Intellectual property right is a legal right that is granted to the inventor to protect his or her invention. It is a legal right of the owner that protects the creation, invention, symbol or design, etc. of the one who created them so that they can enjoy their property without the disturbance of others by preventing anyone from using or copying them for a specified time. Intellectual Property is an intangible property that is a result of human creativity.

There are several types of Intellectual Property for e.g. Patents, trademarks, copyrights, GI etc. Intellectual Property Right gives a person an exclusive right to use his or her creation which means that no one can copy or use that creation without the prior permission of the creator or inventor. In this article, we will only discuss types of patents and laws related to them in India. The creation of the brain is called intelligence.

These works are called property because of their high commercial value. Inventions are intellectual property and can be protected by patents provided the invention is new, non-obvious, useful, and possible. To enable collective bargaining between member countries, the World Trade Organization proposed her TRIPS Agreement. By signing the WTO Agreement, India has taken the necessary initiative and adapted to the needs of the world.

The purpose of this article is to educate pharmaceutical professionals, especially in the field of research and development, about planning inventions through thorough reviews of prior art that save time and money. By providing an indication of the source, full understanding is possible. The current governing body, its role along with the laws protecting the patent system.

Introduction
A patent is a branch of intellectual property rights like Trademark, Copyright, etc. are. The word "patent" is derived from the Latin term "patere" which implies "to lay open," i.e., to make available for public at large.

A patent is a license that confers an exclusive right or title to the owner for a limited or specific period of time to exclude others from making, using, or selling an invention and the violation of these exclusive rights or title of the patent holder is known as patent infringement. In India, the act that govern the patent is Patents Act, 1970. The main motive behind the enactment of the Patent Act is to encourage people to come up with new ideas in their field by awarding them exclusive rights over their inventions.

History of Patent

The Act VI of 1856 was the first legislation in India regarding the patent which was afterward repealed by Act IX of 1857 since it's been enacted without the approval of the British Crown. In 1859, another legislation was introduced for granting 'exclusive privilege '.

This legislation is known as Act XV of 1859. This legislation undergoes some changes to the previous legislation, namely, granting of exclusive privileges to useful inventions only, an extension of priority period from 6 months to 12 months, excluding importers from the definition of investors. In 1872, the Act of 1859 was combined to provide protection relating to designs. The act was renamed "The Patterns and Designs Protection Act" under Act XIII of 1872 which was further amended in 1883. This law was in force for 30 years and was amended again in 1888.

The Indian Patent and Design Act, 1911 repealed all the previous acts that have been enacted. The Current Patent Act ,1970 came into effect in 1972, further amending and consolidating the existing laws relating to patents in India. This act was again amended by the Patents (Amendment) Act, 2005, wherein product patent was extended to all or any fields of technology including food, drugs, chemicals, and micro-organisms.

This amendment repealed provisions relating to Exclusive Marketing Rights (EMRs) whereas a provision for enabling grant of compulsory license and pre-grant and post-grant opposition has been introduced.

Patent

A patent is an exclusive right granted to an invention, generally a product or process that provides a new way of doing something or a new technical solution to a problem. To obtain a patent, technical information about the invention must be published in a patent application.

• The history of Indian patent law begins in 1911 when the Indian Patents and Designs Act 1911 was passed
• The Patents Act, 1970 is the law governing Indian patents to this day. It was first enforced in 1972.
• The Controller's Office of Patents, Designs and Trademarks or CGPDTM is the body responsible for the patent law of India.
• The Patent Office is headquartered in Kolkata with branches in New Delhi, Chennai, and Mumbai. The CGPDTM office is based in Mumbai. Nagpur is home to the Office of Patent Information Systems and the National Institute of Intellectual Property Management.
• The Commissioner oversees law enforcement and advises the Government on related matters.
• The Patent Act was amended repeatedly in 1999, 2002, 2005 and 2006 respectively. These changes were necessary to make patent law TRIPS (Trade Related Aspects of Intellectual Property Rights) compliant.
• The most significant change in patent law took place in 2005, expanding product patents to all areas of technology such as food, pharmaceuticals, chemicals, and micro-organisms. The provisions of the patent law have also changed in 2012, 2013 and 2014.
   

