Friday, October 31, 2014

STELARA / Anti-IL-12 Antibody Decision Set Aside

Janssen Inc v AbbVie Corporation, 2014 FCA 242 Trudel, Webb, Boivin JJA (for the Court) rev’g 2013 FC 1148 Hughes J and setting aside 2014 FC 55 Hughes J

Janssen Inc v Abbvie Corporation 2014 FCA 241 Trudel, Webb, Boivin JJA (for the Court) setting aside 2014 FC 489 Hughes J
2,365,281 / IL-2 antibodies

In 2013 FC 1148 Hughes J dismissed Janssen’s motion to amend its Schedule A to its Defence and Counterclaim so as to remove some and add other prior art references. The decision of the FCA in 2014 FCA 242 reverses that decision of Hughes J. Consequently, because the amendments in question “go to the heart of one of the major invalidity issues” [15], the FCA also set aside Hughes J’s subsequent decision in the infringement action itself, 2014 FC 55 (blogged here and here). In light of the intimate relationship between the validity and infringement issues, the FCA declined to order a new trial solely on the issues most directly affected by the prior art in question; instead, it acceded to Janssen’s request for a new trial of all the issues [32]. The FCA also ordered that the trial would be before a new judge [32].

In 2014 FCA 241 the FCA set aside the injunction that had been granted by Hughes J in 2014 FC 489 (blogged here) in consequence of his liability decision. While the reasons were very brief, it is evident that the injunction was set aside purely in consequence of the setting aside of the liability decision, and not on its own merits.

In 2014 FC 863, Janssen was held to be prima facie in contempt of that injunction, as blogged here. Presumably the setting aside of the injunction would provide a defence to the prima facie contempt.

Thursday, October 30, 2014

Res Judicata in a Bifurcated Action

Merck & Co Inc v Apotex Inc 2014 FC 883 Lafrenière J
            1,275,350 – lisinopril – PRINIVIL

This motion to amend a Responding Statement of Issues raises a very interesting and difficult issue respecting the application of res judicata to a bifurcated action when the law has changed between the liability and damages portions, though at the end of the day I doubt the resolution of that question would make any difference to the outcome.

In the underlying Lisinopril Liability decision, 2006 FC 524 aff’d 2006 FCA 323, Apotex argued that the ‘350 patent was invalid because it was improperly divided from the parent ‘340 application, which disclosed only one invention. Hughes J rejected this on the basis that he was bound by prior case law, including Boehringer (1962), 39 CPR 201, to hold that each claim constitutes a different invention [116]. The FCA affirmed on this basis [39]. Subsequently, in its Viagra decision 2012 SCC 60 [57], the SCC held that Boehringer “does not stand for the proposition that every claim in a patent application is a separate invention.” In this motion Apotex argued that the law having changed – or at least, the Liability decision having been based on a misunderstanding of the law – it should be able to amend its defence in the damages portion of the action to argue that the Merck did not suffer any damages as a result of Apotex’ activities [28.12].

Essentially, the argument is that even though Apotex has been found liable for infringement, it should not be made to pay damages for infringement of an invalid patent. In support, Apotex relied on the UKSC decision in Virgin Atlantic [2013] UKSC 46. In Virgin Atlantic, the EWCA had held the patent at issue to be valid and infringed, and ordered an enquiry as to damages [11]. Subsequently, the EPO held the patent to be invalid [12]. The effect of the EPO decision is that the patent on which the liability decision was based is deemed never to have existed [27]. However, the EPO decision could not be raised by way of an appeal of the liability decision, as the order of the EWCA was final and not subject to appeal [16]. The question before the UKSC was whether the defendant should be able to raise the invalidity in the enquiry as to damage [16]. The UKSC held that the invalidity could be considered in the damages enquiry [37].

Monday, October 27, 2014

No New Cases for the Week of 20 October

No new patent / NOC / data protection cases were released for the week of 20 October 2014.

