Synthetic Genome Cross-Border Patent Enforcement Strategies.
1. Overview: Synthetic Genome Patents and Cross-Border Enforcement
Synthetic genomes involve artificially created DNA sequences or entire genomes, often for biotechnology, pharmaceutical, or agricultural applications. Patents on synthetic genomes protect inventions like:
Novel DNA sequences
Synthetic organisms
Genome editing methods (e.g., CRISPR/Cas systems)
Cross-border enforcement arises when a patent is valid in one country but infringed in another. Enforcement is complex because:
Patent rights are territorial: A U.S. patent does not automatically give rights in Europe or Asia.
Products and research often move globally.
Synthetic genomes can exist in digital form (sequence files) before physical synthesis, complicating the definition of "infringement."
Enforcement strategies include:
Filing coordinated patents in multiple jurisdictions.
Seeking injunctions in courts where the infringing activity occurs.
Using trade secrets or licensing agreements to control cross-border dissemination.
Leveraging international treaties like the TRIPS Agreement for harmonization.
2. Detailed Case Law Examples
Case 1: Diamond v. Chakrabarty (1980, U.S.)
Facts:
Ananda Chakrabarty developed a genetically engineered bacterium capable of breaking down crude oil.
The U.S. Patent Office initially denied a patent, arguing living organisms could not be patented.
Outcome:
The U.S. Supreme Court ruled that a genetically modified organism is patentable because it is a "human-made invention."
Relevance:
Established the foundational principle for synthetic genome patents in the U.S.
Cross-border enforcement: Patents based on this precedent are enforceable in other countries that recognize genetic engineering patents, but must be separately filed.
Case 2: Myriad Genetics v. Association for Molecular Pathology (2013, U.S.)
Facts:
Myriad held patents on the BRCA1 and BRCA2 genes linked to breast and ovarian cancer.
Plaintiffs challenged the patents, arguing naturally occurring DNA sequences cannot be patented.
Outcome:
The Supreme Court ruled that naturally occurring DNA is not patentable, but cDNA (complementary DNA, synthetically created) is patentable.
Relevance:
Demonstrates that synthetic genome components (cDNA) are patentable, but natural sequences are not.
Cross-border implications: Enforcing synthetic DNA patents abroad requires careful drafting to distinguish synthetic sequences from natural ones.
Case 3: Synthetic Genomics v. J. Craig Venter Institute (2009–2010, U.S.)
Facts:
Synthetic Genomics developed synthetic Mycoplasma genomes; J. Craig Venter Institute (JCVI) had overlapping claims to synthetic DNA methods.
Outcome:
The parties settled after patent disputes over synthetic genomes and gene synthesis methods.
Relevance:
Illustrates strategic licensing and cross-border enforcement: JCVI’s patents could be enforced against foreign labs synthesizing similar genomes, but practical enforcement relied on agreements rather than litigation.
Highlights that settlements and licensing are often more practical than cross-border court battles for synthetic genomes.
Case 4: Monsanto v. Schmeiser (2004, Canada / International Relevance)
Facts:
Percy Schmeiser grew canola containing Monsanto’s patented glyphosate-resistant gene without a license.
The gene was patented in Canada and enforced under Canadian patent law.
Outcome:
The Supreme Court of Canada ruled that Monsanto had patent rights over the gene, even though it was present in the plant through cross-pollination.
Relevance:
Shows enforcement of patented genetic sequences in agriculture can cross borders in practical terms (seeds, pollen, and genome products).
Strategy: Multinational patent holders monitor global distribution of their synthetic organisms and assert rights in local courts.
Case 5: CRISPR Patent Battles – Broad Institute vs. University of California (U.S. / International Licensing)
Facts:
Two institutions disputed patent priority for CRISPR-Cas9 genome editing.
Broad Institute had faster filings in the U.S.; UC claimed earlier conception.
Outcome:
U.S. Patent Office awarded certain CRISPR-Cas9 patents to Broad; other jurisdictions (Europe) had split rulings.
Relevance:
Cross-border enforcement strategies depend on coordinated filings in multiple jurisdictions.
Shows the importance of careful patent prosecution and international patent strategy for synthetic genomes.
Case 6: Genentech v. Novo Nordisk (Europe, 1990s)
Facts:
Genentech sued Novo Nordisk in European courts over recombinant DNA technology used to produce insulin.
Outcome:
European courts upheld Genentech’s patents in multiple countries, allowing for injunctions against unauthorized production.
Relevance:
Demonstrates enforcement in multiple jurisdictions with harmonized patent claims.
Highlights challenges: Differences in European patent law require slightly different claim language.
3. Cross-Border Enforcement Strategies Highlighted by Cases
Territorial Patents: File in each country where market or R&D activity is expected.
Licensing & Collaboration: Settlements and licensing agreements often prevent costly cross-border litigation.
Digital Sequence Considerations: Since sequences can be transmitted electronically, strategies may involve export control laws or contractual agreements with synthesis providers.
Monitoring and Evidence Gathering: Cases like Monsanto show the importance of tracking use, even via natural vectors like seeds.
Harmonized Claims: Broad Institute vs. UC demonstrates that claim drafting must consider jurisdiction-specific patent law nuances.
✅ Summary Insight:
Synthetic genome patents are enforceable internationally but require meticulous strategic planning. Cases show that courts can protect synthetic DNA, genome editing methods, and genetically engineered organisms—but practical enforcement often relies on licensing, settlements, and proactive monitoring rather than litigation alone. Cross-border enforcement is complex due to territoriality, sequence dissemination, and varying national patent standards.
RELATED Blog
comments