Novartis Pharmaceuticals Canada Inc. v. Teva Canada Ltd. et al., 2015 FC 770

• Judge: O'Reilly, J.
• Court: Federal Court (Canada)
• Case Date: March 30, 2015
• Jurisdiction: Canada (Federal)
• Citations: 2015 FC 770;(2015), 483 F.T.R. 121 (FC)

Novartis Pharmaceuticals v. Teva Can. (2015), 483 F.T.R. 121 (FC)

MLB headnote and full text

Temp. Cite: [2015] F.T.R. TBEd. JL.008

Novartis Pharmaceuticals Canada Inc. (applicant) v. Teva Canada Limited and Minister of Health (respondents) and Novartis AG (respondent/patentee)

(T-1095-13; 2015 FC 770)

Indexed As: Novartis Pharmaceuticals Canada Inc. v. Teva Canada Ltd. et al.

Federal Court

O'Reilly, J.

June 19, 2015.

Summary:

Novartis Pharmaceuticals Canada Inc. sought an order prohibiting the Minister of Health from granting Teva Canada Ltd. a Notice of Compliance (NOC) which would permit Teva to market a generic version of Novartis's patented product called EXJADE. EXJADE contained an active ingredient called deferasirox (DFS) which acted as an iron chelator (i.e., it bound to iron, and could therefore be used to treat conditions that involved an excess of iron). Novartis's patent was filed in 1997 and would expire on June 24, 2017. The patent covered DFS and other similar compounds, as well as their use in treating conditions involving excess iron.

The Federal Court allowed the application and granted an order prohibiting the Minister of Health from issuing an NOC to Teva, with costs.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of allegation (NOA) - Novartis sought an order prohibiting the Minister of Health from granting Teva a Notice of Compliance (NOC) which would permit Teva to market a generic version of Novartis's patented product called EXJADE - EXJADE contained an active ingredient called deferasirox (DFS) which acted as an iron chelator (i.e., it bound to iron, and could therefore be used to treat conditions that involved excess iron) - Novartis's patent ('951 patent) was filed in 1997 and would expire on June 24, 2017 - The patent covered DFS and other similar compounds, as well as their use in treating conditions involving excess iron - The Federal Court granted the application - The court stated that "I am satisfied that most of Teva's allegations are unjustified. In particular, with respect to utility, I am not persuaded by Teva's allegation that the '951 patent expresses an explicit and overarching promise that the compounds described in it have been found to be useful in treating iron overload disorders in humans. In fact, the stated utility of the novel compounds of the '951 patent is more modest - that the compounds markedly bind to iron, are soluble, and induce excretion of iron in animal tests. On the other hand, I accept Teva's assertion that the claims of the '951 patent relating to the use of the compounds of the patent to reduce iron overload conditions in humans do contain an explicit promise of a specific result, one which was neither demonstrated nor soundly predictable at the filing date (June 24, 1997). Accordingly, Teva's allegation of inutility in respect of the use claims of the patent is justified, but not its parallel allegation in respect of the novel compounds of the '951 patent." - See paragraphs 3 and 36 to 42.

Patents of Invention - Topic 1006

The specification and claim - General - Interpretation of - [See Food and Drug Control - Topic 1105 ].

Patents of Invention - Topic 1582

Grounds of invalidity - Lack of inventive ingenuity (obviousness) - Test for obviousness - The Federal Court stated that "The test for obviousness is well-settled (Apotex v Sanofi-Synthelabo Canada, 2008 SCC 61, [2008] 3 SCR 265 at para 67). It involves a comparison between the state of the art and common general knowledge of the skilled person, on the one hand, and the inventive concept of the patent's claims, on the other. If there is no difference between the two comparators, the claims are obvious. If there is a difference, the claims are obvious if the skilled person would not need to take any inventive steps to bridge the gap. In pharmaceutical cases, it will often be useful also to consider whether the steps taken by the inventors were 'obvious to try'. Relevant factors to take into account would include: whether there was a motive to find the solution that the patent teaches; whether it was more or less self-evident that the steps taken would work; and whether routine trials were carried out, as opposed to prolonged and arduous experimentation." - See paragraph 46.

