Ariad Written Description Ruling Could Significantly Impact Biotech Patents

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The fate of many chemical and biotechnology patents will soon depend on the Federal Circuit’s interpretation of the first paragraph of section 112 of the Patent Act. The debate centers on whether that paragraph contains a written description requirement separate and apart from the enablement requirement. The clause at issue states that a patent “specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same . . . .” 35 U.S.C. § 112. The court’s interpretation will impact a broad range of subjects, including validity, claim construction, prosecution and litigation strategy.

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