Drug Patents and Generic Pharmaceutical Drugs

Dec 2022

When a drug is manufactured and released to the market in the initial period, it is sold under a certain brand names and can only be availed from a pharmacy after being prescribed by the doctor. The patent of the drug is owned by a few brands who are the only eligible brands to manufacture medicine using the same composition, market the product commercially and make profit from it.

Across US, a drug patent has a validity of over 20 years even though the tenure varies between countries as well as on the drug.

And since the companies appeal for the patent long before the drug even undergoes its safety and efficacy trial. And by the time it is released in the market, the leasers get around 10-11 years.

After the tenure is over, the patent is passed on to some other drug manufacturing companies who also leases the right to market the product. But the time the second manufacturer earn the patent, the drug is already categorized as generic drug. And as per the rule of US FDA, generic needs to have identical drug composition in terms of safety, efficacy, route, usage, pharmacokinetics, drug administration, and usage of drug administration.

So, a drug can also be categorized as a generic drug when the composition of the drug matches the above said features. And a pharmaceutical company can only manufacture the drug when:

  • The patent of the drug has expired
  • The company who owns the patent now certifies that the patent of the drug are invalid, or unenforceable.
  • No patents were issued for drug anytime
  • It is being manufactured in a country where patent is not required

Once the drug is commercialized and categorized as a generic drug. The patent holder’s monopoly is dropped. And this at the same time boost competition which eventually leads to a drop in the drug’s price which eventually means that more drug can reach out to more people now.

But, the company who owns the present patent of the drug may choose to extend the tenure of the patent by manufacturing a potent version of this drug that has more significant benefits.

But, the second version needs to go under clinical trial as well along with reapplication for the patent.

Moreover, the upgrade version may need to compete with the original module in order to stay in the market by removing the older one.

Trending Blogs
Protection of Acronyms under Trademark Law
It is known that acronyms are the first letters of a long phrase of words combined together. On the other hand, trademark is about a mark that shall help distinguish the product or service of goods or service from the rest of the items. Therefore, it can be said that an acronym can be registered […]
Read More
Copyright in the Digital World
These days, there is an increased use of smartphones, computers and tablets and multimedia has shown its great influence in our lives. In the digital world, there are several works used by us. Have you thought whose work are we using? Well, none of us have tried to find out the owner of the work […]
Read More
India dropped to 40th position in International Intellectual Property Index
India has fallen to 40th position in the International Intellectual Property Index. This index helps know about the IP climate in the 53 global economies of the present year. This is as per the report US Chamber of Commerce’s Global Innovation Policy Center. As per last year’s report, India has been ranked in the 36th […]
Read More
Copyrights of Music in India
Music is an art more specifically an intangible form of art. Copyrighting a song or a melody protects the basic right of the creator. The copyright also assist the creator financially. In order to ask for copyright the creator needs to file a registration. Once the creator gains the copyright, any infringement to the copyrighted […]
Read More
Drug Patents and Generic Pharmaceutical Drugs
When a drug is manufactured and released to the market in the initial period, it is sold under a certain brand names and can only be availed from a pharmacy after being prescribed by the doctor. The patent of the drug is owned by a few brands who are the only eligible brands to manufacture […]
Read More
Alibaba IPR Report Shows Ideal Brand Protection Program
As per sources, e-commerce giant, Alibaba group has successfully gained success using intellectual property rights-protection. The giant has been able to offer quality service due to well integration of the latest technological improvements coupled with partnerships with top-rated brands. Also, external stakeholders assisted the giant in offering quality service to proactively monitor, go through rights-holders […]
Read More
Can Religious Symbols Be Registered As Trademarks?
Are you planning to register religious symbols as trademarks? Well, you should research thoroughly to understand the use of religious symbols as trademarks. You have to consider the sentiments of people before you plan to use regions symbol for your business. India being a secular country encourages different citizen follows different religions, practicing it and […]
Read More
Pharma Companies File 15% of Patents in India
The Indian Pharma industry is primarily known for its Generic Drugs. But recently, to push its value higher in the market, the Indian pharmaceutical industry is investing more in research and development of new drugs along with increasing the potency of the existing ones to move up the value chain. From 2013-2015, out of the […]
Read More
Lack of Music Publishing Knowledge Robbing Indian Artists of their Rights
In India there has been a lack of knowledge regarding publishing music. It can be said that a large part of publishing an art for is still unexplored. It is not about the common people but the artists and the music companies are oblivious towards it. At the initial stage due to lack of knowledge […]
Read More
Voluntary Cancellation of Trademark Registration
Trademark registration is a timely affair for 10 years, and it is registered as per the Trademark Act, 1999. There are certain rules and laws pertaining to trademarking a symbol for a brand. A proprietor can get a symbol, phrase of the word, or equivalent trademarked to be used for the brand. But there are […]
Read More
X
Download Firm Profile