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International In-house Counsel Journal logoInternational In-house Counsel Journal logo

Written Description Requirement of Patentability

Abstract

One of the requirements for an invention to be patentable is written description, which requires that the invention be described in sufficient detail for one of ordinary skill in the art to reasonably conclude that the inventor had possession of the claimed invention. “The specification shall contain a written description of the invention, …. ” 35 U. S. C. § 112(a). To support a claim, the specification of the patent must describe the claimed subject matter in a way and from the perspective of a person skilled in the art, such that he would understand the metes and bounds of the invention. Without such description, it may be hard for one to understand the exact coordinates of the invention. Such a disclosure would also enable the development of the treasure of knowledge, allowing the future innovators to contribute over what has already been disclosed. The written description requirement also entails that the inventor actually invented the invention and was in possession of it, at the time of filing of the application. A mere wish or a plan for future is not enough. This paper focuses on the niche of the written description required under § 112(a), which is one of the basic principles upon which the “quid pro quo” of the patent grant system is based. This paper examines the nuances of the requirement that guide the compliance. The paper also examines recent case law on this aspect of patentability and evaluates how the Courts have addressed the legal requirement in recent times.

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Author

Portrait image of Anagha Tendulkar
Anagha Tendulkar
In-house Patent Counsel, Cipla, India

Anagha Tendulkar, is an In-house counsel at Cipla Limited, India. Her role majorly focusses on activities relating to ANDA litigations and includes pre-litigation, in- litigation and post- litigation strategizing for early product launch. Other activities include portfolio selection, priming on legal and regulatory hurdles, strategic decision making, due diligence for small molecules and biologicals, etc. Professional background She has about 15 years of experience in this field. Prior to joining Cipla Limited, she was an In- house counsel at Panacea Biotech, India. Her role was to manage various IP related activities for the organization, including identifying early market entry opportunities, patent due diligences, design- around strategies, patent drafting and prosecution. Presentations • Speaker- National Seminar organized by PES, Modern College of Pharmacy, India- “Patent Basics and Overview of Generic Drugs in US” • Invited to address on “Patents- an insight” at a symposium, Modern College of Pharmacy, India Publications/ Posters • "Induced Infringement under US Patent Law" Anagha Tendulkar, Patent In- house counsel, Cipla. International In-house Counsel Journal Vol. 15, No. 59, Spring 2022, 1 “Written Description Requirement of Patentability” Anagha Tendulkar, Patent In- house counsel, Cipla. International In-house Counsel Journal Vol. 15, No. 58, Winter 2022, 1 . “Blocking Effect of the Blocking Act?” Anagha Tendulkar, Patent In- house counsel, Cipla. International In-house Counsel Journal Vol. 14, No. 55, Spring 2021, 1 • “Demethylation and Transcriptional activation of genes involved in metastasis of pancreatic cancer by Methyl-CpG-binding domain 2. ” Tendulkar S. , Ou J. -N. , Tendulkar A. , Szyf M. Pharmacological research day (PRD) annual meeting Montreal, CANADA, Jun 2006. • “Demethylation and Transcriptional activation of genes involved in metastasis of pancreatic cancer by Methyl-CpG-binding domain 2. ” Tendulkar S. , Ou J. -N. , Tendulkar A. , Szyf M. AACR, Washington D. C. , Apr 2006. • “Metabolic engineering of Yeast: Yarrowia lipolytica” Tendulkar A. , Bhave S. Chattoo B. B. , International meeting - “Yeast 2003”, IMTECH, Chandigarh, India, Feb 2003. Education • LL. B, University of Mumbai • Registered Patent Agent, India • P. G. Diploma in Patent Management, AIPS, Mumbai • Research Associate, Department of Pharmacology, McGill University, Canada • Research Fellow, MSU, Baroda, India • Post-graduation, University of Mumbai (Microbiology/ Biotechnology) Achievements • Qualified- Joint All- India CSIR-UGC Test, CSIR, New Delhi, India • Qualified- State Eligibility Test, University of Pune, Maharashtra, India • Awarded Certificate of merit, Post-graduation, University of Mumbai

Company

Cipla logo

Cipla

Cipla Limited is an Indian multinational pharmaceutical company, headquartered in Mumbai, India. It primarily develops medicines to treat respiratory, cardiovascular disease, arthritis, diabetes, weight control, depression, and other medical conditions. Cipla is a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients. For over 80 years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 100 countries. Its portfolio includes over 1000 products across wide range of therapeutic categories with one quality standard globally. Cipla’s emphasis on access for patients was recognized globally for the pioneering role played in HIV/AIDS treatment as the first pharmaceutical company to provide a triple combination anti-retroviral (ARV) in Africa at less than a dollar a day and thereby treating many millions of patients since 2001.

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