NCS Multistage Inc v Kobold Corporation 2023 FC 1486 McVeigh J
2,693,676 / 2,820,652 / 2,738,907 / 2,766,026 / 2,820,704 (NCS) / 3,027,571 (Kobold)
My first post on this case provided an overview of this decision and addressed some miscellaneous issues, while my second post addressed the overbreadth argument. This post addresses the issue of double patenting and the Consolboard [1981] 1 SCR 504, 536–37 safe harbour for so-called ‘forced’ divisionals. Specifically, the question is whether the safe habour for forced divisionals is triggered by an examiner requisition raising a unity of invention objection, or only by a Final Action, or by something in between.
This is the most important legal aspect of the decision. It is unfortunate that NCS’s ‘throw mud at the wall’ litigation strategy meant it was crammed in with dozens of other issues. The entire discussion of divisionals was 40 paragraphs in a 1684 paragraph decision dealing with myriad other matters. As a result, McVeigh J’s analysis left several loose ends unresolved. This post, which is twice as long as McVeigh J’s discussion, tracks down these loose ends in some detail. It might seem unreasonable of me to do so, given that there is now clearly a split in the case law. No doubt future cases will provide more guidance, so it might be said that we need only let the law unfold.
But that is a litigation perspective and this is a patent prosecution problem. There are many legal issues that make no difference in prosecution. A question as to the threshold for obviousness might make it more or less likely that the patent will ultimately be found invalid for obviousness in litigation, but there is nothing a patent agent can do to affect whether the invention is obvious; that means that any change in the rule will not affect how patent agents prosecute current applications. It is not unreasonable to allow the law to unfold slowly on such issues. But the law relating to divisionals affects hundreds of applications every week. Patent agents need to know what steps to take today, to protect the patents they are prosecuting now from double patenting attacks ten years from now, when the issued patents are finally tested in litigation. The patent agent has a more difficult job than the litigator in that respect; the litigator needs to know what the law is today, the agent needs to know what it will be ten years from now.
An inventor cannot have two patents for the same invention: Comm'r of Patents v Hoechst [1964] SCR 49. The rule applies when the claims are “identical or conterminous,” referred to as “same invention” double patenting, and also when the claims of the second patent are not “patentably distinct” from those of the earlier patent, called “obviousness” double patenting: Whirlpool 2000 SCC 67 [63]–[67]; Sanofi 2008 SCC 61 [108]–[115].
The rule applies also to divisional patents, with the caveat that in Consolboard [1981] 1 SCR 504, 536–37, the SCC carved out an exception for what is sometimes call a ‘forced’ divisional, as a opposed to a voluntary divisional:
As I noted earlier, the appellant originally filed a single patent application for letters patent, but was required by the Commissioner of Patents to divide his application into two parts. It may be open to question whether the Commissioner of Patents should have split off the wafers and treated them as the subject of a separate patent but in my view a patentee is not to be prejudiced by enforced divisional applications. If patents are granted on divisional applications directed by the Patent Office, none of them should be deemed invalid, or open to attack, by reason only of the grant of the original patent.
A question then arises as to what constitutes an “enforced” or ‘forced’ divisional, which permits the patentee to take advantage of this safe harbour [226]–[245], as opposed to a so-called ‘voluntary’ divisional, which is not.
The SCC’s Consolboard statement does not provide any guidance on this issue. The SCC was speaking loosely, because a divisional is never “enforced” or “directed” by the Patent Office. If an examiner raises a unity objection, refusing to grant the patent with the full set of filed claims, and the applicant deletes some of the claims in response, the patentee may choose to file a divisional in respect of those claims, but the Patent Office will never require the applicant to file the divisional. In that sense, all divisionals are voluntary. In another sense, all divisionals are forced, because the applicant obviously wanted a patent with the full set of original claims, or it would have filed two entirely different applications in the first place. The SCC must have meant that a divisional is to be considered forced if the Patent Office would have refused to grant the parent application with the full set of claims, so that the only way to get a patent with the claims found in the divisional would have been to file the divisional. The forced / voluntary terminology seems established, so I will continue to use it, but the real question is what it means for the Patent Office to refuse the parent application.
With that terminology in mind, the substantive question is which divisionals can take advantage of the Consolboard safe harbour (‘forced’) and which cannot (‘voluntary’). Is a divisional considered forced if it is a response to a unity of invention objection by the examiner, or it is considered forced only if it is a response to a Final Action? The question arose on the facts on the issue of whether the 652 and 2,749,636 patents were voluntary divisionals of the 676 patent. (The 636 patent was not asserted but McVeigh J found it necessary to address it nonetheless [1229].)
