Bayh-Dole Act: Failing to Disclose Government Funding

Interesting filing from the folks at KEI. That alleges IONIS Pharma (formerly ISIS) and Cold Springs Harbor Labs failed to disclose Federal funding supported development of the inventions underlying their patents covering nusinersen and its for the treatment of spinal muscular atrophy (SMA).  See U.S. Patent Nos. 8,361,977 and 8,980,853.

The Bayh-Dole Act allows private entities to patent inventions developed through federal funding. However, the law requires that the federal funding be disclosed in order to allow the Government to understand and exercise its corresponding rights.

An entity that fails to disclose the funding is then subject to the penalty of title being awarded to the U.S. government – although the Government must demand title.  “The Federal Government may receive title to any subject invention not disclosed to it within such time.” 35 U.S.C. § 202(c)(1).

The KEI filing is in the form of a letter to Inspector General of HHS (parent of NIH) asking for an investigation and action.

Read the Filing: [18jan2017-oig-investigation-request-nusinersen-patents]

If the new Trump Administration is serious about high drug prices, this may be a place to start.  Nusinersen is priced at $750,000 for the first year of treatment and $375,000 for every year thereafter.


6 thoughts on “Bayh-Dole Act: Failing to Disclose Government Funding

  1. 5

    If this eviscerates income for the assignees and Biogen, do you think the prosecuting law firm could find itself facing a malpractice suit?

  2. 4

    The above comments do not appear to relate to this specific article. This article concerns the substantive requirements of the BD Act and it’s implementing regulations.

    1. 3.1

      I’m predicting victory for the government here, with a possible split (Thomas didn’t ask any questions, of course).

      JUSTICE KENNEDY: You want us to say that trademark law is just like a public park — the public park, a public forum, the classic example of where you
      can say anything you want. We treat this — we treat trademarks just like we treat speech in a public park. Thank you very much. Good-bye. That’s it. That’s your

      MR. CONNELL: It — it is my argument. I think the limitation on that, as I said before, are the categories of historically prescribable speech.

      JUSTICE KAGAN: Well, Mr. Connell, this can’t be right …. There’s something different here, in other words, that this is coming up in the context of a government program which provides certain benefits that the government doesn’t have to provide at all.

      CHIEF JUSTICE ROBERTS: [I]t seems to me that you [the Slant’s attorney] are defining the government program differently than the government would.

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