A principle of general application?

Author: Darren Smyth (EIP, London)

Regeneron Pharmaceuticals Inc v Genentech Inc [2012] EWHC 657 (Pat), Patents Court, England and Wales, 22 March 2012

Journal of Intellectual Property Law & Practice (2012) doi: 10.1093/jiplp/jps087, first published online: June 19, 2012

The Patents Court, England and Wales, has upheld the validity of a claim expressed in broad functional terms and, in relation to sufficiency, has, unusually, considered that the invention relates to a ‘principle of general application’ as set out by the House of Lords in Biogen Inc v Medeva plc [1997] RPC 49.

Legal context

In European patent law, there is no specific prohibition on claiming an invention in broad terms. The closest legal provision, that the claims must be ‘supported by the description’ (Article 84 of the European Patent Convention, EPC) is not a ground of invalidity of a patent. However, a claim that is expressed in broad terms will frequently be found either to lack inventive step (because it encompasses obvious subject matter) or to be insufficient.

The requirement for sufficiency is expressed in Article 83 EPC: ‘The European patent application shall disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art.’ Within this broad requirement, UK jurisprudence has established three ways in which insufficiency can arise: classical insufficiency, ‘Biogen insufficiency’ or insufficiency by excessive claim breadth, and insufficiency by ambiguity.

In Biogen the leading judgment stated: ‘If the invention discloses a principle capable of general application, the claims may be in correspondingly general terms’. Therefore, the criterion to be satisfied for a claim which is framed in broad terms to be found sufficient according to Biogen is that it involves ‘a principle capable of general application’.

Accordingly, patentees frequently argue that their invention discloses a principle capable of general application, but cases where this has been accepted are rare. It was recently acknowledged in H. Lundbeck A/S v Norpharma SpA [2011] EWHC 907 (Pat), where the following claim was held not to be insufficient (although the patent was held invalid on other grounds): A process for the synthesis of citalopram, in which a process for the synthesis of [intermediate] according to claim 1 is contained. However, in that case, the part of the claim that was expressed broadly was that part that was peripheral to the actual invention.

Facts

The Genentech patent at issue is EP 1238986 and relates to VEGF. VEGF was known at the priority date as one of a number of angiogenic growth factors (others included FGF, PD-ECGF, EGF, TGF-ß, TNF-α, angiogenin and angiotropin). Because angiogenesis (or neo-vascularisation—the process of new blood vessel growth by outgrowth from pre-existing vessels) is implicated in a large number of diseases, including cancer, rheumatoid arthritis, macular degeneration, and atherosclerosis, a growth factor whose activity could be targeted to control angiogenesis would have been therapeutically highly desirable. However, it was not known that VEGF was such a growth factor.

The main claim of the patent was in the following terms:

Use of a hVEGF antagonist in the preparation of a medicament for the treatment of a non-neoplastic disease or disorder characterised by undesirable excessive neovascularisation, wherein the hVEGF antagonist is:

(a) an anti-VEGF antibody or antibody fragment;

(b) an anti-VEGF receptor antibody or antibody fragment; or

(c) an isolated hVEGF receptor.

Regeneron and Bayer sought revocation of the patent, and also a declaration that a product to be marketed by Regeneron under licence from Bayer called VEGF Trap Eye (VTE) did not infringe.

VTE was found to infringe the patent on the basis that it satisfied the definition of (c) in the claim, even though it did not include the whole of the hVEGF receptor sequence.

The claim was found to involve an inventive step over the pleaded closest prior art, a paper entitled ‘The vascular endothelial growth factor proteins: identification of biologically relevant regions by neutralizing monoclonal antibodies’, which disclosed an anti-VEGF antibody (ie an antibody satisfying the definition of (a) of the claim). The judge accepted that, although the paper stated that the antibody ‘may have therapeutic potential’, it did not render it obvious to use anti-VEGF antibodies in therapy, because of ‘the fact that VEGF was only one of many factors and other agents which could be investigated, the commonly accepted view that there was no single factor responsible, the confusing picture presented by the common general knowledge and the view that achieving anti-angiogenesis therapy would be difficult’.

The judge acknowledged secondary indicia of non-obviousness, including a prestigious award given to one of the inventors, and other accolades in the literature.

