“We have stressed that there is no ‘litmus test’ for determining whether a preamble is limiting. Rather, ‘[w]hether to treat a preamble as a claim limitation is determined on the facts of each case in light of the claim as a whole and the invention described in the patent.’” – CAFC in Eli Lilly v. Teva Pharmaceuticals
The U.S. Court of Appeals for the Federal Circuit today issued two precedential decisions and one nonprecedential decision in cases involving Teva Pharmaceuticals and Eli Lilly, delivering wins and losses for each company. The cases relate to “humanized antagonist antibodies that target calcitonin gene-related peptide (‘CGRP’)” and methods of using such antibodies. All three cases were heard by Judges Lourie, Bryson and O’Malley, with Judge Lourie authoring the decisions.
Lilly Takes a Loss
In the first decision, the CAFC rejected Eli Lilly’s appeal from a decision of the Patent Trial and Appeal Board (PTAB) holding that the claims of Teva’s U.S. Patents 8,586,045 (“045 patent”), 9,884,907 (“’907 patent”), and 9,884,908 (“’908 patent”) were not unpatentable as obvious. The claims at issue are directed to “methods of treatment comprising the step of administering a humanized anti-CGRP antagonist antibody.” CGRP has been linked to symptoms such as headaches, including migraines. The claims here use the anti-CGRP antagonist antibodies to inhibit CGRP activity in the body and reduce symptoms.
Eli Lilly filed for inter partes review (IPR) of certain claims of the patents, asserting that they would have been obvious over a combination of three prior art references: Olesen, Tan and Queen. Olesen taught that BIBN4096BS, a nonpeptide CGRP-receptor antagonist, was safe and effective for treating migraines. Tan described a study in rats, including one experiment that “successfully achieved immunoblockade by inhibiting the effects of exogenously administered CGRP.” Queen explains ways to address traditional problems associated with injecting monoclonal antibodies from donors (e.g., mice) into humans.
The Board first found in construing the claim preambles that they were “limiting to the extent that they require that the recited method must be performed with the intentional purpose of ‘reducing incidence of or treating’ at least one vasomotor symptom . . . or headache.”
While the Board found that Lilly had proven by a preponderance of the evidence that each of the references “discloses or suggests each and every element of the challenged claims,” and that a skilled artisan would have been motivated to combine the teachings of the prior art, it ultimately held that there was no “reasonable expectation of success” in combining the teachings of the prior art to achieve the claimed invention, and thus, Lilly had failed to satisfy its burden of demonstrating that the challenged claims would have been obvious over the combined prior art.
Lilly argued on appeal that a claim preamble containing only a statement of purpose cannot be a claim limitation, as a matter of law, and that no weight should have been given to the preambles. But Teva replied that Lilly was basing its analysis on a false dichotomy between “limiting preambles” and preambles that are mere statements of purpose. The CAFC agreed with Teva, explaining that:
We have stressed that there is no “litmus test” for determining whether a preamble is limiting. See Bicon, Inc. v. Straumann Co., 441 F.3d 945, 952 (Fed. Cir. 2006) (citing Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002)). Rather, “[w]hether to treat a preamble as a claim limitation is determined on the facts of each case in light of the claim as a whole and the invention described in the patent.
The court added that it has traditionally treated statements of intended purpose in method claims like those at issue in the case as limiting. This stands in contrast to apparatus or composition claims, which the court has usually found non-limiting: “Preamble language that merely states the purpose or intended use of an invention is generally not treated as limiting the scope of the claim,” wrote the CAFC, quoting from Bicoin. However, the court noted that it has occasionally found statements of intended purpose in claim preambles to be limiting for apparatus or composition claims as well, “when warranted by the facts.” The court went on to describe its own case law as well as intrinsic evidence that supported its view that there was no error in the Board’s finding that the preambles were limiting.
Lilly also argued that the Board’s claim constructions improperly required proof that a skilled artisan would have had a reasonable expectation of achieving a result that was not claimed, which the court described as “misplaced,” considering its rejection of the argument that the preambles are non-limiting. The CAFC thus found no error in the Board’s conclusion that “what is required is not proof that the recited method would actually bring about the recited result, but rather proof that a person of ordinary skill in the art would have had a reasonable expectation that performing the recited method would bring about the recited result.”
