What is the point of having a drug patent in India?

Last Updated at: May 12, 2020
204
What is the point of having a drug patent in India

One of the biggest beneficiaries of the rapid advancement of technology has, without a doubt, been the pharmaceutical industry. Often regarded as a highly knowledge-driven field, it requires years of research and experimentation to come up with even one drug. Furthermore, a lot of research that happens in this field is unpredictable, with many not leading to anything. Therefore, it becomes crucial to the pharma companies that they make the most out of whatever research bears fruits. So, how do they ensure that they stay financially secure when the research which they do is both expensive and unpredictable? This is where the drug patent comes into the picture as a way for them to protect their best interests. Here’s a look at why drug patents are necessary for the Indian pharmaceutical sector.

  1. Intellectual Property Right and Indian Pharmaceuticals

  2. Drug patent Definition

  3. Drug Patents in India

  4. Types of Drug Patent

  5. Ever-Greening in Pharma Companies 

  6. How Drug Patents Have Helped

Intellectual Property Right and Indian Pharmaceuticals

Since the pharmaceutical industry relies on research and development, it needs to take Intellectual Property rights very seriously. These pharma companies protect themselves by relying on drug patents in India. Therefore, along the years, India has developed its system of patent laws, which help ensure that both the public and pharmaceutical companies strike a good deal. Furthermore, India is also a part of the GATT, which has helped make drug patents in India more efficient. The first significant change came in the form of the Patents Act in 1970, which allowed pharmaceutical companies to patent their drug manufacturing process. 

The drug patent duration at this time was seven years. India became a part of the GATT in 1994, leading to several significant changes in the Indian market, as the country had to comply with GATT and TRIPS laws. After this, Indian pharma companies needed to meet the minimum standard requirements laid down by the TRIPs. As a part of this process, India introduced the system of product patents, which were valid for 20 years. 

Drug patent definition

A patent is a legal document that allows the owner to protect their invention or idea from intellectual property theft. It is a type of Intellectual Property Right that prohibits others from manufacturing, using, marketing, or selling a design without the owner’s consent. Granted by the government, it helps ensure that the owner has supreme rights over their creation or idea. However, a governing authority does several rigorous checks to ensure the plan, product or process is unique and inventive before granting a patent. Drug patents are patents made exclusively for drugs or medicines, which prohibit other companies from marketing, manufacturing, or selling a particular drug. 

Drug Patents in India

After agreeing to the TRIPs Agreement, India, via an amendment to the Patent Act, made transitional arrangements possible in India. A second amendment came in 2000, and soon enough bills followed suit, which helped in extending the drug patent duration, adding new matters, and even introducing compulsory licensing. Through a third amendment, product patents were introduced, along with changes in the fee structure and filing procedure for Indian pharma companies. 

Patent your idea now

Types of Drug Patent

  • Process Patent – Under this system, only the process of manufacture of a drug could be patented, and not the drug itself. Therefore, other competitors could use different methods to manufacture the same drug, leading to a lot of copies and generic medications.  
  • Product patent – As per this system, the actual drug had a patent on it, preventing others from manufacturing it. This ensured that competitors could not make the same drug, and therefore garner a market share for a drug you specialized in. Therefore, since then, this is the system followed in India.
  1. Patent-expired/Non-patented Drugs – Continue supply to both the domestic and export market.
  2. Patented Drugs – Manufacture possible only through compulsory licensing.
  3. The availability of prime ownership encouraged more pharma companies to undertake R&D for new drugs.

Introducing the product patents helped give more power to Indian pharma companies. Before 2005, MNCs and American companies had a significant impact on the Indian healthcare and pharma sector. However, later on, we have seen Indian companies dominate the market, as the market share of the MNCs reduced significantly after 2005. Furthermore, a lot of foreign companies decided to launch their subsidiaries in India and sell medicines through them, as R&D was less expensive in India.

Ever-Greening in Pharma Companies

Ever-Greening is a strategy used by pharma companies to protect their commercial interest better. The plan includes making small changes to an existing product and filing for a separate drug patent. For instance, a pharma company would use the molecular formulae with an altered structure and register a new drug patent. Sometimes it also adds an ingredient that makes no difference to the product and files another drug patent. Also, many pharma companies choose to buy out their competitors. They also try to stall the latter’s research by filing fraudulent infringement claims on these new drug patents. While these strategies are legal, they make medicines more expensive and should be checked.

How Drug Patents Have Helped

Before product drug patents became popular in India, Indian pharmaceutical companies were having a tough time. Generic drug companies do not spend much on research. They sell their drugs for much lower prices and then consolidate the market share. Such companies were making things very difficult for pharma companies who were helping make new drugs. But timely patent law interventions helped pharma companies handle the situation efficiently. However, while drug patents help pharma companies maintain a good profit margin, they should also not try to run a monopoly within the market. Hence, The patent law addition, Competition Act of 2002, prevents a monopoly in any field. Therefore, drug patent laws help in balancing the protection of IP and competition. It also ensures welfare for both companies and the general public.

