From DNA to Intellectual Property - The New Frontier of Genetic Ownership

Vijhai Grayan | Cyber, Tech and Space Fellow

Image sourced from Sangharsh Lohakare via Unsplash.

It started with a dire wolf. Earlier this year, biotech company Colossal Biosciences announced the birth of three dire wolf pups, a species that had been extinct for over 12,000 years. Using DNA recovered from a 13,000-year-old tooth, CRISPR gene editing, and cloning, scientists modified the genome of a grey wolf to produce what they described as the world’s first “successfully de-extincted” animals. These pups, living in a secured 2,000-acre research facility, resemble their prehistoric ancestors in physiology and appearance. More significantly, they represent a turning point in biotechnology: the transformation of genetic code from inheritance to invention.

Biology Is Becoming Software

The convergence of biology and computing has accelerated rapidly. Since the Human Genome Project concluded in 2003, the cost of sequencing a human genome has plummeted from over USD$3 billion to just USD$200. Tools like CRISPR-Cas9 have enabled precise, scalable genome editing, while synthetic biology — the engineering of new biological components and systems — continues to grow, with projections estimating it could generate up to USD$4 trillion in direct economic value every year for the next 10 to 20 years.

In this new landscape, DNA is no longer seen solely as a biological given. It is programmable. Editable. Commercial.

Patent Pending: Life

The implications of synthetic biology carry far-reaching implications that warrant careful examination. In the early 2000s, Myriad Genetics patented the BRCA1 and BRCA2 genes, linked to breast cancer. In 2013, the United States (US) Supreme Court ruled that naturally occurring DNA could not be patented and invalidated Myriad Genetics’ patents. However, synthetic sequences (artificially designed DNA that do not occur naturally) remain eligible for patent protection. 

This shift reframes genetic material as intellectual property. The consequences are already emerging. For example, access to medical treatments tied to patented genes may become more restricted. Moreover, entire species — or synthetic versions of them — may fall under commercial ownership.

These developments call for close scrutiny, not alarmism. Ethical, legal, and economic frameworks built for physical goods must adapt to the new bio-digital frontier. The challenge lies in developing responses that are thoughtful, balanced and fit for purpose.

Reimagining Governance for Synthetic Biology

International frameworks such as the Nagoya Protocol seek to ensure equitable benefit-sharing for genetic resources. However, the rise of synthetic biology challenges the relevance of these underutilised and now outdated international protocols – such as the Nagoya Protocol, which remains unratified by key countries like the US and Australia. If genetic code is recreated digitally, without using original biological material like plant tissue or microbial samples, current international protections often fall short. Synthetic sequences, generated entirely from digital data, fall outside many existing frameworks, exposing critical gaps in global governance.

This is not a call to halt progress; rather, it presents an opportunity to establish forward-thinking governance. As a result, the international community must urgently engage in meaningful dialogue and action around the following key priorities:

• Updating licensing regimes to reflect synthetic biology's complexities

• Clarifying benefit-sharing obligations — ensuring that communities or countries providing the original genetic material receive fair compensation or access to benefits when digital code derived from their genomes is used in commercial or scientific applications.

• Ensuring transparency and oversight in bioengineering research and commercialisation

  
  

By focusing on clarity and fairness, regulatory frameworks can foster innovation while safeguarding public trust.

Emerging Models of Ethical Innovation

New models of ethical, non-extractive innovation are already taking shape around the world. For example, BioBricks offers an open-access registry of genetic parts to support global research collaboration. Similarly, the Open Insulin Project has developed a method for producing low-cost insulin locally, responding to a global market valued at over USD$30 billion.

These approaches demonstrate that synthetic biology can align with public interest. They provide tangible counterpoints to profit-driven models, showing that inclusive and transparent science is possible — and increasingly necessary in a world where synthetic sequencing is the new frontier.

Australia’s Strategic Opportunity

Australia is well positioned to lead in synthetic biology. National research institutions such as CSIRO have long supported bio-innovation. Domestic startups like Vow (cultivated meat), Emyria (digital therapeutics), and Microbio (infectious disease diagnostics) are further pushing scientific boundaries.

However, responsible leadership requires more than technical excellence. It demands an integrated approach. This means aligning intellectual property law with ethical innovation, supporting public-interest biotechnology through dedicated funding streams, and embedding strong accountability mechanisms into the development of commercial biotech.

This is an inflection point. Choices made now will shape the trajectory of the Australian bioeconomy for decades.

A New Biological Era

The reanimation of the dire wolf is emblematic of humanity’s desire to resurrect the past through cutting-edge science.  But beyond the symbolism lies a much larger shift: the redefinition of life as editable code.

Synthetic biology is reshaping medicine, agriculture, energy, and conservation. Its potential is extraordinary. With appropriate governance, it can address longstanding global challenges — from vaccine equity to climate resilience.

The future of the genome does not belong to any one actor. It is a collective project, one that will require legal foresight, public engagement, and scientific responsibility.

This is a moment to design with intention. To create structures that ensure synthetic life enhances human and planetary well-being. We must shape the genome as a shared foundation — not just a tradable asset.

Vijhai Grayan is the Cyber, Tech and Space Fellow for Young Australians in International Affairs. He is a lawyer at a leading Australian technology company and an MBA candidate at the University of Sydney, where he received the Future Leaders Scholarship. With expertise in law, cyber, and technology, he is passionate about the rapid evolution of technology, its profound impact on global society, and its transformative potential to reshape international affairs.

Our 2025 Cyber, Tech and Space Fellow is sponsored by .au Domain Administration (auDA). For more information, visit their website here.