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Tuesday, 5 July 2011

If you think this is big, you should've seen the one that got away... MedImmune v Novartis [2011] EWHC 1669

…Call me Ishmael. Some years ago – never mind how long precisely – having little or no money in my purse, and nothing particular to interest me on TV, I thought I would commence reading some patent judgments and see a bit of the workings of the law.

Chief among my motives was the overwhelming idea of the great whale of a judgment itself. Such a portentous and mysterious monster roused all my curiosity. Then the wild and distant seas of jurisprudence where he rolled his island bulk; the undeliverable, nameless perils of the whale; these, with all the attending marvels of a thousand Patentability and Infringement-related sights and sounds, helped to sway me to my wish. With other Kats, perhaps, such things would not have been inducements; but as for me, I am tormented with an everlasting itch for things remote. I love to sail forbidden seas, and land on barbarous coasts (bordered, no doubt, by the treacherous rocks of prior art). And so I set sail...
Uttering profound apologies to the memory of Herman Melville for hijacking his text; this Kat believes his quest may be over. Sighted this morning, breaking the surface just off the Strand, the judgment of Mr Justice Arnold in MedImmune v Novartis [2011] EWHC 1669 (Pat) certainly fits the legend.

In characteristic style, the judgment is as comprehensive as one would wish. To be fair, this is not a simple case, dealing as it does with issues of infringement and validity of a family of patents in the field of biotechnology and immunology. The issues covered in the judgment span the gamut from construction and infringement through priority, obviousness and insufficiency to added matter. Nevertheless, containing a little over 71,000 words spread over 578 paragraphs and 161 pages - registering as a full 8.4 on the Arnold Scale - this is no lightweight. It is a judgment that one can almost hear proclaim “this is the law” (in a style redolent, no doubt, of Chris Morris introducing the news in The Day Today (see 0:25 in the clip)), before adding “and there are some factual matters too. Quite a few actually…”

For the budding pharmacologists and biotechnologists amongst you, the judgment commences with a rather nice introduction to the science of amino acids, proteins, nucleic acids, genes and genetic engineering. For those less interested in these matters, the discussion of the legal stuff commences around [91]. First, however, the context.

Evidently, there were some patents. The precise relationship between them requires this diagram (left) to explain. The patents were owned jointly by MedImmune and MRC, who alleged that they had been infringed by Novartis’ sales of ranibizumab, a pharmaceutical product sold under the trade mark Lucentis and is approved for the treatment of an eye condition known as wet age-related macular degeneration. Novartis counterclaimed challenging the priority of the patents, and also threw the invalidity kitchen sink at the claimants by alleging obviousness and insufficiency as well as challenging it on the basis of added matter.The Judge commenced his discussion of the law by identifying the skilled person – a team a team consisting of an immunologist and a molecular biologist with some experience in antibody engineering/protein chemistry/cell biology. He then considered the duties and responsibilities of the expert witnesses, noting that:
[114] “The law reports are littered with cases, including some patent cases, in which judges have criticised expert witnesses for failing to be objective or in other ways. It is regrettably true that from time to time an expert witness does succumb to the temptation of giving partisan evidence, and that is clearly unacceptable. But I wish to emphasise that the lawyers who instruct expert witnesses bear a heavy responsibility for ensuring that an expert witness is not put in a position where he can be made to appear to have failed in his duty to the court even though he conscientiously believes that he has complied with that duty. It is also important that courts should be cautious about criticising an expert witness purely on the basis of omissions from his report unless it is clear that the fault lies with the expert rather than those instructing him, bearing in mind that the court will not usually be privy to the expert’s full instructions (whatever may be the effect of CPR r. 35.10(4), which it is not necessary to go into for present purposes).”
With this in mind, Arnold J turned his attention to the experts in the case. Following some discussion on the matter, all were considered to have complied with their duties to the court.

