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October 3, 2012 - Volume 11, Number 8

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Bristol-Myers Squibb Canada Co. et al v. Mylan Pharmaceuticals ULC et al, 2012 FC 1142 (September 27, 2012) – efavirenz – PM(NOC) case
By: Livia Aumand

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 predicted.

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.

Link to decision

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