Thursday, May 31, 2012

Constructing the “But For” World in Section 8 Damages

Teva Canada Ltd v Sanofi-Aventis Canada Inc / ramipril (s 8) 2012 FC 552 Snider J
Apotex Inc v Sanofi-Aventis Canada Inc / ramipril (s 8) 2012 FC 553 Snider J

Apart from the question of the compensable period, Teva / ramipril (s 8) and Apotex / ramipril (s 8) (discussed here and here) raised similar legal issues, and indeed similar factual issues, regarding the assessment of damages, as both cases turned on the construction of the hypothetical “but for” market for ramipril that would have obtained had the prohibition order not been granted. Common legal questions regarding the burden of proof, whether the generics could recover for lost off-label sales, and whether lost business value is recoverable, were also raised. Snider J’s analysis of the legal questions is the same in both cases, and the relevant discussion is often identical save to references to Teva or Apotex. For convenience, in this post I will cite paragraphs to the Teva decision, and refer Teva as the generic, except where there is a relevant difference, but it should be recognized that the same analysis is also provided in the Apotex decision.

Snider J assessed s 8 damages on the basis of the generally applicable principle of “but for” causation, which requires a comparison between the actual state of affairs and the court’s best assessment of what would have happened in the hypothetical world had the statutory stay not been triggered [5]. Generally, Snider J constructed the hypothetical world almost entirely as a matter of determining what would in fact have happened, without regard to various arguments that particular consequences should be ignored for policy purposes.

Wednesday, May 30, 2012

More Debate on the Compensable Period under Section 8

Apotex Inc v Sanofi-Aventis Canada Inc / ramipril (s 8) 2012 FC 553 Snider J

Yesterday’s post discussed the question of the start date of the compensable period for a s 8 claim in Teva / raimpril (s 8). Today’s post discusses the parallel question in Apotex / ramipril (s 8), in which both the start date and the end date were in dispute. Note that of the four dates to be determined in the two cases, only the end date in Teva was uncontroversial. Nor were any of the disputes easy to resolve; all raised significant legal questions relating interpretation of the Regulations. While the facts of both Teva / ramipril (s 8) and Apotex / ramipril (s 8) were unusual in certain respects, NOC litigation is very complex, and no doubt many cases are unusual in one way or another. That the first two cases to arrive at an assessment of s 8 damages have raised difficult issues of interpretation suggests that future litigation will continue to reveal uncertainty in the application of s 8 of the NOC Regulations. This is not to impugn the drafting; anticipating the future fact patterns is no easier for legislative drafters than it is for patent drafters.

Tuesday, May 29, 2012

Compensation Period in S 8 Action Cannot Begin Prior to Date of Statutory Stay

Teva Canada Ltd v Sanofi-Aventis Canada Inc / ramipril (s 8) 2012 FC 552 Snider J

I believe that the companion cases of Teva / ramipril (s 8) and Apotex / ramipril (s 8) 2012 FC 553 are the first s 8 cases to go all the way to the assessment of damages. Snider J's decisions establish a number of important points concerning the start date for the compensable period, the nature of the “but for” scenario which forms the basis for assessing damages, and the nature of the recoverable damages. Overall, Snider J’s approach can be summed up in one sentence: “I am being asked to assess damages as though no prohibition application had been brought.” [183]. That is, Snider J assessed s 8 damages on the basis of the generally applicable principle of “but for” causation, which requires a comparison between the actual state of affairs and the court’s best assessment of what would have happened in the hypothetical world had the “wrong” not occurred. The “wrong” in this context is the statutory stay triggered by the prohibition application; it is not Teva having been kept out of the market by the operation of the NOC Regulations as a whole. (I put “wrong” in quotations as there is no legal wrong in Sanofi having brought the prohibition application; I use the term to emphasize the parallel with the ordinary principles of but for causation of damages in tort law.) From that causal trigger, Snider J constructed the hypothetical world almost entirely as a matter of determining what would in fact have happened, without regard to various arguments that particular consequences should be ignored for policy purposes. The qualification to that strictly factual approach to constructing the “but for” scenario is that Snider J applied the rule, established in Merck Frosst Canada Ltd v Apotex Inc / alendronate (NOC) 2009 FCA 187, that losses caused by the stay, but incurred outside the compensable period, are not recoverable as a matter of law.

