Patent Case Brief - Novartis V Union of India

12/18/2019 Patent Case Brief - Novartis v Union of India - Notes For Free
JANUARY 18, 2018 BY ADMIN
Patent Case Brief – Novartis v Union of India

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Citation – SC Civil Appeal No. 2706-2761 of 2013
Facts: In this case, sequence of events with prior art are as follows:
§ The Zimmerman patent in ’93, which disclosed the imatinib free base – this patent was not
granted in India because India did not provide for pharmaceutical patents prior to 1995;
§ A publication in 1996, which referenced imatinib mesylate;
§ The 1998 patent application before the Indian Patent Of ce, which claimed the
betacrystalline form of imatinib mesylate.
Novartis led for patent of its “Beta Crystalline” form of “Imatinib Mesylate” in 1998 as per
the TRIPS agreement of WTO. The application was processed in 2005 and was rejected in
2006 on the grounds that it failed to satisfy the requirement of novelty and non-obviousness
as per the amended Indian Patent Act. Novartis appealed against the decision in Madras High
Court that was then transferred to the IP Appellate Board. The IP Appellate board rejected
the application on the grounds that the invention was not a new substance but an amended
form of a known substance and that Novartis was unable to show the increase in ef cacy as
laid down in section 3(d) of the Indian Patent Act.
Novartis appealed before the Madras High Court that Section 3(d) violated Article 14 of the
Constitution as the requirement of ‘enhanced ef cacy’ under section 3(d) was vague and
gave unrestricted power to the patent examiner. The High Court rejected the application and
held that the object of section 3(d) was to prevent intellectual monopoly privileges and
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12/18/2019 Patent Case Brief - Novartis v Union of India - Notes For Free
evergreening of patents.
Appealed to the Supreme Court
Issues:
1)What is the ‘Known Substance’ for the purpose of section 3(d)?
2) What is the meaning of ‘ef cacy’ in section 3(d)?
3) Does an increase in bioavailability qualify as increase in therapeutic ef cacy under Section
3(d)?
4) Was the claimed invention by Novartis more ef cacious than the substance that it was
derived from?
Analysis:
1)After the 2005 amendment, Section 3(d) required the claimed invention to be more
ef cacious than the ‘known substance’ from which the claimed invention was derived. In this
case, Novartis was keen to have ‘Imatinib Free Base’ to be identi ed as he ‘known substance’
instead of ‘Imatinib Mesylate’ since it would be easier to prove greater ef cacy in comparison
to Imatinib Free Base. Supreme Court shot down this argument on the grounds that “Imatinib
Mesylate” was anticipated by prior art (publication in 1996) and existed before the claimed
invention hence it was a known substance.
Therefore, Imatinib Mesylate was presumed to be the known substance in this case.
2) While Novartis was arguing for a broader interpretation of ‘ef cacy’ in Section 3(d) which
would include other bene cial properties such as increased stability, etc., Supreme Court
made it crystal clear that ‘ef cacy’ in Section 3(d) only means therapeutic ef cacy. The court
held that “not all advantageous or bene cial properties are relevant, but only such properties
that directly relate to ef cacy, which in case of medicine, is its therapeutic ef cacy.
3) Bioavailability is the increased ability of the drug to dissolve into the bloodstream of the
patient. The Supreme Court on this issue ruled that such an increase of 30% in bioavailability
can qualify for protection under 3(d) if evidence is provided to establish that such an increase
leads to greater therapeutic ef cacy.
4) The Court compared the ef cacy of the claimed invention with the known substance
(Imatinib Mesylate) with reference to its ow properties, better thermodynamic stability and
lower hygroscopicity and concluded that none of the three properties identi ed will qualify
under section 3(d) as it doesn’t contribute to an increased therapeutic ef cacy. Conclusion:
The Supreme Court rejected the appeal led by Novartis and concluded that since there was
no substantive & conclusive material and evidence to prove that beta crystalline form of
Imatinib Mesylate will produce an enhanced or superior therapeutic ef cacy, therefore failed
to meet the requirements under section 3(d).
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12/18/2019 Patent Case Brief - Novartis v Union of India - Notes For Free

JANUARY 18, 2018 BY ADMIN

Patent Case Brief – Novartis v Union of India

Citation – SC Civil Appeal No. 2706-2761 of 2013

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