Biosimilar manufacturing process patent applications first filed more than a year after the biologic is approved, which represent the largest source of patent assertions in biosimilar litigation, could be addressed without requiring intervention by either the courts or Congress.

中文翻译：

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制造工艺专利丛的管理修正

生物仿制药的生产过程专利申请是在生物制剂获得批准后一年多才首次提出的，这是生物仿制药诉讼中最大的专利主张来源，可以在无需法院或国会干预的情况下进行处理。