BioTech IP Review

1. Platform-first patenting (the dominant strategy)

Who: Genentech, Amgen, Moderna, Illumina, CRISPR Therapeutics
Goal: Control how innovation happens, not just what is made.

Characteristics

• Broad method claims
• Modular architectures
• Reusable across indications

Example

• Moderna: mRNA chemistry + delivery + manufacturing
• Illumina: sequencing workflows, not just machines
• CRISPR companies: guide design, editing systems, delivery

Platforms create optionality—new products without new IP from scratch.

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2. Thicketing & layering (defensive dominance)

Who: Amgen, Roche, AbbVie, Pfizer
Goal: Make design-around economically or legally painful.

How it works

• Multiple patents on:
  • composition
  • formulation
  • dosing
  • manufacturing
  • patient selection
• Continuations filed aggressively

Famous example

• Humira (AbbVie): Not one patent wall—a forest

Result: biosimilar delay without winning every case.

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3. Modality control (own the “how”)

Who: Alnylam, Ionis, Beam, Sana, Vertex
Goal: Dominate a therapeutic modality across diseases.

Modalities

• siRNA
• ASO
• base editing
• prime editing
• cell therapies
• gene regulation

Key insight

Owning the modality lets you:

• license vertically
• block competitors horizontally
• pivot indications cheaply

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4. Delivery is king (and the quietest IP war)

Who: Moderna, BioNTech, Alnylam, Sarepta
Goal: Own the hardest part no one sees.

Why delivery patents matter

• Most biology works in vitro
• Few things work in vivo

Delivery IP often outlives:

• target patents
• indication-specific claims

If you own delivery, you own the clinic.

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5. Data + workflow IP (the next frontier)

Who: Illumina, Guardant, Tempus, Roche
Goal: Lock competitors out of learning curves.

Claims focus on

• data processing
• AI-assisted decision systems
• biomarker discovery pipelines
• diagnostic-treatment feedback loops

These are:

• harder to invalidate
• harder to design around
• harder to replicate

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6. Silent blocking (publish to prevent, not to protect)

Who: Big Pharma R&D orgs
Goal: Stop competitors from patenting without revealing secrets.

Tools

• Defensive publications
• Narrow patents with broad disclosures
• Conference disclosures timed with filings

This keeps freedom-to-operate without litigating.

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7. Acquisition-driven IP aggregation

Who: Pfizer, Roche, GSK, BMS
Goal: Buy IP rather than invent everything internally.

Why it works

• Faster than organic R&D
• Consolidates fragmented landscapes
• Converts litigation risk into leverage

IP diligence often drives M&A more than pipelines.

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8. Jurisdictional asymmetry

Who: Global biotechs
Goal: Optimize protection by geography.

Examples

• Broader claims in US
• Manufacturing/process claims in China
• Diagnostics emphasis in EU

Smart filing ≠ same claims everywhere.

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9. Regulatory + IP coupling

Who: Biologics leaders
Goal: Stack patents with exclusivities.

Tools

• BLA exclusivity
• Orphan drug exclusivity
• Pediatric extensions

Regulatory strategy amplifies IP strength.

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10. Litigation as strategy (rare but decisive)

Who: Amgen, Genentech, CRISPR players
Goal: Shape the landscape, not just win damages.

Litigation used to:

• define claim scope
• scare entrants
• force licensing norms

Most big players litigate selectively, not reflexively.

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Summary

Strategy	Purpose	Risk
Platform patents	Long-term dominance	Enablement challenges
Thicketing	Delay competition	Antitrust scrutiny
Modality control	Broad leverage	Tech obsolescence
Delivery IP	Clinical bottleneck	Hard science
Data/workflows	Moat building	§101 risk
Defensive publishing	FTO	No exclusivity
M&A IP	Speed	Integration risk

Big biotech doesn’t patent products—it patents inevitability.