Friday, December 30, 2016
No New Cases Last Week
Not very surprisingly, no new patent / NOC / data protection cases were released over the past week. I hope everyone at the Federal Courts had a good break, and will return ready to deal with all the interesting and difficult issues that patent law throws at us. Here's to 2017!
Tuesday, December 20, 2016
Sublingual Dosage Form Patent Valid but Not Infringed on the Facts
Meda AB v Pharmascience Inc 2016 FC 1362 Manson J
2,629,988 / zolpidem / SUBLINOX / NOC
In this NOC proceeding, Meda’s ‘988 patent was held to be substantially valid, but not infringed by Pharmascience’s PMS-Zolpidem product. This result turned entirely on the facts, and no significant points of law were raised. The overbreadth discussion does provide an interesting example of the role of claim differentiation.
The ‘988 patent is a formulation patent, claiming zolpidem for the treatment of insomnia in a sublingual dosage form comprising an ordered mixture, in which the API is adhered to larger carrier particles, and a bio/mucoadhesive promoting agent [76]. (As I understand it, an “ordered mixture” means a homogeneous mixture, as opposed to a random mixture in which some degree of segregation may occur.
Validity was attacked on the basis of anticipation, obviousness, lack of utility and overbreadth [18]. The anticipation argument failed because the prior art relied on did not teach an ordered mixture or sublingual administration [134]. The patent is a combination patent, in the sense that all the elements were known in the prior art [77], and the question was whether it would have been obvious to combine them. On the facts, Manson J held that the combination was not obvious [154]. Pharmascience’s argument to the contrary was not helped by the fact that in a review article its own expert had described the ‘988 patent as “an unusual approach” and “very different from all the formulations that [he’d] read” [151]. The utility attack was based on the promise of bio/mucoadhesion. Manson J held that “[a]ll that is required is sufficient bio/mucoadhesion to achieve the promised rapid release and absorption” [176] and this promise was demonstrated by examples in the patent [178].
Pharmascience also attacked the patent on the basis of overbreadth. Specifically, Pharmascience argued that the claims were overbroad because it was necessary that the formulation (1) have the bio/mucoadhesive agent on the surface of carrier particles; and (2) be essentially free from water [157], and Claim 1 was invalid because it did not have the first limitation, and all the claims were invalid because none of them had the second limitation. Both limitations were, however, disclosed in the specification, and Meda responded that a POSITA reading the claims in light of the specification would understand those limitations to be implicit [162]. Manson J agreed that a skilled person reading the claim “in light of the specification as a whole, with a mind willing to understand, would know that the formulation would have to be essentially free from water to work” [168]. The attack based on the absence of that limitation therefore failed. However, Manson J held that it was not permissible to read limitation (1) as being implicit in Claim 1, because it was explicit in Claim 2 and following claims, and “the presumption against redundancy precludes this limitation from being implied into claim 1" [168]. Consequently, Claim 1 was invalid for overbreadth [168]. However, this did not substantially affect the strength of the patent as a whole, because Claim 2 was exactly the same as Claim 1 except that it did include this limitation. The interesting point is what would have happened if Claim 2 had omitted this limitation; it seems not unlikely that Manson J would have been willing to find it to implicit, as he did with the requirement of being free from water.
While the patent was held to be substantially valid, Manson J held that Pharmascience’s allegation of non-infringement was justified [195]. The reasoning on this point is not entirely clear, as the discussion was substantially redacted. It is nonetheless clear enough that the result turned on the facts.
2,629,988 / zolpidem / SUBLINOX / NOC
In this NOC proceeding, Meda’s ‘988 patent was held to be substantially valid, but not infringed by Pharmascience’s PMS-Zolpidem product. This result turned entirely on the facts, and no significant points of law were raised. The overbreadth discussion does provide an interesting example of the role of claim differentiation.
The ‘988 patent is a formulation patent, claiming zolpidem for the treatment of insomnia in a sublingual dosage form comprising an ordered mixture, in which the API is adhered to larger carrier particles, and a bio/mucoadhesive promoting agent [76]. (As I understand it, an “ordered mixture” means a homogeneous mixture, as opposed to a random mixture in which some degree of segregation may occur.
Validity was attacked on the basis of anticipation, obviousness, lack of utility and overbreadth [18]. The anticipation argument failed because the prior art relied on did not teach an ordered mixture or sublingual administration [134]. The patent is a combination patent, in the sense that all the elements were known in the prior art [77], and the question was whether it would have been obvious to combine them. On the facts, Manson J held that the combination was not obvious [154]. Pharmascience’s argument to the contrary was not helped by the fact that in a review article its own expert had described the ‘988 patent as “an unusual approach” and “very different from all the formulations that [he’d] read” [151]. The utility attack was based on the promise of bio/mucoadhesion. Manson J held that “[a]ll that is required is sufficient bio/mucoadhesion to achieve the promised rapid release and absorption” [176] and this promise was demonstrated by examples in the patent [178].
