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Prosecution Suspended

Patently-O

One company – Intel – is responsible for the majority of applicant-requested suspended prosecution, with 2000+ applicants pending in suspended form. FujiFilm and Lyft are the two other big users, each with 100+ pending cases. Part C suspends examination following the filing of an RCE for up to three-months.

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A Therapeutic Solution for COVID-19: Repurposing Existing Drugs

Bio Law Blog

These include favipiravir (Avigan), a flu medication produced by Fujifilm subsidiary Toyama Chemical, and ribavirin, a drug used to fight respiratory syncytial virus (RSV). Both are now undergoing clinical trials for COVID-19.

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Biosimilars 2020 Year in Review

Fish & Richardson Trademark & Copyright Thoughts

As of the March 23, 2020 transition, however, all “biological product” applications previously approved under the FD&C Act were “deemed” approved under the PHS Act, and companies can now seek biosimilars and interchangeables of these biological products. As noted above, companies are already taking advantage of these new designations.

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Biosimilars 2021 Year in Review

Fish & Richardson Trademark & Copyright Thoughts

Several other companies have also announced plans to pursue interchangeable status for biosimilar products. Consistent with this, as shown below in Table 2, numerous companies have publicly announced the submission and/or acceptance of new biosimilar BLAs. Stimufend ® (Fresenius Kabi). Neulasta ® (Amgen). pegfilgrastim.