Keep in mind that I generally only blog on substantive patent / pharma cases. If you want to keep abreast of all new Canadian decisions, including procedural decisions and cases outside that core substantive area, I recommend subscribing to the Daily Intellectual Property News service from Alan Macek's IPPractice.

Tuesday, October 14, 2014

More on the Perfect Match Requirement of Listing on the Patent Register

ViiV Healthcare ULC v Teva Canada Ltd 2014 FC 893 Hughes J aff’g 2014 FC 328
Milczynski J (here)
            abacavir & lamivudine. / KIVEXA & TRIZIVIR / 2,289,753

Hughes J applied the “perfect match” requirement for listing of a patent on the Patent Register, as set out by the FCA in the leading case of Gilead / COMPLEREA 2012 FCA 254 (blogged here), to uphold Milczynski J decision (blogged here) that the ‘753 patent cannot be listed on the Patent Register against KIVEXA or TRIZIVIR. There is not really any new law in this decision, though Hughes J does provide a thorough review of the case law at [47], and a list of principles emerging from those cases at [48]. The main point of interest is that in this litigation, the Minister of Health had argued that while a perfect match is required to list a patent claiming a formulation under 4(2)(b) of the NOC Regulation, a perfect match is not required to list of a patent claiming a medicinal ingredient, which is governed by 4(2)(a). However, as Milczynski J held, in Gilead the FCA clearly held that the perfect match is required under 4(2)(a), and Hughes J has now affirmed. In other posts on the listing requirement I have argued that the perfect match requirement is rigid formalism, because eligibility for listing turns on how the claims are drafted rather than on the substantive scope of the claims. I can understand how the “relevant” standard developed by the courts under the old Regulations was too liberal, but requiring a perfect literal match strikes me as too strict; it seems to me that a “would necessarily infringe” standard would strike a better balance. But the point is settled law now.

Here is the summary of the law provided by Hughes J:

[48] I draw the following principles respecting the interpretation of the various subsections of 4(2) of the NOC Regulations having regard particularly to the Federal Court of Appeal decisions and the Reasons of Justice Russell in Bayer, as affirmed by the Federal Court of Appeal:
• There is no sound reason to adopt different legislative requirements of product specificity for the various subparagraphs of subsection 4(2) of the NOC Regulations (Gilead, paragraph 39);
• absent precise and specific matching between what the patent claims and the product/use/dosage forms for which the NOC has been granted to the first person, the Minister cannot properly list the patent (Purdue, paragraphs 43; Abbott, paragraph 49; Gilead, paragraphs 37-38);
• a claim for a formulation means a claim that includes both medicinal and non-medicinal ingredients. A claim directed to medicinal ingredients, without claiming also non-medicinal ingredients, does not qualify for listing as a formulation under subsection 4(2)(b) of the NOC Regulations (Gilead, paragraphs 27 to 32, 49; Bayer, paragraphs 67 to 69).
• where a patent claims only one medicinal ingredient, it cannot be listed as against an NOC obtained for two (or more) medicinal ingredients; at least where, to use the words of Russell J, at paragraph 69 of Bayer, where “…a drug with one medicinal ingredient will have a different effect from a drug where two medicinal ingredients are combined “to achieve the desired effect [emphasis added].” This same distinction appears in Gilead, where Trudel JA wrote at paragraphs 31 and 32:
31 Finally, the overall inventive step of the '475 Patent, as found by the Judge, is the combination of chemically stable medicinal ingredients. The '475 Patent emphasizes the beneficial effects of combining chemically stable combinations of medicinal ingredients.
32 Thus, I conclude that the '475 Patent falls under paragraph 4(2)(a), as the relevant claims consist of chemically stable combinations of medicinal ingredients.

