Patent applications: Kite raises the game
This year, two precedential decisions by the US Court of Appeals for the Federal Circuit, Amgen v Sanofi (2021) and Juno Therapeutics v Kite Pharma (2021) have elevated the standards for satisfying the statutory requirement for enablement and written description of a patent application in the context of inventions that involve antibodies.
The statutory requirement for written description, support and enablement can be found in 35 USC §112(a), which states: “The 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, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.”
In order to invalidate a patent for lack of enablement, “a challenger must show by clear and convincing evidence that a person of ordinary skill in the art would not be able to practise the claimed invention without ‘undue experimentation’.” (Alcon Research, quoting In re Wands, Fed Cir 1988).
This finding requires a conclusion reached by weighing factual considerations as set forth in Wands (known as the “Wands factors”):
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