**3. Intellectual property rights — Its aims and relevance**

Forms of intellectual property rights (IPR) are copyright, trademark (including service mark and geographical indication), trade secret, and patent. Depending on the type, government granted rights enable owners to select who may access and use their property and to protect it against infringement. Since the protections granted by a government vary from jurisdiction to jurisdiction, the acquisition, registration, or enforcement of IPR must be pursued or obtained separately in each territory of interest. Intellectual properties, in general, are creative ideas and expressions of the human mind that have commercial value. The owner of an intellectual property can generally transfer (with or without consideration), license (or rent), or mortgage it to third parties. Most exclusive rights are nothing more than the right to sue an infringer. Those wishing to use an intellectual property held by another, must license it from the owner. In many jurisdictions the law places limits on the restrictions the licensor can impose on the licensee.

A *license* results if the IP owner transfers less than all of his IP rights. The party receiving the license is called the licensee. If the license is given to only a single person and pursuant to the terms of the license is not permitted to license others, the license is termed an *exclusive license*. If licenses are given to multiple parties or to one person reserving the right to license it to others at a future date, the license is termed a *nonexclusive license*. In the case of an exclusive license, the owner of the intellectual property cannot make, use, or sell the intellectual property unless he has expressly reserved the right to do so in the license agreement. If all the rights are transferred to someone, it is known as an *assignment*. Variations in the terms of a license agreement are virtually limitless, depending upon the needs, desires, and bargaining positions of the parties involved.

#### **3.1. Copyright**

organism's genome can be cut at any desired location. Since its invention in 2012, the CRISPR/ Cas system has been widely used for gene editing (silencing, enhancing or changing specific genes) in basic research. The importance of the CRISPR/Cas adaptive immune system is that it is a prokaryotic immune system that confers resistance to foreign genetic elements such as plasmids and phages and provides a form of acquired immunity. CRISPR spacers recognize and silence these exogenous genetic elements like RNAi in eukaryotic organisms. It is in building the elaborate system of DNA-cutting proteins and guide RNA sequences that requires extensive engineering to function in eukaryotic cells, and to insert new genes where the targeted host DNA is excised. For a quick introduction to CRISPR technology, see [22].

On 15 April 2014, the USPTO issued the first patent (US8697359, CRISPR-Cas systems and methods for altering expression of gene products) to cover CRISPR-Cas9 gene editing technology to Feng Zhang, the sole inventor, just six months after the patent application was filed on 15 October 2013. The patent is assigned to MIT, and the Broad Institute with Broad managing the patent's licensing. The patent claims a modified version of the CRISPR-Cas9 system that is found naturally in bacteria and which microbes use to defend themselves against viruses. The patent, *inter alia*, claims methods for designing and using CRISPR's molecular components. It is widely expected that Broad will adopt a liberal licensing policy that would

CRISPR is already revolutionizing biomedical research because it provides a very efficient way of recreating disease-related mutations in lab animals and cultured cells. It also holds the promise of treating genetic diseases in humans in unprecedented ways, *e.g.*, by directly correcting mutations on a patient's chromosomes. Mental illnesses too may find similar remedies. Since 2012, CRISPR's use in research has spread like wildfire. The chemistry behind

The first generation DNA sequencing developed in 1975 by Edward Sanger [23] remained the gold-standard for two and a half decades. It was used in the Human Genome Project that cost \$3 billion and 13 years to sequence the human genome and was completed in 2003. In com‐ parison, next-generation sequencing (NGS) use non-Sanger based, high-throughput technol‐ ogies to sequence millions and billions of DNA strands in parallel, are much faster and cheaper. In fact, an entire genome can be sequenced in a day. And when it is coupled with powerful computational algorithms, say, to answer questions related to mutational spectrum of an organism on a genome-wide scale, we have phenomenal opportunities to understand our biological selves. Targeted sequencing facilitates discovery of disease causing mutations for diagnosis of pathological conditions, and of genes and regulatory elements associated with disease [24, 25]. For trends in DNA sequencing costs, see http://www.genome.gov/sequen‐ cingcosts/. (In 2014, it was less than \$0.1 per raw mega-base of DNA sequence compared to about \$1k in 2004; during 2007-2010, the cost fell sharply.) NGS is not yet ready for clinical use. For recent advances in CRISPR-Cas9 technology see [26]. In principle, NGS and CRISPR technology together would allow one to change a genome at will to almost anything one wants and even elicit enough detailed information about disease risks, ancestry

make the technology available to scientists for research around the world.

the Cas9 protein is still being explored.