In her review of the limited caselaw, McVeigh J [234], noted that in Abbott FC 2009 FC 648 [193], Heneghan J indicated that it was enough that the division was a response to an examiner’s unity of invention objection, saying:
[193] I am satisfied that the [2,358,395] Patent should not be found invalid for double patenting over the [2,285,266] Patent. The Applicants provided evidence to show that claims respecting the improved taste profile were divided out of the ‘266 Patent at the request of the Commissioner of Patents. That was an administrative action lying within the mandate of the Commissioner of Patents. In my opinion, it would be unfair and inequitable to find that the ‘395 Patent should be invalidated, only because the Applicants had followed the directions of the Commissioner.
In Abbott FC [27], Heneghan J noted that “during the prosecution of the ‘266 Patent, the Commissioner of Patents required Abbott to divide out any claim relating to improved taste profile into a separate application,” which led to the 395 patent. This evidently refers to the examiner’s requisition of 28 March 2000 (02285266-2000-03-28-PRO). This was the extent of the objection; in particular, there was no Final Action in the file. This means that for Heneghan J, for the applicant to be able to take advantage of the safe harbour it is enough that the divisional was filed after a requisition by the examiner making a unity objection. For convenience, I’ll call this a ‘requisition only’ approach to the safe harbour. (Note that it is the examiner, not the Commissioner, who issues a requisition, but I take it that Heneghan J is using “the Commissioner” is a synecdoche for the Patent Office as a whole.)
On the other hand, McVeigh J [236] noted that in Biogen FC 2020 FC 621 [106], [197], relating to the 2,562,277 patent, Manson J suggested that a divisional is not considered forced if it is merely a response to a requisition:
[106] Throughout the trial, Biogen characterized the divisional application as “forced.” This is an overstatement, as the August 26, 2011 Office Action was an objection, rather than a rejection by way of a “final action.” At this point in the prosecution process, Acorda’s election to proceed with the use claims and file a divisional for the method claims was voluntary. If Acorda felt that the unity of invention objection was not merited, it could have advocated that the responder method was indeed part of the claimed use invention.
The thrust of Manson J’s remark was that a divisional filed as a response to an examiner’s unity objection is not considered voluntary. The examiner requisitions at issue in Abbott FC and Biogen FC were in substantially similar terms, so it is clear that the two decisions are indeed at odds on this point. Manson J’s statement also suggests that a divisional should be considered forced only if it is in response to a Final Action. I’ll call this a ‘Final Action’ approach.
I should note that strictly a unity objection is never resolved by a Final Action. In response to a unity objection, and prior to a Final Action, the Examiner may refer the application to the Commissioner of Patents for review by a Unity Review Board: see MOPOP 21.07 and 21.07.06. (This is an administrative procedure not specifically contemplated in the Rules.) If the applicant is unsuccessful before the URB, the matter is referred to the Commissioner who may issue a Notice of Direction to the applicant under authority of 36(2.1): “the applicant shall, on the direction of the Commissioner, limit the claims to one invention only.” While 36(2.1) uses mandatory “shall” language, what is mandatory is limiting the claims in the application to a single invention. There is no positive obligation to then pursue a divisional: 36(2.1) provides that any other invention disclosed “may” be made the subject of a divisional application. In any event, notwithstanding the mandatory language, even after a Notice of Direction has been sent to the applicant, this does not in itself terminate prosecution. The applicant can then respond to the Notice of Direction, presumably normally by deleting the objectionable claims. But if the applicant chooses instead to continue the fight, the application will be forwarded to the Patent Appeal Board in a process that “resembles the review of a Final Action”: MOPOP 21.07.06. After the referral to the PAB, an unsuccessful applicant has the option of pursuing the matter through the courts. So, under the current procedure a unity objection is never resolved by a Final Action as such. With that said, this entire scenario was not before Manson J, and presumably his reference to a “final action” can be taken to mean the functionally equivalent referral to the PAB under the unity procedure. With that said, Manson J made no reference to the URB, and it is likely that he did not have the procedural context in mind, given that the divisional at issue was a response to a requisition. It is therefore entirely possible that he would consider a divisional responding to a Notice of Direction to also be forced, even though it precedes the equivalent of a Final Action. It also seems clear enough that he would not require the applicant to go so far as to appeal to the PAB.
With all that out of the way, back to the case at hand. After reviewing Abbott FC and Biogen FC, McVeigh J was of the view that:
[245] The preferred approach is an informed middle ground. Where an inventor can trace the origin of the divisional back to a direction of the Commissioner, it will be immune from double patenting attacks.
It’s not clear from this passage alone what kind of “middle ground” McVeigh J is endorsing. McVeigh J’s language referring to “a direction of the Commissioner” echoes Heneghan J’s reference to “the directions of the Commissioner.” This suggests McVeigh J contemplated a variation on Heneghan J’s approach.
