Pfizer Canada Inc. v Mylan Pharmaceuticals ULC / donepezil (NOC) 2011 FC 547 Hughes J
The interesting issue raised by this case is the conflict between two views of patent construction. The English Court of Appeal has recently said that “[t]he task for the court is to determine what the person skilled in the art would have understood the patentee to have been using the language of the claim to mean” (Virgin Atlantic [2009] EWCA Civ 1062 at [5]). In contrast, the Federal Court of Appeal has equally recently said that “[t]he construction of a patent is a question of law to be determined by the Court, with the assistance of persons of ordinary skill in the art to which the invention relates” (Bridgeview Manufacturing 2010 FCA 188 at [9]). Both of these statements are supported by ample authority, and taken in isolation either might seem anodyne. Yet in practice there is a serious unresolved tension. On the first view, the construction of the patent is a matter of fact, and the meaning of any term or passage must be established by evidence of expert witnesses. On the second approach, construction of the patent is a mixed question of fact and law, and legal arguments and principles are needed to supplement the expert evidence. In the Pfizer v Mylan / donepezil Hughes J comes down firmly in the latter camp. The case illustrates this wisdom of that position. The practical implication, it may be hoped, is that it may no longer be necessary to advance legal argument via expert witnesses.
Tuesday, May 24, 2011
Wednesday, May 18, 2011
Minister has On-Going Duty to Maintain Innovative Drug Register / Participation in SAP Does Not Disqualify from "Innovative Drug" Status
Teva Canada Ltd v Canada (Health) 2011 FC 507 Campbell J
ELOXATIN had been sold by Sanofi from 1999 to 2005 under the “Special Access Program” (SAP) provided for in C.08.010(1) of the Food and Drug Regulations. In 2007 Sanofi received a NOC for ELOXATIN on the basis of an NDS, and ELOXATIN was then listed on the Innovative Drug Register. Consequently, it was eligible for data protection for an eight and a half year term running from the 2007 issuance of the NOC. Teva challenged this listing in 2010. The case raised a procedural point and substantive point.
The procedural point arose because Teva did not challenge the listing in 2007, but in 2010 it requested that ELOXATIN be deleted from the Innovative Drug Register on the basis that it contained a medicinal ingredient that had been “previously approved” and so did not qualify as an “innovative drug” under the definition in C08.004.1(1). The Minister refused to delete it, and notified Teva by letter.
Sanofi argued that Teva could only challenge the listing decision at the time of the original decision, at least in the absence of any new information. The FC agreed with Teva and the Minister, that the Minister has an ongoing duty to maintain the register, and so a decision regarding listing can be made at any time. The Minister accepted that her decision was subject to judicial review, but there was a dispute as to whether Teva had standing. The FC held [18] that Teva did have standing, on the basis that the listing on the Register prevented it from filing an ANDS. The decision in CGPA v Minister of Health and GlaxoSmithKline Inc 2011 FC 465 holding that the Canadian Generic Pharmaceutical Association did not have standing to challenge a listing decision, was distinguished at [34] on the basis that the CGPA is an association which is incapable of filing an ANDS. (While Campbell J referred to this decision as having been released, it is not yet available on the Federal Court website.)
On the substantive point, Teva argued that the Minister’s course of action in allowing extensive use of ELOXATIN under the SAP showed that she must have been satisfied of the safety and efficacy [24]. The FCA rejected this, agreeing with the Minister that approval means market authorization, including safety and efficacy approval, on the basis of an NDS or ANDS under C.08.004. The functional rationale is that an SAP does not require the same data that the normal approval does, and it is the data submitted for the NDS that is the subject of data protection. Teva argued that the data which was the basis for the NDS arose from Sanofi’s participation in the SAP, and so was disclosed prior to the NOC being issued. However, even if this is true on the facts of this case, it is not necessarily true in general. The meaning of “previously approved” in the definition of an innovative drug cannot turn on the extent to which the particular information relied on in the NDS had been previously disclosed.
ELOXATIN had been sold by Sanofi from 1999 to 2005 under the “Special Access Program” (SAP) provided for in C.08.010(1) of the Food and Drug Regulations. In 2007 Sanofi received a NOC for ELOXATIN on the basis of an NDS, and ELOXATIN was then listed on the Innovative Drug Register. Consequently, it was eligible for data protection for an eight and a half year term running from the 2007 issuance of the NOC. Teva challenged this listing in 2010. The case raised a procedural point and substantive point.
