The document summarizes guidance from the USPTO on patent eligibility for biotechnology and nature-based products under 35 USC 101. It discusses tests for patent eligibility, such as the markedly different characteristics test and significantly more test, using examples from case law including Myriad and Chakrabarty. It also analyzes the Federal Circuit's decision in Myriad v. Ambry applying these tests to product and method claims.
The document summarizes four significant U.S. patent cases from 2010: Bilski v. Kappos established that the machine-or-transformation test was a useful test but not the only test for determining patent eligibility. Ariad v. Eli Lilly reaffirmed that written description and enablement are separate requirements. ACLU v. USPTO (Myriad) found isolated DNA sequences were not patentable subject matter. Daiichi Sankyo v. Matrix Labs affirmed that a claimed compound was nonobvious over prior art lead compounds based solely on structural similarity.
The Idaho National Laboratory is actively researching the use of solid oxide fuel cells as electrolyzers to produce hydrogen and syngas on a large scale. They have conducted single cell tests, multi-cell stack tests, and multi-stack tests using cells from Ceramatec Inc. and NASA Glenn Research Center. Stack testing included 10 cell and 20 cell stacks up to a 720 cell 15 kW stack. Tests were run for hundreds of hours to over 1000 hours in a bench-scale or new 15 kW integrated laboratory test facility. Results and observations of cell performance degradation will be presented.
This document discusses recent Supreme Court cases addressing patent eligibility of claims involving abstract ideas or laws of nature in biotechnology. It summarizes the tests developed in Bilski v. Kappos, Mayo v. Prometheus, and Alice v. CLS Bank for determining whether a claim is directed to a judicial exception like an abstract idea. The analysis involves determining whether the claim wholly preempts a fundamental principle and if additional elements together provide an inventive concept. The presentation provides takeaways on applying this analysis in emerging technologies while avoiding overly broad interpretations that could undermine patent law.
Power Point Presentation describing new laws and rules governing patentable subject matter in the U.S., particularly in the biotechnology and pharmaceutical industries
Biotechnology Written Description, Enablement, and Patent EligibilityGary M. Myles, Ph.D.
The document summarizes a presentation on biotechnology patents that covers topics such as the written description requirement, patentable subject matter, and recent relevant court cases. It provides a primer on biotechnology including DNA, proteins, recombinant DNA technology, and therapeutic biotech products. Examples of patented biotech inventions like Enbrel and monoclonal antibodies are also discussed.
This document provides an overview of biotechnology and recent patent law cases affecting patent eligibility of biotechnology inventions. It begins with primers on biotechnology topics like DNA, proteins, and therapeutic products. It then discusses why strong patent protection is essential for biotechnology given the lengthy and expensive research and development process. The document reviews various biotechnology patent claims and recent Supreme Court cases that have impacted patent eligibility of diagnostic methods, natural correlations, and processes applying natural relationships. It concludes with a discussion of personalized medicine and precision diagnostics representing future areas for biotechnology.
The document discusses the current state of patent eligibility forecasts and Section 101 decisions. It notes that courts continue to frequently invalidate patents without dissent. The USPTO is also rejecting many patents, especially in e-commerce, under Section 101. While recent USPTO examiner instructions provide some improvements, more clarification is still needed, such as prohibiting omnibus rejections. A recent Federal Circuit decision found claims eligible but the law remains uncertain. Overall, the landscape for patent eligibility remains challenging but clarification from courts and the USPTO may eventually provide some improvements.
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The document summarizes four significant U.S. patent cases from 2010: Bilski v. Kappos established that the machine-or-transformation test was a useful test but not the only test for determining patent eligibility. Ariad v. Eli Lilly reaffirmed that written description and enablement are separate requirements. ACLU v. USPTO (Myriad) found isolated DNA sequences were not patentable subject matter. Daiichi Sankyo v. Matrix Labs affirmed that a claimed compound was nonobvious over prior art lead compounds based solely on structural similarity.
The Idaho National Laboratory is actively researching the use of solid oxide fuel cells as electrolyzers to produce hydrogen and syngas on a large scale. They have conducted single cell tests, multi-cell stack tests, and multi-stack tests using cells from Ceramatec Inc. and NASA Glenn Research Center. Stack testing included 10 cell and 20 cell stacks up to a 720 cell 15 kW stack. Tests were run for hundreds of hours to over 1000 hours in a bench-scale or new 15 kW integrated laboratory test facility. Results and observations of cell performance degradation will be presented.
