Patent Protection for Personalized Medicine - How Recent Changes in Patent Eligibility Requirements Impact Personalized Diagnostics and Therapeutics.

1. MacMillan, Sobanski & Todd LLC
Patent Protection
for Personalized Medicine
How recent changes in patent eligibility requirements
impact personalized diagnostics and therapeutics
Presented by: Dana Stangel, Patent Attorney, MacMillan, Sobanski & Todd LLC
NoCoBio Precision Medicine Summit
Loveland, Colorado
July 29, 2016

2. www.mstfirm.comMacMillan, Sobanski & Todd LLC
MSTDisclaimer
This presentation is not legal advice.
Attending or participating in this seminar does not make you a
client.
The information is intended to provide a brief overview of the
topic. There may be errors or omissions. No guarantee is
made as to accuracy or completeness.
Laws change and particular fact situations can impact your legal
rights and duties.
For legal advice, consult with an attorney licensed in your state
and aware of your particular situation.
All opinions are those of the presenter and do not represent the
views of any other entity.

3. www.mstfirm.comMacMillan, Sobanski & Todd LLC
MSTOverview
US patents have historically protected new
methods of diagnosis and treatment.
Over the past few years, court rulings have
changed the standard for patent eligibility.
These changes impact how personalized
medicine innovations can be protected.
What was patentable?
What changed and why?
What is patentable now?

4. www.mstfirm.comMacMillan, Sobanski & Todd LLC
MSTThe legal standard for patent eligibility
35 U.S.C. § 101 Inventions patentable:
“Whoever invents or discovers any new and useful
process, machine, manufacture, or composition of
matter, or any new and useful improvement thereof,
may obtain a patent therefor, subject to the conditions
and requirements of this title.”
Until 2012, the idea of patenting medical breakthroughs was
not particularly controversial. While it has always been the
case that laws of nature, natural phenomena, and abstract ideas
were not eligible for patent protection under 35 U.S.C. § 101,
medical inventions were almost never classified as mere laws of
nature, but instead as patentable applications of those laws. If
inventions were new and non-obvious, patent protection could
be obtained.

5. www.mstfirm.comMacMillan, Sobanski & Todd LLC
MSTWhat Happened? Public concern about patent over-reach

6. www.mstfirm.comMacMillan, Sobanski & Todd LLC
MSTTimeline of selected cases
2012: Mayo Collaborative Services v. Prometheus Labs
• Laws of nature are not patent eligible
2013: Association for Molecular Pathology v. Myriad Genetics
• Products of nature (genes) are not patent eligible
2014: Alice Corp. v. CLS Bank
• Abstract ideas are not patent eligible
2015: Ariosa Diagnostics v. Sequenom
• Scientific discoveries are not patent eligible
Mayo v. Prometheus: The Prometheus patents claimed methods for optimizing
dosage of a particular drug based on measuring a patient blood sample for a known
metabolite of the drug. The Supreme Court found that the correlation was a natural
phenomenon, essentially a law of nature, and therefore patent ineligible.
Ariosa v. Sequenom: The Sequenom patent claimed a method for selectively
amplifying fetal DNA in a sample taken from the mother’s blood by identifying
paternal DNA. The Federal Circuit Court of Appeals found the existence of
paternally-derived DNA in the mother’s blood was a discovery of a natural
phenomena, and the additional detection steps were routine and conventional, so the
claims were patent ineligible.

7. www.mstfirm.comMacMillan, Sobanski & Todd LLC
MSTImpact on personalized medicine
Data illustrates rejections in a sample of personalized medicine patent applications
examined in art unit 1634.
Source: Bernard Chao and Amy Mapes, An Early Look at Mayo’s Impact on Personalized
Medicine, 2016 Patently-O Patent Law Journal 10.

8. www.mstfirm.comMacMillan, Sobanski & Todd LLC
MSTWhat is patent eligible now?
Therapeutic methods are usually patent eligible. This includes
tailoring a dosing regime, but may require including steps of
administering a therapeutic substance.
Vaccines, chimeric molecules, and non-naturally occurring
peptides and probes are usually patent eligible.
Diagnostic and prognostic methods are sometimes patentable.
However, including additional steps, such as specifying particular
assays and probes, or including a subsequent treatment step, may
be required.
Genes, SNPS, naturally produced biomarkers, and correlations
between genetic or proteomic signatures with disease states are
usually not independently patent eligible .
X
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?

9. www.mstfirm.comMacMillan, Sobanski & Todd LLC
MSTConclusions
The U.S. standards for determining
patent eligibility are in flux.
The evolving U.S. standard is poorly
aligned with the eligibility
requirements of other countries.
The laws are not consistently applied
by the courts.
Patent protection strategies may
include filing applications with method
claims describing the invention in
different, but overlapping scope.

10. www.mstfirm.comMacMillan, Sobanski & Todd LLC
MST
Thank you.
Colorado Office:
242 Linden Street,
Fort Collins, CO, 80524
Telephone:
970.493.0046
If you would like to contact Dana Stangel,
she can be reached at the Colorado office
of MacMillan Sobanski & Todd LLC and
by email at: stangel@mstfirm.com