As the last bullet point indicates, Hughes J considered whether the prior case law left open the possibility that a patent claiming one medicinal ingredient might be listable against a drug with two medicinal ingredients if there was no synergy between drugs. However, he ultimately held that

[89] In my view, it is not productive when considering the listing requirements of subsection 4(2) of the NOC Regulations to consider synergy or not. The decision of the Federal Court of Appeal in Gilead is sufficiently clear. A patent claim for only one medicinal ingredient cannot support a listing under the NOC Regulations where the underlying NOC is for a combination (synergistic or otherwise) of two or more medicinal ingredients.

For a discussion of the facts related to KIVEXA, see my post on Milczynski J’s decision, here. This appeal also consolidated a closely related proceeding in which Apoex also challenged the listing of the ‘753 patent against KIVEXA [9], as well as a third proceeding in which Apotex challenged the listing of the ‘753 patent against TRIZIVIR. The legal issues were substantially the same in all the proceedings.

Tuesday, September 30, 2014

Prosecution History Estoppel Meets Section 53

NOV Downhole Eurasia Limited v TLL Oil Field Consulting 2014 FC 889 Mosley J
            2,255,065

The pigeons are coming home to roost from the SCC’s ill-advised holding in Free World 2000 SCC 66, [66], that prosecution history is not to be used in claim construction (for my critique of the SCC decision, see here).

The invention at issue in NOV Eurasia v TLL Consulting is a downhole oilwell tool which comprises a valve. The defendant alleged that during patent prosecution the applicant had amended the application to restrict the claims to embodiments which included a transverse valve, and they now sought to assert the patent against the defendants, even though the allegedly infringing tool does not have a transverse valve [9].

If we had a doctrine of prosecution history estoppel, this would be a straightforward matter. If indeed the applicant had given up the scope in question during prosecution, then the patentee would not be estopped from reclaiming that scope in litigation, and the patent would be construed accordingly. The claim, and the patent, would remain valid, but the defendant’s tool (assuming it did not in fact contain a transverse valve), would not infringe. This is an eminently fair and sensible result.

But because the SCC in Free World held that prosecution history cannot be considered as a matter of claim construction, the defendant in this case pleaded that the applicant’s statements were made “with the intention of misleading the Patent Office,” and so the entire patent is void pursuant to s 53(1) [9], which provides that:

A patent is void if any material allegation in the petition of the applicant in respect of the patent is untrue, or if the specification and drawings contain more or less than is necessary for obtaining the end for which they purport to be made, and the omission or addition is wilfully made for the purpose of misleading.

The patentee in this case brought a motion to have the paragraphs pleading s 53 struck. Prothonotary Milczynski granted the motion, but Mosley J reversed, holding, after a review of the case law, that “[i]t remains a live issue whether section 53 of the Patent Act may void an entire patent due to steps taken in the application process” [32]. I think Mosley J is right on this point, but given the low threshold for allowing the pleading to stand I will not review the case law in detail.

The broader point is that the SCC’s Free World holding has created an unpalatable dilemma for the lower courts. If s 53 cannot be used in this manner, then a patentee may be able to narrow the scope of its claim during prosecution to obtain the patent, and then try to reclaim that scope in subsequent litigation. On the other hand, if s 53 can be used, then what would have been a battle over claim construction, turns into an atomic bomb of patent invalidity. This will increase uncertainty, as opposed to the option of admitting prosecution history in claim construction, because the intent element of s 53 is inherently uncertain. Moreover, to the extent that there is any justification for excluding prosecution history, it is to simplify the claim construction exercise; but to introduce exactly the same evidence under s 53 means that while claim construction is simpler, the litigation as a whole is at least as complex. Indeed, it will be more complex, because the stakes have been raised from scope to validity, ensuring that all the more money will be put into this uncertain issue.

It is not unlikely that in this case the s 53 issue will ultimately become moot, even if it does go to trial. The claims themselves refer to “the valve member being transversely movable,” and the court may well construe the claims to exclude tools without a transverse valve even without the aid of the prosecution history. That will be all the more unfortunate, as parties in future litigation will have to engage the s 53 issue, instead of what could have been a much simpler matter of claim construction. The SCC in Free World feared opening the “Pandora’s box” [66] of file wrapper estoppel. By refusing to do so, it opened the far more dangerous box of s 53.

