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California Court of Appeals Decision Affects the Prostate Cancer Drug Market – Medivation Inc. v. Aragon Pharmaceuticals Inc.

Published online by Cambridge University Press:  06 January 2021

Yue (Amy) Han
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Type
Recent Case Developments
Information
American Journal of Law & Medicine , Volume 43 , Issue 4 , November 2017 , pp. 472 - 476
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2017

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References

1 Medivation Inc. v. Aragon Pharm., Inc., 2016 Cal. App. Unpub. LEXIS 6821, (Cal. App., Sept. 15, 2016).

2 Id. at *58.

3 Id. (stating that Jung and Sawyers adapted a molecule with a high binding quality that did not inhibit cancer growth, RU59063, by using a process of trial and error to change the atoms comprising the molecule).

4 Id. at *59 (finding that the JY-series changed the structure of RU59063 to form a pyrazolone, a 5-membered heterocycle containing two adjacent nitrogen atoms, in the molecule's center ring and the A-series substituted new atoms in the left ring of RU59063 to encourage binding).

5 Id.

6 Id. at *59-60.

7 Id. at *61.

8 “Licensed Product” is defined as “any … substance … covered by the claims of the Regents' Patent Rights or whose manufacture, use or sale would constitute an infringement of any claim within the Regents' Patent Rights.” Medivation, 2016 Cal. App. Unpub. LEXIS 6821, at *28.

9 “Field of Use” is defined as the treatment or prevention of disease using the compositions with the chemical structures identified in the Regents' Patent Rights, provided that Regents retains the right to use the compounds for commercial research as positive controls in drug discovery assays. Medivation, 2016 Cal. App. Unpub. LEXIS 6821, at *28-29.

10 Medivation, 2016 Cal. App. Unpub. LEXIS 6821, at *27-28.

11 Id. at *30.

12 Id. at *31.

13 “Subject Invention” is defined as an invention or discovery that was “first conceived and actually reduced to practice under this Agreement.” Medivation, 2016 Cal. App. Unpub. LEXIS 6821, at *6

14 The sponsor refers to Medivation who will pay $154,500 to sponsor the research. Medivation, 2016 Cal. App. Unpub. LEXIS 6821, at *5.

15 Medivation, 2016 Cal. App. Unpub. LEXIS 6821, at *41-43.

16 Id. at *9.

17 Id. at *68.

18 Id.

19 Id.

20 Id.

21 Medivation, 2016 Cal. App. Unpub. LEXIS 6821, at *27-28, at *70.

22 Id. at *68-69.

23 Id. at *12.

24 Id. at *11-12.

25 Id. at *14-15.

26 Id. at *15.

27 Medivation, 2016 Cal. App. Unpub. LEXIS 6821, at *27-28, at *16.

28 Id. at *18-19.

29 Id. at *19.

30 Id. at *20.

31 Id.

32 Id. at *21-22.

33 Medivation, 2016 Cal. App. Unpub. LEXIS 6821, at *27-28, at *22.

34 Id. at *34.

35 Id. at *39.

36 Id. at *44-45 (holding that A52 does not qualify as a subject invention under the SRA).

37 Id. at *54-55.

38 Id. at *81-92 (determining that prospective profits are not recoverable because they are speculative).

39 Medivation Inc. v. Aragon Pharm., Inc., 2016 Cal. LEXIS 10826, *1 (Cal., Dec. 14, 2016).

40 Crona, Daniel J. & Whang, Young E., Androgen Receptor-Dependent and -Independent Mechanisms Involved in Prostate Cancer Therapy Resistance, 9 Cancers 67, 67 (2017).CrossRefGoogle ScholarPubMed

41 Id.

42 Id. at 68.

43 Id.

44 Id. at 69-73.

45 See NIH U.S. National Library of Medicine, A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer, ClinicalTrials.gov (Sept. 26, 2017), https://clinicaltrials.gov/ct2/show/NCT01946204 [https://perma.cc/WD7H-HCS8] (finding that Aragon is sponsoring the clinical trial for apalutamide); XTANDI is an Androgen Receptor Inhibitor That Acts on Multiple Steps of the Androgen Receptor Signaling Pathway Within the Tumor Cell, Xtandi (enzalutamide) (2017), https://www.xtandihcp.com [https://perma.cc/M6BD-KFUV] (showing that the rights to Xtandi are owned by Astellas Pharma Inc. and Pfizer Oncology).

46 Crona & Whang, supra note 40, at 71 (stating that the tri-modal mechanism used by enzalutamide prevents disease progression by interfering with testosterone, a hormone that drives the disease).

47 Id. at 70.

48 Id. at 73.

49 Eric Palmer, Xtandi – Medivation and Astellas Pharma, FiercePharma (2013), http://www.fiercepharma.com/special-report/xtandi-medivation-and-astellas-pharma [https://perma.cc/G9F6-XMXQ].

50 Megan Brooks, FDA Grants Expanded Indication for Enzalutamide (Xtandi), Medscape (Sept. 11, 2014), http://www.medscape.com/viewarticle/831548; See Kate Johnson, FDA Approves Use of Prostate Cancer Pill Before Chemo, Medscape (Dec. 11, 2012), http://www.medscape.com/viewarticle/775977 (showing that the FDA approved Zytiga as a first-line therapy for metastatic CRPC in 2012); What is the Cost of Xtandi?, Prostate.net (May 24, 2013), https://prostate.net/articles/cost-of-xtandi [https://perma.cc/JVE6-KCJ2].

51 Jim Puzzanghera, Pfizer to Pay $14 Billion for Medivation, Whose Drug Xtandi was Discovered by UCLA, LA Times (Aug. 22, 2016, 6:25 PM), http://www.latimes.com/business/la-fi-pfizer-medivation-acquisition-20160822-snap-story.html [https://perma.cc/SAE6-FEA6].

52 J&J Expects to File for Approval to Market Two New Prostate Cancer Drugs, Prostate Cancer Infolink (May 18, 2017), https://prostatecancerinfolink.net/2017/05/18/jj-expects-to-file-for-approval-to-market-two-new-prostate-cancer-drugs/ [https://perma.cc/V2WQ-992C].

53 Id.

54 NIH U.S. National Library of Medicine, An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants with Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC), ClinicalTrials.gov (July 31, 2017), https://clinicaltrials.gov/ct2/show/NCT02257736 [https://perma.cc/TBB7-JV8B].