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

Breaking News: Toyota Loses Trademark Battle over Prius at Indian Supreme Court

The plaintiff, in this case, is Toyota Jidosha Kabushiki Kaisha and they seek to prevent the defendant, a spare parts supplier by the name M/S Prius Auto Industries Limited, from the usage of the trademarks- “Toyota”, “Innova”, and “Prius”. According to the finding of the court, two of the three trademarks mentioned, namely Toyota and […]

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 […]

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 […]

The Common Law Protection Of Trade Secrets And The Need For A Statue

Introduction: A trade secret is anything you use in your business that gives you an advantage over your competitors. A trade secret can be a recipe, process, formula, strategy, technique or device that your competitors do not know, do not have, and cannot use. With development in technology, as well as the ease of sharing, […]

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 […]

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 […]

Liability Of Internet Service Providers In Digital Environment

Isp Liability In India: Internet Service Providers (ISPs) can be liable for the content on the sites they host. They can be liable even if they were merely passively hosting the site, unless they take down the objectionable material when they receive notice of it. The Copyright Act and the Information Technology Act includes the […]

Protection Folklores India Intellectual Property Rights

India is a land of diversity when it comes to folk and ethnic culture with hundreds of ethnic, linguistic and religious groups with diverse origins and lifestyles that, over time, intermingled in part and remained untouched in parts over centuries. Perception about folklore differs in India, mainly associated with tribals and simple rural people, rather […]

Need for Kashmiri Saffron to get the GI tag

The Kashmiri Saffron has been given geographical indication tag recently from Lieutenant Governor G C Murmu. The acquiring of GI tag is a step ahead in bringing the brand among the list of top ones. The tag has been given for the saffron grown in Kashmir. In this regard, it can be said that the […]

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 […]