Friday, August 26, 2016

Jurisdiction of the Federal Court and IP Related Contracts

SALT Canada Inc v Baker 2016 FC 830 Boswell J
            2,222,058

Section 52 of the Act gives the Federal Court “jurisdiction. . . to order that any entry in the records of the Patent Office relating to the title to a patent be varied or expunged.” SALT Canada brought an application for a declaration under s 52 that the register be varied to list SALT as the owner of the ‘058 patent. Boswell J dismissed the application for lack of jurisdiction. In so doing Boswell J review a number of cases and provided a helpful and clear statement of the law related to the jurisdiction of the FC under s 52. However, he did not discuss Kellogg Co v Kellogg [1941] SCR 242, presumably because it was not cited to him. This omission is unfortunate, as that case might be taken to suggest a different result, and it would have been interesting to see how it would have affected his reasoning. Boswell J also emphasized the need for the court which does have jurisdiction hear the dispute to take into account s 51 of the Act, which establishes a priority scheme for patent title based on registration. But that same point, looked at from the other direction, suggests that the FC might have jurisdiction to begin with. So, while Boswell J’s holding initially appears to be a straightforward application of existing law, a closer look suggests there may be a reasonable argument for a broader interpretation of the Court’s jurisdiction.

The case involved two conflicting assignments of rights in the ‘058 patent from the inventor, Dr Markels. The first was a complex series of assignments which ultimately led to the Respondent, Baker. Baker registered his ownership with the Patent Office. Some of the assignments in this series included provisions requiring the ‘058 patent to be reassigned to Markels if certain conditions were breached. Apparently believing that the conditions had indeed been breached, in 2015 Markels assigned title to the Applicant, SALT. Markels also prepared a reassignment from Baker to Markels, which was, however, never executed by Baker. SALT sought to have its ownership registered, but the Patent Office refused on the basis that the assignment was not executed by Baker, the registered owner [3]-[9].

SALT then brought this application for a declaration under s 52 that the register be varied to list SALT as the owner of the ‘058 patent (as well as other additional and alternative relief). A key substantive question related to the interpretation of the various agreements, and whether the conditions in the first series of assignments had been breached, such that Markels was entitled to a reassignment [24].

Thursday, August 18, 2016

Comments on the State of the Art for an Obviousness Attack

Pollard Banknote Limited v BABN Technologies Corp 2016 FC 883 Locke J
            2,752,551

“What is the State of the Art for the Purpose of an Obviousness Attack?” That’s the title of an article I wrote in 2012 (27 CIPR 385). The puzzle is this. Traditionally, under the old Act, the body of prior art which could be set up against the patent in an obviousness attack (the “state of the art”), included only the common general knowledge plus prior art which would be discovered in a reasonably diligent search directed to the problem at hand. But s 28.3, which codified the obviousness in the new Act, provides that the relevant information is that “disclosed before the claim date … in such a manner that the information became available to the public”. That includes all public prior art, not just prior art which would have been found in a reasonably diligent search. There is an open question as to whether s 28.3, which was generally thought to have simply codified the existing non-obviousness requirement, had extended the state of the art. In my article I concluded that “contextual and purposive considerations imply that s. 28.3 was not intended to change the law, and the state of the art remains limited to information that is reasonably discoverable,” but “the argument based on the text of the provision is sufficiently strong that case law directly addressing the question will be needed before the point can be considered settled.”

While a number of decisions under the new Act simply assumed that the relevant state of the art was the same as under the old Act, the first decision to address this question directly, albeit briefly, was Novartis v Teva / deferasirox 2015 FC 770 blogged here, in which O’Reilly J held that indeed the law had not changed. (The question was noted, but not addressed, in 2015 FCA 163 [21].) Now, in Pollard v BABN, Locke J has suggested that he may prefer the opposite conclusion [192-95]. The question was relevant in respect of the Camarato application, which was crucial to the holding that Claim 1 was obvious. As I read his decision, Locke J never directly held that the state of the art extends to all publicly available prior art. Locke J noted the problem and made some comments on it, but his only direct holding was “Even if I was of the view that this reference’s findability in a diligent search was a relevant consideration, I would nevertheless conclude that it is citable for obviousness,” because it was indeed have been found in a diligent search, and so would be part of the state of the art under either test [196]. The phrase “even if I was” is ambiguous. It might suggest that he was of the view and findability is not the test, and his holding that the Camarato application was findable was in the alternative; but it might also mean that it didn’t matter whether findability was the test, given that the reference was in fact findable.

Regardless of the precise holding, Locke J was clearly sympathetic to the argument that the state of the art should comprise all public prior art:

[194] [I]n order to obtain a valid patent, it is not enough for a skilled person simply to make an obvious change to what is known in the art. This principle should apply to any information that was available to the public, even if it would not have been located in a diligent search. For example, should a skilled person be able to obtain a valid patent by simply searching a dusty corner of a public library for a document that describes a forgotten invention and making an obvious change to it?

The problem with the final rhetorical question is that even under the traditional test a person cannot obtain a patent by “simply” searching a dusty corner and making an obvious change, because if the search was simple, by definition it would have been found in a reasonably diligent search. The proper question is whether a skilled person should be able to obtain a valid patent by making an obvious modification to a document that was found after a long and arduous search. The answer to that question is not so easy. The EWCA in Windsurfing [1985] RPC 59, 71 made a very similar argument, which I discuss at more length in my article at 391-93.

Wednesday, August 17, 2016

Protests Do Not Result in a Higher Burden in Subsequent Litigation

Pollard Banknote Limited v BABN Technologies Corp 2016 FC 883 Locke J
            2,752,551

Pollard v BABN raised two issues related to the standard of review. The more significant holding was that a party which protests or submits prior art during prosecution, pursuant to s 34.1, will not be disadvantaged by a higher burden of proof if it subsequently challenges the same patent in litigation. I believe this is the first decision to address this issue.

In Wellcome / AZT 2002 SCC 77 [42]-[44], the SCC apparently held that a challenge to the validity of a granted patent was somehow a form of judicial review of the Commissioner’s decision to grant the patent, and that decision should be treated with deference, so that the patent would only be held invalid if the Commissioner’s decision to grant it was unreasonable. The SCC’s conclusion was rejected by Gauthier J in Cefaclor 2009 FC 991 [350]-[370], who, after a devastating critique of the SCC’s reasoning, held that the correct standard was the traditional balance of probabilities. Subsequent decisions of the FC addressing this issue have consistently followed the lead of Gauthier J, essentially (and rightly, in my view) treating the SCC statements in Wellcome / AZT as having been made per incuriam. Locke J in this case did the same, citing Cefaclor and recognizing, as the SCC did not, that “[t]here is no standard of review applicable to Pollard’s challenge to the validity of the 551 Patent because this is not a judicial review of the decision to allow the 551 Patent to issue. . . . The standard is the balance of probabilities” [129].