Friday, September 26, 2014

Form and Function in the Law of Utility

I have criticized the promise doctrine, both in this blog and in my article “The False Doctrine of False Promise” (2013) 29 CIPR 3. In their article published in the most recent issue of the CIPR, “The Promise of the Patent in Canada And Around the World” 30 CIPR 35, Richard Gold & Michael Shortt defend the promise of the patent. My reply article, “Form and Function in the Law of Utility: A Reply to Gold & Shortt,” has been accepted by the CIPR. A good draft, subject to copy-editing, is available from SSRN. Here is the abstract:

In a recent article, “The Promise of the Patent in Canada And Around the World,” Richard Gold and Michael Shortt argue that the law relating to the controversial “promise” branch of the Canadian law of utility is justifiable as a matter of policy, that it is long established in Canadian law, and that promises are enforced in a number of other jurisdictions. In this article I argue that Gold & Shortt fail to appreciate the functional distinction between the two branches of the utility requirement, which are consequently conflated throughout their article. The points they make in respect of the promise doctrine actually relate, for the most part, to the traditional “scintilla” branch of the law of utility, though they also conflate the promise of the patent with obviousness, sufficiency and overbreadth. This article uses Gold & Shortt’s article as a foil to explore the functional nature of the two branches of the law of utility and the differences between them. I will also contrast utility with sufficiency, obviousness and overbreadth.

Wednesday, September 24, 2014

Inventorship in a Combination Invention

Drexan Energy Systems Inc v The Commissioner of Patents and Thermon Manufacturing Co, 2014 FC 887 O'Keefe J
            2,724,561

In 2006 Steve Makar, Konrad Mech, Wells Whitney and Umesh Sopory perceived some deficiencies heating cables used to keep pipes from freezing in cold environments, and they decide to create a new type of heating cable without those defects [3]. Their collaboration resulted in the ‘561 patent, for which Dr Whitney and Mr Sopory were the only listed inventors. By 2010 the relationship between the men had broken down. The interest of Dr Whitney and Mr Sopory was assigned to Thermon, and Mr Makar and Mr Mech was assigned to whatever rights they had Drexan, one of Thermon’s competitors. In this application Drexan sought to have Mr Makar and Mr Mech added to the ‘561 patent as co-inventors [6]. The court noted that s 52 of the Act gives the court the authority to make such an order, and that the burden lay on the applicant [23].

The court reviewed established law on inventorship and noted that the question is whether Mr Makar and Mr Mech were in some way responsible for the inventive concept, though it is not necessary for them to be wholly responsible for it, “so long as his or her ingenuity is applied to the original inventive concept and not just verification” [24, 26 citing inter alia Wellcome / AZT, 2002 SCC 77, [96]). 

The main legal point of interest is that the heating cable was a combination of elements known in the prior art, and the inventive concept lay in the combination of particular elements, not in the elements themselves [27].

[29] This means that the focus has to be on whether Mr. Makar’s and Mr. Mech’s contributions were directed not only to suggested features (see Weatherford (FC) at paragraph 260), but to how they could actually be combined. Put another way, if there are two competing products that have different advantages and disadvantages, it takes no ingenuity at all to suggest that it would be great if there could be a product that has the advantages of both without the disadvantages of either. If there is any inventive concept at all in combining those two products, it lies in discovering how to make a product that has the desired attributes of both and it is to that process that the inventive contribution must be made.

The case then came down to an issue of credibility [30], and ultimately O’Keefe J held that Mr Makar and Mr Mech were not co-inventors: “Undoubtedly, Mr. Makar and Mr. Mech had useful input into the design of the cable, but the applicant has not proven that it was anything more than suggesting desired features and communicating feedback from potential customers” [56]. The application was therefore dismissed [57].

(Thanks again to IPPractice for posting this case - that's six in a row.)

Thursday, September 18, 2014

Thanks to IPPractice!

