Biologic generics. The phrase doesn’t exactly come tripping off one’s tongue. But for intellectual property lawyers–especially ones that handle life sciences–it may sound something like “whiskey-flavored ice cream.”
The manufacturing processes and patents for biological drugs are very complex, which makes it difficult for generic alternatives to come to market. But Congress is considering several proposals that would put generic biological drugs on the fast track to Food and Drug Administration approval. The prospect of litigation between generic makers and original inventors is one reason that seven firms have added 15 life science IP lawyers (nine partners) since January.
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