HC Reverts Status of Roche’s Case Against Biocon, Mylan
On Apr 25, court had ordered packaging changes to copies of Swiss co’s cancer drug
Mumbai: A division bench of the Delhi High Court has reverted the status of the case where Swiss biotech giant Roche had sued Biocon and Mylan over copies of blockbuster breast cancer drug Trastuzumab sold in India. The case is to be heard on May 10. On April 25, the Delhi High Court sided with Roche and ordered certain labelling and packaging changes to the products of Biocon and Mylan while questioning the regulatory approval process for the drug. However, with the latest decision of the bench, the status will be back as it existed before the release of the April 25 order, experts noted.
According to legal sources, the division bench extensively quizzed both the opposing sides.
Sources said the counsel for Mylan strongly argued that the April 25 order of the single-judge bench had introduced issues like data exclusivity (clinical test data submitted to the regulatory agency for approval of the product), which was not part of the present legal provisions in India.
As part of the April 25 order, the single- judge bench had held that “unless the government of India frames policy to declare as to whether after expiry of patent, the data in public domain can be used as pathways or not, the regulatory authority can neither disclose nor rely upon the first applicant’s data at the time of granting marketing approval to the subsequent applicants. It is for the government to decide that such protection for certain fixed period to the innovator should be granted or not”.
That apart, legal representatives for Biocon and Mylan backed the approval processes followed by the Indian regulatory authority, noting that generics and biosimilars are approved across the world by following an abbreviated pathway.
In a note to ET, Roche maintained: “Despite today's developments, the situation for patients and physicians remains unchanged as there is still no evidence that these products have met the requirements of the biosimilar framework or any other regulatory pathway in India”.
Counsel for Mylan argued April 25 order introduced data exclusivity, which was not part of present legal provisions in India