**2.4. NGS + CRISPR technologies**

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Copyright is an exclusive right conferred by a government on the creator of a work (*e.g.*, original literary, dramatic, musical, artistic works in books, recordings, films, videos, etc.) to exclude others from reproducing it, distributing it to the public, performing it in public, or displaying it in public. Copyright law protects the holder's right to decide how and where his material is used, not just the right to earn profits from the work. Copyright protection comes into effect immediately upon the creation of something that can be protected and is 'fixed' in some way, *e.g.*, on paper, on film, on electronic media (including the Internet), etc. It is not necessary to register a copyright or take any official action to obtain it. However, registration is advisable as it strengthens the owners claim to copyright in litigation. The doctrine of fair use allows non-owners of a copyright work to use such work in a limited way without being accused of infringement.

Things that cannot be copyrighted include abstract ideas, procedures, processes, systems, methods of operations, concepts and principles, regardless of how they are expressed, whether it be by words, illustration, or in some three-dimensional form. Of course, the manner in which they are expressed may be copyrighted, but not the labour that goes into creating a work. Unfortunately, the line between copyrighted material and non-copyrightable ideas, wherever it is drawn, will seem arbitrary to many.

#### **3.2. Trademark and other marks**

A mark used in trade—trademark, service mark, certification mark, collective mark, geo‐ graphical indication—is any sign which can distinguish the goods and services, as appropriate, of one trader from those of another. A mark may be words, logos, pictures, shape of a product or container, or a combination of these. (Certain kinds of marks are not permitted, *e.g.*, marks which are immoral, deceptive, or scandalous, national symbols, national flags, etc.) A trade‐ mark serves to identify the origin of goods and creates goodwill for the owner; it signifies that all goods bearing the mark come from or are controlled by a single source and are of specified quality.

#### **3.3. Trade secret**

It is any device or information that gives an advantage over competitors who do not know about it or do not use it. Its value lies in its secrecy. Its owner is responsible for protecting it (*e.g.*, through non-disclosure agreements, by restricting access, etc.). Infringement of a trade secret is a type of unfair competition. The subject matter of trade secrets usually includes sales methods, distribution methods, consumer profiles and advertising strategies, lists of suppliers and clients, and manufacturing processes. The Coca Cola recipe is a famous example of a trade secret. What information constitutes a trade secret is case specific. Unfair practices related to trade secrets obviously include industrial or commercial espionage, breach of contract, and breach of confidence.

#### **3.4. Patent**

A patent is a limited period monopoly property right granted to an inventor for his invention by a Government subject to prescribed conditions, which include that the invention must be novel, nonobvious to those ordinarily skilled in the art, useful, and fully disclosed. Four types of inventions are eligible for such utility patents: process, machine, manufacture, or composi‐ tion of matter. They are known as statutory subject matter. In exchange of a patent, the inventor describes the secrets related to the invention, publishing them as per law for all to see, absorb, and improve upon but not infringe. This description must be so clear and detailed as to enable a person skilled in the technologies relevant to the said invention to independently reproduce the invention (enablement requirement) without undue extra-solution activity, such as further research, data gathering, etc. on his part. In fact, this description should leave no doubt that the patent applicant was in possession of the claimed invention at the time of filing his application. Patents may be sought on non-trivial improvements over existing inventions. The life of a granted patent is usually 20 years from the filing date of the first valid patent appli‐ cation claiming the invention.

material is used, not just the right to earn profits from the work. Copyright protection comes into effect immediately upon the creation of something that can be protected and is 'fixed' in some way, *e.g.*, on paper, on film, on electronic media (including the Internet), etc. It is not necessary to register a copyright or take any official action to obtain it. However, registration is advisable as it strengthens the owners claim to copyright in litigation. The doctrine of fair use allows non-owners of a copyright work to use such work in a limited way without being

Things that cannot be copyrighted include abstract ideas, procedures, processes, systems, methods of operations, concepts and principles, regardless of how they are expressed, whether it be by words, illustration, or in some three-dimensional form. Of course, the manner in which they are expressed may be copyrighted, but not the labour that goes into creating a work. Unfortunately, the line between copyrighted material and non-copyrightable ideas, wherever

A mark used in trade—trademark, service mark, certification mark, collective mark, geo‐ graphical indication—is any sign which can distinguish the goods and services, as appropriate, of one trader from those of another. A mark may be words, logos, pictures, shape of a product or container, or a combination of these. (Certain kinds of marks are not permitted, *e.g.*, marks which are immoral, deceptive, or scandalous, national symbols, national flags, etc.) A trade‐ mark serves to identify the origin of goods and creates goodwill for the owner; it signifies that all goods bearing the mark come from or are controlled by a single source and are of specified