Patent Law Amendment Act 2005.
Salient features of the Patents (Amendment) Act 2005 related to product patents:

• Extension of product patent protection to products in sectors of drugs, foods and chemical.
• Product patent protection period shall be 20 years.

Introduction of a provision for enabling grant of compulsory license for export of medicines to countries which have insufficient or no manufacturing capacity; provided such importing country has either granted a compulsory license for import or by notification or otherwise allowed importation of the patented pharmaceutical products from India (in accordance with the Doha Declaration on TRIPS and Public Health) Section 3 (d) regarding patentability.

Effects of the Patent Amendment Act 2005
Due to the new patent regime, increased prices of products were considered to be a major hindrance during the time. However, governments are taking aggressive steps to ensure low prices for essential medicines, using compulsory licensing as a tool to curb exorbitant prices.

The amendment intended to make Indian drug and pharmaceutical industries competitive at par with multinational companies.

Despite initial reservations, Indian pharmaceutical companies producing generic drugs have thrived over the past decade.

Also, MNCs have opened Research and Development Centers in India.

Rights granted by Patent

1. Where a patent relates to a process, the patentee has the right to prohibit others from using the process, using products directly derived from the process, or selling, selling or importing products directly derived from the process into India.
2. Where the grant of a patent relates to a product, the patent owner has the right to prohibit others from making, using, offering for sale, selling or importing the patented product in India.

Patent Duration
The duration of each patent in India, whether provisional or full description, is 20 years from the filing date of the patent. However, in the case of an application under the Patent Cooperation Treaty (PCT), the period of 20 years is counted from the international filing date.

Types Of Patents

A patent protects the inventor 's invention and new discoveries that are new and non-obvious. There are three types of patents, and each type of patent protects a specific invention. However, it is possible for one invention to have more than one type of patent available for it.

These three types of patents are explained below:

1. Utility Patents
   This type of patent covers processes, compositions of matter, machines, and manufacturers that are new and useful. This is the most common sort of patent that people seek. It can also be obtained for new improvements to existing processes, compositions of matter, manufactures and machines. As an Indian innovator looking to file a utility patent, one can apply for utility patents in countries such as Australia, UAE, China, Germany, France, and a number of other countries within the European Union.
    
2. Design Patents
   Design Patent is defined as the "surface ornamentation" of an object, and it can also include the shape or configuration of an object. This type of patent can only be obtained where the design is inseparable from the object. This type of patent only protects the object 's appearance. If one want to protect the functional or structural features of your object, you must also register a utility patent.
    
3. Plant Patents
   Plant patents are often obtained to protect new and distinctive plants. In order to obtain this type of patent are the plant is should not a tuber propagated plant (i.e., an Irish potato), the plant is should not be found in an uncultivated state, and the plant can be asexually reproduced. Asexual reproduction means that plants reproduce by grafting or cutting plants, rather than by seeds. Like Utility patents, currently, there is no provision for plant patents in India and you can apply for the same in Australia, the USA, and several European countries.

Patent Application Process

Patenting an invention requires familiarity with the legal procedures associated with the final patent application process. There are recent updates to the patent system in the Patents (Amendments) Rules 2021. With the entry into force of these changes, inventors and patent owners will enjoy a variety of benefits that make the filing process more accessible, fast and seamless. Benefits include an 80% reduction in patent filing costs for educational institutions, and patent issuance, which previously took him 3-4 years, will be reduced to 1-1.5 years.

Therefore, there are two ways for an inventor to apply for a patent. For example, inventors can file their own patents or hire patent prosecution experts to advise them.

