Federal Court - Novartis Pharmaceuticals Canada Inc. v. Teva Canada Limited
Date: 2013 0319
Citation: 2013 FC 283
Toronto , Ontario , March 19 , 2013
PRESENT: The Honourable Mr. Justice Hughes
| || NOVARTIS PHARMACEUTICALS CANADAINC.
| || Applicant
| TEVA CANADA LIMITED andTHE MINISTER OF HEALTH
| || Respondents
| || and
| || NOVARTIS AG andBOEHRINGER MANNHEIM GmbH
| || || Respondent Patentees
| || || |
| || NOVARTIS PHARMACEUTICALSCANADA INC.
| || || Applicant
| || and
| || TEVA CANADA LIMITED andTHE MINISTER OF HEALTH
| || || Respondents
| || and
| || NOVARTIS AG andROCHE DIAGNOSTICS GmbH
| || || Respondent Patentees
REASONS FOR JUDGMENT AND JUDGMENT
 These reasons are common to two applications each brought by Novartis Pharmaceuticals Canada Inc. under the provisions of the Patented Medicines (Notice of Compliance) Regulations SOR/93-133 as amended ( NOC Regulations ). In each application, Novartis seeks to restrain the Minister of Health from issuing a Notice of Compliance to Teva Canada Limited; in one application it is in respect of 4 mg/5 ml strength of zoledronic acid IV infusion (T-1420-11) and in the other it is in respect of 5 mg/100 ml strength of zoledronic acid IV infusion (T-288-12) until the expiry of each of Canadian Letters Patent No. 1,338,895 and 1,338,937. The issues in each application are those of validity of those two patents. Infringement is not an issue in either application. Thus, the two applications proceeded on common evidence and argument and were heard together.
 For the reasons that follow, I find that Teva’s allegations with respect to invalidity, on the basis of inutility and lack of sufficiency of the ‘895 patent, claim 14 to be justified thus the application is dismissed with respect to that patent. I find that Teva’s allegations with respect to invalidity of the ‘937 patent are not justified thus the application will be allowed in respect of that patent. The Applicant is entitled to half of its costs at the middle of Column IV.
 The following is an Index to these Reasons by paragraph number:
| THE PARTIES
|| Paras 4 to 7
| THE '895 PATENT GENERALLY
|| Paras 8 to 12
| THE '937 PATENT GENERALLY
|| Paras 13 to 17
| THE EVIDENCE
|| Paras 18 to 23
|| Paras 24 to 27
| BURDEN OF PROOF
|| Para 28
| PERSON SKILLED IN THE ART
|| Paras 29 to 34
| THE '895 PATENT IN DETAIL
|| Paras 35 to 55
| THE '895 PATENT – CLAIM 14
|| Paras 56 to 64
| THE '937 PATENT IN DETAIL
|| Paras 65 to 78
| THE '937 PATENT – CLAIMS 1 & 2
|| Paras 79 to 83
| BISPHOSPHONATES – TECHNICAL BACKGROUND
|| Paras 84 to 95
|| Paras 96 to 99
| TESTING FOR POTENCY
|| Para 100
| WHAT DID THE '895 INVENTORS DO?
|| Paras 101 to 103
| WHAT DID THE '937 INVENTORS DO?
|| Paras 104 to 107
| THE CONFLICT – AND RESULTING CLAIMS
|| Paras 108 to 113
|| Paras 114 to 116
| THE '895 PATENT - THE INVENTIVE CONCEPT
|| Paras 117 to 119
| THE '937 PATENT - THE INVENTIVE CONCEPT
|| Paras 120 to 138
| DATE OF THE INVENTION - '895 PATENT
|| Paras 139 to 142
| DATE OF THE INVENTION - '937 PATENT
|| Paras 143 to 145
| WHAT WAS THE “COMMON GENERAL KNOWLEDGE” AND “STATE OF THE ART”
|| Paras 146 to 162
| LACK OF UTILITY – PLEADING
|| Para 163
| UTILITY – CLAIM 14 OF THE '895 PATENT
|| Paras 164 to 170
| LACK OF UTILITY – CLAIMS 1 & 2 OF THE '937 PATENT
|| Paras 171 to 172
| SUFFICIENCY – PLEADING
|| Para 173
| SUFFICIENCY – LEGAL PRINCIPLES
|| Paras 174 to 175
| SUFFICIENCY – DATE FOR DETERMINATION
|| Paras 176 to 189
| CONCLUSIONS AND COSTS
|| Paras 190 to 193
 The Applicant Novartis Pharmaceuticals Canada Inc. (Novartis) is the same in each application. It has listed each of the two patents at issue in accordance with the NOC Regulations and has itself obtained Notices of Compliance from the Minister of Health to sell a bone mechanism regulator product in Canada containing zoledronate as an active ingredient. Novartis is a “first person” as described in the NOC Regulations .