Seemingly confirming this, on the facts McVeigh J did review the prosecution history to see if the 636 divisional was forced or voluntary, even though there was no referral to the URB or PAB [1228]–[1236]. This in itself implies that she would not require a referral to the URB or PAB as a prerequisite to considering a divisional to be forced. NCS relied on two Examiner Requisitions in the 676 file dated October 19, 2010 (02693676-2010-10-19-PRO) and June 16, 2011 (02693676-2011-06-16-PRO) [1234], both of which were requisitions which contained unity objections in fairly standard terms. McVeigh J found these requisitions insufficient to establish that the divisional was forced. This means that, contrary to the ‘requisition only’ approach, for McVeigh J a unity objection by an examiner is not in itself enough to establish that division was forced.
Specifically, McVeigh J noted that while the examiner had made two requisitions, “[a] review of the file history leaves it unclear whether NCS divided the 676 Patent [to form the 636 Patent] due to these objections from the Patent Office” [1235]. So, for McVeigh J, while a referral to the URB is not required, a requisition based on a unity objection alone is not enough either. It appears that she would require some evidence connecting the divisional to the objection. This might be called a ‘requisition plus’ approach. It is not enough that a unity objection was made; there must be something more that establishes a causal connection between that objection and the filing of the divisional.
What kind of evidence could establish the necessary connection? Here is the text of the June 16, 2011 requisition that NCS relied on. (The first was in similar terms.)
The application does not comply with subsection 36(1) of the Patent Act. The claims are directed to a plurality of alleged inventions as follows:
[. . . ]
According to subsection 36(2) of the Patent Act, after limiting the claims of the present application to one invention only, the applicant may make any other invention disclosed the subject of a divisional application.
This in itself was not enough to persuade McVeigh J of the necessary connection. So, it would seem that for McVeigh J, a divisional that is simply a response to this language in a requisition does not constitute a forced divisional, and so cannot take advantage of the safe harbour. This is fairly standard language for a unity objection. The language in the 28 March 2000 requisition (02285266-2000-03-28-PRO ) in Abbott FC was in very similar terms:
The claims are directed to a plurality of alleged inventions as follows:
[. . . ]
The claims must be limited to one invention only as set out in Section 36 of the Patent Act.
From this we see that McVeigh J sets a higher bar than Heneghan J in that she came to a different conclusion on essentially the same facts. I don’t think that anything can be made of the difference of the wording between these requisitions, or whether a divisional is forced or not would turn on vagaries of the examiner’s drafting style. But her “middle ground” remark implies she would not go so far as to require a Final Action.
The foregoing tells us what evidence McVeigh J considers is not adequate to establish the necessary connection between the requisition and the divisional, but it does not tell us what kind of evidence is adequate.
The next paragraph offers a hint. In coming to the conclusion that “there is nothing in the record to indicate the 636 Patent is a forced divisional” [1236], McVeigh J stated:
I acknowledge that there are two Examiner Requisitions on October 19, 2010 and June 16, 2011. However, there is no indication as there was above, in the case of the 652 Patent that NCS created a new patent application based on these objections or even in response to these objections.
The reference to the “above” case of the 652 patent is evidently a reference to [1233], where McVeigh J screenshotted the following from the 652 file history correspondence (02820652-2013-07-11-PRO):
So, it appears that McVeigh J took this to be an indication that the 652 Patent was created as a response to the examiner objections. I must say that it is not clear to me what it is about this document that warrants that inference. I am given to understand that a “voluntary amendment” (VA) of this type is not unusual, but neither is it entirely standard. A divisional is typically filed with the intended claims. In some cases, however, perhaps if the applicant has not decided which claims to pursue in the divisional, the applicant may file the divisional with placeholder claims, perhaps the original claims from the parent or claims to the unelected subject matter that was cancelled after the unity objection in the parent. The applicant may then amend the claims after filing by a VA. The VA is usually filed after the initial filing of the divisional, though in this case it was filed at the same time as the divisional application itself was filed. It not clear why that was done; filing a VA adds some expense and an additional step that could have been avoided by simply filing the intended claims as part of the application itself. In any event, the VA is an amendment to the claims that were filed as part of the divisional application, which is considered an entirely separate application (s 36(4)). I can’t see how an amendment to the claims of the divisional establishes a connection to the examiner’s requisition relating to the parent.
In any event, this at least implies that something in the correspondence with the Patent Office during the prosecution of the divisional indicating that the divisional is being filed in response to the objection is the extra step that McVeigh J would require to show that the divisional was filed as a result of that objection. Second, it implies that the above language is sufficient to establish that inference, even though it is not entirely clear why that language is sufficient.
There is a problem, however. As quoted above, McVeigh J held that in contrast to the 652 patent, the file history of the 636 patent left it unclear as to whether the 636 application was also was a response to the examiner requisition. However, the 636 file history (02749636-2011-11-30-PRO) has a very similar VA:
I don’t see any substantive distinction between these. There is a difference in that the 652 VA was filed at the same time as the divisional itself was filed, whereas the 636 VA was filed about ten weeks after the divisional application was itself filed (as is more usual). I don’t know why this would make any difference in McVeigh J’s analysis, but I also don’t see any other difference that might be relevant.
