“We emphasized that there is no“ litmus test ”to determine whether a preamble is limiting. Prefer, ‘[w]Whether a preamble is to be treated as a limitation of claims depends on the facts of the individual case in the light of the entire claim and the invention described in the patent. ‘”- CAFC in Eli Lilly v. Teva Pharmaceuticals
The U.S. Federal Circuit Court of Appeals today issued two precedents and one non-precedent ruling in Teva Pharmaceuticals and Eli Lilly cases that made profits and losses for each company. Cases relate to “humanized antagonist antibodies targeting the 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 drafting the decisions.
Lilly suffers a loss
In the first decision, the CAFC dismissed Eli Lilly’s appeal against a decision by the Patent Trial and Appeal Board (PTAB) that found that the claims of US Patents 8,586,045 (“045 Patent”), 9,884 .907 (“‘907 Patent”) and 9,884,908 (“‘ 908 Patent”) were not as obviously unpatentable. The disputed claims are directed to “methods of treatment which include 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 requested an inter partes review (IPR) of certain claims, claiming that they would have been obvious against a combination of three prior art references: Olesen, Tan and Queen. Olesen taught that BIBN4096BS, a non-peptide CGRP receptor antagonist, was safe and effective in treating migraines. Tan described a study in rats, including an experiment, that “successfully achieved immune blockade by inhibiting the effects of exogenously administered CGRP”. Queen explains how to address traditional problems associated with injecting monoclonal antibodies from donors (e.g. mice) into humans.
In interpreting the preambles of the claims, the board first stated that they were “restrictive in that they require that the method cited be carried out with the intentional purpose of reducing or treating the occurrence of at least one vasomotor symptom”. . . or a headache. “
While the board found that Lilly had demonstrated, by a preponderance of evidence, that each of the references “discloses or suggests every single element of the challenged claims” and that a skilled person would have been motivated to combine the teachings of the prior art, it ruled Finally, that there was no “reasonable expectation of success” to combine the teachings of the prior art in order to achieve the claimed invention, and Lilly had therefore failed to prove that the challenged claims were beyond the combined prior art.
Lilly argued on appeal that a preamble to claims that contained only a statement of purpose could not legally be a limitation of claims and that no weight should have been attached to the preambles. But Teva replied that Lilly was basing her analysis on a false dichotomy between “limiting preambles” and preambles, which are mere declarations of intent. The CAFC agreed with Teva, stating that:
We have emphasized that there is no “litmus test” to determine whether a preamble is limiting. See Bicon, Inc. v. Straumann Co., 441 F.3d 945, 952 (Fed. Cir. 2006) (cited by Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002)). Prefer, “[w]Whether a preamble is to be treated as a limitation of claims depends on the circumstances of the individual case in the light of the claim as a whole and the invention described in the patent.
The court added that it had traditionally treated declarations of purpose in procedural claims such as those at issue in this case as restrictive. This is in contrast to apparatus or compositional claims, which the court has typically found non-limiting: “Preamble language that merely states the purpose or intended use of an invention is generally not treated as a limitation on the scope of the claim” wrote the CAFC, quoting Bicoin. The court pointed out, however, that it has occasionally found that declarations of purpose in claim preambles are also restrictive for device or composition claims “if the facts justify this”. The court then described its own jurisprudence as well as intrinsic evidence to support its view that the board’s finding that the preambles were restrictive was not incorrect.
Lilly also argued that the board’s claim constructions wrongly required evidence that a skilled craftsman had a reasonable expectation to achieve an outcome that was not claimed, which the court called “out of place” as it did the argument rejected that the preambles were non-limiting. The CAFC thus found no error in the board’s conclusion that “it is not necessary to demonstrate that the procedure mentioned would actually lead to the result mentioned, but rather to show that an average person skilled in the art would have reasonably expected that it would be carried out” recited method would produce the recited result. “
Regarding the allegation that PTAB had used the wrong yardstick to judge whether Tan and Olesen would have given a skilled craftsman a reasonable expectation of success, the court agreed with Teva that Lilly’s argument simply misunderstood the board’s decision. Finally, Lilly’s identification of a clue to prove that there was no uncertainty at the time as to whether migraine treatments had to cross the “blood-brain barrier” to be effective has failed, the court said. It added:
Both sides presented ample evidence on the blood-brain barrier, including references to the state of the art and expert opinions. The board weighed the evidence supporting either side of the factual dispute and found that there was still sufficient uncertainty and unpredictability – that is, Lilly’s evidence did not demonstrate sufficient certainty that migraine treatment does not need to cross the blood-brain barrier in order to a well-founded expectation of success for an experienced craftsman.