This post deals with the question of the start date of the compensable period (referred to by Snider J as the "Relevant Period) in Teva / ramipril (s 8). The parties agreed that the end date for the compensation period is 27 April 2007, when the application was dismissed. The NOC Regulations s 8(1)(b) do not allow for any discretion in this respect. But the parties disputed the appropriate start date. Section 8(1)(a) of the NOC Regulations provides that the start date for the compensation period is presumptively the date “on which a notice of compliance would have been issued in the absence of these Regulations,” unless the court concludes that another date is more appropriate.

Friday, May 25, 2012

Snider J Also Rejects Validity Attacks on Section 8

Teva v Sanofi; Apotex v Sanofi / ramipril (NOC) 2012 FC 551 Snider J

Validity attacks on s 8 of the NOC Regulations were raised by Sanofi in two separate actions before Snider J, in which Teva and Apotex are seeking to recover s 8 damages. The same arguments were raised before Hughes J by AstraZeneca in similar circumstances. By agreement of the parties, the validity arguments in all three cases were argued before Snider J and Hughes J together. As described in my previous post, Hughes J rejected these arguments. In her decision dealing with this point alone, Snider J has done the same. Snider J held that most of the validity attacks raised by Sanofi did not arise on the facts of the particular disputes. On the question of whether s 8 complies with TRIPS and NAFTA, Snider J adopted the reasons of Hughes J as her own [55].

Wednesday, May 23, 2012

Futile Attacks on Section 8 of the NOC Regulations

Apotex Inc v AstraZeneca Canada Inc / omeprazole (NOC) 2012 FC 559 Hughes J

In Apotex v AstraZeneca / omeprazole AstraZeneca attacked the validity of s 8 of the NOC Regulations on various grounds, which were all rejected by Hughes J. While the objections were framed phrased a number of ways, AstraZeneca had two basic complaints.

First, AstraZeneca in effect complained that it is being punished simply for invoking section 6 of the NOC regulations: [115]. The essential answer to this is that section 6 and section 8 are a package, and if AstraZeneca does not want to expose itself to section 8 liability, it should not seek to a stay: “In making a choice to list a patent and a choice to institute prohibition proceedings, that party must be mindful that, just as if it had given an undertaking in order to secure an  interlocutory injunction, it must make good the losses suffered by the other party should it fail to secure the prohibition Order” [58]. There is nothing unfair about this, since the automatic stay, like an interlocutory injunction, being decided on the basis of limited information, may wrongly interfere with the rights of the other party. The quid pro quo for the stay is that the patentee will be liable for that harm in the case the stay is “wrongly” triggered. It is worth remembering that the greater availability of interlocutory injunctions formalized in American Cyanamid emerged as a result of the practice of requiring an undertaking from the applicant to compensate the defendant if the defendant’s position was ultimately vindicated. When the applicant was not liable to compensate the defendant, the courts would require a much stronger showing on the merits before granting an interlocutory injunction.

The second basic complaint was that liability under s 8 strikes the wrong “balance” [94], [97]. But as Hughes J pointed out, “[i]t is for Parliament to provide for the appropriate weighing or balancing of interests in enacting the Patent Act, and for the Governor-in-Council to do likewise in promulgating the NOC Regulations. There is no independent ground for arguing that section 8 of the NOC Regulations is invalid, simply because it was not “balanced” in the view of one of the interested parties” [99].

