Tuesday, September 7, 2021

Enabling After-Arising Technology

Pfizer Canada ULC v Seedlings Life Science Ventures, LLC 2021 FCA 154 Locke JA: Gleason, Laskin JJA affg 2020 FC 1 Grammond J

2,486,935 / FC accounting / FC reasonable royalty / FC novelty and utility / FC claim construction / FC Overbreadth

The Seedlings decision is notable for holding that overbreadth is an independent ground of invalidity, but the discussions of insufficiency and entitlement to an accounting are also of interest. In this post, I’ll start with the insufficiency issue, which raises the very difficult issue of how the enablement requirement applies to after-arising technology. The post is long, but the bottom line is that the key holding, that “[t]he disclosure must teach the skilled person to put into practice all embodiments of the invention, and without exercising inventive ingenuity or undue experimentation” [68] This must be wrong, or any invention that is capable of improvement would be invalid for insufficiency. But this means that on its face, Seedlings raises some very obvious avenues of attack on almost any patent, particularly those relating to mechanical inventions. I suspect these attacks will mostly fail—unsurprisingly, there is a very large body of caselaw to the effect that a patent is not invalid simply because it encompasses improvements. Unfortunately, I don’t see a lot of wiggle room for a principled distinction on the facts. So the interesting question will be how the FCA will handle Seedlings going forward and how much the law will ultimately change as a result.

The invention at issue relates to an auto-injector, primarily intended for injecting epinephrine to treat anaphylaxis. The best known auto-injector is the EpiPen. The original EpiPen was relatively bulky—a cylinder about 15 cm long and 2.5 cm in diameter—which made it inconvenient to carry. Another problem was that the needle remained exposed after use, which is a particular concern in light of the risk of transmission of blood-borne diseases [FC 11]–[12]. The patented injector device solved these problems. It is flat and much smaller than the original EpiPen—the size of a thick credit card—so it is more easily carried and used [FC 63]; and it has an actuator that moves forward once the injection is complete to serve as a shield that protects the needle [FC 19]: see the video here. This second aspect of the invention, which I’ll refer to simply as the needle shield, is at the center of the holding on both insufficiency and overbreadth.

A number of claims were asserted, but the claims of particular interest are claims 40, 59, 60 and 62. Claim 40, which is representative of the claims of interest, “describes an auto-injector with a flat housing, that is front-actuated and that has an actuator that also serves as a needle shield. That is the ‘inventive concept’ of this claim” [FC 139]. These claims were invalidated by Grammond J solely on the ground of overbreadth. The FCA affirmed on overbreadth [56]–[65], but held that the claims were also invalid for insufficiency [66]–[72], reversing Grammond J [185]–[186] on that point. The claims were neither obvious nor anticipated ([FC 102], [FC 115], [FC 138] affd [40]–[45]), nor did they lack utility [FC 163]. Grammond J held that none of the asserted claims were infringed by Pfizer’s Next Generation Auto-Injector (NGA) Epipen, which is oval in cross-section, not flat [191], [208]. The FCA did not address infringement in light of its conclusion that the claims were invalid [74]. Consequently, the FCA holding on validity is not obiter, even in a technical sense.

The claims of interest did not contain certain elements relating to the design of the needle shield which were disclosed in the specification, including the shared latch locking mechanism, which holds the syringe in place until use, and then holds the needle shield in place after used: [8], [56], [62]. These are referred to as the “Omitted Elements” because they are found in the specification but omitted from the claims of interest. So, the claims of interest covered any auto-injector with a flat housing and a combined actuator / needle shield, but only described one way to make the needle shield, namely the design which includes the Omitted Elements.

Pfizer’s expert acknowledged that based on the disclosure, a skilled person could make the preferred embodiments, which include the Omitted Elements. Grammond J held that was sufficient to meet the disclosure requirement [FC 186], [66]. The FCA held that this was an error [66], saying:

[68] The disclosure must teach the skilled person to put into practice all embodiments of the invention, and without exercising inventive ingenuity or undue experimentation.

