BIOTECHNOLOGY PATENTS: GENE AND PROTEIN SEQUENCING

INTERLLECTUAL PROPERTY RIGHTS

RESEARCH PAPER

SUBMITTED BY: SUBMITTED TO:

SANDEEP KUMAR MINJ Dr. M.R. Sreenivasa Murthy

ROLL NO: 830 Associate Professor of Law

SEMESTER: 7th SEC: B NUSRL RANCHI

NATIONAL UNIVERSITY OF STUDY AND RESEARCH IN LAW, RANCHI

 INTRODUCTION

Biotechnology comprises any technology that uses living entities, in particular animals, plants or
microorganisms. According to the Organization for Economic Cooperation and Development
(OECD) biotechnology includes any technique that uses living organisms (or parts of organisms)
to make or modify products, to improve plants or animals, or to develop microorganisms for
specific uses.1
Biotechnological inventions can be classified broadly into the following categories: (a) inventions
relating to an organism or material such as living entities of natural or artificial origin (animals,
plants, and microorganisms), biological material (plasmids, viruses and replicas, and parts of
organs, tissues, cells, and organelles), and naturally occurring substances from living entities,
biological material and parts thereof; (b) inventions relating to the process for the creation of a
living organism or production of other biological materials; and (c) inventions relating to the use
of such organisms or biological materials.
Its pharmaceutical applications include production of regulatory protein, blood products, vaccines,
antibiotics, monoclonal antibodies, and DNA hybridization probes. Biotechnology has contributed
to the diagnosis, prevention and control of animal diseases, animal nutrition and growth promotion,
and genetic improvement of animal breeds.
Biotechnology has emerged as one of the most important domains of patenting. It is also one of
the most important areas of conflict between developing and developed economies. Advances in
the life sciences and pharmaceutical sector have had an impact on life expectancy and the quality
of life as most modern medicines are based on biotechnology. One of the earliest bio medicaments
was insulin, a life-saving drug for diabetics. Many anti-cancer drugs based on patented human
gene sequences are prolonging the lives of cancer patients, such as Herceptin for breast cancer and
Avastin, for colon and other cancer. Humira, a patented medicine based on human gene sequences
used to treat auto-immune diseases such as arthritis, was the world's best-selling medicine in 2014.
Drug companies would not be able to fund costly clinical trials and research without being able to
claim exclusive rights to recoup these investments. Patents are also an effective barrier to illicit
copying of medicines and the health risks associated with unauthorized copycat versions.

1
Patents and Innovation: Trends and policy challenges. OECD, Paris, 2004.
This research project will aim to analyze the conditions for the patentability of biotechnological
inventions with reference to the Indian Patents Act. Further, the research will be mainly focused
towards gene sequencing and protein sequencing under the wider ambit of biotechnology.

PATENTING OF BIOTECHNOLOGICAL INVENTIONS

Biotechnology patents fall under the scope of utility patents. A utility patent is available for an
invention or discovery of a new and useful machine, manufacturing process, composition of
matter, or process. This type of patent is also available for improvements to a process that are
considered new and useful. Despite the critical role that biotechnology plays in saving, improving,
and extending human life, there is an extremely complicated process behind the work of patenting
these scientific ideas and advancements.

When an inventor applies for a patent, they must demonstrate that their creation meets certain
eligibility requirements. In terms of novelty, the complication for a biotechnologist is
demonstrating that their creation is a ‘new’ process rather than merely a natural one. The process
also involves having an inventor demonstrate that their invention is the first in the world to do its
specified action. While any invention in the field of technology can feasibly be eligible for a patent,
the patentability of biological materials is often a source of controversy. Some argue that such
biological materials are mere discoveries, and therefore not patentable. Others argue that certain
biological materials are man-made inventions, and are therefore patentable.

Another source of complexity regarding biotechnological inventions results from the fact that
biological material is capable of reproducing itself. The potential for this shift invokes several
complications, as one can imagine. For example, a biological material may be patented as it is one
moment, but might change or morph the next moment. This would beg the question of whether the
patent covers the shift or stops point blank at the invention pre-shift.

