Date: 19991025
Docket: T-809-99
BETWEEN:
AB HASSLE and ASTRA PHARMA INC.
Applicants
- and -
THE MINISTER OF NATIONAL HEALTH AND WELFARE,
GENPHARM INC. and
TAKEDA CHEMICAL INDUSTRIES, LTD.
Respondents
REASONS FOR ORDER AND ORDER
SHARLOW J.
[1] The respondent Genpharm Inc. has filed a submission under the Patented Medicines (Notice of Compliance) Regulations for a notice of compliance with respect to omeprazole capsules. That submission refers to a drug that is the subject of a number of patents held by the applicants AB Hassle and Astra Pharma Inc. (collectively, "Astra"), including patent number 1,292,693 (the "693 patent").
[2] By letter dated March 26, 1999 (the "Genpharm letter"), Genpharm notified Astra of a number of allegations relating to Astra"s patents. One allegation is that the 693 patent is invalid "due to anticipation and/or obviousness."
[3] As required by Regulation 5(3)(b), the Genpharm letter includes what is described as a detailed statement of the legal and factual basis for its allegation that the 693 patent is invalid. As part of the legal and factual basis, Genpharm states that:
| ... all claims of the 693 patent are either anticipated or obvious having regard to the prior art, including that listed and described below... |
[4] This statement is followed by a list of eleven documents. Five of the documents are patents. Six are scientific or technical articles. After the list of documents is an explanation of the allegation, referring to one of the listed patents and four of the listed articles.
[5] In response to the Genpharm letter, Astra commenced an application under Regulation 6(1) for an order prohibiting the issuance of a notice of compliance for omeprazole capsules. It is entitled to such an order if none of Genpharm's allegations are justified.
[6] Genpharm has supported its allegations with an affidavit of Dr. James Steven Rowe. That affidavit sets out a number of his opinions that are intended to support Genpharm's allegation of obviousness with respect to the 693 patent. Dr. Rowe's opinion refers to 28 documents, listed in Exhibit D to his affidavit. Eight of the documents are patents, and twenty are scientific or technical works, including articles, brochures and chapters from textbooks such as "The Theory and Practice of Industrial Pharmacy,"1 "Modern Pharmaceutics"2 and "Drugs and the Pharmaceutical Sciences."3 Of the 28 documents cited by Dr. Rowe, 25 are not listed in the Genpharm letter.
[7] Astra argues that each of the documents listed in the Genpharm letter is an allegation of fact, and seeks an order directing that at the hearing of Genpharm's application for prohibition, Genpharm be prohibited from referring to any documents that are not listed in the Genpharm letter. He relies on the cases that establish that a detailed statement of the legal and factual basis for an allegation cannot be amended to correct a failure to allege sufficient facts to prove the allegations: Hoffmann-La Roche Ltd. et al. v. Apotex Inc. et al. (1997), 72 C.P.R. (3d) 480 (F.C.T.D.), affirmed (1998) 234 N.R.8 (F.C.A.); Hoffmann-La Roche Ltd. et al. v. Minister of National Health and Welfare et al. (1996), 70 C.P.R. (3d) 206 (F.C.A.).
[8] Counsel for Genpharm argues that the documents in the list are not factual allegations, but merely a recitation of some of the evidence Genpharm would cite in support of the allegation of fact that there is prior art that renders the 693 patent invalid due to anticipation or obviousness. He argues that Genpharm is not attempting to add any new facts to its detailed statement. It is merely referring to additional documentation to prove the alleged facts as to the existence of prior art.
[9] A patent is invalid for anticipation if the invention was known to the public before the relevant time. Anticipation is a question of fact, the proof of which must be found in a single patent or other published work containing all of the information needed to produce the claimed invention without the exercise of any inventive skill.4
[10] A patent is invalid for obviousness if, given the state of the art and the common general knowledge as of the relevant date, a person skilled in the art would have come directly and without difficulty to the solution taught by the patent. Obviousness, like anticipation, is a question of fact, but the proof of obviousness must be derived from a consideration of the cumulative effect of the prior art as disclosed by any number of sources, including prior patents and technical and scientific publications.5
[11] In this case, while both anticipation and obviousness are alleged, Dr. Rowe's affidavit appears to be aimed primarily at obviousness. Given the nature of an allegation of obviousness, it seems likely that different experts in a particular art might approach the factual question of obviousness in different ways or by reference to different documents. Therefore, there may be merit to the argument of counsel for Genpharm that the documents referred to by Dr. Rowe are merely evidence of the state of the art at the relevant time which support the factual allegation of obviousness. While I appreciate that it was Genpharm's obligation to give a complete account of the facts on which it intends to rely in these proceedings, it seems to me unduly restrictive, at this preliminary stage, to preclude Genpharm's reliance on the 25 documents cited by Dr. Rowe in support of his opinion.
[12] However, this motion was necessarily argued without the benefit of a full explanation of Dr. Rowe's analysis. I find it impossible to determine from merely reading Dr. Rowe's affidavit whether Genpharm is adding a new factual basis for its allegation or merely expanding its body of evidence. That is a question that is best answered by the judge who hears Astra's application for prohibition.
[13] For these reasons, this application will be denied. Costs of this motion are deferred to the judge at the hearing.
"Karen R. Sharlow"
Judge
Toronto, Ontario
October 25, 1999
FEDERAL COURT OF CANADA
Names of Counsel and Solicitors of Record
| COURT NO: T-809-99 |
| STYLE OF CAUSE: AB HASSLE AND ASTRA PHARMA INC. |
| Applicants |
- and -
| THE MINISTER OF NATIONAL HEALTH AND WELFARE, GENPHARM INC. and TAKEDA CHEMICAL INDUSTRIES, LTD. |
Respondents
| DATE OF HEARING: MONDAY, OCTOBER 18, 1999 |
| PLACE OF HEARING: TORONTO, ONTARIO |
REASONS FOR ORDER
| AND ORDER BY: SHARLOW J. |
DATED: MONDAY, OCTOBER 25, 1999
APPEARANCES: Mr. Gunars A. Gaikis and
| Mr. Sheldon Hamilton |
For the Applicants
Mr. Roger R. Hughes
For the Respondent, Gen Pharm Inc.
SOLICITORS OF RECORD: Smart & Biggar
| Barristers & Solicitors |
| Box 111 |
| 1500-438 University Avenue |
| Toronto, Ontario |
| M5G 2K8 |
| For the Applicant |
| Sim, Hughes, Ashton & McKay |
| Barristers & Solicitors |
| 330 University Avenue, 6th Floor |
| Toronto, Ontario |
| M5G 1R7 |
For the Respondent, Genpharm Inc.
FEDERAL COURT OF CANADA
Date: 19991025
Docket: T-809-99
Between:
| AB HASSLE AND ASTRA PHARMA INC. |
| Applicants |
| - and - |
| THE MINISTER OF NATIONAL HEALTH AND WELFARE, GENPHARM INC. and TAKEDA CHEMICAL INDUSTRIES, LTD. |
Respondents
REASONS FOR ORDER
| AND ORDER |
__________________
1Lachman, Lieberman, Kanig, Lea and Febiger, Philadelphia, 198.6
2Banker and Rhodes, Marcel Dekker Inc., 1979.
4Imperial Tobacco Ltd. v. Rothmans, Benson & Hedges Inc. (1993), 47 C.P.R. (3d) 188 (F.C.A.), Beloit Canada Ltd. v. Valmet OY (1986), 64 N.R. 287 (F.C.A.)