The more interesting issue related to s 34.1. Pollard had been involved in challenging the patent during prosecution by filing 12 protests pursuant to s 34.1, including both prior art submissions and argument [128]. SG argued that “in view of the depth of Pollard’s involvement in challenging the patented invention during prosecution, it benefited from what was effectively a patent opposition process. For this reason, and because of the extraordinary delay SG experienced in obtaining allowance of its patent application, SG argues that a degree of deference to the examiner’s decision to allow the 551 Patent to issue should apply” [128].

Locke J rejected SG’s argument. He noted that SG could not be held accountable for the delay:

[131] Its protests contributed to the delay in the 551 Patent’s issuance only inasmuch as the examiner accepted the arguments contained in those protests and included them in the rejection letters that were sent to the applicant. A more direct reason for the delay in the issuance of the 551 Patent is that it took many exchanges with the patent examiner before the applicant found the claim language that would be accepted. I see no basis for criticizing Pollard for having filed its protests.

The delay should not be attributed to the protests, because if they are well-founded, the examiner should have raised them in any event, and if they are not, the examiner need not and should not require the applicant to respond.

Locke J also raised an important policy issue:

[133] Another concern I would have about raising the burden on Pollard for its validity challenge is that it would, as a result, have a higher hurdle than other interested members of the public who might wish to mount a similar challenge. It should also be noted that an impeachment action, if successful, is a benefit not just to the plaintiff, but also to the public as a whole since an unjustified monopoly is thereby removed from the patent register.

If a party faced a higher burden for issues it raised during prosecution, that would no doubt affect its decision whether to protest or submit prior art under s 34.1, and as Locke J pointed out, it is in the interest of the public as a whole to ensure that unjustified patents are not granted. The flip side of the coin is that a interested party like SG gets two kicks at the can – though that is perhaps not a serious problem if its contribution to the prosecution imposes no significant additional burden on the applicant, as Locke J indicated. 

Locke J also noted on the facts that the applicant was apparently not concerned about the delay, because it “responded at or near the end of the six-month deadline for responding to the examiner’s action in every case but one” [132]. Quare whether this would form the basis for a distinction in a future case? I think not, given the rest of Locke J's reasoning, but the fact that he mentioned this point leaves the question open. And of course, future judges might see the whole issue differently.

Tuesday, August 16, 2016

Claim Held Invalid for Ambiguity for the First Time in 40 Years

Pollard Banknote Limited v BABN Technologies Corp 2016 FC 883 Locke J
            2,752,551

Subsection 27(4) of the Act provides that the claim must define the invention “distinctly and in explicit terms.” A claim that fails to do so will be invalid for ambiguity [136]. However, as Hughes J has pointed out, the bar for holding a claim invalid for ambiguity is very high – the claim must be essentially incapable of being meaningfully interpreted – and as a consequence, an ambiguity attack is very rarely successful: 2005 FC 1725 [50]-[53]. Nonetheless, Claim 2 of  the '551 patent was held to be invalid for ambiguity – apparently for the first time in almost 40 years (see 2005 FC 1725 [51], noting that the last time a claim was held invalid on this ground was 1977).

Recall from yesterday’s post that the invention was a security feature for lottery tickets, and Claim 1 was to a ticket comprising a non-play area on the ticket (containing the bar code), “spaced apart from” the play area (containing the prize information or "game data"). This is shown in Fig 3:

Figure 3. A ticket on which the game data and the bar code are hidden under separate scratch-off layers.

Claim 2 was a dependent claim to

2. The printed document of claim 1wherein the game data is printed around the bar code.

This was apparently intended to be illustrated by Fig 4:

Figure 4. A ticket which shows the game data is printed around the bar code, and both game data and bar code are hidden under a single scratch-off layer.

It is not possible for the game data to be printed around the bar code at the same time as the play area, which contains the game data, is “spaced apart” from the non-play area, containing the bar code, as is required by the dependency [141]. This means that Fig 4 does not really illustrate Claim 2; while the game data is printed around the bar code, the play area is not spaced apart from the non-play area. 

Claim2 was therefore held invalid for ambiguity [144]. This holding of ambiguity is the exception that proves the rule that the bar for a successful ambiguity attack is very high; while the claim was held to be invalid, the claim was internally contradictory, and so was incapable of meaningful interpretation.

Monday, August 15, 2016

Is it Time to Revisit the Rule Against Using Extrinsic Evidence in Claim Construction?

Pollard Banknote Limited v BABN Technologies Corp 2016 FC 883 Locke J
            2,752,551

In this declaratory action brought by Pollard, Locke J declared both claims of the ‘551 patent, owned by Scientific Games (the successor to BABN), to be invalid (Claim 1 for obviousness 242], Claim 2 for ambiguity [144]). On the infringement counter-claim, he held that the claims were not infringed in any event [2]. The decision raises a number of interesting issues, perhaps the most of important of which relates to prosecution history estoppel.

The ‘551 patent relates to a security feature for instant lottery tickets. These tickets have a scratch-off layer covering the “game data” which the customer scratches off to reveal whether the ticket is a winner and the amount of any prize. (In cheaper tickets a paper pull-tab may be used to cover the prize instead of the scratch-off layer.) To prevent fraud, the tickets normally also have validation information, in the form of numbers and/or a bar code, which is checked against the lottery’s online system on redemption to confirm that the ticket had been legitimately sold, that it was indeed a winner, and that it had not previously been redeemed [12]. As additional security, the validation information may also be hidden by a scratch off layer. This was all part of the prior art.

Tuesday, August 9, 2016

Coordinating S 8 NOC and Infringement Actions

Apotex Inc v Alcon Canada Inc 2016 FC 720 Tabib J
            2,129,287, 2,606,370 / travoprost / TRAVATAN Z

NOC proceedings and infringement actions give rise to independent litigation over infringement and validity of the same patents, with potentially conflicting monetary remedies. This decision by Tabib J on a motion for bifurcation of a s 8 damages action deals with some of the complex procedural issues that arise in attempting to resolve this conflict. While appropriate procedural decisions may help reduce duplicative litigation and avoid inconsistent results, it is hard to avoid the conclusion that the remedial overlap is another illustration that the PM(NOC) Regulations’ well-intentioned attempt to create a simple and streamlined patent linkage system has not been a success.

