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

Delhi HC’s Ex Parte Order in Coca-Cola Company & Anr vs Glacier Water Industries Ltd.

This is a case of a Delhi High court ex parte proceeding concerning trademark dilution. The plaintiff filed a suit seeking a permanent injunction, damages and to restrain them from passing off their products as that of the plaintiff. The plaintiff also pleaded the court to restrain the defendants from using the mark ‘KINLEY’ and […]

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 […]

PTAB Should Not Disapprove Claims on the Grounds of Indefiniteness in IPR

Federal Circuit has disapproved of arguments of claims that show any reason other than anticipation pertaining to party procedures. Federal Circuit has rejected the challenge shown by Samsung Electronics America, Inc. The company challenged that PTAB can disapprove claims that are considered indefinite in IPR. Samsung has been charged on the grounds of infringing U.S. […]

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, […]

Well Known Trademark And Indian Law

What is well-known trademark? As per new Trade Mark Rules 2017, a new procedure has been created that allows the Registrar to proclaim a particular trademark as “well known”. Section 2(1)(zg) Of The Trademark Act, 1999 states that well- known trademark is a mark which has become well known to the section of the public […]

Early-Stage Intellectual Property to Raise More Money

What is Artificial Intelligence? Creation of innovative ideas is what matters the most in running a business. People were least bothered to patent the designs. But with increasing use of almost similar ideas in the businesses, it is of great importance to patent the ideas. This shall help in better growth of the business and […]

Intellectual Property Glance

The discussion on intellectual property starts with distributing it into three categories for the same of convenience and clarity. The product of intellectual efforts: The product of intellectual effort could be tangible or intangible encompassing such outcomes as literary creations, artistic creations, books, music, song, dance, drama, sculpture, paintings and even computer programs. It must […]

Why Is Protection of Geographical Indication or Designation of Origin Essential?

Having knowing regarding geographical indication along with designation of origin is something that is of great need these days. Geographical indication or GI indicates a symbol, name or sign relating to a product that corresponds to a definite geographical origin, product’s features, qualities that are due from the origin. To make a sign work as […]

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 […]

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 […]