Public Policy Considerations and Patent Eligible Subject Matter Relating to Diagnostic Inventions Disclaimer: Any views expressed here are offered in order to advance the cause of thinking about the issues presented by recent events in the biotechnology area and do not necessarily represent the view of any individual presenter, corporation, law firm, or clients of law firms presenting today. Claims are summarized for illustration purposes only and do not encompass all claim limitations or interpretations thereof. No practice considerations presented here constitute legal advice and adoption of any part of the practice considerations remains the sole responsibility of the practicing attorney. 1

My Topics Today Public Opinion Impact on Diagnostic Patents Government Response to Public Opinion Diagnostic Methods and Gene Patents Under 35 U.S.C. § 101 Patent Eligibility Practice Considerations 2

Public Opinion Concerns: Why Now?  Access to Tests  Sole Provider Model  Pricing / Reimbursement  Personalized Medicine  Predictive, Preemptive, Early Detection  Multivariate Index Assays / Multiplexing  Whole Genome Sequencing  Limited Experimental Use Exemption 3

Public Policy: ACLU Involvement Don’t Patent “My” Genes Products of Nature from the Human Body Prevents Scientific Research No Experimental Research Exemption Impedes Practice of Medicine Impedes Free Exchange of Information Lack of Alternative Testing for 2 nd Opinion Lack of Reimbursement for Follow-Up Test Costs of Tests 4

Government Reaction Legislative: Leahy-Smith ‘America Invents’ Act: – Section 27 Study on Genetic Testing Executive: Brief of Amicus Curiae in Myriad Judicial: Supreme Court Opens Door to §101 Regulatory Pathway of Diagnostic Tests – Multiple Guidance Reports – Approval Process: PMA vs. 510(K) – Designations of RUO; IUO; and LDT 5

Supreme Court: Section 101 Section 101: Patent Eligible Subject Matter – Judicially Created Exceptions: Laws of Nature, Physical Phenomena, Abstract Ideas, Products of Nature Laboratory Corporation of America Holdings v. Metabolite Laboratories, Inc. 548 U.S. 124(2006) Bilski v. Kappos, 130 S. Ct (2010) Mayo Collaborative Services v. Prometheus Laboratories, Inc. Cert. Granted 6/20/2011; Hearing date scheduled for 12/7/2011 6

Review of Bilski Removed “machine or transformation test” as sole test for determining patent eligibility of a process under 35 U.S.C. § 101 “Advanced Medical Techniques” are Processes Grant, Vacate, Remand to Federal Circuit – Prometheus (Method of Diagnosis) – Classen (Method of Treatment) 7

Mayo v. Prometheus 628 F.3d 1347 (Fed. Cir. 2010), cert. granted, 79 USLW 3554 (June 20, 2011) PENDING SUPREME CT. Supreme Court Oral Arguments 12/7/2011 Methods of Optimizing Therapeutic Efficacy and Reducing Toxicity – Drug Known at the Time of Patent Filing – Problem with Efficacy and Toxicity of Drug – U.S. Pat. Nos.: 6,355,623; 6,680,302 8

Mayo v. Prometheus (Cont.) Method of Testing: 2 Claim Formats – Steps of a) administering drug and b) determining the level of a metabolite of drug and correlating to toxicity or efficacy – Step of a) determining the level of a metabolite of drug and correlating … Federal Circuit: Held Both Types Patent Eligible Supreme Court: Are “transformations” of body chemistry sufficient for eligibility under §101. 9

Classen v. Biogen Idec Slip Op (Fed. Cir. 2011) FEDERAL CIRCUIT Method of immunizing: 2 Claim Formats -Key steps of a) screening immunization schedules and b) immunizing subject according to schedule U.S. Pat. 6,420,139; 6,638,739 Eligible: Physical Steps -Method of determining whether immunization schedule affects incidence/severity of disorder U.S. Pat. No. 5,723,283 Ineligible: Abstract principle 10

Ass. M. Pathology, et al. v. Myriad Slip. Op (Fed. Cir. 2011) FEDERAL CIRCUIT Diagnostic Method Claims and Biotechnology Related Composition Claims: 3 Claim Formats (1) Isolated DNA for BRAC1 and BRCA 2 Eligible: Distinctive from pure product of nature; Functional utility - primers / probes (2) Method of Screening Potential Therapeutics Eligible: Transformation shown by growing; determining growth rate; comparing 11

Myriad (Cont.) (3) Method of Diagnosis using DNA sequences Ineligible: Methods of “Comparing” or “Analyzing” DNA sequences considered Abstract Mental Processes – Federal Circuit advised action steps including “Extracting” or “Isolating” the sample reflect “Transformation” – “Comparing” or “Analyzing” cannot be the entire process 12

§101 Practice Considerations Avoid method claims where “comparing” or “analyzing” represents the entire process Avoid “data-gathering steps and a fundamental principle” Include “probe” and “primer” claims Use action step “determining” Caution: Multiple action steps requiring multiple parties (triggers divided infringement issue) July 27, 2010 Interim Guidance from USPTO 13

Thank You Judith Roesler Roesler Law Offices, PLLC 1000 Centre Green Way, Suite 200 Cary, NC (919)