In The Matter of ratiopharm Inc. and the medicine “ratio-Salbutamol HFA”

Drug: ratio-Salbutamol HFA  

ratio-Salbutamol HFA is an authorized generic version of VENTOLIN HFA, sold in Canada by GSK. ratio-Salbutamol HFA was manufactured, packaged and labelled by GSK, and sold to ratiopharm for sale by ratiopharm. A Panel of the Patented Medicines Prices Review Board (Panel) was considering whether ratio-Salbutamol HFA was sold at an excessive price. The Panel held that the definition of a "patentee" at section 79(1) of the Patent Act includes a license holder who has an exclusive license to promote, market and sell the medicine in Canada.

The Panel further commented on the appropriateness of deductions of rebates when the patentee files Form 2s. Although the Panel declined to rule on the scope of a 2009 decision relating to Pfizer, it did comment in obiter that it is appropriate to take into account the "business reality of the pharmaceutical industry" in calculating the true price of patented medicines. Therefore, it signaled a willingness to allow deductions of rebates to third parties consistent with the Board's Communiqué. However, it declined to do so in this case, given that the evidence tendered by ratiopharm was not substantively sufficient and credible. Therefore, there is an onus on the respondent to prove the reasonableness of any deductions it makes.

The Panel also reiterated that Board Staff bear the onus of proving that it is appropriate to apply the Guidelines in any given case. In this case, the Panel found that it was appropriate to apply the Guidelines and the calculation of excessive revenues arising from the sales of ratio-Salbutamol HFA should be based on the tests set out in these Guidelines.