The patent linkage systems operating in the US and Canada are functionally equivalent to giving an automatic interlocutory injunction to a pharmaceutical patentee threatened by generic entry. In a jurisdiction in which interlocutory injunctions are relatively easy to get, linkage is hardly necessary. So, as I understand it, in the UK a pharmaceutical patentee will normally be able to get an interlocutory injunction against a generic which seeks to launch at risk, and consequently the generic will normally bring a declaratory action to “clear the way.” The effect is that the generic cannot launch before it has been determined that the patents reading on the product are invalid or not infringed. In jurisdictions such as Canada and the US, where interlocutory injunctions are more difficult to obtain, the generic might be able to launch even though its product infringed a valid patent. The patent linkage system addresses this by effectively giving the patentee an automatic interlocutory injunction. In the US, the application for marketing authorization is a deemed infringement, giving rise to a statutory stay which is roughly equivalent to an interlocutory injunction. However, there is no separate hearing to assess the merits of this “injunction,” as there would be in an application for an interlocutory injunction as such. In the Canadian patent linkage system, embodied in the PM(NOC) Regulations, on applying for marketing authorization for a generic drug, the generic is subject to a statutory stay – the automatic interlocutory injunction – while validity and infringement are assessed in an NOC proceeding. The NOC proceeding is intended to be summary in nature, like the hearing in which a true interlocutory injunction application would be decided. And if the patentee is unsuccessful in the proceeding, under s 8 it must compensate the generic which has been wrongly kept out of the market during the period of the stay, just as a party who is granted an interlocutory injunction must normally give an undertaking in damages to compensate the defendant which has been prevented from exercising its legitimate rights. And just as with a traditional interlocutory injunction application, a subsequent infringement action can proceed to a potentially different result on the basis of a more complete record. The Canadian system is therefore intended to statutorily mimic a true interlocutory injunction application more closely than the US linkage system.

However, one feature distinguishes the Canadian linkage system from both a true interlocutory injunction application and the US-style linkage system, namely that the NOC proceeding and any subsequent infringement action are independent proceedings. This means that inconsistent results are possible, in principle and in practice. In the both the US and the UK, a patentee may be liable for foregone profits incurred by a successful generic which was kept off the market by the stay / interlocutory injunction, but in both systems the generic is entitled to compensation only if it prevails in the ultimate infringement action. Thus there can never be a conflict in which the generic is entitled to compensation for having been kept off the market by a stay based on a patent which was valid and infringed. In contrast, in Canada the generic may win the NOC proceeding, and so be entitled to compensation under s 8, and yet lose the infringement action, so that it would be entitled to 8 compensation under s 8 of the NOC Regulations for having been kept out of a market which, under the Patent Act, it had no right to enter.

This potential for conflict has begun to be addressed substantively. As Tabib J states “[t]he law as it stands is to the effect that hypothetical infringement is not a complete defence to a section 8 claim, but that it is a significant factor to be considered in assessing compensation, and that it can indeed reduce damages to zero” (citing 2012 FC 620, blogged here; and see also 2012 FC 559 aff’d 2013 FCA 77 blogged here and here), though as she notes the law “may continue to evolve” [11]. 

This decision by Tabib J on Apotex’s motion for bifurcation wrestles with the problem of how to deal with this issue procedurally. Alcon held two patents related to travoprost, the ‘287 and ‘370 patents. Alcon lost both NOC proceedings, and, after Apotex launched, Alcon commenced an infringement action based on the ‘370 patent only. At the same time, Apotex brought an action for s 8 damages, which Alcon sought to defend by alleging infringement of both the ‘370 patent and the ‘287 patent, as well as the ‘172 patent, which was not listed on the Patent Register and so was not at issue in the NOC proceedings [2], [3]. Apotex now seeks to bifurcate the s 8 action to have validity and infringement of the ‘287 and ‘172 patents determined separately. The parties agreed that validity of and infringement regardng the ‘370 patent were already effectively bifurcated as they will be determined in the infringement action and those findings would be binding in the s 8 action [6]. In some ways the bifurcation decision was quite easy. On the facts, Tabib J found that the issue proposed to be bifurcated were quite distinct, so bifurcation would not lead to wasteful duplication [10]. On the other hand, if bifurcation were refused, duplicative litigation of quantification between the infringement and liability phases might result [12]. Copnsequently, Tabib J granted the motion to bifurcate.

Two interesting points were raised. First, Alcon was apparently concerned that Apotex’s motion for bifuraction was a prelude to a move to consolidate the bifurcated infringement issues relating to the ‘287 and ‘172 patents with the infringement trial of the ‘370 patent, thus delaying the trial and Alcon’s hoped for injunction [7].While Tabib J gave some credence to this concern [7], in the end she considered that in this case bifurcation does not entail joinder, and so Alcon would not be disadvantaged in this manner [10]. The concern nonetheless illustrates the complex procedural considerations that arise because of the separate nature of these proceedings.

Secondly and more fundamentally, Tabib J suggested that if Alcon’s related infringement action was not already bifurcated, the best way forward might have been to consolidate both actions, without bifurcation [12]. This would solve the problem of the separate actions in the most straightforward way possible. However, as this case illustrates, consolidation is not always appropriate. And while consolidation might in some cases be possible, given the vagaries of timing of two independent actions, it is too much hope that this would be routine. It seems, therefore, that parallel s 8 and infringement actions will be coordinated only by ad hoc motions such as this one, with varying degrees of success in avoiding wasteful duplication. The procedural complexity created by our patent linkage system seems destined to endure so long as the system remains in its current form.

Monday, August 8, 2016

Uncontested Removal of Co-Inventor

Novartis AG v Canada (Attorney General) 2016 FC 229 McDonald J
            2,782,650

In this decision, decided in February but only recently released, McDonald J granted an uncontested application by Novartis to delete one of the named co-inventors on the ‘650 patent. The decision states that the application was made “pursuant to sections 31(3) and 52” of the Act [1]. This is a bit odd as was established in Micromass 2006 FC 117 that s 31(3) applies only prior to grant, and after grant, as in this case, s 52 is appropriate: accordingly, the judgment itself was made “pursuant to section 52" of the Act. The application also proceeded on the basis that the test to be met for removal of an co-inventor is that set out under s 31(3), which requires affidavits from the remaining applicant or applicants satisfying the Commissioner that they are the sole inventor or inventors [6]. At the time the application was made, there were some cases suggesting that in deciding whether to remove a co-inventor under s 52, the court should follow the test set out for the Commission of Patents in s 31(3) (see here). That view would also explain why the application was brought pursuant to both sections. Subsequently, however, in Qualcomm 2016 FC 499 (blogged here) Simpson J has held that such affidavits are not strictly required under s 52. The decisions are not inconsistent in the result, since the affidavits were provided in this case and the application was granted, and no doubt it was simpler for Novartis to provide those affidavits rather than argue the point, as the law was unsettled at the time of its application.