Steps in the Patent Application Process.
Step 1 - Protect Your Novel Ideas and Inventions (NDA) - (Provisional application which gives a time of 12 months to complete the inventions, It is filed when the invention is not complete). One particular reason for obtaining a patent is your novel and unique idea. The patent system was created to protect the rights of inventors and encourage them to pursue as many inventions as possible. So, it is understandable that having a single, fresh "idea" that can be patented is of paramount importance. It is therefore your duty as an inventor to protect your ideas and inventions at all costs. Save your ideas in as much detail as possible by writing them down and saving them as soft or hard copies. Another important step is to ensure that you have signed a non-disclosure agreement (NDA) before disclosing your ideas to an agency or patent prosecution.

Step 2 - Check if the Idea Meets the Criteria for Patentability - This is an optional step, but it can save you many times the time, money, and effort. After performing a novelty and patentability search, you can get an idea of ​​whether your invention is patentable. This method will give you a clear idea of ​​whether you should apply for a patent in the first place.

Step 3 - Patent Draft � Drafting of Patents requires knowledge of legal drafting methods and technical details. Depending on the stage of the invention, you can choose between a provisional patent application and a permanent patent application. Choose a provisional patent application if the invention is in the testing stage.

This gives you 12 months to refine your invention to the final stage. A draft patent must contain all the material clauses, detailed description, inventive step, patent specification, etc. retain until patent application is completed and commercialized. Clauses must be written to prevent competitors or people from taking advantage of your invention. Exercise extreme caution and pay particular attention to draft patents.

Step 4 - Filing a Patent - After you have drafted your patent, you can file your patent application with the Office and get a patent application number that gives you many advantages.

The main advantage of the patent application is that it allows you to use words such as patent pending/patent pending for inventions. This will prevent others from exploiting your ideas. The application must be submitted with the patent application. B. Forms 1, 2, 3, 5, 26, 28 and other related applications.

Step 5 - Publication of Patent Application - After filing the patent application, the Indian Patent Office will protect the application. Finally, the patent is published in the the "Gazette" after about 18 months.
Inventors who wish to publish their patents before the expiration of the 18-month period may file Form 9 to request early publication. Your patent will be published within one month of early filing. However, it may not be published due to reasons such as mid-application or withdrawal.

Step 6 - Inventor's Request for Examination - Unlike the automatic 18-month period, once a patent is published, examination of the patent does not occur automatically and requires an applicant's or inventor's request for examination.

The inventor files Form18, (Form 18(A) for Expedited or Expedited.

Examination for Certain Applicants) to formally request examination of the patent by the Patent Office.

After formal filing, the Patent Clerk will examine the patent application in the prescribed manner, and during the examination will ensure that:

• Patent applications are examined in accordance with the Patent Act and related provisionsNovelty, non-obviousness and inventive step, industrial applicability, patentable subject matter, etc. are searched and examined.
• Patent examination After that, the Examiner will issue a First Examination Report (FER) containing the grounds for objection
• The Examiner's objection will extend the registration process for an additional 6-9 months.
• Inventors may request an extension of time by filing Form 4.

Step 7 - Respond to Examiner's Objections - After submission of Form 4, the inventor and patent attorney analyze and understand the examination report. A patent attorney prepares a written response to the objections raised and proves that the invention is patentable and novel. A written response must demonstrate that your design meets all patentability criteria.

Step 8 - Grant of Patent - The examiner has determined that your invention meets all the criteria for patentability and there are no objections. In this case, the patent will be granted to you and will be published in the "Gazette".

Step 9 - Patent Renewals - Once a patent is granted, it must be renewed at regular intervals. According to the TRIPS Agreement, the maximum term of a patent in India is 20 years. Therefore, the patent must be extended for a full 20 years.