As to the contention that the PTAB used the wrong standard to evaluate whether Tan and Olesen would have given a skilled artisan a reasonable expectation of success, the court agreed with Teva that Lilly’s argument simply misread the Board’s decision. And finally, Lilly’s identification of one reference to prove that there was no uncertainty at the time about whether migraine treatments must cross the “blood-brain barrier” in order to be effective failed, said the court. It added:
Both sides presented numerous pieces of evidence on the blood-brain barrier issue, including prior art references and expert testimony. The Board weighed the evidence supporting each side of the factual dispute and found that sufficient uncertainty and unpredictability remained—i.e., that Lilly’s evidence failed to demonstrate enough certainty that migraine treatment does not have to cross the blood-brain barrier to give a skilled artisan a reasonable expectation of success.
Two Strikes for Teva
In the second precedential decision issued today involving the two companies, the CAFC agreed with the PTAB that a different set of patent claims, pertaining to Teva’s U.S. Patents 9,340,614 (“’614 patent”), 9,266,951 (“’951 patent”), and 9,890,210 (“’210 patent”), were unpatentable as obvious over the cited prior art. These patents are directed to the humanized antagonist antibodies that target CGRP themselves, rather than methods of using them. Andrew Hirshfeld, who is performing the functions and duties of the USPTO Director, was also named as Intervenor in this case due to an Arthrex v. Smith & Nephew challenge that was ultimately waived by Teva.
Lilly filed for IPR of various claims of the patents with the PTAB, asserting that they were obvious over prior art references Tan and Queen (described above) as well as Wimalawansa. The latter is “a review article that describes CGRP, including the history of its discovery, its molecular genetics and structure, its biological actions, and its therapeutic potentials.”
The PTAB found that the prior art disclosed or suggested each and every limitation of the challenged claims, that a skilled artisan would have been motivated to combine the teachings of the prior art, and would have had a reasonable expectation of successfully achieving the claimed invention.
Teva argued on appeal that the Board erred as a matter of law in its motivation to combine analysis by deviating from the motivation asserted by Lilly in its IPR petitions. Lilly said in its petitions that “a skilled artisan would have been motivated to combine the teachings of the references to make a humanized anti-CGRP monoclonal antibody for therapeutic use in humans,” while the Board “considered whether a skilled artisan would have been motivated to make the antibody merely to study or use it,” according to Teva. But Lilly and the CAFC both essentially dismissed this as semantics. “The Board upheld its mandate to ‘base its decision on arguments that were advanced by a party’—namely, Lilly—’and to which the opposing party’—namely, Teva—’was given a chance to respond,’” wrote the court. The court likewise dismissed Teva’s argument that the Board discounted safety and efficacy concerns that would have been “demotivating factors—i.e., reasons why a skilled artisan would have been motivated not to make a humanized anti-CGRP monoclonal antibody,” saying that Teva “misses the mark.” The court explained:
The relevant inquiry is not (as Teva suggests) whether the asserted concerns would have presented a reason not to use the claimed antibodies in human treatments. Rather, the relevant inquiry—which the Board extensively analyzed—is whether those concerns would have dissuaded a skilled artisan from making the claimed antibodies to study their therapeutic potential in the first place.
Teva alternatively argued that the Board relied on “unsupported interpretations of isolated statements in the prior art” to find a motivation to study or use anti-CGRP antibodies. But the court found that substantial evidence supported such a motivation and that Lilly had identified evidence supporting the PTAB’s “reasonable readings” of each reference. While Teva naturally disagreed, the court said:
When it comes to competing interpretations of the teachings of prior art references, we must uphold the principle that “[i]f two ‘inconsistent conclusions may reasonably be drawn from the evidence in record, the PTAB’s decision to favor one conclusion over the other is the epitome of a decision that must be sustained upon review for substantial evidence.’”… Under this deferential standard of review, we cannot replace the Board’s reasonable interpretation of references with Teva’s interpretation.
As to Teva’s evidence of secondary considerations of non-obviousness, namely, its AJOVY® product and Lilly’s Emgality® product, the court agreed with Teva that the Board had erred in its articulation of the legal standard governing the “presumption of nexus” between a patented claim and a particular product (Fox Factory v. SRAM), but ultimately said that no presumption of nexus applied here. The court likewise found that Teva’s evidence of a license it entered into with AlderBio Holdings, LLC and Alder Biopharmaceuticals, Inc. (AlderBio) that included the challenged patents lacked sufficient nexus to the challenged claims because Teva had failed to show anything more than the mere existence of the license, with no evidence that the motivation for entering the license agreement had to do with the three challenged patents.
In a third decision, which was nonprecedential, the CAFC found claims of three additional Teva patents, U.S. Patents 9,346,881 (“’881 patent”), 9,890,211 (“’211 patent”), and 8,597,649 (“’649 patent”), obvious for the same reasons as stated with respect to the ’614, ‘951 and ‘210 patents above.