GENERIC: Most Indian pharma companies make huge profits on exporting generic drugs after the period of their IPR of the branded version expires

By Dr Vinod G Shirodkar

In the case of any pharmaceutical products including various branded vaccines like Covishield and Moderna, the Intellectual Property Rights are only for a limited period to enable the company to recover the cost of developing the drugs concerned. At the expiry of the period the drugs become generic medicines which anyone can manufacture. Ironically, though we in India may not get the generic version of branded medicines, advanced countries like the US are the largest importers of cheap generic drugs as compared to expensive branded medicines.

THE PHARMACEUICAL business in India has developed and shown a great rise and rapid growth in its present situation and this is apparently due to the fact that Indian pharmaceuticals meet approximately up to 50% of the different types of vaccine demand of the world , 40% demand for generic drugs in USA and in UK. There is a reported demand of 25% for all Indian pharmaceutical medicines as per the findings of IBEF (Indian Brand Equity Foundation).
The pharmaceuticals domestic business turnover is approximately US 20 billion dollars, that is Rs1.4 lakh crore. Indian pharmaceuticals industry as per the findings of IBEF is expecting to grow approximately up to US dollars 100 billion and market for medical device is expecting a growth of US Dollar 25 billion by the year 2025. It is very interesting to know that the pharmaceutical industry files most of the trademark applications in the a Registry.
As we are aware that trademark is a name or logo given to identify or recognize goods or services and it can even be a sign or number or a letter by which a product can be identified? Like other goods and services in an economy pharmaceutical companies as well as its products, that is medicinal drugs, etc, have to be trademarked for its proper identification and recognition. Such registration helps further enhancing of the growth of pharma companies in India and also protects the products of genuine proprietors from being misused by spurious dealers.
In this present 21st century era even shapes and sounds are recognized as trademarks, that is the shape of a bottle can be registered as a trademark. In India the sound mark registered in pharma business is the sound of “HI” “SA” “MI” “TSU” and this was under musical notations sung and applied by Hisamitsu Pharmaceutical Co Inc of Japan
In the case of pharma goods consumers should be able to make the difference between two products as far as the name or packaging and trade dress is concerned. Hence, pharmaceutical companies have to coin a unique name or trademark for their products and by doing so it helps to safeguard infringement or passing off of its goods or services. There is always a challenge while coining a pharmaceutical product’s name, as the proprietor has to derive a secondary meaning of the name given. This is due to the fact that such medicinal goods names or trademarks are derived or given on the basis of organ, ailment or chemical composition, contained in a particular medicinal drug.
As far as trade marking in this area is concerned the Trademark Registration Authority as well as the courts in India give it special consideration and are more vigilant so that there is no misuse made by anyone in society. This is so because there can be fatal consequences if anyone infringes or copies the trademark of pharmaceutical drugs . The trademark Act 1999 does not allow registration of generic or chemical names for medicinal drugs, etc. So also the courts in India apply a strict approach while deciding the cases of infringement and passing off of trademarks of pharmaceutical products.
I would like to highlight an infringement case of Win Medicare Pvt Ltd v/s Galpha Laboratories Ltd & Others ( IANos 22711/2014 & 26365/2014 in CS(OS) No3507/2014) , where the name Betadine was used by the plaintiff for its product and the defendant started using the name Bectodine M and also applied for registration of its trademark. The Delhi High Court on the principle of likelihood of confusion held that the defendant, despite knowing adopted a deceptively similar trademark of the plaintiff and hence granted an injunction in favor of the plaintiff.
In a case of Cadila Health Care Ltd v/s Cadila Pharmaceuticals Ltd (AIR 2001 SC 1952).The Supreme Court held that in pharmaceutical cases minimum or lesser proof is needed and confusion in this area could be fatal, as compared to non-medicinal products. In this case the name ‘Falcigo’ was used by the petitioner for treating falcipuram malaria and also got its trademark registered in 1996, whereas the respondent company named its drug as Falcitab for the same treatment as that provided by the petitioner’s company drug.
In an interesting judgment passed by the Delhi High Court in the case, Sun Pharma Laboratories Ltd v/s Ajanta Pharma Ltd (CS(COMM)622/2018&I.A.12663/2014 ) it was held that for nutraceutical as well as for pharmaceutical products infringement and passing off test remains the same.
The remedies available for infringement and passing off of pharmaceutical products as well as goods and services of other nature, that is non-pharmaceutical products are the same namely, civil remedy by filing an civil suit for infringement action under Trademarks Act 1999 and passing off action which is a common law remedy, there is also administrative remedy available under Trademarks Registry as well as IPAB (Intellectual Property Appellate board), criminal action under the Trademarks Act as well as IPC (Indian penal code) 1860 can also be availed by the aggrieved party.
There are also remedies under the Custom laws where import or export of pharmaceutical products are conducted by violating or infringing trademarks of genuine proprietors . If the pharmaceutical product or services infringement or passing off is committed by using domain name, then in order to strike off such domain name the aggrieved proprietor may approach for remedy by IN Domain Name Resolution Policy (IDNRP) in cases where the domain is .In and in cases of other domains like .Com one may also approach ICANN (Internet Corporation for Assigned Names and numbers) which adopts Uniform Domain Name Dispute Resolution Policy . Kindly note that the above mentioned Dispute Resolution Policy is also applicable to other non-pharmaceutical goods and services too.
In any society for controlling this menace of infringement of pharmaceutical drugs, along with Trademark Authorities and the courts in India it is also duty of every citizen to be vigilant while purchasing medicines, and last but not the least the pharmaceuticals themselves be more vigilant to make sure that their trademarks are not infringed, as many of this trademarks over a period of years have earned a huge goodwill and reputation.
Only with this in observation then we will be able to fight infringement or passing off of these trademarks in India. It is also the duty of regulatory bodies to make sure that they approve only those pharmaceutical drugs the trademarks of which do not infringe the existing products names or logos .When we speak of infringement or passing off of non-medicinal products then there is mostly a loss of goodwill and money of the registered proprietor, but on the other hand when there is an infringement of medicinal or nutraceutical products and other living beings consumption products , they may have a detrimental and adverse effect on life and health of living beings .
(Note: The contents of this article is intended to provide general information on the subject matter. For specific circumstances the advice of a specialist should be sought.)

Dr Vinod Shirodkar has a PHD in Law on Intellectual Property Rights from the VMSalgacar Law College. He is also one of the Directors of the Real Group of Companies.