A number of insufficiency attacks were made on the patent, and the judge rejected them all. On the matter of Biogen insufficiency, the judgment states:

I consider that the patent discloses a principle of general application within the meaning of the authorities insofar as it claims anti-VEGF antagonism as a treatment for all non-neoplastic diseases. The tumour data in the patent establish that VEGF blockade is likely to be a successful strategy for treatment in cancer. The skilled reader would appreciate that the reason it is likely to be successful is because blocking VEGF is a sufficient intervention to prevent angiogenesis, at least in models of cancer. It is common ground that it is possible to extrapolate that reasoning to at least some non-neoplastic diseases.

Thus the judge placed the invention squarely within the situation where, according to Biogen, it can be claimed in broad terms.

The judge rejected sufficiency attacks based on the time and effort that would be necessary to develop treatments according to the claims, in particular the definition in (c) of the claim, not least VTE itself which was accepted to be ‘very clever’. In this regard, the judgment states:

The fact that a claim may extend to further inventions which make use of the principle disclosed in a patent does not necessarily render the patent insufficient. I do not consider that the fact that the claim extends to VTE makes the present patent insufficient, even in the light of the evidence which I have accepted. Finally, therefore, the judge concluded: ‘The patent is not invalid on any ground alleged. The patent is infringed by VEGF Trap Eye.’

Analysis

Biogen insufficiency in UK jurisprudence relating to broad claims is mirrored by EPO jurisprudence which, however, generally considers the matter as an issue of inventive step. The leading case is AGREVO/T 939/92 according to which, if the technical problem is not solved across the breadth of the claim, the claim lacks inventive step. Lack of inventive step according to AGREVO was separately pleaded, but the judge understandably stated that ‘in the present case this argument traverses the identical ground to that raised by insufficiency’, and so dealt with it accordingly under the insufficiency heading.

Whether expressed as a matter of inventive step or insufficiency, both approaches are intended, in their way, to ensure that the monopoly granted by the patent is commensurate with the contribution to the art. This is still a precept of patent law in Europe.

‘Fair basis’ (that the claims must be fairly based on the description) was a requirement of the Patents Act 1949 in the UK, and is still a requirement in, for example, Australia, but does not survive in that form in current European patent law. Moreover, ‘support’ (that the claims be supported by the description) is not a ground of opposition or revocation. Nevertheless, jurisprudence has been developed in Europe under the current law in relation to inventive step and sufficiency to maintain the balance between contribution to the art and the scope of allowable claim.

In the present case, the claim was unusually broadly defined in that both of the key features were defined in broad functional terms—the medical indication (any disease other than cancer in which undesirable excessive blood vessel growth occurs) and the treatment agent (any antibody or fragment against VEGF or a VEGF receptor, or a VEGF receptor [or, as construed by the judge, part thereof]). Further, VEGF was, as such, already known as an angiogenic growth factor at the priority date of the patent: what was unknown was that VEGF is necessary for pathological angiogenesis, and therefore it was not known what would be the therapeutic effect, if any, of a VEGF antagonist. This might therefore have seemed an unpromising case to successfully argue sufficiency under the Biogen jurisprudence.

The decision rests on a number of findings, key among which are the following: that the patent disclosed a principle of general application; that it was reasonable at the time to predict that anti-VEGF therapy would be effective in relation to non-neoplastic diseases generally; and that allegations of classical insufficiency that specific diseases could not be treated as claimed were not made out. In relation to the ability to make the claimed antagonists, there was no real attack in relation to the antibodies defined in (a) and (b) of the claim, and the objection in relation to the receptor defined in (c) of the claim was only in relation to an antagonist with less than the full extracellular domain of the VEGF receptor. This objection was rejected on the basis that in this industry ‘careful experimentation with a degree of trial and error, sometimes extending over months and years, is entirely normal’, and because:

A patent is not insufficient because it may take much work to develop the most elegant or refined embodiment of its inventive concept. If one were to carry on with the refinement, one would still be making use of the principle disclosed in the patent, working towards an improved embodiment of it.

Practical significance

Because the UK courts since Biogen have so rarely acknowledged that an invention involves a principle of general application, practitioners may have come to believe that such cases would be purely theoretical. This decision should give assurance that in appropriate cases broad protection can be validly obtained.

