Eli Lilly Canada Inc. v. Apotex Inc. et al., 2010 FC 1065

• Judge: Barnes, J.
• Court: Federal Court (Canada)
• Case Date: October 29, 2010
• Jurisdiction: Canada (Federal)
• Citations: 2010 FC 1065;(2010), 377 F.T.R. 157 (FC)

Eli Lilly Can. Inc. v. Apotex Inc. (2010), 377 F.T.R. 157 (FC)

MLB headnote and full text

Temp. Cite: [2010] F.T.R. TBEd. NO.006

Eli Lilly Canada Inc. (applicant) v. Apotex Inc. and the Minister of Health (respondents) and Eli Lilly and Company (respondent/patentee)

(T-1565-08; 2010 FC 1065)

Indexed As: Eli Lilly Canada Inc. v. Apotex Inc. et al.

Federal Court

Barnes, J.

October 29, 2010.

Summary:

Eli Lilly Canada Inc. applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex Inc. until after the expiry of its patent (the '735 patent).

The Federal Court dismissed the application.

Courts - Topic 2286

Jurisdiction - Bars - Academic matters or moot issues - Eli Lilly Canada Inc. applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex Inc. until after the expiry of its patent (the '735 patent) - The '735 patent claimed the use of atomoxetine (formerly named tomoxetine) for treating attention-deficit hyperactivity disorder (ADHD) in adults, adolescents and children - Apotex alleged that the '735 patent was invalid on the grounds of, inter alia, anticipation, obviousness and lack of utility - The court rejected the allegations, holding that the '735 patent was valid - However, the '735 patent was declared invalid in unrelated proceedings - At issue was the proper disposition of the application having particular regard to the implications for a claim by Apotex to damages under s. 8 of the Patented Medicines (Notice of Compliance) Regulations - Eli Lilly was concerned that if it were to prevail on the merits of its application, it might still be exposed to s. 8 damages if its application was dismissed for mootness - It therefore proposed that the court either declare the Apotex allegations to be unjustified; terminate but not dismiss the application; or issue an order of prohibition - Apotex maintained that the only disposition available to the court was the dismissal of Eli Lilly's application - The Federal Court dismissed the application on the ground of mootness - The court was not convinced that any of the forms of relief proposed by Eli Lilly would be appropriate or even permitted - All that was decided in this instance was that none of Apotex's allegations were justified on the record, and that because of the intervening determination that the '735 patent was invalid, Eli Lilly's application had to be dismissed on the basis of mootness - See paragraphs 97 to 104.

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - Eli Lilly Canada Inc. applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex Inc. until after the expiry of its patent (the '735 patent) - The '735 patent claimed the use of atomoxetine (formerly named tomoxetine) for treating attention-deficit hyperactivity disorder (ADHD) in adults, adolescents and children - Apotex alleged that the '735 patent was invalid on the grounds of, inter alia, obviousness - Apotex's obviousness argument was premised on establishing that the tricyclic antidepressants or TCAs (particularly desipramine or DMI) which worked to treat ADHD did so "because of their inhibition of norepinephrine reuptake" - According to Apotex, because atomoxetine was known to be a highly selective norepinephrine reuptake inhibitor (NRI) a person skilled in the art would expect that it, too, would treat ADHD - The Federal Court rejected Apotex' allegation of invalidity based on obviousness - The essential problem with the Apotex evidence was that it did not establish that, in 1995, a person of skill would have understood that the blockade of norepinephrine reuptake was the mechanism of action responsible for treating ADHD - There was a theory linking norepinephrine to ADHD and some suggestion in the prior art that ADHD could be treated by increasing norepinephrine levels in the synaptic cleft - Nevertheless, Apotex's evidence was only sufficient to establish the existence of one unproven hypothesis sitting among of number of others - In the absence of evidence to establish that the successful ADHD drugs worked because of a common noradrenergic effect, the court did not accept that a person of skill in 1995 could have confidently predicted that atomoxetine would also work for that indication - The evidence for this proposition given by the Apotex witnesses rose only to the level of a possibility of efficacy which was not enough to establish obviousness - See paragraphs 33 to 62.

