DESIGNING MARKET LIFE: MAPPING PATENT AND REGULATORY EXCLUSIVITY FOR YOUR ASSET

Once your team understands the difference between patent term, extensions, and regulatory exclusivity, the real work begins. The question is no longer just “When does the patent expire?” It becomes: how do we combine these levers across the United States and Europe to create a protection timeline that matches our development and launch plans?

That design challenge is becoming increasingly difficult as EU rules evolve and regulators link parts of regulatory protection to behaviors such as launch timing and unmet needs. The sections below build directly on Part 1 and focus on how to turn the rules into a deliberate strategy.

The EU Pharma Package: Moving Rules While You Plan Assets

The EU’s Pharma Package is now reshaping these incentives. Proposals from the European Commission and subsequent positions from Parliament and Council all contemplate modulating regulatory exclusivity based on factors such as unmet need, EU launch timing, and comparative trials.

A few trends are clear, even as trilogue negotiations continue:

Baseline regulatory protection will likely remain around 8 years (with varying splits between data and market protection).
The maximum total protection (data plus market) is expected to be roughly similar to or slightly below the current maximum of 11 years, but more heavily conditioned on behaviour such as a timely EU-wide launch.

For innovators, this means the “default” exclusivity for a new product is no longer a fixed number. It becomes a function of regulatory strategy, launch sequencing, and clinical development choices. IP and regulatory counsel need to be at the same table well before EU filing.

The practical takeaway is that patents and regulatory windows must be plotted together to see the real protection timeline.

Mapping Patent and Regulatory Exclusivity Together

When you combine patent or SPC protection and regulatory exclusivity, a few recurring patterns emerge.

• Strong composition-of-matter patent plus full exclusivity stack
  Early-filed patent on the active compound, plus SPC in the EU or PTE in the United States, plus NCE or biologic and orphan or pediatric exclusivities.
  Result: a long period where neither generics nor biosimilars can be approved or launched, even if they are technically ready.

• Weaker patent position but robust regulatory exclusivity
  Narrow or vulnerable patents, but clean NCE and orphan designations.
  Generics may struggle less on the patent side, but still face significant delays accessing data and launching.

• Strong patents but missed regulatory opportunities
  Classic scenario where development or filing choices prevent full use of available exclusivities, for example, no orphan designation pursued early, limited EU strategy, or paediatric studies not aligned with timelines. The asset relies heavily on a 20-year patent plus possible extension, while a competitor with better alignment could have secured additional data or market protection.

  Knowing which pattern your lead asset fits today is often more important than debating the theoretical patent cliff date.

A Practical Playbook for In-House Counsel and R&D Leaders

For teams without in-house IP counsel, a few disciplined practices go a long way.

1. Build a single “exclusivity map” per asset

Create an internal working document that, for each key jurisdiction, lays out:

• Patent filing dates, expected expiration, and any PTA, PTE, or SPC strategy

• Expected or potential regulatory exclusivities (NCE or biologic, orphan, pediatric, new indication, EU 8+2+1 or its successor)

• Dependencies on development or launch choices (for example, timing of EU submission, clinical trial location, unmet need criteria)

  This is the document your commercial forecasts should reference, not just a single patent expiration date.

2. Stress-test development and launch scenarios

Small changes in development can materially shift your exclusivity profile:

• Advancing or delaying an EU filing can affect eligibility for certain extensions under the evolving EU regime.

• Design of pivotal trials, such as comparative versus non-comparative designs or EU versus ex-EU conduct, can impact eligibility for additional data protection.

• The timing and content of paediatric development plans can determine whether you realistically capture the 6-month extension.

  Scenario modelling is not just for big pharma. It is critical for any company whose valuation depends on a handful of core assets.

3. Align the deal strategy with the exclusivity reality

Licensing deals, co-development agreements, and M&A valuations should explicitly reference the exclusivity map:

• For originators, understand where exclusivity could be extended through SPCs or PTE and additional indications before negotiating value.

• For investors or acquirers, distinguish between assets that rely on a single base patent and those that have multiple, well-designed exclusivity layers.

  This reduces surprises when regulators, generic competitors, or biosimilar entrants test the boundaries of your protection.

Where Hylton-Rodic Law Fits In

Companies that do not maintain a large full-time IP department often still operate global development programs. They are expected to understand TRIPS-level patent rules, FDA exclusivities, and the evolving EU Pharma Package while also managing clinical timelines and financing.

Hylton-Rodic Law works with these teams to:

• Design and update asset-level exclusivity maps across major markets

• Coordinate patent filing, SPC or PTE strategy, and regulatory exclusivity planning

• Advise on how exclusivity profiles affect licensing, co-development, and M&A decisions

The goal is simple: turn a patchwork of rules into a deliberate strategy that preserves the real commercial life of your most important products. If your lead asset is still in development, this is the window to build an exclusivity map that protects value before timelines lock.

If you would like a refresher on the underlying patent terms and regulatory exclusivity frameworks that support this strategy, you can read Part 1 of this series, “Beyond the 20-Year Patent: Making Regulatory Exclusivity Work for Your Asset.”

If your team is ready to translate that framework into an asset-level or portfolio-level exclusivity map, you can contact Hylton-Rodic Law to discuss how we can support your development and deal planning.

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