**Abstract**

The issuance of a patent by the government office is basically done by a patent application record that is an agreement between the inventor and the government office. Correspondingly, a patent application is in many ways like a contract. Preparation of a standard patent application is curious because it sets out in a transparent way, the terms and condition by which the patent owner and others will be bound. These criteria of the patent application make it different from writing a scientific paper. The technical subject matter that is available in the patent application have bear some similarities to a scientific or technical paper, although it does not usually need to rise to the level of a blueprint for making the invention protected by the patent. Public officials of government take a long time to review the patent as examiners and judges and business partners. Therefore it is necessary that a patent application should be drafted with these important audiences in mind. The parts of the patent application typically include the Background, Summary, Detailed Description and Drawings, Claims, and Abstract. The patent agent is unlikely to draft the patent application in this order and should ordinarily draft the claims first.

**Keywords:** application, patent, filing, government official

## **1. Introduction**

From last many decades, national and international organizations have made to try with best efforts to homogenize the laws governing intellectual property. To attempt the standardization, the little bit restriction always comes it is either infrastructure or capital, especially in pharmaceutical industries. That is the reason a continuous tension exists in multinational pharmaceutical companies (MNCs) in developing nations. Intellectual always give their maximum efforts to overcome these problems which the easier business environment worldwide. In the World Trade Organization (WTO) earlier, India does not recognize product patents in pharmaceutical. Without product patents, Indian pharmaceutical companies were able to agitate countless generic drugs. In the world, India contributes to leading manufactures in generic drugs. Results of these are that the relative moderate of these generic drugs as compared to patented drugs not only provide chief drugs but also made India the de facto pharmacy for many developing countries [1].

The basic object of the Intellectual Property Right (IPR) to deliver unquestionable absolute right over the fabrication of the mind and to finite exploit it for a fixed duration of time, in order to enable them to gather commercial benefits from their creative efforts.

The application and filing is the first step to patent the drugs for trade worldwide, which provide a platform for the exclusively business without a doubt or question regarding the quality of drugs and its efficacy. The evolution of innovation can explain by the diagram [1, 2] (**Figure 1)**.

The Intellectual property known as IP, gives the right to the people to own their innovation, invention, and creativity in the same way as they own their physical property. In can cover the different forms like **Figure 2**.

In a general way, IPR plays an important role in two principal areas which impact in the Pharmaceutical Industry. First, the pricing and access where the focus on securing competitive marketing which creates the problems in the pricing of drugs. Second, is an issue related research and development incentive, which is the marketing of the new medicines and its price? The consequence of IPRs on R&D expenditure and its grant across the different disease, countries, and organization.

The IPRs patent application preparation and filing, the right of legal work it might be sold, uses, offers for sale and/or imports any technology can be protected by the IPR documents, that gives the power to trade in an authentic way. The inventors are completely satisfy if he/she has legal documents of IPR. For this, there is a process which is followed by the regulatory bodies in every country.

Before, the patent approved a step that is called the provisional application in some country like the United State of America. The provisional patent application duration is 1 year and it provides smoothly, rapidly and affordably got the pending status. The patent is ownership for creativity or innovation product protected by the patent's claims. Before revealing the innovative idea the patent application filing is necessary. The patent should persuade all legal requirements it covers like time limits related to how long the invention was disclosed to the public. Before filing a patent application if the inventions communicate in public it will be denied without any grace period [2–4].

A detailed audit is a must before filing the application itself. From this consequence the broader concept or the principle which are important for the public and it will be drafted in very well manner. The application prepares on the facts of the principle or new idea that is highlighted in the drafts, its importance, and scope in that respective field.

**53**

effective till 1972.

**Figure 2.**

*Different types of IPR.*

*Patent Application Preparation and Filing DOI: http://dx.doi.org/10.5772/intechopen.88377*

erly, so further it is no possibility of challenge.

new molecule make not a possibility such corporation.

system was more conducive and interest for the nation.

