Ariosa v. Sequenom : The End of Precision Medicine? Hassen A. Sayeed, M.D. March 29, 2016 Presented To New York Pharma Forum This presentation represents solely the personal views of the author. It should not be construed as legal advice or a legal opinion on any specific facts or circumstances. This information is not intended to create, and receipt of it does not constitute a lawyer- client relationship. The contents are intended for general informational purposes only, and you are urged to consult your own lawyer concerning your own situation and any specific legal questions you may have. ROPES & GRAY LLP
Disclaimer This presentation represents solely the personal views of the author and does not reflect the view of Ropes & Gray LLP or any of its clients. It should not be construed as legal advice or a legal opinion on any specific facts or circumstances. This information is not intended to create, and receipt of it does not constitute, a lawyer-client relationship. The contents are intended for general informational purposes only, and you are urged to consult your own lawyer concerning your own situation and any specific legal questions you may have. While every attempt was made to insure that these materials are accurate, errors or omissions may be contained therein, for which any liability is disclaimed. ROPES & GRAY
Agenda • Why Does Precision Medicine Matter? • How Has The Patent System Endangered It? • What Does The Future Hold? ROPES & GRAY
Agenda • Why Does Precision Medicine Matter? • How Has The Patent System Endangered It? • What Does The Future Hold? ROPES & GRAY
The Age Of “Imprecision” Medicine? • The top ten-highest drugs in the United States help between 1 in 25 and 1 in 4 of the people who take them • For some drugs, such as statins, as few as 1 in 50 may benefit • The US announced a $215 million national Precision Medicine Initiative in January 2015 • Includes the establishment of a national database of the genetic data of one million people Source: Nature Comment, “Personalized Medicine: Time for one - person trials”, Nichols J. Schork , Nature 520, 609-611 (30 April 2015), available at: http://www.nature.com/news/perosnalized-medicine-time-for-one- ROPES & GRAY person-trials-1.17411
The “One -Size-Fits- All” Drug Regime Fails Many Patients Source of data: Spear, B.B., Heath-Chiozzi, M., & Huff, J. (2001). Clinical application of pharmacogenetics. TRENDS in Molecular Medicine, 7(5), 201-204.); graphic from: ROPES & GRAY http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/PersonalizedMedicine/UCM372421.pdf
What Is Precision Medicine? • Also known as: “Personalized Medicine”, “Targeted Medicine”, “Stratified Medicine” • The use of molecular analysis to better manage disease or predisposition to disease • Generally involves the use a diagnostic device and a therapeutic product to tailor treatment • Pharmacogenomics (the study of DNA and RNA variation and effect on treatment response) is a critically important area of precision medicine ROPES & GRAY
Agenda • Why Does Precision Medicine Matter? • How Has The Patent System Endangered It? • What Does The Future Hold? ROPES & GRAY
What Is Patentable Subject Matter? • 35 U.S.C. § 101: – “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title” • Exception to Section 101 patentability: – Laws of nature, natural phenomenon, and abstract ideas – Logic of pre-emption ROPES & GRAY
The Application Of Section 101 • Three key legal opinions have narrowed what Section 101 means in the context of life sciences – Mayo v. Prometheus Labs , 132 S.Ct. 1289 (2012) – Ass’n Molecular Pathology v. Myriad , 133 S.Ct. 2107 (2013) – Ariosa Diagnostics, Inc. v. Sequenom Inc ., 788 F.3d 1371 (Fed. Cir. 2015) ROPES & GRAY
Patentability Of Diagnostic Methods • Mayo v. Prometheus Labs (2012) – Method of determining proper dosage of drug is not patentable subject matter – Set forth a two-part test for evaluating patentability • (1) Are the patent claims directed to a non-patentable law of nature, algorithm or natural phenomenon? • (2) If so, do the additional elements of the claim “add enough to their statements of the correlations to allow the processes they describe to qualify as patent eligible processes that apply natural laws” or are the additional elements routine, well-understood, and conventional? ROPES & GRAY
Patentability Of Diagnostic Methods Representative claim A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising: (a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and (b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder, wherein the level of 6-thioguanine less than about 230 pmol per 8x10 8 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of 6-thioguanine greater than about 400 pmol per 8x10 8 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject. 11 ROPES & GRAY
Patentability Of A Natural Product • Ass’n Molecular Pathology v. Myriad (2013) – Naturally occurring DNA segment, even when isolated from the body, is a non-patentable product of nature – cDNA was patent eligible subject matter since the removal of the unwanted codes created something new (i.e., no longer a product of nature) ROPES & GRAY
Patentability Of A Diagnostic Method Incorporating A Natural Product • Ariosa Diagnostics, Inc. v. Sequenom Inc. (2015) – U.S. Patent No. 6,258,540 (the “’540 patent”) titled “Non - Invasive Prenatal Diagnosis” – Sequenom‘s ’540 patent was based on the discovery that cell- free fetal DNA (“cffDNA”) can be detected in maternal serum and plasma samples – Claimed methods for detecting paternally inherited nucleic acid of fetal origin in maternal serum, blood or plasma – Marketed as MaterniT21 ROPES & GRAY
Ariosa Diagnostics, Inc. et al. v. Sequenom Inc. et al. • Representative claims--USP 6,258,540 1. A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises amplifying a paternally inherited nucleic acid from the serum or plasma sample and detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample. 25. A method for performing a prenatal diagnosis on a maternal blood sample, which method comprises obtaining a non-cellular fraction of the blood sample amplifying a paternally inherited nucleic acid from the non-cellular fraction and performing nucleic acid analysis on the amplified nucleic acid to detect paternally inherited fetal nucleic acid. 14 ROPES & GRAY
Ariosa v. Sequenom The Federal Circuit Decision • On June 12, 2015 the Federal Circuit found the claims unpatentable (as had the District Court) – Authored by J. Reyna and joined by J. Linn and J. Wallach The decision applied the two step test for patent • eligibility set forth in Mayo ROPES & GRAY
Ariosa v. Sequenom The Federal Circuit Decision • Step 1: The ’540 claims are directed to naturally occurring phenomenon – “ It is undisputed that the existence of cffDNA in maternal blood is a natural phenomenon . Sequenom does not contend that [the inventors] created or altered any of the genetic information encoded in the cffDNA, and it is undisputed that the nucleic acids existed in nature before [the inventors] found them. The method ends with paternally inherited cffDNA, which is also a natural phenomenon. The method therefore begins and ends with a natural phenomenon. Thus, the claims are directed to a thing that is naturally occurring .” ROPES & GRAY
Ariosa v. Sequenom The Federal Circuit Decision • Step 2: Practicing of the claimed methods does not result in an inventive concept – “Sequenom contends that the claimed methods are patent eligible applications of a natural phenomenon, specifically a method for detecting paternally inherited cffDNA. Using methods like PCR to amplify and detect cffDNA was well- understood, routine, and conventional activity . . . . Because the method steps were well-understood, conventional and routine, the method of detecting paternally inherited cffDNA is not new and useful . The only subject matter new and useful as of the date of the application was the discovery of the presence of cffDNA in maternal plasma or serum.” ROPES & GRAY
Ariosa v. Sequenom The Federal Circuit Decision • The Federal Circuit rejected Sequenom’s argument that its methods were patentable because they did not preempt every use of cffDNA – “While preemption may signal patent ineligible subject matter, the absence of complete preemption does not demonstrate patent eligibility . In this case, Sequenom’s attempt to limit the breadth of the claims by showing alternative uses of cffDNA outside of the scope of the does not change the conclusion that the claims are directed to patent ineligible subject matter.” ROPES & GRAY
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