Tuesday, January 31, 2012
Week of 22 January 2012
No new substantive patent decisions were posted on the Federal Courts' websites for the week of 22 January 2012. A long (236 paragraphs) assessment of costs in Janssen Inc. v. Teva Canada Ltd 2012
FC 48 was released, which may be of interest for its detail, and because of the amount involved: the Bill of
Costs presented at $852,423.52 was assessed and allowed for a total amount of $619,158.30 plus
post judgment interest from the date of judgment. The assessment of costs in Simpson Strong-Tie
Company, Inc. v. Peak Innovation Inc. at trial 2012 FC 63 and in respect of the appeal 2012 FCA
15 was also released.
Tuesday, January 24, 2012
Appealing a Finding of Invalidity after Settling
The recent decision of the English Court of Appeal in Apimed Medical Honey Ltd v Brightwake
Ltd [2012] EWCA Civ 5 is substantively uninteresting (see my IPKat post), but it raises an
interesting point of English procedure. The defendant had won at trial on both infringement and
invalidity. The parties settled (the decision was very strong on infringement), but the patentee
wished to appeal the finding of invalidity. Because of the settlement, the defendant had no
interest in appearing, so following guidance provided in Halliburton Energy Services Inc v Smith
International (North Sea) Ltd [2006] EWCA Civ 185, the Comptroller-General of the Patent
Office appeared to argue the case for upholding the decision below that the patent was invalid.
Monday, January 23, 2012
US Federal Circuit Split on Patentable Subject Matter
See my IPKat post for a discussion of last Friday's decision of the US Court of Appeals for the Federal Circuit in Dealertrack v Huber, 2009-1566, -1588 (Fed Cir 2012), which I argue demonstrates that a post-Bilski split has emerged in the Federal Circuit as to the correct approach to patentable subject matter.
Wednesday, January 18, 2012
Amazon.com Patent Granted
Alan Macek's IPPractice blog reports that the Amazon.com's patent was granted yesterday as CA 2246933. My views on the FCA decision are here. The next development will be the new Practice Guidance, which I assume must be forthcoming at some point to tell us what the Patent Office thinks the FCA meant in Amazon.com.
Tuesday, January 10, 2012
Plavix Patent Invalidated by the Distinction Between Demonstrated Utility and Sound Prediction
Apotex Inc v Sanofi-Aventis / clopidogrel 2011 FC 1486 Boivin J
1,336,777 PLAVIX
Two unique features of Canadian law, the false promise doctrine, and the more recent rule that the basis for a sound prediction must be disclosed in the patent itself, mean that lack of utility is one of the most common reasons for invalidating pharmaceutical patents. This was the case in this clopidogrel decision, in which both these doctrines came together to result in a holding of invalidity based on lack of utility.
By way of context, clopidogrel is the enantiomer of the racemic compound referred to as PCR 4099, which is a member of the class of compounds called thienopyridines. An early member of this class, ticlopidine, was synthesized by Sanofi in the early 1970s [411]. Ticlopidine has been approved for use in humans (in 1978 in France [442]); Apotex, for example, holds an NOC for the sale of ticlopidine for humans. Unfortunately, ticlopidine has significant side-effects, so there was a motivation to find a better tolerated but equally or more active member of the class. Sanofi identified PCR 4099 as a lead compound, and carried out extensive studies on it in the 1980s, including roughly a dozen different studies on humans [444]. Based on these studies, “it was found that (i) PCR 4099 was the most potent thienopyridine compound synthesized to that point of time, and, (ii) it was significantly more effective and better tolerated than ticlopidine [446]. However, a long term animal study suggested that PCR 4066 could lead to convulsions. (It is not entirely clear from the discussion of the facts whether this was a side effect of ticlopidine, but it appears not.) A wide range of animal studies demonstrated that clopidogrel was at least as active as PCR 4099, but not toxic [467].
