Drug Regulation Innovation Patent

Roche Moves Delhi HC to Challenge the Approval Granted by DCGI to Yet Another Biosimilar

A couple of weeks ago, I had analyzed the Delhi High Court’s judgment here and here, delivered by Justice Manmohan Singh, imposing some conditions on the sale of Roche’s breast cancer drug, Trastuzumab (Herceptin), by Biocon and Mylan. While Justice Singh allowed Biocon and Mylan to sell the biosimilar of Trastuzumab subject to some conditions, the decision was appealed to a Division Bench which has allowed the two companies to continue marketing the drug till 21st July.
On the heels of this success, Roche has mounted another legal challenge against the grant of approval by the Drugs Controller General of India (“DCGI”) to Hetero for the biosimilar version of another potent drug for treating at least 6 major forms of cancer, named Avastin (Bevacizumab).
Roche’s latest move is especially troubling in light of the fact that Avastin is used to treat a large array of debilitating forms of cancer, including metastatic colon cancer, various forms of lung cancer, renal cancer and ovarian cancer and is in the list of essential medicines declared by the WHO.
As the Economic Times reports, a Subject Expert Committee in the Health Ministry gave the green signal to the marketing of the biosimilar of Bevacizumab by Intas Pharmaceutical for non-small cell lung cancer and by Hetero for colorectal cancer on 7th April, 2016.

When the matter first came up before Justice Valmiki Mehta on Monday (16th May), he did not issue any interim order and deferred the matter to Friday.
On Friday, Justice Mehta reportedly seemed concerned about Roche’s standing to challenge the legality of the approval granted to Hetero, asking Roche’s lawyer, Kapil Sibal, what personal or private interest Roche’s suit was founded upon.

On the basis of the ET report, it appears that Sibal advanced two main arguments to establish Roche’s standing.
First, since Roche has amassed considerable reputation on account of Bevacizumab, he argued, Hetero’s actions amounted to an attempt to misappropriate Roche’s reputation and to free-ride on the considerable investment that the latter has made for the development of the drug.
Second, echoing the argument that Roche put forth while demanding the cancellation of the approval of the biosimilar to Herceptin, he argued that this type of misrepresentation is particularly pernicious because it is likely to put into peril the health and safety of cancer patients who may purchase Hetero’s biosimilar owing to the name Bevacizumab, under the false belief that the drug possesses the same level of safety and efficacy as is possessed by Roche’s Bevacizumab.

The matter is next listed for the 24th of May, by which time Roche has been directed to make a compilation of judgments in support of the proposition that drug innovators have the locus standi to demand judicial intervention to rectify the lapses in the statutorily prescribed process for the grant of biosimilars/generics.
While it is heartening to note that the judge has thus far stayed his hand and has not issued any interim directions, an adverse direction against Hetero could have disastrous consequences for the Indian public health industry.

More specifically, in light of the fact that the process for the grant of approval to biosimilars has become substantially more burdensome in light of Justice Singh’s judgment, a pro-plaintiff ruling in this case could foreclose the possibility of affordable cancer medication being made widely available to India’s 2.5 million cancer patients.
While it is imperative to follow the statutory safeguards that have been engrafted for the purpose of ensuring patient safety, one only hopes that the court doesn’t lose sight of the fact that affordability and accessibility cannot be sacrificed at the altar of patient safety.

Rahul Bajaj

Rahul Bajaj is a fourth year law student at the University of Nagpur. His interest in intellectual property law began taking a concrete shape when he pursued Professor William Fisher's online course on copyright law in the second year of law school. Since then, Rahul has worked on a diverse array of IP matters during his internships. He is particularly interested in studying the role of intellectual property law in facilitating access to education.

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