The claims of interest encompass devices without the Omitted Elements, and “[b]ased on the Federal Court’s finding at paragraph 177 of the Reasons that a skilled person would not know how to make a device without the Omitted Elements, it follows that the 935 Patent does not meet this requirement” [71]. Put conversely, a skilled person would have to exercise inventive ingenuity to design an auto-injector without the Omitted Elements [FC 180], and for that reason, the disclosure was insufficient.

I’ll repeat the key holding: “The disclosure must teach the skilled person to put into practice all embodiments of the invention, and without exercising inventive ingenuity” (my emphasis). This seems to follow from the principle that the claimed invention must be valid across its full scope: if any embodiment falling with the claims is anticipated, or obvious, or lacking in utility, the claim is invalid. It seems reasonable that the same principle should apply to enablement, ie the “how to make” aspect of the disclosure requirement. If the inventive ingenuity is required for a skilled person to make the preferred embodiment, the claim to that embodiment will be invalid for insufficient disclosure: see eg Gilead v Idenix 2015 FC 1156 (here). It would seem to follow that the claim will be invalid if inventive ingenuity is required to make any embodiment falling within the claims.

But that can’t be right, or any claim that encompasses improvements would be invalid. Is a claim to the wheel invalid because it does not teach how to make a wheel with a rubber tire? A rubber tire is ingenious in its own right and rubber itself was not known when the wheel was invented, so it is clear that the original inventor of the wheel would not have known how to make a rubber wheel. A wheel with a rubber tire is nonetheless a wheel.

And indeed the law is clear that a claim is not invalid because it encompasses improvements, even if those improvements are patentable. As Bowen LJ remarked more than a century ago in Wenham Gas (1891) 9 RPC 49 (CA) 56, “The superadding of ingenuity to a robbery does not make the operation justifiable.” It is an infringement to take the essential elements of the patented invention and it does not matter whether other elements are added or subtracted. This is evidently true when the variants are trivial, but it is equally true when the variant is inferior, and it remains true when if the variant happens to work better than the original, whether the improvement is minor, or so substantial as to merit its own patent. There are innumerable cases holding claims to be valid and infringed by a potentially patentable improvement that was not disclosed in the specification.* The point is recognized by s 32 of the Act, which provides that “Any person who has invented any improvement on any patented invention may obtain a patent for the improvement, but he does not thereby obtain the right of making, vending or using the original invention. . .” This necessarily implies that a claim encompassing a patentable improvement may be valid, or person inventing an improvement would indeed obtain the right to the practice the original invention, as the original patent would be invalid simply by virtue of the fact that it encompasses the ingenious improvement.

The rationale is that the original invention enabled the subsequent improvements, so the patentee’s reward will not be commensurate with its contribution unless the claims encompass the improvements. As Romer J put it in The Automatic Coal Gas Retort Co v The Mayor of Salford (1897) 14 RPC 450 (Ch), a case in which the defendants had made “very useful” improvements to the patented apparatus, “[t]he Defendants' apparatus . . . would never have come into operation had it not been for the success of the Patentee's invention.” In In re Fisher 427 F2d 833 (CCPA 1970) 839 the court similarly remarked:

It is apparent that such an inventor should be allowed to dominate the future patentable inventions of others where those inventions were based in some way on his teachings. Such improvements, while unobvious from his teachings, are still within his contribution, since the improvement was made possible by his work.

In T 0292/85 Polypeptide expression/GENENTECH I the EPO Board stating at ¶ 3.1.5 that “The above examples show that the need for a fair protection governs both the considerations of the scope of claims and of the requirements for sufficient disclosure. Unless variants of components are also embraced in the claims, which are, now or later on, equally suitable to achieve the same effect in a manner which could not have been envisaged without the invention, the protection provided by the patent would be ineffectual.”

