On September 30, 2013, Roy J. of the Federal Court released thorough Reasons regarding a novel case. The circumstances involved Hoffmann-La Roche’s Canadian Patent No. 2,103,324, which was filed on November 17, 1993 and was thus expiring on November 17, 2013. In an unprecedented application, Hoffman-La Roche (Roche) sought a declaration from the Court that the ‘324 Patent be amended or that a portion of the disclosure of the ‘324 Patent be stricken. The portion of the patent in question involved the use of the abbreviation “viz.” in the following paragraph:
USP 4,966,891 discloses precursors of 5-FU which are improved in the above mentioned aspect of bioconversion efficiency and toxicities. They are converted to 5′-deoxy-5-fluorocytidine (5′-DFCR) by acylamidases, to 5′-deoxy-5-fluorouridine (5′-DFUR) by cytidine deaminase, and then to 5-FU by pyrimidine nucleotide phosphorylase in vivo which is preferentially localized in the liver, small intestin and tumor tissues. During intensive studies on the pharmacokinetic profiles of the precursors of 5-FU, particularly of N4-(substituted-oxycarbonyl)-5′-deoxy-5-fluorocytidine derivatives, the inventors found that certain specific precursors are selectively converted into 5′-DFCR by an acylamidase isozyme that is preferentially located at the liver but not the other organs of humans, and exhibited more improved pharmacokinetic profiles than the other compounds tested. The further studies based on the above findings enabled the inventors of the present invention to identify that the specific N4-(substituted-oxycarbonyl)-5′-deoxy-5-fluorocytidine derivatives (hereinafter referred to as N4-(substituted-oxycarbonyl)-5′-DFCR) represented by the above mentioned general formula (I) have selectively improved pharmacokinetic profiles in monkeys, viz., 4 to 7 times higher maximum concentration (Cmax) of 5‘-DFUR and 4 times larger higher area under the curve (AUC) of 5‘-DFUR in blood than the other compounds, and less intestinal toxicity, and thus completed the present invention. [para.9]
Roche’s concern was that the use of “viz.” could lead to an allegation being made that the ‘324 Patent overstates the promised utility of all the claimed compounds. As noted by the Court, “viz.” is short for the Latin videlicet, which is most closely translated as “namely; that is to say”. Acknowledging that a more preferable term would have been “e.g.”, Roche argued that the data accurately disclosed would not support the use of “viz.”, as it overstates the case.
Accordingly, Roche decided to take a proactive approach, and applied to invoke subsection 53(2) of the Patent Act in order to correct a patent containing an involuntary error. The novelty in this case is that there is no adversarial party; that is, the patent is not actually being challenged by any party. Justice Roy delivers numerous reasons why subsection 53(2) cannot be recast in such a fashion. They can be summarized as follows:
- The Patent Act already contains two remedies for a patentee who wishes to amend its patent, namely:
- section 47, which allows the reissuing of a patent within four years of its date of issue; and
- section 48, which allows a patentee to disclaim parts of the patent that the patent does not claim to hold by virtue of the patent.
- When section 53 is read as a whole, it is clear that in order to qualify for the remedy envisioned in subsection 53(2), the patent must first fall under subsection 53(1). A proper reading of section 53 does not support subsection 53(2) being taken in isolation in order to fashion a remedy. Therefore, the ‘324 Patent would first have to be found void for either an untrue material allegation in the petition, or for an omission/addition wilfully made to mislead. Subsection 53(2) cannot be used to correct an involuntary error that would not cause the patent to be void.
- It is for Parliament to decide if a new remedy within the Patent Act should be fashioned, when its consequences could be “of a profound nature” [para. 45].
Roche has no remedy under section 47, as the four year limitation period has long since passed. The Court acknowledged this hurdle, but found that one cannot circumvent the clear limitation period provided in section 47 by asking the Court to adopt a novel reading of subsection 53(2) that was never intended by Parliament. With respect to section 48, Roche stated that the disclaimer remedy was “too drastic” [para. 22] given its particular circumstances. Notwithstanding, upon careful weighing of various policy considerations and legislative interpretation, the Court finds that in situations where an applicant seeks to proactively amend its patent on account of an involuntary error, subsection 53(2) is not an available remedy. The application was dismissed without costs.
A copy of the decision can be accessed here.