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Successful Strategies for Diagnostic Method Patents

Alan Douglas Miller, Brian Amos


This article addresses strategies used to obtain patent protection for diagnostic method patents after the 2012 Mayo decision by the U.S. Supreme Court.


USPTO, patents, diagnostics, patentability, 35USC§101

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Mayo Collaborative Services v. Prometheus Laboratories, Inc. 132 S. Ct. 1289 (2012).

Ledford, H. (2016) US personalized-medicine industry takes hit from Supreme Court. Nature 536 (Issue 7617): 382.

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United States Code (U.S.C.) Title 35, Section 102.

35 U.S.C. §103.

35 U.S.C. §112.

Diamond v. Diehr, 450 U. S. 175, 187 (1981).

U.S. Patent No. 6,258,540 B1, issued July 10, 2001, Lo et al., Non-invasive prenatal diagnosis.

Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015).

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Macedo, C.R. and Hudak, S.A. (2016) ARE Patent Law Alert:

USPTO Updates Guidance on Patent Subject Matter Eligibility as Federal Circuit Continues to Issue Decisions Finding Patents Eligible under 35 U.S.C. § 101.

U.S. patents can be searched at the U.S. Patent Office website:

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Pfizer v. Ranbaxy, 457 F.3d 1284 (Fed. Cir. 2006).

Quinn, G. (2017) IPO adopts resolution supporting legislation to amend 35 U.S.C. § 101. IPWatchdog®.

Amos B. and Miller A.D. (2017) European and U.S. Patents - A Different Diagnosis, manuscript submitted for publication.


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