post about it so won't elaborate any further here, but suffice to say that I suspect Arnold J may have got it wrong again. If any chemistry-types can show how my analysis is wrong on claim construction, I'm happy to be corrected.
ReplyDeleteI don't think you're missing anything Max. I suspect Arnold J did not intend to say that the law of inherency no longer applied, but just that he agreed with the argument that novelty only applied to literal disclosure and not equivalents too.
ReplyDeleteI am confused.
ReplyDeleteMy understanding of the decision is that novelty cannot be destroyed by an equivalent (e.g. something outwith the literal scope of the claim).
Actavis though says that that same equivalent may infringe the claim post grant.
A claim can thus be novel over a 54(3) disclosure which is equivalent to the claimed subject matter, but then post grant it can be infringed by the embodiments of that same disclosure.
Something is wrong here. Is it my understanding?
As I wrote on the Tufty thread, in EPC-land in general, there is nothing sacrosanct about the mantra "if what comes after infringes then, if it had instead come before, it would have prejudiced novelty". Activis v Lilly is just one more example of English law getting into alignment with EPC-land.
ReplyDeleteAs far as I know, the accused act, found to infringe, was novel and not obvious.
Suppose in the case next up for assessment by the English courts, the accused act is one that was old or obvious. Then the stage is set for England to create its own form of the long-established Formstein Defence, a pillar of patent law in Germany:
https://en.wikipedia.org/wiki/Formstein_defence
But if I'm wrong about this, somebody please say.
Per the link you reference, and my earlier understanding, the Formstein defence is similar to the UK's Gillette defence and the U.S. Wilson case, so I don't understand your point.
ReplyDeleteWow, Arnold really has stumbled into a minefield here. By deciding that doctrine of equivalents is not relevant to novelty (rather than fudging it) he is opening up an interesting Pandora's Box. That I am sure will be reversed on appeal as something that the UK cannot accept, which means that the validity of patents will be attackable in future cases using a doctrine of equivalents interpretation of the claims.
ReplyDeleteI have gained a new respect for Arnold as agent provocateur
I do not know why Arnold went as far as agreeing with the defendant's assertion (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).
ReplyDeleteA possible way for him to duck the issue completely would have been to allude to a possible Gillette / Formstein defence, wherein embodiments disclosed in the prior art cannot be "equivalents" of the claimed invention.
Nevertheless, his controversial conclusion has certainly made things interesting. I will be getting the popcorn out for the sequel(s) to this case!
I continue to be nonplussed by the various replies here.
ReplyDeleteNeuberger went out of his way to distinguish between scope of protection and claim construction. That alone dishes the "What comes before...." mantra, doesn't it?
Formstein says nothing about the validity (or invalidity) of the asserted claim, just that its scope of protection cannot reach those who perform an obvious variant of the prior art. Formstein is a defence to infringement, not a proof of invalidity.
Where does this leave Arrow Declarations? In the clear, I should have thought.
Two related points I think from two good comments.
ReplyDeletePudding: "embodiments disclosed in the prior art cannot be "equivalents" of the claimed invention."
I don't disagree that this is one solution to the problem. The somewhat disquieting consequence is that the scope of the patent claim would then vary dependent upon the prior art. The patent is no longer a self contained document upon which the public can rely to indicate the scope of monopoly.
Max: "Formstein is a defence to infringement, not a proof of invalidity."
And this, I think, is the point of departure between your view and mine. My expectation is that if a claim covers something which is old or obvious then it must be invalid.
Max Drei,
ReplyDeleteIs this a bifurcation/non-bifurcation issue?
If a Gillette defence is successful in the UK, the patent would, I think, be held infringed but not valid (broad claim construction) or not infringed and valid (narrow claim construction).
If there is a clear anticipation and literal infringement the decision would be, I believe, that the patent would have been infringed but it is not valid, the end result would be revocation.
Pumfrey may have been conflating two issues, but it was the principle he was talking about. A UK eye finds it difficult that a Court could hold that someone infringes an invalid patent without going on to say but it is invalid and then revoke it.
I suspect Arnold does not like Neuberger's decision, hence him flagging the novelty issue.