Significant investment in the biotechnology has been attributable to the patenting system which
first officially started to allow patents for living matter such as microorganisms in 1980 in the case
of Diamond vs Chakrabarty2 which changed the direction of patent laws in the US by holding

2
Diamond vs Chakrabarty, (1980) 26 USPQ 193.
claim to a bacterium valid. At first his patent application was rejected which on further appeal was
granted by the court with order stating "His claim is not to a hitherto unknown natural
phenomenon, but to a non-naturally occurring manufacture or composition of matter-a product of
human ingenuity".

Jurisdictions such as the European Union have even created specific Directives in order to clarify
and harmonize the law in relation to biotechnology patents.3 The Directive for instance clarifies
that human genes, plants and animals are patentable when all conditions for a patent are fulfilled.
Such forms of specific legislation remove the obstacles in front of the judiciary by giving them a
clear direction in regards to biotechnology and it leads to the prevention of conflicting decisions
by different courts leading to a harmonized legal system. The European Patent Convention further
specifies that inventions in relation to human cloning, modification of the human genome and
commercial uses of human embryos will not be granted patents on the basis of ethical and morality
reasons.4

Standards of novelty and non-obviousness are difficult to set for living organisms. Most developed
countries now recognise that novelty is met if the claimed biotechnological product or process
does not exist in the prior art. Sufficiency of disclosure is met for microorganisms by depositing
microorganisms in any of the internationally recognised depository under the Budapest Treaty.
Article 27(2) of the TRIPS Agreement has excluded certain inventions from patentability on the
ground of morality. These include protection to human, animal or plant life or health or to avoid
serious prejudice to the environment. Article 27(3) of the TRIPS Agreement further allows
members to exclude from patentability diagnostic, therapeutic, and surgical methods for the
treatment of human or animals, plants, and essential biological processes for the production of
plants and animals. However, members must provide opportunity for patenting of microorganisms
and non-biological and microbiological processes.

3
Directive 98/44/EC of the European Parliament and of the Council of July 6 th 1998 on the legal protection of
biotechnological inventions (OJ EC L 213/13).
4
Article 53, European Patent Convention.
 BIOTECHNOLOGY PATENTS IN INDIA
Under the Patent Act 1970, every invention must pass a two-step test in order to be patentable –
namely, it must:

● not fall in any of the categories specifically excluded under Section 3 of the Patent Act;
and
● pass the well-known three-pronged test of novelty, inventive step and industrial
applicability.

The Indian Patent Act contains a multitude of provisions under Section 3 that can be used be used
to obstruct the granting of patents to biotechnological inventions. These include inventions for
which the primary or intended use or commercial exploitation is contrary to public order or
morality or which causes serious prejudice to human, animal or plant life or health or to the
environment are unpatentable.5
Discoveries of living things or non-living substances occurring in nature are not patentable subject
matter.6 Thus, micro-organisms isolated from nature and DNA, RNA or proteins isolated from
living organisms are unpatentable. This provision of non-patentability is common to patent laws
of other countries. Although naturally occurring microorganisms are unpatentable, genetically
modified micro-organisms and vaccines are patentable, subject to other requirements. Synergistic
compositions of new or known micro-organisms can also be patentable, as can processes for
isolating such substances. To remove any ambiguity, the act was amended in 2002 to include
“biochemical, biotechnological and microbiological processes” within the definition of potentially
patentable chemical processes. In Dimminaco7 the court clarified that if the end product is a
commercial and vendible entity, the presence of the living organism in the end product cannot be
a bar to patentability of the process.
A new form of a known substance is unpatentable unless it differs significantly in properties with
regard to the known efficacy. This provision essentially prevents the evergreening of patents
through trivial modifications or incremental innovations.8 The Supreme Court provided some