Key Documents Required for Patent Application:

• Form 1 - Application for Grant
• Form 2 - Patent Specification Form
• Form 3 - Commitment and Declaration for Foreign Application under Section 8
• Form 5 - Declaration of Invention, Complete Application
• Power of Attorney
• Priority Document
• Summary of Invention
• Other Documents as required

Opposition To Grant Of Patent

Section 25 of the act deals with the opposition to the grant of patent.

There are two types of oppositions:

1. Pre-grant Opposition
   Section 25(1) of the act deals with Pre-grant Opposition. It states that after the publication of the application and before the grant of a patent, any person in writing can raise his or her objection against the grant of patent.
    
2. Post-grant Opposition
   Section 25(2) deals with Post-grant Opposition. These are objections brought to the applicant after the patent has been granted. Such objections are required to be filed within one year after the notice of granting the patent is posted by filing a notice of objection to the controller.
   
   The notice of opposition must contain the following information:
   
   • The facts on which the objection is based and
   • remedies sought by the other party.
   • Grounds for Opposition

Pre-grant opposition may be filed on the grounds set forth in Section 25(1)(a) through (k) of the Patents Amendment Act 2005.

1. Unlawful Acquisition of Invention.
2. Prediction by Prior Publication.
3. Prediction by Prior Date, Advance Claim in India.
4. Prior Public Knowledge or Public Use in India.
5. Lack of Obviousness and Inventive Step.
6. Unpatentable Subject Matter Invention Inadequate description of failure to disclose information
7. patent application not filed within 12 months of first filing in a treaty country.
8. secret or false source of biological material worldwide.

Similar to the pre-grant opposition as mentioned above, a post-grant opposition could also be filed on a number of grounds as specified under section 25(2) of the Act. It is to be noted that several of the grounds are similar to the grounds required for filing pre-grant opposition.

Patent Infringement

Patent infringement is the violation of the exclusive rights of the patent holder. As discussed earlier, a Patent is a license conferring an exclusive right or title to the inventor for a set period of time to exclude others from making, using, or selling an invention and the violation of these exclusive rights or title of the patent holder is known as patent infringement. It involves activities like unauthorized use, production, sale, or offer of sale of the subject matter or Invention of another person 's patent.

There are two kinds of patent infringement that are mentioned below:

1. Direct Infringement
   Infringement is said to be direct when a product that is substantially close to a patented product or invention is marketed, sold, or used commercially without permission from the owner of the patented product or invention.
    
2. Indirect Infringement
   Indirect infringement occurs when some amount of deceit or accidental infringement happens without any intention of infringement.

Remedies For Patent Infringement

Section 108 of the act deals with the reliefs that a court may grant in any suit for infringement include an injunction subject to such terms, if any, as the court thinks fit and, at the choice or option of the plaintiff, either damages or an account of profits. The court may also order that the goods which are found to be infringing and materials and implements, the predominant use of which is in the creation of infringing goods shall be seized, forfeited, or destroyed, as the court deems fit under the circumstances of the case without payment of any compensation.

Claims of infringement must be brought by litigation in any district or high court having jurisdiction to hear such claims.
A plaintiff who has convinced the court that his patent has been infringed is entitled to the following legal protections:

• Damages
  When assessing damages, the key question is what damages have been suffered by the patent owner. Loss must be a natural and immediate consequence of the defendant's actions. Coverage is compensation for loss or injury.
   
• Account of Profits
  If the patentee claims profit from unauthorized use of his patent, how much of his invention was diverted to determine how much of the infringer's net profit came from that use. is important to determine.
   
• Interlocutory Injunction
  A plaintiff may seek an injunction at the commencement of an action to prevent the defendant from taking the alleged conduct pending trial or further order of the action. The plaintiff must present prima facie evidence to show that the balance of convenience is in his favor.

Laws Governing Patent Infringement
The main regulation governing patent infringement in India is the Patents Act, 1970, which came into force in 1972. As a result, innovations in pharmaceutical, food and agrochemical products are no longer patentable in India. This has enabled innovations patented elsewhere in the world to be copied and commercialized in India.

