Hatch Waxman Act 1984 Analysis
Abstract
The patent system is the driving force behind pharmaceutical innovations1. It provides the innovators 20 years of royalty to recover their investments done in research and development of the new product. It also ensures the company’s ability to further profit from its innovations before generic drug manufacturers can copy and market the drug at a greatly reduced cost2. During this period no one can prepare, sell and copy innovator’s product without his permission. These patented products are costly and are not affordable to all consumers. With a view of making available, the effective treatment option to common public, the patent term restoration act 1984, also known as “Hatch Waxman act”, was passed. It provides an …show more content…
Under the new legislation, generic entrants only needed to submit an Abbreviated New Drug Application (ANDA) that demonstrates the bioequivalence of its drug to the original. The Hatch- Waxman Act includes the guidelines for both innovator and generic firms. When a firm wants to enter in the market with a generic form of a patented product, then it needs to file an ANDA. This certification states that either FDA approves generic version after the expiry date of last patent (para 3 filing) or that its generic product does not infringe the listed patents (para 4 filing). If generic firm files ANDA under para 4, then Innovator is notified and within 45 days Innovator can file infringement action against the generic firm. After the filing of infringement suit, ANDA cannot be approved until the generic firm successfully defends the infringement or until 30 months whichever comes first. The provisions contained in the Act were designed to promote innovation and subsequently make it available to general public at affordable …show more content…
Patent evergreening
Evergreening involves building layers of protection by obtaining separate patents on multiple attributes of a single product. Evergreening is a strategy used by manufacturers of a particular drug to prevent the entry of it generic equivalents in the market. Example: GSK hold patents for ondansetron by utilizing this strategy. In addition to patent on API, the company also patented for salts, hydrates, other enantiomers, other dosage forms and formulation, process of manufacture of API etc. It was granted patent protection in 1987. Further obtaining divisional patents, its patent protection was extended to 2006.
Results and Discussion
Hatch Waxman act plays a very important role in making available the effective treatment to the public via promoting the generic version of the innovator’s product. Several amendments have been done in the Hatch-Waxman act to close the loopholes which restrict the generic drugs to enter the market.
• Non-extendable 30-month stay period
• Limited duration for notifying patent owner: notify the patent owner within 20 days.
• Allowance of declaratory judgment: within 45 days of notification, if patent owner does not file infringement
The patent system is the driving force behind pharmaceutical innovations1. It provides the innovators 20 years of royalty to recover their investments done in research and development of the new product. It also ensures the company’s ability to further profit from its innovations before generic drug manufacturers can copy and market the drug at a greatly reduced cost2. During this period no one can prepare, sell and copy innovator’s product without his permission. These patented products are costly and are not affordable to all consumers. With a view of making available, the effective treatment option to common public, the patent term restoration act 1984, also known as “Hatch Waxman act”, was passed. It provides an …show more content…
Under the new legislation, generic entrants only needed to submit an Abbreviated New Drug Application (ANDA) that demonstrates the bioequivalence of its drug to the original. The Hatch- Waxman Act includes the guidelines for both innovator and generic firms. When a firm wants to enter in the market with a generic form of a patented product, then it needs to file an ANDA. This certification states that either FDA approves generic version after the expiry date of last patent (para 3 filing) or that its generic product does not infringe the listed patents (para 4 filing). If generic firm files ANDA under para 4, then Innovator is notified and within 45 days Innovator can file infringement action against the generic firm. After the filing of infringement suit, ANDA cannot be approved until the generic firm successfully defends the infringement or until 30 months whichever comes first. The provisions contained in the Act were designed to promote innovation and subsequently make it available to general public at affordable …show more content…
Patent evergreening
Evergreening involves building layers of protection by obtaining separate patents on multiple attributes of a single product. Evergreening is a strategy used by manufacturers of a particular drug to prevent the entry of it generic equivalents in the market. Example: GSK hold patents for ondansetron by utilizing this strategy. In addition to patent on API, the company also patented for salts, hydrates, other enantiomers, other dosage forms and formulation, process of manufacture of API etc. It was granted patent protection in 1987. Further obtaining divisional patents, its patent protection was extended to 2006.
Results and Discussion
Hatch Waxman act plays a very important role in making available the effective treatment to the public via promoting the generic version of the innovator’s product. Several amendments have been done in the Hatch-Waxman act to close the loopholes which restrict the generic drugs to enter the market.
• Non-extendable 30-month stay period
• Limited duration for notifying patent owner: notify the patent owner within 20 days.
• Allowance of declaratory judgment: within 45 days of notification, if patent owner does not file infringement