As support for his view that all embodiments must be enabled, including inventive improvements, Locke JA relied on the bargain theory, in particular Thorson P’s statement in Minerals Separation [1947] ExCR 306 (quoted Consolboard [1981] 1 SCR 504, 520 and Teva 2012 SCC 60 [50]), holding that proper disclosure requires that

when the period of the monopoly has expired the public will be able, having only the specification, to make the same successful use of the invention as the inventor could at the time of his application.

This passage, as quoted in Consolboard [1981] 1 SCR 504, 520, was quoted by Locke JA at [68], and emphasized at [69], [70].

With respect, this passage does not support the holding that the claims of interest are invalid. There is no finding or evidence that I can see to the effect that the disclosure failed to describe how to make “the same successful use of the invention as the inventor could at the time of his application.” It is true that the specification failed to describe all possible embodiments of the invention, but there is no evidence that the inventor knew how to make other possible embodiments. (Which likely explains why they were not disclosed.) There may be other ingenious ways of implementing the invention, but if the inventor did not know how to make them at the time of his application, and he discloses how to make what he does know, then the public will be able “to make the same successful use of the invention as the inventor could at the time of his application.” The failure to disclose such improvements is not a failure of consideration, at least on the bargain theory expressed in this passage.

Now, this particular passage is not necessarily an exhaustive statement of the disclosure requirement. As the SCC noted in Consolboard at 518, the disclosure provision “gives the impression of a mélange of ideas gathered at random rather than an attempt to enunciate, clearly and concisely, a governing principle or principles.” Perhaps there are other theories of the bargain that might be invoked. But it is a hard bargain indeed to require the inventor to disclose not just everything he knows, but inventive improvements that he did not and could not have known about.

To summarize, it is perfectly clear that the law does not require the disclosure to teach the skilled person to put into practice all embodiments of the invention without exercising inventive ingenuity. In particular, it is extremely well established that a valid claim may encompass patentable improvements. Indeed, it is so well established that it would seem that I must have misunderstood Locke JA’s decision in reading it to the contrary. Nonetheless, I cannot escape that conclusion in light of the express holding that “[t]he disclosure must teach the skilled person to put into practice all embodiments of the invention,” along with the holding on the facts that the patent is invalid because it would require inventive ingenuity to devise an alternative embodiment.

This is not to say that Grammond J was necessarily right to hold that it is enough for the preferred embodiments to be enabled. It can’t be right to simply say that the specification must enable all embodiments of the invention without exercising inventive ingenuity, but it is difficult to say more. The problem of enablement and improvements, or after-arising technology more broadly, is very difficult.

The problem has been addressed many times in US law, with results that have been described as “doctrinal chaos”: see Robin C. Feldman, Rethinking Rights in Biospace, 79 S Cal L Rev 1 (2005) 22-29. Broadly, there are three lines of authority. An earlier line of authority calls for a flexible multi-factorial approach requiring a reasonable correlation between the disclosure and the claims, while more recently an apparent split has developed between a line of cases holding that disclosure of a single working embodiment satisfies the enablement requirement (the “single embodiment” rule) and another line requiring enablement across the full scope of the claims (the “full scope” rule). I’ve found a series of articles by Professor Kevin Collins to be particularly helpful: “Getting into the 'Spirit' of Innovative Things: Looking to Complementary and Substitute Properties to Shape Patent Protection for Improvements” (2012) 26 BTLJ 1217; "Enabling After-Arising Technology" (2009) 34 J Corp L 1083; Collins “The Reach of Literal Claim Scope into After-Arising Technology: On Thing Construction and the Meaning of Meaning” (2008) 41 Conn L Rev 493.

