|June 27, 2014|
Previously published on June 19, 2014
In a pair of simultaneously released decisions on June 13, 2014, Justice O’Reilly allowed Allergan’s applications (the “Applications”) prohibiting the Minister of Health from issuing NOCs to Cobalt (now “Actavis”) (2014 FC 566) and Apotex (2014 FC 567) to market their generic versions of LUMIGAN RC® until the expiry of Canadian Patent 2,585,691 (the “‘691 Patent”) in 2026.
Allergan was represented by Andrew Reddon, Steven Mason, Steven Tanner and Sanjaya Mendis of McCarthy Tétrault LLP.
Allergan originally marketed a 0.03% bimatoprost (“Bp”) containing formulation for treating glaucoma called LUMIGAN, which Justice O’Reilly referred to as “old Lumigan”. Despite its potency, old Lumigan caused some dose-dependent side effects. Allergan subsequently developed an enhanced bimatoprost formulation which it marketed as LUMIGAN RC®, which Justice O’Reilly referred to as “new Lumigan”.
Remarkably, new Lumigan contained only 1/3 the concentration of Bp as old Lumigan (0.01% vs. 0.03%), but was able to maintain comparable efficacy for treating glaucoma. The inventors of the ‘691 Patent were able to achieve this result through an inventive formulation.
Both Cobalt and Apotex sought early market entry to sell their respective generic versions of new Lumigan prior to the expiry of the ‘691 Patent, which gave rise to the Applications described herein. Both cases engaged the same claims of the ‘691 Patent. Both second persons raised similar issues, which were addressed by Justice O’Reilly.
Construction - Claims 16 and 19 of the ‘691 Patent
The ‘691 Patent is entitled, “Enhanced Bimatoprost Ophthalmic Solution”. At the hearing, Allergan asserted only claims 16 and 19.
Justice O’Reilly found the claims at issue unambiguous, with claim 16 relating to a formulation with lower Bp (0.01%) and higher BAK (200 ppm) than old Lumigan (which had 0.03% and 50 ppm, respectively). Claim 19 was found to relate to the use of that formulation for treating glaucoma or intraocular hypertension.
Obviousness - Determining Inventive Concept a Separate Exercise from Claims Construction
Both Cobalt and Apotex argued that the ‘691 Patent should be given only one interpretation for all purposes - infringement, obviousness, and utility. The second persons thus alleged the inventive concept was simply the same as the claimed invention, meaning a formulation with 0.01% Bp and 200 ppm BAK, which they alleged was an obvious modification of old Lumigan.
Citing his own decision in Hoffman-La Roche (2011 FC 785), Justice O’Reilly held that the interpretation of a patent should be as consistent as possible across the various issues in play. However, Justice O’Reilly recognized that construing the inventive concept for the purpose of the obviousness analysis is a separate exercise from claims construction, meaning that the construction of the claims is not determinative of the inventive concept. This is particularly true where the claim relates to a bare list of ingredients or a bare chemical formula, requiring the skilled person to review the entire specification to determine the inventiveness of what is claimed.
In these cases, the inventive concept posited by Cobalt and Apotex ignored the in vitro and in vivo data contained in the patent which taught the skilled person that increasing BAK surprisingly resulted in greater Bp penetration into the eye. In reviewing the ‘691 Patent as a whole, Justice O’Reilly found the inventive concept of claims 16 and 19 to be a formulation with reduced Bp but with comparable efficacy to old Lumigan, achieved by increasing BAK.
Justice O’Reilly further found that there were significant differences between the inventive concept of the claims and the state of the art at the relevant time, which differences would not have been obvious to the skilled person.
Sound Prediction - Sound Line of Reasoning Implicit in Data
Justice O’Reilly also held that the experimental data disclosed in the ‘691 Patent provided a sufficient factual basis to soundly predict that new Lumigan would deliver a comparable effect to old Lumigan despite only having one-third the amount of Bp.
While the patent did not specifically make a correlation between the disclosed in vitro and in vivo studies, Justice O’Reilly accepted the reasoning of Allergan’s experts that the skilled person would have easily interpreted the data to arrive at the necessary prediction. In doing so, Justice O’Reilly found the sound line of reasoning implicit in the data itself as it would have been readily apparent to the skilled reader; it did not have to be explicitly laid out in the patent.
Anticipation - Broad Generalized Disclosure not Enabling
Both Cobalt and Apotex alleged the ‘691 Patent was anticipated by an earlier compound patent claiming the old Lumigan formulation. These patents disclosed a very general class of compounds and formulations for a broad array of indications that the generics alleged encompassed the formulation of new Lumigan.
Justice O’Reilly found that the patents failed to disclose new Lumigan’s special advantage (embodied in claims 16 and 19) of being able to effectively lower intraocular pressure while using a fraction of the active ingredient usually required for a similar result. In addition, Justice O’Reilly held that the disclosures were not enabling as required by Sanofi (2008 SCC 61). This decision accords with Justice Hughes’ reasoning in Combigan (2012 FC 767), where he held that a patent with broad generalized disclosure did not disclose and enable the specific formulation at issue.
Conclusion - Critical to Review Patent as a Whole
Justice O’Reilly’s decision underscores the critical distinction between claims construction and determining the inventive concept of the claims of the patent, which are separate tasks. This distinction is particularly important where the patent relates to a bare formulation or a bare chemical formula.