Tuesday, May 22, 2012

Award under NOC Section 8 to Be Considered in Damages in Subsequent Infringement Action

Apotex Inc v AstraZeneca Canada Inc / omeprazole (NOC) 2012 FC 559 Hughes J

The automatic stay available to the patentee under s 7(1) of the NOC Regulations is analogous to an automatic interlocutory injunction, and s 8 damages available to the generic are analogous to damages on the undertaking normally required of an applicant who obtains such an injunction: 2008 FC 1185 [54]. One important difference is that while an interlocutory injunction is brought as part of the infringement action, NOC proceedings and an infringement action are entirely separate. This gives rise to a problem of coordinating remedies if the final decision is inconsistent with the “interlocutory” stage. It is now well-established that if the generic is unsuccessful in the NOC proceedings, it cannot claim damages under s 8 if the patent is subsequently held to be invalid (Apotex v Syntex / naproxen (NOC) 2010 FCA 155). This is even though a defendant would have been able to recover such losses on the undertaking if the NOC system did not exist, and an interlocutory injunction, rather than an automatic stay, had been granted to patentee.

This decision of Hughes J is an important development in addressing the converse problem: is the generic entitled to s 8 damages even if the patent is later held to be valid and infringed by the same generic in an infringement action? If an interlocutory injunction is granted, the defendant is entitled to damages on the undertaking only if it is subsequently successful in the action itself. The separation of the NOC proceeding from the infringement action implies that in contrast, a patentee will be liable to a generic which is successful in the NOC proceedings, even if the patent is subsequently held to be valid and infringed. The difficulty with this result is that the generic would be entitled to damages for having been kept out of a market which it had no right to enter, as a holding in an NOC proceeding does not have in rem effect.

Tuesday, May 15, 2012

Equitable Election Does Not Preclude a Section 8 Claim after Amalgamation

Teva Canada Limited v. Wyeth LLC, 2012 FCA 141 Sharlow JA: Dawson, Stratas JJA rev’g 2011 FC 1169 Hughes J

Wyeth entered into authorized generic agreement with Novopharm under which Wyeth licensed Novopharm to sell a generic version of a Wyeth drug. To protect Novopharm’s position as the authorized generic, Wyeth also agreed to make commercially reasonable efforts to enforce the patent against third parties. Ratiopharm then served an NOA on Wyeth. At Novopharm’s request pursuant to the agreement, Wyeth instituted NOC proceedings against Ratiopharm. Wyeth lost, and Ratiopharm brought a section 8 claim against Wyeth. Then, after Novopharm changed its name to Teva, Teva and Ratiopharm amalgamated. Teva is seeking to continue Ratiopharm’s section 8 claim against Wyeth, on the basis of the rule that an existing cause of action is unaffected by amalgamation.

In the decision under appeal, Hughes J held that in the circumstances the doctrine of equitable election precluded Teva from continuing the section 8 action. The FCA has now reversed, pointing out that Novopharm’s request that Wyeth institute proceedings against Ratiopharm, could not affect Ratiopharm’s right to section 8 damages [36]. In my view, this reasoning is sound. Neither Ratiopharm nor Novopharm ever elected between two inconsistent courses of action; any apparent inconsistency arose only subsequently, as a result of the amalgation. As I noted in my post on the decision under appeal, the result is not unfair to Wyeth, which is exposed to the same liability that it would have faced if Novopharm and Ratiopharm had not merged. There is no reason why that merger should confer a windfall on Wyeth.

A second question, not addressed by Hughes J given his decision on equitable election, was whether Wyeth was entitled to an order to the effect that Ratiopharm’s claim for section 8 damages, now continued by Teva, should be reduced to reflect gains realized by Novopharm, Teva’s other corporate predecessor, under its licence agreement with Wyeth [38]. Wyeth’s argument is that while in fact Novopharm had the generic market to itself, in the “but for” scenario which forms the basis for assessing Ratiopharm’s damages, Ratiopharm and Novopharm would have shared the market [40]-[41]. This means that Novopharm’s profits in the “but for” scenario would have been lower than they were in fact. If Ratiopharm’s damages are not adjusted to reflect this excess profit actually gained by Novopharm, then Teva will be in a better position than it would have been had the “but for” scenario actually taken place [43]. The FCA rejected this argument as well.

