Skip to main content

Thank you for visiting You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.


Federal judge invalidates icosapent ethyl patents — but on the basis of a common statistical mistake

If the decision is allowed to stand, it will have major implications for pharmaceutical patents and biomedical innovation.

Access options

Rent or Buy article

Get time limited or full article access on ReadCube.


All prices are NET prices.


  1. 1.

    Du, M.M. United States District Court. District of Nevada. Case 2:16-cv-02525-MMD-NJK. Document 381 (30 March 2020).

  2. 2.

    Bays, H. E. et al. Am. J. Cardiol. 108, 682–690 (2011).

    CAS  Article  Google Scholar 

  3. 3.

    Bhatt, D. L. et al. N. Engl. J. Med. 380, 11–22 (2019).

    CAS  Article  Google Scholar 

  4. 4.

    Ford, R. A. Cornell Law Rev. 99, 71–128 (2013).

    Google Scholar 

  5. 5.

    Mori, T. A. et al. Am. J. Clin. Nutr. 71, 1085–1094 (2000).

    CAS  Article  Google Scholar 

  6. 6.

    Thryv, Inc. v. Click-To-Call Technologies, LP, 590 US (2020).

  7. 7.

    Mason, R. P., Libby, P. & Bhatt, D. L. Arterioscler. Thromb. Vasc. Biol. 40, 1135–1147 (2020).

    CAS  Article  Google Scholar 

Download references

Author information



Corresponding author

Correspondence to Gregory Curfman.

Ethics declarations

Competing interests

D.L.B. was the chair and international principal investigator of REDUCE-IT, with funding paid to Brigham and Women’s Hospital, and discloses the following relationships: advisory board: Cardax, Cereno Scientific, Elsevier Practice Update Cardiology, Level Ex, Medscape Cardiology, PhaseBio, PLx Pharma, Regado Biosciences; board of directors: Boston VA Research Institute, Society of Cardiovascular Patient Care, TobeSoft; chair: American Heart Association Quality Oversight Committee; data monitoring committees: Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Cleveland Clinic (including for the ExCEED trial, funded by Edwards), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo), Population Health Research Institute; honoraria: American College of Cardiology (senior associate editor, clinical trials and news,; vice-chair, ACC Accreditation Committee), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; clinical trial steering committee for RE-DUAL PCI, funded by Boehringer Ingelheim; executive committee for AEGIS-II, funded by CSL Behring), Belvoir Publications (editor in chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees, including for the PRONOUNCE trial, funded by Ferring Pharmaceuticals), HMP Global (editor in chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (guest editor, associate editor), Medtelligence/ReachMD (CME steering committees), Level Ex, MJH Life Sciences, Population Health Research Institute (operations committee, publications committee, steering committee and USA national co-leader for COMPASS, funded by Bayer), Slack Publications (chief medical editor, Cardiology Today’s Intervention), Society of Cardiovascular Patient Care (secretary/treasurer), WebMD (CME steering committees); other: Clinical Cardiology (deputy editor), NCDR-ACTION Registry Steering Committee (chair), VA CART Research and Publications Committee (chair); research funding: Abbott, Afimmune, Amarin, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Cardax, Chiesi, CSL Behring, Eisai, Ethicon, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Idorsia, Ironwood, Ischemix, Lexicon, Lilly, Medtronic, Pfizer, PhaseBio, PLx Pharma, Regeneron, Roche, Sanofi Aventis, Synaptic, The Medicines Company; royalties: Elsevier (editor, Cardiovascular Intervention: A Companion to Braunwald’s Heart Disease); site co-investigator: Biotronik, Boston Scientific, CSI, St. Jude Medical (now Abbott), Svelte; trustee: American College of Cardiology; unfunded research: FlowCo, Merck, Novo Nordisk, Takeda.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Curfman, G., Bhatt, D.L. & Pencina, M. Federal judge invalidates icosapent ethyl patents — but on the basis of a common statistical mistake. Nat Biotechnol 38, 939–941 (2020).

Download citation

Further reading


Quick links

Nature Briefing

Sign up for the Nature Briefing newsletter — what matters in science, free to your inbox daily.

Get the most important science stories of the day, free in your inbox. Sign up for Nature Briefing