This proceeding brought by Bristol-Myers Squibb Canada Co. and
Merck Sharpe & Dohme Corp. ("Applicants") under the
Patented Medicines (Notice of Compliance) Regulations
dealt with two patents related to the Applicants' SUSTIVA
(efavirenz) product. Justice Barnes granted an order of
prohibition with respect to the patent covering the compound
efavirenz, finding that Mylan's allegation of inutility was
unjustified. In respect of the second patent, which covers a
specific crystal polymorph form of efavirenz, Justice Barnes
refused to issue a prohibition order as he found Mylan's
allegation of non-infringement to be justified.
Justice Barnes found Mylan's allegation of inutility
regarding the compound patent (Canadian Patent No. 2,101,572
(" '572 Patent")) to be unjustified on the basis that
Mylan's Notice of Allegation ("NOA") was legally
insufficient. Specifically, he held that Mylan's NOA did
not inform the Applicants of the case they were required to meet
since Mylan's evidence with respect to its allegation of
inutility was significantly different than what it had asserted in
its NOA. Consequently, the Applicants were found to have met
their burden on the issue of utility.
Despite finding the NOA to be insufficient, Justice Barnes
addressed the merits of Mylan's allegation of inutility.
Mylan had argued that the disclosure of the '572 Patent
promised that efavirenz potently inhibited all major resistant
mutant HIV reverse transcriptase ("RT") strains.
Consequently, Mylan argued that since the patentee had not tested
the compound against each of the major HIV RT strains, this
"promised utility" was neither demonstrated nor soundly
In rejecting Mylan's allegation of inutility, Justice Barnes
noted that this issue turned on claims construction, stating that
it was not appropriate to ascribe meaning to words in the claims by
reference to "stray words" found in the
disclosure. In particular, Justice Barnes relied on the
fact that the '572 Patent only disclosed testing data for
certain HIV RT strains, which counselled against construing the
claims as promising utility against other, untested HIV RT
strains. Thus, Justice Barnes held that Mylan's
allegation of inutility was unjustified on its merits.
With respect to the polymorph patent, Canadian Patent No.
2,279,198 (" '198 Patent"), Justice Barnes rejected
Mylan's allegation that the crystal polymorph form covered by
this patent was anticipated or obvious. However, he held that
the Applicants had not met their burden of proving that Mylan's
allegation of non-infringement was unjustified. The
Applicants had argued that Mylan's product would infringe the
'198 Patent, since any efavirenz crystal form would ultimately
convert in small amounts under certain conditions into the form
covered by this patent. However, Justice Barnes found that
the Applicants' had not put forward sufficient evidence to
establish that this would occur and, thus, no prohibition order
would issue in respect of the '198 Patent.
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