Orange Book Blog

I shared my thoughts on the Teva v. Lilly decision earlier this year, and it appears I continue to be in the minority of those who view this decision as a fact-intensive application of existing law giving deference to a jury verdict, rather than a sea-change in the law creating a separate standard for method of treatment claims.

However, I can’t blame anyone who takes the latter position, as numerous statements in the panel opinion can very reasonable be read in such a way.

Lilly petitioned for rehearing en banc. Unsurprisingly, Lilly framed the issue entirely as the panel setting out a distinct legal standard for method of treatment claims. In a bold and cleverly worded statement, Lilly framed the question as this: “Whether adding functional method-of-use limitations to otherwise non-enabled genus claims renders the claims enabled, as the panel held.”¹

The answer to Lilly’s question plainly must be “no.” While I’m sure prosecutors are already ensuring they are writing method of use genus claims, I don’t think anyone could reasonable defend that distinction as an end-around the holding of Amgen v. Sanofi and the established enablement and written description requirements.  

The problem I think Lilly will have is that there was no finding here that the genus of antibodies was not enabled or not adequately described—those claims were eliminated in IPR on obviousness grounds. Thus, Lilly is presenting something of a strawman argument.

While admittedly much of the language of the panel opinion focuses on the method of use aspect of the claims and certain sentences out of context seem to suggest that was the sole basis of its holding, the opinion also very clearly lays out why a reasonable jury could have found the genus of antibodies as “well-known” based on Lilly’s own IPR arguments. That language certainly seems to suggest that the panel did not conclude the genus of antibodies itself suffered from a lack of written description or enablement.

Indeed, nearly every page of the opinion described how the genus was “well-known.” See Panel Opinion at e.g., 4 (“Lilly maintained that, by November 2006, anti-CGRP antagonist antibodies ‘were well known in the art’—indeed, that the prior art was ‘replete with exemplary disclosures of anti-CGRP antagonist antibodies.’”), 9 (“circumstances like those here—where a claim pertains to a well-known genus”); 12-13 (“A reasonable jury could have found that anti-CGRP antagonist antibodies themselves and methods of making them were well known, replete, or extensively described in the prior art—based on Lilly’s own statements that they were ‘well known,’ ‘replete,’ or ‘extensively described’ in the prior art.”); 13 (“against a backdrop of antiCGRP antagonist antibodies (and methods of making them) being well known”); 14 (“As already discussed, a reasonable jury could have found that, by the priority date, (1) anti-CGRP antagonist antibodies and methods of making them were well known….”); 17 (“That is not the case here, where anti-CGRP antagonist antibodies were well known in the prior art and disclosed in the specification”); 17 (“a well-known genus”); 19 (“In both cases, the relevant point remains: a reasonable jury could have found that a skilled artisan reading the specification would have understood that anti-CGRP antagonist antibodies were well known (and disclosed)….”); 20 (“AbbVie did not involve the circumstances relevant here and in that precedent—i.e., a well-known genus…”); 23 (“In light of the well-known status of anti-CGRP antagonist antibodies… Given that anti-CGRP antagonist antibodies (and methods of making them) were already well known….”).

Lilly’s petition argued that the panel “invoked one perceived difference” from the Supreme Court’s recent decision in Amgen v. Sanofi: the claims reciting a method of treatment. While I would agree the panel’s first sentence distinguishing Amgen supports such a statement:

The asserted claims here are unlike the claims in Amgen and Baxalta, however, because they do not claim humanized anti-CGRP antagonist antibodies themselves; instead, they claim only the use of such antibodies for the different, limited purpose of treating headache. 

the panel’s opinion continues:

In light of the well-known status of anti-CGRP antagonist antibodies and the routine nature of humanization, the more relevant “research assignment” in this case would have been determining which humanized anti-CGRP antagonist antibodies treat headache.  See Amgen, 987 F.3d at 1084 (observing that the specification’s teachings must be “at least commensurate with the scope of the claims”).  That assignment was completed; the specification disclosed that all such antibodies work for that purpose.

Thus, the panel seemed to find a second key distinction as the Amgen case did not involve any factual finding that the genus was already well-known. Why the panel did not lead with this distinction is certainly puzzling, as it is the far more important distinction.

Lilly’s en banc petition also downplays another important point and distinction from Amgen: a jury heard the evidence and found Lilly had not proven lack of written description or enablement by clear and convincing evidence. Indeed, the entirety of Lilly’s acknowledgment of this fact is a single statement “Following a jury verdict for Teva, Appx4554-62, the district court granted JMOL for Lilly on enablement and written description.” Lilly’s petition never grapples with the standard it needed to meet to obtain JMOL, that “a reasonable jury could not have returned the verdict.” The petition does not even use the term reasonable, let alone explain how a reasonable jury could not credit Lilly’s own arguments regarding the well-known status of anti-CRGP agonists and conclude that there was therefore not clear and convincing evidence of a lack of enablement and a lack of written description.

As a side note, I have always found the invocation of JMOL following a jury verdict to be interesting, as by definition it requires a conclusion that the seated jury was “not reasonable.” It also seems that the Seventh Amendment guarantees a right to a jury trial, not necessarily a reasonable jury…. But that’s a topic for another time.

In sum, while I think Lilly makes excellent points about how one plausible reading of the Federal Circuit’s opinion would lead to an absurd result, I am not sure it shows that the ultimate conclusion of the panel was erroneous. Indeed, it is precisely because Lilly’s proposed reading of the opinion is so absurd that I think objectively the opinion must be read to be limited to the facts that the genus was described as “well-known” being sufficient for a reasonable jury to conclude there was not clear and convincing evidence of invalidity as the key holding.

It will be interesting to see if the Federal Circuit decides to clarify the opinion, as some amici have invited it to do. For example, in a joint brief filed by Amgen and Sanofi (the adverse litigants from the Supreme Court), the parties acknowledged “the Panel indicated that Lilly’s admissions could dictate the outcome of this case without distinguishing at all between composition of matter and method of treatment claims” and argued “the Court should limit its decision to these unique circumstances.”

I agree such clarification would be helpful. We’ll see if the Federal Circuit takes the invitation. On Monday it invited Teva to respond, and I expect we’ll see a very strong brief emphasizing the “well-known” aspect of the genus, which was already laid out in Teva’s opening brief to the court, which included sections such titled “Precedents concerning novel classes of antibodies or methods of using novel small-molecule drugs are not controlling with respect to novel methods of treatment using known classes of antibodies” and “The district court erred by treating this case as if it involves claims to a novel class of antibodies.”

¹ Lilly also raised a second question regarding whether a specification’s disclosure of species outside the scope of a claimed genus constitutes a disclosure of representative species that can provide written-description support, but that is a topic for a different article.