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Industry committee  Mr. Masse is correct. Currently, section 21.09 of the Patent Act states that a CAMR authorization is valid for two years from the date of the grant. That was reflective of several WTO requirements in the decision, including paragraph 2(c) of the waiver, which requires a country t

November 1st, 2010Committee meeting

Mona Frendo

Industry committee  When CAMR was developed and reviewed by Parliament, there was testimony by several pharmaceutical manufacturing companies that the duration of the average pharmaceutical supply contract was two years, so that was taken into consideration. There was also the interest in making s

November 1st, 2010Committee meeting

Mona Frendo

Industry committee  I'm sorry. Could you repeat the question for me, please?

November 1st, 2010Committee meeting

Mona Frendo

Industry committee  I guess we're dealing with the hypothetical, because it didn't happen in the Apotex example.

November 1st, 2010Committee meeting

Mona Frendo

Industry committee  If we use that as an example, Apotex had already gone through the approval process with Health Canada for that particular drug; that was met. When it applied for the first time for its authorization under CAMR, it took less than two weeks for the Commissioner of Patents to issue

November 1st, 2010Committee meeting

Mona Frendo

Industry committee  I'm sorry. I meant section 21.05. Clause 5 of Bill C-393 would change the current provisions in section 21.05 of the Patent Act by deleting all the references to quantity. It would also add a new proposed section, 21.051, that would put the onus on the authorization holder—the

November 1st, 2010Committee meeting

Mona Frendo

Industry committee  I'm sorry. I didn't hear you.

November 1st, 2010Committee meeting

Mona Frendo

Industry committee  Currently it's the Minister of Health who would verify that the labelling requirements, which are a WTO requirement, are met. That's currently in section 21.04 of the Patent Act.

November 1st, 2010Committee meeting

Mona Frendo

Industry committee  Perhaps I'll start, and then others can respond. As I mentioned earlier on the WTO waiver decision, in light of the concern that there was a need in developing countries but that there was this existing international intellectual property obligation system in place and the mode

November 1st, 2010Committee meeting

Mona Frendo

Industry committee  Section 21.05 of the Patent Act presently states that the quantity of the pharmaceutical product that can be authorized for export--so that's manufactured and sent--to an importing country, may not be more than the amount that the importing country stated in its notification. Aga

November 1st, 2010Committee meeting

Mona Frendo

Industry committee  Are we talking about the Liberal amendment?

November 1st, 2010Committee meeting

Mona Frendo

Industry committee  No. As I understand it, that's simply a technical amendment that references schedule 2. So the country list would be referred to as schedule 2 rather than schedules 2, 3 and 4. That doesn't deal with the authorization—

November 1st, 2010Committee meeting

Mona Frendo

Industry committee  No, it does not.

November 1st, 2010Committee meeting

Mona Frendo

Industry committee  That subsection states that the Commissioner of Patents “shall...authorize the person to make, construct and use a patented invention solely for the purposes directly related to the manufacture of the pharmaceutical product named in the application”. So it ties the authorization

November 1st, 2010Committee meeting

Mona Frendo

Industry committee  Tying the authorization is important because this mechanism, the WTO decision that CAMR is based on and that Canada adopted, was carefully defined and limited. It was not intended to be a broad-based infringement of existing intellectual property rights, but in the circumstance

November 1st, 2010Committee meeting

Mona Frendo