The latest draft implementation guidelines for China’s Drug Administration Law (“Guidelines”) are out and open for comment. Previously, the new implementation measures for early dispute resolution mechanisms for drug patents (“Patent Linkage Measures”) came into effect on July 4, 2021. The Guidelines indicate that the final approval of generic chemical drug applications for marketing approval will be stayed pending Paragraph IV litigation results. Technical review for things like safety and efficacy will proceed regardless. Although previously published Patent Linkage Measures indicate that the maximum stay period is 9 months, these Guidelines only say “a certain period.” The regulatory approval process for generic biologics and traditional Chinese medicines will not be…
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How Smart is a “Skilled Person in the Art”?
Let’s start with a riddle: can you name a person who has read every book, every journal, conducted every known experiment, and is knowledgeable about every single patent prosecution / litigation in the world? The answer? A “skilled person in the art.” This person is also known as a “person having ordinary skill in the art”, “a person of ordinary skill”, “person having ordinary skill in the art”, “PHOSITA”, “POS”, or simply, “a skilled person.” The skilled person in the art is a fictional legal entity, one who widely serves as a reference standard in patent laws around the world for evaluating inventiveness/obviousness. This skilled person also appears in patent…
