Trastuzumab/Herceptin has been controversy’s child (please read my previous posts on Herceptin here and here.) Initially it was considered for Compulsory license u/s 92 and then last year in a very surprising development Roche decided not to pursue Herceptin patents in India. In a SPICY IP exclusive Prashant had blogged about this development over here.
Shortly thereafter, after regulatory approval a “biosimilar” version developed jointly by Biocon and Mylan was launched in India under the brand names CANMAb™ and Hertraz™ respectively. Swaraj had blogged about the pricing issues of Biocon’s product here. Just when you thought Roche had given up, in a strategic move Roche sued Biocon and its partner Mylan and seeking injunction. The Drug controller general of India was also made party to this suit.
Two specific issues were raised in the suit. Roche alleged that the Defendants (Mylan and Biocon) had not satisfied the requirements for a biosimilar drug in accordance with the guidelines.Please see Shamnad’s article here where he discusses the battleground shift from patents to regulatory.The other issue raised was that of passing off; where Roche contended that the defendants were seeking to pass off their products as being equivalent in quality and class to Herceptin® by referring to their products as “biosimilar version of Trastuzumab/Herceptin®.
Justice Manmohan Singh found merit in the second argument (passing off) and granted an interim injunction restraining US based pharma generic and Bangalore based Biocon from claiming any similarity to Roche’s Herceptin. The Delhi high court order can be accessed here.
Did the defendants satisfy the requirements for biosimilars in accordance with guidelines?
Roche’s counsel argued that Mylan and Biocon’s products were being misrepresented as biosimilar versions of Herceptin/Trastuzumab without following procedures in accordance with Guidelines on similar Biologics.
Biosimilars unlike generic small molecule drugs are produced at the cellular level and are no means identical to the innovator product, but are therapeutically equivalent. In October 2012, Govt of India released guidelines for approval of biosimilars or follow on biologics which provide for a detailed and comprehensive process for comparison of similar biologic with the reference biologic. Our Guest blogger Christopher Ohly had blogged about this over here.
Roche contended that after the issuance of the Guidelines all the applications d marketing authorization of biosimilars in India are required to be evaluated based on Guidelines and only products which have been approved under the guidelines should be allowed to be represented as biosimilar products.
Roche alleged that protocol and study design for CANMAb™ was filed and approved prior to the release of guidelines. Roche also argued that Biocon was already conducting the penultimate phase of Clinical trials for their product CANMAb™ before the guidelines became effective. Roche’s requested that Biocon and Mylan should be restrained from referring to their products as a “biosimilar product” until appropriate tests and studies as prescribed under the said Guidelines have been conducted. Considering the elaborate procedures mentioned in guidelines, Roche also claimed it was impossible to obtain a biosimilar approval within such a short period.
Trademark passing off?
The Counsel for Roche argued that Biocon and Mylan have misrepresented their products by referring to them as biosimilar Trastuzumab/Herceptin®. Such misrepresentations fall within the scope of passing off since the defendants seek to pass off their products as being similar in class and quality as Herceptin®. Roche contended that misrepresentations like these are likely to deceive the patients using Trastuzumab regarding the efficacy and safety of defendant’s products. They also alleged that the defendant’s Biocon and Mylan seek to take unfair advantage of goodwill and reputation enjoyed by innovator Roche’s product.
Delhi High Court Order (available over here)
On the first issue the learned judge opined that no specific interim injunction needs to be passed as the defendants would not be entitled to launch their product without requisite approvals. However it is imperative and necessary for defendants to disclose the nature of the approvals of biosimilar product to the Court on the next hearing.
On the second issue of passing off the Court found merit in Roche’s argument and granted interim injunction restraining defendants from relying on any data related to Roche’s Herceptin® and also preventing the defendants from claiming any similarity to Herceptin. Justice Manmohan Singh opined in the event that the interim order is not passed in this regard, the plaintiffs would suffer prejudice and irreparable injury.
Since biosimilars (unlike conventional small molecules) are never exact copies of innovator biologics regulatory approval standards remain an important area of debate. Read this article for more on regulatory frameworks for biosimilars.
With regard to the issue of passing off, courts have always applied a stricter standard especially in case of medicinal products to safeguard public since any confusion in this respect could have severe repercussions.
In fact in the international platform there is a fierce debate raging on whether biosimilars should be treated as unique products with uniquely distinguishable International Non-proprietary names(INN’s) leave alone trademarks. The bio-pharma industry is divided on this issue and their contention is that “if biosimilars are not same why should INN’s be same?”
The next hearing is scheduled for Feb 28, so watch this space for more.
I would like to thank Mr.Yagna Praveen very much for bringing this news to my attention