Vital info on patents and trademarks in Indian pharma. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 75.

1. What are the basic requirements to obtain patent and trademark protection?

India’s Intellectual Property Law is TRIPS compliant. The Patents Act, 1970 and the Trademarks Act, 1999 provide protection and regulate patents and trademarks in India.

PATENTS

The requirements to obtain a patent are:

1. An application for grant of patent may be made by the inventor or the legal representatives and assignees of such inventors.
2. The application must be made to the Controller of Patents.
3. The application must contain the complete specification of the invention describing the invention and the subject matter to which it relates. A complete specification must detailed enough that a person possessing average skill and average knowledge of the art to which the invention relates should be capable of working that invention.
4. The application will then be examined by an examiner who shall inquire into whether the invention is patentable under the provisions of the Act or has been already been published or disclosed in any manner.
5. Depending upon the decision of the examiner, the patent shall either be granted by the Controller or, in case the patent is refused or an amendment to the application is required, the applicant shall be given an opportunity to be heard before a decision is made.

Patents are valid for 20 years from the date of filing the application.

TRADEMARK

1. Any person who has either been using the trademark of proposes to use the trademark may file an application with the Registrar of Trademarks to register the trademark.
2. Indian is a contracting party to the Madrid Protocol and follows the Nice Agreement Concerning the International Classification of Goods and Services for the Purposes of Registration of Trademarks. Therefore, a single application may be filed to register a trademark in multiple categories of goods.
3. The Registrar may admit the application in full or partially or reject it in entirety. In the latter two cases, an opportunity for hearing must be provided.

Trademarks are registered for a period of ten years from date of registration and can be renewed thereafter.

2. What agencies or bodies regulate patents and trademarks?

The Office of the Controller General of Patents, Designs and Trademarks is the regulatory body for patents and trademarks.

3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?

PATENTS

An invention to be patentable must be new, inventive and useful. The three requirements may be elaborated as follows:

1. Firstly, the invention must not be patented in India and should not be common knowledge.
2. Secondly, it must involve an inventive step i.e. the invention should be non-obvious to the person skilled in the art. The standard for this is that if a person skilled in the art is in the workshop, such person would not be able to arrive at the invention using existing knowledge. This necessitates that the invention technical advance as compared to existing knowledge and/or has economic significance.
3. The third requirement is that the invention is useful i.e. capable of industrial application. It may be noted that computer programs are not considered inventions but can be copyrighted.

A patent may not be registered if the invention is frivolous or contrary to well established natural laws or the primary use of such invention is contrary to public order and morality or is harmful to human, animal or plant life and the environment. The Act also states that “any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products” is not patentable.

TRADEMARKS

A trademark is defined as “a mark capable of being represented graphically and which is capable of distinguishing the goods or services of one person from those of others and may include shape of goods, their packaging and combination of colors”. Therefore, any mark fitting the above definition may be registered as long as the registration of such a mark is not prohibited under any other provision of the Act. For instance, a trademark may not be registered if it is deceptively similar to an already registered trademark, scandalous in nature, or if the trademark is merely an indication of the quality, quantity, intended purpose or the geographical origin of the goods.

4. How can patents and trademarks be revoked?

PATENTS

After a patent has been published but before it has been granted, any party may make an opposition to the grant of patent to the Controller. Depending upon the representations made by the parties, the Controller main maintain the patent or order that the application be amended or revoked. This is known as pre-grant opposition. The patent technically cannot be revoked in this proceeding as it has not been granted yet. Revocation of patent may be done on the petition of an interested party, the Central Government or in a case where infringement proceedings have been filed the defendant may be plead that the patent is invalid and should therefore be revoked.

Essentially, a patent may be revoked if it does not fulfil the requirements of invention as specified above or has been obtained by someone not entitled to file the application or the grant of patent is in contravention of the interests of the true inventor. Patents granted on the basis of incorrect, false, misleading or incomplete specification can also be revoked. Lastly, if the invention is already claimed in a valid claim or complete specification of an earlier date or if it is discovered that the patent has been published prior to the application date, then the patent will be revoked.

TRADEMARKS

Similar to patents, trademarks can also be opposed both prior to and after registration. Any person may within three months from the advertisement of the trademark but before such registration make a representation to the Registrar to oppose grant of the trademark. The Registrar will arrive at a decision after hearing both parties.

Trademarks may be cancelled by the Registrar on the following grounds.

1. The registered used has used the mark in a way that is likely to cause confusion or deception
2. The proprietor or the registered user misrepresented or failed to disclose some fact material to the application for registration
3. Circumstances have changed in such a manner that were the trademark were to be registered on the date of application for cancellation, the trademark would not have been granted.
4. Registration ought not to have been affected having regard to rights vested in the applicant by virtue of a contract in the performance of which he is interested

5. Are foreign patents and trademarks recognized and under what circumstances?

India is a signatory to the Patent Cooperation Treaty 1970 (PCT). Therefore, patent applications filed under the PCT will be considered as valid applications as long as a corresponding application has been filed before the Controller in India. The relevant date for the application will be the international filing date accorded under the PCT.

India is a Contracting party to the Madrid Protocol. Therefore, trademarks made through the international application are recognized in India. India also recognizes the concept of well-known marks. Therefore, a foreign well-known mark will not be permitted to be registered in India irrespective of whether such well known mark has been registered or used in India.

6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?

A drug will continue to remain a new drug for four years after it has been approved. To import or market a new drug, the permission of the marketing authorization holder must be obtained. The rationale behind this is that the drug can thereby be studied in safe and controlled environment. However, it also gives the holder of the marketing authorization a window within which to maximize the profits from selling the drug.

For more information on what constitutes a new drug see Question 3 in the Regulatory, Reimbursement and Pricing Overview.

7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?

A new form of a known drug will not be patentable unless an increase in efficacy can be shown. Additionally, mere discovery of any new property or new use for a drug is also not patentable.

Please note that India has a robust compulsory licensing policy for drugs and devices. Under the Patents Act the Controller may grant any person a license with or without the consent of the patent holder if:

1. The reasonable requirements of the public with respect to the patented invention are not being satisfied
2. The patented invention is not available to the public at a reasonable price
3. The patented invention is not worked in the territory of India
4. 3 years have expired from the date of grant of patent

The terms of grant of the compulsory license will be determined by the Controller. Before making a decision, the Controller must look into whether the applicant for compulsory license is capable of undertaking risk, providing capital and working the invention to public advantage.

There are no restrictions on the types of medicines which may be granted trademark protection.

8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?

While there were certain exchange control approval requirements in the case of foreign technology collaborations, the approval requirements were liberalized in 2009. A prior approval of a government/regulatory body is currently not required in case of a patent of trademark license agreement.

However, it is to be noted that with respect to patents, a person who acquires a share, title or interest in a patent, whether by license or otherwise, is required to apply to the Controller of Patents for registration of such title or interest.