In facts, patents are "regional" its consideration only on those countries where they have been applied for and granted. Every country has its own legal office where it documented that the patent applicability is worldwide or it is only to its own country. Patent acceptability and its innovative idea can be challenged and if it's finding any demerits should be rejected. To maintain the discipline and hierarchy in the legal office the team must examine the whole content of the application prop-

After World War II, The international pharmaceutical Industry grows rapidly. The demands of antibiotics create a challenge for the company in the research and development division. As the year gone following the wars saw the rapid growth in number industry and establish as MNCs by infiltration in many countries. The headquarters of such MNCs established in developed countries from where business manage. Due to the lack of trained skill human source in developing countries as well as a necessary technology for which big capitals are required to developed a

After independence India was faced many challenges like as one of the poorest countries in the world, with also increase problems in the health sector to overcome this government takes any initiative for the amendment in patent law which make the business easy. For this government of India appoint two committees one is the Patent Enquire Committee (1948–1950) and the Patents Revision Committee (1957–1959). The object was to review the patent law and ensure that the patent

India by 2020 reached as a global leader in the field of the pharmaceutical industry. This country established as a leader of generic drugs manufacturers. India passed its first patent law in 1856 under the British colonial rule and it is based on the British Patent Law of 1852, here inventors have right for 14 years duration privileged. In 1911, the British government introduces the Indian Patents and Design Act with removing the Inventions and Designs Act of 1888 which is

Worldwide the developing countries as a consumer for the many products its importance partly increase, in 1994 all members of the World Trade Organization were required to adopt the Trade Related Intellectual Property Standards (TRIPS). By growing the Pharmaceutical MNCs worldwide, The World Trade Organization came into existence on 1 January 1995, and along with it came the Trade-Related Aspects of Intellectual Property Rights TRIPS Agreement. Covering the international instruments for strengthens the IPR. India initially not in favor

**Figure 1.** *Evaluation of IPR.*

*Patent Application Preparation and Filing DOI: http://dx.doi.org/10.5772/intechopen.88377*

**Figure 2.** *Different types of IPR.*

*Intellectual Property Rights - Patent*

any grace period [2–4].

that respective field.

can explain by the diagram [1, 2] (**Figure 1)**.

property. In can cover the different forms like **Figure 2**.

The application and filing is the first step to patent the drugs for trade worldwide, which provide a platform for the exclusively business without a doubt or question regarding the quality of drugs and its efficacy. The evolution of innovation

The Intellectual property known as IP, gives the right to the people to own their innovation, invention, and creativity in the same way as they own their physical

In a general way, IPR plays an important role in two principal areas which impact in the Pharmaceutical Industry. First, the pricing and access where the focus on securing competitive marketing which creates the problems in the pricing of drugs. Second, is an issue related research and development incentive, which is the marketing of the new medicines and its price? The consequence of IPRs on R&D expenditure and its grant across the different disease, countries, and organization. The IPRs patent application preparation and filing, the right of legal work it might be sold, uses, offers for sale and/or imports any technology can be protected by the IPR documents, that gives the power to trade in an authentic way. The inventors are completely satisfy if he/she has legal documents of IPR. For this, there is a

Before, the patent approved a step that is called the provisional application in some country like the United State of America. The provisional patent application duration is 1 year and it provides smoothly, rapidly and affordably got the pending status. The patent is ownership for creativity or innovation product protected by the patent's claims. Before revealing the innovative idea the patent application filing is necessary. The patent should persuade all legal requirements it covers like time limits related to how long the invention was disclosed to the public. Before filing a patent application if the inventions communicate in public it will be denied without

A detailed audit is a must before filing the application itself. From this consequence the broader concept or the principle which are important for the public and it will be drafted in very well manner. The application prepares on the facts of the principle or new idea that is highlighted in the drafts, its importance, and scope in

process which is followed by the regulatory bodies in every country.

**52**

**Figure 1.** *Evaluation of IPR.*

In facts, patents are "regional" its consideration only on those countries where they have been applied for and granted. Every country has its own legal office where it documented that the patent applicability is worldwide or it is only to its own country. Patent acceptability and its innovative idea can be challenged and if it's finding any demerits should be rejected. To maintain the discipline and hierarchy in the legal office the team must examine the whole content of the application properly, so further it is no possibility of challenge.

After World War II, The international pharmaceutical Industry grows rapidly. The demands of antibiotics create a challenge for the company in the research and development division. As the year gone following the wars saw the rapid growth in number industry and establish as MNCs by infiltration in many countries. The headquarters of such MNCs established in developed countries from where business manage. Due to the lack of trained skill human source in developing countries as well as a necessary technology for which big capitals are required to developed a new molecule make not a possibility such corporation.

After independence India was faced many challenges like as one of the poorest countries in the world, with also increase problems in the health sector to overcome this government takes any initiative for the amendment in patent law which make the business easy. For this government of India appoint two committees one is the Patent Enquire Committee (1948–1950) and the Patents Revision Committee (1957–1959). The object was to review the patent law and ensure that the patent system was more conducive and interest for the nation.

