Industry committee  Certainly, there were a number of safeguards built into the Patent Act to ensure that the regime would be used and applied in accordance with the WTO decision and the objectives by which it was implemented in Canada. Bill C-393 does remove a number of those amendments. I'm not going to go through it now that we've had various changes and amendments, but Bill C-393 does remove a number of those safeguards.

Industry committee  Section 21.16 of the Patent Act presently describes the obligation on the authorization holder to provide the patentee or patentees, as the case may be—and it was that case in the Apotex example—as well as the Commissioner of Patents with a copy of the agreement. So once the agreement is signed with an importing country or user to supply a particular drug to a particular country, that's the obligation that appears.

Industry committee  I'm sorry. I was just simply going to add to that point that, as has been mentioned before, throughout this regime it tries to ensure that the drugs are not exported for commercial purposes. So again, providing this kind of information as part of providing an obligation on the authorization holder to provide a copy of the agreement, when signed, to the patentee and to the importing countries, helps ensure that there is transparency, but also that there are measures in place to ensure the regime is not used for commercial purposes, which would be contrary to the objectives of the WTO decision.

Industry committee  That's right. The key provision on duration is clause 9. Clause 10 deals only with the renewal. If there is no limit on duration as a result of clause 9, then there is no consequence for clause 10.

Industry committee  I'm sorry. Can you repeat the question? I apologize, but I didn't hear the front end of that question.

Industry committee  It dilutes them less than would be the case if there were no time limit on export, because the WTO decision and CAMR in turn provide opportunities for a generic version of patented products to be made. These are protected products in Canada that will be made and sent to other countries.

Industry committee  I think patentees would have that concern, certainly.

Industry committee  Yes.

Industry committee  It's in clause 10 of the bill, which speaks to the renewal of the authorization under CAMR. So yes, there would be the possibility, if the need were identified, that the authorization under CAMR could be extended for another two years to deal with any circumstances that may arise.

Industry committee  Right, it's clause 10, which deals with section 21.12 of the Patent Act. Clause 9 deals with section 21.09 of the Patent Act and clause 10 deals with section 21.12.

Industry committee  Yes, if you read clauses 9 and 10 of Bill C-393 together, they would allow a CAMR authorization holder to produce and export the drugs authorized in the application indefinitely. That is the consequence of clauses 9 and 10 read together, because there would be no limit to the duration of a CAMR authorization and no need for renewal because it would be indefinite.

Industry committee  If clause 9 were struck down? Is that what you're suggesting?

Industry committee  If clause 9 were struck down.... I'll just take a look at it.

Industry committee  If clause 9 carries, then the licence is indefinite, because there is no limit to the duration of the licence. Clause 9 is the provision in the Patent Act that deals with the original duration of a CAMR authorization. Section 21.12 only deals with the renewal, in the circumstances that it is needed, but section 21.09 is the original provision that deals with the original duration of the licence.

Industry committee  That's my understanding. Yes.