This document discusses recent Supreme Court cases addressing patent eligibility of claims involving abstract ideas or laws of nature in biotechnology. It summarizes the tests developed in Bilski v. Kappos, Mayo v. Prometheus, and Alice v. CLS Bank for determining whether a claim is directed to a judicial exception like an abstract idea. The analysis involves determining whether the claim wholly preempts a fundamental principle and if additional elements together provide an inventive concept. The presentation provides takeaways on applying this analysis in emerging technologies while avoiding overly broad interpretations that could undermine patent law.
Power Point Presentation describing new laws and rules governing patentable subject matter in the U.S., particularly in the biotechnology and pharmaceutical industries
Biotechnology Written Description, Enablement, and Patent EligibilityGary M. Myles, Ph.D.
The document summarizes a presentation on biotechnology patents that covers topics such as the written description requirement, patentable subject matter, and recent relevant court cases. It provides a primer on biotechnology including DNA, proteins, recombinant DNA technology, and therapeutic biotech products. Examples of patented biotech inventions like Enbrel and monoclonal antibodies are also discussed.
This document provides an overview of biotechnology and recent patent law cases affecting patent eligibility of biotechnology inventions. It begins with primers on biotechnology topics like DNA, proteins, and therapeutic products. It then discusses why strong patent protection is essential for biotechnology given the lengthy and expensive research and development process. The document reviews various biotechnology patent claims and recent Supreme Court cases that have impacted patent eligibility of diagnostic methods, natural correlations, and processes applying natural relationships. It concludes with a discussion of personalized medicine and precision diagnostics representing future areas for biotechnology.
The document discusses the current state of patent eligibility forecasts and Section 101 decisions. It notes that courts continue to frequently invalidate patents without dissent. The USPTO is also rejecting many patents, especially in e-commerce, under Section 101. While recent USPTO examiner instructions provide some improvements, more clarification is still needed, such as prohibiting omnibus rejections. A recent Federal Circuit decision found claims eligible but the law remains uncertain. Overall, the landscape for patent eligibility remains challenging but clarification from courts and the USPTO may eventually provide some improvements.
Essays Experts is the only custom writing service that uses ultra modern approaches coupled with thorough training in providing high quality academic writing services. Our services will enable you achieve success and realize your academic dreams. At http://www.essaysexperts.net/ ,we are the best solution for your academic assignments.
Ethics and the Law: The Case of Myriad Genetics, Ethics in Patenting and Eth...Kirby Drake
This document discusses the case of Myriad Genetics and the controversy surrounding human gene patents. It provides background on gene patents and Myriad's patents on the BRCA1 and BRCA2 genes. The Association for Molecular Pathology sued Myriad, arguing the patents were invalid as products of nature. The court agreed the composition claims were directed to unpatentable natural phenomena, though it did not rule on constitutional questions. The document examines the conflicting ethical issues around gene patenting and licensing practices, and possible policy solutions like compulsory licensing or research exemptions.
This document discusses the case of Myriad Genetics and the ethics around patenting human genes. It summarizes that Myriad Genetics holds patents on the BRCA1 and BRCA2 genes linked to breast cancer and faces criticism for aggressively enforcing these patents. The document also summarizes a key lawsuit where a court invalidated Myriad's gene patents, finding that isolated DNA is not patentable subject matter. The document discusses ongoing debates around the ethics, impacts on research and healthcare, and potential policy solutions regarding human gene patents.
Obtaining patentable claims after Prometheus and MyriadMaryBreenSmith
The Supreme Court cases significantly changed what is patentable subject-matter in the U.S. But how broadly has the scope of patentable subject matter been narrowed by these decisions? Presentation analyzes major claim types in diagnostics and gene-type patents and whether they remain patentable under this new case law.
This document provides information on biosimilars and interchangeable biosimilars for health care providers. It defines key terms like reference product, biosimilar, and interchangeable. It describes the FDA approval pathways for biosimilars and generics. The FDA recommends a comparative analytical assessment and targeted clinical studies to demonstrate biosimilarity or interchangeability to a reference product. Clinical studies generally show biosimilars and interchangeable biosimilars are equivalent to their reference products in terms of safety, efficacy, and immunogenicity, including after switching. To date, the FDA has approved 4 interchangeable biosimilars.
The document discusses the Myriad case regarding whether gene sequences and diagnostic methods can be patented. It summarizes the case history from the District Court of Southern District of New York to the US Supreme Court. It also analyzes the key issues around whether isolated DNA, diagnostic methods, and transformative steps in a process are eligible for patent protection under US law. The highest court reconsidered the Prometheus case and determined that well-understood routine steps or merely comparing information would not be patentable.