India by 2020 reached as a global leader in the field of the pharmaceutical industry. This country established as a leader of generic drugs manufacturers. India passed its first patent law in 1856 under the British colonial rule and it is based on the British Patent Law of 1852, here inventors have right for 14 years duration privileged. In 1911, the British government introduces the Indian Patents and Design Act with removing the Inventions and Designs Act of 1888 which is effective till 1972.

Worldwide the developing countries as a consumer for the many products its importance partly increase, in 1994 all members of the World Trade Organization were required to adopt the Trade Related Intellectual Property Standards (TRIPS).

By growing the Pharmaceutical MNCs worldwide, The World Trade Organization came into existence on 1 January 1995, and along with it came the Trade-Related Aspects of Intellectual Property Rights TRIPS Agreement. Covering the international instruments for strengthens the IPR. India initially not in favor

of TRIPS as other developing countries. As a member of WTO India modifies its domestic intellectual property laws in order to comply with the agreement.

In the world, the most difficult aspect of the World Trade Organization's Agreement on Trade-related Aspects of International Property Rights (TRIPS) is over the issue of patents for pharmaceutical drugs. From 1 January 1995, The TRIPS agreement come into effect, this agreement stretches the scope of intellectual property rights. Patents shall be available for any invention it declared in article 27, whether the products or process in all fields of technology. In India Parliament granted by act 1970 that patent rights only to manufacturing processes, rather than to the end products themselves,"

In the world, India is the country which not only a chief exporter of drugs but also the primary producer of drugs for its own population. Generic drug share market is large portion covered by this country [1–3].

### **2. Patent basic**

The basic aspects of the patent system must know very well and it is outlined before to practical aspects. The primary logic behind the generation of a patent system was to honor an inventor by a full right to the invention of duration for a number of years it depends upon the country legal authority. The new inventions which support to stimulate and promote the further technological process and innovation, it is fruitful when the patent has public access. The countries or group of countries have legal authority that patent is the exclusive rights for the innovations. In a trade or commercial business, a patent provides their owners which stop from the making, using, offering for sale, selling or importing a product or a process without their permission (a license). By the patent system, it is clear that how the inventor can protect their patent and also it is necessary that how to respect other innovation by participating in it. Keep in mind that the patent itself is a regional right, it workable in limited either in a country or a group of countries. Patent never is "world patent" as it only territorial. Therefore the filing of a patent is a choice of the territory and the region where the patent protected. The desire of territory is based on the country market potential, manufacture's competitor place, research center place, and various other places. It is a fundamental part of the patent application filing. The basic criteria of patentability—Must be patentable subject matter in US geography, Unity of invention, capable of industrial applicability. In most of the countries, the primary object is the novelty, in some countries also seen the double standard of novelty depending on the place of the invention it is inside the territory or outside the territory. The comparison of novelty and art of skill in the invention should be superior to the existing patent in the same field. In a patent, the non-obviousness is one of the most difficult things to define. Its contribution to defining the level of technology. The examiner of the patent has the ability to disclose in the prior art but also identifies the art of the skill in the innovative person. In the Pharmaceutical world, patent protection is very important which uplift the development of the new medicine for disease those consequences these countries. The patent protection boosts the pharmaceutical industry for the investment of the billion to develop the new molecules, making sure that the product sale [3, 4].

The pharmaceutical product takes a very long time to develop and enter the market for human use. A new dosage form an average takes around 10–15 years during this period medicine efficacy and safety must be proved by a different phase of a clinical trial. A significant period lost the new drug before entering the market that is a disadvantage in the pharmaceutical field. On innovation

**55**

development).

**Figure 3.**

*New drug development.*

a.Claims

c.Drawings

d.Background

**3. Structure of application**

to cover the application with the following parts.

b.Detailed description (or specification)

*Patent Application Preparation and Filing DOI: http://dx.doi.org/10.5772/intechopen.88377*

patent role is that it protect the innovation it either territorial or global, but in case of pharmaceutical product, there must be some extent of flexibility by which the monopoly right decrease so that it does not affect the cost of medicine. The world moving towards the differential pricing of medicines, making the cost of medicine cheaper in developing countries. From the developing countries, the revenue generated is very less and around 1% as compared developed countries. Developing countries contribute the minimum incentive to the research, it comes maximums from the developed countries. To provide the health patent is not only the obstacle along with it has other factors like poor infrastructure lack of sanitation and shortage of funding for even generic drugs **Figure 3** (New drug

The concept behind the patent for innovation is a contract on a temporary basis, where society agrees to the monopoly that allowing a high level amounts that doing so provide will provide a strong incentive for innovation. Creating revenue from manufacturers and production give the strong back up to research and development also encourage in the interest in development for the new molecule in pharmaceutical. A balance is necessary between the research and development in aspect to economic, because from research and development there is no scope to generate direct revenue from the customer. Indirectly it gives very strong revenue to the market [4, 6].