The bottom line from the analysis so far is that that McVeigh J would require something more than a unity objection to establish that the divisional was forced; there must be something in the file history of the divisional to indicate it was filed in response to the requisition. However, it is not clear what it is about the VA that allowed McVeigh J to draw that inference. The confusion about the role of the VA is compounded by the apparent inconsistency between the treatment of the 652 and 636 divisionals. Consequently, it is not clear what evidence is needed to establish the connection that McVeigh J would require.
The foregoing relates to McVeigh J’s discussion of whether the 636 divisional was forced. She then turned to the question of whether the 652 divisional was forced [1236]. In that context, her analysis turned on what appears to be an entirely separate point:
[1244] As can be seen, Parliament created two avenues for the Patent Office when objecting to a multiplicity of invention. Subsection 36(2) allows the inventor to voluntarily divide, whereas subsection 36(2.1) enforces a division.
[1245] NCS adopts the position that both voluntary and forced divisional applications are possible under subsections 36(2) and 36(2.1) of the Patent Act.
[1246] However, I am of the view that subsection 36(2.1) is comparable to the Supreme Court’s wording of “enforced divisional application” in Consolboard at paras 536-537. This further supports adopting the approach in Biogen FC.
This seems to be saying that only a divisional issued pursuant to 36(2.1) would be considered forced. As noted above, 36(2.1) is used by the Commissioner after a review by the URB. This means that only a divisional that went to the URB is to be considered forced. As McVeigh J notes [1246], this is similar to the Biogen FC approach of requiring a Final Action, with the caveat that a referral to the URB is not strictly a Final Action, though it follows a similar procedure. While neither McVeigh J nor Manson J mentioned the URB, I expect they would both consider it sufficient if the divisional were filed as a consequence of a Notice of Direction pursuant to 36(2.1) without requiring the applicant to continue resisting so as to provoke a true Final Action.
It is not clear to me how to reconcile McVeigh J’s analysis of the 636 and 652 divisionals. The “middle ground” language [245], and the discussion at of the 636 patent at [1233]–[1236], implies a ‘requisition plus’ approach, while the discussion of the 652 patent at [1244]–[1246] implies a ‘final action’ approach. These seem to be two entirely different tests. McVeigh J held the 636 patent to be a ‘voluntary’ divisional on the basis of the first test [1236], and she held the 636 patent to be a ‘voluntary’ divisional on the basis of the second test [1247], thus confirming that these two lines of reasoning are indeed distinct grounds for holding that the division is voluntary. One way to reconcile the tests would be to say that both tests must be satisfied to take advantage of the safe harbour, but this seems strained — if McVeigh J had intended a two-pronged test, one would have expected her to say so explicitly.
To this point I have been trying to unpack McVeigh J’s decision. Now we can turn to policy considerations. There are a few points at which the divisional might be considered forced: (1) if made as a response to an examiner’s requisition; (2) after a referral to the URB and a subsequent Notice of Direction by the Commissioner pursuant to 36(2.1); (3) after the subsequent Final Action by the examiner; (4) after an adverse PAB decision; (5) after an adverse court decision. All of these might additionally be combined with McVeigh J’s suggestion that there must be something extra in the divisional file to establish a connection between the requisition and the divisional.
Regardless of the point where we draw the line in the prosecution of the parent, it is difficult to see any policy justification for requiring something extra in the file to establish a causal connection with the divisional. First, I must say that I have difficulty understanding why the standard sequence of events is not sufficient to establish a causal connection. Typically, a unity objection is made to the parent patent, identifying two groups of claims, and instructing the applicant to elect Group A or Group B; the applicant does indeed delete Group B; the applicant subsequently files a divisional claiming Group B (or substantively similar claims); the divisional application explicitly indicates that it is a divisional of the parent, as is required to claim divisional status and the benefit of the same filing date. What else is really needed to establish that the division was caused by the requisition?
Further, if a ‘requisition plus’ rule is established, patent agents will simply add the necessary wording, once they find out what it is. That will be pure formalism, and it is difficult to see what is gained. If the special words are already standard boilerplate, then it won’t make any difference. If new words need to be used – for example, if it is necessary to file placeholder claims and a VA simultaneously — there will be a period of potentially prolonged uncertainty before we find out what the special words are. And there is also the question of existing divisional patents. If agents need to add new words that are not now normally included, this would effectively mean that all past divisionals are deemed to be voluntary. This is effectively a retroactive change in the law with the injustice that entails, for no apparent benefit. The broader point here is that specific words in the divisional file will never be a reliable indication of a causal connection (assuming some evidence is necessary beyond the requisition), because the patent agent will use whatever words are necessary to invoke the safe harbour. For simplicity, in the remainder of this policy discussion I will assume there is no such requirement, though we cannot rule it out as a legal requirement.
