Synthetic Genome Patent Enforcement In Multinational Biotech Collaborations.
Synthetic Genome Patent Enforcement in Multinational Biotech Collaborations
Enforcing patents in the field of synthetic genomes and biotechnology is a highly complex area, particularly in multinational collaborations. Companies often jointly develop technologies, share know-how, and create licensing agreements across borders. Key legal issues include:
Patentability: What constitutes a patentable invention in the biotech/genome field.
Infringement: Unauthorized use of patented organisms, genes, or synthetic DNA.
Jurisdictional challenges: Laws differ in the US, EU, and other regions.
Contractual disputes: Ownership and licensing disputes often arise in collaborations.
Below are six major cases that illustrate these principles.
1. Diamond v. Chakrabarty (U.S., 1980)
Facts:
Ananda Chakrabarty genetically engineered a bacterium capable of breaking down crude oil. The U.S. Patent Office refused the patent because it was a living organism.
Holding:
The U.S. Supreme Court ruled that a human-made living organism is patentable under U.S. law. The Court stated that living things, if created artificially, fall under "manufacture" or "composition of matter."
Significance:
Opened the door for patents on genetically engineered organisms.
Multinational collaborations now rely on this precedent to claim patent protection for synthetic microorganisms, enzymes, and genetically engineered cells.
Provides a foundation for enforcing rights against unauthorized use across different jurisdictions.
2. Association for Molecular Pathology v. Myriad Genetics (U.S., 2013)
Facts:
Myriad Genetics held patents on isolated human BRCA1 and BRCA2 genes, which are linked to breast cancer. Plaintiffs argued these patents were invalid because genes are naturally occurring.
Holding:
Naturally occurring DNA cannot be patented, even if isolated.
Synthetic complementary DNA (cDNA), which is artificially created, is patentable.
Significance:
Defines the line between natural genes (non-patentable) and synthetic genetic constructs (patentable).
Multinational biotech companies must structure collaborations to differentiate between naturally derived sequences and synthetic sequences for enforceable patents.
3. Monsanto Canada Inc. v. Schmeiser (Canada, 2004)
Facts:
Monsanto’s genetically engineered “Roundup Ready” canola was found in a farmer’s field. The farmer argued he did not knowingly plant the patented seeds.
Holding:
Cultivating patented genetically modified seeds without permission constitutes infringement.
Accidental growth of patented seeds is insufficient as a defense if the patented trait is exploited.
Significance:
Clarifies that unauthorized use of genetic material, even unintentionally, can be infringement.
In multinational collaborations, this principle is critical for drafting agreements defining permitted use, cultivation, or distribution of patented organisms.
4. Sequenom Inc. v. Ariosa Diagnostics (U.S., 2016)
Facts:
Sequenom patented a method of non-invasive prenatal testing using cell-free fetal DNA. Ariosa developed competing tests.
Holding:
The court invalidated Sequenom’s patents, holding that the method relied on a natural phenomenon and lacked sufficient inventive application.
Significance:
Illustrates the enforcement risk of patents that claim broad natural phenomena rather than novel inventions.
In synthetic genome collaborations, companies must ensure that claims describe inventive steps beyond mere discovery of natural sequences.
5. Moderna and Pfizer vs. Alnylam (U.S., 2020s)
Facts:
Alnylam Pharmaceuticals sued Moderna and Pfizer, claiming infringement of patents covering lipid nanoparticles (LNPs), used to deliver mRNA vaccines.
Outcome:
Some courts ruled that Alnylam’s claims were too broad and did not cover Moderna/Pfizer’s specific methods.
Some cases settled, others continue.
Significance:
Highlights the complexity of patent enforcement in multinational collaborations.
Companies working together internationally must carefully negotiate licensing rights and indemnities.
Demonstrates the challenge of overlapping patent portfolios in cutting-edge synthetic genome and mRNA technologies.
6. CRISPR Patent Disputes (Broad Institute vs. University of California / Editas)
Facts:
The CRISPR genome editing technology led to disputes between the Broad Institute and University of California (and later companies like Editas) over who held valid patents on key CRISPR applications.
Outcome:
U.S. Patent Office and courts granted different patents for different applications (e.g., eukaryotic vs. prokaryotic use).
Licensing agreements and arbitration were used extensively to settle commercial use rights.
Significance:
Illustrates that in collaborative multinational projects, patent ownership disputes can significantly impact commercial deployment.
Arbitration is often used instead of litigation due to technical complexity and confidentiality concerns.
Key Takeaways for Multinational Synthetic Genome Collaborations
Patentability Matters: Only synthetic constructs, not naturally occurring sequences, are enforceable in most jurisdictions.
Infringement Can Be Broad: Unauthorized use, even accidental, can be actionable.
Jurisdictional Variation: Enforcement strategies must account for differences between U.S., Canadian, European, and other patent laws.
Contract Clauses Are Critical: Ownership, licensing, and dispute resolution clauses prevent costly litigation.
Technical Specificity: Patent claims must be inventive, not merely descriptive of natural phenomena.
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