Issues of construction are dealt with between [249] and [302]. There is little to report: the summary of the law given in Virgin Atlantic v Premium Aircraft Interiors [2009] EWCA Civ 1062, [2010] RPC 8 was applied and the relevant phrases found within the claims were construed in light of the specification and drawings. No dictionaries were harmed (or even mentioned) in the construction of the claims, which can only be a good thing.

Moving, then, to the question of priority (see [303] to [345]), the Judge referred to his own earlier opinion in Intervet UK v Merial [2010] EWHC 294 (Pat), which the parties agreed was an accurate summary of the relevant principles. Accordingly, the essential question was whether the relevant patents could find support from matters disclosed in the prior application – in this case a document referred to as PD3 (UK Patent Application No 9 024 503, filed 12 Nov 1990). Following in-depth consideration of the technical disclosure of PD3, Arnold J concluded that Novartis’ attack succeeded: neither of the claims under investigation were entitled to priority from PD3 – the earlier document’s disclosure had not directly and unambiguously given the skilled person what was in the claim whose priority was in question.

When assessing the obviousness of the patents, the Judge applied the tried and tested Pozolli reformulation of the classis Windsurfing test. There were two pieces of prior art over which the patents were claimed to be obvious: the first was a paper referred to as Parmley & Smith, and the second was a conference paper delivered by Professor Smith (of Parmley & Smith fame) in Banbury. Whereas the published paper was not considered to render the claimed inventions obvious, the Judge considered that:
[411] “…there can be no serious dispute that Professor Smith’s talk made it obvious to try phage display of antibodies provided that there was a sufficient expectation of success having regard to the other factors considered above. The only question is whether it would have given the skilled team a reasonable expectation of success within a reasonable time.”
The main issue was accordingly whether it was obvious to try the techniques described in the talk. Mr Justice Arnold explained that his
[412] “…assessment of the evidence as a whole is that the message Professor Smith conveyed was a positive one: he was reasonably confident of success, while recognising that success was not guaranteed because there were potential problems. Furthermore, as the skilled team would have appreciated, his confidence was not the result of blind optimism, but of the work and scientific analysis he had undertaken.”
The Judge continued, noting that:
[420] “Subject to consideration of the secondary evidence relied on by each side, the conclusion which I draw from the evidence is that Professor Smith’s talk at the Banbury Conference would have given the skilled team a reasonable expectation of success within a reasonable time. Not merely did he explicitly propose antibody phage display, but in addition he said that he was going to do the experiment. Furthermore, he addressed the concerns which arose out of Parmley & Smith and gave reasons as to why he nevertheless considered the experiment worth carrying out, as well as explaining potential solutions if problems were encountered. Finally, his tone was one of encouragement.”
Following discussion of the secondary evidence – some of which was alleged to suggest that the claimed inventions were not obvious (including Professor Smith’s own work in which he expressed disappointment with the results of some relevant experiments (see discussion at [431]), the reaction to the invention ([437])), and some the opposite (that other people had the same idea at around the same time (see [438] to [455])) – the Judge concluded that the claimed inventions were obvious in light of the prior art. He noted that:
[457] “…the Opposition Division rejected the allegation that 877 was obvious over Professor Smith’s talk at the Banbury Conference. This was on the ground, however, that “the contents of the oral disclosure by Dr Smith in April 1990 have not been sufficiently substantiated”: see [17.2]. It appears that the only evidence before the Opposition Division on this point was a declaration of Dr Plückthun (which is not in evidence before me) and Professor Smith’s grant application. By contrast, in the present case I have had the benefit of detailed evidence from Professor Smith. Furthermore, in the light of that evidence, MedImmune did not dispute the content of the disclosure.”
Moving on to the question of insufficiency, the Judge explained that
[458] “A patent is invalid “if the specification does not disclose the invention clearly enough and completely enough for it to be performed by a person skilled in the art” (section 72(1)(c) of the 1977 Act). Unlike section 32(1)(f) of the Patents Act 1949, the 1977 Act does not provide that it is a ground of invalidity that “any claim of the complete specification is not fairly based on the matter disclosed in the specification”. This is because no such ground is provided for by the EPC. Nor has the position changed in this respect following the coming into force of EPC 2000.”
Nevertheless, the House of Lords had considered, on no less than three occasions, how an overly broad claim might be struck down if mistakenly granted (in Biogen Inc v Medeva plc [1997] RPC 1; Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2004] UKHL 46, [2005] RPC 9; and Generics (UK) Ltd v H. Lundbeck A/S [2009] UKHL 12, [2009] RPC 13 – a useful summary of the findings of the last case is found at [475]).

