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Prathiba Singh, Vaidyanathan, Sibal win biosimilar drug battle for Biocon, Mylan in Delhi HC

Nalini Sharma

The Delhi High Court yesterday gave the go-ahead to Bangalore-based pharma company Biocon and US-based Mylan Inc. to manufacture and sell their biosimilar drugs for the treatment of early breast cancer and metastatic gastric cancer.

The Division Bench of Badar Durrez Ahmed and Sanjeev Sachdeva, JJ. passed this interim order in the on-going battle with Swiss pharma giant Roche after a lot of back-and-forth during the past few hearings.

The Court had in April 2016 allowed Biocon and Mylan to sell their biosimilar drug for metastatic breast cancer only.

But first, let’s understand the background.

Trastuzumab, a drug created by Roche for the treatment of breast cancer was introduced in India in 2000, and was initially imported and priced at Rs. 1,35,200 for a 450 mg vial. Depending on the condition and the type of cancer a person suffers from, they would need anything from 2 mg to 8 mg every 90 minutes for the first 12 weeks of chemotherapy.

Quite obviously, the drug was unaffordable for most women in the country. The pricing, however, was not the issue in the case.

In 2013, Roche’s patent for Trastuzumab in India lapsed. For reasons unknown, the company did not appear for a post-grant challenge and gave up on the renewal of the patent. At that point, Biocon and Mylan decided to swoop in.

The two companies brought to the Indian market their “new” drugs – Canmab and Hertraz – which were “biosimilars” of Trastuzumab.

So what exactly is a biosimilar?

According to the Central Drugs Standard Control Organization (CDSCO), a similar Biologic product is that which is similar in terms of quality, safety and efficacy to an approved Reference Biological product based on comparability.

Under the Biologics Price Competition and Innovation Act, a product may be demonstrated to be “biosimilar” if data shows that, among other things, the product is “highly similar” to an already-approved biological product.

Excited to have cheaper, more affordable options in the country, the Drug Controller General of India approved Biocon and Mylan’s drugs as “biosimilars” of Trastuzumab.

As expected, Biocon, Mylan and the Drug Controller General of India were dragged to court by Roche.

The court proceedings so far

Roche approached the Delhi High Court seeking an injunction against the companies from claiming biosimilarity and using the data relating to Trastuzumab’s manufacturing, safety, efficacy and sales for their drugs.

Justice Manmohan Singh of the Delhi High Court in April 2016, in a 227-page interim order, granted an injunction to Roche against the companies. However, he also stated that the companies were allowed to continue selling their drug without calling it a biosimilar of Trastuzumab or using any of their data.

In response, Biocon, Mylan and the Drug Controller General moved the High Court in appeal against Justice Singh’s order.

Three days later, the matter came up before a Division Bench of Justices Ahmed and Sachdeva, who overruled the single judge order, stating that the position as on April 24, 2016 one day before Justice Manmohan Singh passed the order, shall continue.

By virtue of this order, Biocon and Mylan were now allowed to sell their drugs for one indication – metastatic breast cancer. The status of two other indications – early breast cancer and metastatic gastric cancer was still uncertain.

Meanwhile, companies like Reliance and Cadila also brought their drugs to the market selling them with package inserts that did not mention Trastuzumab. Package inserts are leaflets provided along with a prescription or over-the-counter drugs to provide additional information about that drug.

So what happened yesterday?

The Division Bench heard arguments from numerous Senior Counsel. Rajiv Nayyar and Sandeep Sethi represented Roche, ASG Sanjay Jain represented the Drug Controller General of India, Senior Counsel Prathiba M Singh – briefed by Senior Partner Vijay Sondhi of Luthra and Luthra – was for Biocon, while Senior Counsels CS Vaidyanathan and Amit Sibal appeared for Mylan.

The question before the Bench was whether Biocon and Mylan should be allowed to sell their drugs as “biosimilars” for the additional two indications using the package insert including Trastuzumab’s data.

Nayyar and Sethi opposed five paragraphs in the package insert being used by Biocon and Mylan. Nayyar contended that the companies had not conducted the requisite tests and were instead using the information regarding Roche’s tests in their package inserts.

Justice Ahmed opined that the information regarding Roche’s tests was publicly available information and that Roche was not bound by data exclusivity.

Sethi responded that the essential condition of data exclusivity was that other companies had access to the test results for the means of comparison with their own tests and not to blatantly copy the data.

Justice Ahmed was unfortunately not convinced. He told the Senior Counsel,

“This is not a case of patents but you’re trying to disguise it as one.”

The Bench further held that Roche did not have the right to a claim over Trastuzumab since their patent had expired and the mere use of Roche’s data by Biocon or Mylan did not amount to passing off.

Further, the Bench opined that the Drugs Controller General of India had approved Biocon and Mylan’s package insert. In light of this, the appropriate remedy for Roche would be to challenge the decision of the licensing authority.

Concluding the proceedings, the Bench stated,

“Since an appropriate authority has granted an approval, no restriction can be imposed on any of the indications.”

Biocon and Mylan were therefore given the green light to go ahead with the sales of their “biosimilars” for the other two indications – early breast cancer and metastatic gastric cancer as well.

The copy of the order is awaited.

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