An IP Strategy for Genome Editing Technologies: How PtBio Uses the PCT to Bring Its Innovations from Japan to Global Markets

Interview with Mr. Keisuke Okuhara, Representative Director and CEO of PtBio Inc., about the company's use of the PCT System. This interview was conducted in June 2026 at the company's headquarters on the Hiroshima University campus, the Innovation Plaza (Higashihiroshima City)

Key Points

1. PtBio Inc. is a startup originating from Hiroshima University. Leveraging genome editing technologies and Bio DX, the company analyzes genomic information from a wide range of biological resources and is engaged in data-driven breeding and the creation of new biotechnology businesses. One of its flagship achievements is  a reduced-allergen egg in which ovomucoid, the principal protein responsible for egg allergies, has been removed through genome editing.
2. While numerous patents exist in the field of genome editing, such as CRISPR-Cas9, Hiroshima University's Platinum TALEN technology and ZF-ND1 can be used without infringing those patents. Having obtained an exclusive license from Hiroshima University, the company is applying the technology in the medical, food, and environmental fields.
3. The company uses the PCT System for international patent applications. In deciding where to enter the national phase, however, it considers not only major markets such as the United States and China, but also future business opportunities in Southeast Asia and India.

Could you tell us about your company's business?

PtBio Inc. is a startup established in 2019 based on technologies developed at Hiroshima University. Building on genome editing technologies developed by Professor Takashi Yamamoto, the company's Chief Technology Officer, and Bio-DX technology led by Professor Hidemasa Bono, the company’s Chief Scientific Officer, it is committed to solving social issues. By analyzing genomic information from diverse biological resources, the company is engaged in data-driven breeding and the creation of new biotechnology businesses.

One of its most notable achievements is a reduced-allergen egg in which ovomucoid, the principal protein responsible for egg allergies, has been removed through genome editing.

The company is also pursuing intellectual property (IP) protection for related technologies, including methods for detecting ovomucoid, heat-processing techniques, and chicken breeds.

In addition, the company is collaborating with a University in Malaya on research aimed at addressing water quality and odor problems through genome analysis. It is also working to accelerate the practical implementation of genome editing technologies in Southeast Asia and India.

What is your company's intellectual property strategy?

The field of genome editing is covered by a large number of patents, so we carefully investigate the patent landscape to avoid infringement before conducting our business. We have confirmed that Hiroshima University's Platinum TALEN technology does not use CRISPR-Cas9, which is currently subject to patent disputes. As Platinum TALEN is a different generation of genome-editing technology, the risk of becoming involve in such paten dispute is considered low.

For the restriction enzyme ND1, we developed ZF-ND1 by combining ND1 with Zinc Finger technology, whose key patents have expired. We obtained patents covering this technology and are conducting joint research with drug discovery startups.

Having obtained exclusive licenses from Hiroshima University for these technologies, we are pursuing applications in the medical, food, and environmental fields.

We also file patent applications jointly with Hiroshima University. More recently, we have filed patent applications for technologies developed in-house, including a method for estimating mutation introduction efficiency using genome editing tools.

How does your company use the PCT System?

For technologies originating from Hiroshima University, such as Platinum TALEN and ZF-ND1, as well as the method for analyzing off-target risk that was jointly filed with Hiroshima University, we have been pursuing foreign patent protection by using the direct PCT filing route [filing a PCT application without claiming priority of an earlier national or regional application].

However, in the case of ZF-ND1 (PCT/JP2019/033045), although the application entered the national phase in more than ten jurisdictions, including Europe, the United States, and China, it was not entered into the national phase in Thailand or India because, at the time of national-phase entry, we had not yet fully anticipated the importance of those markets. We have since revised our IP strategy to place greater emphasis on Southeast Asia and India through PCT applications.

We have established a framework that enables us to consider international patent protection from the research stage, with commercialization in mind. We also actively pursue overseas patent protection for inventions arising from collaborative research with universities.

As a general rule, the costs associated with foreign patent filings are covered through fundraising or from our own budget. However, securing sufficient funding for foreign filings remains a significant challenge for university startups. We are therefore exploring ways to reduce costs, including the use of generative AI to lower translation expenses.

We believe that one of our greatest strengths is the close collaboration between the university and our startup, which enables us to develop an intellectual property strategy focused on commercialization from the earliest stages of research.