Pharma Patent Searches Need Upgrade to Match Modern Innovations

The Bottom Line

• Traditional freedom-to-operate analysis is no longer an adequate risk management tool due to the pace and complexity of pharmaceutical advancements.
• Artificial intelligence-assisted inventions often challenge conventional assumptions about how inventions are described and claimed.
• Broadening the scope of analyses, accounting for jurisdiction-specific realities, and collaborating across functions are crucial to successful FTO programs.

Freedom-to-operate, or FTO, analysis has long served as a critical risk-management tool in pharmaceutical development. Before companies commit to large-scale clinical trials, manufacturing investments, or global commercialization, they rely on FTO assessments to evaluate whether existing patent rights could restrict their ability to bring a product to market.

Those assessments followed a familiar and largely predictable framework for many years. Patent counsel conducted keyword- and classification-based searches, reviewed granted patents and published applications, and focused primarily on composition-of-matter claims associated with a defined product candidate.

In 2026, however, that framework is increasingly misaligned with the realities of pharmaceutical innovation. Advances in biologics, peptides, monoclonal antibodies, and other complex therapeutic modalities have fundamentally reshaped patent landscapes. These technologies are protected not by single, isolated patents, but by dense, interconnected portfolios spanning multiple technical dimensions and jurisdictions.

Meanwhile, artificial intelligence is transforming both drug discovery and patent drafting, introducing claim structures and risk profiles that traditional FTO searches struggle to capture. Against this backdrop, patent enforcement has become more strategic and aggressive, raising the stakes for companies that underestimate freedom-to-operate risk.

As a result, FTO can no longer be treated as a narrow legal exercise conducted late in development. It must be understood as a continuous, integrated process that evolves alongside science, regulation, and commercial strategy.

Biologics Patent Complexity

The shift from small molecules to biologics and advanced therapies has dramatically increased the complexity of patent landscapes. Unlike traditional chemical compounds, biologics and peptides are rarely protected by a single composition-of-matter claim that clearly defines the scope of exclusivity. Instead, protection is often layered across multiple patent families, each covering different aspects of the product and its use.

A single biologic therapy may implicate patents covering amino acid sequences, functional variants, binding properties, epitope specificity, methods of treatment, dosing regimens, formulations, manufacturing processes, cell lines, and delivery devices. In many cases, these patents are held by different entities and prosecuted across multiple jurisdictions, creating overlapping rights that are difficult to untangle through conventional search strategies.

Monoclonal antibodies illustrate this challenge particularly well. Antibody patents frequently rely on functional or genus-style claiming, defining inventions by binding affinity, biological activity, or target specificity rather than precise sequences alone. As antibody engineering techniques have advanced, the number of potentially relevant variants has expanded, making it increasingly difficult to assess FTO based solely on sequence comparison or narrow structural searches.

These dynamics aren’t limited to antibodies. Peptide therapeutics, protein-based drugs, and emerging modalities such as cell and gene therapies exhibit similar patterns. This means FTO risk in these areas is rarely binary. It emerges from cumulative exposure across multiple claims and patents, each of which may independently constrain commercialization.

AI’s Expanding Role

AI has become deeply embedded in modern pharmaceutical research, from target identification to lead optimization and candidate selection. These tools enable companies to explore vast chemical and biological spaces more efficiently, but they also complicate downstream patent analysis. AI-assisted inventions often challenge traditional assumptions about how inventions are described and claimed.

Patent applications associated with AI-enabled research may rely on functional language, probabilistic models, or performance-based parameters that don’t map cleanly onto traditional keywords or classification systems. Claims sometimes define broad classes of molecules by reference to biological outcomes or computational criteria rather than explicit structural features. For FTO purposes, this creates a risk that relevant patents won’t surface in standard searches, even when they may ultimately be asserted against a product.

The long and dynamic nature of patent prosecution in this area amplifies the uncertainty. Many AI-related applications remain pending for extended periods, during which claim scope may change substantially.

Early publications may provide little insight into the final form of the claims, yet those claims may later emerge as significant barriers to commercialization. FTO analyses that focus primarily on granted patents or static snapshots of published applications risk overlooking these emerging threats.

