CaseApotex Inc v Allergan Inc et al, 2015 FCA 137, aff’g 2014 FC 567

Drug: LUMIGAN RC® (bimatoprost)

Nature of case: Appeal from section 6 prohibition application under thePatented Medicines (Notice of Compliance) Regulations (PMNOC Regulations)

Successful party: Allergan Inc

Date of decision: June 3, 2015

Summary

Allergan obtained a prohibition order against Apotex under section 6 of the PMNOC Regulations with respect to the drug bimatoprost and Canadian Patent No. 2,585,691 (691 Patent). Apotex’s appeal to the Federal Court of Appeal (FCA) on the basis of inutility; obviousness; anticipation; and failure to provide adequate reasons was dismissed with costs. The FCA confirmed that elements of the doctrine of sound prediction that would be self-evident to a person of ordinary skill in the art (POSITA) need not be explicitly disclosed in the patent.

Background

Allergan distributes an ophthalmic solution for glaucoma or high eye pressure under the brand name LUMIGAN RC®. LUMIGAN RC® is covered by the 691 Patent which expires in 2026. Apotex applied to the Minister of Health for a Notice of Compliance (NOC) to distribute a generic version of LUMIGAN RC®, alleging its ophthalmic formulation did not infringe the 691 Patent, or alternatively, that the patent was invalid.  Mr. Justice O’Reilly granted Allergan’s application for a section 6 prohibition order on June 13, 2014 in 2014 FC 567.

Apotex appealed Justice O’Reilly’s decision on the following grounds: inutility; obviousness; anticipation; and O’Reilly J.’s failure to provide adequate reasons. The FCA dismissed Apotex’s appeal with costs.

Apotex appeal

Inutility

Apotex argued that the utility of the 691 Patent was not soundly predicted because the line of reasoning was not explicitly disclosed in the patent. The FCA dismissed this ground, citing its previous decision inEurocopter v Bell Helicopter 2013 FCA 219, confirming that elements of the doctrine of sound prediction that would be self-evident to a POSITA need not be explicitly disclosed in the patent. Having determined that the line of reasoning would have been self-evident to a POSITA for the 691 Patent, the FCA dismissed Apotex’s arguments on the lack of sound prediction.

Obviousness

Apotex then argued that the Federal Court erred in law when applying the obviousness inquiry from Sanofi-Synthelabo. The FCA held that:

  • the Federal Court correctly construed the inventive concept by reading the patent as a whole when the inventive concept was not readily discernable from the claims themselves;
  • Apotex could not demonstrate any palpable and overriding error with respect to the Court’s findings on the state of the art, the differences identified between the state of the art and inventive concept or on the obvious to try test; and
  • In finding that the invention was not obvious to try, the Court considered that the LUMIGAN RC® formulation required experimentation and inventive steps; extensive, expensive testing; and resulted in a commercially successful product.

Anticipation

Apotex argued that Canadian Patent No. 2,144,967 (967 Patent) anticipated the 691 Patent. Justice O’Reilly found as fact that (1) the 967 Patent, asserted to be the genus patent, did not disclose the special advantage of the 691 Patent; and that (2) the 967 patent did not enable the 691 Patent as an inventive step was required. Apotex was unable to show that these two factual findings were palpably and overridingly wrong and Apotex’s appeal on anticipation was dismissed.

Adequacy of reasons

Apotex also argued that the Federal Court reasons ignored substantial portions of evidence and did not explain why Allergan’s evidence was preferred. The FCA held that an appellate court may presume a judge reviewed all of the evidence and that preference for one party’s evidence is not in itself evidence of a judge ignoring another party’s evidence. Accordingly, the FCA found Justice O’Reilly’s reasons to be adequate and the Apotex appeal was dismissed.

Link to decisions:

Apotex Inc v Allergan Inc et al, 2015 FCA 137

Allergan Inc et al v Apotex Inc, 2014 FC 567