I’d like to give a big thanks to Alan Macek’s IPPractice for providing timely access to recent judicial decisions, as the Federal Courts have gotten increasingly slow about releasing new decisions on their website. The last five cases I’ve blogged about have come to my attention via the IPPractice Daily Email service, and four of those are recent FC decisions which have still not been released on FC website, and so are only publicly available through IPPractice. (The fifth is a BCSC case, available on Canlii, which I don’t check on a regular basis.)

Timely access to recent caselaw is essential to keep up with the latest trends and developments. Alan’s service helps us all, and I urge you to help him; if you have a copy of unreleased public reasons that you wouldn’t mind making public, consider sending it to Alan so he can make it available to the rest of us.

Wednesday, September 17, 2014

What is "the" Inventive Concept?

Alcon Canada Inc v Apotex Inc 2014 FC 791 Kane J
            2,606,370 / travoprost formulation / TRAVATAN Z / NOC


The ‘370 patent relates to formulations of travoprost, an anti-glaucoma drug, with a non-conventional preservative system, based on zinc ions. The motivation for the invention was to avoid the potentially harmful effects on the cornea of conventional preservatives such as benzalkonium chloride (BAK). In this NOC proceding Apotex successfully attacked the ‘370 patent as being obvious, though a inutility attack failed.


The conclusion that the claims at issue were obvious ultimately turned on the facts. One of Alcon’s own prior art products, the tear replacement product Systane Free, also used a non-conventional preservative system which very similar, even in the specific components, to the claimed formulation [236], [342]. The evidence accepted by Kane J was to the effect that it would have been obvious to extend the same preservative system to travoprost, given the acknowledged motivation to avoid the use of BAK [348].


Inventive Concept
There is, however, one aspect of Kane J’s opinion which I find disquieting. A substantial part of the obviousness analysis concerned the identification of the inventive concept [163]-[197], including extensive testimony from the experts, and a thorough parsing of the specification. (Kane J noted that because the claims were to a bare chemical formula, the inventive concept cannot be identified without looking at the specification [180], which, in my view, is clearly correct.) Kane J’s ultimate identification of the inventive concept drew heavily from elements identified in the specification itself. 

None of this analysis is objectionable in principle; certainly, expert evidence and the specification should be considered in assessing the putative inventive contribution. But the overall tenor of the analysis suggests a focus on identifying “the” inventive concept from the specification, which then becomes the focus of the obviousness analysis. This would be problematic in two respects. First, by focusing on the specification, this analysis could turn the obviousness inquiry into a subjective analysis, in which the question is whether the inventive contribution identified by the applicant is obvious. This is contrary to the principle that the obviousness analysis is objective. It would be evidently be wrong to hold an invention to be non-obvious because the applicant asserts in the specification that it is a work of genius, but it is also wrong to hold a patent obvious because the contribution identified by the applicant turns out to be obvious. For example, the inventor may believe that she has discovered a whole new class of compounds with unexpected properties, and she has claimed both the genus and some particular species. It may turn out that the inventor had overlooked some relevant prior art, and in fact it was obvious or anticipated that some members of the class had the properties in question, but it was nonetheless surprising that the particular claimed species had those properties. The question is not whether what the inventor thought she had contributed is truly inventive; it is whether what she actually contributed is inventive: see Nichia Corporation v Argos Ltd[2007] EWCA Civ 741 at [14]-[19].


Second, as a corollary, it would be wrong to focus on identifying “the” inventive concept, which is thereafter the sole focus of the obviousness analysis. If a putative inventive concept is examined and found to be wanting, the objective nature of the obviousness analysis makes it necessary to ask whether some other aspect of the invention might be inventive. So, if an invention claims a solution to a problem, it may be non-obvious either because the solution was non-obvious, or because the problem itself was non-obvious; it is necessary to ask both questions, not just one. As the EPO Guidelines explain, the question is the formulation of the objective technical problem:

The objective technical problem derived in this way may not be what the applicant presented as "the problem" in his application. The latter may require reformulation, since the objective technical problem is based on objectively established facts, in particular appearing in the prior art revealed in the course of the proceedings, which may be different from the prior art of which the applicant was actually aware at the time the application was filed. In particular, the prior art cited in the search report may put the invention in an entirely different perspective from that apparent from reading the application only. Reformulation might lead to the objective technical problem being less ambitious than originally envisaged by the application.


