Drug Regulation Patent

Trastuzumab Biosimilar Litigation Saga: A New Order from the Delhi High Court


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Last week, the Delhi High Court issued yet another order in the Trastuzumab litigation saga. This time, it is common order in two suits bearing CS (COMM) 1119/2016 (Roche v. Cadila, DCGI and DoB) and CS (COMM) 540/2016 (Roche v. DCGI, DoB and Hetero Drugs Ltd.). This litigation saga has previously been covered here, here, here, here and here. Suffice to say that broadly, the prayers in these suits are similar to the ones in the other suits against Biocon/Mylan and Reliance.

By this order, the Court decided to proceed with the suits, deciding solely on the question of maintainability. Therefore, the order does not contain anything of substance as far as IP rights are concerned.

Even on the issue of maintainability, the order does not contain anything of substance. The history of the proceedings as recorded in the order indicate that the parties were heard as to the maintainability of the suit earlier in 2016/2018 and this revolved around the question of whether the plaintiffs had any cause of action de hors the alleged invalidity of the marketing approval granted by the DCGI. In particular, the contentions seem to have focused on whether the suits are maintainable in a situation where the approval granted by the DCGI for the biosimilar were appealable under Rule 122DC of the Drugs and Cosmetics Rules.

The Court took into account the fact that in the other suits, judgments were issued by a Single Judge of the Delhi High Court on April 24, 2016. This was in the case bearing CS (OS) 355/2014 and CS (OS) 3284/2015, i.e. the Biocon/Mylan and Reliance matters. In those judgments dated April 25, 2016, the Single Judge had ruled, among others, that the appeal remedy under Rule 122DC of the Drugs and Cosmetics Rules does not enure to the benefit of Roche and therefore, those suits were maintainable. The judgment dated April 25, 2016 was appealed before the Division Bench, where the mattes are pending and there was also an appeal to the Supreme Court in the Reliance matter, covered in my previous post.

Thus, as on date, it appears that the Division Bench is seized of the same issue of maintainability in the Biocon/Mylan and Reliance matters. The Supreme Court order dated December 17, 2019 in the Reliance matter did not also deal with the aspect of maintainability of the suits in the light of Rule 122DC of the Drugs and Cosmetics Rules.

There was an argument raised that the earlier judgments dated April 25, 2016 did not address an important aspect of interpretation of Rule 122DC (on the meaning of the term “any person aggrieved”) and therefore, there was a need for the Court to answer the same in this case. However, though all of these prior orders related entirely to other parties, the Court felt that in view of the pendency of the matter before the Division Bench in other proceedings where the same issue of spending among other issues, it may not be appropriate to foray into the same issue again. The fact that there was no finding in the Supreme Court order on this issue and that the Division Bench orders were restored by the Supreme Court, also weighed on the mind of the Court.

Moreover, the Court notes, the law itself had undergone some change in the meantime since the New Drugs and Clinical Trial Rules, 2019 were notified in March 2019. The Court noted that though an appeal provision existed in these new rules as well, it was confined only to the applicant before the DCGI and not to others. In these circumstances, the Court held that the matter could not proceed.

There also appears to be an application filed by Cadila (in CS (COMM) 540/2016) that the suit was liable to be stayed under Section 10, CPC in view of a previously instituted suit by Cadila in Bombay High Court. The Court clarified that it was not giving any finding on the same.

Further, there also appears to be an Order VII, Rule 11 application for rejection of plaint by Hetero Drugs (CS (COMM) 540/2016) (summons was issued in this suit on January 9, 2017). Frankly, it does not look like the Court has expressly dismissed this application since all applications have been listed for disposal on the next date. However, by refusing to go into the maintainability issue, it appears that it has been indirectly rejected this application and it is unclear whether there would be anything left for the Court to decide on this application on the next date.

Adarsh Ramanujan

Adarsh Ramanujan

Adarsh is an independent counsel with offices in Delhi and Chennai. Before starting his own practice he spent considerable time with Lakshmikumaran & Sridharan at their New Delhi and Geneva offices. He obtained his B.Sc. LL.B. (Hons.) degree (Gold Medalist) from National Law University, Jodhpur and LL.M. degree from University of California, Berkeley. He is a qualified Patent Agent in India. A major portion of his time is spent practicing in the areas of IP & Technology Laws as well as in International Trade Law. He has however branched out into doing commercial litigation and arbitration work. His expertise also extends to regulatory laws such as environmental laws, biodiversity laws and cyber laws. Adarsh has taught patent law in NLU, Delhi, NLU, Jodhpur and at the CEIPI Institute (University of Strasbourg). He has authored or co-authored close to 30 publications on diverse topics, including on IP, WTO, constitutional law and international tax.

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