Court Finds Sanofi Improperly Listed Insulin Device Patent in FDA’s Orange Book

Regulatory NewsRegulatory News | 17 February 2020 |  By 

The US Court of Appeals for the First Circuit last week ruled that Sanofi improperly submitted a patent for its insulin device in the US Food and Drug Administration’s (FDA) Orange Book and could potentially be held liable for extending its monopoly.

The case concerns Sanofi’s insulin glargine product Lantus, which first won FDA approval in 2000, and pulled in almost $8 billion in US sales in 2014.

With its original application, Sanofi submitted a patent for listing in the Orange Book, which claimed the drug insulin glargine, and which was sold only in vials or cartridges for reusable injectors. That patent, according to court documents, was set to expire in August 2014, although Lantus’ period of regulatory exclusivity extended to February 2015. Had Sanofi filed nothing else with FDA, insulin glargine competitors could have hit the market in 2015.

But in 2006, Sanofi filed a supplemental application with FDA to sell insulin glargine in a disposable injector pen device, called the Lantus SoloSTAR. In 2007, the FDA accepted this supplement for the SoloSTAR and categorized it as a change to Lantus's labeling or container.

Six years later, in 2013, Sanofi submitted patents associated with the SoloSTAR to FDA for listing in the Orange Book. The complaint references a number of those patents, but they were pared down to one patent named, "Drive Mechanisms Suitable for Use in Drug Delivery Devices," which is set to expire in 2024.

Also in 2013, competitor Eli Lilly planned to market a competing insulin glargine product, called Basaglar, in its own injector pen, known as the KwikPen. Confronted with the Orange Book listing of the device patent, Lilly submitted a Paragraph IV certification stating that its Basaglar KwikPen product would not infringe that patent.

But within 45 days of Lilly’s submission, Sanofi sued Lilly for patent infringement, which triggered the 30-month stay of FDA approval for Basaglar. Sanofi and Lilly in September 2015 settled the suit and Basaglar was approved by FDA in December 2015, but the competitor did not hit the market until a year later as Sanofi granted Lilly a royalty-bearing license to sell Basaglar beginning in December 2016.

In 2016 and 2017, Merck and Mylan also submitted applications to market insulin glargine in injector pens, along with Paragraph IV certifications on the patents that Sanofi had listed for the Lantus SoloSTAR. After it settled with Lilly, Sanofi also sued Merck, which ended up halting its work on insulin glargine altogether, and Mylan, which received a complete response letter last August.

The plaintiffs in this case, who are direct insulin glargine purchasers, allege that Sanofi artificially restricted competition in the market for insulin glargine through the use of this improperly listed device patent.

And indeed, the appeals court finds that the statute and regulations “clearly require that only patents that claim the drug for which the NDA [new drug application] is submitted should be listed in the Orange Book.” But this Sanofi device patent, which neither claims nor mentions insulin glargine or the Lantus SoloSTAR, “does not fit the bill.”

In addition, although Sanofi argues that the regulations require listing in the Orange Book any patents that contain "integral components" of an approved drug, the court says, “We see nothing in the statute or regulations that welcomes such a further expansion of the already stretched statutory terms, whereby an integral part of an injector pen becomes the pen itself, and in turn is a drug. One would not think, for example, that a patent claiming only a transmission system must be read as also claiming any car in which it is used.”

The opinion also points out how FDA has passed up opportunities to stretch the statutory terms in this way. And FDA does not police the accuracy of an applicant's contention that a patent claims a drug, nor does the agency claim to have any special expertise in construing patents, the opinion adds.

“The principal questions posed on this appeal are whether Sanofi improperly submitted a patent for listing in the Orange Book and, if so, whether Sanofi is potentially liable under the antitrust laws to drug purchasers who were allegedly harmed by the effective extension of Sanofi's monopoly. We answer ‘yes’ to both questions and vacate the dismissal of the plaintiffs' complaint to the extent that the district court held otherwise,” the opinion says.


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