The FDA recently proposed an amendment to its regulations defining the term “biological product.” The proposed amendment...
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BiosimilarsIP.com Legal provides analysis of legal decisions from federal courts and from the PTAB related to biologics and biosimilars.
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Prior to 1994, the term of a U.S. patent was 17 years from the date of issuance. When the Uruguay Round Agreements Act (“URAA”)...
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We previously wrote about Genentech’s U.S. Patent No. 6,407,213 (“the ’213 patent”) to Carter, first in October 2017, and more...
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RFEM’s Biosimilars IPR Dashboard provides current information on IPR proceedings related to proposed biosimilar...
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On June 14, 2018, Senator Orrin Hatch of Utah, the co-author of the Hatch-Waxman Act, filed an amendment to the Hatch-Waxman Act in an...
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On March 8, 2018, Amgen Inc. (“Amgen”) filed suit against Adello Biologics, LLC (“Adello”) in the District of New Jersey, alleging...
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As we recently covered, May 15, 2018, saw the FDA granting approval to Hospira (now a Pfizer subsidiary) for its Retacrit injection, a...
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