Janssen Biotech, Inc. v. Abbott Laboratories

Whether Section 112 of the Patent Act, which requires the specification of a patent application to "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," forecloses the Federal Circuit"s written-description mandate, which in implementation (i) has required a heightened, actual reduction-to-practice standard for biotechnology patents, (ii) has licensed de novo appellate review of what the Federal Circuit labels a fact question, and (iii) has led to substantial unpredictability and instability in patent protection.