AIPLA Biotech Committee Annual Meeting 2011 Practice Strategies In View of Recent Case Law Developments Panel – James Kelley, Eli Lilly and Company – Ling Zhong, Ratner Prestia – Judith Roesler, Roesler Law Offices PLLC 1

Overview I.Public Policy /Government Response II.Cases – Patentable Subject Matter III.Bioinfomatics Practice Considerations IV.Divided Infringement 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. 2

Public Policy: Why Now?  Common practice to patent methods of diagnosis, etc.  Better understanding of the extent of control available to patent holder in the area of testing and research  Personalized Medicine considered new era  Predictive of individual susceptibility  Early detection of disease at molecular level  Preempt progression of disease by early detection  Targeted therapeutics and dosages based on testing  Companion tests will become more commonplace 3

Don’t Patent “My” Genes  New concerns that patents will… Restrict the practice of medicine Prevent further study, testing, or examination of patented genes Impede free exchange of information Increase the costs of tests considered essential  Cost of HER-2 Test $20 ICT / $140 FISH (2000) Ridolfi, Ren, et al., Modern Pathology, Vol. 13, No. 8, 866, 871 (2000)  Cost of HER-2 Test $194 ICT / $794 FISH (2009) Helwick, Caroline, Medscape Article , reporting American Society for Clinical Pathology 2009 Annual Meeting, Abstract 86 (2009)  Cost of BRCA 1 + BRCA 2 $3,340 (2011) Pollack, A. The New York Times (August. 24, 2011) 4

Government Reaction  Legislative: Leahy-Smith ‘America Invents’ Act Section 27 Study on Genetic Testing: USPTO mandate to provide study in nine months to address "effective ways to provide independent, confirming genetic diagnostic test activity where gene patents and exclusive licensing for primary genetic diagnostic tests exist.“ … Look for opportunity to comment following Federal Register notice - expected within two months …  Executive: Brief of Amicus Curiae in Myriad  Judicial: Supreme Court opens door to §101 5

Government Reaction - Judicial  Supreme Court Biotechnology/Diagnostic Methods Validity Challenges based on Section 101: Laboratory Corporation of America Holdings v. Metabolite Laboratories, Inc. 548 U.S. 124, 135 (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 Myriad ? Fed. Cir. Denied ACLU Petition for Panel Rehearing 9/13/2011 – Myriad’s Petition Pending 6

Public Policy – Myriad No (Fed. Cir )  Direct Challenge to Biotechnology Under § 101 as compared to LabCorp, Bilski, Prometheus and Classen  Public Policy Agenda: Not all claims are challenged  Declarations of original 20 plaintiffs illustrate public policy concerns Access to tests: Costs, Payer reimbursement, Restriction on alternative testing options Access to technology/results: Impediment to further research, epidemiology studies, development of therapies, and improved tests Patient outcomes: Significance of test results 7

Patentable Subject Matter- Myriad  Composition Claims Eligible Under §101 Isolated DNA (1) Distinctive from pure product of nature i.e. DNA in human body (2) Functional utility - primers / probes US Pat. Nos. 5,745,282 (Cl. 1, 2, 5, 6, 7); 5,837,492 (Cl.1, 6, 7); 5,693,473 (Cl. 1)  Method of Screening potential cancer therapeutics via changes in cell growth rates Eligible Transformation shown by “growing” “determining growth rate” and “comparing” US Pat. No. 5,747,282 (Cl. 20)  Methods Comparing or Analyzing DNA Sequences Ineligible Considered abstract mental processes that fail machine-or-transformation test. US Pat. Nos.: 5,753,441 (Cl. 1); 5,710,001 (Cl. 1); 5,709,999 (Cl. 1); 6,033,857 (Cl. 1,2) 8

Practice Considerations- Myriad  Per Federal Circuit Opinion (2011)  Composition Claims Practice Considerations: Recite language drawn to isolated DNA, primers, probes  Method Claims Practice Considerations: Avoid claims reflecting mere data-gathering, mere inspection, comparing or analyzing as entire process Recite transformation / action step in method claims (Manipulation of Sample; Extracting; Isolating, Sequencing) Recite claims to probes, primers, kits Provide support in specification for variety of claims 9

Mayo v. Prometheus 628 F.3d 1347 (Fed. Cir. 2010), cert. granted, 79 USLW 3554 (June 20, 2011)  Question Presented to Sup. Ct.: Whether a patentee can monopolize basic, natural biological relationships  Patents relate to correlating drug metabolite levels to drug efficacy and toxicity - U.S. Pat. Nos. 6,355,623; 6,680,302  Method of optimizing therapeutic efficacy with key steps of (a) administering drug (b) determining level of metabolite and correlating level with drug efficacy or toxicity - some claims eliminate “administering” step. Eligible  Methods recite series of steps of treatment  Practice Consideration per Fed. Cir. 2010: Recite “determining” step 10

Classen v. Biogen Idec App , 1649 (Fed. Cir. 2011) §101 Method Claims / § 271(e)(1) Safe Harbor Method of immunizing with key steps of screening immunization schedules and immunizing subject according to schedule Eligible by physical step of immunization U.S. Pat. Nos. 6,420,139; 6,638,739 Method of determining whether immunization schedule affects incidence/severity of disorder Ineligible because attempts to claim abstract idea unfettered to any physical steps U.S. Pat. No. 5,723,283 Practice Considerations per Fed. Cir. 2011: Recite “physical” steps / §271(e)(1) Safe Harbor Narrowed 11