Turning to the facts before him, Arnold J explained (at [485]) that the relevant claims were “method claims of fairly broad scope, and not claims to a single product.” To this extent, he noted, the facts were “much closer to Biogen v Medeva and Kirin-Amgen v Hoechst than it is to Generics v Lundbeck”.

He concluded that MedImmune was –
[491] “… correct to characterise the invention disclosed in the Patents as a principle of general application. At its core, it is a technique for selecting a binding molecule of interest from amongst a potentially large population of other binding molecules. The technique does not depend on the precise identity of the binding molecule. On the contrary, part of the usefulness of technique is that it can be applied to a diverse range of binding molecules, fragments and derivatives. Nor does the technique depend on the precise application which the user has in mind. Nor does implementation of the technique for the purpose of a new application involve undue burden on the part of the skilled team….”
Accordingly, the relevant claims were not invalid on grounds of insufficiency.

Added Matter
A patent is invalid, according to s72(1)(d) PA 1977 if “the matter disclosed in the specification of the patent extends beyond that disclosed in the application for the patent, as filed”. Lord Justice Jacob had summarised this (when Jacob J) in Richardson-Vicks’ Patent [1995] RPC 568 at 576 (this wording being subsequently adopted by the Court of Appeal in Vector Corp v Glatt Air Techniques Ltd [2007] EWCA Civ 805, [2008] RPC 10) as follows:

“I think the test of added matter is whether a skilled man would, upon looking at the amended specification, learn anything about the invention which he could not learn from the unamended specification.”

Applying this to the facts, Mr Justice Arnold was of the opinion that the specification as filed contained clear disclosure of the relevant material and the claims of the patents in issue accordingly did not disclose any new matter.

Turning finally to the issue of infringement, MedImmune had alleged that the process by which Novartis manufactured ranibizumab fell within their claims, and that accordingly the ranibizumab so produced was a product obtained directly by means of that process. This was important as the process in question was carried out in the U.S. and therefore s60(1)(b) could not bite (it requiring that the process be used in the UK). This left only s60(1)(c).

Novartis denied that the ranibizumab it produced was made by the patented process. The Judge agreed. Accordingly, there could be no infringement, but Arnold J nevertheless went on to consider the meaning of “product obtained directly” within s60(1)(c). He noted that the leading English authority on the section was the decision of the Court of Appeal in Pioneer Electronics Capital Inc v Warner Music Manufacturing Europe GmbH [1997] RPC 757. This he stated (at [539]) had “decided that a product could be obtained directly from a claimed process despite further processing provided that there was no loss of identity, there being no such loss where it retained its essential characteristics.” Rejecting Novartis’ arguments to the contrary, the Judge therefore concluded (at [549]) that if Novartis’ ranibizumab had been produced by a process falling within the relevant claims of MedImmune’s patents then it would have been a product obtained directly by means of that process, infringing under s60(1)(c). This conclusion was not affected by Art 8(2) of the Biotech Directive.

And thus, the whale is beached.

1 comment:

Anonymous said...

Length of 511 patent: 535 paragraphs plus tables, figures and claims. Length of judgment: 578 paragraphs. Which is more guilty of excessive length?

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