Head of Patent Practice at the Patentus patent bureau, Aleksey Mikhaylov, suggests that Biogen restored the patents after learning that Generium had begun clinical trials of its generic. As the expert explained, the owner of the patent rights must pay a fee for renewing the patent rights every year; if the owner fails to do this once, the patent will expire, but can be restored within three years.
Aleksey also noted that one of the valid patents for Nusinersen contains the so-called Swiss invention formula, which describes the method of using the active substance when releasing a drug for the treatment of spinal muscular atrophy in a certain way.
Expert adds: “It is quite possible that Generium knew about patent 2793459 (which was obtained on the basis of a cascade divisional application), but the decision to enter the market could have been made at a time when the Supreme Court had not yet overturned the ruling of the Presidium of the Intellectual Property Court in the case of patents for Dapagliflozin, in which the court found the practice of filing divisional applications in a cascade to be illegal.”
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