In summary, PCR 4099 was more efficacious than ticlopidine and clopidogrel was at least equally active. PCR 4099 was better tolerated than ticlopidine, except for convulsions, while clopidogrel was less toxic that PCR 4099. This means that at the relevant date it seemed that clopidogrel was clearly better than ticlopidine, and ticlopidine was actually approved for human use. Nonetheless, Boivin J held that Sanofi had neither established demonstrated utility or a sound prediction of utility. What explains this?
1,336,777 PLAVIX
Two unique features of Canadian law, the false promise doctrine, and the more recent rule that the basis for a sound prediction must be disclosed in the patent itself, mean that lack of utility is one of the most common reasons for invalidating pharmaceutical patents. This was the case in this clopidogrel decision, in which both these doctrines came together to result in a holding of invalidity based on lack of utility.
By way of context, clopidogrel is the enantiomer of the racemic compound referred to as PCR 4099, which is a member of the class of compounds called thienopyridines. An early member of this class, ticlopidine, was synthesized by Sanofi in the early 1970s [411]. Ticlopidine has been approved for use in humans (in 1978 in France [442]); Apotex, for example, holds an NOC for the sale of ticlopidine for humans. Unfortunately, ticlopidine has significant side-effects, so there was a motivation to find a better tolerated but equally or more active member of the class. Sanofi identified PCR 4099 as a lead compound, and carried out extensive studies on it in the 1980s, including roughly a dozen different studies on humans [444]. Based on these studies, “it was found that (i) PCR 4099 was the most potent thienopyridine compound synthesized to that point of time, and, (ii) it was significantly more effective and better tolerated than ticlopidine [446]. However, a long term animal study suggested that PCR 4066 could lead to convulsions. (It is not entirely clear from the discussion of the facts whether this was a side effect of ticlopidine, but it appears not.) A wide range of animal studies demonstrated that clopidogrel was at least as active as PCR 4099, but not toxic [467].
In summary, PCR 4099 was more efficacious than ticlopidine and clopidogrel was at least equally active. PCR 4099 was better tolerated than ticlopidine, except for convulsions, while clopidogrel was less toxic that PCR 4099. This means that at the relevant date it seemed that clopidogrel was clearly better than ticlopidine, and ticlopidine was actually approved for human use. Nonetheless, Boivin J held that Sanofi had neither established demonstrated utility or a sound prediction of utility. What explains this?
Monday, January 9, 2012
Plavix: Obvious or Not?
Apotex Inc v Sanofi-Aventis / clopidogrel 2011 FC 1486 Boivin J
1,336,777 PLAVIX
Clopidogrel, the claimed compound at issue in this case, is the dextro-rotatory enantiomer of a racemic compound referred to as PCR 4099. Clopidogrel has superior pharmacological properties as compared with the racemate, in particular greater activity and lower toxicity. Patent 1,194,875, which was conceded to be part of the common general knowledge [608], claimed a genus encompassing PCR 4099, which was also specifically disclosed as the lead compound in Example 1 of the ‘875 patent [611]. The obviousness question was therefore simply whether the enantiomer was obvious over the racemate. In the NOC proceedings, which culminated in Apotex Inc v Sanofi-Synthelabo Canada Inc, 2008 SCC 61, the SCC held that it was not. In these infringement proceedings, Boivin J held to the contrary. What accounts for the differing conclusions?
1,336,777 PLAVIX
Clopidogrel, the claimed compound at issue in this case, is the dextro-rotatory enantiomer of a racemic compound referred to as PCR 4099. Clopidogrel has superior pharmacological properties as compared with the racemate, in particular greater activity and lower toxicity. Patent 1,194,875, which was conceded to be part of the common general knowledge [608], claimed a genus encompassing PCR 4099, which was also specifically disclosed as the lead compound in Example 1 of the ‘875 patent [611]. The obviousness question was therefore simply whether the enantiomer was obvious over the racemate. In the NOC proceedings, which culminated in Apotex Inc v Sanofi-Synthelabo Canada Inc, 2008 SCC 61, the SCC held that it was not. In these infringement proceedings, Boivin J held to the contrary. What accounts for the differing conclusions?