 The Respondent Teva Canada Limited (Teva) is a “second person” as so described in the NOC Regulations . It seeks to sell generic versions of Novartis’ drug. Application T-1420-11 deals with Teva’s intent to seek a Notice of Compliance to sell such a drug for administration by IV infusion in a 4 mg/5 ml dose and has served upon Novartis a Notice of Allegation dated July 20, 2011 in accordance with the NOC Regulations . Application T-288-12 deals with Teva’s intent to seek a Notice of Compliance to sell such a drug for administration by IV infusion in a 5 mg/100 ml dose and has served upon Novartis a Notice of Allegation dated December 23, 2011 in accordance with the NOC Regulations .
 The Respondent Minister of Health is charged with various duties under the NOC Regulations , including the issuance of a Notice of Compliance to a “second person”, such as Teva, in appropriate circumstances. The Minister took no active role in these proceedings.
 Novartis asserts, and Teva does not challenge, that Canadian Patent 1,338,895 is owned by the Respondent Boehringer Mannheim GmbH and that Canadian Patent 1,338,937 is owned by the Respondent Novartis AG. Neither of these entities took any active role in these proceedings.
THE '895 PATENT GENERALLY
 Canadian Letters Patent No. 1,338,895 (the '895 patent) resulted from an application filed with the Canadian Patent Office on July 29, 1987. Therefore, that patent is governed by the provisions of the “old” Patent Act, RSC 1985, c. P-4, applicable to patents, the application for which was filed in the Canadian Patent Office prior to October 1, 1989.
 The '895 patent claims priority from an application filed in the Federal Republic of Germany on August 1, 1986. This is the presumed “date of invention” upon which the issue of obviousness is to be determined provided that the priority document is in the evidence and supports the claimed invention. A different date of invention can also be proved by evidence as to what the inventors did.
 The '895 patent was issued and granted to Boehringer Mannheim GmbH on February 4, 1987. The patent is to be construed as of that date. The term of the patent is to be calculated as being seventeen (17) years from the date of grant; thus this patent’s term will expire February 4, 2014.
 The '895 patent names Elmar Bosies and Rudi Gall, both of the Federal Republic of Germany, as inventors. The record shows that Bosies is deceased and Gall is “fearful of death”; therefore, we have no evidence from the inventors in these proceedings.
 Only claim 14 of the ‘895 patent is at issue in these proceedings.
THE '937 PATENT GENERALLY
 Canadian Letters Patent No. 1,338,937 (the '937 patent) resulted from an application filed with the Canadian Patent Office on October 19, 1987. Therefore, that patent, like the '895 patent, is governed by the provisions of the “old” Patent Act , applicable to patents applied for in Canada before October 1, 1989.
 The '937 patent claims priority from an application filed with the Swiss Patent Office on November 21, 1986. This is the presumed “date of invention” upon which the issue of obviousness is to be determined based on the evidence as discussed with respect to the ‘895 patent.
 The '937 patent was issued and granted to Ciba-Geigy AG of Switzerland on February 25, 1997. The patent is to be construed as of that date. The term of the patent is to be calculated as being seventeen (17) years from that date; thus, this patent’s term will expire February 25, 2014.
 The '937 patent names Knut A. Jaeggi and Leo Widler, both of Switzerland, as inventors. One of them, Leo Widler, provided evidence in these proceedings.
 The '937 patent contains two (2) claims, claims 1 and 2, both of which are at issue in these proceedings.
 As is usual in these proceedings, the evidence took the form of affidavits, exhibits to affidavits, transcripts of cross-examination, and exhibits to cross-examination. The Court had no opportunity to see or hear the witnesses, or to observe their demeanour.
 The Applicants have filed the affidavits, with exhibits, of the following persons:
• Dr. Leo Widler : He is one of the named inventors of the '937 patent. He is a Senior Investigator, Global Discovery chemistry at the Novartis Research Institutes for Biomedical Research in Basel, Switzerland. He provided some history as to bisphosphonates generally, and particular history leading up to the '937 patent. He was cross-examined.
• Dr. Martin Knauer : of Bensheim Germany He is a Patent Attorney employed by Roche Diagnostics GmbH as Director and Senior Patent Counsel for patent conflicts. He filed two affidavits attaching as exhibits documents of Boehringer Mannheim (acquired by Roche) relating to developments leading to the '895 patent. He was cross-examined.
• Dr. Frank H. (Hal) Ebetino (expert) : of Blackrock, Ireland. He is a consultant in drug discovery and development with specific expertise in the bisphosphonate (BP) field. He is a Visiting Scholar at the University of Southern California, and a Visiting Research Professor at Queen’s University, Belfast. He worked with Proctor & Gamble in the early development of BPs. He provided a history of the development of generations of BPs. He dealt with arguments and evidence of Teva as to obviousness and sufficiency of the ''937 patent. He was cross-examined.
• Dr. Mark Lundy (expert) : of West Chester, Ohio. He is President of Osteoresearch LLC, a consulting firm for the pharmaceutical industry. He received a PhD I Biomedical Sciences from Albany Medical College and started his courses...