Date: 19991117
Docket: T-1266-99
BETWEEN:
NOVARTIS AG and
NOVARTIS PHARMACEUTICALS CANADA INC.
Applicants
- and -
APOTEX INC. and
THE MINISTER OF HEALTH
Respondents
REASONS FOR ORDER AND ORDER
BLAIS J.
[1] This is a motion for an order granting leave to the applicants to file further evidence within seven days of the date of this order.
[2] This proceeding was commenced in response to a notice of allegation dated May 28, 1999 in which the respondent Apotex Inc. alleged invalidity of Canadian Letters Patent 1,332,150.
[3] The applicants suggest that the notice of allegation referred to a large number of documents as being prior art which was relied on for the purposes of the alleged grounds of invalidity, namely anticipation, obviousness and claims being overly broad.
[4] On September 9, 1999, Novartis filed its evidence in support of the notice of application. In response to Apotex" allegations of invalidity, Novartis filed the affidavit of Dr. James W. McGinity, a Professor at the University of Texas at Austin and additional affidavits of Dr. Carl Stillers, Dr. Andreas Orfanos, Dr. Guy Rousseau and Nancy Gallinger. The only prior art which is dealt with by Dr. McGinity is that set out in Apotex" notice of allegation.
[5] In response to the affidavit of Dr. McGinity, Apotex has now filed the affidavits of Dr. Langer, Dr. Robinson and Dr. Sherman.
[6] The applicants suggest that the Langer affidavit raises new matters not previously raised in Apotex" notice of allegation, suggesting in particular, new issues of fact and law are contained in Apotex" affidavits that were never mentioned in the notice of allegation.
[7] The applicants suggest that Apotex has introduced for the first time 13 new prior art documents that are not referred to in the notice of allegation. These new documents are attached to the Langer affidavit as exhibits: 4, 7, 8, 9, 15, 18, 21, 23, 32, 33, 34, 35 and 36.
[8] The applicants suggest that these new prior art documents were never before raised in support of Apotex" allegation of invalidity.
[9] The respondent Apotex suggests that the documents referred to in the Langer affidavit, do not represent new matters or new issues of fact and law.
[10] The respondent particularly referred to Dr Langer"s affidavit at paragraph 25 where Dr Langer sworn that his "affidavit did not raise any new matters but, rather, simply provided, further illustrations and examples of matters already raised and discussed in Apotex" Notice of Allegation and the documents identified therein or a response to a matter raised in the Applicants" affidavit evidence".
[11] The respondent also pointed out that the applicants did not file an affidavit in response to Dr Langer"s affidavit or cross-examined Dr Langer on his affidavit.
[12] The respondent suggests that Dr Langer"s expert opinion is uncontradicted and in the circumstances is the only evidence of any probative value before the Court on this motion.
[13] Counsel for the respondent Apotex suggested that he should have the last word and be entitled to file evidence last.
[14] I have reviewed the affidavits in support of the originating notice of motion and the evidence filed by the respondent Apotex.
[15] I have read carefully the affidavit of Dr Robert Langer and particularly paragraph 5 wherein Dr Langer wrote:
| I considered it appropriate not only to comment on the specific documents referenced by Apotex in its Notice of Allegation but also to draw to the Court"s attention additional documents which I thought would be useful in considering the matters raised in Apotex" Notice of Allegation. |
[16] Also in paragraph 10:
| In rendering this opinion, I considered it helpful to provide some explanation of the word "emulsion" in the sense that the word is used in the "667 Patent. Accordingly, I made reference to three documents (exhibits 7, 8 and 9 to my previous Affidavit) which provide some explanation of the use of the word "emulsion". |
[17] Also in paragraph 11:
| Once again, these three additional documents do not raise any new matters but, rather, simply provide an explanation of the use of a word contained in the "667 Patent. The documents are perfectly consistent with and illustrative of the discussion already found on page 2 of the Notice of Allegation. |
[18] With all due respect, I am not convinced that those new documents did not raise any new matters. I am satisfied that the applicants could not anticipate the entire contents of the evidence, given in the detailed statement filed in the notice of allegation.
[19] I am of the opinion that the respondent Apotex had the responsibility to identify clearly in the notice of allegation the prior art it was referring to.
[20] For those reasons, the motion is granted.
[21] The applicants are allowed to file further evidence on or before November 24, 1999.
[22] Cross-examinations shall be completed on or before March 24, 2000.
[23] The applicants" record shall be filed and served on or before April 24, 2000.
[24] The respondents" record shall be filed and served on or before May 26, 2000.
[25] Costs in the cause.
Pierre Blais Judge
OTTAWA, ONTARIO
November 17, 1999