I don’t want to digress too much into the details of the US debate, but I’ll try to give the flavour. In “Getting into the 'Spirit' of Innovative Things”(2012) 26 BTLJ 1217, 1229–31,  Collins distinguishes between “classic improvements” and “overlooked-improvement” cases, with the latter illustrating clearly that a patent need not enable all embodiments. Collins uses a stylized version of the Wright Brothers invention to illustrate both. The Wright Brothers realized that an airplane could be stabilized by raising and lowering different portions of the wing surface at the same time. They disclosed airplanes that had wings with a flexible frame that allowed the entire surface of the wing to be warped. The Wright Brothers airplanes were made with canvas stretched over a wooden frame. Suppose that after the filing date, a different inventor devises a new an ingenious form of canvas. It is uncontroversial that an airplane made exactly according to the Wright Brothers’ disclosure, using the new canvas instead of the type of canvas available to the Wright Brothers, would nonetheless infringe. This is an example of an “overlooked” improvement, which never gets litigated because it is so intuitively clear that the patent cannot be invalid for failure to enable the improvement, even though the patent did not enable an embodiment with that technology. Overlooked improvements are very common; as Collins notes, they arise for example when the invention is a mechanical device and a later embodiment is made out of materials that were not known at the time of the application (“after-arising materials). So, as another example, suppose a patent claims a new kind of doorknob, at a time when wood, metal and glass were commonly used for doorknobs, and subsequently plastic is invented. It is uncontroversial that a doorknob made of plastic would infringe, even though a plastic doorknob was not enabled by the patent. This alone shows that the “all embodiments” rule can’t be right.

Then there are classic improvements, which are improvements to the invention itself. Collins gives the example of Glen Curtiss’s improvement on the Wright Brothers’ airplane, which used the same conception of stabilization by raising and lowering different parts of the wing, but Curtiss accomplished this by inventing wings with ailerons—flaps that could move independently of the rest of the wing. This was an improvement that was not disclosed and which eventually supplanted wing-warping technology. Now, as noted above, there are many cases holding that improvements are infringed by valid claims of the original patent. But there is an argument to be made that at least in some circumstances, the improvement should be outside the scope of the original patent. As Collins explains at 1230:

First, the more significant the Wright Brothers’ invention in terms of the social value that it creates, and the smaller the additional increment of social value contributed by Curtiss, the stronger the case for allowing the Wright Brothers’ patent to encompass airplanes stabilized with ailerons. Second, the more cumulative the pattern of technological advance and the less confidence inspired by the market for patent licenses, the stronger the case for allowing Curtiss to be free of the Wright Brothers’ patent. Third, the more costly the process of creating and commercializing the innovations in the airplane industry, the stronger the need to reduce competition and augment the monopoly power attributable to the patent regime, and thus the deeper earlier patents should reach into later-developed improvements. Fourth, the more prominence one gives to the prospect function of patents, the more certain one becomes that the Wright Brothers’ patent should encompass Curtiss’s improved airplane.

This analysis suggests a multi-factorial approach that attempts to balance these factors with the need to encourage the pioneer invention in the first place. (Whether the courts are in a position to undertake such balancing successfully is another question.)

On another reading of the cases, particularly In re Hogan 559 F2d 595 (CCPA 1977) and Plant Genetic Systems 315 F3d 1335 (Fed Cir 2003), a key question relates to whether the foreseeability of the after-arising technology, so that all embodiments that were specifically desired, or perhaps all embodiments that could be envisaged at the time of the application, would have to be enabled, but there would be no requirement to enable embodiments that were completely unknown at the time of the patent, including patentable improvements, That may (or may not) allow the cases to be reconciled, but it is not entirely satisfactory normatively: as Feldman argues in Rethinking Rights in Biospace at 27, this rule “has a perverse effect.”

In designing a coherent vision of the footprint of the invention, one would expect to reduce a patent holder’s reach as technology advances farther away from what was known at the time of the patent. The more the science advances, the more we would anticipate that new products are substantially different from what the patent holder accomplished and, therefore, should not be covered by the patent. Thus, we would expect to create the strongest limits on a patent holder’s reach for embodiments that are the farthest from the state of the art at the time of the invention.

That approach is very similar to Grammond J’s holding that only preferred embodiments need to be enabled, though on that reading of the US cases, the enablement requirement would extend to embodiments that are objectively desirable, not just those which were identified by the patent as being desirable. For that reason, I am not sure that I agree with the FCA’s holding that Grammond J erred on that point. And when I say “I’m not sure,” I mean I’m not sure. This area is very difficult.

