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PRESENTATION ON PATENT ACT 1970 BYZEBA KHAN C-02 RAHUL AGARWAL 17 SAMAKSH SETH 31

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WHAT IS A PATENT A patent is a set of exclusive rights granted by a state (national government) to an inventor or their assignee for a limited period of time in exchange for a public disclosure of an invention. It is the right granted to anyone who invents or discovers any new and useful process, machine, article of manufacture, or composition of matter, or any new and useful improvement thereof.

PATENT LAW Patent law is a specific area of law that encomes the legal regulation, jurisprudence, and enforcement of specific intellectual property rights known as patent rights. A patent law is a government issued right granted to individuals or groups that protects their original inventions from being made, used, or sold by others without their permission for a set period of time.

PATENT ACT 1970 No product patent for chemicals, food and medicine No patents for agriculture and horticulture products Compulsory licences Patents to be worked in India.

WHAT CAN BE PATENTED 1) The invention must fall into one of the five “statutory classes’: Processes, Machines Manufactures Compositions of matter, and New uses of any of the above 2) The invention must be “useful” 3)The invention must be “novel” 4) The invention must be “non obvious’

WHO CAN APPLY FOR A PATENT A patent can be made by any person whether a citizen of India or not, claiming to be the true or first inventor of the invention or by his “assignee” or legal representative. Application may be made alone or tly with any other person. A company or firm cannot be named as the true inventor. The term person includes the Government.

NOVARTIS AG VS. Union Of India

INTRODUCTION Novartis is the world’s leading pharmaceutical company filed patent application for its new version of cancer drug. The drug is called gleevec(raw form of imatinib) and is very expensive. In 1993, Novartis patented imatinib.

OVERVIEW OF THE CASE The patent application at the center of the case was filed by Novartis in India in 1998 The patent application claimed the final form of Gleevec (the beta crystalline form of imatinib mesylate) Novartis applied for Exclusive Marketing Rights (EMR) for Gleevec from the Indian Patent Office and the EMR were granted in November 2003.

Novartis made use of the EMR to obtain orders against some generic manufacturers who had already launched Gleevec in India. Novartis set the price of Gleevec at USD 2666 per patient per month; generic companies were selling their versions at USD 177 to 266 per patient per month.

ISSUES INVOLVED

1. Whether gleevec is a patentable

product? 2. Whether it involves ever greening?

JUDGEMENT When examination of Novartis' patent application began in 2005, the application was rejected by the patent office and by an appeal board under the presence of Aftab Alam .J. and Ranjana Prakash Desai .J.

REASON The case hinged on s.3(d) which specified that such inventions are patentable only if "they differ significantly in properties with regard to efficacy."  Novartis did not present evidence of a difference in therapeutic efficacy between the final form of Gleevec and the raw form of imatinib, and that therefore the patent application was properly rejected by the patent office and lower courts.

AFTER JUDGEMENT Novartis went to court to try to invalidate Paragraph 3d; Novartis lost that case and did not appeal. Novartis did appeal the rejection by the patent office to India's Supreme Court, which took the case. But the Supreme Court case hinged on the interpretation of Paragraph 3d. 

Anand Grover, the lawyer representing Indian companies said that the Supreme Court had ruled that Gleevec was not new, not innovative and did not satisfy the criteria under section 3(d) which states that inventions that are a mere "discovery" of a "new form" of a "known substance" do not result in increased efficacy of that substance are not patentable." If the application is allowed to grant patent for gleevec it becomes re-patenting and lie within the purview of ever greening which is prohibited under the Indian Patent Law. Since the patent for the already existing drug has expired manufacturing and selling of generic versions within the country at cheap rate.

MERITS OF JUDGEMENT A majority of Indian population uses generic version of glivec at cheap rate and enjoy the easy accessibility of medicine. The judgment has paved a clear path to establish and secure human rights by complying right to health through this judgment. It can be proudly concluded that Human rights win as giant pharma Novartis loses the case.

The judgement garnered widespread from international organisations and advocacy groups like  WHO, etc. who welcomed the decision against evergreening of pharmaceutical patents. OPPOSITION Ranjit Shahani, vice-chairman and managing director of Novartis India Ltd is quoted as saying "This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options.

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