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Novartis loses seven-year Glivec battle against the Indian Patent Office

     
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Novartis loses seven-year Glivec battle against the Indian Patent Office

   
 

The Hon’ble Supreme Court of India has rejected an appeal filed by Novartis to grant product patent of the beta crystalline form of Imatinib Mesylate (Glivec).

It is noted that the beta crystalline form of Imatinib Mesylate fails in the tests of invention and patentability under section 2 (j) (ja) and section 3(d). While ruling out the judgment, the Hon’ble court has also considered the objects intended to achieve through the amendments made by the Parliament.

However, the Hon’ble court has also clarified certain points about clauses (j) and (ja) of section 2(1). The new products in chemicals and especially pharmaceuticals may not necessarily mean something altogether new or completely unfamiliar or strange or not existing before. It may mean something “different from a recent previous” or “one regarded as better than what went before” or “in addition to another or others of the same kind”. If the product is a new form of a known substance with known efficacy, then the subject product must pass, in addition to clauses (j) and (ja) of section 2(1), the test of enhanced efficacy as provided in section 3(d) read with its explanation.

A special emphasis is added in the judgment that “It will be a grave mistake to read this judgment to mean that section 3(d) was amended with the intent to undo the fundamental change brought in the patent regime by deletion of section 5 from the Parent Act. That is not said in this judgment.”

The time line of seven years battle is as follows:

1998:     Novartis applied for Glivec patent in India claiming priority of Patent application filed in Switzerland

2002:     Novartis applied for grant of exclusive marketing rights

2003:     The Indian Patent Office granted EMR

2006:     The Indian Patent Office rejected Novartis's Glivec patent application

2007:     After formation of the Intellectual Property Appellate Board, five writ petitions transferred from the Hon’ble High Court to IPAB

2009:     IPAB dismissed writ petition challenging the constitutional validity of section 3 (d) and Special Leave Petitions (SLPs) were filed

2011:     The matter was heard

April 1, 2013:   The Hon’ble Supreme Court rejects Novartis's appeal

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