Pre-Grant Opposition Filed by Natco against Gilead

Abbreviated New Drug Application (ANDA)
  • Hyderabad-based generic pharmaceutical company Natco Pharmaceuticals filed a ‘pre-grant opposition’ with the Indian Controller General of Patents, Designs & Trademarks against the granting of a patent to U.S. pharmaceutical major Gilead Sciences for its drug Sovaldi, used for the treatment of Hepatitis C, on the grounds that its pro-drug and compound, sofosbuvir, is a known product, and is therefore not inventive enough.
  • Indian Pharmaceutical Alliance (IPA) and Initiative for Medicine and Access to Knowledge (I-MAK) have also filed pre-grant opposition on similar grounds earlier.
  • Under India’s patent laws, the validity of a pending patent application can be contested by a third party. And the grant of a patent can be opposed on the grounds that it lacks a novel and inventive step, among others.
  • Sofosbuvir, a once-daily regimen, is a direct-acting anti-viral (DAA), which reduced treatment time to 12 weeks from 24-48 weeks, and will potentially replace the injection based therapy.
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Exams Perspective:

  1. What are generic drugs?
  2. What is Hepatitis C?
  3. What is a pro-drug and What is Sovaldi ?
  4. What is Indian Controller General of Patents, Designs & Trademarks?
  5. What are Patents?
  6. What are the grounds for opposition of patents in India?