Friday, September 10, 2021

What is “the Core of the Invention”?

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 / FCA Sufficiency / FC accounting / FC reasonable royalty / FC novelty and utility / FC claim construction / FC Overbreadth

The FCA Seedlings decision is important for expressly affirming that overbreadth is an independent ground of invalidity and holding on the facts that the claims of interest were invalid for that reason. In my article Overbreadth in Canadian Patent Law: Part I (2020) 33 IPJ 21, I suggested that a revival of overbreadth as an independent ground of invalidity runs the risk of turning into a new kind of the promise doctrine, in which claims to perfectly good inventions will be invalidated based on an idiosyncratic parsing of the disclosure. Seedlings has done nothing to assuage my fears, and much to confirm them. Seedlings holds that a claim is overbroad if it omits elements which are at “the core of the invention.” Seedlings is express that “the core of the invention” is different from the essential elements of the claim, and, more importantly, Seedlings also makes it clear that “the core of the invention” is different from the inventive concept. Identifying the inventive concept has proven contentious enough and now we have a similar sounding but somehow different concept to wrestle with. The prior caselaw does not provide any assistance. As Locke JA acknowledges at [50], [52], in almost all of the prior cases, overbreadth overlaps with another ground of invalidity, so we cannot find guidance as to how overbreadth might apply as a distinct ground of invalidity. And indeed, in Seedlings itself, overbreadth overlaps with insufficiency both in the facts and in the reasoning. (See here for my post on insufficiency.) We are nonetheless assured that it is “a distinct ground of invalidity that must be considered separately” [50]. In this post I do my best to try to understand how overbreadth operates as an independent doctrine. Unfortunately, I come up empty-handed. It appears to me that to the extent that overbreadth is different from insufficiency, “the core of the invention” was identified largely arbitrarily.

With the FCA nonetheless expressly approving overbreadth doctrine, we will undoubtedly see overbreadth raised regularly in upcoming litigation. Given the very limited guidance provided by Seedlings, we can expect trial judges to struggle with how to apply the doctrine. I expect we will see a variety of approaches with more or less arbitrary results, which will ultimately have to be sorted out by the FCA. I have no idea where we will end up, but it will certainly be interesting times for patent litigators.

Overbreadth background

It is well established that a claim may be invalid because it is overbroad. What is—or was—less clear is whether overbreadth is an independent ground of invalidity, distinct from the well-known requirements of novelty, non-obviousness, utility and enabling disclosure. Put another way, is it possible for a claim to subject-matter that is new, useful, non-obvious, and enabled, to nonetheless be invalid for overbreadth? In the vast majority of cases in which a patent is held to be invalid for overbreadth, the patent discloses patentable subject-matter but claims subject-matter that is not patentable on the one of the standard grounds. For example, in BVD [1937] SCR 221, the inventor invented a new fabric using thermoplastic woven into a yarn with cotton, but the patentee claimed a fabric in which thermoplastic was “associated” with cotton. As a result, the claim encompassing the prior art which disclosed a similar process using thermoplastics in the form of sheets, and consequently, that the prior art “constitutes a complete anticipation of the claims of the respondent,” unless, as a matter of construction, those claims could be limited to a thermoplastic yarn (232-33). The Court held that the claims could not be so limited, and consequently, “[t]he claims in fact go far beyond the invention. Upon that ground the patent is invalid” (237). So, in BVD overbreadth was not an independent ground of invalidity; the claim was invalid for lack of novelty, and in saying the claim was overbroad the Court was merely observing that, given the disclosure, the inventor might have drafted a valid claim. That scenario may be contrasted with a patent where the inventors thought they discovered something new and exciting, but in fact everything they disclosed was anticipated. In that case, we wouldn’t say the claim was overbroad, because there would be no way for the patentee to have drafted a valid claim based on the disclosure.

In Part I of my Overbreadth article, I pointed out at 32–34 that “overbreadth” is almost always used in the same way as in BVD, as being a no more than a reflection of some other ground of invalidity, including anticipation, obviousness, ambiguity, or most commonly, lack of utility. Indeed, until very recently there was only one Canadian case that clearly employed overbreadth as an independent ground of invalidity, namely Amfac (1986) 12 CPR(3d) 193 (FCA); in Part II of my Overbreadth article, (2021) 33 IPJ 147, I argued Amfac was wrongly decided, both on its facts and in its approach to overbreadth, as it struck down a claim to an invention that was new, useful, non-obvious and sufficiently disclosed, without providing any principled justification for doing so. I didn’t argue that overbreadth should be definitively ruled out as an independent ground of invalidity, but I did argue that overbreadth as an independent ground has no support in the caselaw, and that if overbreadth was to be revived, the Amfac approach should be avoided.

