1. Diagnostics: Patent Eligibility and the Industry Perspective
Presentation to MATTO
Kimya Harris, Ph.D.
Melissa Hunter-Ensor, Ph.D., Esq.
Moderator: John Cosmopoulos

2. What is Patent Eligible Subject Matter?
35 U.S.C. § Any new and useful:
Process
Machine
Manufacture or composition of matter or improvement thereof
“Anything under the sun made by man”
Unpatentable subject matter (judicial exceptions)
Laws of nature
Products of nature
Mathematical algorithms

3. AMP v. MYRIAD GENETICS, Sup Ct June 2013 Subject Matter Eligibility of Products
BRCA1 and BRCA2 are genes that account for most inherited forms of breast and ovarian cancer.
Myriad’s genetic test identified women at increased risk of suffering from breast or ovarian cancer.
Two types of claims were at issue:
(i) composition claims directed to isolated DNA molecules;
(ii) composition claims directed to cDNA
Court found that isolating DNA molecules was not sufficient to confer patent eligibility, because “Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes.”
cDNA is not a “product of nature” and is patent eligible under § 101.

4. Mayo v. Prometheus, Sup. Ct
Mayo v. Prometheus, Sup. Ct. March 2012 Subject Matter Eligibility of Processes
The court found that medical tests that rely on correlations between drug dosages and treatment are not eligible for patent protection.
The court reasoned that natural laws themselves may not be patented, and natural laws cannot be patented in connection with processes that involve “well-understood, routine, conventional activity.”

5. How do Myriad and Prometheus affect patent eligibility for diagnostics?
The Court’s analysis of patent eligibility in Myriad focused on whether products occurred in nature.
Include claims to compositions that are not naturally occurring.
Capture molecules (Abs/Nucleic acids) fused to a substrate.
Polynucleotides comprising a detectable moiety.
Humanized or chimeric antibodies.
The Court’s analysis of patent eligibility in Prometheus focused on laws of nature, mental steps, and routine conventional activity.
Include claims to diagnostic methods featuring patentable compositions (e.g., antibodies, microarrays, detectable polynucleotide probes that hybridize to SNPs).
Claims to companion diagnostics (e.g., a method of treating a patient by administering drug X, wherein the patient is selected as having disease Y).

6. Highlights from the USPTO Interim Guidance on Subject Matter Eligibility (Dec. 2014)
Includes all claims (product and process) “directed to” a judicial exception
Step 2A analysis: compare product in the claim to its naturally occurring counterpart to identify markedly different characteristics
Includes structure, function, and/or other characteristics
Step 2B analysis: determine if additional elements add significantly more to the exception
Streamlined eligibility analysis: claim clearly does not seek to pre- empt all uses of the exception
Clear statement that mere possibility that something exists in nature does not bar eligibility
Kimya Harris

7. Comparison of Patent Eligibility for Diagnostics Worldwide
Europe
Canada
Japan
Australia
Methods
- Patentable
- Must have in vitro step
- “Diagnostic method” or “diagnostically effective amount”
- Not patentable
- “Method of using X as an indicator for Y”
Patentable
Compositions &
Kits
- Composition limited by use
Relevant Court Decisions
- Myriad patents opposed
- Patents upheld on appeal
- Patent eligible subject matter affirmed
- No Myriad challenges
- CHEO challenged gene patent
No Myriad challenges
- Myriad upheld by Federal Court of Australia
- “Isolated genes are not naturally occurring”
- Standard for “invention” is an artificially created state of affairs
Kimya Harris

8. Case Studies
Correlation between a SNP in a certain gene (or SNPs in multiple genes) and diagnosis of a specific disease.
Higher levels of phosphorylation at a specific serine position of a certain protein represents a biomarker of patients with bipolar disease who will respond to lithium treatment (patient stratification tool/companion Dx type situation).
The inverse correlation between low levels of a specific protein in the tumor microenvironment and the aggressiveness of the tumor.

9. Case Studies (continued)
Identification of a (or more than one) circulating biomarker that is correlated to a disease.
Panel of mutations in one or more genes that provide responses to specific clinical questions (e.g. Is the cancer invasive? How to stratify patients or classify the cancer?)
Correlation of certain altered methylation patterns with increased probability of carcinogenesis in specific tumor types.