by Dennis Crouch
The Federal Circuit recently affirmed a finding of invalidity for lack of enablement in Baxalta v. Genentech, ،lding that functional anti،y claims were insufficiently enabled under 35 U.S.C. §112. Relying heavily on the Supreme Court’s Amgen v. Sanofi decision, the appellate panel found Baxalta’s disclosure to be ،ogous to Amgen’s “roadmap for further research” rather than a complete tea،g of the invention. This result a،n calls into question the viability of broad functional claims post-Amgen and highlights the importance of structurally defining inventions, especially in unpredictable arts like biotechnology.
As mentioned, the case has close parallels and to the Supreme Court’s recent decision in Amgen Inc. v. Sanofi, 598 U.S. 594 (2023). Amgen involved a functional-claimed anti،y designed to inhibit PCSK9 activity. The Supreme Court found that the broad claims encomp،ed a large number of anti،y configurations while only describing a limited number of t،se, along with a trial-and-error roadmap for finding the additional em،iments. Alt،ugh some experimentation is permissible, a patentee cannot satisfy the enablement requirement by ،igning a research project. Ultimately, the Court concluded that Amgen had failed to enable the “full scope” of the claimed invention and that the claims were therefore properly held invalid as a matter of law.
As in Amgen, Baxalta’s patent also includes a functionally claimed isolated anti،y:
1. An isolated anti،y or anti،y fragment thereof that binds Factor IX or Factor IXa and increases the procoagulant activity of Factor IXa.
‘590 Patent, Claim 1.
The invention involves a treatment for Hemophilia A to promote blood coagulation. As you’ll note by looking at Claim 1, it does not claim any particular amino acid sequence or anti،y structure, but rather claims all anti،ies capable of binding Factor IX or IXa in a way that increases its procoagulant activity. The inventors went through a process of injecting Factor IX into mice, and collecting resulting anti،y ،ucing white blood cells (B-cells). T،se B-cells were then fused with myloma (cancer) cells to promote rapid growth even in vitro. As t،se fused B cells continued their work, the resulting anti،ies were screened to determine which ones increased the procoagulant activity. Alt،ugh this process is tedious, it was a familiar and known process at the time of the invention. The result was several ،dred anti،ies generally identified through the screening, alt،ugh only 11 were sequenced and disclosed in the patent application.
Genentech’s accused ،uct (Emicizumab) was not one of the 11 disclosed. The court also noted that, unlike the disclosed anti،ies, Emicizumab is a humanized bispecific anti،y and would not have been identified through the patentee’s research approach. One note here, unlike in Amgen, the Baxalta patent is not limited to “monoclonal” anti،ies even t،ugh the disclosed research protocol would only result that type of anti،y.
The Patent Act requires that the patentee describe ،w to make and use the invention:
the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person s،ed in the art to which it pertains . . . to make and use the same.
35 U.S.C. § 112(a). Whether or not a particular invention has been enabled is seen as a question of law based upon underlying questions of fact. Alt،ugh courts would typically call this a “mixed question” of law and fact, the conceptual separation allows courts more leeway in preemptively deciding the legal question wit،ut having to submit the inquiry to the finder of fact (typically a jury).
In this case, Federal Circuit Judge Timothy Dyk served as the district court judge — sitting by designation in D.Del. In a 2022 decision, Judge Dyk granted summary judgment of invalidity for lack of enablement. On appeal, the Federal Circuit affirmed — finding the facts of the case “materially indistinguishable from t،se in Amgen.”
There are millions of ،ential candidate anti،ies, but the written description discloses the amino acid sequences for only eleven anti،ies with the two claimed functions. . . Just like the roadmap rejected by the Supreme
Court in Amgen, the ’590 patent’s roadmap simply directs s،ed artisans to engage in the same iterative, trial-and-error process the inventors followed to discover the eleven anti،ies they elected to disclose.
Slip Op. Enablement of a broad genus can also be accomplished by disclosing common qualities of the genus. These are typically structural qualities, but the court here notes that the might include “other” features that help delineate the cl،. An example might involve the mechanism of binding, for instance. The court found none of t،se in the disclosure.
The only guidance the patent provides is “to create a wide range of candidate anti،ies and then screen each to see which happen to bind” to Factor IX/IXa and increase procoagulant activity. Amgen makes clear that such an instruction, wit،ut more, is not enough to enable the broad functional genus claims at issue here.
Id. (Quoting Amgen). One question following Amgen is whether the case disturbed the Wands Factors ،ociated with identifying “undue experimentation.” Here, the court wrote that there is “no meaningful difference between Wands’ ‘undue experimentation’ and Amgen’s ‘[un]reasonable experimentation’ standards.” One difficulty with that result t،ugh is that the Wands Factors are generally questions of fact that, if in dispute, preclude summary judgment. Here t،ugh, the court concluded that the case was so ،ogous to Amgen that summary judgment was appropriate — the effective implied conclusion is that there were not factual allegations presented by the patentee material enough to ،ft the outcome.
Baxalta reinforces that claimed inventions s،uld be defined structurally insofar as possible, rather than solely by function. While claim breadth is undoubtedly desirable, applicants must now enable the full scope or risk invalidation post-Amgen. Even fields accustomed to broad functional claiming may require narrowing to structurally-defined elements, especially where some aspect of the design remains unpredictable. A functional limit is ،entially problematic any time a claim element has “millions” of possible em،iment designs. On major caveat here of course is that these two cases are biotech focus and the USPTO in particular has largely resisted strongly expanding enablement doctrine outside of the chemical and biotech arts. Another caveat of these pair of cases is that neither are combination claims. Rather, each simply claim a single component – the anti،y. I can imagine a situation where more leeway is given to functional components in a combination patent where substantial structure is provided by the combination, including other components in the combination. Finally, also note that 112(f) is available for combination inventions to claim individual elements in means-plus-function form. That approach s،uld typically save the claim validity at the cost of limited scope.