 

 

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What is the point of having a drug patent in India?

204

One of the biggest beneficiaries of the rapid advancement of technology has, without a doubt, been the pharmaceutical industry. Often regarded as a highly knowledge-driven field, it requires years of research and experimentation to come up with even one drug. Furthermore, a lot of research that happens in this field is unpredictable, with many not leading to anything. Therefore, it becomes crucial to the pharma companies that they make the most out of whatever research bears fruits. So, how do they ensure that they stay financially secure when the research which they do is both expensive and unpredictable? This is where the drug patent comes into the picture as a way for them to protect their best interests. Here’s a look at why drug patents are necessary for the Indian pharmaceutical sector.

  1. Intellectual Property Right and Indian Pharmaceuticals

  2. Drug patent Definition

  3. Drug Patents in India

  4. Types of Drug Patent

  5. Ever-Greening in Pharma Companies 

  6. How Drug Patents Have Helped

Intellectual Property Right and Indian Pharmaceuticals

Since the pharmaceutical industry relies on research and development, it needs to take Intellectual Property rights very seriously. These pharma companies protect themselves by relying on drug patents in India. Therefore, along the years, India has developed its system of patent laws, which help ensure that both the public and pharmaceutical companies strike a good deal. Furthermore, India is also a part of the GATT, which has helped make drug patents in India more efficient. The first significant change came in the form of the Patents Act in 1970, which allowed pharmaceutical companies to patent their drug manufacturing process. 

The drug patent duration at this time was seven years. India became a part of the GATT in 1994, leading to several significant changes in the Indian market, as the country had to comply with GATT and TRIPS laws. After this, Indian pharma companies needed to meet the minimum standard requirements laid down by the TRIPs. As a part of this process, India introduced the system of product patents, which were valid for 20 years. 

Drug patent definition

A patent is a legal document that allows the owner to protect their invention or idea from intellectual property theft. It is a type of Intellectual Property Right that prohibits others from manufacturing, using, marketing, or selling a design without the owner’s consent. Granted by the government, it helps ensure that the owner has supreme rights over their creation or idea. However, a governing authority does several rigorous checks to ensure the plan, product or process is unique and inventive before granting a patent. Drug patents are patents made exclusively for drugs or medicines, which prohibit other companies from marketing, manufacturing, or selling a particular drug. 

Drug Patents in India

After agreeing to the TRIPs Agreement, India, via an amendment to the Patent Act, made transitional arrangements possible in India. A second amendment came in 2000, and soon enough bills followed suit, which helped in extending the drug patent duration, adding new matters, and even introducing compulsory licensing. Through a third amendment, product patents were introduced, along with changes in the fee structure and filing procedure for Indian pharma companies. 

Patent your idea now

Types of Drug Patent

  • Process Patent – Under this system, only the process of manufacture of a drug could be patented, and not the drug itself. Therefore, other competitors could use different methods to manufacture the same drug, leading to a lot of copies and generic medications.  
  • Product patent – As per this system, the actual drug had a patent on it, preventing others from manufacturing it. This ensured that competitors could not make the same drug, and therefore garner a market share for a drug you specialized in. Therefore, since then, this is the system followed in India.
  1. Patent-expired/Non-patented Drugs – Continue supply to both the domestic and export market.
  2. Patented Drugs – Manufacture possible only through compulsory licensing.
  3. The availability of prime ownership encouraged more pharma companies to undertake R&D for new drugs.

Introducing the product patents helped give more power to Indian pharma companies. Before 2005, MNCs and American companies had a significant impact on the Indian healthcare and pharma sector. However, later on, we have seen Indian companies dominate the market, as the market share of the MNCs reduced significantly after 2005. Furthermore, a lot of foreign companies decided to launch their subsidiaries in India and sell medicines through them, as R&D was less expensive in India.

Ever-Greening in Pharma Companies

Ever-Greening is a strategy used by pharma companies to protect their commercial interest better. The plan includes making small changes to an existing product and filing for a separate drug patent. For instance, a pharma company would use the molecular formulae with an altered structure and register a new drug patent. Sometimes it also adds an ingredient that makes no difference to the product and files another drug patent. Also, many pharma companies choose to buy out their competitors. They also try to stall the latter’s research by filing fraudulent infringement claims on these new drug patents. While these strategies are legal, they make medicines more expensive and should be checked.

How Drug Patents Have Helped

Before product drug patents became popular in India, Indian pharmaceutical companies were having a tough time. Generic drug companies do not spend much on research. They sell their drugs for much lower prices and then consolidate the market share. Such companies were making things very difficult for pharma companies who were helping make new drugs. But timely patent law interventions helped pharma companies handle the situation efficiently. However, while drug patents help pharma companies maintain a good profit margin, they should also not try to run a monopoly within the market. Hence, The patent law addition, Competition Act of 2002, prevents a monopoly in any field. Therefore, drug patent laws help in balancing the protection of IP and competition. It also ensures welfare for both companies and the general public.

 

 

0

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