“Enablement is required, even for generic claims to biological materials.” – CAFC
On June 21, the United States Court of Appeals for the Federal Circuit (CAFC) denied a petition for rehearing and rehearing en banc filed by Amgen Inc., Amgen Manufacturing, Limited, and Amgen USA, Inc. (Amgen) in their case against Sanofi, Aventisub LLC, FKA Aventis Pharmaceuticals Inc., Regeneron Pharmaceuticals Inc., and Sanofi-Aventis U.S. LLC (Sanofi). Judge Lourie was joined by Judges Prost and Hughes in a separate opinion on the denial of the petition for panel rehearing.
A group of intellectual property professors; GlaxoSmithKline plc; and Biogen Inc., Bristol-Myers Squibb Company, Corning Incorporated, and Merck Sharp & Dohme Corp. filed amicus briefs.
Biotech Can’t Skirt Enablement
Amgen first argued that the CAFC “created a new test for enablement,” after the CAFC denied their claims on the basis that they did not provide sufficient enablement. However, the court was not convinced, stating “[w]hat is new today is not the law, but generic claims to biological materials that are not fully enabled. Enablement is required, even for generic claims to biological materials.” Specifically, Amgen and amici argued that requiring broad generic claims in biotechnology be supported by a disclosure that enables the full scope of claims will make it impossible to obtain the proper protection for inventions in the field of biotechnology.
Responding to this argument, the CAFC noted that enablement only precludes protection for inventions broader than are disclosed or enabled, and that if the genus claimed had in fact been invented by the time of filing, then it would have been fully enabled. Merely “[d]rawing a fence around subject matter without filling in the holes, is not inventing the genus.” Therefore, entitlement to a broad genus goes along with the requirement to disclose and enable a sufficient number of species to warrant such protection.
Amici argued that the CAFC recently adopted a “numbers-based standard” to evaluate enablement that asks not whether experimentation is undue but how long it would take to make and screen every species. However, the CAFC stated that this mischaracterizes the law, noting that the problem was not “simply that the claimed genus was numerous—it was that it was so broad, extending far beyond the examples and guidance provided.”
The Sky is Not Falling
Amgen and amici also argued that the CAFC’s decisions on enablement threatened innovation and will “devastate” the incentives to invest in drug discovery. However, here, too, the CAFC was unconvinced, stating “enablement is part of our law, and for good reason.” Contrary to the reasoning put forth in the petition for rehearing, the CAFC reasoned that one should not gain exclusivity over claimed subject matter without disclosing how to make and use it, because this would stifle invention by allowing inventors to claim what they have not invented. To buttress their argument that enablement will not stifle innovation, the CAFC cited to U.S. Patent No. 8,030,457, which Amgen received to protect the PCSK9 antibody that it invented and which it additionally purports to cover by the claim the court invalidated. “Thus,” the CAFC concluded, “the failure to obtain unsupported, unenabled claims has not deprived [Amgen] of patent protection on the fruits of its investment.”
The CAFC also addressed the concern that others may invent another species within the broad genus and undermine Amgen’s competitive advantage. To this, the CAFC said the doctrine of equivalents would provide sufficient protection.
A Seismic Shift is Not Warranted
Finally, Amgen argued that the CAFC should overrule case law that holds enablement is a question of law. The CAFC recognized that one may reasonably ask why enablement is a question of law when written description, which goes hand in hand with enablement, is not. After all, both of these relate to disclosure in the patent specification. However, in denying the petition for a rehearing, the CAFC held that they are bound by their precedent and declined “to recommend to the court that it go en banc to overrule longtime precedents simply because a party has questioned it, especially where the arguments that Amgen ma[de] provide[d] no compelling reason to introduce such a seismic shift.”
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