The law also imposed restrictions on the importation of ready-to-eat foods and introduced strict price control regulations. It was found to be detrimental to foreign investment in the country because it was inconsistent. Since India became a member of the WTO in 1992, it has become important to amend existing legislation to meet the requirements of the TRIPS Agreement.

In order to comply with the TRIPS agreement, the introduction of exclusivity and a mailbox system were important. Under EMR, a foreign company is granted exclusive rights to sell pharmaceuticals and agricultural products in the Indian market for a specified period of his five years. The mailbox system is the system that receives all pharmaceutical and agricultural patent applications. It was amended in 1999, 2001, 2001 and 2005 to implement these provisions of the 1970 Patent Act.

However, these provisions were not sufficient to bring Indian patent law into line with global patent law. Therefore, in 2005 an important amendment called the Patent Amendment Act was passed. The main provisions of the

The major provisions of the amendment act are as follows:

1. Product Patents:
   This amendment provided patent protection for products, as opposed to previous provisions of the law which provided patent protection only for processes. Process patent protection means that only the process used to produce a product can be patented, not the final product. Using a different process than the original inventor used to create the same product is not considered patent infringement.
    
2. Compulsory License:
   This provision has been introduced pursuant to the TRIPS Agreement. It activated a compulsory license, allowing the government to release patented products to the public for non-commercial purposes in the event of a national emergency. Nevertheless, governments can invoke compulsory licenses if patented products are not made available to the general public at an affordable price.
    
3. Other Provisions:
   After this change, patent holders could challenge licenses that prevented the general production of their drugs. The law also provided for pre-grant and post-grant opposition clauses. Provisions have also been introduced to protect national interests from patent infringement.

How to Avoid Patent Infringement?
There are several ways to avoid patent infringement, some of which are listed below. However, the company must remember to include a clause in the contract that the manufactured product is the exclusive right of the company.

This ensures that employees do not later claim their rights to the invention.

1. Obtaining Proper License From The Patent Holder

   Any use of registered material by a company or legal entity must obtain permission from the patent owner prior to use. Royalty-free materials generally refer to the use of online materials that are available for free. However, it is best to give due credit to the owner of such rights in order to avoid infringing the owner of their exclusive rights in such material.
    

2. Creation Of Original Products

   Companies can hire people who can use their creativity and intelligence to create original products. However, the company must remember to include a clause in the contract that the manufactured product is the exclusive right of the company. This ensures that employees do not later claim their rights to the invention.
    

3. Patent Infringement Claims

   The Patents Act of 1970 gives patent owners the power to sue if their exclusive patent rights are infringed. According to the statute of limitations, the statute of limitations for filing a lawsuit is three years within the patent infringement period. The burden of proof of patent infringement by a defendant usually rests with the plaintiff, although in some cases the court has discretion to determine the burden of proof. In India, both District Courts and High Courts have the power to hear patent infringement cases. However, only the High Court has the right to hear any counterclaim seeking revocation of a defendant-filed patent. A patent owner may bring an action wherever he resides, does business, or where a cause of action arises. Section 48 of the Indian Patent Act contains the rights of the patent owner.

The following activities are listed as infringements of the patent owner's rights:

• Making
• Using
• Importing
• Offering it for Sale
• Selling the Patented Process.

Section 108(1) of the Patents Act 1970 provides for the exoneration of plaintiffs if their patents are infringed.

The remedies available to patent owners are:
Preliminary/ Temporary Injunction:
A injunction is enforced by the court in the early stages of a lawsuit filed by a plaintiff. This is done to prevent defendants from using other patented products to further profit. To enforce an injunction, the patentee must prove that the patent is valid and that the defendant has infringed the patent. Moreover, subsequent infringement of his patent rights has done him irreparable harm.

