Beyond patent enforcement: the Herceptin phoenix


Debashish Banerjee and Shukadev Khuraijam

Beyond patent enforcement: the Herceptin phoenix

While Western pharmaceutical companies struggle to enforce their IP rights in India, Roche has taken an unorthodox but surprisingly effective stance, as Debashish Banerjee and Shukadev Khuraijam explain.

Roche sprung a surprise of sorts at the expense of Indian biopharmaceutical company Biocon and US drugmaker Mylan when it succeeded in securing an interim injunction restraining them from relying upon, or otherwise referring to, Herceptin, Herclon or Biceltis or using any data relating to the drug trastuzumab marketed as Herceptin, Herclon or Biceltis including data relating to its manufacturing process, safety, efficacy and sales.

The injunction extended to any press releases, public announcements, promotional or other materials for their drugs Canmab and Hertraz and stopped them claiming any similarity with Herceptin, Herclon or Biceltis.

Trastuzumab is a $6 billion per year biological drug sold by Roche under the brand names Herceptin, Herclon or Biceltis and is a blockbuster drug for the treatment of human epidermal growth factor receptor 2-positive (HER2+) breast cancer. Roche obtained approval for import and marketing of trastuzumab in India in 2002 and patent protection for ‘Herceptin’ was also secured under Indian patent 205534, which had a term up to May 2019.

Case report, Roche, Biocon, Mylan, Herceptin