Ipr-group5 Novartis (1)

8/11/2019 Ipr-group5 Novartis (1)

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NOVARTIS AGINTELLECTUAL PROPERTY RIGHTS

Presented By :

Vidit Garg 221164

Himalaya Tarani 221173

Jai Chowdhary 221176

Akshay Maken 221177

Presented To:

Prof. Neeti Shikha


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Overview of Patent inPharmaceuticals

Patent is an intellectual property tool that safe

guards the invention of an inventor.The validity of patent is for 20 years from the date offiling of patent application.


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INTRODUCTION

Novartis International AG is a Swiss multinationalpharmaceutical company based in Basel, Switzerland.

In 1993, Novartis AG filed an initial patent application inthe United States covering the drug imatinib which gota patent in US.

A patent could not be secured for a pharmaceuticalcompany at that time in INDIA.

In 1997,Novartis applied for a patent for a new form ofimatinib, the beta crystalline form. Which was againgranted patent for the United States.(Zimmerman Patent)


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INTRODUCTION (CONT.)

In 1998, Novartis applied in India for patent on Gleevec (thebeta crystalline form of imatinib mesylate). It was kept in themail box for 7 years before getting processed.

In2003, the Patent Office granted Novartis ExclusiveMarketing Rights (EMR) in India, which allowed Novartis toenjoy generic Gleevec manufacturers and raise the priceof Gleevec almost ten-fold.

In 2005, the application was processed once the lawallowed product patent in pharmaceutical.

In January 2006, the Madras Patent Office refused to grantNovartis a patent for imatinib mesylate.


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ISSUES REGARDING THE CASE

Is Imatinib Mesylate, the salt version of the free base formof Imatinib, an invention that is patentable under Indianlaw?

Is the beta crystalline version of Imatinib Mesylate aninvention patentable under Indian law?

Section 3(d) is unconstitutional as it violates the provisionof the TRIPS agreement.

The Indian patent act doesn't define the term 'efficacy'and provides unguided power on the Controller. Hence itis arbitrary, illogical and vague.


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RULE

Sections 2(1)(j), 2(1)(ja) and 3(d) of Indian Patent Act,

1970 (as amended in 2005) Section 2 (1) In this Act, unless the context otherwiserequires-

(j) "invention" means a new product or process involvingan inventive step and capable of industrial application;

(ja) "inventive step" means a feature of an invention thatinvolves technical advance as compared to the existingknowledge or having economic significance or both andthat makes the invention not obvious to a person skilled inthe art
http://www.spicyip.com/docs/statute-combined%20patents%20act%202005.pdfhttp://www.spicyip.com/docs/statute-combined%20patents%20act%202005.pdfhttp://www.spicyip.com/docs/statute-combined%20patents%20act%202005.pdfhttp://www.spicyip.com/docs/statute-combined%20patents%20act%202005.pdf


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RULE (CONT.)

3(d) - the mere discovery of a new form of a known

substance which does not result in the enhancement ofthe known efficacy of that substance or the merediscovery of any new property or new use for a knownsubstance or of the mere use of a known process,machine or apparatus unless such known process resultsin a new product or employs at least one new reactant.

MERE DISCOVERY OF A NEW FORM OF KNOWNSUBSTANCEMERE DISCOVERY OF ANY NEW USE OF KNOWNSUBSTANCE


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ANALYSISNovartis had filed for a patent application in 1998. However,the application for the patent filing was processed only in theyear 2005 after India allowed for product patents.

The authority in charge of granting patents, The AssistantController of Patents and Designs rejected the application ofNovartis on the ground that if failed to satisfy the requirementof novelty and non-obviousness as per the Indian Patents Act,

1970. Novartis filed for appeal before the Madras High Court in2006. But the case was transferred to Appellate Tribunal Boardunder Sec117G.


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ANALYSIS

The board held that Novartis met the requirements ofnovelty and non-obviousness as per the Patents Act.

The enhanced efficacy was asserted by Novartis withrespect to the better flow properties and thermodynamicstability, but the most important being bioavailability( 30%increase).

However it was discovered that they did not compare it withthe salt that they marketed but with the free form ofimanitib.

The board argued that Novartis failed to fulfill therequirements as per Section 3(d) of the Indian Patents Act,1970 and the efficacy could only be therapeutic efficacy


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Novartis decided to go for a proceeding before the Madras High Court with thecontention that Section 3(d) is not compliant with TRIPS and therefore violative of Article14 of the Constitution of India.

The Madras High Court held that it did not have jurisdiction to decide a case concerningthe compliance of a domestic Indian law with an international treaty

Novartis relied on a case from the United Kingdom, Equal Opportunities Commission & Another v. Secretary of State for Employment.

The Madras High Court distinguished the facts of the Novartis dispute with those underEqual Opportunities Commission, because the European Community Law had beendomesticated as the domestic law of England through the European Communities Act,whereas the Indian government had not domesticated TRIPS .

Since Article 64 of TRIPS expressly provides that disputes should be taken to the DisputeSettlement Body of the WTO, the Madras High Court held that Novartis should seek toenforce TRIPS though that mechanism and not an Indian court


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ANALYSIS(CONT.)The Court interpreted Section 3(d) in accordance with the text ofthe statute and context of the legislation, to mean that it wasmeant to deal with pharmaceutical products and chemicalsubstances only.

Major objective of this section was to prevent "Evergreening" andthus discourage monopoly of certain players in the market.Therefore a higher threshold of qualifying standards was set up forpharmaceutical products

The test of efficacy can only be 'therapeutic efficacy .

Novartis claimed that the beta crystalline form had 30% morebioavailability as compared to the older versions, but later it wasdiscovered that they did not compare it with imanitib mesylate(the salt that was previously marketed) but with the free form ofimanitib.


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THE DECISION TAKERS

JUSTICEAFTAB ALAM

JUSTICE RANJHNAPRAKASH DESAI


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CONCLUSION

While no doubt the effect of the judgment was to ensure

the availability of affordable life saving drugs to people inIndia and elsewhere, the crux of the judgment lies in thefact that Novartis AG was denied a patent not onaccount of the pricing of its drugs or its profit motive buton the basis of invention.

The Court also suggested that efficacy can be definedas the ability of a drug to produce a desired therapeuticresults but it did not provide any guidance on howenhancements might be quantified.


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CONCLUSION( CONT.)

The decision of the court was to prevent the

practice of abuse of patents through Evergreening ,thus preventing anti -competitive practices in themarket.

The Court has also laid down a very strict and high

standard for the qualification of a product as an"invention", thereby upholding the principle of socialwelfare.


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MERITS OF JUDGEMENT

A majority of Indian population uses generic version of

glivec at cheap rate and enjoy the easy accessibility ofmedicine.

The judgment has paved a clear path to establish andsecure human rights by complying right to health throughthis judgment.

It can be proudly concluded that Human rights win asgiant pharma Novartis loses the case.


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THANKYOU

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Ipr-group5 Novartis (1)