Permanent Injunctions:
Injunctions are invoked when a case is finally decided by a court. If the defendant is convicted of patent infringement, the injunction is commuted to a permanent injunction. However, if the defendant is released from liability, the preliminary injunction remains dissolved and does not become a permanent injunction.

Damages:
If the defendant is proven guilty, the plaintiff will receive damages or a statement of earnings from the defendant. Damages cannot be awarded to the plaintiff if the defendant asserts ignorance and proves that he or she had no reasonable grounds to believe that the named patent existed at the time of infringement.

Patent infringement litigation has several defenses that exempt defendants from liability:

1. In case of litigation or in case of res judicata.
2. Where plaintiff is ineligible to bring an action for infringement.
3. Where defendant has an express/implied license to use the patented product.
4. Patent revoked for illegality.
5. For pharmaceuticals, governments may retain exclusive rights to manufacture patented products for public benefit.
6. Where the alleged infringement is obvious and novel.

Exceptions Or Limitations To Patent Rights In India

1. Compulsory Licensing:
   It is the authorization given to the third party by the government to make, use or sell a particular product or use a particular process that has been patented, without the prior permission of the patent owner. There are certain prior conditions, mentioned under sections 84-92, which need to be fulfilled if a compulsory license is to be granted in favor of someone.
    
2. Exception on Experimental / Scientific Research:
   Section 47(3) deals with the exception of the experimental and scientific use of Patented invention. The use of a patented invention for experiments/ scientific research 's and teaching purposes does not come under infringement.
    
3. Exception Regulatory use or Private use:
   The section which deals with the exception of regulatory use or private use is section 107A of the Indian Patent (Amendment) Act, 2005. It is also referred to as bolar provision. Under this exemption, there are certain act that does not amount to infringement of patent if they are performed solely for uses reasonably related to the development and submission of information required for obtaining regulatory approval for the manufacture, use, construction, sale or import of any product. This provision helps the prompt availability of the products, particularly generic drugs immediately after the expiry of a patent.
    
4. Foreign ships, aircraft or land vehicles:
   This exception is governed by Section 49 of the Indian Patent Act. When the foreign vessels, aircraft, or land vehicles accidentally or temporarily comes or enter in India, the patent rights granted to the inventor are not infringed when the patented invention is used exclusively for the needs of foreign vessels, aircraft, or land vehicles and other accessories of alike nature.

Landmark Judgments

1. Hoffmann-La Roche Ltd vs Cipla Ltd., Mumbai Central
   After independence, this was the first case of patent infringement. In this case, the plaintiff relied on the defendant's temporary injunction against the sale of generic drugs. The court rejected the plaintiff 's plea by saying that the sale of the plaintiff 's patented product was for public interest and also a case of a counterclaim for the revocation of the patent was ongoing in another court proceedings.
    
2. Dr Snehlata C. Gupte v. Union of India and Ors
   In this case, the court cleared the most important point that is related to the date as to when the patent could be considered to be granted. According to some person 's the patent is granted as soon as the decision for its non-rejection from the patent granting authority comes. However, the court in this case held that the issue of a certificate in case of granting patents is a mere formality which means patent could not be considered to be granted. An application for the grant of a patent shall be considered accepted after the order is sent by the controller.

Conclusion
The passage of the Patents Act helped protect new inventions which led to the growth of trade and technology in India. The Patents Act 1970 also gave patent holders many rights to protect and promote their inventions. gave This law helps encourage people to develop new ideas in the field by giving them exclusive rights to inventions. If you want to obtain a patent for your invention, you must go through a detailed procedure prescribed by law.

Patents can bring great benefits to individuals and businesses and can increase the return on investment in developing new technologies. Patenting must be done with an intelligent strategy that balances business interests and a wide range of options for implementing the technology when exploring how, where and when to patent. For example, companies that focus on international considerations and regulations can achieve significant savings in certain countries and improve the rights conferred by patents.

Award Winning Article Is Written By: Mr.Pulok Rai

Authentication No: MR306010380100-01-0323