Recently, overbreadth has resurfaced as an independent doctrine. In Aux Sable v JL Energy 2019 FC 581 (here) and Servier v Apotex 2019 FC 616 (here), overbreadth was invoked as an independent ground of invalidity, though in neither case was it the sole ground for invalidity. The trend was not uniform: see Lilly v Apotex 2020 FC 814 (here), rejecting an allegation of overbreadth as being “very akin to the promise doctrine” [356].

Then, at first instance in Seedlings, Grammond J held certain claims—claims 40, 59, 60 and 62, which I’ll refer to as “the claims of interest”—to be invalid solely on the basis of overbreadth, as discussed here. The FCA affirmed that these claims are invalid for overbreadth [56]–[65]. The FCA also held them invalid for insufficiency [66]–[72], reversing Grammond J [185]–[186] on that point. At the same time, Locke JA specifically affirmed that “overbreadth is a distinct ground of invalidity that must be considered separately” [50].

The claims of interest 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.

Overbreadth is a proper ground of invalidity

Locke JA began by stating that “overbreadth remains a proper ground of invalidity” [50] and, as noted, he specifically reaffirmed that “overbreadth is a distinct ground of invalidity that must be considered separately” [50], quoting and relying on his decision in Western Oilfield 2021 FCA 24 [128]–[130]. In this section, I will argue that the cases and principles cited by Locke JA in support for this proposition are all equally consistent with the view that overbreadth is not an independent ground of invalidity.

In Western Oilfield [128]–[130] Locke JA addressed the argument that there is no statutory basis in the Act for overbreadth by saying it is supported by the combination of subsections 27(3) and 27(4) of the Patent Act. He summarized the effect of these provisions at [51] by saying:

The invention must be described in full, and the claims define a subset of the described invention that the inventor seeks as exclusive property. It follows that the scope of the claims cannot exceed the disclosure.

I agree, but I don’t see this as saying that overbreadth is necessarily an independent ground of invalidity. The invention, according to s 2, is “any new and useful art, process, machine, manufacture or composition of matter,” or improvement thereof. (The definition predates codification of the non-obviousness requirement, so we should gloss this as meaning any new, useful and non-obvious subject-matter.) So that merely invokes the standard patentability requirements.

The real question is what is means to “correctly and fully describe the invention and its operation or use as contemplated by the inventor,” as required by 27(3)(a). It seems to me reasonable to interpret this as requiring no more than the standard requirements of sufficiency. In setting out the sufficiency requirement at [68], Locke JA quoted Consolboard [1981] 1 SCR 504, 520 which in turn quoted Thorson P’s statement in Minerals Separation [1947] ExCR 306 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 with described.

It seems to me to be quite reasonable to say that this is what it means to “correctly and fully describe the invention and its operation or use as contemplated by the inventor.”

I am not saying that the text of s 27(3),(4) definitively excludes the possibility of overbreadth as an independent ground of invalidity. The disclosure provisions are a mess: as the SCC noted in Consolboard at 518, it “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.” It includes disparate requirements including enablement (how to make), ambiguity, best mode, and even a duty to disclose the invention distinct from the claims, at least according to Teva 2012 SCC 60. So it is possible that there is an overbreadth doctrine lurking here somewhere ready to spring to life, in the way the US written description doctrine emerged twenty years ago. If the courts want to introduce overbreadth as a new independent requirement, s 27 is a good hook to hang it on; but there is nothing in s 27 that requires the law to go beyond the established aspects of insufficiency.

Now, as I’ll discuss below, Locke JA held that overbreadth means the claim cannot extend beyond “the core of the invention.” But there is nothing I can see in the text of the Act to support that; prima facie, “the invention” in s 27(3), (4) is being used as it is defined in s 2.

The second justification provided by Locke JA is a policy argument based on the bargain theory articulated in Free World 2000 SCC 66 [13], summarized by Locke JA at [59], quoting Western Oilfield 2021 FCA 24 [129]:

If a patent claims more than it describes, or more than the inventor has made, it gives the patentee more than the bargain entitles them to. Such a claim violates the bargain and is therefore invalid.

