BEYOND THE 20-YEAR PATENT: MAKING REGULATORY EXCLUSIVITY WORK FOR YOUR ASSET

When in-house teams ask “How long are we protected?”, they usually hear a simple answer: patent term is 20 years from filing. That’s legally accurate and commercially misleading.

In practice, the effective period during which a life sciences product can enjoy meaningful exclusivity depends on how well a company coordinates three levers:

• Patent protection

• Patent term extensions or supplementary protection certificates (SPCs)

• Regulatory exclusivity (data and market protection)

In today’s market, a regulatory exclusivity strategy that is mapped alongside patents is often what determines whether an asset has a short tail or a durable commercial life. For small and mid-sized companies without in-house IP counsel, the risk is clear: filing solid patents but missing out on years of additional protection because regulatory and patent strategies were never designed in tandem.

Hylton-Rodic Law is often brought in after value has been left on the table. The better moment is when your lead programs are still in development and clinical plans are still flexible.

The Baseline: Patent Protection and Extensions

Under the WTO TRIPS Agreement and most national laws, the default patent term for inventions is 20 years from the filing date of the patent application.

For life sciences, that term is eroded by long development timelines and regulatory review. By the time a drug or biologic is approved, a substantial portion of the patent term has already run.

Two mechanisms matter most here:

Core patent term
20-year term from filing (utility patents), assuming maintenance fees are paid.

Patent term adjustment/extension (PTA/PTE)
In the United States, Patent Term Adjustment (PTA) compensates for certain delays at the USPTO.
Patent Term Extension (PTE) can add up to 5 years to a patent covering an FDA-approved product, subject to a cap that the total patent life post-approval cannot exceed 14 years.
In the EU and UK, SPCs can extend protection for certain medicinal products for up to 5 additional years, plus a potential 6-month paediatric extension, giving a maximum of 25 years from the original filing.

Patent term extensions do not change who can reference your clinical data or when generic or biosimilar applications can be filed; they change whether a follow-on competitor must wait for the extended patent/SPC to expire before launching.

Even with strong patents and extensions, competitors may still be blocked or enabled by a separate exclusivity system that patents do not control.

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Regulatory Exclusivity: A Separate but Powerful Right

Regulatory exclusivity is often misunderstood as “extra patent life.” In reality, it is a regulatory right that operates independently of patents.

United States For small molecules approved via an NDA, key FDA exclusivities include:

• New Chemical Entity (NCE) Exclusivity – 5 years
  Prevents FDA from accepting ANDAs or 505(b)(2) applications referencing the innovator’s drug for 5 years (with a limited 4-year exception for Paragraph IV challenges).

• New Clinical Investigation Exclusivity – 3 years
  Protects changes (for example, new indication or dosage form) supported by new clinical investigations essential to approval.

• Orphan Drug Exclusivity – 7 years
  Blocks approval of the same drug for the same orphan indication.

• Pediatric Exclusivity – 6 months
  Adds six months to existing patents and exclusivities if agreed paediatric studies are completed.

  For biologics, reference product exclusivity under the Biologics Price Competition and Innovation Act creates a 12-year window during which biosimilars cannot be approved, with a 4-year bar on biosimilar application submission.

  These windows can run concurrently or stack in specific ways. For example, an NCE small molecule with orphan designation and pediatric exclusivity can achieve a combined period where generics cannot be approved that is significantly longer than five years, even before considering patent term extension.

EU, EEA, and UK The traditional European framework is the “8+2+1” model:

• 8 years of data exclusivity
  Generic or biosimilar applicants cannot rely on the originator’s data in their applications.

• 2 years of market protection
  Applications can be filed and approved, but no generic or biosimilar product can be placed on the market.

• +1 additional year
  Available in certain cases, for example, where a new indication with significant clinical benefit is approved.

In other words, regulators are using your clinical and preclinical dossier as a policy lever to incentivize innovation, independent of patent rights.

Looking Ahead: From Rules to Strategy

This first article outlines the building blocks: core patent terms, extensions, and the primary United States and EU or UK regulatory exclusivity regimes. In practice, those rights rarely operate in isolation. What matters is how they come together over time for a specific asset.

In the second part of this series, “Designing Market Life: Mapping Patents and Regulatory Exclusivity for Your Asset,”  we look at how shifting EU rules, development choices, and launch sequencing shape the real protection timeline for your product, and how to build an exclusivity map that your commercial and business development teams can actually plan around.

If you are developing a drug or biologic and want to understand how patent terms, SPCs, or PTE and regulatory exclusivity could shape the commercial life of your asset, you can contact Hylton-Rodic Law for strategic IP and exclusivity planning support.