The newly revised Patent Law launches protection term compensation system for invention patent which stipulates protection term adjustment for loss of term caused by patent examination and, laying particular emphasis on drug, patent term extension for delays caused by regulatory review and approval.
Patent term adjustment
Patent term will be adjusted to compensate for the unreasonable delays because of patent examination conducted by the patent administration department where the invention patent is granted later than four years after filing and three years after the date of request for substantive examination. Term loss caused by delays on the side of the applicant will not be compensated. This amendment requires a higher efficiency in patent examination, which may benefit inventions with a short product life cycle.
Drug patent term extension
The patent relating to a new drug approved for marketing in China may be granted a maximum five-year patent term extension by the patent administration department as a compensation for the time taken by regulatory review and approval; and the total effective patent term after the drug is approved for market launch shall not exceed 14 years. While their scope, in particular the definition of "new drugs" remains to be clarified, these provisions embody enhanced protection for original drugs, whose regulatory review and approval can take far longer time than generic drugs.
It should be noted that both the adjustment and supplement are granted only in the request of the patentee. Meanwhile, for drug patent, the adjustment and the supplement should be simultaneously applicable for they are directed to different procedural delays but it remains to be specified by further regulations and interpretations.
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