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Recorded Webinar
Biggest challenge for Pharmaceuticals/ Biotechnology/ Life science industry (USA/Europe/India) to patenting incremental innovation in India: Section 3(d) of The Indian Patent Act
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
Section 3 [Inventions not patentable] of Indian Patent Act defines what is not patentable under Indian Patent Law. Section 3(d) has been very controversial as several patents from big pharmaceuticals such as Novartis, Eli Lily, Gilead, Roche, Tibotec, Tharavnce, Bayer, AstraZeneca, Pfizer have been rejected or revoked by Indian patent office on the ground of failure to be patentable in accordance with Section 3(d) of Patent Act 1970, that says that the mere discovery of a new form of an old drug does not make it an invention if such new form does not result in the enhancement of the known efficacy. Such inventions are mere incremental innovation, result in frivolous patents and contribute to ever greening of patents. Assessment of efficacy is another critical issues as the word “efficacy” has not been defined anywhere in the stature. Swiss pharma giant, Novartis, sought to declare Section 3 (d) as being “unconstitutional”, violating TRIPs agreement provisions and also raised concerns over the discretion of patent authorities to define and determine the “enhancement of efficacy”, after Novartis was refused grant of patent because the invention failed to prove enhancement of efficacy. The case, already fought in the Chennai High Court and the Intellectual Property Appellate Board, is now pending before the Supreme Court, India's highest judicial authority. Novartis contends that patents granted on Glivec in 40 countries prove sufficiently that the company is right in challenging the Indian patents law.
On one hand, section 3(d) is important to ensure availability of drugs at affordable price in developing countries like India by discouraging ever-greening of patents, but on other hand it also discourages MNCs to invest in India in pharmaceutical drugs. This presentation is an attempt to interpret Section 3 (d) of Patents Act 1970 to provide better understanding of the provisions support with relevant case-laws.
Who should attend
This webinar will provide valuable assistance to :
- Patent Attorney / Patent Agents / Patent Consultants / IPR Professionals
- Pharmaceutical companies or financial or investment institutions, or service providers as CROs, CMOs concerned with Biologics/Biotechnology/ Biogenerics, Biopharmaceuticals/ Biotherapeutics
- Head/VP/Director, Senior Managers of Commercial Affairs, Business Development, Marketing & Sales, Commercial Affairs, Legal Affairs Pricing and Reimbursement, Health Economics, Intellectual Property, Pharmacovigilance, Clinical Immunology
- Head/VP/Director, Senior Managers of R&D Biotechnology Clinical/Nonclinical/Pharmaceutical
- VP / Director of Product Development, or QA
- VP / Director of Business Development
- Director Regulatory Affairs or Clinical Operations
- VP / Director of Pharmaceutical/Healthcare/Biotechnology
- QA Manager
- Clinical Quality Assurance
- Research and Development
- Clinical Serv
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