Intellectual Property Rights

Novartis Glivec Case Study

Plaintiff

Novartis International AG is a Swiss multinational pharmaceutical company based in Basel, Switzerland, which rank number 2 in term of selling among worldwide pharmaceutical industry. Novartis was created in 1996 through the merger of Ciba-Geigy and Sandoz. Novartis has been in India since 1947. The Group operates in India through four entities namely Novartis India Limited, Novartis Healthcare Private Limited, Sandoz Private Limited and Chiron-Behring Vaccine Private Limited. In India Novartis have a presence in pharmaceuticals, generics, vaccines, OTC, eye care and animal health.

Some famous drugs of Novartis are:-

Clozapine (Clozaril), Diclofenac (Voltaren),Carbamazepine (Tegretol), Valsatan (Diovan) and Imatinib mesylate (Gleevec/Glivec) etc.

Defendants

Union of India & others

The Indian Patent Act, 1970 constituted by Indian government

Nacto Pharma Ltd.

Natco Pharma limited was established in Hyderabad in 1981. It ranks among fastest growing pharmaceutical in India and has five manufacturing facilities across India. It has pharmaceutical R & D. Natco has one of most selling generic market in India and abroad.

Some of the most selling generics are:-

Deferasirox, Imatinib Mesylate, Bendamustine, Bortezomib, Lenalidomide, Ibandronate etc.

M/S Cancer Patient Aid Association

Cancer Patients Aid Association (CPAA) is a registered charitable non-governmental organisation (NGO), which work for cancer patients. It was established in 1969, it devote to service of all needy patients of cancer in India and neighbouring countries like Bangladesh, Bhutan, Nepal and Pakistan.

Controversy

1. In 1997 Novartis file an application of patent for beta crystalline form of Imatinib mesylate but at that time Indian Patent Act was in transitional stage so application lay dormant under “the mailbox procedure”.

2. When the Indian Patent act came into force after amendment in 1^st Jan 2005, its application taken up for consideration then the Assistant Controller of Patents and Designs rejected the application for granting the patent.

3. Novartis filed petition directly to Madras high court for challenging decision of the Assistant Controller and also filed two writ petition for seeking declaration that Section 3 (d) of the act is unconstitutional because it not only violate article 14 of constitution of India but also not in compliance with TRIPS . Madras high court transferred case to IPAB in 2007.

4. In June 2009 appellate board rejected Novartis appeal.

5. In Aug 2009 approached to Supreme Court of India and filed Special Leaving Petition (SLPs) at that time two objectors namely Nacto Pharma Ltd. And M/S Cancer Patient Aid Association filed SLP to challenging the finding recorded by IPAB in favour of Novartis AG.

6. In Dec 2012 the finding of Supreme Court of India was that the beta crystalline form of Imatinib mesylate fails the both test to invention and patentability as provided in clause (j), (j a) of Section 2 (1) and Section 3 (d) respectively so appeal was dismissed with cost.

Patent In Question

A number of derivative of N-phenyl-2-pyrimidineamine were synthesized in early 1990’s. One of which was CGP 57148 later assign the International Nonproprietary Name ‘Imatinib’ by WHO. Patent was granted in 1996 in US and European countries to one of the inventor Jurg Zimmerman on behalf of Novartis AG. After more R & D, Novartis synthesize beta crystalline form of the Imatinib mesylate again; it got patent over it in US along with 40 countries but not in India.

Novartis claim was it has 30 % improvement in bioavailability than free form of Imatinib mesylate.

Plaintiff Argument/Expectation from court

Novartis arguments were:-

1. Zimmerman patents (free base of Imatinib) and the journal articles published by Zimmerman et al. do not constitute prior art for the beta crystalline form of Imatinib mesylate, there by it shows ‘novelty’ and ‘inventive step’.

2. Beta crystalline form of Imatinib mesylate has enhanced efficacy than Imatinib or Imatinib mesylate so it pass criteria of section 3(d).

3. Beta crystalline form of imatinib mesylate from the free base of imatinib was the result of an invention which involved technical advance as compared to the existing knowledge and brought into existence a new substance.

Defendants Argument/Expectation from court

1. They primarily focused on that beta crystalline form of imatinib mesylate is neither novel nor non obvious because publication of imatinib mesylate in ‘Cancar Research’ and ‘Nature’.

2. Efficacy as referred to in section 3(d) should be interpreted as therapeutic efficacy not mere physical efficacy as it shows 30 % improvement in bioavailability i.e. more soluble than free form of imatinib. So it does not improve therapeutic efficacy of drug.

3. They highlight the point of affordability and availability of life saving drugs to the patients.

Patent Law Involved

1. Section 3 (d) “the mere discovery of any new property of new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process result in a new product or employs at least one new reactant.”

Explanation:-

According to the provision of sub section any salt, polymorph , isomers etc must be differ in term of efficacy. Beta crystalline form of imatinib mesylate shows 30 % bioavailability improvement which is physical efficacy not improve therapeutic efficacy .

2. Section 2 (1) j “invention means any new and useful- (i) art, process, method or manner of manufacturing; (ii) machine, apparatus or other article; (iii) substance produced by manufacture”.

Explanation:-

New means something different from recent previous and better than what went before for pharmaceuticals.

Final Judgement by court

The beta crystalline form of Imatinib mesylate fails the both test to invention and patentability as provided in clause (j), (j a) of Section 2 (1) and Section 3 (d) respectively so appeal was dismissed with cost.

Arguments by Novartis considered not according to Indian law system, it fails the main criteria of patentability.

Interpretation in relevant to patent law

There are mere Improvement in physical property in the beta crystalline form of Imatinib mesylate from known substance (free form of imatinib), not in efficacy improvement from known substance, so it is not patentable.

Further novelty was lost due to publication of free form of imatinib so it does not consider new, so it is not patentable.

It is many times in field of pharmaceuticals that there is mere rearrangement or different form of known drug may produce slight improvements in physical property, they are not liable to patent but if it may increase therapeutic efficacy many times of known drugs may liable to patentable.

Conclusion

The decision Indian Court over Novartis case is welcome able from the point of views to treatment of cancer patients. Millions of people die due to cancer because its treatment

Is not affordable in developing countries. To make it available and affordable to patient of cancer, AIDS etc. deadly diseases such claims should not be granted. This is subject matter of human health.

Generic medicines are cheaper in cost and easy access to patient for their treatment. It will boost up our domestic generic market of India which is a largest generic market in world and export it to many under develop countries like Africans for deadly diseases treatment .