5
Section 3(b), Indian Patent Act, 1970.
6
Section 3(c), Indian Patent Act, 1970.
7
Dimminaco A.G. v. Controller of Patents Designs, (2002) I.P.L.R. 255 (Cal).
8
Section 3(d), Indian Patent Act, 1970.
guidelines for the interpretation of the scope of this section in its well-known Glivec9 judgment
(2013). The court observed that the provision sets a higher invention threshold for medicines and
drugs and other chemical substances. The term ‘efficacy’ is not defined in the act. The court held
‘efficacy’ to mean “the ability to produce a desired or intended result”. The efficacy test depends
on the function, utility or purpose of the product under consideration. Thus, a medicine will
undergo a test for therapeutic efficacy. A mere change of form of a chemical substance with
properties inherent to that form would not qualify as enhancement of efficacy of a known
substance.
Further, plants and animals in whole or any parts thereof other than micro-organisms but including
seeds, varieties and species along with essentially biological processes for production or
propagation of plants and animals are non-patentable under the Act.10 Although the act does not
define an ‘essentially biological process’, in Monsanto (2013) the Intellectual Property Appellate
Board (IPAB) provided some guidelines on what constitutes one. The IPAB agreed with
Monsanto’s submission that the plant cell in the claimed process was transformed as a result of
human intervention in the manner claimed in the application, and was therefore patentable. Thus,
although genetically modified plants or seeds are not patentable in India, processes for the genetic
modification of plants are patentable.
This provision differs from the patent laws of countries like the US, the European Union that
follow liberal patent standards and where patents are also granted to genetically modified animals
and plant varieties.

GENE AND PROTEIN SEQUENCING

Protein sequencing

Protein sequencing is the practical process of determining the amino acid sequence of all or part
of a protein or peptide. This may serve to identify the protein or characterize its post-translational
modifications. Typically, partial sequencing of a protein provides sufficient information (one or

9
Novartis v. Union of India, Civil Appeal No. 2706-2716 of 2013.
10
Section 3(j), Indian Patent Act, 1970.
more sequence tags) to identify it with reference to databases of protein sequences derived from
the conceptual translation of genes.

The two major direct methods of protein sequencing are mass spectrometry and Edman
degradation using a protein sequenator (sequencer). Mass spectrometry methods are now the most
widely used for protein sequencing and identification but Edman degradation remains a valuable
tool for characterizing a protein's N-terminus.

Under appropriate circumstances, it should be possible to obtain commercially significant patent

protection for certain aspects of a protein structure. Although case law has held that data sets per
se are not patentable, they may be protected indirectly by associating the data set with a particular
physical structure or use. For example, it may be possible to protect the three-dimensional structure
of a protein or a portion of that protein when the requisite data set is included in a computer-
readable memory.

In theory, a new protein structure may still be patentable even if the structures of homologous
proteins, such as naturally occur-ring isoforms or species or allelic variants, are known. However,
the scope of any available patent protection may be very narrow as the new structure would have
to independently satisfy the triple test of patentability.

Gene Sequencing

DNA sequencing is the process of determining the nucleic acid sequence – the order of nucleotides
in DNA. It includes any method or technology that is used to determine the order of the four bases:
adenine, guanine, cytosine, and thymine. The advent of rapid DNA sequencing methods has
greatly accelerated biological and medical research and discovery.11

Knowledge of DNA sequences has become indispensable for basic biological research, and in
numerous applied fields such as medical diagnosis, biotechnology, forensic biology, virology and
biological systematics. Comparing healthy and mutated DNA sequences can diagnose different
diseases including various cancers,12 characterize antibody repertoire,13 and can be used to guide

11 Behjati S, Tarpey PS (December 2013). "What is next generation sequencing?". Archives of Disease in Childhood. Education and Practice Edition.
12 Chmielecki J, Meyerson M (14 January 2014). "DNA sequencing of cancer: what have we learned?". Annual Review of Medicine. 65 (1): 63–79.
13 Abate AR, Hung T, Sperling RA, Mary P, Rotem A, Agresti JJ, et al. "DNA sequence analysis with droplet-based microfluidics". Lab on a Chip.
patient treatment. Having a quick way to sequence DNA allows for faster and more individualized
medical care to be administered, and for more organisms to be identified and cataloged.14

The rapid speed of sequencing attained with modern DNA sequencing technology has been
instrumental in the sequencing of complete DNA sequences, or genomes, of numerous types and
species of life, including the human genome and other complete DNA sequences of many animal,
plant, and microbial species.