It is true, of course, that the WindsurfingPozzoli approach as approved by the SCC in Sanofi 2008 SCC 61 [67] refers to identification of the inventive concept as one of the steps, but the inventive concept is by no means the focus of the analysis. Indeed, the test is very casual about the inventive concept: “Identify the inventive concept of the claim in question or if that cannot readily be done, construe it.” That is, don’t worry too much about the inventive concept – the crucial question [67(4)] is whether the differences between the state of the art and the invention as claimed were obvious.


This is a long-winded discussion for a point that probably had no real effect on the result, but there was a similar problem with Kane J’s analysis in the earlier Travoprost case, 2014 FC 699 discussed here. I am concerned that this may signal a new trend that has the effect of improperly turning the obviousness analysis into a subjective inquiry, in the same way that the promise doctrine has made utility a subjective inquiry.


Utility
Turning then to utility, the issue turned entirely on the construction of the promise. Apotex argued that the patent promised minimization or reduction of side effects [352], while Alcon argued that the utility is simply to be useful and to meet the USP preservative efficacy testing standards [351]. Like O’Keefe J in the recent decision Dow v NOVA decision, 2014 FC 844 (blogged here), Kane J relied both on the leading FCA decision, Plavix 2013 FCA 186, for the proposition that the promised utility must be explicit [408], and that “not every statement of advantage in the specification rises to the level of promised utility” [356], and also on Zinn J’s statement in Fournier / Fenofibrate 2012 FC 741 (discussed here), for the proposition that the focus should be on the claims [360]. In light of this jurisprudence, and noting in particular the absence of any promise of reduced side effects in the claims [416], Kane J held in favour of Alcon’s interpretation of the promise [417]. This construction of the promise effectively decided the issue of utility in favour of Alcon, because Apotex’s argument was focused entirely on the promised utility as Apotex had construed it [427], and did not address the issue of demonstrated or soundly predicted utility from the perspective of “simple utility” [440]. The unchallenged evidence led by Alcon was therefore sufficient to establish utility on the basis of sound prediction [446].


Note: see also 2014 FC 699 in which the claims of a different patent, 2,129,287, were to the use of travoprost for the treatment of glaucoma, as opposed to the travoprost formulation. Kane J held the claims of the '287 patent were obvious and anticipated, though the utility attack also failed: see here.

Tuesday, September 16, 2014

Commissioner Not to Be Named as a Party in Appeals from Refusal of Application

Blair v Attorney General of Canada, 2014 FC 861 Strickland J
            Application 2,286,794 / “SUBWAY TV MEDIA SYSTEM”

The ‘794 application claims a subway car with video screens mounted at the junction of the sidewall and ceiling [6]. The Commissioner rejected the claims as being obvious, and Strickland J, applying a deferential standard of review to the Commissioner’s application to the facts of the (correct) obviousness test, affirmed.

The most interesting aspect of this decision is Strickland J’s holding that the Commissioner should not be named as a respondent in the appeal [42]. This seems to be a departure from past practice, though as Strickland J pointed out, in cases such as Harvard College v Canada (Commissioner of Patents), 2002 SCC 76, and The Attorney General of Canada and The Commissioner of Patents v Amazon.com, Inc 2011 FCA 328, the issue of the Commissioner being named as a party does not appear to have been disputed [49]. I don’t have a good sense of what the practical implications of this holding will be, but it was Attorney General which sought to have the Commissioner removed, so presumably the government is satisfied that it can properly conduct such appeals without the participation of the Commissioner.