Now we can return to the question of where to draw the line. We can rule out options (4) and (5). No one so far has suggested going so far as to requiring the applicant to go to the PAB or beyond. The outcome of a PAB decision may be an outright rejection of the application: see MOPOP 26.08. It unreasonable to require the applicant to risk rejection of the application as a prerequisite to taking advantage of the safe harbour. Moreover, requiring a PAB decision would appear to be contrary to Consolboard, as there was no mention of a PAB decision requiring the division, though it is conceivable that there was one and it was not mentioned. I included options (4) and (5) nonetheless for completeness, and to point out that there is no reason in principle to draw the line at a Final Action rather than a PAB rejection; whether the applicant decides to withdraw claims from the parent and file a divisional after any of these steps, the reason is always that the cost and inconvenience of filing a divisional is outweighed by the cost of fighting the objection.
The real question, then, is whether the safe harbour should be triggered by a requisition only, or whether the applicant needs a URB referral or a Final Action. Since a URB referral and a Final Action are closely linked, we can treat them together. These are very onerous requirements. Final Actions, or a trips to the URB, are rare. This is because a Final Action is intended as a last resort when a true impasse is reached. Indeed, an applicant is required to respond “in good faith” to a requisition: Rule 86(3). A refusal to divide in response to a unity objection solely to provoke a referral to the URB so as to protect the safe harbour, would arguably not be made in good faith. Moreover, I am given to understand that in practice unity objections tend to be raised early in proceedings and the examination does not take place until any perceived lack of unity issue is resolved. That means that a trip to the URB and possibly a Final Action would be provoked at the very outset of examination, before any of the substantive objection have been raised. That is clearly not the function of a Final Action. Further, while unity objections are routinely made very early in prosecution on the basis of the application submitted by the applicant, it also happens that a unity objection is made later in prosecution, based on new prior art discovered by the examiner or submitted by a third party pursuant to 34.1(1). In such a case, the applicant may agree with the examiner that the unity objection is appropriate. It seems wrong to require the applicant to disagree with the examiner in order to provoke a Final Action so as to take advantage of the safe harbour. It might be said that if the examiner and the applicant agree the parent claims two patentably distinct inventions, then there is no need for the safe harbour. But it is one thing for the examiner and the applicant to agree, and it is another for the applicant to be confident that a court ten years from now will agree. And just because the applicant agrees that division is appropriate, it does not necessarily mean that the applicant believes that the parent contains two distinct inventions. It is enough that the applicant is of the view that there are arguably grounds for believing the application contains two inventions; that is enough to warrant examining the two putative inventions separately. This is not to suggest that provoking a referral in order to take advantage of the safe harbour is conduct that should be sanctioned; that would put applicants in an even more impossible position. The point is that a rule requiring a Final Action or URB referral in order to take advantage of the safe harbour incentivizes conduct that is harmful to the patent system as a whole by increasing cost and delay.
Thus, the Final Action / URB approach would dramatically restrict the availability of the safe harbour. It would be tantamount to abolishing the safe harbour, or dramatically increasing the cost of the patent system. That in itself does not imply the Final Action approach is wrong. We need to ask whether it would be desirable to dramatically restrict the safe habour. This would be harsh for the applicant, but that might be justified if there is an offsetting benefit to the public.
There is a straightforward argument in favour of restricting or abolishing the safe habour. The safe harbour may protect what is in fact a second patent for the same invention, which should properly have been included in the parent application. Indeed, that is the whole point — if the divisional is patentably distinct, a safe harbour is not needed. It is unfair to the applicant to penalize them for double patenting that was not their fault, but regardless of whose fault it might be, the public will suffer the consequent harm of double patenting. We might therefore want to restrict the availability of the safe harbour, accepting the unfairness to the applicant, in order to protect the public from the harms of double patenting. Requiring the applicant to pursue more onerous steps before taking advantage of the safe harbour effectively restricts the availability of the safe harbour and therefore provides more protection to the public against the harms of double patenting.
How difficult should it be for the applicant to take advantage of the safe harbour? How hard should the applicant have to fight in resisting the Patent Offices improper unity objection? That depends on how much the public is harmed by double patenting. We should require the applicant to fight hard—all the way to a URB referral or a Final Action, if the harm to the public is large; in other words, we are willing to tolerate significant unfairness to the patentee if the harm to the public is substantial. On the other hand, if the harm to the public from double patenting is minimal, then we should not tolerate as much unfairness to the patentee. It follows that to decide where to draw the line for the safe harbour, we need to assess the harm to the public from double patenting in the context of divisionals.
How bad is the double patenting problem? The double patenting doctrine “is aimed at the problem of evergreening; extending the monopoly that was granted on the first patent by filing a new patent that does not offer a new invention to the public”: Mylan v Lilly 2016 FCA 119 [26]. When Consolboard was decided, the evergreening problem was substantial. The term ran from grant and applications were not published until grant, so if the inventor could file two patents for the same invention, it could get early protection by vigorously prosecuting the first application and potentially many years of extended protection by delaying prosecution of the second. The problem is now substantially mitigated because applications are now laid open after 18 months, so the inventor can get at most an extra 18 months, after which the first application will be prior art against the second. I will discuss this in a subsequent post.