The first DNA sequences were obtained in the early 1970s by academic researchers using laborious
methods based on two-dimensional chromatography. Following the development of fluorescence-
based sequencing methods with a DNA sequencer,15 DNA sequencing has become easier and
orders of magnitude faster.16

Gene patents are among the most contentious, opaque and poorly understood aspects of modern
IP. Inventions and products or services that hinge on knowledge of or direct use of the sequences
that make up genetic material, typically DNA, or the proteins that genes encode, are becoming
common and very important. Societal concerns about the appropriateness of allowing patenting of
these components of living systems have also become prominent.
Patents Granted on Human DNA Sequences Patents on biotechnological developments date from
the early days of the United States patent system. Louis Pasteur received a patent for a process of
fermenting beer in 1873. The first patent for isolating nucleic acid was issued in 1945, and the first
patent for preparing ribonucleic acid by a fermentation process was issued in 1966.
Despite the fact that PTO has granted patents on human DNA, controversies over patenting
nonhuman living organisms and patenting human DNA sequences has led to fears over patenting
human organs and, ultimately, of humans. To quell such concerns, proposals have been made to
impose a moratorium on all biotechnology-related patents, particularly those involving human or
animal genetic material, until the ethical qualms about the scope of ownership rights are resolved.
Evaluating the impact of a moratorium one must consider the potential harms such an action will
prevent against potential harms it will cause. On the one hand, proponents of a moratorium suggest
that the principal harm induced by human DNA sequence patents is of an ethical nature. Another
concern is that the threat of blocking patents might impede research. Some argue that a moratorium

14 Pekin D, Skhiri Y, Baret JC, Le Corre D, Mazutis L, Salem CB, et al. (July 2011). "Quantitative and sensitive detection of rare mutations using droplet-based microfluidics".
15 Olsvik O, Wahlberg J, Petterson B, Uhlén M, Popovic T, Wachsmuth IK, Fields PI (January 1993)
16 Pettersson E, Lundeberg J, Ahmadian A (February 2009). "Generations of sequencing technologies". Genomics. 93 (2): 105–11.
on human DNA patents may have disastrous implications for further scientific developments.This
immense research expenditure which supports biotechnology inventions and product development
will not occur without the promise of a financial return.
Another consequence of a moratorium would be an increased level of secrecy and restricted flow
of information. This would actually harm the research communities, as the absence of patent
protection would cause commercially-sponsored research entities to restrict dissemination of any
character of their research. A moratorium would have the greatest and most direct impact on the
pharmaceutical industry, especially the commercial biotechnology sector. In turn, ripple effects
would emanate to the financial sectors that support biotechnology. A moratorium would impede
the commercial incentives to pursue research and development of new diagnostics and biologics.
Ultimately, of course, the public--as consumers of biotechnology products in the form of medical
therapies or improved agricultural products--would be harmed if companies were to cease or
curtail research in development in response to an inability to obtain patents.

PATENTABILITY OF GENE AND PROTEIN SEQUENCING INVENTIONS

European Union:
From the earliest gene cloning experiments of the 1980s the nucleotide sequence and function of
many genes had already been discovered and, in isolated form, these genes began to become the
subject of patents around the world. These have included genes from microorganisms, plants,
insects and animals with industrial and agricultural applications as well as human genes, including
disease-associated variants, having practical applications in diagnostic and therapeutic settings.
The patenting of genes when isolated from their natural environment has always been controversial
but in Europe, after some considerable debate, the practice gained acceptance with the introduction
in July 1998 of EU Directive 98/44/EC on the legal protection of biotechnological inventions.17
The Directive provides that biotechnological inventions shall be patentable if they concern
biological material which is isolated from its natural environment or produced by means of a
technical process, even if it previously occurred in nature.18 This principle is applied to elements
isolated from the human body, including the sequence or partial sequence of a gene, even if the

17 Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions (OJ EC L 213/13)
18 Article 3, Directive 98/44/EC.
structure of the element is identical to a natural element.19 However, the simple discovery of such
an element cannot constitute a patentable invention. An important further provision of the
Directive is that the industrial application of a sequence or partial sequence of a gene must be
disclosed in the patent application. Failure to do this will be fatal to the application.
Unlike the position in the United States following the recent Supreme Court decision in Myriad,
in the European Union naturally occurring genetic sequences, whether of human or other origin,
remain patent-eligible. Isolated DNA sequences are patentable under the EPC irrespective of
whether or not they are naturally occurring and irrespective of whether or not they are human
sequences.
In a landmark decision in the Relaxin case,20 an appeal board explained that the rules merely
interpreted existing law and that claims to DNAs encoding the human protein preprorelaxin that
are obtained by technical processes are patent-eligible and do not fall within the category of alleged
inventions that are excluded from protection as mere discoveries. The reasoning in that case was
affirmed in the BRCA1 sequences case21 concerning a claim to DNA encoding the BRCA1 gene
and corresponding to the ’282 patent at issue in Myriad. The appeal board treated as irrelevant any
economic effects flowing from patent grant because there was no basis in the EPC for
distinguishing between inventions in different technical fields (echoing the provisions of the TRIPs
agreement) and because the exclusionary nature of the rights granted was the same for all patents.