Saturday, July 23, 2016

Blogging Break

I'll be on vacation for a couple of weeks. I'll resume blogging when I get back, starting with any cases I might have missed while I was away.

Wednesday, July 13, 2016

Another Twist on Blinding the Expert

Bristol-Myers Squibb v Teva 2016 FC 580 Mactavish J
            2,250,840 / 2,317,736 / atazanavir / REYATAZ

In a number of recent cases (see here), the parties have tried “blinding” their experts from certain facts in a laudable attempt to reduce the problem of hindsight bias. The Atazanavir decision raised another twist on this practice, which is this subject of today's post. For an overview of the facts, see this post, which also discusses some of the issues related to obviousness; and see this post discussing claim construction.

The point arose in the context of the 840 patent, which claims atazanavir. One of Teva’s experts on obviousness, Dr Romero, was blinded perhaps even more thoroughly than in most previous cases:

[192] Dr. Romero was not told the name of the drug that was at issue in this proceeding, other than the fact that it was a protease inhibitor, nor was she told the names of the parties. She was also asked not to carry out any independent research that might identify the drug in question.

That is, it seems that Teva tried to place Dr Romero in the place of the notional skilled person, trying to solve the problem facing the inventors, without knowledge of their solution. There are a couple of caveats even to this degree of blinding. One is that an expert like Dr Romero cannot forget her own current knowledge, and to the extent that she is familiar with approaches that would not have been common knowledge at the time, she cannot fully avoid the effects of hindsight, even when blinded to the particular facts. Also, as Mactavish J pointed out, “Dr. Romero was provided with a limited selection of the prior art that had been ‘cherry-picked’ by Teva, and her evidence has to be viewed with this in mind” [193]. This point was not merely theoretical; Mactavish J expressed concern that Dr Romero had only been provided with papers dealing with an azapeptide backbone, the class which atazanavir belongs to, and not prior art dealing with other possible backbones [194].

With those caveats, no approach is perfect and this heightened degree of blinding seems to be helpful in avoiding hindsight bias. However, it did not help Teva win its case. The details of Dr Romero's evidence were not spelled out by Mactavish J, but it seems the gist was that there were a finite number of modifications that the POSITA would have made in trying to make a better protease inhibitor [212]. However, Dr Romero proposed some modifications to the backbone which would never have led to atazanavir [195], and

[211] Dr. Romero does not identify which compounds or which substitutions should be made to obtain an improved protease inhibitor in her evidence, or how the POSITA should prioritize them. Importantly, Dr. Romero never states that the POSITA would make the substitutions necessary to get to atazanavir.

In the end, Dr Romero’s evidence may have hurt Teva’s case as much as it helped. The 840 patent survived the obviousness attack, and was ultimately held to be valid.

The fact that blinding the expert did not help Teva in this case helps confirm the value of the practice. If a witness blinded in this manner had arrived directly at the claimed invention, it would seem to be good evidence that the invention was obvious. (Though even this degree of blinding would not be conclusive, in light of the caveats noted above, as well as Locke J’s observation in 2016 FC 382 [46].)

Tuesday, July 12, 2016

A Summary Judgment Procedure under the NOC Regulations?

Janssen Inc v Celltrion Healthcare Co, Ltd 2016 FC 651 Hughes J
            2,261,630 / infliximab / INFLECTRA / REMICADE

This decision marks either a straightforward application of s 5(1) of the NOC Regulations, or a procedurally innovative use of s 6(5)(b) of the Regulations to effectively allowing a summary disposition of an NOC proceeding. Unfortunately, Hughes J was writing under a time constraint [1], and the decision is brief and some key facts are not clear (at least to me).

Janssen’s 630 patent covers the use of infliximab in treating rheumatoid arthritis [28]. Celltrion had already received an NOC for rheumatoid arthritis and related indications (the RA indications) based on a NDS filed before the 630 patent was granted, and so it did not have to address the 630 patent at that time [8]. (An infringement action is now underway [9].) Then, after the 630 patent was granted, Celltrion sought an NOC for indications related to inflammatory bowel disease (the IBD indications) [10]. Hughes J stated that “Celltrion was required to address the 630 patent under [the PMNOC Regulations].” Celltrion sent an NOA to Janssen, which then brought an application for an order of prohibition [10]. In response, Celltrion brought a motion under s 6(5)(b) asking that Janssen’s application be dismissed as an abuse of process, evidently on the general ground that the 630 patent did not cover the indications for which the NOC was being sought..Celltrion’s motion was granted by Aalto J.

Hughes J affirmed in brief reasons, in part adopting Aalto J’s reasons as his own [25]. But Hughes J also went to on to rely on Biolyse 2005 SCC 26 to conclude that “in a case such as the present one, where a patent claims a particular use of a drug it is that use that must be compared with the intended use by the generic and not just the drug” [27].

My difficulty with this case is that it is not entirely clear to me whether Celltrion was comparing its product with Janssen’s in seeking its NOC. Celltrion’s application was apparently based on an SNDS, not an ANDS or SANDS [10], and there is no suggestion in Hughes J’s reasons that Celltrion was comparing its drug to Janssen’s. If Celltrion was not comparing its product with Janssen’s, then the reasoning in the case strikes me as a bit odd. Biolyse held that it is only necessary to address patents on the register if the party submitting the application for an NOC compares its drug with that of the another drug against which the patent is listed. In other words, a party who is relying on their own data does not need to address the listed patents, even if the submission is for the same indications; it is only “copy-cats” who need to address listed patents. This was affirmed by the subsequently amended s 5(1), which says patents listed against a drug must be addressed only if “the submission directly or indirectly compares the drug with, or makes reference to, another drug.” (See also the RIAS to the 2006 amendments, SOR2006-242 at 1519-20.) So, if Celltrion was not comparing its product to Janssen’s then it would follow directly from per s 5(1) that it would not be required to address the 630 patent at all, even if the 630 patent was listed against infliximab, and even if Janssen’s NOC covers the IBD indications. The puzzle is that on this view of the decision, it is not clear why “Celltrion was required to address the 630 patent under [the PMNOC Regulations]” [10] in the first place.