This makes sense, but it doesn’t suffice to establish overbreadth as an independent ground of invalidity. Overbreadth is an independent ground of invalidity only if it is possible that a claim to subject-matter that is new, useful, non-obvious and sufficiently disclosed, can nonetheless be invalid. If the patent sufficiently discloses a new, useful and non-obvious invention, how can it be said that a claim to that invention gives the patentee more than the bargain entitles them to?

This is not a rhetorical question. I am not saying that there can’t possibly be an answer. But the bargain theory itself does not imply that overbreadth must be an independent doctrine. On the contrary, if anything, the bargain theory articulated by the SCC in Free World suggests it is not. The Court said

[13] Patent protection rests on the concept of a bargain between the inventor and the public. In return for disclosure of the invention to the public, the inventor acquires for a limited time the exclusive right to exploit it.

If we understand “invention” to mean new, useful and non-obvious subject-matter, this suggests that an inventor who adequately discloses such subject-matter is entitled to claim it, which implies that overbreadth cannot be an independent ground of invalidity. The SCC continued:

It was ever thus. Even before the Statute of Monopolies (1623), the Crown rewarded an inventor with a limited monopoly in exchange for public disclosure of “a new invention and a new trade within the kingdom ... or if a man hath made a new discovery of any thing”: Clothworkers of Ipswich Case (1653), Godb. 252, 78 E.R. 147, at p. 148,

Again, this looks like the bargain refers to the disclosure of a new invention. The SCC continues:

The argument for the respondents is that the appellant has failed to live up to its side of the bargain in two ways. In the first place, it did not make a new discovery of anything. The appellant's patents teach nothing that was not well known beforehand.

So, the bargain might fail if what the patent disclosed was anticipated.

Secondly, even if the patents are valid, the appellant overreaches its bargain with the public by now asserting a monopoly over devices that are in no way disclosed, taught or claimed in its patents.

Or the bargain might fail for not adequately disclosing the invention. The straightforward reading of this discussion from Free World is that the inventor’s side of the bargain is sufficient disclosure of new, useful and non-obvious subject-matter; I don’t see anything in Free World to suggest it goes beyond that.

It is perhaps worth keeping in mind that in the early days of patents no formal disclosure at all was required, and patents were regularly granted on no more than a title. The dissemination of knowledge, which is now seen as a central function of the patent system, was originally accomplished by a requirement, specific to each patent, that the patentee hire apprentices, often requiring them to be of English birth (presumably to ensure that some knowledge would remain in England if a foreign patentee returned to his home country after exploiting the patent in England). When the requirement for a written specification first emerged, patentees would regularly try to cut corners so as to preserve their secrets, and failure to make adequate disclosure was perhaps the single more common reason for invalidating a patent. Historically, at least, to say that the scope of the claims cannot exceed the disclosure is merely to say that the claimed subject-matter must be sufficiently disclosed, in contrast to the prior practice in which the scope of protection normally exceeded that which was disclosed. Historically, then, the emphasis on disclosure in the Free World discussion simply emphasizes the important of sufficient disclosure in the modern patent system; it does not imply that there is some additional ground of invalidity.

Locke JA also stated that overbreadth is “a principle of patent law that has been widely accepted for many decades” citing Farbwerke Hoechst v Comm’r of Patents [1966] ExCR 91, 106 affd [1966] SCR 604 and Fox, 4th ed at 199-201. The reference to Hoechst is presumably to Thurlow J’s well-known statement that “There are two fundamental limitations on the extent of the monopoly which an inventor may validly claim. One is that it must not exceed the invention which he has made, the other is that it must not exceed the invention he has described in his specification.” This is certainly correct, but again, it does not imply that overbreadth is an independent ground of invalidity. In Hoechst itself the claims were held to be invalid for lack of sound prediction of utility across the full breadth of the claim, as I discuss in Overbreadth Part I at 33. I’m not entirely sure which specific passage from Fox Locke JA had in mind. The most relevant passage I can find is that in which Fox begins by saying that “A claim may appear on its face to be too broad to be supported” (200). Fox cites Neilson v Harford (1841) 1 WPC 295, 355, which merely states that a claim must be to specific subject-matter, and not to a principle as such: this reflects the rule against abstract claims set out in s 27(8) and Shell Oil [1982] 2 SCR 536, and has nothing to do with overbreadth as an independent ground of invalidity. Fox continues: “Claims that are covetous in that they operate as a mere attempt to appropriate unexplored ground or that do not disclose any special advantage are not sufficiently distinct and explicit to comply with the statute,” citing Hoechst Pharmaceuticals v Gilbert & Co [1965] 1 Ex CR 710, and Société des Usines Chimiques Rhone-Poulenc v Jules R. Gilbert Ltd 35 Fox Pat C 174 (Ex), both utility cases. These cases make the point that overbreadth is almost always simply a way of articulating a different ground of invalidity, most commonly lack of utility across the full scope of the claim, with Amfac being the sole exception.