Anticipating something new in Germany

Authors: Christopher Hayes and Jens Toftelund Madsen (H Lundbeck A/S, Copenhagen, Denmark)

Eli Lilly & Co v (1) Egis Gyogysergya Rt; (2) Neolab Ltd and interveners (i) Stada Arzneimittel AG; (ii) ratiopharm GmbH; (iii) Hexal AG; (iv) Sandoz Pharmaceuticals GmbH. X ZR 89/047 December 16 2008

he Xth Senate of the German Supreme Court (Bundesgerichtshof) has allowed an appeal against the decision of the 3rd Senate of the Federal Patent Court (Bundespatentgericht) which rendered Eli Lilly's patent for the pharmaceutical compound olanzapine null and void.

Legal context

The Bundespatentgericht (BPatG) had interpreted previous case law as having established the principle that a disclosure of a general chemical formula of a genus of chemical compounds is a disclosure of all members of that genus even where all members have not been expressly described. Therefore, if the compound could be made without effort, such a disclosure was novelty-destroying. In overturning the first instance decision, the Bundesgerichtshof (BGH) restated the principles of novelty in German patent law, bringing them firmly back into line with the jurisprudence of the European Patent Office (EPO) and its contracting member states.

The following key points should be noted:

* The BGH has overruled previous case law regarding novelty and anticipation.
* With regard to chemical compounds, for a publication to be a novelty-destroying anticipation it must clearly and expressly disclose the compound in question.
* This decision incorporates the EPO's ‘photographic’ approach to novelty into German patent law.
* This decision harmonizes the EPO's approach with Germany and demonstrates the uniformity of outcome when applied in Germany and the UK.

Facts

Eli Lilly is the proprietor of European Patent 454,436, which claims the chemical compound the generic name of which is olanzapine, a schizophrenia treatment marketed by Eli Lilly under the brand name Zyprexa®. Using the problem-solution approach, the problem is defined as obtaining an antipsychotic medication with a reduced propensity for extra-pyramidal side effects; olanzapine was the solution to this problem in the patent in suit.

Analysis

First instance decision

The validity of the olanzapine patent was successfully challenged before the Bundespatentgericht (BPatG, 4 June 3Ni21/04 (EU)). The BPatG accepted that the patent in suit was anticipated by the prior publication of a scientific paper by Chakrabati.

Chakrabati contained a general chemical formula, akin to a so-called Markush formula, and which contained olanzapine. There was no express disclosure of olanzapine by Chakrabati, nor was there an indication that the authors had made or tested olanzapine in their scientific model.

In reaching its decision, the BPatG applied earlier decisions of the BGH, notably Fluoran (BGHZ 103, 150) and Elektrische Steckverbindung (Electrical Plug Connection) (BGHZ 128, 270 Elektrische Steckverbindung), to reach the conclusion that Chakrabati was a novelty-destroying disclosure. This was because a person skilled in the art starting from the general formula could work out each compound contained within the formula and therefore could conceptualize olanzapine.

The BPatG went further: based on Chakrabati, it would have been obvious for the person skilled in the art to make olanzapine. There were methods disclosed in Chakrabati which could have been used to deliver olanzapine to the person skilled in the art. In effect, the BPatG's reasoning was that a person skilled in the art could fill in the gaps in Chakrabati from the specific compounds and methods disclosed in the publication to produce olanzapine. The same logic was applied to a number of prior art publications which also disclosed Markush formulae, which were even broader in scope than Chakrabati. The BPatG therefore held that these were also novel-destroying anticipations.

Decision of the Bundesgerichtshof on novelty

The BGH looked at the alleged Chakrabati anticipation in detail. In Chakrabati, several compounds of the genus were expressly described, although olanzapine itself was not. The BPatG held that the skilled reader would be able to fill in the missing pieces from Chakrabati using his own technical knowledge would therefore be led to olanzapine.

The BGH stated that in determining whether a publication was novelty-destroying, the Court should not undertake a process whereby the skilled addressee's technical knowledge could be used to work the invention. Rather, it must determine what is ‘directly and clearly’ derived from the publication.

At paragraph 26, the BGH explains this, pointing out that it is acceptable to read the claims and specification and to include those pieces of knowledge so plainly evident to the skilled reader or absolutely necessary to make the invention work, should not be construed as supplementing the requirements for anticipation. Indeed, the BGH states that Electrical Plug Connection lays down the principle that the modifications were so obvious to the skilled reader that he reads the publication essentially almost along with his own thoughts, even if he is unaware that he is doing this. Therefore, for the purposes of determining whether an anticipation is detrimental to novelty, it is not permissible to supplement the publication further.

