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

3D Printing and IPR

The three-dimensional or 3D printing service is different from the traditional way of manufacturing. In the 3D process, objects are created layer wise to get the desired three dimensional impacts. Since the inception of this latest idea in 1980s, it has gone through several changes in the technology used. This requires use of different production […]

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 […]

The Clash Of Jurisdiction Of CCI And TRAI

Overlapping Jurisdiction The Competition Act, 2002 read with section 18 of the legislation delegates to the Competition Commission of India (the “CCI”) the duty of “promoting and sustaining competition” in the Indian economy. This implies that the CCI will have principal jurisdiction to regulate conditions of competition in the relevant market of India. Whereas, Section […]

Fluid Trademarks

Fluid mark is often thought of as a conventional mark which can be converted to a living form with some specific representation. In other words, fluid trademark is a modern method of branding that shall help achieve success easily in this digital era. As per the name, the mark tends to change with time. This […]

Evaluation Intellectual Property Rights

Intellectual property has always existed since the dawn of time but there were no laws in place for their protection. Intellectual property is intangible asset, be it music, creative writing, arts, discoveries, inventions and development of unique words, symbols and artwork. Intellectual property rights is a generic term that covers copyright, industrial design, trade secrets, […]

Celebrity Rights – Public, Private or Intellectual Property

Celebrity lives are mostly public these days through different sources but they too want to maintain certain privacy. This has triggered the need to maintain celebrity rights on different properties. There are several company options that are selling products with celebrity faces from bags to soaps to cosmetics to many others. It requires suitable celebrity […]

Trademarking surnames

Having difficult surnames may be challenging to explain others and also when you want to register the name as trademark. As per the trademark and merchandise act of 1958, it is stated that a mark can be refused if one choose a personal name or surname. Though, there is no such clear specification in the […]

Artificial Intelligence and Intellectual Property Law

What is Artificial Intelligence? The division of Science which deals with making machines equipped with human-like intelligence to act in human-like fashion and the exhibit human capabilities is known as Artificial Intelligence (AI). Multiple disciplines like Computer Science, Psychology, Philosophy, Sociology, Mathematics, Biology and Neuron Science contribute to the development of AI. Benefits Of AI […]

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 […]

For a music composer, lyricist, a producer, or any performer, protecting music is a big concern under the U.S. copyright protection laws. By copyright, it indicates legal protection that is offered to the original work of music of the creator from others to use it by their name. The copyright law shall prevent others from […]