Pharmascience also attacked the patent on the basis of overbreadth. Specifically, Pharmascience argued that the claims were overbroad because it was necessary that the formulation (1) have the bio/mucoadhesive agent on the surface of carrier particles; and (2) be essentially free from water [157], and Claim 1 was invalid because it did not have the first limitation, and all the claims were invalid because none of them had the second limitation. Both limitations were, however, disclosed in the specification, and Meda responded that a POSITA reading the claims in light of the specification would understand those limitations to be implicit [162]. Manson J agreed that a skilled person reading the claim “in light of the specification as a whole, with a mind willing to understand, would know that the formulation would have to be essentially free from water to work” [168]. The attack based on the absence of that limitation therefore failed. However, Manson J held that it was not permissible to read limitation (1) as being implicit in Claim 1, because it was explicit in Claim 2 and following claims, and “the presumption against redundancy precludes this limitation from being implied into claim 1" [168]. Consequently, Claim 1 was invalid for overbreadth [168]. However, this did not substantially affect the strength of the patent as a whole, because Claim 2 was exactly the same as Claim 1 except that it did include this limitation. The interesting point is what would have happened if Claim 2 had omitted this limitation; it seems not unlikely that Manson J would have been willing to find it to implicit, as he did with the requirement of being free from water.
While the patent was held to be substantially valid, Manson J held that Pharmascience’s allegation of non-infringement was justified [195]. The reasoning on this point is not entirely clear, as the discussion was substantially redacted. It is nonetheless clear enough that the result turned on the facts.
Friday, December 16, 2016
No New Cases for the Last Two Weeks
No new patent / NOC / data protection cases have been released in the last couple of weeks.
Note 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 copyright and trade-mark cases, I recommend subscribing to the Daily Intellectual Property News service from Alan Macek's IPPractice.
Note 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 copyright and trade-mark cases, I recommend subscribing to the Daily Intellectual Property News service from Alan Macek's IPPractice.
Thursday, December 1, 2016
Are Damages an Element of a Claim under Section 7 of the Trade-marks Act?
Excalibre Oil Tools Ltd v Advantage Products Inc 2016 FC 1279 Manson J
2,264,467 / 2,373,734 / 2,386,026 / torque anchor
E Mishan & Sons, Inc v Supertek Canada Inc 2016 FC 986 Hughes J
2,779,882 / Industrial Design 146,676 / expandable garden hose
Tuesday’s post provided the background to the threats claim brought under s 7(a) of the Trade-marks Act, and yesterday’s post discussed the safe harbour for purely informative communications. Today’s post discusses the proposition, agreed to by counsel in Supertek 2016 FC 986 [7] and affirmed by Hughes J [28], that “Damages are . . . an essential element in a claim under section 7(a) of the Trade-marks Act.” Manson J put it somewhat differently, and more accurately, in Excalibre: “It is settled law that evidence of actual or potential damage is a necessary element for finding liability under section 7" [286, my emphasis]. The difficulty with this proposition, particularly in Hughes J’s formulation, is that if resulting loss is an element of the tort, then the plaintiff is not entitled to an injunction to restrain false statements discrediting its wares, and perhaps not even its costs in the action, unless loss has already been suffered. This is a very strange proposition. Certainly, a plaintiff is not entitled to a monetary award unless it has proven its loss, but why should a plaintiff be helpless to prevent false statements from discrediting its wares simply because it had the good sense to act promptly? Surely it is better to prevent the loss from happening in the first place than to provide relief after the fact.
2,264,467 / 2,373,734 / 2,386,026 / torque anchor
E Mishan & Sons, Inc v Supertek Canada Inc 2016 FC 986 Hughes J
2,779,882 / Industrial Design 146,676 / expandable garden hose
Tuesday’s post provided the background to the threats claim brought under s 7(a) of the Trade-marks Act, and yesterday’s post discussed the safe harbour for purely informative communications. Today’s post discusses the proposition, agreed to by counsel in Supertek 2016 FC 986 [7] and affirmed by Hughes J [28], that “Damages are . . . an essential element in a claim under section 7(a) of the Trade-marks Act.” Manson J put it somewhat differently, and more accurately, in Excalibre: “It is settled law that evidence of actual or potential damage is a necessary element for finding liability under section 7" [286, my emphasis]. The difficulty with this proposition, particularly in Hughes J’s formulation, is that if resulting loss is an element of the tort, then the plaintiff is not entitled to an injunction to restrain false statements discrediting its wares, and perhaps not even its costs in the action, unless loss has already been suffered. This is a very strange proposition. Certainly, a plaintiff is not entitled to a monetary award unless it has proven its loss, but why should a plaintiff be helpless to prevent false statements from discrediting its wares simply because it had the good sense to act promptly? Surely it is better to prevent the loss from happening in the first place than to provide relief after the fact.
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