More importantly for the present purposes, the evergreening problem does not arise at all in respect of divisionals. A divisional will necessarily have the same expiry date as the parent. This is because the divisional necessarily has the same filing date as the parent (78.2(b)). That is the point of a divisional. Otherwise, in response to a unity objection, the applicant would have to withdraw some claims and file an entirely new patent application with a new priority date, with the attendant risk that invalidating prior art would have arisen in the interim. That would be unfair to the applicant, which did after all actually file a sufficient specification fully disclosing the second invention on the original filing date, so there is no reason to deny the applicant the benefit of the original filing date. The solution to the problem is to allow a divisional, which has the same priority date as the parent (per 78.2(b)), thereby avoiding the problem of intervening prior art. In all other respects the divisional is like an entirely separate application: s 36(4). Since the divisional necessarily has the same filing date as the parent, it necessarily has the same expirty date, under the current rule that the term runs from filing. The mischief of term extension through double patenting simply cannot arise in respect of a divisional under current law, as McVeigh J recognized in AbbVie v JAMP Pharma 2023 FC 1520 [609]–[610]: see also MIPS v Bauer Hockey 2018 FC 485 [302] and GlaxoSmithKline v Apotex 2003 FCT 687 [89].
The same objection can be made to McVeigh J’s argument that “[a]n applicant should not be penalized for electing for a divisional, but such an election should not be a mere attempt to secure the claims and take advantage of the earlier priority date of the parent patent” [245]. This implies that the safe harbour should be denied when the applicant is trying to game the system by using a divisional to take advantage of the earlier priority date of the parent patent. The problem with that reasoning is that the applicant can never “take advantage of the earlier priority date of the parent,” because the parent never has an earlier priority date; the priority date of the parent and the divisional are always the same: s 78.2(b).
Another type of harm was noted by Kelen J in GlaxoSmithKline v Apotex 2003 FCT 687 [89]–[90]. He acknowledged that the original rationale for the rule against double patenting did not apply in respect of divisionals under the new Act [89], but he went on to make the following observation:
[90] I cannot agree with GSK that "the sin of double patenting" has evaporated. GSK has overlooked the impact that a second patent can have under the Regulations. Under paragraph 7(1)(e) of the Regulations, the Minister is prohibited from issuing the requested NOC for 24 months once the owner of a patent has applied for an order under subsection 6(1). The effect of this provision is to put in place a mandatory injunction that remains in force until either the case is disposed of or the 24-month period expires. The existence of additional patents allows the patent-holder to bring additional applications, thereby obtaining multiple injunctive periods. There is no need to look further than the case at bar for an excellent example of this practice. Even though Apotex successfully invalidated the '637 patent in 2001, the filing of this application by GSK has prohibited Apotex from bringing its product to market for the past two years.
I’ll call this the “NOC problem”. It arose in that case because GSK filed an application claiming dry formulation paroxetine and carved out a divisional claiming dry formulation paroxetine without microcrystalline cellulose. The patent based on the parent issued and was added to the patent register. Apotex promptly filed an NOA and the NOC litigation over the parent ensured. Then the divisional claiming dry formulation paroxetine without microcrystalline cellulose issued and was added to the patent register, and the litigation started all over again. If the two are not patentably distinct, the patentee would surely lose in the second litigation if it lost in the first. But as Kelen J pointed out, it can nonetheless get the benefit of the statutory stay (though there is a second order disincentive because of the prospect of s 8 damages). So, the NOC problem was real.
I say it “was” real, because the NOC problem that arose in GlaxoSmithKline v Apotex no longer exists, as McVeigh J recognized in AbbVie v JAMP Pharma 2023 FC 1520 [613]. As a result of 2006 amendments, SOR/2006-242, the patent list is now ‘frozen.’ The generic is now only required to respond to patents that were listed at the time it filed its NOA: NOC Regs 5(4). Consequently, the statutory stay cannot be triggered by a divisional patent added to the list after the generic files its NOA. The generic can be sued in an ordinary infringement action on the basis of a subsequent divisional — whether or not that divisional was patentably distinct from the patent — but that doesn’t cause substantial harm because there is no equivalent of the statutory stay. Under current FCA jurisprudence, the patentee will never get an interlocutory injunction. (Even if the law were relaxed, it is unlikely that a patentee would get an interlocutory injunction in a case in which its action was based on a patent that was prima facie the same as the patent at issue in litigation which it had already lost.) Without the statutory stay, there is no benefit to bringing an action based on a patent which is not patentably distinct from the earlier patent; if it lost on the first, it will almost certainly lose on the second.
So, the evergreening problem no longer exists in respect of divisionals, and the NOC problem no longer exists either.
