Featured Articles
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Since approved by US-FDA at year-end 2002 and commercially launched in the U.S. in early 2003, Humira (Adalimumab) has become the most lucrative drug in history, accruing a total revenue of over 200 billion US dollars for its owner AbbVie. Unfortunately for its owner, the monopoly on the Humira market is scheduled to end in 2023...
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In the U.S., pharmaceutical patents are eligible for patent term extension (PTE), which extends the term of a patent beyond the standard 20 years. PTE is governed by 35 U.S.C. § 156 as part of the Hatch Waxman Act and is meant to compensate for the loss of patent term due to delays in the regulatory approval process...
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Drug Patent Linkage System in New Chinese Patent Law
The 4th amendment to the Chinese Patent Law taking effect from June 1, 2021 represents a significant milestone in the evolution of the patent regulatory framework in China, given the unprecedented level of protection to which patent owners will become entitled. A particularly notable change is the introduction of a drug patent linkage system in China, modeled on the U.S. Hatch Waxman Act...
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In 2021, the fourth amendment to China's Patent Law established a drug patent linkage system, and stipulated a 12-month market exclusivity period for first-generation chemical generic drugs...
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It was found that generic drugs that chose the fourth paragraph statement (i.e., challenging the patent of the original drug) did not go on the market soon after approval, and the first generic drug exclusivity system did not achieve the expected effect in practice. The main reasons are "empty exclusivity period", lengthy and expensive patent litigation and patent settlement agreements...
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The establishment of an antitrust review mechanism for patent settlement agreements is one of the aspects that needs to be improved urgently, and this article will elaborate on this...