United States:
The more general proposition of whether products isolated from a natural environment could be
the subject of a patent claim has been brought into sharp focus by the patents of Myriad Genetics,
Inc for the BRCA1 and 2 genes, known to increase predisposition to breast cancer. In the U.S., in
a challenge to Myriad’s patents lodged by the Association for Molecular Pathology22, the Supreme
Court held that a naturally occurring DNA segment is a product of nature and, as such, cannot be
patented. In contrast, so-called complementary DNA - an artificial product designed to mirror the
coding parts of genes - is eligible for patent protection because it is not naturally occurring.

19 Article 5, Directive 98/44/EC.

20 Howard Florey case, ECLI:EP:BA:2002 T/0272/95.
21 University of Utah case, ECLI:EP:BA:2007, T 1213/05.
22
Association for Molecular pathology v. Myriad Genetics, 569 U.S. 576.
However, it does have implications for the patenting of non-human intron less genes, short nucleic
acid molecules such as primers or probes or non-coding RNA, all of industrial, agricultural or
medical utility, with a sequence identical to one occurring in nature.

India:
India is similar to the U.S. and Australia whereby DNA isolated from nature is not patentable
unless it has been modified by human intervention on or after the isolation procedure. Again the
provision of an industrial application is essential. In sub-section 3(c), “the mere discovery of a
scientific principle or the formulation of an abstract theory or discovery of any living thing or non-
living substance occurring in nature ” is not an invention. Thus, merely isolated naturally occurring
genes are considered a discovery and not an invention and are therefore deemed to be not
patentable as per sub-section 3(c). Gene isolation is required to be patentable. Genes as they are
found in situ are not patentable. For instance, a patent can be granted for the isolated DNA
sequence corresponding to the coding region of a human gene only if the sequence is new and was
isolated by a method that would be considered non-obvious by a skilled person, and if it presents
unexpected, surprising properties. For this reason then, the sequence function must be disclosed in
the patent application and filed to meet the industrial applicability requirements.
In sub-section 3(i), only those methods purposely designed to free any concerned subject from an
existing disease, or designed to increase its economic value or, better, the product thereof, are
patentable.

Further, it explains that in vivo diagnostic methods practiced on human/animal body cannot be
patentable but if diagnosis is performed in vitro i.e. on tissue or fluids that have been removed
from body are entitled to be patentable in light of inventive measures. Hence, diagnostic methods
employing DNA primers or probes or the like that are different from naturally occurring
genes/DNA sequences that exhibits modified functions would be considered as patentable
inventions.

A Single Judge of this Court in Emergent Genetics India Pvt. Ltd. Vs. Shailendra Shivam23,
again dealing with an application for interim relief held:

23 2011 (47) PTC 494.

(a) sequences obtained from nature (e.g., the sequence for a gene) cannot per se, be original. The
microbiologist or scientist involved in gene sequencing discovers facts; there is no independent
creation of a work, essential for matching the originality requirement; such a scientist merely
copies from nature-genetic sequence that contains codes for proteins; therefore, there is no
minimum creativity;

(b) there is no copyright protection for any idea; that when the use of an idea or procedure requires
copying of the plaintiff’s expression, there is no copyright infringement;

(c) that since there could be no copyright of ideas, the merged expression / idea is incapable of
copyright; granting copyright protection of the sole or limited way of expression of an idea, would
mean no one can practice the idea or procedure expressed without being guilty of copyright
infringement;

(d) pleadings of the nature and quality of information which is confidential are crucial and in the
absence thereof there is no question of confidentiality;

