Section 112 Requirements for Life Sciences Patents

Anagha Tendulkar, In-house Patent Counsel, Cipla

35 U.S.C. §112(a) of the US Patent Act is one of the integral parts of the quid pro quo patent system that balances the benefit of disclosure of the invention to the public and the inventor’s right to enjoy the monopoly over the invention for 20 years from filing of the patent application. Two key requirements of this statute are that the specification needs to have written description support for the invention (written description requirement) and that the specification be enabled in a manner such that the invention can be made and practiced by a person skilled in the art without having to perform “undue experimentation” (enablement requirement). This article explores the enablement and written description requirements and how the courts have evaluated and interpreted the same. The enablement requirement is very nuanced and has received attention from the United States Supreme Court. The highest court has allowed a writ regarding the requirement which would potentially provide more clarity on the level of description and teaching necessary to meet the requirement. This article discusses this writ and the arguments made on both sides. This article further explores a written description case for which a writ of certiorari has been filed with the Supreme Court . This federal circuit case was earlier discussed in an article about written description, but the court has reversed the holding. The article will focus on this reversal and the issue presented to the Supreme Court.

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India Intellectual Property Pharmaceutical May 2023 Vol.16, No. 63, Spring 2023

Anagha Tendulkar

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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

Cipla

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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.

India Intellectual Property Pharmaceutical May 2023 Vol.16, No. 63, Spring 2023

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