Importance Of Patents In Pharmaceutical Industry

Patent is essentially an Intellectual Property. When a patent is registered, the exclusive right to utilise the intangible creation of the human mind rests with the person in the name of who, the patent is registered. 

The owner of the pharmaceutical patents has the sole right to exclude anyone from making, offering for sale, using, or selling the invention for a period of 20 years from the date of registering the patent.

Criteria for Patentability

The patent can be granted the geographical patent rights, it should cater to the following criteria:

The invention should essentially be a patentable subject matter.

It should contain the unity of invention

It should be capable of industrial application

Pharmaceutical patents help in the innovative development of new medicines for various diseases. With the help of patenting the manufacturing processes of the drugs and medicines, the companies can safeguard their investment done on the whole process thereby, remaining unique in the market. When the pharma companies know that their drugs and medicines are safe in the market, they can spend millions of dollars without worrying and further spend on the research and development as they know they will be able to take benefit of the sales. 

We know that the pharma products are not manufactured in a day. From the inception of the idea to devising a formula to testing and then final application, it is a long process. On an average, for a new medicine to enter the market, it takes 10-15 years of hardwork and patience. 

As the cost of producing the medicine is more, patent protection is mandatory in the pharma industry. Patents become legal protection of the investors and encourage the investors to recoup the investments.

Patents relating to pharmaceutical inventions

Patent claims related to a pharmaceutical product can be an active ingredient that will be either used separately or with prodrugs, salts etc. Patent in pharma industry can be a manufacturing process as well that includes the process and the product both. While developing the drugs, the element of invention must always be there to distinguish it from the rest of the drugs in the market.

Patents relating to formulations and compositions

An active patented ingredient can be used in various forms or dosages such as tablets, ointment, capsules, solutions as so on. This in turn, can be formulated into different pharmaceutical products. A huge number of products are manufactured using this technique with the help of same ingredient but patented differently. However, the claim over these processes are not inventive and patenting the same depends upon the rules prevalent.

Patents are an important tool in the pharmaceutical industry and it is due to intellectual property rights, we can see numerous inventions in the medical field everyday. 

Consequences of Patent Infringement in India

This article aims to provide the reader with some insights on the consequences of patent infringement in India. The patent registration in Ahmedabad secures the products or services of a merchant who wishes to secure his/her products from being copied. Even the manipulation of entries in a register with an intention to copy a patent is considered to be a criminal offense as per the Indian Patents Act, 1970.

All such penalties are stated in the Indian Patent Act, 1970. However, the exact consequences of the infringement of a patent are not stated but the Section 48 deals with rights that have been conferred to the patentee. Some of the notable ones are:

1. The patentee has the exclusive right to prevent a third party from using, selling, distributing or importing the products that have been patented by the patentee under the act. 

2. When the subject matter is a process, the patentee has the sole right to prevent the third party from using, selling, distributing, or importing any products or services produced by the process in India. 

The Patent Infringement in India as per the Indian Patent Act, 1970

According to the provisions stated in the act, the following activities will lead to a patent infringement:

1. The imitation of the invention by discoloration.

2. Mechanical Equivalents

3. Capturing the essential features of the subject matter.

4. Some immaterial variation in the invention

The mechanical variation here would mean altering some features of the invention and creating a new concept out of it. 

The patentee can file a complaint for the infringement of the patent up to three years from the date of such infringement and the jurisdiction will be the geographical area where such infringement has taken place. The patentee must produce a proof that shows that an infringement has occurred. 

Constitutes of a patent infringement

The following things must be present while instituting a suit for the patent infringement:

1. The patentee
2. The exclusive license of the patentee
3. The compulsory license
4. Assignee

It should be noted that a suit for the infringement of a patent can only be instituted when the patent is sealed legally. When the license and the patenting of the subject matter are in the process, the patentee cannot file a suit for any infringement. The patentee, however, can file a suit for the damages caused due to infringement during the period of the date of publication and the date of grant. 

The Remedies and Relief

1. Administrative relief:

The patent owner can directly move to the collector of customs and prohibit the entry of such good in the Indian market. The patent owner should provide all the details of the consignment such as the name of the exporter, consignee, name of the ship, port of entry and so on. 

2. Civil Relief:

3. Injunctions:

Temporary injunctions are granted when there are prima facie pieces of evidence in the favour of the plaintiff while the permanent injunction is granted only after the complete trial. 

4. The accounts of profit or damages are granted when it is proved that the defendant was aware of the patent on the date of infringement.

The court has the right to order the delivery up of the infringed goods. The rule 7 of the Civil Procedure Code talks about the same. According to the provisions of this rule, a police commissioner will reach the warehouse or the commercial/residential property of the defendant and seize all the infringed goods. This process is conducted without giving any prior notice to the defendant. 

When the imposed infringement is fake

At times, the plaintiff files a suit against the defendant without the defendant being actually responsible for the infringement. In such cases, the defendant may seek the following reliefs:

➧  Injunction against the threats.
➧  Ask for the damages if any.
➧  A declaration stating that the claims are non-justifiable. 