Invitrogen Bioservices India ... vs Pr. Bangalore on 29 November, 2019

Aggrieved by observations and order passed by Ld.CIT under Section 263 of the Act, assessee is
in appeal before us. 4.1 Ld.AR submitted that assessee is engaged in development of bio
informatics software used in analyzing gene sequences, protein sequences in Silicon Valley
owning, gene expression profiling, ITA Nos.868 & 869(B)/2016 pathways development and
software customization by using platforms like C++, Java etc. It was submitted that the software
developed is carried on by assessee are either for its own products or independent projects, and
that the independent projects relate to development of software, tools or application for external
customers. It has been submitted that these projects are contractor by the parent company directly
with external agencies and are billed directly to them. Assessee invoices its parent company and
receives compensation for the projects on cost plus markup basis. 4.2 Ld.AR submitted that
assessee in its own product category undertakes end to end development of software products,
tools and application. It has been submitted that the major product released in its own products,
segment includes Vector NTI which is a stand-alone text of software which allows both
academicians as well as professionals to carry out detailed research in the field of genomics. It has
been submitted that this software is equipped with comprehensive seaward of tools which allow
mapping and analyzing DNA and protein sequence, aligning different DNA
and protein sequence to compare them and creating a viewing 3-D models of protein structures.

" The assessee company developed software viz., Vector NTI Advance which is used in its research
activity for analysing gene sequence, protein sequence, Salic on cloning, gene expression
profiling etc by using platforms like C++, Java etc. These are and the activities of assessee
company itself and software which are developed are for its own research activity and only the
results of this research activities exported to the parent company. The term used in Section 10 B
is "export computer software". The assessee's claim of development of software being bio infirm
at a tools for its own research and development and thereafter transferring the results of the
research and development through CDs cannot be ITA Nos.868 & 869(B)/2016 termed as export
of computer software and is only export of results of the research and development carried out by
it."

Rest of the World:

The Myriad patents have also been challenged in Australia, where the High Court decided that
claims to isolated nucleic acid sequences encoding the BRCA1 mutant polypeptide were invalid
by virtue of not defining a “manner of manufacture”. Rather the substance of the invention was
considered to be the information embodied in the sequence of nucleotides of the molecule. This
was deemed to be an inherent part of the molecule, not made, created or modified by human action.
Following the Myriad decision, isolated naturally occurring nucleic acid molecules, whether DNA
or RNA, human or non-human, coding or non-coding are no longer patentable in Australia. Also
not patentable are cDNA, synthetic nucleic acids, probes and primers or interfering/inhibitory
nucleic acids in situations where they merely replicate the genetic information of a naturally
occurring organism.
In Japan, China, Korea and Canada, isolated DNA, including human DNA, is patentable in
principle, provided that function and industrial application are provided by the patent application.
The extent to which this industrial application must be demonstrated experimentally across the
scope of the claims varies and biological data may be required. In China it is necessary to indicate
that any genetic resource from which the gene was isolated has been legally obtained. China does
not allow companies or research institutes to patent life forms; however patenting genes is
permissible. Indeed, in 2001, Shanghai Joint Gene Technology Co. Ltd, the largest gene
technology company in China, applied for more than 3700 gene patents, including patents for
genes dealing with cancer, obesity, high blood pressure and senile dementia, which are expected
to be of high value for clinical diagnosis and the development of new medicines.
 CONCLUSION

Patenting of genes and DNA (deoxyribonucleic acid) sequences has been at the centre of a
disagreement for many years now. On one side are the exponents of gene patents, composed of
pharmaceutical, biotech and agricultural bio industries, who argue that genes must be patentable
to give firms the confidence to invest money and time required in the development of gene-based
drugs or genetically modified crops.

More of global cooperation is required in the biotechnology field since unlike other industries
which can deliver competitive advantages through cheaper or rapid manufacturing, biotechnology
companies gain monetary benefits by virtue of IP protections for their inventions. The current
system of legal uncertainty, legal uncertainty, ambiguous enforcement about the patentability of
DNA sequences could add to the decline in the level of innovations. Whereas on the other hand,
critics of gene patents maintain that genes are not new discoveries at all, and by allowing them to
be patented, control is placed in the hands of a few forestall research and restricting access to new
treatments for the poor.

The purpose of a patent is to foster and incentivize innovation. Therefore, it is imperative that such
incentives are given to inventors in the field of biotechnology patents as well given the fact that
most of these inventions have huge impacts in the advancement of medicine globally.
Biotechnology can be effectively utilised to create new and more effective medicare for each and
every person. The manipulation of proteins and genes may seem to be a step too far for some
people but their mindset needs to be changed given the overwhelming benefits associated with
such inventions.