Blocking Effect of the Blocking Act?

Anagha Tendulkar, Patent In- house counsel, Cipla

The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch Waxman Act 1984, was enacted in 1984 to balance the privileges offered to brand name pharmaceutical companies, helping them to continue to innovate, with those to the generic pharmaceutical companies, providing incentives to bring low-cost generics early to the market. In 2019, The Lower Health Care Costs Act of 2019, was introduced in The House of Representatives, to improve public health and to end surprise medical bills. Interestingly, one of the provisions of this Bill, BLOCKING Act of 2019, proposes to remove the barrier to an approval of subsequent Abbreviated New Drug Application posed by the 180 days exclusivity of the first filer. The Bill is proposed to reduce the out- of- pocket expenses on health care, a purpose similar to why the Hatch Waxman act was enacted. Does this proposal however, have a flip side, threatening to do exactly opposite of what it proposes to do?

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India Competition Pharmaceutical June 2021 Vol.14, No. 55, Spring 2021

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, including pre-litigation and in- litigation strategizing. Another major role involves closing settlements and ensuring early generic launches. She is involved in various other activities such as portfolio selection, evaluation of potential launch dates, priming on legal and regulatory hurdles, strategic decision making, suggesting design- around strategies, due diligence, and patent analysis. Professional background She has about 14 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 • “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 Competition Pharmaceutical June 2021 Vol.14, No. 55, Spring 2021
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