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Patents are generally used and are one of the major forms of Intellectual Property Rights (IPR) in the pharmaceutical industry, at domestic as well as international level. Having a patent ensures that a new drug or medicine is protected for a certain period (i.e., 20 years in India). This means that only the inventor of the drug or medicine is permitted to bring it to the market.
If everyone kept their ideas to themselves and worked secretly, scientific progress would be really slow. This is why a patent makes it mandatory for the inventor to publish their invention so that the competitors can also learn about it and come up with their own unique ideas. Nevertheless, if crucial details are mentioned about an invention, the risk of it being copied is increased. This is why a patent also guarantees that such an invention is protected for a specific period. Once this term is exhausted, the competitors can introduce their own versions of the product.
This article will help you learn about what a drug patent is in the context of India, and also mention the major amendments that took place under the Patent Amendment Act, 2005 and other relevant provisions which are concerned with the patenting of drugs.
Let’s understand the meaning and characteristics of patents before we dive into the details of drug patents.
The word “patent” originates from the Latin term “patere” which means “to lay open” (i.e., to make available for public inspection). A patent provides an exclusive right over an invention to the inventor that is a patent holder. Patents are basically a form of contract which are executed by the inventor with the government of a country where he chooses to disclose the entire invention. In return of this, the government agrees to grant an exclusive right to the inventor which prevents others from using or producing that invention.
However, it is necessary to note that not all inventions can be patented. As per Section 2(1)(j) of the Patents Act, 1970, a patent is described as “any new product or process involving an inventive step and capable of industrial application.” Only such an invention gets the protection by the patent law. A patent is a kind of an IPR which protects the inventor’s invention from being used or created by others. A patent right is a territorial right. This means that a patent right granted in India is only valid within the Indian territory. All the major rules and regulations concerned with the patents in India are included under the Patent Law of 1856, The Patent and Design Act of 1911, The Patents Act of 1970 and Rules of 1972, and The Patent Amendment Act of 2005.
Since India is a signatory of the TRIPS agreement, it had to amend its patent laws to make it compliant with the agreement’s provisions. This is the reason why, in 2005, the Patent Amendment Act had been introduced in India.
A drug patent refers to a patent which is required by the pharmaceutical companies for their drugs. This patent grants exclusive rights of the drug’s creation, usage, manufacture, sale and import to the pharmaceutical company. Others cannot create, use, manufacture, sell or import this drug unless the patent expires.
The objectives of The Patents Act are the following:
Every year, pharmaceutical companies spend crores of rupees for the research and development of drugs. At present, from the clinical trial’s beginning to receiving marketing approval, the success rate of a drug candidate is between 10 to 20%. The success rate has remained the same from the past few decades. The drugs innovated are patented by the pharmaceutical companies who obtain exclusive marketing rights for the drugs for 20 years. The money involved in the research and development of these drugs is recovered through the pricing at which these drugs are purchased by the general public. The pharmaceutical companies must get their invented drug registered under the Patents Act which grants 20-year exclusive right to own the patent and also rights to market the drug which is also fixed for the term of these 20 years. During this period, no other company is permitted to use or produce the same drug. The patent expires upon the completion of the term of 20 years after which other drug companies are allowed to manufacture and sell the same drug under their own name. The early Patents Act of the 1970s only recognized the process patents and not the product patents. This enabled the Indian pharmaceutical companies to manufacture the same drug with the help of another process known as reverse engineering. However, this changed after the 2005’s amendment act which allowed for product patents for the pharmaceutical inventions.
The pharmaceutical industry is a profound knowledge driven industry wherein the inventors must be aware of patenting their inventions.
There are various types of pharmaceutical or drug patents:
The polymorph patents are granted as per the Section 3(d) of the Patents Act, 1970. The Indian Patent Office is the concerned authority for granting the polymorph patents to the pharmaceutical companies. According to Section 3 (d), “the mere discovery of a new form of a known substance does not result in the enhancement of the known efficacy of that substance; the mere discovery of any new property or new use for a known substance; or the mere use of a known process, machine, or apparatus unless such a known process results in a new product or employs at least one new reactant.”
In case of this clause, all the substances namely salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations, and other derivatives of known substances shall be considered to be the same, except in cases where they majorly differ in properties concerning efficacy.
The Section 3 (d) of the Indian Patents Act, 1970, helps to prevent the evergreening of patents by stating that only those pharmaceutical derivatives that showcase significantly enhanced effectiveness are eligible for patent. This section also guarantees that new forms can only be granted patent in case of being truly meritorious and that in case of trivial inventions, the patents will not be granted.
As opposed to discovery, invention refers to finding out something which hasn’t been found out by anyone else. There are many cases in various branches of science wherein many individuals made the same discovery. This does not stop an individual from filing a patent application and getting patent approval, since a patent comes with monetary benefits. Patents by granted for products that are developed and invented through human intervention.
After a pharma company files a patent application, the patent is granted to the company for their invention as per the Section 21 of the Indian Patent Act, 1970. The inventor company must describe the invention in writing (patent application) to the government to seek the patent. The patent will only be awarded if there is no pre-granted opposition to the patent application. The patent application gets royalty for such inventions upon receiving the grant.
It is possible to transfer patent rights from the original patentee to another individual through the operation of law. There are three main ways through which a patent can be transferred from one person to another viz., granting a license, through assignment, or transmission. A patent license is granted by the patentee to enable another person or company to create, manufacture or sell the patented invention. Through assignment, the original patentee’s entire ownership is transferred to another person or company. For this, a written document known as assignment deed must be signed by the assignor (patentee) as well as the assignee (person or company receiving the assignment). Transmission of patent is required in case of transferring the patent’s ownership to another person due to the demise of the patentee. The patent gets transferred to the heirs or estate as per the patentee’s will or according to the inheritance laws.
A patent is a legal protection which is granted to an inventor for 20 years. In exchange, as an obligation, the inventor must disclose his invention for the public. A drug that gets patented gives a pharma company an exclusive right to ownership, and it cannot be created, manufactured, sold or imported by other pharma companies unless they have been granted permission for it by the inventor pharmaceutical company. Indian patent law is an important piece of patent legislation which ensures the balance of interests of both the consumer and the inventor. In today’s time, pharmaceutical companies can file for patents for many drugs and processes. The patent required for a pharma drug depends on the drug’s type.
Before filing for patent application, you must check the patentability criteria and the types of patents available for the pharmaceutical products or processes. If you need assistance in filing patent registration, reach out to Registrationwala now!
Hey there, I'm Dushyant Sharma. With the extensive knowledge I've gained in past 8 years, I have been creating content on various subjects such as banking, insurance, telecom, and all the important registration and licensing processes for various companies. I'm here to help everyone with my expertise in these areas through my articles.
