SEEING that Kluwer Patent Blog's best author has just dealt with the EPO's controversial "Closest Prior Art" approach ([1] below; we wrote about this in [1, 2, 3, 4]), and moreover seeing that the UK Supreme Court [2,3] threw out European Patents that "sought to cover genetically modified mice that contain chimeric human-mouse antibody genes, as well as human antibodies made using those mice," we're witnessing yet more evidence of the comprehensive failure of the EPO under Benoît Battistelli and António Campinos, whose rush to grant as many patents as possible by rushing searches (aka Early Certainty From Google) led not only to grants of software patents in Europe but also grants/awards of monopolies that courts everywhere would reject (if one can afford the legal challenge; it's expensive to appeal all the way up to the UK Supreme Court). AstraZeneca Kat wrote about it yesterday [2], calling it "a majority judgment"; why were these patents granted in the first place? And how many European Patents, if scrutinised properly, would suffer the same fate? SUEPO showed (about a year ago) how legal validity associated with European Patents had collapsed. One can guess how the EPO's management responded. ⬆
As readers of this blog will be aware, the EPO applies a quite peculiar and unique method to the analysis of inventive step, the “problem-solution approach”. This approach breaks the statutory question of Art 56 whether the invention was, having regard to the state of the art, obvious to a person skilled in the art, down into a 3-step test. This involves (1) the determination of the “closest prior art”, (2) the formulation of the “objective technical problem”, and (3) the assessment whether or not the claimed invention would have been obvious to the skilled person. One might quip that this approach has replaced a single problem (the determination of obviousness/inventive step) with three problems. This is because parties nowadays frequently argue about (i) what the closest prior art was, (ii) what the objective problem was, and of course (iii) whether the invention, expressed as the solution to the objective technical problem, was obvious or not at the priority or filing date. This contribution will focus on question (i), i.e. the question of what is (or should be) the closest prior art, and whether the EPO’s approach towards the closest prior art has changed in the last couple of years.
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The concept of the closest prior art within the problem solution approach has been invented to facilitate and objectivize the examination of inventive step. The facilitation resides in the presumption that if the invention is not obvious starting from the closest prior art document, then it will a fortiori also be non-obvious starting from further remote prior art. Thus, if and when one document can be identified clearly as being closest prior art, the examination of inventive step can be focused and limited on this one document (in combination with any further document from the state of the art). The question is what happens in cases where (a) several documents are (arguably) about equally close to the invention and (b) if no document qualifies as a sensible starting point. In scenario (a), an Opponent was, at least in the past, usually allowed to present multiple attacks for lack of inventive step even if they start from different “closest” prior art documents.
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At present, T 320/15 seems to not have been used by other Boards to prevent an Opponent from presenting more than one inventive step attack. Therefore, one should not overestimate the practical relevance of this decision, in particular for the appeal stage. This is even more so because several recent decisions rather point in the opposite direction, supporting a more liberal approach for the choice of the starting point for the assessment of inventive step.
Albeit in a somewhat unusual context, the criteria for the determination of the closest prior art were put to a test in T 405/14. In this case, the Appellant argued that the skilled person would never start from document D2 when document D1 was available. This argument relied on the view that document D1, in addition to sharing many features with the claimed invention, also addressed the same problem as the invention, which was (arguably) not the case for D2.
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This would then no longer be so different from the inventive step approaches taken by at least some national courts in EPC member states. In Germany, for example, the concept that there is a preference of a “closest” prior art and that the examination of inventive step can be stopped once it has been shown that the invention is not obvious starting from the “closest prior art”, has long been dismissed and criticized. The prevailing opinion in Germany is that inventive step must be present vis à vis the entire prior art and should not depend on the choice of the starting point in an individual case.
