BIOTECHNOLOGY-RELATED PATENTS

1. Concept of Biotechnology

(1) Definition of biotechnology

Biotechnology is a technology or study of utilizing of life functions. In other words, it is a technology or study, which yields products beneficial to humans by applying biological mechanisms to the technical or industrial processes. The life functions refer to hereditary, survival, growth, feedback, metabolism, information recognition, processing functions, etc. of a life form. Biotechnology is classified into old biotechnology which centers around conventional fermentation or plant breeding and new biotechnology which centers around genetic manipulations.

(2) Key technologies and technical characteristics of biotechnology

The new modern biotechnology uses the following key technologies as a means of using bio-functions: genetic engineering and technologies relating to cell fusion, cell culture, and enzymes.

1) Biotechnology is a technology to modify the genetic information of a life form.
The technology of genetic manipulations and cell fusion belong to this field. In terms of applications, it is another aspect of plant or animal breeding. As recent developments, the technology involving mutants of specific regions or protein synthesis belong to this field as well.

2) Biotechnology is a process of growing breeds of life forms of high-level functions in mass production or maximizing the functions thereof. The technology of cell culture in mass production or bioreactor belongs to this field. Accordingly, biotechnology leads to sound industry only if it effectively combines the technologies of breeding and processing. Meanwhile, the technology of artificial cloning by using the reproductive functions of advanced life forms has recently been taken up by the role of key technology in the field of new biotechnology.

2. Matter for Caution when filing A patent Application

(1) Academic database

For example, if a sequence were registered at the GenBank and immediately disclosed, it could be viewed as loss of novelty. Hence, the time of disclosure must be delayed until after a patent application is filed. In particular, if a sequence is disclosed at the GenBank and then later published in a research paper, the starting date in calculating the constructive novelty is the date of disclosure at the GenBank. Moreover, in the US and Europe, the systems of constructive novelty differ from that of Korea, and hence due care is warranted in setting the date of disclosure for a sequence.

(2) Depositing of microorganisms

1) Depositing microorganisms
With respect to the filing of a patent application relating to a microorganism, the microorganism must be deposited with a depository designated by the Commissioner of the Korean Intellectual Property Office or an international depository according to the Budapest Treaty, and the depository receipt thereof must be attached to the application. (Article 2 of the Enforcement Decree of the Patent Law)

※ Depository Institutions of microorganisms (Korea)
Korean Cell Line Research Foundation (KCLF)
Korean culture Center of Microorganisms (KCCM)
Korean Collection for type Cultures (KCTC)

2) Submission of sequence listing

ⅰ. Submission of sequence listing
At the time of filing of a patent application, a sequence listing along with its electronic file in
a format which can be read by a computer, should be submitted.

ⅱ. Scope of application of the submission requirement for sequence listing
The base sequence which comes under the submission requirement is a straight
sequence or a cyclical sequence, without side chains, consisting only of ten or more of nucleotides, each with a base or transformant base. Also coming into the submission requirement is an amino acid sequence, which is a straight sequence or a cyclical sequence, without side chains, having four or more of L-amino acids or their transformants in binding to form a protein commonly existing in nature.

ⅲ. Method of preparing sequence listing
The sequence listing should be prepared by KOPatnetIn, a freeware distributed by the Korean Intellectual Property Office (KIPO), according to the “Outlines of the Methods for Preparing and Submitting Sequence Listing for a Patent Application Involving a Nucleotide
or Amino Acid Sequence” (KIPO Notice No. 98-12). Since the outlines incorporate the WIPO standards of ST.25, the sequence listing prepared according to the outlines can satisfy not only the requirements in Korea but also the requirements of international search and preliminary examination authorities at the time of filing an international patent application. Also, it satisfies the requirements of respective designated countries thereafter.

3. Requirements for Patentability of Biotechnology

(1) Patentable subject in biotechnology

Obviously, an invention in the area of biotechnology requires industrial applicability, novelty and inventive step as is the case for inventions in other industries. Nevertheless, since inventions in this area have the potentials of causing moral or legal problems, there are limitations on patentable subjects therein. In particular, industrial applicability sometimes is a very important requirement in biotech-related inventions.