This conclusion is also seems to me to be correct. If Novopharm and Ratiopharm had not merged, Novopharm would have gained the same windfall, and this would not be any objection to Ratiopharm’s claim. Further, such a windall to Novopharm must have been contemplated by Wyeth, as the possibility of third party generic entry was expressly addressed in the agreement between them. Wyeth could have controlled that windfall by contract, for example by specifying that Novopharm would be bear a corresponding share of the liability for section 8 damages if Wyeth’s efforts to exclude third party entry were unsuccessful. On its face, the contract allocated the risk entirely to Wyeth; presumably as a consequence, Wyeth obtained a better royalty than if Novopharm had shared the risk. If Wyeth could now require Teva to offset the excess profits gained by Novopharm, it would in effect be doing an end-run around the contractual allocation of risk.

Monday, May 14, 2012

Relevance of Non-infringing Alternatives to Damages

Merck & Co, Inc v Apotex Inc / lovastatin 2012 FC 454 Rennie J*

This decision by Rennie J on a motion to strike is the first step in a potentially significant change in the law of damages. In the liability portion of this bifurcated action, Snider J found Apotex liable for infringement of Merck’s patent protecting a process for making lovastatin: 2012 FC 1265 (overview here). Merck sought an accounting, but was denied. This is a preliminary motion in the damages portion of the action, in which Apotex sought to amend its statement of defence to plead that it could have employed a non-infringing alternative process for producing Apo-Lovastatin. While the decision implies in places that this is raised as a complete defence, it is more precise to say that the non-infringing alternative should be considered in determining the hypothetical position that Apotex would have been in but for the infringement [12].

This plea was rejected by Prothonotary Aronovitch, in light of the decision of the House of Lords in United Horse-Shoe and Nail Co Ltd v Stewart Co (1888), 5 RPC 260 (HL), which explicitly held that the existence of a non-infringing alternative is irrelevant to the calculation of damages, and the acceptance of that decision in Domco (1986), 10 CPR (3d) 53 (FCTD) and Jay-Lor 2007 FC 358. Rennie J held that despite this authority, which was properly interpreted by the Prothonotary, Apotex’s position was an arguable claim which should be allowed to proceed to trial. He pointed out that there was some support for Apotex’s position in US law and that there were only two cases on point in Canadian law [24]. Most importantly, at [25]-[27] he accepted Apotex’s argument that the principle in United Horse Shoe was potentially subject to reassessment in light of the general principles of causation in calculation of monetary remedies stated by the SCC in Cadbury Schwepps v FBI Foods [1999] 1 SCR 142 and Canson Enterprises [1991] 3 SCR 534.

My view is that Rennie J was clearly correct in allowing this pleading to stand. As I argued in “A Remedial Benefit-Based Approach to the Innocent-User Problem in the Patenting of Higher Life Forms” (2004), 20 CIPR 79 at 93-95, the principle stated in United Horse Shoe is inconsistent with the “but for” approach to causation which has been invariably accepted by the SCC as the correct approach to all forms of monetary remedy. My article was relied on by the SCC in Monsanto Canada Inc. v. Schmeiser, 2004 SCC 34 [102] as stating the correct principle in respect of an accounting of profits, and, as I argued in the article, there is no difference in principle on this point between an accounting and damages. (I would also point out that Jay-Lor is not particularly strong authority on this point, as it was clear on the facts that the defendant could not have competed as effectively without infringing.)

*In my initial post I misidentified the judge as Zinn J, rather than Rennie J. My apologies.

Friday, May 11, 2012

A Purposive Interpretation of the Promise of the Patent

Astrazeneca Canada Inc v Mylan Pharmaceuticals ULC / anastrozole (NOC) 2012 FCA 109 Evans JA: Sharlow, Dawson JJA aff’g 2011 FC 1023 Rennie J

After the shocking decision in Pfizer v Apotex / latanoprost (NOC) 2011 FCA 236, blogged here, this brief decision of the FCA in Astrazeneca v Mylan / anastrozole (NOC), is the second FCA decision in a row to adopt a moderate approach to interpreting the promise of the patent, coming close on the heels of Mylan v Pfizer / donepezil (NOC) 2012 FCA 103 (blogged here). Whether this marks a trend, or a split in the Court, remains to be seen.

