The patent covers amlodipine besylate, the active ingredient in Norvasc needed for making low cost alternatives. Since the ruling in favor of Pfizer makes clear the patent is enforceable, Apotex’s generic product would infringe the legal protection afforded.
The decision by Judge James Rosenbaum in the Chicago-based federal court is subject to appeal.
“The court decision is another important victory for medical innovators who invest in high-risk research to develop life saving medicines, as well as for the patients who benefit from those medicines,” said Jeffrey Kindler, vice chairman and general counsel of Pfizer.
Mr Kindler said the company would continue to defend its position as the distributor of amlodipine besylate type products; the company faces further attack from other generic manufacturers seeking to invalidate Norvasc’s patent. Such challenges are expected to be heard later this year.
Another large pharma company to recently face a patent challenge, AstraZeneca, has not been so lucky. A US court has allowed the genericization of its top-selling hypertension and angina treatment, Toprol-XL. AstraZeneca is expected to appeal the decision, although the company has already been affected by the ruling, suffering a drop in share price of almost 5%.