As we reported yesterday, four cases being argued next week at the Federal Circuit attracted amicus briefs. The second one we will preview is a patent case entitled Amgen Inc. v. Sanofi, Aventisub LLC. This case concerns patent law’s enablement requirement with respect to antibody claims. Amgen asserts “the district court erred in holding that any reasonable juror was required to find that Sanofi-Regeneron established non-enablement by clear-and- convincing evidence.” This is our argument preview
In its opening brief, Amgen argues that its “patents provide [persons of ordinary skill] a wealth of enabling information.” It contends that “Sanofi-Regeneron failed to identify a single, actual antibody that could not be made following the patents’ roadmap.” Further, Amgen asserts that Sanofi-Regeneron’s own expert merely speculated that “‘[t]here might be kind of an antibody’ out there waiting to be found,” but Amgen argues that “[s]uch speculation is not clear-and-convincing proof of non-enablement.”
Sanofi, in its response brief, maintains that, “[a]s a matter of law, Amgen’s patents were not enabled . . . . [and that] [t]he undisputed evidence established that making and using the full scope of Amgen’s functional genus claims requires undue experimentation.” Sanofi contends that Amgen’s “patents do not describe species representative of the claimed functional genus” and, thus, “lack adequate written descriptions as a matter of law.”
In Amgen’s reply brief, it reaffirmed that, because “the facts and law support the jury’s enablement verdict—and [Sanofi] certainly has not shown that every reasonable juror would be compelled to find it disproved enablement by clear-and-convincing evidence—this Court should reverse.”
This case attracted three amicus briefs: one in support of Amgen, and two in support of Sanofi.
Bristol-Myers Squibb Company and Merck Sharp & Dohme Corp. filed an amicus brief in support of Amgen. In it, they contend that the district court’s enablement standard focusing on whether iterative trial and error is necessary goes too far and would require inventors “to reduc[e] to practice and describ[e] every single possible member of the claimed genus.” According to amici, this “would make it far too difficult for pioneers of therapeutic antibodies to obtain sufficiently robust and reliable patent protection.”
Pfizer Inc. filed an amicus brief in support of Sanofi. In it, Pfizer points out that, “[i]f patentees are permitted to claim antibodies in a purely functional manner, as Amgen did in this case, such antibodies may nevertheless be captured by patents that fail to teach others how to arrive at such optimized antibodies.”
Eli Lilly and Company also filed an amicus brief in support of Sanofi. It argues the Federal Circuit should both hold that Amgen’s claims lack “enablement and make clear that, until such time as this wholly unpredictable field becomes predictable, purely functional antibody claims are per se invalid as lacking sufficient written description.”
Oral arguments will be heard on Wednesday, December 9. We will keep track of this case and report on any developments.