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Biosimilars 2020 Year in Review

Fish & Richardson Trademark & Copyright Thoughts

Pfizer/Hospira). Pfizer/Hospira). 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. January 3, 2019. adalimumab-adaz.

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Rx label and database linkages plausibly deceive consumers; mostly not precluded by FDCA

43(B)log

Hospira, Inc., Deception/capacity to deceive: H-2 argued that the market here, including pharmacies, pharmacists, wholesalers, or insurance companies, are “sophisticated and well-acquainted with labeling strictures,” making deception implausible. In Belcher Pharmaceuticals, LLC v. 4th 1374, 1380–81 (11th Cir.

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Patentee doublethink in regulatory submissions and patent prosecution is inequitable conduct: Belcher v. Hospira (US)

The IPKat

The US Courts of Appeal of the Federal Circuit (CAFC) found in Belcher Pharmaceuticals v Hospira, Inc that a formulation patent was unenforceable in view of inequitable conduct, in the form of contradictory submissions to the patent office and the regulatory agency (FDA) by the patentee. adrenaline formulation into the market.

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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. Nivestym ® (Pfizer/ Hospira). Retacrit ® (Pfizer/Hospira).