In Novartis Pharms. Corp. v. Torrent Pharma Inc., the Federal Circuit upheld a patent for the heart drug ENTRESTO, allowing Novartis to extend its claims to include both bonded and non-bonded drug components. This ruling raised issues regarding patent enablement, with the court concluding that patents like U.S. Patent No. 8,101,659 could cover concepts not properly enabled. Critics argue this undermines patent law, as it allows monopolies over drug formulations without the necessary detailed disclosures, contravening established legal precedents.
In the Novartis case, the Federal Circuit’s decision potentially extends patent monopolies to drug products without proper enabling disclosures, contradicting Supreme Court precedent.
The court emphasized that the patentee, Novartis, successfully argued for a broad claim construction to include bonded complexes while failing to enable those full claims.
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