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From Antitrust Law Daily, November 5, 2018

Claims that Sanofi improperly listed patent, engaged in sham litigation fail again

By Nicole D. Prysby, J.D.

A federal district court in Boston has again rejected claims that drug manufacturer Sanofi-Aventis U.S. LLC improperly listed a patent in the FDA Orange Book and engaged in sham litigation for protection of its patents. It is not clear from FDA guidance whether drug delivery devices such as pen injectors should be listed in the Orange Book; therefore doing so was not objectively unreasonable. In addition, the litigation to enforce to patent was not sham litigation, based on the extensive litigation. The court also rejected new allegations added to the complaint, that Sanofi engaged in improper "serial petitioning." Even if Sanofi did not prevail on all aspects of lawsuit against alleged infringers, that did not demonstrate that the litigation was a sham. None of the lawsuits were individually baseless and Sanofi has a protective right to sue and defend colorable claims related to its listed patents. The court also found that whether it considered the antitrust allegations as an overall scheme of improper listings and improper litigations, or as individual actions of improper Orange Book listing and suing competitors, there was no change in the conclusion that the plaintiffs failed to state an antitrust claim. The plaintiffs have appealed the decision (In re Lantus Direct Purchaser Antitrust Litigation, October 24, 2018, Dein, J.).

The plaintiffs were two corporations that purchased insulin-glargine products from Sanofi, the manufacturer. They claimed Sanofi had improperly delayed the entry into market of a competitive product marketed by Eli Lilly, by improperly listing patents in the Orange Book, pursuing sham patent infringement litigation against Lilly, and engaging in a pattern of anticompetitive serial petitioning.

Sanofi is the holder of the original patent for insulin glargine, a patent that expired in 2015. Sanofi also obtained a patent for an injector pen (‘864) which expires in 2024 and relates to a "pre-drug-filled delivery device." It does not mention insulin glargine. Sanofi listed the pen ("Lantus SoloSTAR") patent in the Food and Drug Administration’s Orange Book. Lilly developed a competing injector-pen product for insulin glargine, which it planned to market as soon as Sanofi’s patent for insulin glargine expired in 2015. Just prior to FDA approval for Lilly’s injector-pen product, Sanofi filed a lawsuit, claiming infringement. Lilly and Sanofi settled their claims.

The plaintiffs argued that Sanofi improperly listed patent ‘864 in the Orange Book, as it was merely a package change and that Sanofi had no reasonable basis to believe that its patent claims were valid or that they were infringed. The plaintiffs’ complaint was dismissed in January 2018 and they filed a Second Amended Complaint (SAC) which the defendants again moved to dismiss.

Sherman Act. The plaintiffs asked the court to reconsider its prior holding that the complaint failed to state a claim that Sanofi unreasonably listed the ‘864 Patent in the Orange Book. The court again rejected the plaintiffs’ arguments, finding that they failed to show the decision to list the ‘864 patent was unreasonable. Although the plaintiffs expanded their argument as to why the ‘864 patent was for packaging only and precluded from being listed in the Orange Book, the court disagreed. The Lantus SoloSTAR was approved not merely as packaging, but as a drug product. The FDA’s position has been that insulin injector pens are considered "pre-filled drug delivery systems" and that "pre-filled drug delivery systems" are drug products for Orange Book listing purposes. Communications between the FDA and Sanofi may have discussed the SoloSTAR pen as "packaging," but only in the context of where to place the drug label. The FDA clearly approved SoloSTAR as a "disposable insulin injection device" and therefore a drug product for Orange Book purposes.

The plaintiffs repeated their assertion that since the ‘864 Patent does not expressly mention Lantus, Lantus SoloSTAR, or insulin glargine, it is improper to list it in the Orange Book as claiming Lantus SoloSTAR. Again, the court disagreed. The FDA’s guidance regarding what a patent must expressly claim is ambiguous and is reasonably read to allow for the listing of the ‘864 Patent, because it has interpreted "drug products" for which patents must be listed in the Orange Book, to include "pre-filled drug delivery systems." There has been some confusion on the issue. For example, in 2011, the FDA stated that it has been unable to reach a decision on whether a patent that claims a drug delivery device whose use is integral to the administration of the active ingredient, but that does not claim the active ingredient of the approved drug product, should be submitted for listing in the Orange Book. But the confusion on the issue supports Sanofi’s position that the ambiguous listing requirements allow for its interpretation permitting the listing of the ‘864 Patent.

The court also declined to reconsider its prior decision on the sham litigation issue. The plaintiffs amended their complaint to allege that based on the differences in the products, Sanofi could not reasonably have expected that it would prevail in its infringement case. They also alleged that other actions of Sanofi contradicted its position that the KwikPen infringed Sanofi’s patents. Sanofi did not sue Lilly immediately after the KwikPen was first marketed and in a different context, asserted that Lilly’s patent was unenforceable. But the court found it did not matter if Sanofi was likely to prevail at trial—if it had even a colorable claim of infringement, it is afforded Noerr-Pennington immunity. The litigation between Sanofi and Lilly was extensive, which negated the assertion that no reasonable pharmaceutical company would expect to succeed on the infringement claims.

The plaintiffs added allegations related to serial petitioning. They argued that Sanofi has filed two additional lawsuits, which, when assessed in connection with the Lilly lawsuit, constitute a pattern of anticompetitive petitioning for which Sanofi is independently liable under federal antitrust law. The court rejected that argument. Even if Sanofi did not prevail on all aspects of the cases, that did not demonstrate that the litigation was a sham. None of the lawsuits were individually baseless and Sanofi has a protective right to sue and defend colorable claims related to its listed patents.

The court also found that the allegations failed for lack of causation. Because the ‘864 Patent and settlement based on the patent barred Lilly’s entry into the market and because the serial petitioning claims were dismissed, there was no evidence that Sanofi caused any market delay after 2016.

Finally, the court noted that whether it considered the antitrust allegations as an overall scheme of improper listings and improper litigations, or as individual actions of improper Orange Book listing and suing competitors, there was no change in the conclusion that the plaintiffs failed to state an antitrust claim.

The case is No. 16-12652-JGD.

Attorneys: David P. Germaine (Vanek Vickers & Masini PC) for FWK Holdings LLC. Linda P. Nussbaum (Nussbaum Law Group, PC) for Cesar Castillo, Inc. Alisha M. Crovetto (Jones Day) for Sanofi-Aventis US, LLC.

Companies: FWK Holdings LLC; Cesar Castillo, Inc.; Sanofi-Aventis US, LLC

MainStory: TopStory Antitrust MassachusettsNews

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