Drug: SUSTIVA efavirenz
This is a proceeding commenced under the Patented Medicines (Notice of Compliance) Regulations, seeking an order to prohibit the Minister of Health from issuing a notice of compliance to Mylan for efavirenz, an anti-retroviral drug used to treat HIV infection. An Order of prohibition was granted in respect of one patent, but the application was dismissed in respect of the second patent.
Mylan made an allegation of inutility in respect of the first patent. The Court found that BMS met its burden on the issue of inutility on the basis that the Notice of Allegation was insufficient, and granted the Order of prohibition. The Court also addressed Mylan’s inutility allegation on the merits. In particular, the Court first discussed the principles of claim construction and noted that resort to the disclosure is permissible but elements cannot be imported from the disclosure to the claims. The Court noted that “[i]t is also not appropriate to ascribe meaning to words in the claims by reference to “stray phrases” found in the disclosure”. The Court held that Mylan read a promise into the claims to found its allegation of inutility. Accordingly, on the merits, the Court found that Mylan’s allegation was not justified.
In respect of the second patent, which claimed a particular polymorph characterized by x-ray powder diffraction, the Court noted that Mylan improperly attempted to read purity into the claims, and accepted BMS’ construction of the claims. The Court found that the polymorph claimed in the patent was not anticipated and was not obvious. In respect of the allegation by Mylan that it would not infringe the patent, the Court noted that Mylan provided no information about its product and refused to provide samples. BMS argued that an adverse inference should be drawn. The Court held that BMS’s expert could have conducted experiments to respond to Mylan’s allegation of noninfringement, but did not. Accordingly, the Court found that BMS failed to demonstrate that Mylan’s allegation of non-infringement is not justified.