Update on U.S. Regulation of BiosimilarsMichael Swit
This document summarizes key issues regarding U.S. regulation of biosimilars, including the filing of the first biosimilar applications, requirements for demonstrating interchangeability, state substitution laws, challenges around naming conventions, and arguments on both sides of the naming debate. Industry is pursuing clinical trial designs aimed at demonstrating interchangeability, while FDA guidance is pending and naming remains controversial with pros arguing it ensures traceability and cons arguing it reduces biosimilar uptake.
Patents and Biotechnology- A Presentation by Dr. Kalyan Kankanala - BananaIPBananaIP Counsels
Patents and Biotechnology- A Presentation by Dr. Kalyan Kankanala - BananaIP
BananaIP Counsels, formerly Brain League IP Services, founded in 2004 at the Indian Institute of Management (IIM) Bangalore’s incubation center (NSRCEL), is recognized as an IP/Patent trailblazer in India. The firm’s mission is to help clients maximize business value from their Intellectual Property (IP)/Patents, and gain competitive advantage in the market place. In its evolution from Brain League, BananaIP carries forward the firm’s core values – Merger of Technology,Management and Law, Swift Adaptation to changes in competitive environment, and business driven approach to Intellectual Property (IP)/Patent Services.
Contact Us for Intellectual Property Services
BananaIP Counsels
Regd Office
No.40,3rd Main Road,JC Industrial Estate,
Kanakapura Road,Bangalore – 560 062.
Email: contact@bananaip.com
Telephone: +91-80-26860414 /24/34
Luke Lightning presented on pre-clinical drug development and ADME (absorption, distribution, metabolism, excretion) studies. He discussed why ADME is important for assessing a compound's developability. He provided examples of his experience conducting ADME studies at Alquest Therapeutics and a previous company. The presentation covered regulatory considerations for ADME studies, in vitro and in vivo study types and costs, and options for conducting studies in-house or outsourcing them. An example ADME work plan was presented, along with a summary of key points and future directions for ADME research.
U.S. Regulation of Biosimilars: Key IssuesMichael Swit
September 2014 Presentation at the Regulatory Affairs Professionals Society Regulatory Convergence Conference in Austin, Texas, with a focus on:
• The “Good” News –351(k) BLAs Have Been Filed at FDA
• Interchangeability
• State Substitution Laws
• Naming
• Where FDA Stands on Biosimilars
Biosimilars are biologic medicines that are developed to be similar to existing approved biologic medicines known as reference medicines. Biosimilars must demonstrate similarity to the reference medicine in terms of quality, safety and efficacy through comprehensive testing and analysis. While biosimilars may provide reduced costs and increased access to biologic treatments, they are more complex than traditional small molecule drugs due to differences in size, structure, manufacturing processes, and potential for immunogenicity. Thorough evaluation and regulation is required to ensure biosimilars are interchangeable for the reference product without compromising patient safety.
Drug discovery clinical evaluation of new drugsKedar Bandekar
The document discusses the process of new drug development from initial idea to market launch. It takes 12-15 years and over $1 billion. The process involves identifying a biological target, screening compounds to find hits, optimizing hits to develop leads, and conducting preclinical and clinical trials. Key steps include target identification and validation, high-throughput screening to find initial hits, hit-to-lead and lead optimization processes to improve properties, and three phases of clinical trials to test safety and efficacy in humans. Characteristics of ideal lead compounds include high target affinity and selectivity, drug-like properties, and favorable absorption and toxicity profiles.
Drug discovery clinical evaluation of new drugsKedar Bandekar
The document discusses the process of new drug development from initial idea to market launch. It takes 12-15 years and over $1 billion. The process involves identifying a biological target, screening compounds to find hits, optimizing hits to develop leads, and conducting preclinical and clinical trials. Key steps include target identification and validation, high-throughput screening to find initial hits, hit-to-lead and lead optimization processes to improve properties, and progression through preclinical and clinical phases of drug development. Characteristics of ideal lead compounds include high target affinity and selectivity, efficacy, appropriate physicochemical properties, and favorable ADME profile.
Assn. for molecular pathology vs. mtriad genetics case studyAltacit Global
This document summarizes a case study on the lawsuit between the Association for Molecular Pathology and Myriad Genetics regarding patents on the BRCA1 and BRCA2 genes. Myriad's scientists discovered the genes linked to breast cancer in 1994 and were granted patents. However, a lawsuit challenged the patents, arguing that genes cannot be patented. While a district court invalidated Myriad's patents, an appeals court upheld them. Ultimately, the US Supreme Court ruled that isolated DNA is not patentable subject matter, invalidating Myriad's patents.
In view of the U.S. approval process for biosimilars, companies are gearing up to either produce their own biosimilar products, or to defend against their entry onto the market. While the Biologics Price Competition and Innovation Act (BPCIA) spells out many of the requirements, the pathway for approval is complicated. Our panel of experts discuss the features of the BPCIA and how it operates for both approved biologics as well as biosimilar entrants. They also make some predictions on its impact for life science companies.
