At the center of the dispute were Amgen's
While the parties stipulated to infringement, the case still included two jury trials, two appeals to the CAFC, and the demise of the U.S.P.T.O.'s "antibody exception" for satisfying the written description requirement before arriving at the
On appeal, Amgen argued, inter alia, "that the embodiments in the patent are structurally representative for the purpose of fulfilling the written description requirement, and such evidence is sufficient to indicate a structure/function correlation establishing enablement." The CAFC disagreed. Relying on its own precedent of In re Wands, the court affirmed the determination that the patents required undue experimentation to practice the full scope of the claims and accordingly were not enabled.
The CAFC reiterated that "[w]hile functional claim limitations are not necessarily precluded, such limitations pose high hurdles for fulfilling the enablement requirement for claims with broad functional language." The court further stated (seemingly akin to the representative species analysis for written description) that: "[i]t is appropriate, however, to look at the amount of effort needed to obtain embodiments outside the scope of the disclosed examples and guidance."
The Court took up the case to assess whether the CAFC applied a heightened enablement standard to genus claims. A multitude of amicus briefs were filed, with many warning of a potentially dire impact on investment in research and development. However, oral arguments dealt little with this issue. As discussed by the Court, the parties appeared to agree on the controlling law and appropriate standard. The parties' dispute focused on the theoretical size of the claimed genus and the number of species necessary to enable the full scope.
In a unanimous decision, the Court implicitly affirmed In re Wands and the CAFC's undue experimentation test for enablement. Relying on 19th and early 20th century precedent, the Court confirmed that the full scope of a claim must be enabled. However, the Court made clear that it is not necessary to describe how to make and use every embodiment within a genus. While the number of examples necessary to enable a claim will vary from case to case, the Court stated that "it may suffice to give an example (or a few examples) if the specification also discloses 'some general quality running through' the class that gives it 'a peculiar fitness for the particular purpose.'"
Exactly how Amgen v.
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