※ Table: Subject matters of protection according to the examination standards

Type
Subject
Patentability
Note

Product
Genes
(DNA sequence)
Patentable
Possible for cases where applicability has been shown
-mere genome sequence unpatentable (Note 1)

Proteins (amino
acid sequence)
Patentable

Microorganisms
( virus, bacteria, etc.)
Patentable
Compulsory deposition of relevant microorganisms

Animals
Patentable, but limited to those not contrary to public morality
Refer to Examination Standards for Animal-related Inventions

Plants
Patentable for plant variants which can be reproduced asexually
Artucle 31 of the Patent Law (Plant for Patent Invention)

Human body parts
Unpatentable
Exclusive of inventions, which harm human dignity, from patentable subjects

Process
Operations, treatment methods
Unpatentable for huaman, patentable for animals
The treatment and diagnostic methods for human are medical acts, which are deemed to lack industrical appplicability(Article 29(1)) of the Patent Law.(Note2)

Gene therapy
Unpatentable for huaman, patentable for animals

Methods of diagnosis
Unpatentable for huaman, patentable for animals

(Source : Guide to Biotechnology, published by the Korean Industrial Property Office)

Note 1) Where applicability is shown, it is patentable, but with a mere genome sequence, it is unpatentable.

With respect to this requirement, there was an international controversy for patentability of expressed sequence tags (ESTs).
＊An expressed sequence tag (EST) is defined as a short fragment (generally 150~500 base pairs) corresponding to the portion of a gene, in which the structure and the functions thereof have not been identified. The crux of the problem is the standards of determining applicability with respect to gene fragments such as ESTs.

Note 2) The treatment and diagnostic methods of humans are medical acts and hence are deemed to be without industrial applicability. (Article 29(1) of the Patent Law)

Consequently, the gene therapy on humans, which has attracted active research in the recent years, is a treatment method which is unpatentable. However, if it is claimed as a product such as a vector for gene therapy, then it may be a patentable subject.

(2) Examination Standards for Biotechnology

For effective examinations, the Korean Intellectual Property Office established “Examination Standards in Biotechnology,” which became applicable on March 1 of 1998, and the Examination Standards were revised in December 29 of 2000 and took effect on January 1, 2001.

※ Main points of revised examination standards

1) Standards for determining patentability of HGP products (DNA fragments, SNP, etc.)

ⅰ. Industrial applicability
ⅰ) The utility as a probe for obtaining a full-length DNA is deemed to be without industrial applicability.
ⅱ) If the specification merely states that it could be used in a forensic test, it is deemed to be without industrial applicability.
ⅲ) If the relationships with any specific disease are explained in detail in the specification, and if the product could be used in diagnosis of a specific disease, etc., the fact proven experimentally, then the industrial applicability is deemed to exist therein.

ⅱ. Inventive step
If the specification merely specifies that it is a gene of a specific protein by way of using
the results of homologous search, it is deemed to lack inventive step.

2) Standards for determining unity of application in response to a voluminous
application

ⅰThe standards for determining unity are consistent with the examination guide
ⅰ) The unity of application is determined by determining whether there exists technical characteristics.
ⅱ) The special technical characteristics should be improvements, which are distinguishable from prior arts.

ⅱ Similarity in origin does not make special technical characteristics. An application involving multiple genes, shown as a result of genome analysis to have different functions though they are of the same origin, is in violation of the rule of unity.

3) Decisions and examples relating to recent biotech inventions

ⅰ. Genes
Where there is an illustration of a variant in the detailed description of an invention, the claims limiting the scope of the variant and the functions of the corresponding gene are sustained.
ⅱ. Proteins
ⅰ) Where there is an illustration of a variant in the detailed description of an invention, the claims limiting the scope of the variant and the functions of the corresponding protein are recognized.
ⅱ) If the sequence is unspecifiable, an application which specifies the descriptions of functions, physicochemical properties, origins, and the preparation methods is recognized.
ⅲ. Monoclonal antibody
If an antigen satisfies the requirements for patentability, the monoclonal antibody specified by said antigen is also recognized.
ⅳ. Establishment of examination standards for antisense
The description requirements for patent claims and specification were added.
ⅴ. Examples of recognizing novelty were added.