There is an extensive literature describing the splintered US caselaw. In addition to the Collins and Feldman articles already cited, see also Bernard Chao, Rethinking Enablement in the Predictable Arts: Fully Scoping the New Rule, 2009 Stan. Tech. L. Rev. 3; Robin C. Feldman, Rethinking Rights in Biospace, 79 S. Cal. L. Rev. 1 (2005) at 22-29; TJ Chiang, Levels of Abstraction, supra note 186 at 1111-16; Jeffrey A. Lefstin, The Formal Structure of Patent Law and the Limits of Enablement, 23 Berkeley Tech. L.J. 1141, 1175 (2008); Rantanen, J., The Doctrinal Structure of Patent Law’s Enablement Requirement, 69 Vand. L. Rev. 1679 (2016) at 1681-83; Christopher A Cotropia, “After-Arising Technologies” (2005) 61 NYU Ann Surv Am L 151. No one has developed an entirely satisfactory solution to the problem; merely describing the current state of US law is hard enough.

In UK law, the problem arose in Regeneron v Kymab [2018] EWCA Civ 671, in which the Lord Justice Kitchin, as he then was, emphasized at [231]:

it is not the law that a specification must necessarily enable the skilled person to make or perform all of the embodiments of a claimed invention. Were it otherwise, claims would be insufficient if they covered inventive improvements

See similarly [265]. While Lord Kitchin was elevated to the UKSC soon afterwards, his EWCA decision was reversed in Regeneron v Kymab [2020] UKSC 27, with the Court stating almost the opposite on the issue of enablement, saying at [59] that the requirement that

the disclosure in the patent should enable substantially all products within the scope of a product claim to be made by the skilled person as at the priority date, is part of the bedrock of the law.

This is very close to Locke JA’s holding in Seedlings, but it is subject to the same critique that it ignores the problem of after-arising technology. That problem was sidestepped by the UKSC; it had been raised only through discussion of a leading EPO decision, T 0292/85 Polypeptide expression/GENENTECH I, and the UKSC dealt with Polypeptide expression by a narrow distinction, which adequately explained Polypeptide expression without touching on the broader problem of improvements and after-arising technology.

In any event, my point here is not to endorse any particular approach to the problem of enablement and after-arising technology, but merely two make two points: (1) the rule that the disclosure must enable all embodiments can’t possibly be right; (2) the problem is very difficult.

Another problem arises in the application of Locke JA’s insufficiency analysis to the facts. As noted above, after stating that “[t]he disclosure must teach the skilled person to put into practice all embodiments of the invention,” Locke JA stated that “[b]ased on the Federal Court’s finding at paragraph 177 of the Reasons that a skilled person would not know how to make a device without the Omitted Elements, it follows that the 935 Patent does not meet this requirement” [71]. With respect, the fact that a skilled person would not know how to make a device without the Omitted Elements does not imply that the specification does not teach how to make all embodiments. If there is actually only one way to make a device falling within the claims, namely the preferred embodiment, then the patent did actually teach how to make all possible embodiments. So far as I can tell, there was no finding by Grammond J that it is possible to make a combined actuator / shield in some other way. He found that the patent “does not teach how to make the invention without these elements” [FC 176] and that replacing the Omitted Elements “is not something that the skilled person could do without having recourse to inventiveness” [FC 177], and “making a device that would omit one of the three elements that I identified above would require a substantial redesign” [FC 180]. None of these statements is equivalent to a finding that there is actually another way to make a device falling within the claims without those elements; it may be that a skilled person would not know how to make an alternative embodiment because in fact no alternative embodiment can be made. (Recall that Pfizer’s NGA EpiPen did not infringe.) Thus, the patent was invalidated because of a possibility that there might be embodiments falling within the claims that were not enabled. (Perhaps there was evidence in the record to the effect that it was in fact possible to make an alternative embodiment, but if so, it was not the basis for the decision.)

