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The Tax Publishers Roche Products (I) Ltd. & Ors. v. Drugs Controller General of India & Ors. [IA Nos. 2371/2014, 2988/2014, 29990/2014, 4649/2014, dt. 25-4-2016] Bio-similar equivalent of Herceptin or clinically (drug) known as Trastuzumbab by Biocon Limited and Mylan Pharmaceutricals India Pvt. Ltd. whether have violated clinical testing phases under Drugs and cosmetics act, 1940, Is there a violation of passing off or misrepresentation by using the brand names and original names patented by Roche on the same by misleading that they were similar to Herception the original brand of Roche. *Facts:* Plaintiffs - Roche India/Roche Switzerland alone with one Genentech were the patent owners of a monoclonal antibody anti-breast cancer drug called Trastuzumab in the brand name of Herceptin, Herclon and Biceltis. A monoclonal antibody is a biological drug which undergoes biological synthesis upon interaction with tissues. Defendents - Drug Controller of India, Biocon, Mylan Inc, Mylan India had developed a bio-similar of the said drug which has been granted manufacturing and marketing rights in India. Issues - Whether the said drug manufacturing and marketing right was granted after complying with clincal trials. The use of the brand name Herceptin or INN word in the brochures and product inlets were passing off and reference to the original brand Herceptin was deception by the defendents? That they should not market the drug without adhering to the process. Injunction be granted against the misuse/passing off. Held partly against the defendents: The said bio-similar had skipped certain trial processes, thus has to go through the process as per the trials. This is bound to take time thus as interim below will apply. Biocon and Mylan may produce, sell, market their bio-similars ad interim. The defendents will not use any representation that resembles or denotes the name Herception, Herclon or Biceltis. The product literature will also not be used to denote the relevance to Herception etc. They can market their bio-similar CANMAb and Hertraz as CANMAb or Biocons Trastuzumab or Mylans Trastuzumab. If the defendents were to claim that their bio-similar was descriptively different they can apply for fresh licence or reapply to the authorities. No injuction was granted is to be noted which denotes that in granting bio-similar IPR on critical medicines unless established by the plaintiff of violating their patent rights, it may not be possible to secure injunction in the interest of price, affordability and critical requirement of the medicine. The decision explains what a bio-similar is as well and how it is different to a normal chemical drug. A normal drug is a chemical compound which synthesizes on intake through chemical reaction. The similar version of this chemical formula is what is generics. On the contrary there are active organism drugs, where the drug itself is either a biological organism, or a DNA, R-DNA etc. these are biological drugs. In case of biological drugs it may not be possible to exactly bring in the same formula all the time, thus generics in biological synthesized drugs are called bio-similars. One of the plea by defendents was also that after the introduction of their bio-similars the plaintiffs felt an apparent threat to their monopoly which was at an expensive price vis a vis the bio-similars thus the suit had come up.

The Tax Publishers

Roche Products (I) Ltd. & Ors. v. Drugs Controller General of India & Ors. [IA Nos. 2371/2014, 2988/2014, 29990/2014, 4649/2014, dt. 25-4-2016]

Bio-similar equivalent of Herceptin or clinically (drug) known as Trastuzumbab by Biocon Limited and Mylan Pharmaceutricals India Pvt. Ltd. whether have violated clinical testing phases under Drugs and cosmetics act, 1940, Is there a violation of passing off or misrepresentation by using the brand names and original names patented by Roche on the same by misleading that they were similar to Herception the original brand of Roche.

Facts:

Plaintiffs - Roche India/Roche Switzerland alone with one Genentech were the patent owners of a monoclonal antibody anti-breast cancer drug called Trastuzumab in the brand name of Herceptin, Herclon and Biceltis. A monoclonal antibody is a biological drug which undergoes biological synthesis upon interaction with tissues.

Defendents - Drug Controller of India, Biocon, Mylan Inc, Mylan India had developed a bio-similar of the said drug which has been granted manufacturing and marketing rights in India.

Issues -

Whether the said drug manufacturing and marketing right was granted after complying with clincal trials.

The use of the brand name Herceptin or INN word in the brochures and product inlets were passing off and reference to the original brand Herceptin was deception by the defendents?

That they should not market the drug without adhering to the process.

Injunction be granted against the misuse/passing off.

Held partly against the defendents:

The said bio-similar had skipped certain trial processes, thus has to go through the process as per the trials. This is bound to take time thus as interim below will apply.

Biocon and Mylan may produce, sell, market their bio-similars ad interim.

The defendents will not use any representation that resembles or denotes the name Herception, Herclon or Biceltis. The product literature will also not be used to denote the relevance to Herception etc.

They can market their bio-similar CANMAb and Hertraz as CANMAb or Biocons Trastuzumab or Mylans Trastuzumab.

If the defendents were to claim that their bio-similar was descriptively different they can apply for fresh licence or reapply to the authorities.

No injuction was granted is to be noted which denotes that in granting bio-similar IPR on critical medicines unless established by the plaintiff of violating their patent rights, it may not be possible to secure injunction in the interest of price, affordability and critical requirement of the medicine.

The decision explains what a bio-similar is as well and how it is different to a normal chemical drug. A normal drug is a chemical compound which synthesizes on intake through chemical reaction. The similar version of this chemical formula is what is generics. On the contrary there are active organism drugs, where the drug itself is either a biological organism, or a DNA, R-DNA etc. these are biological drugs. In case of biological drugs it may not be possible to exactly bring in the same formula all the time, thus generics in biological synthesized drugs are called bio-similars.

One of the plea by defendents was also that after the introduction of their bio-similars the plaintiffs felt an apparent threat to their monopoly which was at an expensive price vis a vis the bio-similars thus the suit had come up.