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  .

References

        I.            Civil Appellate Jurisdiction, Civil Appeal nos. 2706-2716 of 2013, In the Supreme court of India.

      II.            http://www.thehindubusinessline.com/companies/novartis-loses-sevenyear-glivec-battle/article4569021.ece

    III.            http://www.novartis.in/history.html

    IV.            http://en.wikipedia.org/wiki/Novartis

      V.            http://en.wikipedia.org/wiki/Novartis_v._Union_of_India_%26_Others

    VI.            http://www.natcopharma.co.in/

  VII.            http://www.natcopharma.co.in/index.php/products-a-services/indian-operations

VIII.            http://www.cpaaindia.org/aboutus/index.htm

Utility Model .... a IPR

Abstract

The Utility Model is an intellectual property rights. Utility Model protection is granted in considerable number of countries. Utility Models are short term registered rights granted for inventions for shorter period of time  that often lack same degree of inventive step that patent law require in different country. Utility Models are often referred as small patents, petty patents, innovation patents, short term patents etc. Utility Models are providing low cast and economical entry point to small and medium enterprises (SMEs) into intellectual property system of a country.

Introduction

“A Utility Model is an exclusive right granted for an invention, which allows the right holder to prevent others from commercially using the protected invention, without his authorization, for a limited period of time.”

 In other word it is similar to patent it require short duration of time to register , cheaper in cost of registration but term of protection is less than a patent(7 to 10 years) and it is a type of “second- tier protection” that is , a utility models considered weak because they are granted without substantial examination.

Silent features of a Utility Model:-

1.      They are incremental inventions.

2.      It requires short duration of time to register.

3.      They are cheaper in cost (registration cost).

4.      They are particularly suited for Small and medium enterprises (SMEs).

5.      They are commonly use for mechanical innovation.

6.      Minor improvement to and adaptations of existing product could qualify a utility model.

7.      Utility Models are granted for products not for processes in many countries.

8.      It does not require substantial examination.

Literature Review

 Utility Model is relatively a new form of intellectual property rights. Currently small but significant number of countries and region provide utility model protection. Major industrial nation like Germany, South Korea, Japan, EU members such as Austria, Denmark, Finland, Greece, Hungry, Italy, Poland, Spain etc; and emerging economies such as Brazil and China provide some form of Utility Model protection. India does not have such type of system. In total about 75 countries providing Utility Model protection in all over world.

Criteria for Utility Model Protection:-   

Novelty-The invention of Utility Model should be considered novel. That is its knowledge does not available to public either written description as in patent or publications i.e. in prior art but oral discloser does not destroy novelty in case of utility model in some countries (Germany).  

Inventive Step-The Utility Model inventive step is satisfied by anything beyond handiwork and prior art. It has less rigorous requirement for inventive character.

Non-registrable invention- According to German Utility Model there is inventions which are not eligible for Utility Model protection some are:-

1.      Process for manufacture or use.

2.      Programs of computers.

3.      Plant animal varieties.

4.      Discoveries, scientific theories and mathematical model.  etc

Procedure for obtaining Utility Model protection

Application- Files an application in prescribed format or form.

Examination-The absolute conditions that is allowable subject matter is examined. It does not require inventive step, minor improvement or adaptations of existing product could qualify examination. Prior art is check for Utility Model.

Registration-It takes about 2 to 6 month for registration of utility model.  Term of protection of utility model is about 7 to 10 years. In Germany initially it is granted for 3 years this may be renewed for another 3 years followed by 2 years each up to maximum term of 10 years.

Difference between Utility Model and Patents

1.      The requirements for acquiring a utility model are less stringent than for patents. While the requirement of "novelty" is always to be met, that of "inventive step" or "non-obviousness" may be much lower or absent altogether. 

2. The term of protection for utility models is shorter than for patents and varies from country to country (usually between 7 and 10 years without the possibility of extension or renewal).
3. In most countries where utility model protection is available, patent offices do not examine applications as to substance prior to registration. This means that the registration process is often significantly simpler and faster, taking, on average, six months.
4. Utility models are much cheaper to obtain and to maintain.
5. Patent protection is available in almost all major countries but Utility model protection is available only in some countries based on the technology.
6. Conversion of patent in to utility model is always possible but Conversion of utility model in to a patent is possible under certain circumstances.
7. All new invention or substantial improvement invention can be protected in patents but in Utility Model all marginal improvement invention can be protected.

Objective and Scope of the project

The objective of this project is to discuss relatively new form of intellectual property rights Utility Model. Its criteria and procedure. Differentiate it with patents. Its features and demerit.

Scope of this topic is not confined to Utility Model protection in some countries .Developing countries are adding such protection into their law system.

Result and Discussion

In country like India we need to promote and encourage the inventors to participate in economical development of the country. A less technical system than patent is required to enable SMEs to take advantage of Intellectual property.

India needs an effective legal protection system to bridge the gap between patentable and non patentable to boost development. It will also attract foreign investor to invest in India and to protect their minor incremental invention in India.

Conclusions

Utility models are an important, second tier means of protecting inventions at lower cost for short duration of time. They are complementally and even competitive to patents .Utility models are considered particularly suited for SMEs that make "minor" improvements to, and adaptations of, existing products. Utility models are primarily used for mechanical innovations.

The "Innovation patent," recently launched in Australia, was introduced as a result of extensive research into the needs of small and medium-sized enterprises, with the aim of providing a low-cost entry point into the intellect.

 It is a weak in nature but due to proper adaptations by law system of different countries, for social and economical development of their people and country, it seems effective.

Bibliography

        I.            http://www.wipo.int/sme/en/ip_business/utility_models/utility_models.htm

      II.            http://www.wipo.int/sme/en/ip_business/utility_models/where.htm

    III.            http://indiapatents.blogspot.in/2009/06/difference-between-patent-and-utility.html

    IV.            Dr. Hans Peter Brack, “Utility models and their comparison with patents and implications for US Intellectual property law system”, Boston college intellectual property & Technology forum.

      V.            Divya Pandey and Rishu Shrivastava “Issue for consideration of utility model” S.S. RANA & Co.  Advocates .

    VI.            Rohit Kumar Vohra, ”Intellectual Property Rights”, Aayam Herbal Pvt. Ltd. Jaipur

Reference

        I.            Dr. Hans Peter Brack, “Utility models and their comparison with patents and implications for US Intellectual property law system”, Boston college intellectual property & Technology forum, page no. 2-5, 9.

      II.            Divya Pandey and Rishu Shrivastava “Issue for consideration of utility model” S.S. RANA & Co.  Advocates, Page no. 1-3.

    III.            Rohit Kumar Vohra, ”Intellectual Property Rights”, Aayam Herbal Pvt. Ltd. Jaipur Page no. 4.

IPR is....

Intellectual Property Rights (IPR) a emerging field in India and all over the world.....

The question arises why? 

 Answer is simple, people going to aware of this new asset or property.....  but still people don't know more about it......

 

So don't worry about it i will teach you all about IPR.... You just read and understand my blog.....

 

So just with me..... This is Ritesh....

Questions will be appreciated.....