On the other hand, if Celltrion was comparing its drug to Janssen’s for the IBD indications, that would explain why Celltrion was required to address the 630 patent. In that case Biolyse would not be directly applicable, as Celltrion’s product would be a “copy-cat” drug, in the sense of relying on Janssen’s data, even if Janssen’s data were for an unpatented indication. On those facts, Hughes J’s holding would not be a direct application of Biolyse, but rather an extension, which would mean that a generic need not address a listed patent even if the generic is indeed piggy-backing off the data submitted by the patentee, so long as the indication for which an NOC was sought did not infringe. Normally that would require an NOC proceeding based on an allegation of non-infringement pursuant to s 5(1)(b)(iv)t, but perhaps the motion under s 6(5)(b) was based on the view that the non-infringement issue was so clear that it would be an abuse to proceed with the NOC proceeding. In other words, s 6(5)(b) was being used for a summary disposition of the NOC proceeding. If that is what happened, then the decision is procedurally quite significant.

Friday, July 8, 2016

A Teaching Example on Claim Construction

Bristol-Myers Squibb v Teva 2016 FC 580 Mactavish J
            2,250,840 / 2,317,736 / atazanavir / REYATAZ

My previous post gave an overview of the facts of this decision and discussed some of the issues related to obviousness. This post discusses a tricky claim construction issue that arose in the context of the 736 patent. While it did not raise any new legal issues, it is a good example of the tension between the primacy of the claims and the principle that purposive construction requires that the claims are read in the context of the specification as a whole.

Monday, July 4, 2016

Discovery of Something Unexpected about Something Obvious

Bristol-Myers Squibb v Teva (NOC) 2016 FC 580 Mactavish J
            2,250,840 / 2,317,736 / atazanavir / REYATAZ

In this NOC proceeding Mactavish J held Novartis’ 840 patent, which claims the compound atazanavir [53], to be valid in the face of obviousness and anticipation attacks, while she held BMS’s 736 patent, which claims the bisulfate salt of atazanavir [273], to be obvious. A central dispute between the parties in respect of both patents was whether the inventive concept of the claimed inventions comprised just the compound itself, as Teva argued, or the compound and all its properties, as the patentees argued. The idea is that the more properties that are part of the inventive concept, the less likely it is that they will all be predictable, and so the less likely it is that the patent will be held obvious. In this post, I will argue that this idea is wrong; the number of properties in the inventive concept does not affect how likely it is that the claimed invention will be held to be obvious. In another post I will suggest that multiplying the inventive concepts might actually make invalidity more likely. The 736 patent also raised a very tricky claim construction problem, which I will discuss in a subsequent post.

Atazanavir is used in the treatment of HIV/AIDS. The first class of anti-HIV drugs were known as nucleotide reverse transcriptase inhibitors (or NRTIs) [13]. While these had potent activity against HIV, they were susceptible to the evolution of drug resistance and had unpleasant side-effects [14], [15]. A new class of anti-HIV drugs was developed, known as protease inhibitors [16]. These has a number of advantages over NRTIs, but the first generation protease inhibitors had poor bioavailability, which resulted in poor compliance and a consequent potential for the development of drug resistance [22]. There was therefore a strong motivation to develop second-generation protease inhibitors [23]. One of these was atazanavir, which came on the market in 2003 and which remains one of the best second generation protease inhibitors [24-25]. The 840 patent, which claimed atazanavir and its salts, disclosed only the free base form. While the free base had good inherent bioavailability, it was not sufficiently orally bioavailable in solid form to be a viable product [266-67]. The problem facing the inventors of the 736 patent was to develop a form of atazanavir having properties suitable for an oral pharmaceutical dosage form, including improved oral bioavailability [268]. They performed a salt screen, and solved the problem with the bisulfate salt which was claimed in the 736 patent. (Ciba-Geigy, which became Novartis, developed atazanavir, and BMS acquired the rights to atazanavir from Novartis and then developed atazanavir bisulfate.)

Monday, June 20, 2016

Miscellaneous Issues in Levofloxacin Damages

Janssen Inc v Teva Canada Ltd / levofloxacin 2016 FC 593 Hughes J
            1,304,080 / levofloxacin / LEVAQUIN

Friday’s post discussed the standing issue in Levofloxacin Damages. This post discusses the three other contentious issues, quantum, pre-judgment interest, and mitigation [25].

Damages are assessed as the difference between the patentee’s actual position and the position it would have been in but for the infringement. The main issue respecting quantum was a purely factual one as to which “but for” scenario was most likely. Hughes J resolved this in favour of the scenario preferred by Janssen’s expert [106], with a few relatively minor modifications. While that finding was based on the evidence as a whole, it seems that Teva’s witness did not help his case by arguing that the infringement actually benefitted Janssen to the tune of $4 million [95].

Because a generic cannot normally ramp up its sales immediately on expiry of the patent, absent infringement there will be some period post-expiry during which the patentee has lingering elevated market share. Consistently with established law (see 2013 FC 751, blogged here), Hughes J allowed recovery of damages for these lost post-expiry sales, on the general principle that the patentee is entitled to recover losses caused by the infringement [109]. On the facts, the runoff period allowed by Hughes J was two months for retail sales, and one year for hospital sales [112].

Hughes J also allowed a claim for price suppression – that is, the losses due to the reduced price at which LEVAQUIN was sold in order to compete with infringing generic entry. This is nothing new [116]; the loss is caused by the infringement whether a patentee loses sales entirely, or makes the sales but at a lower price. Of more interest, Teva was eventually forced to withdraw from the marketplace as a result of the injunction granted by Hughes J at the end of the liability phase, but the evidence showed that as a practical matter, Janssen could not raise its price to hospitals after Teva withdrew; the price reduction was effectively locked in, as a matter of customer relations [117]. Hughes J allowed recovery for that continued price suppression. Given the factual finding, recovery for locked-in price suppression follows directly from the principle that the patentee is prima facie entitled to recover losses caused by the infringement. The point was raised again in the context of the argument that Janssen should have mitigated its loss by raising its prices again [144]. Hughes J dismissed this argument on the basis that the burden lies on the defendant to prove that mitigation was possible and the plaintiff failed to make reasonable efforts to do so, and Teva had not discharged its burden in this regard.

