Merck —
Fosalan
Patent Application 153109 · once-weekly alendronate dosing
Unipharm and Teva opposed Merck’s patent application concerning once-weekly administration of alendronate.
A technically and evidentially intensive patent opposition.
The opposition involved extensive scientific and legal evidence concerning pharmaceutical dosing and patentability. The hearing extended over twelve full days of witness and expert examinations, with a substantial evidentiary record.
The case also addressed the patentability of dosage-regimen claims and inventive step in the context of a known pharmaceutical compound.
The opposition was accepted and the application was refused.
On 5 August 2010, the Patent Registrar held that the application was not patentable. Merck’s appeal to the District Court was dismissed, and its subsequent application for leave to appeal to the Supreme Court was also dismissed. The Supreme Court endorsed the use of the ‘obvious to try’ framework in assessing inventive step and reiterated that appellate intervention in the Patent Registrar’s factual and professional findings should be limited.