The
world is focused on overcoming human biological limitations and inventing
technologies for healthy living. Amid this trend, biotechnology is attracting
attention as a representative field that will solve humanity's long-cherished aspirations
and homework in the 21st century. In this issue, we will look at the status of
patent applications for biotechnology, ethical issues and other issues, and
patent management strategies for biotechnology in the global environment(1)
based on various patent standards of countries.
First,
let's look at the definition and concept of biotechnology inventions. The
European Patent Convention defines biotechnology inventions as ‘products
consisting of biological material’ or ‘products containing biological
material’. This refers to inventions related to the process of producing,
processing, or using DNA sequences, genes, proteins, or biological materials.
Additionally, biological material refers to any material that contains genetic
information and can reproduce or reproduce on its own in a biological system.
This includes living organisms as well as biological tissue and DNA.
Biotechnology patents are patents for biotechnology inventions, including
plants, animals, human cells, tissues, and organs, or genetically modified
animals, plants, and genetically modified seeds.
Biotechnology patents with many things to consider
Over
the past few decades, biotechnology has grown rapidly and ranks among the top
10 technology fields, accounting for approx. 4% of the total number of
applications filed at the EPO.
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| Number of EPO biotech applications and its increase/decrease rates by year |
Applications in the biotechnology field range from microorganisms to agricultural and medical patents. When registering patents for biotechnology inventions, not only legal and economic aspects but also ethical and social aspects are considered. Sometimes, social controversies and issues arise as various opinions clash as to whether an applied invention is truly suitable for a patent. Examples include genetically modified plants (GMOs), animal cloning, or the use of human embryonic stem cells.
In
biotechnology field, basic procedures such as ‘gene isolation’ are essential
for research. For example, polymerase chain reaction (PCR) is a basic process
in genetic engineering that can amplify extremely small amounts of DNA as
desired. A number of patents have been applied for on the subject of this PCR.
Patents about PCR were licensed to other researchers, making it easier to use PCR, and as a result, many researchers were able to actively conduct other research. This can be seen in the exponential increase in the number of scientific papers referencing PCR technology that appeared between 1987 and 1997 following the announcement of the PCR patent. Typically, research costs may increase because patent fees must be paid when using a license, and this cost will act as an important factor in research.
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EPO
respects traditional knowledge
In
order to prevent the indiscriminate privatization of traditional knowledge, the
EPO goes through a process to check whether the subject of the application
corresponds to the traditional knowledge of a specific country when granting a
patent. In this case, EPO uses specialized databases such as the Traditional
Knowledge Digital Library of India (TKDL). In 2009, the EPO signed an agreement
with the Government of India to get online access to this database. In
addition, EPO also refers to Asian data that describes traditional knowledge of
Asian countries.
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| (left) Indian Traditional Knowledge Digital Library (TKDL)/ (right) EPO's Asian patent information database |
Biotechnology stands on the standards of ethics
The
EPO strictly adheres to the European Patent Convention, which serves as its
legal basis, and considers ethical issues when granting patents. The law (EPC article
53) sets out several exceptions where patents may not be granted for ethical
reasons. These include human cloning, modifying human genome, and use of human
embryos. Below table shows that patentable and non-patentable inventions in the
biotechnology presented by the EPO.
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| EPO's list of patentable biotech inventions and non-patentable biotech inventions |
The EPO does not grant patents on genes with no known activity or on unidentified gene fragments. Additionally, for a human gene, the activity of the gene must be described in the application and must be meaningful as a patent, not just a discovery. There must be a medically important benefit, and the application will be rejected if it conflicts with ethical issues without proof of gene function.
It is possible to obtain a patent under the law even if the animal's genes have been modified, but most of the related applications submitted to the EPO concern genetically modified mice used in medical research. The EPO applies ethical standards to this. If a modified genetic invention is found to cause suffering to animals, it can only be patented only for the case ‘provides substantial medical benefit to humans or animals.’
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Dispute issue: a genome editing tool CRISPR-Cas9 and patent rights
CRISPR-Cas9,
called the third generation genetic scissors, is a genome editing technology
that uses cutting enzymes to remove the DNA that causes disease in the human
body and treats the disease by recombining and editing the desired gene in its
place. CRISPR-Cas9 is attracting attention as a historic invention that saves
humanity from disease and creates a new future.
(*CRISPR- Clustered Regularly Interspaced Short Palindromic Repeats)
The first people to announce CRISPR-Cas9 were Professor Jennifer Anne Doudna of UC Berkeley and Professor Emmanuelle Marie Charpentier, who were in the same lab at the time. They were honored as joint recipients of the Nobel Prize in Chemistry in recognition of their achievements in 2020. However, even though UC Berkeley applied for the technology using genetic scissors earlier in 2012, the Broad Institute, which applied later in 2013, obtained a patent before UC Berkeley by using the expedited review system, leading to a long dispute between UC Berkeley and Broad Institute (MIT and Harvard Univ.) over the patent rights for CRISPR-Cas9.
This legal battle, which began in 2015, is still ongoing, focusing on the infringement review by the U.S. Patent and Trial Board (PTAB) (2). Following is the argument of each research institute during the second round of the patent dispute.
▶UC Berkeley: Through infringement proceedings under U.S. patent law, the CRISPR-Cas9 system that operates in eukaryotic cells is included in UC Berkeley's patent claims.
▶The Broad Institute (MIT, Harvard): A technician with ordinary knowledge who can understand the differences between prokaryotic cells and eukaryotic cells cannot expect the CRISPR-Cas9 gene editing function to be successful in the eukaryotic cell environment.
- Recognized as 'Broad Institute have priority' by the U.S. Patent and Trial Board
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| UC Berkeley vs Broad Institute |
The outcome of this dispute is expected to have a ripple effect enough to reorganize the global CRISPR licensing market. The CRISPR-Cas9 patent battle can be referred to be a volume war that combines financial power, original research capabilities, and the ability to effectively conduct litigation in foreign countries with different patent systems and procedures. Furthermore, if the market value of the CRISPR-Cas9 invention is overwhelmingly large, patent disputes are expected to expand to other countries and not be limited to the United States or EPO. In fact, CRISPR-Cas9 patent disputes are beginning not only in the United States and Europe, but also in China and Japan.
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< Biotechnology patent management strategy in a global environment >
1. Review the
aspects that can be socially and ethically discussed during patent examination.
Also, prepare evidence to persuade that the invention meets social and ethical
standards and countermeasures to counterarguments.
2. Manage the
schedule, cost, and funds of the research project reasonably through a patent
license agreement appropriate for the purpose.
3. Conduct
research that does not infringe traditional knowledge monitoring global patent
databases. Use various databases from each country to plan original research.
4. In-depth
search of prior arts and trial precedents. Submit application conforming to
patent eligibility.
5. Understand
different patent standards and systems/laws in detail by country. Secure
capabilities to respond to global conflicts
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1. Full text excerpt: Patent management: protecting intellectual
property and innovation 2021, Oliver Gassmann, Martin A. Bader, Mark James
Thompson, Springer
2. The Dong-A Ilbo, article “The MIT-Harvard team won the second round
of the genetic scissors patent dispute.”
The Dong-A Ilbo (www.donga.com), https://www.donga.com/news/article/all/20220306/112194171/1
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