We think you have liked this presentation. If you wish to download it, please recommend it to your friends in any social system. Share buttons are a little bit lower. Thank you!
Presentation is loading. Please wait.
Published byIsaiah Rustin
Modified about 1 year ago
© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved. Patenting Biomarkers and Diagnostic Methods Neil P. Shull, Ph.D., J.D. S TERNE, K ESSLER, G OLDSTEIN & F OX P.L.L.C. F.I.R.E. Series LXIX March 8, 2012
© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.. Overview of issues What can be patented? Is it useful? How much data is needed? Potential prior art issues What should be claimed? Who would infringe? 2
© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.. Biomarkers Proteins and their isoforms Gene expression products (mRNA) Genetic abnormalities (mutations, SNP’s, chromosomal anomalies) Metabolites (drugs, endogenous) Small RNAs 3
© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.. Focus On Claims “The U.S. is strictly an examination country and the main purpose of the examination, to which every application is subjected, is to try to make sure that what each claim defines is patentable. To coin a phrase, the name of the game is the claim.” Giles Sutherland Rich*, Extent of Protection and Interpretation of Claims, American Perspectives, 21 Int’l Rev. Indus. Prop. & Copyright L. 497, 499 (1990) (emphasis added). * Born in Rochester 4
© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.. What to claim The biomarker itself, in isolated form –Nucleic acid, peptide, small molecule Methods of diagnosis –Correlate the presence/absence of a biomarker with a diagnosis Apparatus –Arrays –Computer readable medium 5
© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.. Examples U.S. Patent 8,114,590 – Regents of University of California 1. A method for determining a prognosis of a patient with chronic lymphocytic leukemia (CLL) comprising: (a) obtaining a biological sample of the patient comprising lymphocytes; (b) determining the sample expression level of phosphodiesterase 7B (PDE7B); (c) comparing the expression level of PDE7B in the patient sample relative to a baseline expression level of said PDE7B; and (d) associating a higher relative patient PDE7B expression level with a higher risk course of CLL, thereby determining the prognosis of the patient with CLL. 6
© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.. Examples U.S. Patent 8,076,089 - Industrial Technology Research Institute (TW) 1. A method of detecting liver cirrhosis or liver cancer in a subject, comprising the steps of: (a) providing a specimen of serum from a subject suspected of having liver cirrhosis or liver cancer; (b) using a biomarker consisting of SEQ ID NO:23 to identify and capture autoantibodies in the specimen by contacting the biomarker with the specimen to form a biomarker-autoantibody complex; (c) detecting the biomarker-autoantibody complex in step (b): and (d) correlating the presence of the biomarker-autoantibody complex with liver cirrhosis or liver cancer, wherein the presence of the biomarker- autoantibody complex indicates that the subject has liver cirrhosis or liver cancer. 7
© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.. Examples U.S. Patent 8,014,952 – Queen Elizabeth Hospital and Vermillion, Inc. 1. A tangible computer-readable medium having computer-executable instructions for performing a method of qualifying lung carcinoma status in a subject, which method comprises: (A) transforming data extracted from a spectrum generated by mass spectroscopic analysis of a biological sample taken from the subject to identify component peaks of the spectrum; and then (B) matching the peaks to biomarker sets listed in Table 1 or Table 2, wherein positive matches to the biomarker sets are useable to qualify lung cancer. 8
© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.. What can be patented? 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. 35 U.S.C. § 101 9
© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.. 10 What can be patented? An invention can be patented if: The invention is eligible for patenting (“statutory subject matter”) And The invention is “new” and “unobvious” as measured against the “prior art”
© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.. 11 What cannot be patented? Inventions that cannot be patented –Abstract ideas –Mental processes –Abstract mathematical formulas –Laws of nature –Inventions that clearly do not work (e.g., perpetual motion machines) –Inventions that are illegal
© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.. The Machine-or-Transformation Test In October 2005, the USPTO issued a set of examiner guidelines indicating that a method claim must either transform physical matter or be tied to a specific machine in order to be patent-eligible. The Federal Circuit repeated this machine- or-transformation test as a mandate in In re Bilski (545 F.3d 943 (Fed. Cir. 2008)) 12
© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.. Bilski at the Supreme Court The U.S. Supreme Court disagreed, saying that the machine-or-transformation test was not the only test for patent eligibility Abstract ideas are not patent eligible Although the Bilski case involved a business method patent, the case has ramifications for biotechnology 13
© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.. Prometheus v. Mayo Representative Claim 1. 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. 14
© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.. Prometheus v. Mayo Court said this is patentable subject matter “The Supreme Court’s decision in Bilski did not undermine our preemption analysis of Prometheus’s claims and it rejected the machine-or transformation test only as a definitive test.” Prometheus, slip op. at 14. The Supreme Court decided to review and a decision is expected soon. 15
© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.. Utility The claimed invention must have a specific, substantial and credible use A biomarker must have an associated biological function –Experimental data –Association/homology with known biomarker –Animal models for a specific disease are usually enough –Cell culture assays may or may not be enough Depends on the correlation 16
© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.. How much data? Enablement –A person of skill in the art would have been able to make and use the invention –Correlation between experiments and claimed invention –The less predictable – the more you need to show 17
© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.. How much disclosure? Written description –Need to show possession of the invention –If claiming a genus, need to set forth “a representative number of species” of the genus –For multiple biomarker panels, try and recite as many combinations as possible 18
© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.. How much disclosure Written description –Need to provide the “thing” you are claiming (i.e., mutation, protein sequence) (Billups- Rothenberg, Inc. v. ARUP) Claims required “detecting a mutation” in a gene Sequence of the gene and mutations were not provided Only a method for detecting mutations in the future was disclosed Just providing a research plan to obtain that “thing” is not enough 19
© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.. How many inventions are claimed? Inventors should try and identify which biomarkers have better predictive value than others Claims are supposed to be directed to one invention Example – claimed method of detecting 5 of a list of 50 genes Examiner may require restriction –Required to choose one group of 5 genes Is it possible to narrow down the discovery to the best combination? Can you afford to file divisional applications? 20
© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.. Is it novel? The sequence information now publicly available makes it more difficult to find novel biomarkers –If the sequence is not publicly available, should consider composition claims Even if the sequence is publicly available, if this is the first association of the biomarker with a specific diagnosis, it is likely novel 21
© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.. Is it obvious? Have similar biomarkers been used for similar diagnoses? What makes the claimed biomarkers better than those already public? –Unexpected results 22
© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.. Who would infringe? To prove infringement of a patented process, the Patentee must show that the Defendant has performed each step of the claimed process (BMC Resources v. Paymentech) – If a third party collects a sample or does the analysis, it may not be infringement – Independent conduct of multiple actors via “arms-length cooperation” is not infringement 23
© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.. Non-legal considerations How crucial are the biomarkers to the assay? –Is it possible to diagnose without them? –Are they only part of the panel? –Will anyone need to license the patent? –Especially and issue with SNPs The more important the marker is to the diagnosis, the more valuable it should be 24
© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.. Non-legal considerations Will someone need to license multiple patents to perform the assay? Will it be worth it to license multiple patents? 25
© 2011 Sterne, Kessler, Goldstein, & Fox P.L.L.C. All Rights Reserved.. 26 Questions ? Comments? firstname.lastname@example.org Thank You
Proteomics Examination Yvonne (Bonnie) Eyler Technology Center 1600 Art Unit 1646 (703)
© 2011 Edwards Wildman Palmer LLP & Edwards Wildman Palmer UK LLP Patenting Methods of Medical Treatment in the United States AIPPI 2011 Forum/ExCo Peter.
Korean Intellectual Property Office October 19, 2011 Sunhee Lee, SUGHRUE MION PLLC RECENT CASES IN BIOTECH/PHARM/CHEM & 2011 AMERICA INVENTS ACT.
Orlando, Florida | Mayo v. Prometheus by:Jon M. Gibbs Lowndes, Drosdick, Doster, Kantor and Reed PA.
“REACH-THROUGH CLAIMS” “Reach-through claims” are claims to future inventions based on currently disclosed inventions. These include claims directed.
Post-Prometheus Interim Examination Guidelines Daphne Lainson Smart & Biggar AIPLA 1.
Public Policy Considerations and Patent Eligible Subject Matter Relating to Diagnostic Inventions Disclaimer: Any views expressed here are offered in order.
Mayo v. Prometheus Labs – The Backdrop June 12, 2012 © 2012, all rights reserved.
Examination Practice in Applications Presenting “Reach-Through Claims” George Elliott Practice Specialist Technology Center 1600
Patentability Considerations in the 3-D Structure Arts Patentability Considerations in the 3-D Structure Arts Michael P. Woodward Supervisory Patent Examiner.
1 1 AIPLA 1 1 American Intellectual Property Law Association Patentable Subject Matter in the US AIPPI-Symposium Zeist 13 March 2013 Raymond E. Farrell.
© 2011 Barnes & Thornburg LLP. All Rights Reserved. This page, and all information on it, is the property of Barnes & Thornburg LLP which may not be reproduced,
1 Bioinformatics Practice Considerations October 20, 2011 Ling Zhong, Ph.D.
Bilski: Will It Affect Bioscience Method Claims? Mark T. Skoog, Ph.D. Merchant & Gould MIPLA Biotech/Chemical Law Committee November 2009.
EVALUATING SUBJECT MATTER ELIGIBILITY UNDER 35 U.S.C. §101 Marjorie Moran Supervisory Patent Examiner Art Unit 1631.
