Bioavailability is still not efficacy

What happened

A patentee obtained an interim injunction on a salt-form patent over an earlier expired patent covering the free acid. The generic manufacturer appealed.

What the fight was about

Whether the salt form cleared section 3(d), and whether there is a gap between what a genus patent covers and what it discloses.

What the court decided

The interim injunction was set aside. On section 3(d), enhanced bioavailability is not synonymous with therapeutic efficacy - applying the Supreme Court's reasoning directly - so the salt form was vulnerable. On coverage versus disclosure, the Court rejected reliance on a gap between broad coverage and actual disclosure, holding that no such dichotomy should exist. A credible challenge to validity was established, which was enough to defeat injunctive relief.

Why an inventor should care

The efficacy test set in 2013 is being applied, not softened. A better-absorbed salt is not automatically a patentable one.

What a patent professional should take from it

Read together with the genus-species line: at the interlocutory stage the question is vulnerability, and a credible section 3(d) challenge is frequently enough.

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This is an editorial case note prepared by Ragulika IP - a summary of a decision, not the text of the judgment, and not authority. Read the judgment itself before relying on any point.