For filling of application, the ideal requirements of the patentability and also the application must be filed by the competent authority for a certain country or a group of countries. A quick focus must be given when filing the application and try

#### *Patent Application Preparation and Filing DOI: http://dx.doi.org/10.5772/intechopen.88377*

**Figure 3.** *New drug development.*

*Intellectual Property Rights - Patent*

to the end products themselves,"

**2. Patent basic**

market is large portion covered by this country [1–3].

of TRIPS as other developing countries. As a member of WTO India modifies its domestic intellectual property laws in order to comply with the agreement. In the world, the most difficult aspect of the World Trade Organization's Agreement on Trade-related Aspects of International Property Rights (TRIPS) is over the issue of patents for pharmaceutical drugs. From 1 January 1995, The TRIPS agreement come into effect, this agreement stretches the scope of intellectual property rights. Patents shall be available for any invention it declared in article 27, whether the products or process in all fields of technology. In India Parliament granted by act 1970 that patent rights only to manufacturing processes, rather than

In the world, India is the country which not only a chief exporter of drugs but also the primary producer of drugs for its own population. Generic drug share

The basic aspects of the patent system must know very well and it is outlined before to practical aspects. The primary logic behind the generation of a patent system was to honor an inventor by a full right to the invention of duration for a number of years it depends upon the country legal authority. The new inventions which support to stimulate and promote the further technological process and innovation, it is fruitful when the patent has public access. The countries or group of countries have legal authority that patent is the exclusive rights for the innovations. In a trade or commercial business, a patent provides their owners which stop from the making, using, offering for sale, selling or importing a product or a process without their permission (a license). By the patent system, it is clear that how the inventor can protect their patent and also it is necessary that how to respect other innovation by participating in it. Keep in mind that the patent itself is a regional right, it workable in limited either in a country or a group of countries. Patent never is "world patent" as it only territorial. Therefore the filing of a patent is a choice of the territory and the region where the patent protected. The desire of territory is based on the country market potential, manufacture's competitor place, research center place, and various other places. It is a fundamental part of the patent application filing. The basic criteria of patentability—Must be patentable subject matter in US geography, Unity of invention, capable of industrial applicability. In most of the countries, the primary object is the novelty, in some countries also seen the double standard of novelty depending on the place of the invention it is inside the territory or outside the territory. The comparison of novelty and art of skill in the invention should be superior to the existing patent in the same field. In a patent, the non-obviousness is one of the most difficult things to define. Its contribution to defining the level of technology. The examiner of the patent has the ability to disclose in the prior art but also identifies the art of the skill in the innovative person. In the Pharmaceutical world, patent protection is very important which uplift the development of the new medicine for disease those consequences these countries. The patent protection boosts the pharmaceutical industry for the investment of the billion to develop the new molecules, making sure that the

The pharmaceutical product takes a very long time to develop and enter the market for human use. A new dosage form an average takes around 10–15 years during this period medicine efficacy and safety must be proved by a different phase of a clinical trial. A significant period lost the new drug before entering the market that is a disadvantage in the pharmaceutical field. On innovation

**54**

product sale [3, 4].

patent role is that it protect the innovation it either territorial or global, but in case of pharmaceutical product, there must be some extent of flexibility by which the monopoly right decrease so that it does not affect the cost of medicine. The world moving towards the differential pricing of medicines, making the cost of medicine cheaper in developing countries. From the developing countries, the revenue generated is very less and around 1% as compared developed countries. Developing countries contribute the minimum incentive to the research, it comes maximums from the developed countries. To provide the health patent is not only the obstacle along with it has other factors like poor infrastructure lack of sanitation and shortage of funding for even generic drugs **Figure 3** (New drug development).

The concept behind the patent for innovation is a contract on a temporary basis, where society agrees to the monopoly that allowing a high level amounts that doing so provide will provide a strong incentive for innovation. Creating revenue from manufacturers and production give the strong back up to research and development also encourage in the interest in development for the new molecule in pharmaceutical. A balance is necessary between the research and development in aspect to economic, because from research and development there is no scope to generate direct revenue from the customer. Indirectly it gives very strong revenue to the market [4, 6].
