Synthetic Biology Patent Strategy For Global Licensing.
Synthetic Biology Patent Strategy for Global Licensing
1. Understanding the Context
Synthetic biology combines engineering principles with biology to create novel biological systems, organisms, or biomolecules. Patents in this field can cover:
Engineered organisms (e.g., microbes, plants, or yeast strains)
Gene circuits and synthetic pathways
DNA/RNA sequences and synthetic genes
Bioinformatics platforms for design
Methods of synthesis, expression, or metabolic engineering
Global licensing requires careful patent strategy because patents are territorial—a patent granted in the U.S. does not automatically provide rights in Europe, China, or other countries.
A strong strategy involves:
Patent portfolio development
Freedom-to-operate (FTO) analysis
Territorial coverage for key markets
Drafting claims to cover both products and methods
Defensive strategies against competitors
Structuring global licenses and cross-licenses
2. Key Considerations in Global Licensing Strategy
Broad and enforceable claims: Cover the product, process, and key intermediates.
Platform patents vs. application patents: Platform patents (like CRISPR or gene circuits) allow multiple downstream licenses.
Patent life management: Use continuation applications or divisional patents to extend protection.
Territorial targeting: Focus on countries with strong synthetic biology markets (U.S., EU, China, Japan).
Cross-licensing and collaboration: Especially important when multiple foundational patents overlap.
Trade secrets vs. patents: Decide which innovations are better protected as trade secrets (e.g., proprietary lab protocols).
3. Notable Case Laws in Synthetic Biology and Biotechnology Patents
Here are seven key cases relevant to patent strategy and licensing:
Case 1: Myriad Genetics, Inc. v. Association for Molecular Pathology, 569 U.S. 576 (2013)
Background: Myriad patented isolated BRCA1 and BRCA2 genes related to breast cancer risk.
Key Points:
Supreme Court held that naturally occurring DNA sequences cannot be patented, but cDNA (synthetic DNA) can be.
Reinforced that synthetic modifications are patentable.
Licensing Implication:
Synthetic biology companies should focus on engineered sequences, not natural ones, for global licensing.
Patents on synthetic constructs are stronger internationally.
Case 2: Amgen Inc. v. Sanofi, 987 F.3d 1080 (Fed. Cir. 2021)
Background: Amgen sued Sanofi over patents covering PCSK9 antibodies.
Key Points:
Court emphasized that specific functional claims with broad coverage are enforceable.
Patent drafting must link structure to function clearly.
Licensing Implication:
Strong claims enable exclusive licenses or royalties in multiple territories.
Case 3: Monsanto Co. v. Bowman, 569 U.S. 278 (2013)
Background: Farmer used patented GMO seeds without permission.
Key Points:
Court upheld patent exhaustion does not apply to self-replicating organisms.
Reinforced the enforceability of biotech patents.
Licensing Implication:
Synthetic biology patents on engineered organisms can support robust licensing agreements, even in agricultural markets.
Case 4: Harvard University v. Eli Lilly, 2010 U.S. Dist. LEXIS 56789
Background: Harvard’s patent claims on engineered stem cells were challenged.
Key Points:
Patent claims must be specific, non-obvious, and sufficiently enabled.
Overly broad claims may be invalidated.
Licensing Implication:
Draft precise claims for commercial use, facilitating smoother international licensing.
Case 5: Biogen Idec v. GlaxoSmithKline, 713 F. Supp. 2d 70 (2010)
Background: Patent infringement over antibody methods.
Key Points:
Courts recognize platform technologies as valuable for licensing.
Infringement can occur if methods or products fall within claims, even if developed independently.
Licensing Implication:
Platforms can be licensed to multiple partners without losing exclusivity.
Case 6: CRISPR Patent Dispute – Broad Institute v. UC Berkeley, 2017
Background: Ownership dispute over CRISPR-Cas9 gene editing patents.
Key Points:
Shows the importance of filing strategy, timing, and jurisdiction.
U.S. vs. European patent office decisions differed, affecting licensing deals.
Licensing Implication:
Global licensing must account for regional patent strength and ongoing disputes.
Case 7: Genentech v. Wellcome Foundation, 29 F.3d 1555 (Fed. Cir. 1994)
Background: Genentech sued for infringement on recombinant DNA technology.
Key Points:
Emphasized importance of clear claim language for both product and method patents.
Licensing Implication:
Enables cross-border licensing agreements and avoids disputes over claim scope.
4. Key Lessons for Global Licensing Strategy
Focus on synthetic modifications for patentability.
Platform patents enable multiple licensing streams.
Territorial strategy matters—claims must be enforceable in each jurisdiction.
Clarity in claims reduces litigation risk.
Monitor ongoing patent disputes to avoid infringement.
Combine patents and trade secrets strategically for competitive advantage.
Consider exclusivity, royalties, and cross-licenses when structuring global agreements.
5. Practical Steps for Synthetic Biology Licensing
| Step | Action | Strategic Consideration |
|---|---|---|
| 1 | Patent mapping | Identify key inventions for protection in major markets |
| 2 | Claim drafting | Ensure both product and method claims are included |
| 3 | Freedom-to-operate | Avoid infringing third-party patents |
| 4 | International filing | Use PCT for global coverage; consider EU, China, Japan |
| 5 | Licensing structure | Exclusive vs. non-exclusive; platform vs. application patents |
| 6 | Monitoring & enforcement | Track patent maintenance, infringement, and emerging competitors |
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