McVeigh J raised another objection:
[1239] First, following the approach in Abbott FC [ie requisition only], this assertion potentially opens a door to misuse the patent prosecution process. Every inventor could file as many patents as they desire in a single application, and then when the Patent Office suggests division, the inventor has protection from double patenting attacks because the divisionals were “forced.”
[1240] The underlying policy rationale of double patenting must be kept in mind. Allowing inventors to expand their domain via decisions that are made by the patentees themselves is counterintuitive to the rationale underpinning double patenting. Accepting NCS’s approach means inventors can benefit from accidental misuse of the system, or worse, knowingly expand their domain in the knowledge that forced divisional applications are immune from double patenting attacks.
I’ve quoted this argument in full because I don’t understand it. When McVeigh J says “Every inventor could file as many patents as they desire in a single application,” I take it she means that an inventor could file a single application claiming many different inventions. In that case, yes, under the ‘requisition only’ approach the inventor would indeed have protection from double patenting attacks because the divisionals were ‘forced.’ But the inventor would have protection from double patenting attacks even without the safe harbour because the inventions are patentably distinct. Moreover, I fail to see how the patentee can be said to have expanded their domain. If the patentee discloses multiple inventions in the application, the patentee is entitled to protection for those multiple inventions. The patentee’s domain is defined by the claims, the patentee is entitled to claim all the inventions that it disclosed, and so far as the scope of the domain is concerned, it makes no difference whether those claims are found in single patent or multiple patents. The only thing the applicant gains by filing a single application with multiple inventions is filing fees. That is why the examiner can object based on lack of unity; the unity objection is really an administrative mechanism for ensuring that the fees charged for examination are commensurate with the work involved. That is why the s 36(1) provides that a patent is not invalid simply because the examiner fails to raise a proper unity objection.
McVeigh J raised yet another argument in AbbVie v JAMP Pharma 2023 FC 1520:
[614] However, I am not convinced that this amendment [freezing the patent register] completely removes the potential for unfair advantage from double patenting under the Regulations. As JAMP points out, a first person with more patents under a given drug on the Register will make more work for a second person seeking a NOC for a biosimilar. This is ordinarily not a problem where several patents correspond to the same drug on the Register, but it may constitute an unfair advantage for a first person where more work is created than a single invention warrants, i.e. where a generic manufacturer has to do a disproportionate amount of work due to a double patent.
If I understand this argument correctly, the idea is that it is more work for a second person to address two patents for the same invention rather than one. This is not correct in the context of divisionals. First suppose that the divisional was prompted by a unity objection made by the examiner. If the claimed subject-matter of the divisional is patentably distinct from the parent, then there is no grounds for complaint. The problem can only arise if the unity objection was improper. If the improper objection had not been made, then the claims of the divisional would have issued as claims in the parent. Since the disclosure of the patent and divisional are the same, it is no more work for the second person to address those claims in two patents (with the same disclosure), rather than one.
The objection is no stronger even as applied to an entirely unprompted divisional, for exactly the same reason. The double patenting objection only bites when the subject-matter claimed by the divisional is not patentably distinct from the parent. In that case, the patentee might have included the claims of the divisional along with the parent, but chose not to; but because it is a divisional, the disclosure is the same. Again, it is no more difficult for the second person to address claims in two patents with the same disclosure than if those same claims had been found in a single patent with that same disclosure. That is true because the disclosure is the same either way; whether the divisional was forced or voluntary doesn’t matter. Further, even if we suppose that the claims of the divisional somehow would not have been filed at all, so that there were some inconvenience of having to address new claims, it cannot possibly be very much inconvenience to address claims that are not patentably distinct, based on the same disclosure; certainly not enough to justify making the applicant fight through to the URB or a Final Action.
Finally, there is the argument that even if there is no harm to the public, it is just wrong to allow two patents for the same invention: see GlaxoSmithKline v Apotex [91]. Maybe so, but it is so wrong that we want to deny the applicant the protection of the safe harbour which the SCC endorsed in Consolboard, even in the absence of any harm to the public? To my mind, that would be contrary to a purposive interpretation of the Act. The Patent Act is intended to benefit the public. Throwing sand in the gears of the system without any corresponding benefit will simply harm the public. Kelen J adverted to 36(2) of the Act in support of his position. I fail to see how that provision supports his view that granting two patents for the same invention is a grievous sin.
To summarize, the question is how hard we should require the applicant to fight in opposing a unity objection before permitting it to take advantage of the Consolboard safe harbour. The safe harbour can result in the divisional being valid even though it is not patentably distinct from the parent. If this causes substantial harm to the public, we should require the patentee to fight hard; if there is not much harm to the public, then we should be more lax in allowing the applicant the benefit of the safe harbour.
As it turns out, this is not a difficult question to answer. There is no harm to the public at all in the context of a divisional.