Locke JA also noted that “the Supreme Court itself, in AstraZeneca [2017 SCC 36] at para. 46, recently indicated that ‘[a]n overly broad claim may be declared invalid’” [55]. But that passage does not suggest that overbreadth is an independent ground of invalidity. The sentence in which the quoted phrase appears goes on to say that if one claim is held invalid for overbreadth, remaining valid claims will be valid in light of s 58. This is really about the effect of s 58; it does not mean overbreadth is an independent ground of invalidity, as it also makes sense if overbreadth is used in the BVD sense, as simply articulating an established ground of invalidity. With respect, citing this as support for the view that overbreadth is an independent ground of invalidity illustrates just how little support there is for that proposition.

In any event, Seedlings itself is now authority for the proposition that overbreadth is an independent ground of invalidity and the more immediate issue (at least until and unless the matter is taken up by the SCC), is to understand what overbreadth doctrine actually entails. That the cases and principles cited by Locke JA do not provide clear support for that proposition also means that those cases and principles do not provide guidance as to when overbreadth properly operates independently.

Locke JA more or less acknowledged as much, saying “[o]verbreadth often overlaps with other grounds of invalidity,” and this “makes it difficult to define circumstances in which a patent claim would be invalid for overbreadth but not also invalid on other grounds” [50], [51]. He then stated that “In this regard, it may be helpful to consider Amfac” [52]. As noted above, Amfac is the only FCA or SCC decision to have applied overbreadth as an independent ground of invalidity. We might therefor expect that it would be a source of guidance, now that the FCA has reaffirmed the continued vitality of overbreadth as an independent basis for invalidity. However, that does not seem to be the case.

In my article I argued that Amfac was wrongly decided because it looked to the disclosure, rather than the claims, to determine which elements are essential. As I said at (2021) 33 IPJ 147, 159:

Instead of asking whether the claims were in fact broader than the inventor’s contribution, the court in Amfac in effect asked whether the claims were broader than what the court believed the inventor believed to have been their contribution. This can go wrong at two levels: the inventor might be wrong as to what their true contribution is; and the court might be wrong in construing what the inventor said. The likelihood of error is acute, because the disclosure was never intended to define the nature of the invention: that is the purpose of the claims. Claims were introduced in order to make the essential elements of the invention clear to the court, so as to avoid the risk of the court construing the invention too broadly as a result of a focus on the disclosure. Even if the inventor is correct about the nature of their invention, a focus on the disclosure will mean that the validity of the patent turns on a fine parsing of the disclosure. So, in Amfac, it appears that if the specification had placed more emphasis on the basic invention, or perhaps less on the improvement, [the claim at issue] would have stood. Scrutiny of the disclosure, asking a question that the disclosure was never intended to answer, was the same defect that plagued the search for the promise of the patent, before the promise doctrine was abolished in AstraZeneca Canada Inc. v. Apotex Inc.

Locke JA seems to have acknowledged this critique:

[52] The awkward aspect of Amfac, and of the present case, is that determining that a feature is essential had to be done by reference to the disclosure, not the claims. This is awkward because it is the claims that define the scope of the monopoly that the inventor asserts, and it is they that are typically reviewed to determine the essential features of the invention for the purpose of claim construction. . . Accordingly, one might reasonably ask how a feature can be found to be essential when it is absent from the claim.

