Decoding the Novartis - Natco Pharma Issue !!

What is Evergreening?

• Evergreening is the practice whereby pharmaceutical firms extend the patent life of a drug by obtaining additional 20-year patents for minor reformulations or other iterations of the drug, without necessarily increasing the therapeutic efficacy for patients.

Benefits of Evergreening to patent holders

• Evergreening allows pharmaceutical companies to obtain or extend monopoly protection for old drugs simply by making minor modifications to existing formulations or dosages, or by identifying a new therapeutic use for an existing medicine.

What is GLIVEC ?

• It is brand name of IMATINIB

• Novartis holds the patent right to produce Imatinib

• It is used to treat many cancers including chronic myeloid leukemia [ a type of blood cancer]

Who is Novartis?

• Novartis International AG is a Swiss multinational pharmaceutical company based in Basel, Switzerland, ranking number two in sales among the world-wide industry in 2010.

• Novartis is the third largest beneficiary of registered patents in India, behind Roche and SanofiNovartis is the third largest beneficiary of registered patents in India, behind Roche and Sanofi

What section 3[d] of Patents act says

• Section 3(d), as introduced in April 2005 into the Indian patent law, represents a unique requirement to be fulfilled for patentability of certain types of pharmaceutical inventions. According to Section 3(d), in order for a new form of a known substance to be patentable, it must show an enhanced efficacy with respect to the known efficacy of the substance concerned.

What is TRIPS

• The Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) is an international agreement administered by the World Trade Organization (WTO) that sets down minimum standards for many forms of intellectual property (IP) regulation as applied to nationals of other WTO Members

What TRIPS article says about Patent

• TRIPS Article 27.1 requires that “patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.

Madras High court judgement on patent evergreening issue

• Madras High Court had in 2007 held that the appropriate route to challenge non-compliance with TRIPS is the WTO Dispute Settlement Body and not the Indian courts.

Why the Glivec case has emerged ?

• Novartis is the producer of “Imatinib” and got patent rights for 20 years. Now 20 years time period is over. Then Novartis produced a new crystalline salt form of Imatinib mesylate. It claimed that it is a new product and applied for patent right for another 20 years.

• But patents office rejected Novartis’s claim then it moved to Intellectual Appellate tribunal board and it also rejected then moved to supreme court it also rejected its claim.

Why patent office rejected Novartis’s claim ?

• In 2006, the Indian patent office ruled that the new salt form did not deserve a new patent, since it did not meet the provision of “increased efficacy” required under Sec. 3(d).

Controversial issue of “efficacy”

• Novartis argued that the salt form would have higher levels of availability in the body of the patient, but the Madras High Court clarified that “efficacy” means “therapeutic efficacy in healing a disease”

Who is IPAB ?

• IPAB stands for Intellectual Appellate Tribunal Board

• It works under the ministry of commerce and industry.

• IPAB also rejected the Novartis’s claim. The IPAB had upheld the contention of the Indian Patent Office that the drug, Glivec, is simply a new form of imatinib and hence not patentable as per Section 3 (d) of Indian Patent Act.

• Then Novartis moved the case to supreme court.

Supreme court judgement

• It is important to note that the Supreme Court did indeed clarify that Section 3(d) does not bar patent protection for all incremental inventions of chemical and pharmaceutical substances, provided they pass the test of the expanded scope of Section 3(d).

Importance of Supreme court judgement

• In India, about 2,00,000 people suffer from chronic myloid leukaemia and about 30,000 are added every year. After this judgement, the prices of the drug will remain low, all these people would benefit.

What needs to be done ?

• “On one hand we have a large number of companies who have invested billions in research, in developing new molecules, in new drug discoveries and in research. On the other hand, there is a social obligation to provide affordable and cheap drugs and healthcare. We have to strike the right balance”

What is compulsory license ?

• A compulsory license, also known as statutory license or mandatory collective management, provides that the owner of a patent or copyright licenses the use of their rights against payment either set by law or determined through some form of arbitration. In essence, under a compulsory license, an individual or company seeking to use another's intellectual property can do so without seeking the rights holder's consent, and pays the rights holder a set fee for the license.

• In March 2012, India granted its first compulsory license ever. The license was granted to Indian generic drug manufacturer Natco Pharma Ltd for Sorafenib tosylate, a cancer drug patented by Bayer

Timeline of Issue

· 1997- Novartis filed a patent application in India for its drug Glivec.

· 2005- India introduced the Indian Patent Act to prevent the evergreening or patenting of new forms of already known molecules.

· 2005- The patent controller in Chennai denied Novartis the sought Patent.

· 2006- Novartis challenged the Indian govt and four other Companies in Madras Court.

· 2007- The Madras court ruled against Novartis’s Case.

· 2009- The Intellectual Appellate Board rejected a fresh appeal.

· 2009- Novartis approached Supreme Court of India

· 2013- Supreme Court Denied the Patent

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Additional Reading !!!

What is the Difference between Patents vs. Copyrights?

Patent	Copyrights
Inventor/Designer has complete rights over the idea in whichever form it is used == right to exclude others from making, using, offering for sale or selling	Copyrights on the other hand given for a work in particular form like a book, an audio and only that exact reproduction, example cut and paste of text falls under its ambit.
It requires compulsory registration.	Does not require a registration, once the work is created it is a property of the author.
Patent rights are thus usually given for a brief period say 20 years.	The rights are given for the entire lifetime of the author and extend for 50 years even after the death of the producer.