Section 3(d) upheld by Supreme Court denying Glivec Patent to Swiss Giant Novartis AG.

The Supreme Court has ruled that Swiss giant Novartis AG's cancer treatment drug Glivec does not deserve a patent in India. The Supreme Court's benchmark judgment has broad consequences especially to bring clarity on the ability of global drug makers/ giants, to sell lucrative drugs under patent coverage in the country, while at the same time is directed to prevent ever greening of patents.

Novartis has been fighting since 2006 to win a patent for Glivec, but, India has refused protection for Glivec on the grounds that it is not new medicine but an amended version of a known compound.

The Glivec Journey:

• In 1993, Novartis filed patent for the drug beta crystalline BC version of Imatinib (Imatinib Mesylate), used for the treatment of Cancer;
• In 1998 Novartis filed patent for Glivec with Chennai Patent Office;
• In 2002, Novartis also applied for exclusive marketing right (EMR) and was granted the same on November 2003, based on which, Novartis sued generic drug makers before the High Court of Madras and Bombay;
• On about January 2006, Cancer Patients Aid Association along with few other drug makers filed representations by way of pre-grant oppositions;
• Novartis filed Writ Petitions on about May 2006 before the High Court of Madras challenging the constitutional validity of Section 3(d) of the Indian Patens Act, 1970;
• At some stage during the pendency of the Writ Petitions, the Central Government brought into force the provision, in which appeals against the order or decision of the Controller could be filed with the Intellectual Property Appellate Board (IPAB);
• The Madras High Court on April, 2007 transferred the said writ petitions to IPAB, making the first case to be transferred to the Appellate Board, in India.
• In June 2009, it was held that although the beta crystalline (BC) version of IM (Imatinib Mesylate) was both novel and inventive, yet it failed the test under Section 3(d), which requires demonstration of "significantly enhanced therapeutic efficacy�;
• Novartis then approached the Supreme Court challenging IPAB�s order, in 2009 August.
• The Apex Court delivered its land mark decision on 1st April 2013, rejecting Novartis�s plea by citing violation of Section 3(d). It was observed �In view of the findings that the patent product, the beta crystalline form of Imatinib Mesylate, fails in both the tests of invention and patentability as provided under clauses (j), (ja) of section 2(1) and section 3(d) respectively, the appeals filed by Novartis AG fail and are dismissed with cost.�

The decision was welcomed not only by the generic drug makers but also by the social organizations and public health aid groups in India as this decision will act as a major setback for inventors and multinationals who are considering drug discovery and development as an investment in India.

Source: Copy of Supreme Court�s Judgment