The BGH then turned to Fluoran, which the lower Court had interpreted as stating a principle that, in a genus patent, all members of that genus are disclosed, whether expressly described or not. This, the BGH held, was not a correct statement of the law. Further, in distinguishing Fluoran, the BGH noted at paragraph 28 that Fluoran was issued under the 1968 Patent Act, the appeal being only on a point of law, and the Senate held that it was bound by the factual findings of the BPatG. In summary, the deciding factor was whether there was a concrete disclosure of the specific compound.

Simply because someone of skill had the ability to make a greater or lesser number of the compounds disclosed by a general formula did not, for the purposes of the evaluation of novelty, equate to a specific disclosure of all compounds covered by the general formula. To be considered a valid anticipation, the specific compound must be disclosed. To the extent that the Fluoran case purported to lay down a different principle, the BGH stated that this did not represent the law of novelty in German patent law.

Applying this reasoning also to UK patent 1,533,235, which did not expressly describe olanzapine, the BGH held that this patent, or patents derived from this priority application, nor the publication by Schauza & Mager did not constitute a specific disclosure of olanzapine, and hence could not form a novelty-destroying anticipation.

Decision of the Bundesgerichtshof on inventive step

A further publication by Chakrabati (Schauza & Mager Pharmazie (1983) 38) also describes a structure–activity relationship analysis of various compounds, in order to aid in the development of an antipsychotic with a lower propensity for extrapyramidal side effects. Some compounds showed promise under this paradigm, and warranted further study. Since olanzapine was not one of the compounds reported, there was nothing presented in Chakrabati that would make the choice of olanzapine an obvious choice for further analysis.

While acknowledging that the subgroup of compounds to which olanzapine belonged appeared to have the greater potential for further development, the BGH stated that this was not in and of itself obvious to the skilled reader, who would not discount other subgroups of compounds for further testing from the outset without testing them further.

The choice of synthesizing this subgroup of compounds would have been obvious to a person skilled in the art only if he had a reason to synthesize them in the first place. No such rationale was held to be provided in the prior art. The validity of the inventive step contained within the patent in suit was therefore also upheld.

Harmonisation with EPO law

In reaching its decision, the BGH has importantly stated that there is no divergence between German national and EPO jurisprudence on this point regarding novelty in patent law. At paragraph 29, the BGH states that the jurisprudence of the German courts is aligned with that of the EPO and that, according to EPO case law, a ‘photographic’ disclosure is required to be potentially novelty-destroying.

Comparison with the UK olanzapine decision

In the corresponding UK case on olanzapine (Dr Reddy's Laboratories (UK) Ltd v Eli Lilly & Company Ltd [2008] EWHC 2345 (Pat)), Floyd J reached the same conclusion regarding novelty and inventive step, upholding the validity of the olanzapine patent. At paragraph 29, the BGH made reference to the analogous litigation in the UK, stating that the German law of novelty was in line with the EPO jurisprudence and that the EPO approach was also being implemented in the UK. Using this harmonized approach, the BGH and the High Court in the UK reached the same conclusion regarding this patent, with both courts citing the same EPO decisions as the foundation for their reasoning.

Practical significance

As a result of the strict interpretation and application of Fluoran in Germany, the German patent courts had been viewed by innovator companies as being quite anti-patent and markedly divergent from the jurisprudence of the EPO regarding novelty of chemical compounds. This decision of the highest national court in Germany restates the law of novelty in German patent law.

This decision brings the determination of novelty under German case law firmly into line with the EPO, and with contracting member states such as the UK. From the point of view of innovator companies (and their competitors), this decision brings clarity and certainty that compounds previously disclosed in a Markush formula will be viewed in the same way in Germany as in other EPO member states. Thus, the novelty of such compounds is not destroyed by the mere disclosure of the Markush formula in an earlier publication.

While there will invariably be the occasional debate within society as to where the threshold for novelty should be set for patentable inventions, it should be accepted that, wherever this level is placed, it is desirable that it be consistent. Different jurisdictions should not have different novelty requirements; particularly if they are contracting states to the European Patent Convention, since national laws should be interpreted in an analogous manner.

