Improper Listing of Insulin-Pen Patents in the Orange Book

In re Lantus Direct Purchaser Antitrust Litig., 18-2086, 2020 WL 728628 (1st Cir. Feb. 13, 2020)

This class-action antitrust decision from the 1st Circuit reversed a lower court dismissal — holding that consumers had alleged sufficient injury based upon Sanofi’s improper listing of patents in the FDA Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations).

The court explains:

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 FDA statute calls for listing of patents “which claim[ ] the drug for which [an application is submitted] or which claim[ ] a method of using such drug.” 21 U.S.C. § 355(b)(1).

Here, the listed patent at issue is US Patent 8,556,864 which covers the drive mechanism for Sanofi’s SoloSTAR Insulin Pen.  The Orange Book listing is important because it can be used to trigger a 30-month stay of FDA approval of a competitor’s product. The drive mechanism is apparently part of the SoloSTAR pen thus it appears that a generic knock-off competitor would infringe the patent.  But, the appellate panel still held that it was improperly listed in the orange book since the patent does not claim the drug or a method of using the drug. The court writes:

[B]ecause the claims of the ‘864 patent do not mention the drug for which the sNDA was submitted, the patent does not “claim the drug,” and it was improper for Sanofi to have submitted it for listing in the Orange Book as a drug claiming either insulin glargine or the Lantus SoloSTAR. The regulations clearly require a patent not to be submitted if it does not claim the drug for which the application was filed: “For patents that claim a drug product, the applicant must submit information only on those patents that claim the drug product, as is defined in § 314.3, that is described in the pending or approved NDA.” 21 C.F.R. § 314.53(b)(1) (emphasis added).

On remand, the district court will take-up the case again and likely focus on whether the improper listing actually caused harm to consumers.



9 thoughts on “Improper Listing of Insulin-Pen Patents in the Orange Book

  1. 1

    OT, but Eric Schmidt has an article in the NY Times. Surreal. One of the prime people to burn down the patent system telling us Google needs the federal government’s help.

    1. 1.1

      link to

      Basically, the person that decimated the innovation engine by decimating patents is now saying that the innovation engine needs help through federal funding.


    2. 1.2

      So let’s just end patents that have been the innovation engine of the USA including the founding of Google and then tell Congress that we Google can innovate and we don’t need no stin king patents. And then say what we really need is some help with that there innovation by beefed up spending by the federal government on innovation.

      All the while we have bank accounts that are bursting with 10’s of billions of dollars.

      1. 1.2.1

        With the likes of Citizens United, Corporatocracy may feel that it is ‘safe’ to ‘bow’ to their (bought) government, even as that government appears to be in a tug of war between neo-fascism and neo-socialism. In part no doubt to the fact that both sides of the aisle have been $poken to.

        Corporatocracy’s money is (from a Rational Actor’s point of view) better spent on buying influence than any direct paying for innovation. Pace of innovation pales to control for established entities.


          Jimmy Carter understood that a strong patent system forced even corporations with near monopolistic power to innovate or they would face replacement.

          What has happened is Google has hurt innovation in the USA and as a monopoly or near monopoly it does not matter to them in the USA. But–outside the USA where China is using patents to create their own innovation engine, then it matters.

          So what does Google do? They have crippled the innovation engine that could have kept them alive and outside the USA a new challenger arises.


      2. 1.2.2

        “And then say what we really need is some help with that there innovation by beefed up spending by the federal government on innovation.”

        Literally a leftist corporatist plot if true lol.

    3. 1.3

      And the people that he is most afraid of is China. How is China trying to become more innovative? Patents.

      Just unbelievable. No sha me. A Mark Lemley like character. (Just give me all the money as I burn down all that exists ’cause ’cause.)

      1. 1.3.1

        Turning away from Mr. Schmidt for a moment, it may be worthwhile to note that it is the established Democratic Party that is most afraid of a “Bernie Nomination.”

        Not a peep from the other side of the aisle. In fact, the other side appears to be salivating at the prospect.

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