In the Matter of ratiopharm Inc.

Drugs: ratio-Omeprazole, ratio-Ketorolac, ratio-Brimonidine, ratio-Paroxetine, ratio-Cefuroxime, ratio-Lamotrigine, ratio-Acyclovir, ratio-Ramipril, ratio-Diltiazem, ratio-Simvastatin, ratio-Sertraline, ratio-Quetiapine, ratio-Fenofibrate and ratio-Tamsulosin

The main issue in this proceeding involved the definition of “patentee” as it pertains to the requirement to report to the Patented Medicines Prices Review Board (PMPRB). ratiopharm does not hold any patents. However, it is authorized to sell certain medicines in Canada by the holders of the patents. The Board held that ratiopharm must file Form I information with respect to twelve drugs at issue. Regarding two additional drugs, the Board ordered ratiopharm to produce further documentation.

The Board held that s. 79(1) of the Patent Act refers to both persons entitled to the benefit of the patent and to persons entitled to exercise rights in relation to the patent. In the case where the person entitled to the benefit of a patent grants another person the right to sell the medicine, that second person is entitled to exercise rights in relation to the patent regardless of whether the agreement between the parties disclaims the actual granting of patent rights. This exercise of rights is the ability to sell the medicine and arguably claim damages for infringement of the patent.

The Board held that the references to “medicine” in the Patent Act are clear and apply equally to patentees whether they be in the brand name pharmaceutical industry or the generic pharmaceutical industry.