Recent case law and evolving U.S. Patent and Trademark Office (USPTO) practices are raising the stakes for how follow-on patent portfolios are drafted, prosecuted, defended, and challenged.
In Sterne Kessler’s webinar “Navigating the Follow-On Patent Battlefield in Bio-Pharma,” Director Christopher Gallo, Ph.D. and Counsel Pratibha Khanduri, Ph.D. explore the battleground surrounding follow-on biopharmaceutical patents and how to successfully navigate this complex IP landscape. Key highlights from the presentation include:
- Broad Biopharma Genus Claims Need Concrete Structural Support: Where a claim covers a broad class of molecules, a small number of examples or a description of function alone may not establish possession. Representative species, common structural features, precise definitions, and clear “blaze marks” can become decisive.
- Claim Type Matters, but Method Claims Are Not Automatically Safer: A method-of-treatment claim using a known and predictable class of molecules may be assessed differently from a claim to the class itself. The support must be evaluated against what the claim actually requires, the technology’s predictability, and the knowledge in the art.
- Obviousness-Type Double Patenting (ODP) and Patent Term Strategy Should Be Addressed Before Filing: ODP is an increasingly common issue for follow-on portfolios. Applicants should evaluate whether patentable distinctness can be established, whether patent term is commercially important, and how claim overlap can be reduced before filing.
- PTAB Institution Risk Makes Cross-Forum Coordination Essential: Discretionary denial factors (such as settled expectations), real-party-in-interest identification, consistent claim construction, parallel litigation, and prior proceedings increasingly influence whether an AIA trial is instituted. Patent owners and challengers should develop a coordinated strategy early across the PTAB, reexamination, district court, and regulatory landscapes.
- Product Data and Disclosure Timing Are Strategic Assets: Unexpected-results evidence should be developed early, with comparisons to the closest prior art. Clinical trial disclosures and regulatory timelines should also be coordinated with the filing strategy to avoid the company’s own public materials becoming prior art or statements relevant to validity and infringement.