The procedural point arose because Teva did not challenge the listing in 2007, but in 2010 it requested that ELOXATIN be deleted from the Innovative Drug Register on the basis that it contained a medicinal ingredient that had been “previously approved” and so did not qualify as an “innovative drug” under the definition in C08.004.1(1). The Minister refused to delete it, and notified Teva by letter.
Sanofi argued that Teva could only challenge the listing decision at the time of the original decision, at least in the absence of any new information. The FC agreed with Teva and the Minister, that the Minister has an ongoing duty to maintain the register, and so a decision regarding listing can be made at any time. The Minister accepted that her decision was subject to judicial review, but there was a dispute as to whether Teva had standing. The FC held [18] that Teva did have standing, on the basis that the listing on the Register prevented it from filing an ANDS. The decision in CGPA v Minister of Health and GlaxoSmithKline Inc 2011 FC 465 holding that the Canadian Generic Pharmaceutical Association did not have standing to challenge a listing decision, was distinguished at [34] on the basis that the CGPA is an association which is incapable of filing an ANDS. (While Campbell J referred to this decision as having been released, it is not yet available on the Federal Court website.)
On the substantive point, Teva argued that the Minister’s course of action in allowing extensive use of ELOXATIN under the SAP showed that she must have been satisfied of the safety and efficacy [24]. The FCA rejected this, agreeing with the Minister that approval means market authorization, including safety and efficacy approval, on the basis of an NDS or ANDS under C.08.004. The functional rationale is that an SAP does not require the same data that the normal approval does, and it is the data submitted for the NDS that is the subject of data protection. Teva argued that the data which was the basis for the NDS arose from Sanofi’s participation in the SAP, and so was disclosed prior to the NOC being issued. However, even if this is true on the facts of this case, it is not necessarily true in general. The meaning of “previously approved” in the definition of an innovative drug cannot turn on the extent to which the particular information relied on in the NDS had been previously disclosed.
Tuesday, May 17, 2011
Exact Matching Required in PM(NOC) Listing of Dosage Claims
Purdue Pharma v Canada (Attorney General) / TARGIN 2011 FCA 132 Layden-Stevenson JA: Blais CJ, Stratas JA aff’g 2010 FC 738 Crampton J
As described in the previous post, Purdue Pharma sought to list 2,098,738 against TARGIN. TARGIN is a controlled release combination of two active ingredients, oxycodone and naloxone. The ‘738 patent claims a controlled release oxycodone formulation “comprising” oxycodone in a matrix. None of the claims expressly mention naloxone. Yesterday's post critiqued the FCA’s suggestion that the ‘738 patent was restricted to drugs containing only oxycodone, so that TARGIN could not infringe. If TARGIN could not infringe, the ‘738 patent would not be eligible for listing. However, even if TARGIN might fall within the scope of the ‘738 patent, it does not follow that the ‘738 patent can be listed. Since the 2006 amendments it is clear that list eligibility and infringement do not exactly coincide: it is not true that any patent that would be infringed by production of a particular drug is therefore eligible for listing against that drug (RIAS to SOR/2006-242 at 1512). Even if TARGIN potentially infringes, listing eligibility is a distinct question. This is the issue of “product specificity.” Is the match between the product and the patent sufficiently close?
As described in the previous post, Purdue Pharma sought to list 2,098,738 against TARGIN. TARGIN is a controlled release combination of two active ingredients, oxycodone and naloxone. The ‘738 patent claims a controlled release oxycodone formulation “comprising” oxycodone in a matrix. None of the claims expressly mention naloxone. Yesterday's post critiqued the FCA’s suggestion that the ‘738 patent was restricted to drugs containing only oxycodone, so that TARGIN could not infringe. If TARGIN could not infringe, the ‘738 patent would not be eligible for listing. However, even if TARGIN might fall within the scope of the ‘738 patent, it does not follow that the ‘738 patent can be listed. Since the 2006 amendments it is clear that list eligibility and infringement do not exactly coincide: it is not true that any patent that would be infringed by production of a particular drug is therefore eligible for listing against that drug (RIAS to SOR/2006-242 at 1512). Even if TARGIN potentially infringes, listing eligibility is a distinct question. This is the issue of “product specificity.” Is the match between the product and the patent sufficiently close?