In the decision under appeal, blogged here, Rennie J developed a principled approach to construing the promise of the patent by considering text, context and purpose. While the FCA did not specifically hold that this approach was required, as Mylan did not contest Rennie J’s interpretive framework [21], the FCA decision considered much the same factors as did Rennie J, and in a similarly holistic fashion. This may be simply because Rennie J’s decision shaped the points argued on appeal, but nonetheless, in tenor the FCA decision provides an endorsement of Rennie J’s framework. The appeal turned primarily on the interpretation of a sentence stating that it is “a particular object of the present invention to provide” compounds with fewer undesirable side effects than a prior art compound, aminogluthethimide (AG) [8]. Mylan invited the Court to interpret this as being determinative of the promise. The Court rejected this “microscopic” approach to the promise as “misguided” [32]. This is in contrast to the latanoprost decision, 2011 FCA 236, in which a somewhat differently constituted panel (Sharlow JA was on both) focused microscopically on the fact that the claimed invention was intended to treat a chronic disease.

The FCA anastrozole decision also has some very interesting dicta that further suggests a principled shift in the approach to the promise of the patent. At the outset the Court noted that the invention met the minimum threshold required for utility, and was therefore patentable as of the filing date, unless the patent promised more than the required minimum [7]. The Court subsequently noted at [30] that

it is agreed that the 420 patent would be valid if it only claimed the compound anastrozole and its inhibitory effects on aromatase. It was thus unnecessary for the patent also to promise fewer side effects than AG. Even though tests, which AstraZeneca did not disclose, had been conducted showing that anastrozole was selective, a promise in the patent to this effect would be entirely gratuitous, and could only provide competitors with another basis for attacking its validity.

Similarly, at [37]

even if anastrozole would not be commercially or clinically useful if it produced no fewer side effects than AG, it is agreed that it was patentable as a novel and useful compound, and as an aromatase inhibitor. It would be rational to seek patent protection for anastrozole on this basis, in case it turned out to be selective. . .

This suggests, in effect, that if an inventor has in fact invented and disclosed a patentable invention, she should be presumed to want a valid patent for it. As I have argued elsewhere, this accords both with common sense, and with a purposive approach to patent interpretation. As the SCC has said, “the guiding principle” of purposive construction is that “where the language of the specification, upon a reasonable view of it, can be so read as to afford the inventor protection for that which he has actually in good faith invented, the court, as a rule, will endeavour to give effect to that construction." (Consolboard [1981] 1 SCR 504 at 521, quoting Western Electric v Baldwin Int’l Radio [1934] SCR 570 at 574). If taken to its logical conclusion, this implies that a patentee should never be presumed to promise more than the minimum scintilla of utility required to sustain a valid patent. If that presumption were determinative, the entire promise of the patent doctrine would collapse. However, that presumption of purpose is not determinative within the framework articulated by Rennie J, because text and context must also be considered. It is nonetheless a powerful point in favour of construing the promise of the patent minimally.

Thursday, May 10, 2012

Patent Listing Refused Though Generic Formulation Would Necessarily Infringe

Gilead Sciences Canada, Inc. v. Canada (Minister of Health) / COMPLERA 2012 FC 2 Mosley J

