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Intellectual property - Patents - Medicines - Validity of patent - Anticipation - Application for order under the Patented Medicines (Notice of Compliance) Regulations to prohibit the Minister from issuing a notice of compliance to the Respondent for its clarithromycin tablets, until after the expiration of Applicants' patent - Whether a valid patent can be issued if the composition of matter claimed by the patent was inevitably made by following prior literature, even though the very existence of that composition of matter was unknown at the relevant time

The Applicants, a brand name pharmaceutical company, applied for an order prohibiting the Minister of Health from issuing a notice of compliance ("NOC") to the Respondent, Ratiopharm, for Ratiopharm's clarithromycin 250 mg or 500 mg tablets until after the expiry of six patents owned by Abbott. Abbott manufactures a drug called Biaxin Bid, in which the active medicinal ingredient is clarithromycin, an antibiotic used in the treatment of upper respiratory infections. Abbott markets its Biaxin Bid in 250 mg and 500 mg tablets pursuant to an NOC issued by the Minister. Ratiopharm applied for a NOC to market its own version of clarithromycin, based on a comparison of its product with Biaxin Bid. Abbott does not have a patent for clarithromycin, but has patents listed for Biaxin Bid for three forms of clarithromycin, which it has named Form 0, Form I and Form II. Ratiopharm's proposed clarithromycin product contains Form II. However, Form 0 is inevitably produced in the process of making both clarithromycin Form I and Form II, but is so unstable that if nothing is done to stabilize it, it quickly becomes a different form of clarithromycin. It was not identified as a unique substance until it was stabilized by Abbott, as disclosed in its 274 patent, which expires in 2017.

In its notice of allegation, Ratiopharm alleged that its product was non-infringing because clarithromycin Form 0 can only be asserted against the final product produced by Ratiopharm, which was Form II, and not against an intermediate product used by the second person. It also alleged that the 274 patent was invalid for anticipation as it was disclosed in a prior patent, such that a person skilled in the art had all of the information needed to produce the claimed invention - Form 0 - without the exercise of any inventive skill.