Monday, May 16, 2011
“Comprising”
Purdue Pharma v Canada (Attorney General) 2011 FCA 132 Layden-Stevenson JA: Blais CJ, Stratas JA aff’d 2010 FC 738 Crampton J
Purdue Pharma sought to list patent 2,098,738 against TARGIN under the PM(NOC) regulations. TARGIN is a controlled release combination of two active ingredients, oxycodone and naloxone. The ‘738 patent claims a controlled release oxycodone formulation “comprising” oxycodone in a matrix. None of the claims expressly mention naloxone. Does the ‘738 patent encompass TARGIN? If it does not, then a generic version of TARGIN cannot infringe, and the ‘738 patent is not eligible for listing. That question, which turns on the meaning of “comprising”, is the subject of this post. Whether the ‘738 patent would be eligible for listing even if the TARGIN did potentially infringe is a separate question which will be discussed in a subsequent post.
Normally “comprising” defines an open-ended list which does not exclude additional unrecited elements or method steps. On this standard interpretation, a formulation of TARGIN which used the claimed controlled released technology would infringe the ‘738 patent. However, Crampton J accepted the submission of the OPML that in this patent, “comprising” was a limiting term, from which is follows that TARGIN would not infringe.
Purdue Pharma sought to list patent 2,098,738 against TARGIN under the PM(NOC) regulations. TARGIN is a controlled release combination of two active ingredients, oxycodone and naloxone. The ‘738 patent claims a controlled release oxycodone formulation “comprising” oxycodone in a matrix. None of the claims expressly mention naloxone. Does the ‘738 patent encompass TARGIN? If it does not, then a generic version of TARGIN cannot infringe, and the ‘738 patent is not eligible for listing. That question, which turns on the meaning of “comprising”, is the subject of this post. Whether the ‘738 patent would be eligible for listing even if the TARGIN did potentially infringe is a separate question which will be discussed in a subsequent post.
Normally “comprising” defines an open-ended list which does not exclude additional unrecited elements or method steps. On this standard interpretation, a formulation of TARGIN which used the claimed controlled released technology would infringe the ‘738 patent. However, Crampton J accepted the submission of the OPML that in this patent, “comprising” was a limiting term, from which is follows that TARGIN would not infringe.
Friday, May 13, 2011
No Section 8 Damages for Permanent Loss of Market Share
Teva Canada Ltd v Sanofi-Aventis Canada Inc / ramipril (NOC) 2011 FCA 149 Dawson JA: Noël JA; Sharlow JA dissenting, affm’g 2010 FC 1210 Simpson J, affm’g 2010 FC 150 Milczynski Pr
In Sanofi-Aventis / ramipril 2011 FCA 149 Dawson JA, in a brief decision from the bench for herself and Noël JA, affirmed the FCA’s holding in Merck Frosst Canada Ltd v Apotex Inc / alendronate (NOC) 2009 FCA 187 that section 8 of the NOC regulations does not permit recovery of losses – in particular loss of market share – suffered after the expiry of the statutory stay, even if those losses were caused by the stay. Sharlow JA in dissent was of the view that Merck Frosst was wrongly decided [14], while the majority felt it should not be disturbed [5]. (Note that Noël JA wrote for the Court in Merck Frosst.)
Sharlow JA dissented on the basis that “[t]he damages contemplated by section 8 are intended to be analogous to the undertaking a party is normally required to offer when seeking an interlocutory injunction in ordinary commercial litigation,” and “an undertaking in damages is normally broad enough to cover all losses resulting from the injunction” [12]. There is a great deal to be said for Sharlow JA’s position as a matter of principle. On the other hand, while section 8 is analogous to an undertaking, it is not one. The rights of the second person are defined by the regulations, and, as the various RIASes make clear, the scheme as a whole is intended to "balance" enforcement of patent rights with encouragement of generic entry. Thus while Sharlow JA at [14] criticized as a "narrow" and "literal" interpretation of the relevant provision in Merck Frosst, it is quite reasonable to suppose that an interpretation which is in some ways unprincipled may be required to give effect to the precise balance sought by the legislature. This was in effect the position taken by the FCA in Merck Frosst at [101-102] in having regard primarily to the text rather than principles of causation in interpreting the amended section 8.
In Sanofi-Aventis / ramipril 2011 FCA 149 Dawson JA, in a brief decision from the bench for herself and Noël JA, affirmed the FCA’s holding in Merck Frosst Canada Ltd v Apotex Inc / alendronate (NOC) 2009 FCA 187 that section 8 of the NOC regulations does not permit recovery of losses – in particular loss of market share – suffered after the expiry of the statutory stay, even if those losses were caused by the stay. Sharlow JA in dissent was of the view that Merck Frosst was wrongly decided [14], while the majority felt it should not be disturbed [5]. (Note that Noël JA wrote for the Court in Merck Frosst.)