At first glance, the main consequence of this decision appears to lower the bar for novelty in Germany, which will be welcomed by innovator companies. The significance of this decision has much wider ramifications. As noted above, this decision brings this aspect of German patent law into harmony with the EPO, and the jurisprudence of other contracting member states.

Regardless of where along the spectrum the threshold for novelty is set, it should be consistently applied both within the jurisdiction and across jurisdictions, particularly as the vast majority of patent litigation is multi-jurisdictional in nature. This decision therefore should be welcomed as it brings clarity and certainty with regard to patents for chemical compounds previously disclosed in a Markush formula or contained within a general chemical formula.

House of Lords addresses ‘Biogen insufficiency’

Authors: Paul Inman and Simon Spink (Howrey LLP)

Citation: Journal of Intellectual Property Law & Practice 2009 4(7):459-461; doi:10.1093/jiplp/jpp075



Generics (UK) Limited & Ors v H. Lundbeck A/S [2009] UKHL 12, 25 February 2009

In this decision, the House of Lords addressed its own earlier decision in Biogen v Medeva where the oft-cited principle of ‘Biogen insufficiency’ arose. As stated by Lord Walker in his opinion, ‘The distinction between product claims and process claims, especially in relation to the appropriate test for sufficiency, is at the heart of this appeal’.

Facts

Lundbeck's patent for escitalopram, a single enantiomer drug for the treatment of depression, claimed both the product itself and the method for its manufacture. Generics challenged the patent on grounds of novelty, obviousness, and insufficiency. At first instance ([2007] EWHC 1040 (Pat)), Kitchin J found that the enantiomer was both novel and inventive but that, by the priority date, enantiomers of known racemates were ‘obviously desirable goals’. He therefore followed the principle apparently laid down by Lord Hoffmann in the House of Lords in Biogen v Medeva, namely that ‘the first person to find a way of achieving an obviously desirable goal is not permitted to monopolise every other way of doing so’. To do so would exceed the ‘technical contribution’ to the art. On that basis, he found the claims to the enantiomer invalid for so-called ‘Biogen insufficiency’.

On appeal ([2008] EWCA Civ 311), Lord Hoffmann (unusually sitting in the Court of Appeal) held that Kitchin J had misinterpreted his judgment in Biogen which, he said, applied only to ‘product-by-process’ type claims and not to ‘simple product claims’ such as Lundbeck's claim. With Jacob LJ in agreement, the Court of Appeal overturned the finding of insufficiency.

In October last year, the Lords gave permission to Generics to appeal further. The Lords heard the appeal in January and gave their decision less than 6 weeks later.

Analysis

The Lords' decision (lead judgment by Lord Neuberger) was unanimous in dismissing Generics' appeal and upholding the claims to the enantiomer.

The Lords agreed that when seeking to revoke a patent for ‘sufficiency’, in addition to considering the clarity and completeness of the specification (under the Patents Act 1977, section 14(3)), consideration must also be given to the ‘support’ given by that description for the claims (under section 14(5)(c)). As Lord Walker pointed out:

Section 14(3) and (5)(c) operate together, as EPC Articles 83 and 84 operate together, to spell out the need for an ‘enabling disclosure’, which is central to the law of patents.

Though section 14(5)(c) had been thought to be more relevant to the examination process than revocation proceedings, this judgment confirms the position in Asahi Kasei Kogyo KK's Application [1991] RPC 485, that section 14(5)(c) has a place in the assessment of sufficiency.

The Lords agreed (following the recent trend of the UK Patents Courts) that clear principles arising from the EPO and its boards of appeal should be adhered to in the UK. In this case, the principle laid down in the EPO's decision T409/91 EXXON/Fuel Oils [1994] (OJEPO 653) that ‘the monopoly to be granted to the patentee is to be assessed by reference to the ‘technical contribution’ made by the teaching of the patent', was key.

In the Court of Appeal, Lord Hoffmann had said that Kitchin J was mistaken in equating the ‘inventive concept’ of Lundbeck's patent (ie the process), with the ‘technical contribution’. What he should have found was that the novel and non-obvious enantiomer was itself the technical contribution.

The Lords' analysis of this section of Lord Hoffmann's speech, particularly on the part of Lord Walker, went somewhat further. Lord Walker considered how the two concepts, ‘inventive step’ and ‘technical contribution’, should be defined and distinguished. He suggested that the ‘inventive concept’ is concerned with the identification of the core of the invention, whereas the ‘technical contribution’ to the art is concerned with the evaluation of its inventive concept: how far forward has it carried the state of the art?