Friday, January 6, 2012
Double Recovery in Transnational Patent Litigation
Apotex Inc v Sanofi-Aventis / clopidogrel 2011 FC 1486 Boivin J
1,336,777 PLAVIX
The recent decision of the Federal Court of Canada invalidating Sanofi’s Canadian Plavix patent raises some interesting points relating transnational patent litigation. Sanofi holds US and Canadian patents for Plavix (clopidogrel). Apotex imported bulk clopidogrel from a third jurisdiction into Canada and then exported it into the US for sale there, so the same pills that were infringing the US patent by sale in the US, were also infringing the Canadian patent by importation into Canada [251]-[253]. The parties entered into a settlement agreement respecting the US litigation. The settlement was subject to regulatory approval, and provided for alternate terms in the event of regulatory denial; in particular, if Sanofi prevailed in subsequent litigation, damages were specified to be 50% of Apotex’s net sales. Regulatory approval was denied, Sanofi prevailed in the subsequent US litigation (492 F Supp 2d 353 (SDNY 2007), aff'd, 550 F 3d 1075 (Fed Cir 2008)), and, in an October 2010 decision (748 F.Supp.2d 293 (SDNY)), Sanofi was awarded damages of 50% of Apotex’s net sales, as provided for in the settlement agreement. In November, 2010 Apotex paid into court US$556,000,000 in respect of the judgment. The Canadian litigation went to trial in April of 2011, after US proceedings were concluded. Apotex argued that Sanofi should not be able to “com[e] to Canada to sue Apotex and recover a second time for the same Apo-clopidogrel in respect of which they have already secured judgment and payment in the U.S.” [276]. Apotex raised three legal arguments to give effect to this general point of principle.
1,336,777 PLAVIX
The recent decision of the Federal Court of Canada invalidating Sanofi’s Canadian Plavix patent raises some interesting points relating transnational patent litigation. Sanofi holds US and Canadian patents for Plavix (clopidogrel). Apotex imported bulk clopidogrel from a third jurisdiction into Canada and then exported it into the US for sale there, so the same pills that were infringing the US patent by sale in the US, were also infringing the Canadian patent by importation into Canada [251]-[253]. The parties entered into a settlement agreement respecting the US litigation. The settlement was subject to regulatory approval, and provided for alternate terms in the event of regulatory denial; in particular, if Sanofi prevailed in subsequent litigation, damages were specified to be 50% of Apotex’s net sales. Regulatory approval was denied, Sanofi prevailed in the subsequent US litigation (492 F Supp 2d 353 (SDNY 2007), aff'd, 550 F 3d 1075 (Fed Cir 2008)), and, in an October 2010 decision (748 F.Supp.2d 293 (SDNY)), Sanofi was awarded damages of 50% of Apotex’s net sales, as provided for in the settlement agreement. In November, 2010 Apotex paid into court US$556,000,000 in respect of the judgment. The Canadian litigation went to trial in April of 2011, after US proceedings were concluded. Apotex argued that Sanofi should not be able to “com[e] to Canada to sue Apotex and recover a second time for the same Apo-clopidogrel in respect of which they have already secured judgment and payment in the U.S.” [276]. Apotex raised three legal arguments to give effect to this general point of principle.
Wednesday, January 4, 2012
Joinder and Limitations
Janssen Inc v Teva Canada Ltd / levofloxacin 2011 FC 1480 Hughes J
In 2006 Daiichi Pharmaceutical Co, Ltd (the patentee) and Janssen-Ortho Inc (its licencee, now Janssen Inc) prevailed against Teva (then Novopharm) in an infringement action relating to levoflaxin: 2006 FC 1234 aff'd 2007 FCA 217. In this motion the plaintiffs sought to add three related companies, namely Janssen Inc’s parent company Johnson & Johnson, and two other companies owed by Johnson & Johnson, all of which were asserted to have been part of the levoflaxin production and distribution system, and to have suffered loss consequent on Teva’s infringement. Hughes J dismissed the motion. Without deciding whether those companies were entitled to damages as “person[s] claiming under the patentee” as required by s 55(1), Hughes J held that the determination of that issue was a question that might require “discovery, further evidence, expert evidence if needed, and full argument and submissions respecting the evidence and the jurisprudence” [22]. Consequently it was not appropriate to add the companies to this action, in which the determination that the two original plaintiffs were entitled to damages had already been made. Hughes J distinguished McIntosh v Society of Composers, Authors and Music Publishers of Canada, 2004FCA 57 as being a case in which “there had not yet been a trial and the proceedings were still in the early stages such that further discovery could comfortably be included” [27].
