Amgen Biosimilar Rows Reveal Manufacturing Patents' Value

Law360 (November 4, 2020, 4:51 PM EST) -- Unlike small chemical drugs, biologic medicines, such as therapeutic proteins and monoclonal antibodies, are typically large molecules with complex structures.

Because biologics are made in living cells, the manufacturing processes for biologics are complex. Even small changes in manufacturing conditions can have significant effects on the composition and activity of biologics.[1]

Patents that protect the manufacture of biologics, from growing the cells that make the biologics to purifying the biologics, have taken a central role in U.S. biosimilar litigation under the Biologics Price Competition and Innovation Act.

Manufacturing Patents Under the BPCIA

The BPCIA provides a patent dispute resolution process for...

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