Breaking News: One More Opposition Have Joined in Gilead’s Sofosbuvir Oppositions Saga.

Gilead’s Sofosbuvir is always in news for its cost for the treatment of hepatitis C virus (HCV) infection, Gilead’s Indian Patent Publication 3658/KOLNP/2009 covering Sofosbuvir is also making news in Pharma sector for its Oppositions.

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Patent oppositions & litigations in India in past five years (or) more have shown the strategies of Indian pharma companies, where most of the Indian companies are using them as a main weapons to tackle Innovator’s patents or patent publication related to pharmaceutical products.

Sofosbuvir is a nucleotide analog which is discovered by Pharmasset and developed by Gilead Sciences for the treatment of hepatitis C virus (HCV) infection. The price of Sofosbuvir, quoted in various media sources as $84,000 to $168,000 for a course of treatment in the U.S., £35,000 in the UK for 12 weeks which has engendered considerable controversy. In September 2014, Gilead announced that it would permit generic manufacturers to sell sofosbuvir in 91 developing countries and that it would sell a name brand version of the product in India for approximately $300 per course of treatment. The structure of Sofosbuvir is given below:

In India Gilead filed the following patent applications (main) for Sofosbuvir.

i) IN 6087/DELNP/2005 which covers Sofosbuvir metabolites.
ii) IN 3658/KOLNP/2009 which covers Sofosbuvir as a main product.

However, IN ‘6087 has been rejected by Indian Patent Office (Delhi). Gilead appealed to the Delhi High Court and the Court set aside the order and asked the Patent Office to review the case.

Recently Virupaksha Organics Limited has filed a Pre-Grant opposition against Gilead’s Indian patent application no. 3658/KOLNP/2009 on the grounds of lack of novelty Section 25 (1)(b), obviousness Section 25(1)(e), 25(1)(g) Insufficiency, 25(1)(h) and also Section 3(d) (as it is the phosphoramidate ester). However, this is not the first time IN ‘3658 is opposed, previously IN ‘3658 was opposed by Initiative for Medicines Access & Knowledge (I-MAK), Natco Pharma Limited, Indian Pharmaceuticals Alliance (IPA), Initiative for Medicines Access and Knowledge (I-MAK) and Delhi Network of Positive People (DNP+), Sankalp Rehabilitation Trust and Optimus Pharma. Natco seems to be withdrawn its Oppositions, however, there are no official confirmation as documents are available.

Natco is the 1st company in India to get approval for generic sofosbuvir tablets, 400mg, from Drugs Controller General (India).

Gilead had followed a Voluntary licensing strategy and succeded for its Tenofovir drug which is patented in India (for Tenofovir Alafenamide), used in the treatment of HIV/AIDS. Now In 2014, Gilead seems to be playing the same strategy for Sofosbuvir (Sovaldi) in India.

Its only the final decision of IPO is awaited and the it is sure that the decision of IPO on the grant of Sofosbuvir patent will effect the Indian Pharma sector.

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