While it is open to the companies in question to bring an infringement action [23], this ruling did not have purely procedural consequences. The applicable limitations period is 6 years, and Hughes J held that this should be calculated from the date of the filing of the motion for joinder, namely 30 August 2011. Consequently, “the claim for damages would be limited to any claim arising after August 30, 2005" [34], while the period of infringement ran from November 2004 to November 2006 [31].
In 2006 Daiichi Pharmaceutical Co, Ltd (the patentee) and Janssen-Ortho Inc (its licencee, now Janssen Inc) prevailed against Teva (then Novopharm) in an infringement action relating to levoflaxin: 2006 FC 1234 aff'd 2007 FCA 217. In this motion the plaintiffs sought to add three related companies, namely Janssen Inc’s parent company Johnson & Johnson, and two other companies owed by Johnson & Johnson, all of which were asserted to have been part of the levoflaxin production and distribution system, and to have suffered loss consequent on Teva’s infringement. Hughes J dismissed the motion. Without deciding whether those companies were entitled to damages as “person[s] claiming under the patentee” as required by s 55(1), Hughes J held that the determination of that issue was a question that might require “discovery, further evidence, expert evidence if needed, and full argument and submissions respecting the evidence and the jurisprudence” [22]. Consequently it was not appropriate to add the companies to this action, in which the determination that the two original plaintiffs were entitled to damages had already been made. Hughes J distinguished McIntosh v Society of Composers, Authors and Music Publishers of Canada, 2004FCA 57 as being a case in which “there had not yet been a trial and the proceedings were still in the early stages such that further discovery could comfortably be included” [27].
While it is open to the companies in question to bring an infringement action [23], this ruling did not have purely procedural consequences. The applicable limitations period is 6 years, and Hughes J held that this should be calculated from the date of the filing of the motion for joinder, namely 30 August 2011. Consequently, “the claim for damages would be limited to any claim arising after August 30, 2005" [34], while the period of infringement ran from November 2004 to November 2006 [31].
Tuesday, January 3, 2012
Plavix Patent Invalid
Apotex Inc v Sanofi-Aventis / clopidogrel bisulfate 2011 FC 1486 Boivin J
In a decision dated 6 December 2011, and released on the FC website today, Boivin J has held the Plavix patent (1,336,777) to be invalid for lack of demonstrated utility and lack of sound prediction, and as being obvious to try. This is the same patent that was held to be not invalid in NOC proceedings that culminated in the SCC decision in Apotex v Sanofi 2008 SCC 61. I will have more to say once I have read and digested this massive (790 paragraphs, 248 pages) decision.
In a decision dated 6 December 2011, and released on the FC website today, Boivin J has held the Plavix patent (1,336,777) to be invalid for lack of demonstrated utility and lack of sound prediction, and as being obvious to try. This is the same patent that was held to be not invalid in NOC proceedings that culminated in the SCC decision in Apotex v Sanofi 2008 SCC 61. I will have more to say once I have read and digested this massive (790 paragraphs, 248 pages) decision.
Amazon.com Patent Allowed
Alan Macek reports that the Amazon.com patent application has been allowed. I must admit that I am very surprised, as I had predicted that the Patent Office would refuse the patent in light of the FCA decision. I still agree with Barry Sookman that the consequence is that the SCC will not hear an appeal, and the law of patentable subject matter therefore remains very uncertain. It will be interesting to see how (and whether) CIPO revises its practice guidance relating to patentable subject matter.
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