Nowadays in India, people are becoming more and more aware of patenting their products and services. This is a good way to secure their inventions and stay away from the cheats. 

Patent Law In India And The Pharmaceutical Industry

The introduction of Intellectual property rights in India turned to be a boon for the pharma industry. The pharma industry is contributing a lot to the health sector by developing new drugs in the market. Thankfully, due to the introduction of the pharmaceutical patent laws, the research and development was regulated up to a great extent and now India is also a proud member of GATT. 

When the Patents Act was introduced in 1970, the pharmaceuticals manufacturers were able to patent the manufacturing process of drugs and medicines. Later in 1994, Indian signed the GATT agreement and a number of changes occurred. Today, a pharma company need to comply with the rules of GATT and TRIPS. Failing to comply with the agreement, the company will no more be able to deal with WTO. 

Patent Law in India

The Patent Act 1970 facilitated India to enter the global trade market. The patent laws have been a significant contribution to the TRIPS agreement. For India, it took some time to implement the rules of TRIPS and things were streamlined after three amendments in the act. 

Effect of Process Patent

When the patent laws were formulated, only the process of manufacturing the drugs were patented and under this system, the drugs could not be patented. The competitors could produce the same drug by some other process and sell it in the market. With the introduction of product patent, even the products could be patented hence, securing the complete thing.

The Section 5 (1) that talked about patenting the drug manufacturing process was replaced and the product patent law was made applicable. This even included the applications used during the transitional phase. 

People were afraid that due to these patent rights, the cost of drugs would go up but that did not happen. The Indian Pharmaceutical industry adapted to the changes very well and things were streamlined very soon. The Indian Pharma companies started dominating the overall market even after the TRIPS agreement. Among the major pharmaceuticals companies, the maximum are the Indian companies. Later, the foreign companies started dealing under the name of Indian pharma companies by way of a subsidiary. 

What can be patented?

Section 2 (1) deals with the registration of patent and it says that the invention is the introduction of any new idea, knowledge or product. If any one within or outside the country has knowledge about the idea or the concept is being already sold in the market, it will be not be patented. The patent should be registered before informing about the idea to anyone. 

Nevertheless, here are some of the innovations that do not come under the category of invention:

1. A method of horticulture or agriculture
2. A presentation of Information
3. An invention whose use is against public order.
4. A process of medical treatment of animals or human beings
5. A discovery of a new property or a new use of an existing property.

Infringement of trademarks and its remedies in India

A trademark is a symbol or an emblem used to distinguish some goods and services from the rest of the market. Trademarks come under the gamut of Intellectual Property (IP) and the rights attached to them are precious commodities that cannot be tampered with. The insights on trademark registration in Ahmedabad will help you understand the importance of a trademark for your business.

This blog aims to explain what is called an infringement, who has the right to sue for an infringement and what are the remedies to it. Let us have a look at them one by one.

Infringement of Trademarks:

For an infringement, the registration of a trademark is compulsory. If a commodity or service is not 

registered under the Trademarks act and someone uses it for his benefit, it will not be called 

infringement. To start an infringement action, the following prerequisites must prevail.

1. The alleged infringement symbol must be similar or deceptively identical to the registered trademark.
2. The goods from which the infringement has taken place must be registered under the trademark.
3. The infringing mark is used with an intention to initiate a new trade.
4. The use of the mark has come into action as it was used as a trademark for some other property.

As per the trademarks act, the following actions are called an infringement of a registered trademark:

1. When the party has used the trademark for selling the similar goods and services for which, the
trademark has already been registered.
2. The trademark has been used for promotional purposes for similar goods or services, which is withering the distinguished identity of the original trademark.
3. Under the act, the oral use of the trademark is also considered as an infringement.

Who has the right to sue?

The proprietor who has registered for the trademark, his/her heirs and his/her legal representatives have the right to sue the alleged party for infringement. The assignee of the trademark can sue the other party for the infringement of the trademark.

Remedies for Infringement

1. Civil Remedies

When an infringement occurs, the court of the competent jurisdiction, which is lower than the District court has the right to grant Anton Pillar orders, interlocutory injunctions, damages, and account of profits.

2. Criminal Proceedings

Regardless of the kind of infringement and complaint against the alleged party, there are two ways to
deal with the case

• Civil remedy
• Criminal remedy

Under the civil procedure, the plaintiff asks the court to pay off for his loss and under the criminal
procedures, the plaintiff asks for punishment of the convict as an award for the infringement.

3. Administrative Remedies

If someone tries to register a relatively identical trademark, the registry can stop the new registration
and protect the earlier trademark that is already registered with them. In case, a similar trademark is
registered by mistake, the registry can be moved to remove the trademark.

Learn the procedures of the trademark registration in Ahmedabad and stay safe from these infringements of Intellectual Property.