The UK Supreme Court today found Regeneron's valuable antibody platform technology patents invalid for insufficiency. In doing so, the UK Supreme Court overturned the Court of Appeal decision and confirms the strong sufficiency requirement in the UK. The Supreme Court decision places emphasis on the principle of sufficiency that a patent claim should be enabled across its whole scope. As summarised by the UK Supreme Court itself, the Court of Appeal reasoning was seen as increasing the rewards obtainable by inventors in a complex, rapidly developing field like genetic engineering. The Supreme Court found in a majority ruling that the Court of Appeal swayed the balance too much in favour of patentees in a way that was not warranted by UK or EPO law. The full UK Supreme Court judgment can be read here.
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In a majority judgment, the UK Supreme Court found the Court of Appeal's reasoning logically sound, but ultimately considered it to be inconsistent with the UK and EPO law on insufficiency. In particular, the UK Supreme Court understood the principle that a patent should enable substantially all products within the scope of a claim at the priority date to be part of the bedrock of both UK and EPO law. In the words of Lord Briggs, who led the majority judgment, "[t]o water down that requirement would tilt the careful balance thereby established in favour of patentees and against the public in a way which is not warranted by the EPC, and which would exceed by a wide margin the scope for the development of the law by judicial decision-making in a particular Convention state".
The Supreme Court thus did not think the patent bargain was satisfied if the benefits of an invention could only be realised after the priority date, if and when all embodiments within the range could be made. Kymab's appeal was therefore upheld, and the Regeneron patents found invalid for insufficiency.
In a dissenting view, Lady Black first noted agreement between the Court of Appeal and Supreme Court on the legal principles. For Lady Black, the two courts disagreed in the application of these principles to the case in question. Contrary to the Supreme Court majority, Lady Black agreed with the Court of Appeal that the invention related to a broad general principle, that this principle was employed in all mice across the range of the claim, and that the patent should be rewarded by a commensurate broad scope of protection.
A key part of the UK Supreme Court judgment are the "principles of sufficiency" provided on paragraph 56. According to principle vi)
"the patentee has to demonstrate in the disclosure that every embodiment within the scope of the claim has been tried, tested and proved to have been enabled to be made. Patentees may rely, if they can, upon a principle of general application if it would appear reasonably likely to enable the whole range of products within the scope of the claim to be made. But they take the risk, if challenged, that the supposed general principle will be proved at trial not in fact to enable a significant, relevant, part of the claimed range to be made, as at the priority date" (emphasis added).
Chalk one up for antibody maker Kymab. The U.K. Supreme Court invalidated a pair of Regeneron patents around antibody-producing mice, putting to rest a lawsuit Regeneron filed against Kymab seven years ago.
Known as patents ‘287 and ‘163, or the “Murphy patents,” they sought to cover genetically modified mice that contain chimeric human-mouse antibody genes, as well as human antibodies made using those mice. Regeneron sued Kymab in U.K. High Court in 2013 alleging that its Kymouse technology infringed patents covering its Velocimmune platform.
The Supreme Court upheld 4-1 the decision of a High Court from 2016 to revoke Regeneron’s claims, reversing an Appeals Court’s verdict that the patents were valid.
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The U.K. verdict is just the latest in a string of decisions that have come down on Kymab’s side. In April, the U.S. Patent and Trademark Office’s Trial and Appeal Board shut down a request from Regeneron to invalidate four Kymab patents. And that decision followed similar ones from patent offices in Japan and Australia—the Japanese Patent Office upheld Kymab’s patents in unappealable decisions, while IP Australia rejected Regeneron’s opposition to a Kymab patent on all grounds. Regeneron has appealed the latter decision.
For its part, Regeneron emphasized that the Supreme Court decision applies only within the U.K.
"The decision renders the two patents invalid and revoked in the UK only. Regeneron’s rights concerning these patents in other European jurisdictions remain in full force and effect," the company said in a statement. "The 287 patent validity was upheld at the Europe-wide level by the Technical Board of Appeal of the European Patent Office (“EPO”) in 2015, and the 163 patent validity was upheld by EPO Opposition Division in 2018. Proceedings before the EPO’s Technical Board of Appeal on the 163 patent are ongoing.