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In the Aftermath of the “Myriad Case” – Myriad Is Denied Preliminary Injunction Against Ambry Genetics

Published online by Cambridge University Press:  20 January 2017

Emanuela Gambini
Emanuela Gambini*
Affiliation:
Queen Mary - University of London
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Abstract

On March 10, 2014, the U.S. District Court of Utah, Central Division, decided in University of Utah Research Foundation, et al., v. Ambry Genetics Corporation, holding that “Plaintiffs are not entitled to a preliminary injunction”, as they “are unable to establish that they are likely to succeed on the merits of the claims” nor “that the equitable factors support issuance of the requested injunction”.

This case note gives an overview of the U.S. District Court's of Utah memorandum decision and order denying plaintiffs’ motion for preliminary injunction and discusses its implications for the implementation of the criterion of isolation to “synthetic” DNA sequences, such as primers and probes.

Type
Case Notes
Information
European Journal of Risk Regulation , Volume 5 , Issue 3 , September 2014 , pp. 407 - 412
Copyright
Copyright © Cambridge University Press 2014

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References

1 See In the United States District Court of Utah, Central Division, University of Utah Research Foundation, et al., v. Ambry Genetics Corporation, Memorandum Decision and Order Denying Plaintiffs’ Motion for Preliminary Injunction, 10 March 2014, available on the Internet at <https://ecf.utd.uscourts.gov/cgi-bin/show_public_doc?214md2510-7> (last accessed on 25 June 2014).

2 See Supre

3 Ibid., at p. 2.me Court of the United States, Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al., 13 June 2013, 569 U.S. 12-398 (2013), available on the Internet at <http://www.supremecourt.gov/opinions/12pdf/12-398_1b7d.pdf> (last accessed on 25 June 2014).

4 In the United States District Court for the District of Utah, Central Division, University of Utah Research Foundation, et al., v. Ambry Genetics Corporation, Motion for Preliminary Injunctive Relief and Memorandum in Support, 9 July 2013, available on the Internet at <https://archive.org/details/726487-gov-uscourts-utd-89779-5-0> (last accessed on 25 June 2014), at p. 4.

5 See “BRCA Patent Owners and Gene by Gene, Ltd. Resolve Patent Suit”, available on the Internet at <http://investor.myriad.com/releasedetail.cfm?ReleaseID=824154> (last accessed on 25 June 2014).

6 Title 35 U.S.C. § 283 Injunction, available on the Internet at <http://uscode.house.gov/view.xhtml?path=/prelim@title35/part3&edition=prelim> (last accessed on 25 June 2014).

7 In the United States District Court of Utah, Central Division, University of Utah Research Foundation, et al., v. Ambry Genetics Corporation, Memorandum Decision and Order Denying Plaintiffs’ Motion for Preliminary Injunction, supra note 1, at p. 55.

8 In the United States District Court for the District of Utah, Central Division, University of Utah Research Foundation, et al., v. Ambry Genetics Corporation, Motion for Preliminary Injunctive Relief and Memorandum in Support, supra note 4, at p. 30.

9 In the United States District Court of Utah, Central Division, University of Utah Research Foundation, et al., v. Ambry Genetics Corporation, Memorandum Decision and Order Denying Plaintiffs’ Motion for Preliminary Injunction, supra note 1, at p. 60.

10 Claims 16 and 17 of the ‘282 Patent and claims 29 and 30 of the ’492 Patent. See In the United States District Court of Utah, Central Division, University of Utah Research Foundation, et al., v. Ambry Genetics Corporation, Memorandum Decision and Order Denying Plaintiffs’ Motion for Preliminary Injunction, supra note 1, at p. 49.

11 Claims 7 and 8 of the ‘441 Patent; claim 4 of the ‘857 Patent; claim 5 of the ‘721 Patent; claims 2 and 4 of the ‘155 Patent. Ibid., at pp. 50-54.

