IP Law Daily Sanofi’s patents for insulin formulations invalid for obviousness
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Tuesday, November 19, 2019

Sanofi’s patents for insulin formulations invalid for obviousness

By Peter Reap, J.D., LL.M.

On appeal, challenges to the PTAB’s rulings on motivation to combine, reasonable expectation of success, and commercial success were rejected.

The Patent Trial and Appeal Board did not err in finding two patents owned by Sanofi-Aventis Deutschland GMBH which describe and claim certain formulations of a particular kind of insulin were unpatentable for obviousness, a divided U.S. Court of Appeals for the Federal Circuit has decided. The Board’s findings that a relevant artisan would have had a motivation to combine prior-art references to arrive at the claimed inventions with a reasonable expectation of success were supported by substantial evidence. Further, in light of the strength of the motivation to combine and reasonable expectation of success part of the obviousness analysis, Sanofi’s argument that its commercial-success evidence undermined the Board’s determination of obviousness was rejected (Sanofi-Aventis Deutschland GmbH v. Mylan Pharmaceuticals Inc., November 19, 2019, Taranto, R.).

Sanofi’s U.S. Patent Nos. 7,476,652 and 7,713,930 are for certain formulations of a particular kind of insulin. The ’930 patent issued from a continuation of the application that issued as the ’652 patent, and the two share a specification. The patents involve a genetically engineered form of insulin—insulin glargine (sometimes called simply "glargine")—identified in the patent as "Gly(A21)-Arg(B31)-Arg(B32)-human insulin." Sanofi first commercially sold glargine in the U.S. in May 2001, under the trade name Lantus®.

Mylan petitioned the USPTO for inter partes reviews of all claims of the ’652 and ’930 patents, arguing unpatentability for obviousness based on combining either the Lantus® Label or an article by Owens with one or more of three secondary references. The parties did not dispute that, for each claim, the asserted combinations of references teach every claim limitation. The main dispute was whether a relevant artisan would have been motivated to combine these references in the way claimed in the two patents at issue, with a reasonable expectation of success.

The Board issued two final written decisions determining that all claims in both patents are un-patentable for obviousness based on combinations of Lantus® Label or Owens with Lougheed, FASS, and/or Grau. The Board found that a relevant artisan would have been motivated to make the required combination based on a recognition that insulins had an aggregation problem in vials with air space and that surfactants (like the standard ones claimed here) offered a solution. The Board also determined that, given the prior art analysis, Sanofi’s evidence of commercial success was too weak to support a conclusion of nonobviousness. Sanofi appealed.

Motivation to combine. Sanofi challenged the Board’s finding of a motivation to combine the prior-art references to arrive at the claimed glargine formulation with certain surfactants. Sanofi first argued that the Board was required, under KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), to find in the prior art a recognition of an aggregation problem for glargine specifically, not just for insulins generally. In Sanofi’s view, KSR demands more than a factually supported finding that recognition of an aggregation risk for insulins generally would have motivated a relevant artisan to address aggregation for this particular insulin. The Federal Circuit was not persuaded.

The Board did not depart from KSR when it made, and relied on, findings that a relevant artisan would have recognized a potential aggregation-in-the-vial problem with glargine as part of the general recognition of aggregation problems with insulins. Nothing in KSR demands the kind of prior-art identifications of a problem at the level of specificity that Sanofi urged, the appellate court explained.

Sanofi also contended that the Board committed legal error when it cited the shared patent specification. Sanofi asserted that the Board’s reliance on this material was legally improper in light of the Federal Circuit’s longstanding recognition that a tribunal should not "look[] to knowledge taught by the inventor . . . and then use[] that knowledge against its teacher." Panduit Corp. v. Dennison Mfg. Co., 774 F.2d 1082, 1092 (Fed. Cir. 1985). But here, the PTAB did not violate that principle, the Federal Circuit said, because it did not use the specification for its teachings about the inventor’s discovery. Rather, it used the specification for its teachings about prior art knowledge, and that use of a specification was not just common, given patent drafters’ standard practice of reciting prior art in setting out the background of the invention, but permissible, according to the appellate court.

Finally, the Board’s finding of a motivation to combine was supported by substantial evidence. The Board’s findings with respect to the motivation to combine were detailed and well supported.

Reasonable expectation of success. Sanofi challenged the Board’s finding that a relevant artisan would have had a reasonable expectation of success in adding the claimed surfactants to the existing glargine preparation in the way claimed in the patents at issue here. It argued that the Board looked at insulins generally and did not make adequately supported findings about glargine specifically.

The Board began its reasonable expectation of success analysis by finding that a number of nonionic surfactants—including the claimed nonionic surfactants—were shown in the prior art to have been successfully used to prevent aggregation of various types of insulins and other peptides. The prior art supported this determination, the Federal Circuit observed. The Board also reasonably credited Mylan’s evidence that the presence of phenols in a glargine formulation would not have dissuaded a relevant artisan from expecting success in using nonionic surfactants. The Board did not expressly address Sanofi’s arguments about the potential for discoloration or peroxide formation, but the Board rejected them implicitly as bases for finding no reasonable expectation of success, according to the court. Sanofi failed to show that its evidence on these two particular potential consequences undermined the Board’s finding of a reasonable expectation of success.

Commercial success. Sanofi challenged the Board’s analysis of commercial success. The Board did not err in finding that Sanofi’s commercial success evidence was ultimately "weak" so as not to warrant an ultimate conclusion on obviousness different from the one strongly indicated by the motivation-to-combine and reasonable-expectation-of-success analysis, the appellate court opined.

The Board determined that Sanofi’s blocking patents made Sanofi’s commercial success with the modified Lantus® product—following its commercial success with the original Lantus® product—"weak" as evidence of obviousness. There was no reversible error in that ruling. The Federal Circuit has explained that the existence of a blocking patent in circumstances like those present here may deter non-owners and non-licensees of that patent from investing the resources needed to develop a later, "blocked" invention, because of the risk of infringement liability and associated monetary or injunctive remedies, and thus, depending on the record, justify discounting evidence of commercial success because the blocking patent can help explain why, for reasons other than non-obviousness, no one else arrived at the later patent’s improvement despite a potential economic benefit from meeting a market demand.

Dissent. In a dissenting opinion, Circuit Judge Pauline Newman argued that the majority "today enlarges the criteria of invalidity, to include hindsight analysis of foreseeability of the problem and its solution, citing information in the inventor’s patent specification as prior art against the invention." She claimed that by doing so, the court added to the unpredictability of judicial assessment of obviousness.

This case is Nos. 19-1368 and 19-1369.

Attorneys: Adam Banks (Weil, Gotshal & Manges LLP) for Sanofi-Aventis Deutschland. Douglas H. Carsten (Wilson, Sonsini, Goodrich & Rosati, PC) for Mylan Pharmaceuticals Inc.

Companies: Mylan Pharmaceuticals Inc.

MainStory: TopStory Patent FedCirNews

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