The purpose of the PM(NOC) Regulations is to provide a pharmaceutical patentee with what amounts to an automatic interlocutory injunction when faced with generic entry into the market: 2010 FCA 155 [36]. A crucial difference is that instead of the assessment of the likelihood of success on the merits that would be undertaken in an application for an interlocutory injunction, the trigger for the statutory stay is simply that the patent is listed against the drug on the Patent Register. There is nonetheless a functional parallel between these requirements. Likelihood of success in a patent action depends on likelihood of success on both validity and infringement. The fact that the patent has been examined and granted establishes some likelihood of success in respect of validity. The likelihood of success in respect of infringement, on the other hand, is determined by the criteria for listing the patent against the drug on the Register. As explained in the RIAS to the 2006 Amendments, under the original Regulations, as interpreted by the courts, the criteria for listing were too generous, with the consequence that a patent could be listed, and thus trigger the automatic stay, even though the patent might be irrelevant to the drug at issue. As I have discussed in a previous post, the FCA interpretation of the new Regulations has been very strict, but the results in those particular cases were arguably justifiable, as it was not clear on the facts that a generic version of the drug would necessarily infringe the patent in question. In the COMPLERA case Mosley J took the next step, and upheld the decision of the Minister of Health to refuse to list a patent which would necessarily be infringed by any generic version of COMPLERA. In my view, COMPLERA shows that the pendulum has now swung too far the other way.

The facts are relatively simple. COMPLERA is formulated with three medicinal ingredients: (1) tenofovir; (2) emtricitabine; and (3) rilpivirine [3]. The ‘475 patent at issue includes formulation and compound claims to tenofovir and emtricitabine in combination with a non-nucleoside reverse transcriptase inhibitor (NNRTI) [24]. Rilpivirine is an NNRTI [10]. None of this is contested. While Mosley J noted that rilpivirine is not expressly referenced in any of the claims “and can be included only by deductive reasoning because it falls within a named class” [28], the necessary deduction is purely a matter of logic. Thus it is perfectly clear that a generic form of COMPLERA would infringe the ‘475 patent. 

Mosley nonetheless held that the ‘475 patent cannot be listed, essentially because it does not claim a combination specifically naming rilpivirine. Mosley J explained that “[o]n a plain and ordinary reading of paragraph 4(2)(b), all of the ingredients in the NDS have to be found in the formulation in the claim” [47]. I agree with that interpretation of the Regulation, but I don't see how  it justifies the result, as it seems to me that all of the ingredients in the NDS, namely tenofovir, emtricitabine and rilpivirine, are indeed found in the formulation in the claim. The formulation lists an NNRTI, rather than rilpivirine specifically, but I fail to see why this matters. If I point at a shipping container and say that “a Volkswagen Golf, a Ford F150 pick-up truck, and a bicycle are found in this container,” then my statement is true if the container holds a Volkswagen Golf, a Ford F150 pick-up truck, and a Cervélo R5ca bicyle, notwithstanding that I used the generic term “bicycle” rather than specifying the make and model.

Nor is a requirement to specifically name the compound is sensible on a purposive interpretation. Suppose a patentee discloses and claims a revolutionary new class of drugs that cures cancer. As is commonly the case, the best species of the class may be developed afterwards, and so is not disclosed in the pioneer patent. Consequently, under the COMPLERA decision, the pioneer patent could not be listed. At the same time, there might be no patent at all claiming the species specifically, if, for example, it was the result of routine refinements that simply had not yet been carried out at the time of the pioneer patent.

The requirement of product specificity in listing patents on the register plays a parallel role to the requirement of a likelihood of success in seeking an interlocutory injunction. It is important to strike the right balance in so-called "product specificity" in order to ensure that the NOC Regulations provide adequate protection to a patentee, without allowing abuse by listing of irrelevant patents. The old Regulations, as interpreted, adopted an extreme position by allowing a patent to be listed even though it was irrelevant to the formulation in question, and so could not possibly be infringed by a generic version of the drug. The COMPLERA decision adopts another extreme position by refusing to list a patent that must necessarily be infringed by a generic version of the drug. A caveat is that it may be appropriate to refuse to list a patent that would necessarily infringe if the technical advance disclosed by the patent is too minor to warrant the protection of a statutory stay: this, presumably, is the policy behind the exclusion of different chemical forms from the definition of “claim for the medicinal ingredient” in s 2. But that caveat does not justify the COMPLERA decision, as is illustrated by my example of the blockbuster pioneer patent.