Indeed, Amfac is “awkward”—but was it correctly decided in law? Was its approach to overbreadth correct? Remarkably, the FCA affirmed that overbreadth is an independent ground of invalidity without ever saying whether Amfac, the prior leading case, was correctly decided. Since Amfac was not expressly overruled, presumably it remains good law. Moreover, Locke JA also said that “it may be helpful to consider Amfac” [52]. We should probably understand “may” to mean “is” helpful, and if Amfac is helpful, it is presumably still good law. But the fact that the FCA in Seedlings declined to say so expressly casts some kind of doubt on the decision. Moreover, as I’ll discuss below, the approach to overbreadth taken in Seedlings clearly departs from that set out in Amfac. Maybe Locke JA is suggesting that the claim in Amfac was indeed overbroad, but the approach is not? In any event, all I can say for now is that Seedlings does not endorse or apply the Amfac approach, and it will be for a subsequent case to clarify whether the Amfac approach is sound.

Decision on the facts

If the prior case law doesn’t give much guidance, what can we learn about the proper approach to overbreadth from Seedlings itself?

The central holding is that a claim will be considered overbroad if it omits an element that goes to “the core of the invention” [54], [60], [62]. So, the key question is how to determine what constitutes the core of the invention: “[t]he challenge in the present appeal is in determining which elements go to the core of the invention such that their absence from the claims results in invalidity for overbreadth” [60].

The core of the invention is not the same as the essential elements of the claim [54] [60]. That makes sense, or a claim could never be overbroad, because the claim always contains all the essential elements, as well as some non-essential elements.

Nor is the core of the invention the same as the inventive concept. This is a crucial point, because it means that a claim that is new and non-obvious across its full breadth might nonetheless be overbroad. Locke JA did not state expressly that the core of the invention is different from the inventive concept, but that is perfectly clear from the facts.

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 is 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 a shield which moves forward once the injection is complete to protect the needle [FC 19]. (See the video here.) Accordingly, 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].

Thus, Grammond J held expressly that the inventive concept was an auto-injector with a flat housing and an actuator that serves as a needle shield. The claims of interest all included these elements, which is why they were not obvious [FC 1390]–[141]. The claims of interest were not overbroad because they went beyond the inventive concept, because they did not in fact go beyond the inventive concept.

The “core of the invention” was something quite different. 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 (hence the “shared” latch): [8], [56], [62]. The Omitted Elements relate to the implementation of the needle shield [62], which is part of the inventive concept. These are referred to as the “Omitted Elements” because they are found in the specification but omitted from the claims of interest. Grammond J held that the fact that the Omitted Elements were not mentioned in the claims of interest rendered them invalid for overbreadth [FC 174], and the FCA affirmed [62]–[65]. It is the Omitted Elements that were “the core of the invention.” So, it is clear that from the facts that the core of the invention is different from the inventive concept.

Why were the Omitted Elements the core of the invention?

Locke JA noted that a key pair of findings by Grammond J supported the conclusion that the Omitted Elements are the core of the invention, namely that “the 935 Patent does not describe how to make the invention without the Omitted Elements [FC 176] and an uninventive skilled person would not know how to do so [FC 177]” [63] (and see also [57B]. So, it would seem that the Omitted Elements are the core of the invention because implementing the invention without those elements would require inventive ingenuity.

To digress, I’ll note that this is different from the Amfac approach, which essentially identified the “core of the invention” purely by examination of what aspects were emphasized in the disclosure. The FCA in Amfac stated that the issue of determining the key elements “involves solely the construction of the patent and . . . no reference to the prior art is either required or proper in this case.” Now, Locke JA’s identification of the “core of the invention” in Seedlings did not turn on the prior art as such, but it did not involve “solely” construction of the patent, as his analysis turned on an extrinsic factor, whether the skilled person would know how to make the invention without the Omitted Elements. That is something that cannot be determined by inspection of the patent alone. This difference would explain why Locke JA did not endorse Amfac. This is welcome, as the Amfac approach was clearly wrong, in my view; but while the Seedlings approach is different, it is not clear that it is better.

Now, as noted above, Locke JA acknowledged that overbreadth often overlaps with some other ground of invalidity. And in this case, overbreadth overlaps with insufficiency. It is not just that the factual basis for the holding of overbreadth is the same as the factual basis for the holding of insufficiency; the reasoning itself is the same. This is key passage regarding overbreadth:

[63] The fact that the Omitted Elements are described in all of the embodiments of the 935 Patent is not enough, without more, to require that they be included in the claims in issue. However, a key pair of additional findings by the Federal Court is that the 935 Patent does not describe how to make the invention without the Omitted Elements (see paragraph 176 of the Reasons), and an uninventive skilled person would not know how to do so (see paragraph 177 of the Reasons).

