U.S Drug Maker Gilead’s Oral Hepatisis C Drug ‘Sofosbuvir’ is The End For Injection Treatment But ‘Not Inventive’ says India – (full-time)

Source: Full-Time Whistle

15 Jan 2015

The patent application of U.S drug maker Gilead is rejected by The Indian Patent Office for Hepatitis Drug Sofosbuvir. However, intellectual property (IP) experts caution that the patent application rejection may not quite open the flood gates for other Indian drug companies to make similar versions of the drug.

First of all, Let me give a small identification for the relevant terms.

The Gilead Foundation, a non-profit organization established in 2005, seeks to improve the health and well-being of underserved communities around the world.They focus on expanding access to HIV and hepatitis education, outreach, prevention and health services.
Intellectual property (IP) is a legal term that refers to creations of the mind. Examples of intellectual property include music, literature, and other artistic works; discoveries and inventions; and words, phrases, symbols, and designs. Under intellectual property laws, owners of intellectual property are granted certain exclusive rights. Some common types of intellectual property rights (IPR) are copyright, patents, and industrial design rights; and the rights that protect trademarks, trade dress, and in some jurisdictions trade secrets.

India’s status is accepted in the world as the ‘pharmacy of the developing world

In the first crucial patent decision of this year, the Indian Patent Office has rejected one of the patent applications covering US drug-maker Gilead’s hepatitis C drug Sofosbuvir.

However, intellectual property (IP) experts warn that the patent application rejection may not quite open the flood gates for other Indian drug companies to make similar versions of the drug. Other patent applications on the main drug are pending, and the one that is rejected for not being inventive is a base compound, an expert said.

However, this could be an initiator step to a long litigious journey on the drug, experts agree, especially if Gilead chooses to defend its patent.

Gilead’s sofosbuvir had hit global headlines last year over the pricing of the breakthrough medicine, one of the first of several oral Hepatitis C drugs. It costs $ 84,000 for 12 weeks in the US and is expected to be pegged at less than $1000 for the same period in India.

According to a statement issued by Medecins Sans Frontieres (MSF), who also oppose various patent applications by MNCs in India, Sofosbuvir has been priced by Gilead at $84,000 for a treatment course, or $1,000 per pill in the US.
Pre-grant oppositions

The latest patent-related order comes even as sofosbuvir faced pre-grant oppositions against it at the Indian patent offices in Delhi and Kolkata.

They included oppositions from U.S.-based legal group I-MAK (Initiative for Medicines, Access & Knowledge), Delhi Network of Positive People, the Indian Pharmaceutical Alliance (representing large domestic drugmakers) and Hyderabad-based drugmaker Natco.

A pre-grant opposition under the amended Patents Act allows interested parties to oppose a patent application on a product before the Patent Office decides on whether to grant or deny a patent.
The Patent office said on Thursday, “the oppositions filed u/s 25(1) by the opponents as mentioned above at present is infructuous with this rejection of the application U/S 15 for further processing of the Patent Grant.”

This entry was posted in Hepatitis C, Indian Patent Law, Patents, Sofosbuvir. Bookmark the permalink.

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