Some interesting issues were raised with respect to whether pre-judgment interest should be compounded, with Janssen US relying on Zinn J’s decision in Cefaclor Damages 2014 FC 1254 (blogged here) [134], but Hughes J held that the terms of the liability judgment 2006 FC 1234, [135], awarding pre-judgment interest, not compounded, applied to Janssen US as well as to Janssen Canada [138], so the substantive issues were not really engaged.

Friday, June 17, 2016

A Purposive Interpretation of the Standing Provision

Janssen Inc v Teva Canada Ltd / levofloxacin 2016 FC 593 Hughes J
            1,304,080 / levofloxacin / LEVAQUIN

This Levofloxacin Damages decision is the damages phase of 2006 FC 1234 aff’d 2007 FCA 217, in which Hughes J held Claim 4 of the ‘080 patent, a compound claim to levofloxacin, to be valid and infringed by the Novopharm (now Teva). The decision turned largely on the facts, with the most legally significant issue being the standing of Janssen US to claim damages.

The standing issue was important to the bottom line. Hughes J ultimately held that Janssen US did have standing and he awarded it over $13m, while Janssen Canada was awarded just under $5.5m. The standing issue arose in light of the structure of Janssen’s supply chain. Daiichi, the owner of the ‘080 patent, supplied levofloxacin API to Janssen Puerto Rico, which manufactured finished tablets and then routed them, financially, at least, through Janssen US to Janssen Canada for sale in Canada. It was these sales that were displaced by Teva’s infringing sales, and Janssen US was claiming for the lost profit it would have made on its sales to Janssen Canada [54]. (Daiichi, while a named plaintiff, had settled with Teva and did not participate in the damages proceeding [5].)

Standing is statutorily governed by s 55(2) of the Act which provides that infringer is liable in damages “to all persons claiming under the patentee” for losses sustained as a result of infringing acts. Hughes J thoroughly canvassed the case law, which generally interprets “claiming under” quite broadly, including an assignee, a licensee, including a non-exclusive licensee [43]. Moreover, the Canadian courts take a very pragmatic approach in determining whether a party is a licensee, as the license need not be in writing and may be inferred from the facts [43].

However, in one case, Servier v Apotex 2008 FC 825, Snider J held that none of the companies in the Servier global family, except ADIR, the patentee, and Servier Canada, which exploited the patent in Canada, had standing to seek damages [Servier 67-95]. Hughes J characterized Servier as holding that an entity that did not operate “in Canada'” did not have standing [42], and that the claim must be one in respect of a use in Canada and not elsewhere in the corporate chain [43]. He also distinguished Servier on the basis that in that case, each of the foreign entities had its own geographical sphere of operation and those entities not operating in a Canadian sphere could not be considered to have standing, whereas in this case “the J&J group of companies are operating as a team whereby licensed tablets ultimately found their way to Canada” [67].

Stepping back from the cases, in defining who may claim damages s 55(2) has two effects, at least potentially. On the one hand, it gives standing to entities which might not otherwise have standing under a common law test. And on the other hand, it may operate to deny recovery to some entities. The exclusionary effect of s 55 only bites if the entity claiming standing actually suffered a loss as a result of the infringement of the Canadian patent. If we are to give a purposive interpretation to s 55(2), we must ask when it is right to hold that an entity should not recover, even though it has actually suffered loss caused by the infringement. There is a prima facie argument that such loss should always be recoverable, on the basis that a wrongdoer should be liable for all the harm it causes, or the wrong will not be sufficiently deterred and victims will not be adequately compensated.

This intuition is not always sound. Suppose that Company A, which is at arms length to both the patentee and the infringer, produces feedstock for the process used by the patentee to produce the API. The feedstock itself is not patented and so A does not need or take a license. As a consequence of infringement, the patentee reduces production, and so A suffers lost profits on the consequently reduced sales of the feedstock. Should A be able to recover? Apart from any limits imposed by s 55(2), it might seem that A should be able to recover, on the basis that it has suffered a loss caused by the infringer. But now suppose that A also supplied the feedstock to the infringer, and when A’s sales to the patentee went down, its sales to the infringer went up by exactly the same amount. In that case A should clearly not recover because it would have suffered no loss. Now suppose that instead, the infringer bought the feedstock, not from A, but from arms length Company B, so that A’s loss was B’s gain. Should A recover? From a law and economics perspective, the answer is no. The shift in profit from A to B is a mere transfer; while A has lost, B has gained, and in the broader picture, no harm was done. To impose liability on the infringer for A’s loss would consequently cause over-deterrence. This is one of the main justifications for the general reluctance of tort law to provide recovery for pure economic loss: see CNR v Norsk [1992] 1 SCR 1021. Denying recovery to A in such a case also makes sense purely in terms of patent policy, because A is not operating under the patent, and so refusing to allow it to recover does not adversely affect the incentive to invent. In this scenario, in which A did not have a licence and so did not “claim under the patentee,” s 55(2) would operate to deny recovery to an entity that had suffered a loss as a result of the infringement, and this result would be sound as a matter of policy.

This analysis suggests that the role of standing, and s 55(2) of the Act, is to prevent recovery by an entity which has suffered a loss as a result of the infringement when that loss did not affect the incentive to invent. Put another way, by analogy with the requirement for an “antitrust injury” in US competition law, we might say that only an entity that has suffered a “patent injury” should be entitled to recover. This is broadly consistent with the “claiming under” requirement of s 55, on the reasoning that if the entity’s loss is linked to its rights under the patent, then the loss would adversely affect the incentive to invent. So, for example, the profits made by a licensee contribute to the incentive to invent via the royalty paid for that license.

This theory supports Hughes J’s holding in this case that Janssen US has standing. I’m not sure whether it is consistent with Servier, because the nature of the loss that would have been claimed by the excluded entities in that case is not clear to me. This theory is at least consistent with Snider J’s rejection of the highly speculative scenario advanced by Servier in support of its claim at [88-89].

Thanks to Smart & Biggar for posting this decision before it was posted on the FC website.