As Locke JA acknowledged in holding the claims to be overbroad, “[t]hese findings would seem to lead more readily to a conclusion of insufficiency than overbreadth” [64]. [64]. And so his reasoning on insufficiency echoes that on overbreadth:

[71] In the present case, Seedlings’ claims in issue encompass devices that do not include the Omitted Elements. As a result, these claims are broader than the embodiments described in the disclosure. For claims of this scope to be valid, subsection 27(3) requires that the disclosure teach a skilled person how to make such devices. Based 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.

It would therefore be tempting to say that Seedlings is merely another example in which overbreadth is redundant, except that Locke JA held expressly that it is “a distinct ground of invalidity that must be considered separately” [50].

The immediate problem is to try to understand elements of overbreadth as an independent ground of invalidity; Seedlings tells us that it is distinct ground of invalidity, but what exactly is distinct about it? We have seen that the prior caselaw does not help answer this question, as there are no cases actually applying overbreadth as an independent ground, except Amfac, and it is not clear whether the Amfac approach is still good law. And even Seedlings itself does help understand what the distinct elements of overbreabth might be, because of the overlap between overbreadth and insufficiency on the facts and reasoning.

With that said, I’ll attempt to unpack the decision a bit more. Even though the factual basis and reasoning is similar, there is perhaps a slightly different emphasis. The patent was insufficient because it did not enable alternative embodiments, ie those without the Omitted Elements. It was overbroad because the claims were not limited to the core of the invention, namely the Omitted Elements. The question is how to determine what constitutes the “core of the invention,” keeping in mind it is not the same as the inventive concept. Locke JA noted that for overbreadth, “the focus is . . . whether that feature is so key to the invention described in the disclosure that a claim that omits it encompasses embodiments that were not contemplated in the disclosure” [54]. This is a bit circular, but it does suggest that the feature must be “key to the invention” in some way.

Locke JA held on the facts that the Omitted Elements were the core of the invention because an uninventive skilled person would not know how to make the invention without the Omitted Elements, but it is not clear whether that it is the test for what constitutes the core of the invention.

If it is the test, then it is difficult to see any difference between overbreadth and insufficiency, at least as understood in Seedlings. In my last post, I argued that Seedlings was wrong in holding that sufficiency requires that the patent enable all embodiments of the claimed invention. It is possible that in a future case the FCA might hold that the patent need not disclose how to make all embodiments without the exercise of inventive ingenuity. What would that imply for overbreadth? Either the FCA would similarly modify the holding on overbreadth at the same time, in which case there would still be no difference between overbreadth and insufficiency; or it would not, in which case overbreadth, understood as requiring enablement of all embodiments, would be subject to all the same criticisms that I levied against Locke JA’s holding on insufficiency in my last post.

The other possibility is that the ability to make all embodiments without inventive ingenuity is not the test for overbreadth, but merely a factual finding that supported the conclusion of overbreadth, so that there might be alternative considerations that go to establishing the core of the invention. That would be consistent with Locke JA’s holding that overbreadth is a distinct ground of invalidity that must be considered separately.

If there are other factors, such that overbreadth is truly independent, that would mean that a claim might be invalid for overbreadth if it did not include the “core of the invention” even though it is sufficiently enabled across its full scope. (I will have to be abstract here, as I can’t think of what other factors might plausibly support that conclusion.)

Now, Locke JA’s description of the Omitted Elements as “the core of the invention” might be taken to suggest that the Omitted Elements were themselves inventive, ie that it required inventive ingenuity to design the needle shield with the Omitted Elements as disclosed in patent. But so far as I can tell, there was no finding to that effect. Grammond J did say the elements were novel [FC 178] and his discussion suggests that there was evidence that might have supported a finding that Omitted Elements were inventive, but there is no actual finding to that effect. This means there are two possibilities: elements can be “the core of the invention” even though they are not themselves inventive; or an element must be inventive to constitute the core of the invention. I’ll discuss these in turn.

First consider the possibility that elements need not be inventive in order to constitute “the core of the invention.” That is the straightforward reading of Seedlings; because the decision did not turn on whether the Omitted Elements are inventive, it follows strictly that the claims of interest would be invalid for overbreadth even if it did not require inventive ingenuity to devise the Omitted Elements. That conclusion is entirely consistent with Locke JA’s reasoning, which turns on the fact that it would not have been possible to make an alternative implementation without inventive ingenuity.