(Note that this decision was rendered in January of this year, but it was only recently made available on the FC website.)

Wednesday, May 9, 2012

Authorization under the Special Access Programme Is Not Previous Approval for the Purpose of the Data Protection Regulations

Teva Canada Limited v. Canada (Health) / ELOXATIN 2012 FCA 106 Stratas JA: Blais, Noël JJA aff’g 2011 FC 507 Campbell J

The main question in this appeal was whether widespread authorization for sale under the Special Access Programme of the Food and Drug Regulations means that a drug is not eligible for listing on the Register of Innovative Drugs. ELOXATIN had been sold by Sanofi from 1999 to 2005 under the Special Access Program, C.08.010(1) (SAP). 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 on the basis that authorization under the SAP meant that ELOXATIN was “previously approved” and so did not qualify for listing as an “innovative drug” under the definition in C.08.004.1(1).

Campbell J dismissed Teva’s application for judicial review of the Minister’s decision to list ELOXATIN (blogged here). The FCA has now affirmed, essentially for the same reasons given by Campbell J. First, “sales under the Special Access Programme alone are not evidence of a determination by the Minister of the safety and efficacy of a drug” [28]. Second, a test that looks at whether the Minister in fact had sufficient information to evaluate the safety and effectiveness of Eloxatin “creates lack of clarity and uncertainty” [30]. For this reason, the issuance of a notice of compliance and a drug identification number constitutes “the magic moment” of approval [31]. And third, the data protection regulations are intended to implement TRIPS and NAFTA, and those treaties imply that the approval in question is marketing approval, and in particular issuance of a notice of compliance and a drug information number [37].

While these reasons strike me as persuasive, there is some merit to Teva’s underlying complaint, which was that the authorization of ELOXATIN under the SAP was widespread, and the Minister had received “massive” amounts of information regarding ELOXATIN’s safety and efficacy [29]. In response Campbell J pointed out that “the SAP sales record proves nothing about oxaliplatin’s safety and effectiveness; it proves that many seriously ill people were willing to take the unapproved ELOXATIN in a hope of getting well” [FC 27]; and as the Stratas JA noted, a case by case inquiry looking beyond authorization itself, to the amount of information actually available to the Minister, would undermine the goals of clarity and certainty [32]. While I agree with both these observations, the result is potentially a kind of evergreening, if Sanofi can sell its product under the SAP and then get data protection once the patent has expired. This contrasts with the paradigmatic use of data protection, which is to provide some form of protection to a drug that is not patentable in the first place. If that is the real problem, then it would be better to respond, institutionally at least, by controlling the use of the SAP in the first place. I should emphasize that I am not suggesting that the SAP was in any way misused in this case, as that point was not in issue in this case. It may be that this was simply a case in which the SAP, properly used, nonetheless resulted in widespread authorization. In that case the lesson may be that the complex administrative structure for regulation and protection of drug products cannot deliver ideal results in all cases.

Tuesday, May 8, 2012

EWCA on Ex Turpi Causa

Les Laboratoires Servier v Apotex Inc [2012] EWCA Civ 593  rev'g [2011] EWHC 730 (Pat)

In earlier installments of the log-running perindopril saga, Servier obtained an interlocutory injunction preventing Apotex from marketing perindopril in the UK, on the basis of a European patent which was ultimately held to be invalid. Apotex sought damages on the undertaking, but Servier pointed out that the perindopril which would have been sold in the UK, but for the interlocutory injunction, would have been manufactured in Canada and would have infringed a valid Canadian patent. Arnold J, in a decision blogged here, held that ex turpi causa prevented Apotex from recovering damages on the undertaking  The EWCA has now reversed; but while Apotex will be able to claim on the undertaking, its damages will be reduced by the amount which Servier could recover under Canadian law for the infringing manufacture. My post on IPKat discusses the EWCA decision in more detail.