Friday, June 10, 2016

Affidavit from Remaining Inventors Not Required When Correcting Inventorship of Granted Patent

Qualcomm Incorporated v Canada (Commissioner of Patents) 2016 FC 499 Simpson J
            3,860,309

Qualcomm applied for an order pursuant to s 52 of the Act, to delete Mr Palanki as a co-inventor on the ‘309 patent. The application was not opposed by CIPO and Mr Palanki consented to the order sought on the basis that he was not a co-inventor. The only difficulty is that some decisions, in particular Imperial Oil 2015 FC 1218 (blogged here) and Segatoys 2013 FC 98, had suggested that in deciding whether to remove a co-inventor, the Court should follow the test set out for the Commission of Patents in s 31(3) [5], which provides that when a joint applicant for a patent is removed as not being an inventor, the prosecution may be carried on by the remaining applicants “on satisfying the Commissioner by affidavit that the remaining applicant or applicants is or are the sole inventor or inventors” [6]. In this case, even though it was uncontested that Mr Palanki was not an inventor, there was no affidavit that the remaining named inventors were the sole inventors. Simpson J held that the affidavit in question is essentially a housekeeping requirement to promote the efficient processing of pending patent applications in the Patent Office and it is not required when an issued patent is being considered by the Court under s 52 [9]-[10]. She therefore granted the application. I note that this is not inconsistent with Imperial Oil and Segatoys in the result, since in both of those cases the application was also granted: neither was a case in which an application to amend under s 52 was refused for failure to provide the affidavit in question.

Thursday, June 9, 2016

Hearsay is Inadmissible

Pfizer Canada Inc v Teva Canada Ltd 2016 FCA 161 Stratas JA: Ryer, Gleason JJA var’g 2014 FC 248 (here) and subsequent reasons re pre-judgment interest 2014 FC 634 (here) Zinn J
            1,248,540/ 2,199,778 / venlafaxine / EFFEXOR XR / NOC s 8 / Venlafaxine s8 FCA

As discussed in yesterday’s post, which dealt with the burden of proof in establishing causation, the FCA in Venlafaxine s8 held that in order to establish its compensable loss under s 8 of the PM(NOC) Regulations, Teva had to show that it “would and could” have supplied the market for venlafaxine. While Zinn J did not articulate the requirement in quite this way, he nonetheless applied the proper principles of causation in holding that Teva had established the necessary causal link [70]-[73], and in the result he awarded Teva almost $125m as compensation for having wrongly been kept off the market for venlafaxine [2]. However, the FCA held that Zinn J’s holding was vitiated by the fact that he improperly relied on hearsay evidence in coming to this conclusion [75]-[121], and the FCA therefore set aside Zinn J’s judgment and remitted the matter to him for redetermination [174]. At the same time, the FCA also affirmed Zinn J’s holdings with respect to the appropriate start date for the compensable period, on authorized generics in constructing the hypothetical world, and on the start date for assessing pre-judgment interest.

Teva’s position was that if it had received its NOC, its supplier, Alembic would have been able to supply adequate quantities of venlafaxine product at the relevant time [41]. While this was accepted by Zinn J, the only evidence on Alembic’s capacity was provided by Mr. Major, a former executive of Ratiopharm (now Teva) [36]. The difficulty is that almost all of Mr Major’s testimony was hearsay, sometimes double or even triple hearsay. Despite Pfizer’s objections, Zinn J admitted the hearsay evidence, saying the objection went to weight rather than admissibility [121]. The FCA disapproved, noting that

[83] Recently, some rules of evidence have been liberalized, allowing for more flexibility. Seduced by this trend towards flexibility, some judges in various jurisdictions have been tempted to rule all relevant evidence as admissible, subject to their later assessment of weight. But according to our Supreme Court, this is heresy. The trend towards flexibility has not undermined the need for judges to take a rigorous approach to admissibility, separating that analytical step from others, such as determining the weight to be given to evidence.

After reviewing the evidence in question, the FCA remarked that “All of the mischief associated with admitting hearsay evidence is present in this case” [119]. Because Zinn J had admitted evidence that should have been excluded, and that error might have affected the outcome of the case, the FCA set aside the Zinn J’s judgment [121]. I am not sufficiently familiar with evidentiary rulings in the Federal Courts to say whether Zinn J’s decision to admit hearsay evidence was unusual, or whether this FCA’s decision signals a course correction to the FC generally.

On the issue of the start date for the compensable period, Pfizer had argued that the appropriate date was the end of the 45 day waiting period under s 7(1)(d) during which the Minister is precluded from issuing an NOC. The waiting period starts at the time the generic serves an NOA and allows a patentee to seek a prohibition order. In effect, Pfizer argued that in the hypothetical world, it should be assumed that rather than seeking an order of prohibition, Pfizer would have done nothing at all, so that Teva’s NOC would have issued only after the expiry of the waiting period. Zinn J rejected this arugment (see here), and the FCA affirmed for substantially the same reasons, based on the plain meaning of the Regulations as well as the case law [126]-[133].

The FCA also reaffirmed its holding in Apotex Ramipril s. 8 FCA 2014 FCA 68 (see here) that entry of authorized generics should be considered as part of the hypothetical world [134]-[138]

Finally, the FCA also affirmed Zinn J’s holding that pre-judgment interest should be calculated from the date on which the cause of action arises, which is typically the start of the compensable period, and not on the date that the prohibition application is dismissed [145].

Wednesday, June 8, 2016

Burden of Proof Respecting Alternative ‘But For’ World

Pfizer Canada Inc v Teva Canada Ltd 2016 FCA 161 Stratas JA: Ryer, Gleason JJA var’g 2014 FC 248 and 2014 FC 634 Zinn J
            1,248,540 / 2,199,778 / venlafaxine / EFFEXOR XR / NOC s 8 / Venlafaxine s8 FCA


In his Venlafaxine s8 FC decision, 2014 FC 248 (blogged here), Zinn J awarded Teva almost $125m, including interest, under s 8 of the PM(NOC) Regulations, as compensation for having wrongly been kept off the market for venlafaxine [2]. The FCA has now vacated that award because it was based on inadmissible hearsay evidence, and remitted the matter to Zinn J for redetermination [159], [174]. The decision is primarily of interest for its clarification of the “could and would” requirement for establishing causation of loss, which is discussed in this post.

Section 8 provides that a generic that is kept off the market by operation of the statutory stay under the NOC Regulations is entitled to compensation for “any loss suffered” during the relevant period, if the patentee is ultimately unsuccessful in obtaining an order of prohibition. The courts have (rightly) interpreted this as providing compensation only for loss that was caused by the statutory stay that is triggered by the patentee’s application for an order of prohibition under the Regulations [45]. The loss typically takes the form of lost sales of product that the generic would have made had it not been kept off the market [45].

The losses caused by the patentee’s triggering conduct is the difference between the sales actually made by the generic (zero), and the sales that the generic would have made in the hypothetical world where the patentee’s impugned conduct did not take place [47]. Some issues, in particular the start and end dates to the compensable period, are specific to the NOC context, but the causation inquiry is the same as for patent infringement, in that “in both types of claims the court’s task is the same: to assess a hypothetical world where the defendant’s impugned conduct did not take place” [47]. Consequently, the FCA in this case looked to its prior damages decision in Lovastatin 2015 FCA 171 (blogged here and here) as setting out the relevant principles.