1. Concept of Biotechnology

(1) Definition of biotechnology

Biotechnology is a technology or study of utilizing of life functions. In other words, it is a technology or study, which yields products beneficial to humans by applying biological mechanisms to the technical or industrial processes. The life functions refer to hereditary, survival, growth, feedback, metabolism, information recognition, processing functions, etc. of a life form. Biotechnology is classified into old biotechnology which centers around conventional fermentation or plant breeding and new biotechnology which centers around genetic manipulations.

(2) Key technologies and technical characteristics of biotechnology

The new modern biotechnology uses the following key technologies as a means of using bio-functions: genetic engineering and technologies relating to cell fusion, cell culture, and enzymes.

1) Biotechnology is a technology to modify the genetic information of a life form.
The technology of genetic manipulations and cell fusion belong to this field. In terms of applications, it is another aspect of plant or animal breeding. As recent developments, the technology involving mutants of specific regions or protein synthesis belong to this field as well.
2) Biotechnology is a process of growing breeds of life forms of high-level functions in mass production or maximizing the functions thereof. The technology of cell culture in mass production or bioreactor belongs to this field. Accordingly, biotechnology leads to sound industry only if it effectively combines the technologies of breeding and processing. Meanwhile, the technology of artificial cloning by using the reproductive functions of advanced life forms has recently been taken up by the role of key technology in the field of new biotechnology.

2. Matter for Caution when filing A patent Application

(1) Academic database
For example, if a sequence were registered at the GenBank and immediately disclosed, it could be viewed as loss of novelty. Hence, the time of disclosure must be delayed until after a patent application is filed. In particular, if a sequence is disclosed at the GenBank and then later published in a research paper, the starting date in calculating the constructive novelty is the date of disclosure at the GenBank. Moreover, in the US and Europe, the systems of constructive novelty differ from that of Korea, and hence due care is warranted in setting the date of disclosure for a sequence.

(2) Depositing of microorganisms

1) Depositing microorganisms
With respect to the filing of a patent application relating to a microorganism, the microorganism must be deposited with a depository designated by the Commissioner of the Korean Intellectual Property Office or an international depository according to the Budapest Treaty, and the depository receipt thereof must be attached to the application. (Article 2 of the Enforcement Decree of the Patent Law)

※ Depository Institutions of microorganisms (Korea)
Korean Cell Line Research Foundation (KCLF)
Korean culture Center of Microorganisms (KCCM)
Korean Collection for type Cultures (KCTC)

2) Submission of sequence listing

ⅰ. Submission of sequence listing
At the time of filing of a patent application, a sequence listing along with its electronic file in a format which can be read by a computer, should be submitted.

ⅱ. Scope of application of the submission requirement for sequence listing
The base sequence which comes under the submission requirement is a straight
sequence or a cyclical sequence, without side chains, consisting only of ten or more of nucleotides, each with a base or transformant base. Also coming into the submission requirement is an amino acid sequence, which is a straight sequence or a cyclical sequence, without side chains, having four or more of L-amino acids or their transformants in binding to form a protein commonly existing in nature.

ⅲ. Method of preparing sequence listing
The sequence listing should be prepared by KOPatnetIn, a freeware distributed by the Korean Intellectual Property Office (KIPO), according to the “Outlines of the Methods for Preparing and Submitting Sequence Listing for a Patent Application Involving a Nucleotide
or Amino Acid Sequence” (KIPO Notice No. 98-12). Since the outlines incorporate the WIPO standards of ST.25, the sequence listing prepared according to the outlines can satisfy not only the requirements in Korea but also the requirements of international search and preliminary examination authorities at the time of filing an international patent application. Also, it satisfies the requirements of respective designated countries thereafter.

3. Requirements for Patentability of Biotechnology

(1) Patentable subject in biotechnology

Obviously, an invention in the area of biotechnology requires industrial applicability, novelty and inventive step as is the case for inventions in other industries. Nevertheless, since inventions in this area have the potentials of causing moral or legal problems, there are limitations on patentable subjects therein. In particular, industrial applicability sometimes is a very important requirement in biotech-related inventions.

