With only two precedential IP decisions coming down from the Federal Circuit in the second half of September, pickings were a little slim for blogging. That said, the opinion in Baxalta v. Genentech (2022-1461) — drafted by Chief Judge Kimberly Moore and joined by Judges Raymond Clevenger and Raymond Chen — is an important one to cover since it demonstrates how the court interpreted and applied the Supreme Court’s recent enablement decision in Amgen v. Sanofi.

Recall in Amgen, the Supreme Court articulated its view that 35 U.S.C. § 112 plainly requires that “[i]f a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class” and warned that “the more a party claims, the broader the monopoly it demands, the more it must enable.” In this vein, the court characterized the Amgen claims as an attempt to “monopolize an entire class of things defined by their function” even though the class was much broader than the 26 expressly disclosed antibodies and opined that Amgen’s “roadmap” for obtaining antibodies other than those expressly disclosed “amount[ed] to little more than two research assignments.”

The Baxalta claims at issue here were also related to antibodies, i.e., claims covering monoclonal antibodies that could provide an alternative treatment for the blood-clotting disorder Hemophilia A. Claim 1 of U.S. Patent No. 7,033,590 reads as follows:

An isolated antibody or antibody fragment thereof that binds Factor IX or Factor IXa and increases the procoagulant activity of Factor IXa.

The District of Delaware granted summary judgment of invalidity for lack of enablement under 35 U.S.C. § 112. On appeal, Baxalta argued that summary judgment was improper because skilled artisans could make and identify claimed antibodies (with new variable regions) using the hybridoma technology disclosed in the ’590 patent and that such routine screening does not amount to undue experimentation.

The Federal Circuit disagreed. It explained that the hybridoma methods in the ʼ590 patent only disclosed 11 antibodies by amino acid sequence that had the claimed binding properties and that these 11 antibodies amounted to “only 1.6% of the thousands of screened antibodies” resulting from the hybridoma protocol employed by the inventors. Yet, the scope claims at issue could cover “millions of potential candidate antibodies.” As such, the disclosure of only 11 antibodies that possessed the two required functions in the claims and the lack of explanation as to why those 11 antibodies perform the claimed functions (or why the other screened antibodies do not) does not allow a skilled artisan “to predict which of these potential millions of antibodies would have the claimed function.” In fact, according to the Federal Circuit,

[t]he only guidance the [ʼ590] patent provides is ‘to create a wide range of candidate antibodies and then screen each to see which happen to bind’ to Factor IX/IXa and increase procoagulant activity

that, in the eyes of the appellate panel, amounts to nothing more than the type of trial and error found in Amgen to be incapable of satisfying the enablement requirement.

To summarize with the exact words of the appellate panel, “[t] he facts of this case are materially indistinguishable from those in Amgen.” As such, it is no surprise that the Federal Circuit upheld the invalidity finding by the lower court. However, we will need to wait and see how the appellate court will interpret and apply Amgen to different types of inventions. For example, the Supreme Court in Amgen did provide that “[a] specification may call for a reasonable amount of experimentation to make and use a claimed invention, and reasonableness in any case will depend on the nature of the invention and the underlying art.” 

In short, while more cases from the Federal Circuit would be helpful to fully flesh out the Amgen enablement standard, the panel did make it clear that it “see[s] no meaningful difference between Wands’ ‘undue experimentation’ and Amgen’s ‘[un]reasonable experimentation” standards’” and that it “do[es] not interpret Amgen to have disturbed our prior enablement case law, including Wands and its factors.”  Given that the Amgen decision pretty much solidified the Federal Circuit’s general trend of limiting claim scope to what is (mostly) expressly disclosed, it may not be reasonable to expect that genus-type claims in other types of inventions will fare much better.