The key issue in this appeal was whether Teva would have been able to supply the market with venlafaxine in the hypothetical world in which it had received its NOC. In Lovastatin, the key issue was whether the generic (Apotex), would have been able to compete in the market with a non-infringing alternative in the hypothetical world in which it did not infringe. In Lovastatin the FCA held that to establish causation, the defendant generic would have to show that in the hypothetical world it “would have and could have” had access to sufficient quantities of non-infringing product [49]. By the same token, in this case Teva had to establish that it “would and could” have supplied the market with venlafaxine if the NOC had been granted [53].

The first issue dealt with by the FCA concerned the burden of proof. The FCA held that Teva, as the claimant, had the burden of proof concerning what would and could have happened had its product not been kept off the market, on the general principle that the plaintiff must prove its loss [53]-[55]. Specifically, Teva had argued that it would and could have obtained venlafaxine from its supplier, Alembic, and Teva therefore bore the burden of proof on that issue.

That much was straightforward. But the FCA also noted a caveat. “Suppose Pfizer took the position that [Teva] would not have tried to obtain venlafaxine from Alembic but instead would have given up and pursued another business objective, such as getting another generic drug to market” [65]. In that case, the burden would lie with Pfizer to prove that alternative hypothetical [63]:

a defendant that sets up a new issue bears the burden of proving it. The plaintiff, having proved its version of the hypothetical world, does not have to disprove other speculative hypotheses.

The point is important one because it introduces a significant caveat on the holding in Lovastatin, in which, in discussing the “would” branch of the causation requirement, the FCA at [94] held that even though

Apotex had capacity to make the non-infringing lovastatin and that Apotex would have made an accounting profit by producing the non-infringing tablets, Apotex has not established that it would have pursued that alternative in the "but for" world. Specifically, Apotex did not point to evidence that demonstrated the profits that it would have made through the non-infringing alternative would have been greater than value lost in any of the identified scenarios (for example, the research and development activities foregone by repurposing the Winnipeg facility). As such, notwithstanding whether it had the capacity to produce the non-infringing alternative, Apotex has not satisfied its persuasive burden to demonstrate on the facts that it would have produced the non-infringing lovastatin.

The first part of this paragraph evidently says that Apotex had established its verison of the hypothetical world, namely that it would (or at least could) have supplied the market with a non-infringing alternative, while the second part of the paragraph seems to say that Apotex also bore the burden of proving that it would not have pursued a different business objective, namely exiting the lovastatin market in favour of some other opportunity (see here for a more detailed discussion). This holding in Lovastatin is very difficult to reconcile with the holding in Venlafaxine s8 FCA that “Teva would not have borne the burden of proving that it would not have pursued a different business objective” [65]. Indeed, this statement from Venlafaxine s8 is so directly on point that it almost seems to be specifically targeted at this particular holding from Lovastatin.

The point was strictly obiter, because Pfizer did not in fact make any such argument; it simply contested the very hypothetical relied on by Teva, with the result that the burden remained with Teva [66]. However, the issue was fully considered, including reliance on the SCC decision in Rainbow Caterers [1991] 3 SCR 3, and the remark regarding Pfizer’s burden to prove an alternative hypothetical was made in the context of explaining why the burden remained with Teva in the context of the arguments made in this case [58]-[66]. The point was certainly more fully reasoned than the brief and somewhat cryptic discussion of this issue in Lovastatin [93]-[95]. Moreover it was expressly stated as a general principle of law, rather than, as in Lovastatin, a finding on the facts. It would seem to follow that this statement from Venlafaxine s8 FCA now represents the law on this point. 

In my view the approach taken in Venlafaxine s8 is preferable to that taken in Lovastatin, for policy reasons discussed here, for the practical reason that it is unduly burdensome to require a plaintiff not only to prove one hypothetical world, but also to disprove all other potential hypothetical worlds, and for the legal reason that the SCC in Hamilton v Open Window Bakery Ltd 2004 SCC 9, held that it is open to the a party to adopt the hypothetical world that is “least burthensome” to it [11]. It will be interesting to see how this issue plays out in future cases.

Monday, May 23, 2016

Blogging Break

I'll be taking a break from blogging for a couple of weeks. I'll resume in mid-June, starting with any cases I might have missed in the interim.

Wednesday, May 18, 2016

Xpresspost is a Designated Establishment

Biogen Idec Ma Inc. v Canada (Attorney General) 2016 FC 517 Elliott J

In Biogen v Canada (Attorney General) Elliott J held that use of Canada Post’s Xpresspost™ service is delivery to the designated establishment under s 5(4) of the Patent Rules, such that correspondence addressed to the Commissioner is deemed to be received by the Commissioner on the date of delivery to the designated establishment (or the next following business day that the Patent Office is open), as opposed to the date on which it is physically received by the Patent Office. While this application for judicial review arose in the context of a conflict proceeding under the Old Act (perhaps the last! [4]), it is of more general interest because the applicable rules under the Old Act were repealed without transitional provisions [20], so the case was decided under the “Rules of General Application” of the new Rules. The decision will also be relevant to Copyright Regulations, Industrial Design Regulations, Trademarks Regulations and Integrated Circuit Topography Regulations, all of which employ the same delivery process using a “designated establishment” [4].

Applying a deferential standard of review [43], Elliott J held that the Commissioner’s decision that only Registered Mail™ was permitted was unreasonable [144]. The broader question raised by this case is why the Commissioner adopted such an unreasonable position in the first place, particularly since, as detailed by Elliott J, the Commissioner’s interpretation would result in more cost and inconvenience for everyone, including the Patent Office as well as its clients.

Monday, May 9, 2016

FC Interpretation of Transitional Patent Listing Provisions Affirmed

Gilead Sciences Inc v Apotex Inc 2016 FCA 140 Boivin JA: Pelletier, Rennie JJA aff’g 2016 FC 295 (judgment), 2016 FC 231 (reasons) Heneghan J
            2,261,619 / tenofovir (PMPA) / TRUVADA

In brief reasons delivered from the bench, the FCA has affirmed Heneghan J’s decision in favour of Apotex (blogged here) which turned on the transitional provisions of the PM(NOC) Regulations relating to patent listing, saying “we see no error of law in the Federal Court Judge’s analysis and conclusions that would warrant this Court's intervention.” [1].