Patents of Invention - Topic 1593

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Prior art (incl. common general knowledge and mosaicing) - [See Patents of Invention - Topic 1589 ].

Patents of Invention - Topic 1603

Grounds of invalidity - Anticipation - By previously published article or patent - Eli Lilly Canada Inc. applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex Inc. until after the expiry of its patent (the '735 patent) - The '735 patent claimed the use of atomoxetine (formerly named tomoxetine) for treating attention-deficit hyperactivity disorder (ADHD) in adults, adolescents and children - Apotex alleged that the '735 patent was invalid on the grounds of, inter alia, anticipation by prior patent (the '009 patent) - The Federal Court rejected Apotex' allegation of invalidity based on anticipation - The person of skill looking at the '009 patent was trying to understand what it meant and in so doing would be influenced by the prior art - The court did not accept that such a person would equate the use of achieving a psychotropic effect in the '009 patent with the successful treatment of ADHD, particularly in the face of the other suggested uses for those compounds and considering what was known about the available ADHD treatment options at that time - In such a context a person following the teaching of the '009 patent would have no obvious reason to consider any of the compounds claimed as being useful ADHD drugs, let alone necessarily infringe by attempting to put them into use for that purpose - As the court understood Apotex's argument, the '009 patent would be anticipatory with respect to any subsequent claim to the use of any one of its compounds for any psychotropic indication - It was only in that context that one could conclude that by carrying out the teaching of the '009 patent an infringement of the '735 patent would necessarily occur - The court was not persuaded that the teaching of the '009 patent anticipated the inventive promise of the '735 patent - Even if one accepted that in assessing the '009 patent as anticipatory one should consider each compound as a separate invention, one would still have to make a decision to use atomoxetine to treat ADHD in the absence of any suggestion that it would work - See paragraphs 63 to 77.

Patents of Invention - Topic 1605

Grounds of invalidity - Anticipation - Particular patents - [See Patents of Invention - Topic 1603 ].

Patents of Invention - Topic 1653

Grounds of invalidity - Anticipation by prior patent - What constitutes anticipation - [See Patents of Invention - Topic 1603 ].

Patents of Invention - Topic 1723

Grounds of invalidity - Lack of utility and operability - Chemical products and substances intended for food and medicine - Eli Lilly Canada Inc. applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex Inc. until after the expiry of its patent (the '735 patent) - The '735 patent claimed the use of atomoxetine (formerly named tomoxetine) for treating attention-deficit hyperactivity disorder (ADHD) in adults, adolescents and children - Apotex alleged that the '735 patent was invalid on the grounds of, inter alia, lack of utility - The Federal Court rejected Apotex's allegation of invalidity based on lack of utility - Where a patentee maintained that it could demonstrate the utility of its invention, its disclosure obligation was limited to the provision of a full description of the invention and the means to work it - It was only where the patentee relied upon a sound prediction of utility that it was required to disclose in the patent both the factual data on which the prediction was based and the line of reasoning followed to support it - Eli Lilly asserted in its Notice of Application that it had "established by virtue of studies that atomoxetine was useful for the treatment of ADHD" - Because Eli Lilly was relying upon an assertion of demonstrated utility, it said that it carried no obligation to disclose the MGH Study or its findings in the '735 patent - In the result, Apotex's evidence pointing only to the absence of such evidence in the '735 patent would not be capable of rebutting the statutory presumption of validity - The court was accordingly bound on this record to reject Apotex's allegation of inutility because it had failed to satisfy its initial evidentiary burden - See paragraphs 78 to 96.

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - [See Patents of Invention - Topic 1723 ].

Patents of Invention - Topic 1725

Grounds of invalidity - Lack of utility and operability - Particular patents - [See Patents of Invention - Topic 1723 ].

Cases Noticed:

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2009), 346 F.T.R. 78; 75 C.P.R.(4th) 165; 2009 FC 320, folld. [para. 21].

Novopharm Ltd. v. Eli Lilly & Co. (2010), 376 F.T.R. 227; 2010 FC 915, consd. [para. 28].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2007), 361 N.R. 308; 59 C.P.R.(4th) 30; 2007 FCA 153, refd to. [para. 31].