※ Table: Subject matters of protection according to the examination standards

Type
Subject
Patentability
Note

Product
Genes
(DNA sequence)
Patentable
Possible for cases where applicability has been shown
-mere genome sequence unpatentable (Note 1)

Proteins (amino
acid sequence)
Patentable

Microorganisms
( virus, bacteria, etc.)
Patentable
Compulsory deposition of relevant microorganisms

Animals
Patentable, but limited to those not contrary to public morality
Refer to Examination Standards for Animal-related Inventions

Plants
Patentable for plant variants which can be reproduced asexually
Artucle 31 of the Patent Law (Plant for Patent Invention)

Human body parts
Unpatentable
Exclusive of inventions, which harm human dignity, from patentable subjects

Process
Operations, treatment methods
Unpatentable for huaman, patentable for animals
The treatment and diagnostic methods for human are medical acts, which are deemed to lack industrical appplicability(Article 29(1)) of the Patent Law.(Note2)

Gene therapy
Unpatentable for huaman, patentable for animals

Methods of diagnosis
Unpatentable for huaman, patentable for animals

(Source : Guide to Biotechnology, published by the Korean Industrial Property Office)

Note 1) Where applicability is shown, it is patentable, but with a mere genome sequence, it is unpatentable.

With respect to this requirement, there was an international controversy for patentability of expressed sequence tags (ESTs).
＊An expressed sequence tag (EST) is defined as a short fragment (generally 150~500 base pairs) corresponding to the portion of a gene, in which the structure and the functions thereof have not been identified. The crux of the problem is the standards of determining applicability with respect to gene fragments such as ESTs.

Note 2) The treatment and diagnostic methods of humans are medical acts and hence are deemed to be without industrial applicability. (Article 29(1) of the Patent Law)

Consequently, the gene therapy on humans, which has attracted active research in the recent years, is a treatment method which is unpatentable. However, if it is claimed as a product such as a vector for gene therapy, then it may be a patentable subject.

(2) Examination Standards for Biotechnology

For effective examinations, the Korean Intellectual Property Office established “Examination Standards in Biotechnology,” which became applicable on March 1 of 1998, and the Examination Standards were revised in December 29 of 2000 and took effect on January 1, 2001.

※ Main points of revised examination standards

1) Standards for determining patentability of HGP products (DNA fragments, SNP, etc.)

ⅰ. Industrial applicability
ⅰ) The utility as a probe for obtaining a full-length DNA is deemed to be without industrial applicability.
ⅱ) If the specification merely states that it could be used in a forensic test, it is deemed to be without industrial applicability.
ⅲ) If the relationships with any specific disease are explained in detail in the specification, and if the product could be used in diagnosis of a specific disease, etc., the fact proven experimentally, then the industrial applicability is deemed to exist therein.

ⅱ. Inventive step
If the specification merely specifies that it is a gene of a specific protein by way of using
the results of homologous search, it is deemed to lack inventive step.

2) Standards for determining unity of application in response to a voluminous application

ⅰThe standards for determining unity are consistent with the examination guide
ⅰ) The unity of application is determined by determining whether there exists technical characteristics.
ⅱ) The special technical characteristics should be improvements, which are distinguishable from prior arts.

ⅱ Similarity in origin does not make special technical characteristics. An application
involving multiple genes, shown as a result of genome analysis to have different functions
though they are of the same origin, is in violation of the rule of unity.

3) Decisions and examples relating to recent biotech inventions

ⅰ. Genes
Where there is an illustration of a variant in the detailed description of an invention, the claims limiting the scope of the variant and the functions of the corresponding gene are sustained.
ⅱ. Proteins
ⅰ) Where there is an illustration of a variant in the detailed description of an invention, the claims limiting the scope of the variant and the functions of the corresponding protein are recognized.
ⅱ) If the sequence is unspecifiable, an application which specifies the descriptions of functions, physicochemical properties, origins, and the preparation methods is recognized.
ⅲ. Monoclonal antibody
If an antigen satisfies the requirements for patentability, the monoclonal antibody specified by said antigen is also recognized.
ⅳ. Establishment of examination standards for antisense
The description requirements for patent claims and specification were added.
ⅴ. Examples of recognizing novelty were added.

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