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.
Life Sciences Intellectual Property Review (LSIPR) tracks the increasing challenges for intellectual property specialists in the rapidly evolving world of life sciences. From gene patents to stem cell research, we provide the very best news and analysis.
To continue reading this article and to access 4,500+ articles, our digital magazines and special reports published for LSIPR subscribers only then you will need a subscription.
If you are already subscribed please login.
Official LSIPR subscribers include:
Allen & Overy
Arnold & Siedsma
Birch, Stewart, Kolasch & Birch LLP (BSKB)
Carpmaels & Ransford
European Patent Office
George Washington Law School
Kirkland & Ellis International LLP
Marks & Clerk
NiKang Therapeutics Inc.
Powell Gilbert LLP
Procopio, Cory, Hargreaves & Savitch LLP
The United States Patent and Trademark Office (USPTO)
World Intellectual Property Office
Case report, Roche, Biocon, Mylan, Herceptin