Sharlow JA dissented on the basis that “[t]he damages contemplated by section 8 are intended to be analogous to the undertaking a party is normally required to offer when seeking an interlocutory injunction in ordinary commercial litigation,” and “an undertaking in damages is normally broad enough to cover all losses resulting from the injunction” [12]. There is a great deal to be said for Sharlow JA’s position as a matter of principle. On the other hand, while section 8 is analogous to an undertaking, it is not one. The rights of the second person are defined by the regulations, and, as the various RIASes make clear, the scheme as a whole is intended to "balance" enforcement of patent rights with encouragement of generic entry. Thus while Sharlow JA at [14] criticized as a "narrow" and "literal" interpretation of the relevant provision in Merck Frosst, it is quite reasonable to suppose that an interpretation which is in some ways unprincipled may be required to give effect to the precise balance sought by the legislature. This was in effect the position taken by the FCA in Merck Frosst at [101-102] in having regard primarily to the text rather than principles of causation in interpreting the amended section 8.
Wednesday, May 11, 2011
Guidance for Pleading Early Infringement
Apotex Inc v Allergan Inc / gatifloxacin 2011 FCA 134
Pharmaceutical patentees view damages as a poor substitute for a permanent injunction, and are therefore anxious to bring an action against a generic producer as soon as possible. The question of what acts constitute infringement, or are sufficient to support a quia timet action, are therefore important. The FCA decision in Allergan, affirming a decision of Beaudry J refusing to strike Allergan’s statement of claim, helps to fill in this picture.
Pharmaceutical patentees view damages as a poor substitute for a permanent injunction, and are therefore anxious to bring an action against a generic producer as soon as possible. The question of what acts constitute infringement, or are sufficient to support a quia timet action, are therefore important. The FCA decision in Allergan, affirming a decision of Beaudry J refusing to strike Allergan’s statement of claim, helps to fill in this picture.
The Federal Courts have consistently been unwilling to allow an infringement action to be brought simply on the basis that the generic has applied for or obtained an NOC. In Allergan the Court of Appeal stated that “the mere fact that a defendant pharmaceutical company has sought regulatory approval to market a medicine does not by itself support an action for patent infringement” [4]. This point had not previously been settled (see AstraZeneca 2010 FCA 112 [8-9], affm’g 2009 FC 1209), and while this statement was strictly obiter, it is consistent with the thrust of the prior case-law. The point must now be considered settled.
However, in Allergan the patentee did not rely on the generic having obtained an NOC. Rather, the main thrust of its allegations was that Apotex had obtained a tentative approval for a US ANDA, and that the ANDA indicated that Apotex had made infringing product in Canada, and that it had and intended to import infringing product into Canada for formulation and export to the US: see the decision appealed from, T-1267, 9 Nov 2010. Consequently, it was not a quia timet action at all: “[t]he claims of past and continuing infringement support the claim of future continuing infringement” [14].
This point is not directly relevant to the paradigmatic case in which the patentee seeks to prevent manufacture and sale into the Canadian market. Of more general interest is the holding respecting particularity of the pleading. The courts have consistently been unwilling to allow an action based on a bald general allegation of infringement, on the basis that an action cannot be allowed to serve as a fishing expedition: the leading case is AstraZeneca (see esp. 2009 FC 1209 [17]) and see Eli Lilly / olanzapine 2011 FC 255 [8-9], also striking the statement of claim. The particulars pleaded in Allergan did go beyond those pleaded in either AstraZeneca or Eli Lilly, and the FCA held at [8] that it was reasonably open to the trial judge to hold that they were adequate. Thus we now have case-law on both side of the line separating adequate from inadequate pleading of material facts.
In Allergan Apotex also argued that Allergan’s statement of claim should be struck on the basis that the regulatory use exception of s. 55.2(1) applies, as in Eli Lilly. However, as the FCA pointed out [12-13], Allergan is distinguishable as in Eli Lilly “there is absolutely nothing pleaded that is not part of the regulatory requirements” (2011 FC 255 [28]), while in Allergan the allegations clearly went beyond those requirements. The FCA also stated that “the existence of even a strong defence to a claim does not justify an order striking the claim” [9]. This is not entirely easy to reconcile with Eli Lilly, but in any event, the FCA relied mainly on the differences in the allegations.
Subscribe to:
Posts (Atom)