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?
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