Two blows to Teva
In the second precedent decision issued today, affecting the two companies, the CAFC agreed with PTAB that a different set of claims relating to Teva’s US Patents 9,340,614 (“‘614 Patent”), 9,266,951 ( “‘951 patent”) and 9.890.210 (“‘ 210 patent”), were obviously not patentable compared to the cited prior art. These patents are directed to humanized antagonist antibodies that target CGRP itself rather than methods for using them. Andrew Hirshfeld, who performs the functions and duties of the USPTO director, was in this case due to an Arthrex v. Smith & Nephew challenge, which Teva eventually waived, also appointed as intervenor.
Lilly submitted a patent application to PTAB for various patent claims, claiming that they were obvious to the prior art references Tan and Queen (described above) and Wimalawansa. The latter is “a review article describing CGRP, including the history of its discovery, its molecular genetics and structure, its biological effects, and its therapeutic potential”.
The PTAB noted that the prior art disclosed or suggested every single limitation of the challenged claims that a person skilled in the art would have been motivated to combine the teachings of the prior art and have a reasonable expectation of successfully realizing the claimed invention.
Teva argued on appeal that the board had erred in law in its motivation to combine the analysis by deviating from the motivation claimed by Lilly in her IPR petitions. Lilly said in her petitions that “an experienced craftsman would have been motivated to combine the teachings of the references to produce a humanized anti-CGRP monoclonal antibody for therapeutic use in humans,” while the board “considered whether an experienced craftsman would motivate.” would have been”. only make the antibody to study or use, ”says Teva. But Lilly and the CAFC both essentially dismissed this as semantics. “The Board maintained its mandate to” base its decision on arguments put forward by one party “- namely by Lilly – and to which the opposing party – namely Teva -” was given the opportunity to respond “”, wrote the court. The court also dismissed Teva’s argument that the board of directors disregarded safety and efficacy concerns that were “demotivating factors” – that is, reasons a skilled craftsman would have been motivated not to make a humanized anti-CGRP monoclonal antibody, and said that Teva “missed” the grade. “The court stated:
The relevant investigation is not (as Teva suggests) whether the raised concerns were a reason not to use the claimed antibodies in the treatment of humans. Rather, the relevant question, which has been analyzed in detail by the board, is whether these concerns would have deterred a person skilled in the art from producing the claimed antibodies in order to investigate their therapeutic potential in the first place.
Alternatively, Teva argued that the board relied on “unsupported interpretations of individual statements in the prior art” to find motivation to study or use anti-CGRP antibodies. However, the court found that substantial evidence supported such motivation and that Lilly had identified evidence to support the “reasonable readings” of each reference by the PTAB. While Teva disagreed, of course, the court said:
When it comes to competing interpretations of the teachings of the prior art references, we must maintain the principle that “[i]If two ‘inconsistent conclusions can be drawn from the documented evidence, the PTAB’s decision to favor one conclusion over the other is the epitome of a decision that must be sustained when checked for substantial evidence.’ “… By this respectful standard In the review, we cannot replace the Board’s reasonable interpretation of the references with Teva’s interpretation.
Regarding Teva’s evidence of secondary considerations of non-obviousness, namely the AJOVY® product and Lilly’s Emgality® product, the court agreed with Teva that the Board of Directors in formulating the legal standard that contained the “presumption of connection” between a patent claim and a specific product (Fox Factory vs. SRAM), but ultimately said that there was no presumption of connection here. The court also found that Teva’s evidence for a license it had entered into with AlderBio Holdings, LLC and Alder Biopharmaceuticals, Inc. (AlderBio) that contained the challenged patents was insufficiently related to the challenged claims, as Teva did not more than the mere existence of the license, without any evidence that the motivation for concluding the license agreement had to do with the three challenged patents.
In a third decision, which had no precedent, the CAFC found three other Teva patents, US Patents 9,346,881 (“‘881 Patent”), 9,890,211 (“‘ 211 Patent”) and 8,597 .649 (“‘649 Patent”), apparently for the same reasons as given above with respect to the’ 614, ‘951, and’ 210 patents.