It is any device or information that gives an advantage over competitors who do not know about it or do not use it. Its value lies in its secrecy. Its owner is responsible for protecting it (*e.g.*, through non-disclosure agreements, by restricting access, etc.). Infringement of a trade secret is a type of unfair competition. The subject matter of trade secrets usually includes sales methods, distribution methods, consumer profiles and advertising strategies, lists of suppliers and clients, and manufacturing processes. The Coca Cola recipe is a famous example of a trade secret. What information constitutes a trade secret is case specific. Unfair practices related to trade secrets obviously include industrial or commercial espionage, breach of contract, and

A patent is a limited period monopoly property right granted to an inventor for his invention by a Government subject to prescribed conditions, which include that the invention must be novel, nonobvious to those ordinarily skilled in the art, useful, and fully disclosed. Four types of inventions are eligible for such utility patents: process, machine, manufacture, or composi‐ tion of matter. They are known as statutory subject matter. In exchange of a patent, the inventor

accused of infringement.

202 Biotechnology

it is drawn, will seem arbitrary to many.

**3.2. Trademark and other marks**

quality.

**3.3. Trade secret**

breach of confidence.

**3.4. Patent**

Patent monopoly differs from market monopoly; a patent is a right to exclude, a right to prevent trespassing. In this sense it is similar to, say, the right to keep one's personal properties free from trespassers. A patent grants its owner the right to exclude others from making, using, selling or offering to sell, and importing the claimed invention in the country of grant; it does not confer any right to practice the invention. This is because in practicing the invention, one may well need complementary patents held by others unwilling to license or there may be other laws, rules or regulations that prevent its practice. Patents are issued only to the first inventor (or group of joint inventors) of an invention who files a legally valid patent applica‐ tion; all others are barred, even if they independently created the invention. Consequently, those other inventors must get a license from the first inventor if they wish to practice the invention. Although grant of patents is subject to country-specific constraints, there is univer‐ sal agreement among nations that patents seeking pre-emptive monopoly of abstract ideas (*e.g.*, mathematical formulas), laws of nature, natural phenomena, and products of nature are ineligible. What else to exclude from patent monopoly is a national prerogative, largely dependent on government policy related to prevailing socio-economic conditions it must manage, and international treaty obligations.

Two recent rulings by the Supreme Court of the United States (SCOTUS) are of importance to the biotechnology industry since it invokes the dictum that "laws of nature, natural phenom‐ ena and abstract ideas" are not patentable. In March 2012, the court ruled against Prometheus Laboratories in California observing that it could not patent metabolite levels to guide drug dosing [28]. Then, in June 2013, the court struck down a patent claim by Myriad Genetics of Utah that linked certain DNA sequences to female breast cancer [29]. It held that a naturally occurring DNA segment is a product of nature and its mere isolation does not make it patentable. However, cDNA may be patentable as it is not a naturally occurring substance. Thus to get a gene patent one will have to show that it is significantly different from any natural gene. However, in a diametrically opposite ruling, the Federal Court of Australia in *D'Arcy v Myriad Genetics Inc.* [2014] FCAFC 115 on 05 September 2014 ruled unanimously that isolated DNA and RNA are patentable subject matter under Australian law (Patents Act 1990 (Cth) s 18(1), Statute of Monopolies s 6). To say the least, this makes gene patenting a complex issue if such patents are sought in multiple countries.

Governments grant patents to human inventors only. Post-grant they may be assigned to people or institutions. A patent granted by a government is enforceable only in the territory it governs. One may, however, seek patents for the same invention from multiple countries. Patent laws of a country do not over-ride its other laws that might regulate the invention's use. Patent laws of a country may take into account moral, cultural, ethical, social, environmental, or scientific concerns of society. Patent rights may be exercised by the patentee, his heirs or assigns. When a patent expires, the related invention becomes the common heritage of mankind.

Limited period patent monopoly may provide an enormous first mover advantage to an entrepreneur, especially if it involves new technology that could lead to a natural monopoly.

#### **3.5. Traditional knowledge**

The World Health Organisation (WHO) defines traditional medicine as [30]:

Traditional medicine is the sum total of the knowledge, skills, and practices based on the theories, beliefs, and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of health as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness.

This knowledge, much of it undocumented and available only to small groups of people through oral transmission from generation to generation, predates molecular biology by centuries and hence belongs to prior art (public domain). Its importance to synthetic biology is that such knowledge may provide promising directions of research in the hunt for exotic genes.
