Blocking Effect of the Blocking Act?

Anagha Tendulkar, Patent In- house counsel, Cipla, India

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?

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