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - Novartis sought an order prohibiting the Minister of Health from granting Teva a Notice of Compliance (NOC) which would permit Teva to market a generic version of Novartis's patented product called EXJADE - EXJADE contained an active ingredient called deferasirox (DFS) which acted as an iron chelator (i.e., it bound to iron, and could therefore be used to treat conditions that involved excess iron) - Novartis's patent ('951 patent) was filed in 1997 and would expire on June 24, 2017 - The patent covered DFS and other similar compounds, as well as their use in treating conditions involving excess iron - The Federal Court was not satisfied that Teva's allegations of obviousness and insufficiency were justified - "Considering the state of the art and the common general knowledge of the skilled person at the filing date, the novel compounds of the '951 patent were not obvious. Further, Novartis has not, as Teva contends, hidden the real invention by failing to identify DFS as the compound that would ultimately make it onto the market. In my view, Novartis sufficiently disclosed its invention by identifying 30 compounds that displayed the useful properties described in the patent - binding to iron, solubility, and inducing excretion." - See paragraphs 4 and 43 to 55.

Patents of Invention - Topic 1593

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Prior art - [See Patents of Invention - Topic 1589 ].

Patents of Invention - Topic 1721

Grounds of invalidity - Lack of utility and operability - General - The Federal Court stated that "Generally speaking, the utility requirement represents a fairly low threshold. The exception is where the inventors explicitly promise a specific result, particularly if the stated utility is set out in the claims as opposed to the disclosure. An explicit promise set out in the disclosure can apply to all claims but, at the same time, it may be appropriate to distinguish between the promise of the compound claims, on the one hand, and the promise of the use claims, on the other (Apotex Inc v Pfizer Canada Inc, 2014 FCA 250 at paras 64, 65, 71, 77, 87, 88)." - See paragraph 34.

Patents of Invention - Topic 1723

Grounds of invalidity - Lack of utility and operability - Chemical products and substances intended for food and medicine (incl. selection patents) - [See Food and Drug Control - Topic 1105 ].

Patents of Invention - Topic 1725

Grounds of invalidity - Lack of utility and operability - Particular patents - [See Food and Drug Control - Topic 1105 ].

Patents of Invention - Topic 1779

Grounds of invalidity - Insufficiency - Particular cases - [See Patents of Invention - Topic 1589 ].

Cases Noticed:

AstraZeneca Canada Inc. et al. v. Apotex Inc. et al. (2014), 457 F.T.R. 227; 2014 FC 638, refd to. [para. 31].

Allergan Inc. et al. v. Canada (Minister of Health) et al., [2015] N.R. Uned. 127; 2015 FCA 137, refd to. [para. 32].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2014), 465 N.R. 306; 2014 FCA 250, refd to. [para. 34].

Sanofi-Synthelabo Canada Inc. et al. v. Apotex Inc. et al., [2008] 3 S.C.R. 265; 381 N.R. 125; 2008 SCC 61, refd to. [para. 46].

Wenzel Downhole Tools Ltd. et al. v. National-Oilwell Canada Ltd. et al., [2014] 2 F.C. 459; 443 N.R. 173; 2012 FCA 333, refd to. [para. 53].

Dow Chemical Co. et al. v. NOVA Chemicals Corp. (2014), 462 F.T.R. 222; 2014 FC 844, refd to. [para. 53].

Eurocopter v. Bell Helicopter Textron Canada Ltd. et al. (2012), 404 F.T.R. 193; 2012 FC 113, affd. (2013), 449 N.R. 111; 2013 FCA 219, refd to. [para. 53].

Eli Lilly & Co. et al. v. Apotex Inc. (2009), 351 F.T.R. 1; 2009 FC 991, refd to. [para. 53].

Takeda Canada Inc. et al. v. Canada (Minister of Health) et al. (2015), 480 F.T.R. 82; 2015 FC 570, refd to. [para. 55].

Counsel:

Anthony Creber and Alex Gloor, for the applicant;

David Aitken and Scott Beeser, for the respondent, Teva Canada Limited;

Unrepresented, for the respondent, Minister of Health;

Unrepresented, for the respondent/patentee.

Solicitors of Record:

Gowling Lafleur Henderson, LLP, Lawyers, Patent and Trade-mark Agents, Ottawa, Ontario, for the applicant;

Aitken Klee, LLP, Ottawa, Ontario, for the respondent, Teva Canada Limited;

William F. Pentney, Deputy Attorney General of Canada, Ottawa, Ontario, for the respondent, Minister of Health;

Gowling Lafleur Henderson, LLP, Ottawa, Ontario, for the respondent/patentee.

This application was heard at Ottawa, Ontario, on March 30, 2015, by O'Reilly, J., of the Federal Court, who delivered the following decision on June 19, 2015.