This raises a problem of the burden of proof. In the absence of a finding that it is possible to make an alternative embodiment, this means that Seedlings effectively applied a presumption that there are alternative embodiments falling within the claims and the burden is on the patentee to prove that there are no other possible embodiments. This is problematic for two reasons. First, placing the burden on the patentee seems to me to be inconsistent with the presumption of validity in s 43(2), weak though that presumption is. Second, it asks that the patentee to prove a negative—that there can be no alternative embodiments. I’m not sure how to discharge that burden—would it be enough for the patentee’s expert to testify that she can’t think of any alternative embodiments? On what basis could an expert opine that no other embodiments are possible? Now, putting the burden on the party attacking the patent also seems unreasonable, as it would ask them to prove that there is some alternative embodiment, even though it would require inventive ingenuity to think of it. But as between these two unsatisfactory options, it seems to me that the statutory presumption of validity implies that the burden must be on the party attacking the patent. Note that the problem of the burden will not arise in cases in which the defendant’s device itself incorporates a patentable improvement, thereby proving that such an alternative embodiment does exist. But if the burden is on the patentee, then a defendant who has reproduced the preferred embodiment exactly would be able to attack the validity simply by challenging the patentee to prove that no alternative embodiments are possible.

This problem of the burden arises from the holding that non-obvious embodiments must be enabled. If, for example, it is only necessary to disclose embodiments that were or could have been envisaged by a skilled person at the time of the application, then it would not be unreasonable to ask the party challenging the patent to identify such embodiments, and then require the patentee to prove that they were enabled.

There are two kinds of cases that will help clarify these issues going forward. First, the central issue will be raised if a defendant’s device is a patentable improvement which clearly infringes, for example if the claim is to the wheel and the defendant’s device is a spoked wheel. The defendant will then rely on Seedlings to say “My improvement is an embodiment of the invention that was not enabled by the original patent. That proves that the disclosure of the original patent did not teach the skilled person to put into practice all embodiments of the invention. The original patent is therefore invalid for insufficiency.” As I read Seedlings, such an argument should succeed, but that would fly in the face of the overwhelming body of caselaw to the contrary. Such a case would force the FCA to resolve that tension. I doubt that kind of argument will succeed (though it is certainly worth trying), but the FCA is loathe to overrule itself, so my best guess is that the future panel will somehow distinguish Seedlings.

Second, in some cases the defendant practices exactly the preferred embodiment that was disclosed and enabled by the original patent. The defendant in such a case may rely on Seedlings to say, “Notwithstanding that my device is not an inventive improvement, inventive improvements on the invention may exist, and the patent is invalid unless the patentee proves they do not exist.” I suspect this attack will also fail—given that Seedlings never explicitly discussed the burden of proof, I can imagine the FCA rejecting the attack on the basis that the patent is presumed to be valid, thereby effectively overruling Seedlings without doing so explicitly. But this attack is also worth running as an alternative—it will be very cheap to do so, since it simply involves asserting the burden against the patentee.