There was substantial harm when Hoechst and Consolboard were decided, because the divisional might have a later expiry date (and still the SCC was willing to allow a safe harbour). That harm is now gone. There was still some harm, albeit less, under the old PM(NOC) Regs. That harm is also now gone. So now we are left with the argument that there is some inconvenience to the second person in an PM(NOC) action, although surely there is very little — I have argued that there is none at all. And then there is the argument that it is just wrong to allow two patents for the same invention. We seem to be clutching at straws to preserve double patenting as a ground of invalidity.
We can now return to the question of how difficult it should be for the applicant to take advantage of the safe harbour. If the public is seriously harmed by double patenting, a more stringent approach might be desirable, requiring the applicant to fight all the way to a URB referral or a Final Action. If the harm to the public from double patenting is minimal, then we should not tolerate as much unfairness to the patentee.
It turns out that this question is very easy to answer. As we have seen, there is simply no double patenting problem at all in respect of divisional patents. This clearly implies that a relaxed approach to the safe harbour is best. Nothing in the SCC authority requires otherwise.
Indeed, given that there is no harm at all from double patenting in the context of divisionals, it would be preferable to abolish the doctrine entirely, so that a divisional patent would never be subject to a double patenting attack based on the parent, regardless of whether it is forced or voluntary. We should recall that double patenting doctrine is entirely the creation of the courts. It has no basis whatsoever in the Act. Suppose that double patenting doctrine did not exist and it was now argued for the first time that a divisional patent is invalid if it is not patentably distinct from the parent. Would the courts today be willing to read language into the Act to invalidate the divisional? Surely not. While the the courts will sometimes read language into legislation as a matter of statutory interpretation, a strong justification is required to depart from the text, such as absurd consequences, or a result that is inconsistent with the purpose of the Act. Neither of remaining arguments for the double patenting doctrine in the context of divisionals — inconvenience to the second party, if any, and ‘it’s just wrong’ — is remotely strong enough to justify reading language into the Act.
The courts created the double patenting doctrine. Now that the problems it was intended to address have been eliminated in the context of the divisionals, the double patenting doctrine should also be eliminated in that context. It might be said that now it is established law, and we are stuck with it, for better or for worse. I don’t find that persuasive. The courts created double patenting doctrine of their own initiative to address a specific problem. If the courts have the authority to create the doctrine, how can it be said that they do not have the authority to abolish it, now that the rationale for the doctrine has vanished? (What could the legislature even do to abolish a doctrine that isn’t found in the Act in the first place?) I don’t see any impediment to this in the SCC juriprudence. Hoechst, Consolboard, and Whirlpool were all decided under the old Act. Sanofi held that a selection patent is not invalid for obviousness type double patenting over a genus patent because a species is not obvious over the genus [113]. The double patenting doctrine was not applied, it was not challenged, and divisionals were never mentioned. This can’t be taken to affirm the continued vitality of double patenting doctrine in the divisionals context.
I would note that in Consolboard 537 the SCC cited JR Short Milling [1941] Ex CR 69 and Fox 4th at 270, as authority for the proposition that patents granted on divisional applications directed by the Patent Office should not be open to attack by reason of the grant of the original patent. Fox in turn cited Lovell Mfg v Beatty Bros (1962) 41 CPR 18 (Ex Ct) 68, in which Thorson P held as follows:
Finally, the basic objection to double patenting is that it would extend the life of the monopoly if a patent were granted for a device and a patent for the same device were granted subsequently. This did not happen in the present case for the two patents referred to, indeed, the plaintiff's three patents, were issued on the same day. This puts an end to the matter.
This seems to me to be both common sense and good authority for the proposition that a double patenting objection cannot be raised in respect of patents which expire on the same day. At the time, it would have been a matter more or less of coincidence that the patents expired on the same day, because they were issued on the same day. (The complete file history for the patents at issue in Lovell is not available online, but so far as I can tell, the patents were for related but distinct inventions, with different specifications, that had been filed at the same time by the same applicant. Presumably they were examined together and issued on the same date for that reason.) With divisionals under current law, it is matter of necessity, since the parent and the divisional will always have the same filing date. But in either case, the principle is the same: if the second patent cannot extend the life of the monopoly “that puts an end to the matter,” and the double patenting objection is not available.
In summary, there is simply no double patenting problem at all in respect of divisional patents. Double patenting has nonetheless grown into a complex area of law that is especially problematic in patent prosecution. There is no reason to ever hold a divisional is invalid for double patenting over its parent, so the best approach would be to simply hold that double patenting doctrine does not apply at all to divisionals, on the authority of Lovell Mfg. But at the very least, the FCA should clearly affirm the ‘requisition only’ approach to the Consolboard safe harbour. Nothing in Consolboard or any other SCC or FCA authority requires otherwise. We do not need strict rules around the safe harbour in order to protect the public from a double-patenting harm that does not exist. There are some issues in patent law that are truly difficult, such as how to deal with indirect infringement in the pharma context. The safe harbour for divisionals is not one of those issues.