Sanofi-Aventis Canada Inc. v. ratiopharm Inc. et al. (2010), 367 F.T.R. 307; 82 C.P.R.(4th) 414; 2010 FC 230, refd to. [para. 31].

Sanofi-Synthelabo Canada Inc. et al. v. Apotex Inc. et al. (2008), 381 N.R. 125; 69 C.P.R.(4th) 251; 2008 SCC 61, appld. [para. 33].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2009), 385 N.R. 148; 72 C.P.R.(4th) 141; 2009 FCA 8, refd to. [para. 35].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2008), 337 F.T.R. 17; 71 C.P.R.(4th) 237; 2008 FC 1359, refd to. [para. 63].

Calgon Carbon Corp. v. North Bay (City) et al. (2008), 375 N.R. 372; 64 C.P.R.(4th) 337; 2008 FCA 81, refd to. [para. 64].

Lundbeck Canada Inc. et al. v. ratiopharm Inc. et al. (2009), 357 F.T.R. 75; 79 C.P.R.(4th) 243; 2009 FC 1102, dist. [para. 71].

Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., [1981] 1 S.C.R. 504; 35 N.R. 390; 56 C.P.R.(2d) 145, refd to. [para. 79].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd. (2002), 296 N.R. 130; 21 C.P.R.(4th) 499; 2002 SCC 77, refd to. [para. 80].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2008), 377 N.R. 9; 67 C.P.R.(4th) 23; 2008 FCA 108, refd to. [para. 92].

Eli Lilly Canada Inc. v. Apotex Inc. et al., [2010] F.T.R. Uned. 895; 2010 FC 952, refd to. [para. 101].

Authors and Works Noticed:

Biederman, Joseph, et al., A Double-Blind Placebo Controlled Study of Desipramine in the Treatment of ADD: I (1989), 28(5) J. Am. Acad. Child Adolesc. Psychiatry 777, generally [para. 41, footnote 6]; p. 783 [paras. 51, 57].

Garfinkel, Barry, et al., Tricyclic Antidepressant and Methylphenidate Treatment of Attention Deficit Disorder in Children (1983), 22(4) J. Am. Acad. Child Adolesc. Psychiatry 343, p. 343 [para. 58].

Greenhill, L.L., Pharmacologic Treatment of Attention Deficit Hyperactivity Disorder (1992), 15(1) Psychiatr Clin North Am. 1, p. 5 [para. 59].

LaRosa, Angela, and Brown, Ronald T., Recent Developments in the Pharmacotherapy of Attention-Deficit/Hyperactivity Disorder (ADHD) (2002), 33(6) Professional Psychology, Research and Practise 591, pp. 592, 594 [para. 56].

Pliszka, S.R., et al., Catecholamines in Attention-Deficit Hyperactivity Disorder: Current Perspectives (1996), 35(3) J. Am. Acad. Child Adolesc. Psychiatry 264, p. 264 [para. 61].

Shenker, Andrew, The Mechanism of Action of Drugs Used to Treat Attention-Deficit Hyperactivity Disorder: Focus on Catecholamine Receptor Pharmacology (1992), 39 Adv. Pediatrics 337, generally [para. 54].

Wilens, Timothy, et al., Pharmacotherapy of Adult ADHD, in A Comprehensive Guide to Attention Deficit Disorder in Adults (1995), pp. 171 to 172 [para. 60].

Zametkin, Alan J., and Rapoport, Judith L., Neurobiology of Attention Deficit Disorder with Hyperactivity: Where Have We Come in 50 Years? (1987), 26(5) J. Am. Acad. Child Adolesc. Psychiatry 676, generally [para. 39, footnote 5].

Counsel:

Patrick Smith and Jane Clark, for the applicant;

Andrew Brodkin, Dino Clarizio and Miles Hastie, for the respondents.

Solicitors of Record:

Gowling Lafleur Henderson, LLP, Ottawa, Ontario, for the applicant;

Goodmans, LLP, Toronto, Ontario, for the respondents.

This application was heard on May 3-5 and 10, 2010, at Toronto, Ontario, by Barnes, J., of the Federal Court, who delivered the following judgment at Ottawa, Ontario, on October 29, 2010.