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What Are the Next Steps for Gene Editing Technology -- from the Perspective of Patent

06

JAN

2019

In recent days, a report on genetically edited babies has attracted a lot of attention and has been spread in major media. According to the report, “the first genetically edited babies who can resist possible future infection with HIV” were born. Thus, it seems that Pandora’s box has been opened. The plot that once appeared in the movie happened to be around us. Subsequently, the “gene-edited babies” event encountered Rashomon. Experts and scholars around the world have expressed their views on such an issue as ethics and morality.

So, what is gene editing technology? What is the patent filing status of gene editing technology relevant patents? What problems might be faced from the perspective of patents? What are the current disputes about gene editing technology? This article will discuss these issues.

What is Gene Editing Technology?

Gene editing technology, known as “the scissors of God,” it is a vivid description, usually referring to the insertion, deletion, modification or substitution of DNA in a living organism. Gene editing techniques are able to target these operations to specific sites in the genome.

When it comes to current gene editing technology, nucleases play an important role in the use of nucleases to generate site-specific double-strand breaks at desired positions in the genome, followed by biological methods to repairing the double-strand breaks. A nuclease is a type of hydrolase that cleaves a phosphodiester bond in a polynucleotide, and the phosphodiester bond is a “bridge” between nucleotides in the polynucleotide. There are roughly four types of nucleases: zinc finger nucleases (ZFNs), transcriptional activation-like effector nucleases (TALENs), homing endonucleases, and CAS endonucleases (CRISPR-Associated endonuclease). Among them, CRISPR/Cas9 is one of the most advanced “molecular scissors,” and Professor Dr. Feng Zhang has made significant contributions in this field.

Gene editing technology can be applied to medical area (such as treatment of cancer or autoimmune diseases), agriculture, food and other fields. As a disruptive technology innovation in the field of biotechnology in those years, it is expected to become the technology which may win the Nobel Prize in the future.

Patent Filing Status of Gene Editing Technology in China

As a technology with great application prospects and value in the industry, how about the filing of patent applications on gene editing? In order to be more targeted, we mainly focus on CRISPR/Cas9 gene-edited technology from the number of patent applications in China, the ranking of domestic applicants, technical subdivision, etc. (data source: Incopat; data information until Dec 20th, 2018)

Figure 1: patent applications in China

According to Figure 1, since 2012, the number of applications in China involving this topic has been growing rapidly, which is consistent with relevant global growth trends. In addition, in general, patent applications need to be published after 18 months, and we cannot obtain relevant information before the patent application is published. Therefore, the data in 2017-2018 is not complete.

Figure 2: Applicant ranking in China

According to Figure 2, Massachusetts Institute of Technology where Professor Zhang is working has carried out a well-planned patent strategy in China. At the same time, Chinese universities and research institutes represented by the Institute of Genetics and Developmental Biology of the Chinese Academy of Sciences and Shanghai Jiaotong University also have outstanding performances in this field.

Figure 3: Domestic applicants ranked in China

It can be seen from Figure 3 that, for the CRISPR/Cas9 technology, universities and research institutes are the main research forces. Therefore, it seems like that China’s CRISPR/Cas9 technology is currently in the initial stage of industrialization.

Figure 4: Application status by provinces

In Figure 4, most of the patent applications in this technical field are currently from Beijing, Shanghai, Jiangsu and Guangdong.

Figure 5. Technical decomposition Diagram

According to Figure 5, the subject matters for patenting are diverse, and the protection themes that different applicants focus on are also distinct. So, did the researcher of gene-edited babies file any patent application(s) in gene editing field? It is found that he has applied for more than ten patent applications in china, but it doesn’t seem to be directly related to CRISPR (there is also the possibility that the application has not been disclosed), and most of the applications are related to immunization and sequencing technologies.

Potential Challenges from the Perspective of Patent

At present, the debate about “gene-edited babies” is mainly focused on ethics. Then, from the perspective of patent application, what problems, even warning limit or “red lines” may exist in writing a patent application?

Ethics. According to Article 5.1 of the PRC Patent Law, no patent right shall be granted for any invention if its disclosure, use or manufacture is contrary to the laws or social morality or detrimental to public interest. Patent Examination Guidelines further clarify that the application of industrial or commercial purposes of human embryos falls within the scope of such inventions that violate “social morality.”

Access to genetic resources. According to Article 5.2 of the PRC Patent Law, no patent right shall be granted for any invention where acquisition or use of the genetic resources, on which the development of the invention relies, is not consistent with the provisions of the laws and administrative regulations. For those inventions involving gene editing, the legal acquisition of genetic resources is also a significant issue due to the manipulation of genes.

Patent Eligibility of Subject Matter. In China, methods for diagnosis or for treatment of diseases as well as animal and plant varieties belong to the non-patent eligible subject matter under Article 25.1.3. Therefore, methods for diagnosing or treating diseases by gene editing technology and animals or plants obtained by this technique fall within the scope of non-patent eligible subject matter.

Practicality. Surgical procedures with non-therapeutic purposes performed on humans or animals are considered to be not practically applicable. In addition, to meet this requirement, it is also necessary for an invention to be reproducible and applicable industrially. Therefore, if the experiment shows the CRISPR/Cas9 technology is only effective to a particular individual, or there is a high possibility of off-target, which cannot be repeated or applied in the industry, the invention is also potentially faced with practicality issues.

Patent Disputes Related to Gene Editing Technology

Due to the great value and influence of this technology, the patent ownership dispute is also one of the focuses in this field.

The pioneers in the field, Professor Dr. Jennifer Doudna of the University of California at Berkeley and Professor Dr. Feng Zhang of the Massachusetts Institute of Technology attach great importance to the patent filing of CRISPR/Cas9 gene editing technology, and both of them actively carry out patent portfolio management in the United States. Professor Zhang skillfully took the advantage of the relevant provisions of the US patent application review and obtained authorization earlier in the United States. Currently, patent litigation between the two scientists is still in progress.

In China, up to now, it appears that there are no patent invalidations or litigations for genetic editing including CRISPR/Cas9.

Outlook

As the patent applications related to gene editing submitted in recent years have entered procedures for substantive examination, the examination standards will become clearer. Moreover, gene editing technology is still in a stage of rapid development. With the increase in the number of patent applications and authorizations in this field, its industrial application will be more extensive, and commercialization will be more active. At present, activities such as patent licensing between research institutions and enterprises have been gradually carried out, and it is believed that the value of gene editing technology will be more comprehensively realized in the future.

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