If it is possible for elements to be “the core of the invention” even though there is nothing inventive about them, it is very difficult to see what the difference is between the “core of the invention” and the preferred embodiment. But Locke JA explicitly held that the core of the invention does not simply mean the preferred embodiments [58]. So, the “core of the invention” need not be inventive, but neither is it simply the preferred embodiment. I’ve run out of ideas on this angle—I have simply have no idea what the “core of the invention” might be.

The other possibility is that the Omitted Elements were the “core of the invention” because they were inventive. This possibility is more problematic as a reading of Seedlings, since there was never any finding that the Omitted Elements were inventive. At the same time, the phrase “the core of the invention” seems to suggest that the elements in question must be inventive—how can something that is not inventive nonetheless be the “core” of the invention? Perhaps it was assumed, or conceded, that the Omitted Elements were inventive.

In any event, suppose a future decision clarifies that “the core of the invention” must be inventive. If that were the test, it would be necessary to have a trial within a trial focusing on the obviousness of the putative “core of the invention,” separately from the obviousness of the claimed invention. Apart from the practical problems with that inquiry, that definition of the “core of the invention” would not be consistent with the prior caselaw, as there are no overbreadth cases undertaking such an inquiry. Furthermore, even if the disclosed implementation of the claimed invention is inventive, why should the inventor be confined to that implementation? If there are alternative implementations which would be obvious to a skilled person, it would seem completely perverse to insist that the claim must be limited to the clever embodiment which was disclosed, even though the alternative implementations that were encompassed by the claims would have been obvious to a skilled person. And if the alternative embodiments are not obvious, then we are back to the problem of improvements.

There is another problem with suggesting that elements are “the core of the invention” if they are independently inventive. Locke JA began his analysis of overbreadth by noting that “When an inventor drafts and files a patent application, they describe how to make and use their invention, but they do not necessarily know the scope of the invention they have made because they are not necessarily familiar with all of the prior art” [53]. This acknowledges that it is dangerous to rely on the disclosure to identify the key elements of the invention; but how is that danger to be avoided? He continued by noting that “It is not uncommon for the focus of the claims to evolve during prosecution of the patent application as prior art is revealed,” and “[i]n addition, a patent application often describes more than one invention,” with the result that the applications may be divided, so that “the claims of a patent that issues from the application in question may omit some elements that might have been considered important to the invention when the application was published.” “Clearly,” he concluded, “overbreadth should not apply to invalidate claims in these circumstances.” What are “these circumstances”? The passage might be read narrowly, to mean that overbreadth should not be applied when key elements appear in the specification because they were also claimed in a divisional. This is supported by the latter part of the paragraph. The opening remark that the inventor is not necessarily familiar with all the prior art, suggests a broader reading, perhaps to the effect that an element should not be considered essential if it was emphasized in the disclosure but only because the inventor was not aware of the relevant prior art. Both of these interpretations are problematic because they mean that the core of the invention turns on the inventor’s subjective state of knowledge at the time of the application. This is contrary to the general principle that validity is determined objectively, barring some kind of bad faith or wilful misleading—though the best mode requirement also turns on a subjective inquiry.

In any event, it does appear that cases in which the key features are the subject of a divisional constitute a kind of safe harbour against overbreadth. So, in this case, if the patentee had obtained a separate divisional patent claiming embodiments with the Omitted Elements, it would appear that the claims to the patent at issue would be valid, even if the 935 patent and the claims of interest were otherwise exactly the same. It is truly extraordinary to suppose that the validity of the patent at issue should turn on whether a divisional patent had also been obtained. It is also not clear whether the safe harbour would require the divisional to actually be granted, or simply sought. (And of course, seeking a voluntary divisional would be dangerous in light of Canadian double patenting doctrine.)

So, there are a variety of conceptual and practical reasons why it seems to me impossible to identify the core of the invention with an inventive implementation. But there are similarly good reasons why the core of the invention cannot be identified with a non-inventive implementation.

In summary, Seedlings holds that a claim will be invalid for overbreadth if the claim does not comprise elements which constitute “the core of the invention.” I have no idea how to determine what constitutes the core of the invention. There are interesting times ahead.

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