12 Ibid., at p. 13.

13 Ibid., at p. 49.

14 Ibid., at p. 15.

15 In the United States District Court of Utah, Central Division, University of Utah Research Foundation, et al., v. Ambry Genetics Corporation, Plaintiffs’ Reply Memorandum in Support of Motion for Preliminary Injunctive Relief, available on the Internet at <https://archive.org/details/726487-gov-uscourts-utd-89779-5-0> (last accessed on 15 April 2014), at p. 40.

16 In the United States District Court of Utah, Central Division, University of Utah Research Foundation, et al., v. Ambry Genetics Corporation, Memorandum Decision and Order Denying Plaintiffs’ Motion for Preliminary Injunction, supra note 1, at p. 75.

17 Ibid., at p. 78.

18 Ibid., at p. 75.

19 Ibid., at p. 76.

20 See Supreme Court of the United States, Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al., supra note 2, at pp. 14-15.

21 U.S. Supreme Court, Diamond v. Chakrabarty, 447 U.S. 303, 16 June 1980, available on the Internet at <http://caselaw.lp.findlaw.com/scripts/getcase.pl?court=us&vol=447&invol=303> (last accessed on 25 June 2014).

22 In the United States District Court of Utah, Central Division, University of Utah Research Foundation, et al., v. Ambry Genetics Corporation, Memorandum Decision and Order Denying Plaintiffs’ Motion for Preliminary Injunction, supra note 1, at p. 83.

23 Ibid., at p. 85.

24 U.S. Supreme Court, Mayo Collaborative Services, Mayo Medical Laboratories, et al. v. Prometheus Laboratories, Inc., 566 U.S. (2012), 20 March 2012, available on the Internet at <http://www.supremecourt.gov/opinions/11pdf/10-1150.pdf> (last accessed on 25 June 2012), at p. 1334.

25 Ibid., at p. 1294.

26 Ibid.

27 In the United States District Court for the District of Utah, Central Division, University of Utah Research Foundation, et al., v. Ambry Genetics Corporation, Motion for Preliminary Injunctive Relief and Memorandum in Support, 9 July 2013, supra note 4, at p. 16.

28 In the United States District Court of Utah, Central Division, University of Utah Research Foundation, et al., v. Ambry Genetics Corporation, Plaintiffs’ Reply Memorandum in Support of Motion for Preliminary Injunctive Relief, supra note 15, at pp. 56-57.

29 U.S. District Court for the Northern District of California, Ariosa Diagnostic, Inc. v. Sequenom, Inc., 30 October 2013, available on the Internet at <http://docs.justia.com/cases/federal/district-courts/california/candce/3:2011cv06391/249148/254> (last accessed on 25 June 2014).

30 In the United States District Court of Utah, Central Division, University of Utah Research Foundation, et al., v. Ambry Genetics Corporation, Memorandum Decision and Order Denying Plaintiffs’ Motion for Preliminary Injunction, supra note 1, at p. 98.

31 Ibid., at p. 106.

32 USPTO, Utility Examination Guidelines, 5 January 2001, available on the Internet at http://www.uspto.gov/web/offices/com/sol/notices/utilexmguide.pdf (last accessed on 25 June 2014).

33 USPTO, Memorandum on the Supreme Court Decision in Association for Molecular Pathology v. Myriad Genetics, Inc., 13 June 2013, available on the Internet at <http://www.uspto.gov/patents/law/exam/myriad_20130613.pdf> (last accessed on 31 March 2014).

34 USPTO, Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws Of Nature, Natural Phenomena & Natural Products, 4 March 2014, available on the Internet at <http://www.uspto.gov/patents/law/exam/myriad-mayo_guidance.pdf> (last accessed on 25 June 2014).

35 USPTO, Memorandum on the Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws Of Nature, Natural Phenomena & Natural Products, 4 March 2014, available on the Internet at <http://www.uspto.gov/patents/law/exam/myriad-mayo_guidance.pdf> (last accessed on 25 June 2014).

36 Ibid.

37 Ibid., at p. 4.