1 Single Nucleotide Polymorphisms (SNP) Gary Jones SPE, Technology Center 1600 (703)
1 1 AIPLA Firm Logo American Intellectual Property Law Association Politics, Health Care, Subject Matter Eligibility, & Patent Preemption Mercedes K. Meyer,
Wolf, Greenfield & Sacks, P.C. | 600 Atlantic Avenue | Boston, Massachusetts | | fax | wolfgreenfield.com Recent Developments.
11 Post-Bilski Case Law Update Remy Yucel Director, Central Reexamination Unit.
Stem Cells Peter Paras, Jr.. 2 Overview Introduction — Definitions Types of Stem Cells — Origin Examination of Stem Cell Claims — Statutes — Sample Claims.
1 Written Description Analysis and Capon v. Eshhar Jeffrey Siew Supervisory Patent Examiner AU 1645 USPTO (571)
Impact of Myriad Decisions on Patent Eligibility of Biotechnology Inventions in Australia and the US.
35 USC 101 Update Business Methods Partnership Meeting, Spring 2008 by Robert Weinhardt Business Practice Specialist, Technology Center 3600
Vector Claims in Gene Therapy Applications: In vivo vs. In vitro Utilities Deborah Reynolds SPE GAU
© Copyright 2015 Saul Ewing LLP Diagnostics: Patent Eligibility and the Industry Perspective Presentation to MATTO Kimya Harris, Ph.D. Melissa Hunter-Ensor,
Utility and Written Description Steve Kunin Deputy Commissioner for Patent Examination Policy Esther Kepplinger Deputy Commissioner for Patent Operations.
Myriad The Future of DNA Claims Mercedes Meyer, Ph.D., JD AIPLA 1.
1 Demystifying the Examination of Stem Cell-Related Inventions Remy Yucel, Ph.D. Supervisory Patent Examiner Technology Center 1600 United States Patent.
Animals and Transgenesis Peter Paras, Jr.. 2 Overview Introduction — Definitions Types of Transgenic Animals — How they are made Examination of Transgenic.
Examination Issues: Immunology Yvonne (Bonnie) Eyler Quality Assurance Specialist Technology Center 1600 USPTO (571)
1 Biotechnology Partnership Meeting April 17, 2001 James Martinell Senior Level Examiner Technology Center 1600.
INTERIM GUIDELINES FOR PATENT SUBJECT MATTER ELIGIBILITY ARDIN MARSCHEL SPE AU 1631 (571)
What is Happening to Patent Eligibility and What Can We Do About It? June 24, 2014 Bruce D. Sunstein Denise M. Kettelberger, Ph.D. Sunstein Kann Murphy.
Utility Requirement in Japan Makoto Ono, Ph.D. Anderson, Mori & Tomotsune Website:
Recent Cases on Patentable Subject Matter and Patent Exhaustion Mojdeh Bahar, J.D., M.A. Chief, Cancer Branch Office of Technology Transfer National Institutes.
AIPLA Biotech Committee Annual Meeting 2011 Practice Strategies In View of Recent Case Law Developments Panel – James Kelley, Eli Lilly and Company – Ling.
Proteomics and “Orphan” Receptors Yvonne (Bonnie) Eyler Technology Center 1600 Art Unit 1646 (703)
1 TC 1600 Subject Matter Eligibility Under 35 USC § 101 Andrew Wang SPE 1631 (571)
Trilateral Project WM4 Report on comparative study on Examination Practice Relating to Single Nucleotide Polymorphisms (SNPs) and Haplotypes. Linda S.
Biotechnology/Chemical/Pharmaceutical Customer Partnership: Recent Examiner Training and Developments Under 35 USC § 101 Drew Hirshfeld Deputy Commissioner.
© 2008 International Intellectual Property June 16, 2009 Class 2 Introduction to Patents.
Patentability of Reach-Through Claims Brian R. Stanton Practice Specialist Technology Center 1600 (703)
Patent Overview by Jeff Woller. Why have Patents? Patents make some people rich – but, does that seem like something the government should protect? Do.
Biotechnology/Chemical/Pharmaceutical Customer Partnership Topic: Biotechnology/Chemical/Pharmaceutical Customer Partnership Topic: Examining Issues When.
In re Bilski (Fed Cir. 2008) Patentable subject matter In re Bilski (Fed Cir. 2008) Patentable subject matter December 2, 2008 John King Ron Schoenbaum.
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP AIPLA BIOTECHNOLOGY COMMITTEE WEBINAR Leslie McDonell The contents of.
Patentable Subject Matter and Design Patents,Trademarks, and Copyrights David L. Hecht, J.D., M.B.A, B.S.E.E.
* Statements of fact and opinions expressed are those of the speaker individually and are not the opinion or position of Research In Motion Limited or.
More on Section 101 Patent Law Prof. Merges
How to Claim your Biotech- Based Invention Deborah Reynolds Detailee, TCPS
© 2017 SlidePlayer.com Inc. All rights reserved.