In older days, in Germany, equivalents were considered under the heading novelty. At least in EPO practice, equivalents are excluded when it comes to novelty. And that is why we have a coherent set of case law from the Boards.
ReplyDeleteI dare think of the consequences if this would not be any longer the case. Then the all set of decisions of the BA on novelty, priority, added matter would become obsolete.
Where would we end with the certainty presently found in the case law of the Boards being put aside?
Arnold hasn't understood what 'inventive concept' means in the Actavis v Lilly questions (in the way that I think Neuberger understood it). The inventive concept must (surely?) necessarily relate to novel and inventive subject matter, and therefore the prior art will necessarily be excluded from being an equivalent. I cannot believe an appeal court in the UK would ever come to a different understanding. Arnold's dislike of the Supreme Court decision is no excuse for him to have a tantrum about it.
ReplyDeleteQuick reaction to Observer, who writes above that if the claim covers something old or obvious it must be invalid. Operative word "covers". Neuberger went out of his way to distinguish "covers" from "means". That's an earthquake in England, but for mainland Europe merely a statement of the status quo.
ReplyDeleteIf the accused act is something that was old or obvious, it would be unjust to find it to infringe. Formstein is a defence to infringement.
In Activis the claim was to disodium, the accused act dipotassium. Dipotassium was not part of the prior art, disodium not old and not obvious.
But with the re-formulated Improver questions, dipotassium can fall within reach of the disodium claim, by its being found an Art 69 Protocol "equivalent".
Some people here in Germany put it this way: that to be an "equivalent" it has to be new and inventive. I think that's a misleading way to express it. Better to think about old or obvious as a rebuttal to the charge of infringement. If memory serves, Neuberger muttered something about equivalents and inventiveness, in Germany, somewhere in his Opinion.
An artefact of bifurcation? Quite possibly. But can it withstand the intellectual fightback by the English patent judges. Let us see.
@Observer
ReplyDelete"The patent is no longer a self contained document upon which the public can rely to indicate the scope of monopoly".
Well, that conclusion was already pretty clear from the Supreme Court's decision (especially the use of hindsight and/or expert opinion to determine what is an "equivalent" of the claimed invention).
What troubles me most about this is that it leaves the door open for a (deliberately) "narrow" claim to be afforded - by the doctrine of equivalents - a scope of protection that captures embodiments disclosed in the prior art. The particular absurdity about this is that a broader version of the same claim would have been invalidated by the same prior art disclosures (if those disclosures fall within the scope of the claim "as a matter of normal interpretation").
If careful (narrow) claim drafting will enable patent holders to prevent the public from performing the prior art, then this begs the question of why we bother with all this troublesome examination of patents in the first place. I mean, what is the point of carefully examining the validity of a claim "as a matter of normal interpretation" if a completely different standard (effectively no examination for validity) will be applied to the additional scope of protection provided by "equivalents" of the claimed invention?
The Protocol on interpretation applies to Article 69 only, not Article 54 EPC.
ReplyDeleteAt some point a Court is going to have to decide how the new Improver questions apply to a disclaimer. Presumably the questions will be used to derive a smaller version of the disclaimed scope to try and catch a possible infringer. Given that the test does not affect novelty it could be used to mitigate the loss of scope due to the disclaimer, unless of course a disclaimer requires 'strict compliance with literal meaning'
ReplyDeleteDoes anyone understand where this leaves the third of the new protocol questions?
ReplyDelete“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?”
If “strict compliance” has no relevance for validity then why would the patentee ever have such an intention? Why would anyone voluntarily give up protection?
The previous formulation of the question was about interpretation and written with the validity/infrigment balance in mind. The patentee may want a narrow claim to be safe on validity even if the prior art so far on record may have allowed a broader claim.
There now seems to be no upside to strict compliance - so why in future (leaving aside the intent of old patents may have had the old law in mind) would the skilled person ever think that a patentee intended to let infringers off the hook?
It's only an equivalent if it is obvious to the skilled person... this works backwards too. If the variant predates the patent the patent must be obvious over the variant. So any infringement by equivalence of a product predating the patent is impossible? Is that right?
ReplyDelete