In assessing the technical contribution, Lord Walker indicated that regard should be to the ‘lasting strategic importance’ of the invention to the art. How this will be interpreted in future cases relating to sufficiency remains to be seen.

Perhaps surprisingly, the Lords also drew support from a line of EPO case law starting with Kawasaki Steel Corp [1994] OJEPO 695, which dealt with the issue of obviousness. In this decision, the Board of Appeal had concluded that:

an otherwise obvious entity, may become nevertheless non-obvious and claimable as such if there is no known way or applicable (analogy) method in the art to make it and the claimed methods for its preparation are therefore the first to achieve this in an inventive manner.

Although in none of these decisions of the Board was any consideration given to insufficiency, Lord Neuberger noted that the argument based on obviousness considered by the Board was very similar to the insufficiency reason given by Kitchin J. He concluded that ‘it is fanciful to suggest that, if the reason had been arguable, it would not have been raised before or by the Board by now’.

With those principles in mind, Lord Neuberger considered whether (leaving aside Biogen) there was anything in the legislation (either UK or EPC) which meant that Lundbeck's claim to its enantiomer should be held invalid for insufficiency, and concluded:

... the product claim in the present case is valid. I appreciate that this means that, by finding one method of making a product, a person can obtain a monopoly for that product. However, that applies to any product claim.

The remaining question was whether Lord Hoffmann's Biogen speech should make any difference. Although they accepted that certain sections of Biogen, if read out of context, could be construed to support Kitchin J's first instance finding, the Lords ultimately agreed that Biogen was concerned with a very complicated claim that was certainly not comparable with Lundbeck's simple product claim.

Lord Walker said:

Statements of general principle relating to inventions with many embodiments may be irrelevant to an invention which consists of a single chemical compound. ... That is in my opinion the fundamental reason why Biogen does not provide a direct answer to this appeal.

Lord Mance's view was:

... perhaps even more relevant in my view is the fact that nowhere in Biogen Inc. v. Medeva plc do the speeches treat or discuss the claim as a simple claim in respect of a novel product. ... It seems to me therefore that the Court of Appeal was not in the present case bound by the reasoning or result in Biogen Inc. v Medeva plc to arrive at a conclusion that the present claims 1 and 3 were invalid.

And Lord Neuberger said:

the opinion of Lord Hoffmann in Biogen [1997] RPC 1, though a tour de force as Lord Walker says, is of no assistance to the appellants in this case. It applied in the light of the very unusual nature of the claim in that case.

Thus, each of the Lords dismissed the appeal and found Lundbeck's patent claims to its simple enantiomer product sufficient, and therefore valid.

Practical significance

In upholding the Court of Appeal judgment, the House of Lords have confirmed that:

* the principles arising in Biogen do not apply to a simple product claim;
* if a product is novel and non-obvious, the product itself is the ‘technical contribution’ to the art;
* a product which is an ‘obviously desirable goal’ (such as an enantiomer) should not be treated any differently to other product claims. On the contrary, Lord Neuberger went as far as saying:

... where (as here) the product is a known desideratum, it can be said (as Lord Walker pointed out) that the invention is all the more creditable, as it is likely that there has been more competition than where the product has not been thought of.

This decision is good for the research-based pharmaceutical industry, whose business is often reliant on patent claims to simple pharmaceutical products. Further, by removing the threat of ‘Biogen insufficiency’ against such patents, UK patent law has become better aligned to Europe, providing patentees with greater cross-border certainty.

However, it does not provide comprehensive guidance as to the scope of application of Biogen, which remains House of Lords authority, so to some extent the spectre of ‘Biogen insufficiency’ still hangs over patentees. In the Court of Appeal, Lord Hoffmann indicated that the principles in Biogen only apply to the sort of claims then in issue, ie ‘product-by-process’ type claims. Lord Neuberger, however, suggested that the claim in Biogen was ‘almost a process-by-product-by-process claim’. Thus, while the reach of ‘Biogen insufficiency’ has certainly been considerably curtailed by the Lundbeck speeches, where the limits lie remains to be decided.

What is also less clear is the extent to which the concept of ‘lasting strategic importance’ of the invention will play in assessing the ‘technical contribution’ in the future.