*See eg Grip Printing (1885), 11 SCR 291, 299 holding that the defendant’s product infringed, notwithstanding that it embodied “which may or may not be improvements”; Wright v Brake Service [1925] Ex CR 127, 132 stating “One cannot escape infringement by adding to or subtracting from a patented device or machine by changing its form, or making it more or less efficient, while he retains its principle and mode of operation”; Lightning Fastener v Colonial Fastener [1932] Ex CR 89 noting at 99–100 that “even if it was an improvement that would not negative infringement,” and “The law protects a patented combination machine even if the infringing machine possesses improvements, patentable improvements; that is immaterial”; Riddell v Patrick Harrison & Co, [1956] Ex CR 213 noting that “even if the defendant's apparatus had patentable advantages over the plaintiff's, . . . the plaintiff's invention is not to be defeated on that account”; Unipak Cartons [1956-1960] Ex CR 396 noting “It is established law that an improvement may be an infringement. . . even if [it] were a patentable improvement,” and finding infringement on the facts; Dominion Rubber v Acton Rubber (1963) 42 CPR 7 (Ex CR) 14 noting “it is well established that even an improvement in a method or device cannot save it from the charge of infringement if it comes within the claims of the patent in suit”; Johnson Controls v Varta Batteries (1981), 57 CPR (2d) 132, 146 noting it was irrelevant that the defendant's method is a significant improvement or commercial improvement on the patented method, aff’d on this point (1984), 80 CPR (2d) 1; Standal Estate v Swecan International Ltd (1989), 28 CPR (3d) 261 (FCTD) 271 finding infringement though infringing device was patented improvement; Computalog v Comtech (1992), 44 CPR (3d) 77 (FCA) 89 quoting Johnson Controls with approval; Airseal Controls 53 CPR (3d) 259 (FCTD) 270, noting that even a patented improvement may infringe; Lishman v Erom Roche Inc (1996), 68 CPR (3d) 72 (FCTD) 84 stating that “The law is clear that where the alleged infringing manufacture or product falls within the words of a claim, it is no defence to show that it involves ingenuity”; SmithKline Beecham v Apotex 2001 FCT 770 [58–64] affd 2002 FCA 216 holding that the product in question would infringe even if it were an improvement, citing various authorities. In Sanofi 2008 SCC 61 the SCC stated thjat “[a] system of genus and selection patents is acceptable in principle” [19] and the Court noted that the dextro-rotatory isomer of the racemate “is encompassed within the scope of the claims in the [genus] patent” [6], even though the genus patent did not disclose how to separate the enantiomers—that was the inventive concept of the patent in suit. While the SCC did not expressly hold that the genus patent was valid, as it was not at issue, the implication is that it was. See also Kirin-Amgen [2004] UKHL 46 [80] Lord Hoffmann noted that “There is no difficulty in principle about construing general terms to include embodiments which were unknown at the time the [patent description] was written”; in Regeneron v Genentech [2013] EWCA Civ 93 [173] Kitchin LJ stated that “A claim for an invention of broad application may properly encompass embodiments which may be provided or invented in the future and which have particularly advantageous properties, provided such embodiments embody the technical contribution made by the invention”; in T 0292/85 Polypeptide expression/GENENTECH I the Board stated that a claim “may generically embrace the use of unknown or not yet envisaged possibilities, including specific variants which might be provided or invented in the future.” This is only a partial list of in which the point has been expressly recognized. 

PS (9 Sept): I’ve just finished reading the recent decision of the EWCA FibroGen v Akebia Therapeutics [2021] EWCA Civ 1279 revg [2020] EWHC 866 (Pat). The decision was largely concerned with functional claims, which, by their nature, may encompass after-arising technology. Birss LJ, writing the lead judgment, expressly approved at [71]-72] the folling statement by the German Supreme Court (Bundesgerichtshof) in Dipeptidyl-Peptidase-Inhibitoren X ZB 8/12 (11th Sept 2013) (my emphasis):

That a claim worded in [a generalised form] also covers substances that do not yet exist or that have not been discovered yet, is no cause for concern. As long as using them makes use of the invention, it is not problematic that substances are also covered that cannot be found without an inventive effort.

This decision, which of course is subsequent to Regeneron v Kymab [2020] UKSC 27, makes it clear that Regeneron v Kymab cannot be taken to have held that inventive improvements must be enabled.




  1. Regeneron does not say that the whole of the claim has to be enabled, just the relevant range. The UK High Court decision in Illumina v MGI ([2021] EWHC 57 (Pat)) was the first UK case since Regeneron to consider the issue of sufficiency and provided guidance as to how the principles set out in Regeneron should be applied. In his judgement, Mr. Justice Birss (now Lord Justice Birss) ruled that the only features requiring enablement over the entire scope of the claim according to the principles set out in Regeneron are those relating to the "core inventive concept" of the claim.

    1. Yes, that's right. I said "almost" the opposite advisedly. And then the question is how to decide what the relevant range is. Birss J has since indicated that this depends on "the essence or core of that invention". Anyway, my point is that the question is tricky and wasn't squarely addressed by the UKSC.