Costs of Error

Enforcement strategies have evolved in parallel with patent portfolios in biologics and advanced therapies growing more sophisticated,. Patent owners are increasingly willing to assert rights across a range of claim types, including method-of-use, formulation, and manufacturing claims that were once considered secondary. These assertions are often timed strategically to coincide with regulatory milestones or anticipated launches, maximizing leverage.

In this environment, FTO risk isn’t limited to clear cases of copying or direct overlap. Even arguable infringement can trigger litigation, regulatory delays, or licensing demands that disrupt development timelines. For products with high development costs and narrow windows of market opportunity, such disruptions can have outsized commercial consequences.

The global nature of biologics markets further amplifies these risks. Enforcement strategies vary significantly across jurisdictions, and a patent that poses limited risk in one market may be decisive in another. Companies that fail to account for these differences early may find themselves forced to renegotiate launch plans or accept unfavorable licensing terms late in the development process.

Traditional FTO Methodologies

Despite these developments, many FTO analyses continue to rely on methodologies developed for drugs in less crowded patent landscapes. Keyword- and classification-based searches remain common starting points, as does an emphasis on composition-of-matter claims tied to a small number of lead candidates. While these tools remain useful, they are increasingly insufficient on their own.

The difficulty of capturing broad or functional claims is one persistent limitation. Biologics patents often define inventions in ways that are intentionally flexible, allowing coverage to extend beyond specific sequences or structures. Narrow searches may miss these claims or underestimate their potential relevance.

Incomplete geographic coverage is another challenge. As companies pursue global commercialization strategies, overlooking patents filed in Asia or emerging markets can undermine carefully planned launches. Differences in national patent practices, claim interpretation, and enforcement mechanisms further complicate the analysis.

Perhaps most important, traditional FTO approaches are often episodic. Analyses are conducted at specific development milestones and then set aside, even as competitor portfolios continue to evolve. In fast-moving therapeutic areas, this static approach leaves companies exposed to new risks that emerge between formal FTO reviews.

A Better Framework

Addressing these challenges requires rethinking FTO as a dynamic process that evolves alongside the product and the patent landscape. Advanced analytics and AI-enabled patent tools can support this shift by identifying patterns and relationships across large datasets, including patent families, prosecution histories, and citation networks. When used in combination with expert legal analysis, these tools can improve visibility into emerging risks that might otherwise go unnoticed.

Broadening the substantive scope of FTO analyses is equally important. Rather than focusing narrowly on composition-of-matter claims, modern assessments must systematically evaluate method-of-use, formulation, manufacturing, and combination claims—considering how a product’s profile may change over time. Lifecycle management strategies, including new indications or delivery formats, should be considered early to avoid downstream surprises.

Global integration is also essential. Effective FTO strategies must reflect jurisdiction-specific realities, aligning patent analysis with regulatory timelines and anticipated launch sequences. By prioritizing markets based on commercial importance and enforcement risk, companies can allocate resources more efficiently while maintaining comprehensive coverage.

Finally, successful FTO programs depend on cross-functional collaboration. Intellectual property considerations can’t be siloed from scientific, regulatory, and business decisions.

Early and ongoing communication among IP counsel, research and development teams, regulatory affairs, and business development allows companies to identify risks sooner and respond more flexibly. In this model, FTO informs not only legal strategy but also research direction, partnership decisions, and portfolio planning.

Takeaways

FTO analysis remains indispensable to pharmaceutical innovation, but its traditional execution no longer reflects the complexity of modern therapeutics. In 2026, biologics, peptides, antibodies, and other advanced modalities are protected by dense, evolving patent landscapes shaped by functional claiming, AI-assisted invention, and global enforcement strategies. Static, composition-focused searches are increasingly likely to miss material risks.

Companies that adapt by adopting more dynamic, technology-enabled, and globally integrated approaches will be better positioned to manage uncertainty proactively. In doing so, they can transform FTO from a reactive legal safeguard into a strategic tool that supports innovation, investment, and timely patient access. That evolution is no longer optional in an era of increasingly complex science and competitive markets.

This article does not necessarily reflect the opinion of Bloomberg Industry Group, Inc., the publisher of Bloomberg Law, Bloomberg Tax, and Bloomberg Government, or its owners.

Author Information

Sanandan Malhotra is senior IP counsel at Novo Nordisk, specializing in life-sciences patent law and advising on biologics, peptide therapeutics, and data-driven drug discovery.

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