Transcript Webinar Diagnostic Inventions

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.
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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
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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
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Public Policy: ACLU Involvement
• Don’t Patent “My” Genes
• Products of Nature from the Human Body
• Prevents Scientific Research
• No Experimental Research Exemption
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Impedes Practice of Medicine
Impedes Free Exchange of Information
Lack of Alternative Testing for 2nd Opinion
Lack of Reimbursement for Follow-Up Test
Costs of Tests
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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
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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. 3218 (2010)
• Mayo Collaborative Services v. Prometheus
Laboratories, Inc. Cert. Granted 6/20/2011;
Hearing date scheduled for 12/7/2011
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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)
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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
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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.
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Classen v. Biogen Idec
Slip Op. 2006-1643 (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
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Ass. M. Pathology, et al. v. Myriad
Slip. Op. 2010-1406 (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
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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
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§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
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Thank You
Judith Roesler
Roesler Law Offices, PLLC
1000 Centre Green Way, Suite 200
Cary, NC 27513
(919) 228-6321
[email protected]
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