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MacMillan, Sobanski & Todd LLC
Patent Protection for Personalized MedicineHow recent changes in patent eligibility requirements impact personalized diagnostics and therapeutics
Presented by: Dana Stangel, Patent Attorney, MacMillan, Sobanski & Todd LLC
NoCoBio Precision Medicine SummitLoveland, ColoradoJuly 29, 2016
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.
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?
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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.
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MSTWhat Happened? Public concern about patent over-reach
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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.
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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.
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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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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.
www.mstfirm.comMacMillan, Sobanski & Todd LLC
MST
Thank you.
Colorado Office:242 Linden Street, Fort Collins, CO, 80524Telephone: 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: [email protected]
