Prometheus & Myriad The Future of Diagnostic & Gene Claims Mercedes Meyer, Ph.D. Kevin Noonan, Ph.D.

2 | The Future of Diagnostic Claims Discussion Points  A rear view of Classen and Labcorp.  AIA 35 USC § 101 change.  USPTO Memo Guidance March 21, 2012  The tension – McKesson & Akamai  35 U.S.C. § 287(c)  Smartgene – March 30, 2012

3 | The Future of Diagnostic Claims More Discussion Points  The politics –The public –The stakeholders –The politician – Congresswoman Wasserman-Schultz AIA S. 27 The Hearings Feb. 16 & Mar. 9 –The White House, DOJ, USPTO, NIH –LDTs, CLIA, and the FDA Stakeholders: Pharma, Consumers/Patients, Companion diagnostic manufacturers, Payers, Physicians, Regulatory, and Testing Labs

4 | The Future of Diagnostic Claims Some myths on gene patents  Patents and Costs –No evidence was found demonstrating that patents accelerated or inhibited test development for certain conditions (e.g. hearing loss). –Price for genetic tests did not appear to correlate with patent status. Some for-profit providers had the same cost as not-for- profit testing providers. –Patents have been found not impede consumer utilization of the tests. –The marketplace is the driver of gene testing. –Incorrect data – the myth that 20% of the human genes are patented is false. Whole Genome Sequencing – does not infringe a gene patent.

5 | The Future of Diagnostic Claims Some more myths on gene patents  Patents and Innovation –No evidence for a “tragedy of the anticommons” regarding basic research >9,000 scientific journal articles on BRCA genes post-patenting –“Isolated DNA” claims not infringed by genetic diagnostic testing Claims require isolation of full-length genes capable of producing encoded protein Isolation not required for genetic diagnostic tests –Oligomer claims of questionable validity –Gene patents do not inhibit information about genes Genetic information is not patented and gene patent claims not infringed by in silico analyses

6 | The Future of Diagnostic Claims A Slippery Slope & The Future  Some (Judge Moore) voice a concern that if DNA patents are attacked there will be a slippery slope effect to capture other compounds. –Antisense, siRNA. –Proteins and peptides. Antibodies and their fragments.  Method of treatment claims are recognized for Orange Book listings.  Companion Diagnostics.

7 | The Future of Diagnostic Claims A Slippery Slope & The Future  Consider these examples: –Isolated chemical compound from crude oil useful as a lubricant –Isolated chemical compound from a plant useful as a drug –Isolated protein from an animal useful to cure/ameliorate human disease –From a human?

8 | The Future of Diagnostic Claims Myriad DNA Claims - Eligible? USPN 5,693,473  1. An isolated DNA comprising an altered BRCA1 DNA having at least one of the alterations set forth in Tables 12A, 14, 18 or 19 with the proviso that the alteration is not a deletion of four nucleotides corresponding to base numbers in SEQ. ID. NO:1.

9 | The Future of Diagnostic Claims Myriad DNA Claims - Eligible? USPN 5,747,282  7. An isolated DNA selected from the group consisting of: –(a) a DNA having the nucleotide sequence set forth in SEQ ID NO:1 having T at nucleotide position 4056; –(b) a DNA having the nucleotide sequence set forth in SEQ ID NO:1 having an extra C at nucleotide position 5385; –(c) a DNA having the nucleotide sequence set forth in SEQ ID NO: 1 having G at nucleotide position 5443; and, (d) a DNA having the nucleotide sequence set forth in SEQ ID NO:1 having 11 base pairs at nucleotide positions deleted.

10 | The Future of Diagnostic Claims Is Licensing “THE” Issue?  Single Providers –Myriad / BRCA1 & 2 –Canavan Disease – Miami Children’s Hospital  Multiple Providers –Long QT Syndrome has two providers with separate blocking patents –Hearing loss – multiple providers for patents and unpatented genes –Hereditary hemochromatosis – multiple LDTs; no IP impact –Alzheimer’s Disease –Lynch Syndrome (HNPCC) –Familial adenomatous polyposis (FAP) –Spinocerebellar ataxia

Myriad Internationally Gene Patent Attacks Globally

12 | The Future of Diagnostic Claims International Stance  Canada – Myriad attacked the government. Today, Myriad’s patents are primarily ignored.  Europe – Opposed by Institut Curie. –UK – provides BRCA testing without payment to Myriad.  Australia – the government investigated and came close to banning gene patents.  Japan – exclusively licensed the rights to Falco.

Questions? Mercedes K. Meyer, Ph.D. Drinker Biddle & Reath LLP Washington, DC Kevin E. Noonan, Ph.D. McDonnell Boehnen Hulbert & Berghoff LLP Chicago, IL 60606