The webinar is 60 minutes, complete with Q&A.
Scientific Validity of Replacements for Animal-Derived AntibodiesRebeccaClewell
Summary of the recommendations by the EURL-ECVAM Scientific Advisory Committee (ESAC) on the Scientific Validity of Replacements for Animal-Derived Antibodies. Presented at the ICCVAM Communities of Practice Webinar 2020, "Use of Animal-free Affinity Reagents", January 2020.
Presentation at the Biosimilars and Follow-On Biologics 2014 Americas Conference, sponsored by Paradigm Global Events, February 12, 2014. Presentation focused on:
•Interchangeability
•State Substitution Laws
•Naming
•Risk Evaluation & Mitigation Strategies (REMS) and Their Impact on Biosimilars
•Where FDA Stands on Biosimilars
More Related Content
Similar to Issac Patent Eligibility Presentation Mid Winter Orlando 2015
Ethics and the Law: The Case of Myriad Genetics, Ethics in Patenting and Eth...Kirby Drake
This document discusses the case of Myriad Genetics and the controversy surrounding human gene patents. It provides background on gene patents and Myriad's patents on the BRCA1 and BRCA2 genes. The Association for Molecular Pathology sued Myriad, arguing the patents were invalid as products of nature. The court agreed the composition claims were directed to unpatentable natural phenomena, though it did not rule on constitutional questions. The document examines the conflicting ethical issues around gene patenting and licensing practices, and possible policy solutions like compulsory licensing or research exemptions.
This document discusses the case of Myriad Genetics and the ethics around patenting human genes. It summarizes that Myriad Genetics holds patents on the BRCA1 and BRCA2 genes linked to breast cancer and faces criticism for aggressively enforcing these patents. The document also summarizes a key lawsuit where a court invalidated Myriad's gene patents, finding that isolated DNA is not patentable subject matter. The document discusses ongoing debates around the ethics, impacts on research and healthcare, and potential policy solutions regarding human gene patents.
Obtaining patentable claims after Prometheus and MyriadMaryBreenSmith
The Supreme Court cases significantly changed what is patentable subject-matter in the U.S. But how broadly has the scope of patentable subject matter been narrowed by these decisions? Presentation analyzes major claim types in diagnostics and gene-type patents and whether they remain patentable under this new case law.
This document provides information on biosimilars and interchangeable biosimilars for health care providers. It defines key terms like reference product, biosimilar, and interchangeable. It describes the FDA approval pathways for biosimilars and generics. The FDA recommends a comparative analytical assessment and targeted clinical studies to demonstrate biosimilarity or interchangeability to a reference product. Clinical studies generally show biosimilars and interchangeable biosimilars are equivalent to their reference products in terms of safety, efficacy, and immunogenicity, including after switching. To date, the FDA has approved 4 interchangeable biosimilars.
The document discusses the Myriad case regarding whether gene sequences and diagnostic methods can be patented. It summarizes the case history from the District Court of Southern District of New York to the US Supreme Court. It also analyzes the key issues around whether isolated DNA, diagnostic methods, and transformative steps in a process are eligible for patent protection under US law. The highest court reconsidered the Prometheus case and determined that well-understood routine steps or merely comparing information would not be patentable.
Update on U.S. Regulation of BiosimilarsMichael Swit
This document summarizes key issues regarding U.S. regulation of biosimilars, including the filing of the first biosimilar applications, requirements for demonstrating interchangeability, state substitution laws, challenges around naming conventions, and arguments on both sides of the naming debate. Industry is pursuing clinical trial designs aimed at demonstrating interchangeability, while FDA guidance is pending and naming remains controversial with pros arguing it ensures traceability and cons arguing it reduces biosimilar uptake.
Patents and Biotechnology- A Presentation by Dr. Kalyan Kankanala - BananaIPBananaIP Counsels
Patents and Biotechnology- A Presentation by Dr. Kalyan Kankanala - BananaIP
BananaIP Counsels, formerly Brain League IP Services, founded in 2004 at the Indian Institute of Management (IIM) Bangalore’s incubation center (NSRCEL), is recognized as an IP/Patent trailblazer in India. The firm’s mission is to help clients maximize business value from their Intellectual Property (IP)/Patents, and gain competitive advantage in the market place. In its evolution from Brain League, BananaIP carries forward the firm’s core values – Merger of Technology,Management and Law, Swift Adaptation to changes in competitive environment, and business driven approach to Intellectual Property (IP)/Patent Services.
Contact Us for Intellectual Property Services
BananaIP Counsels
Regd Office
No.40,3rd Main Road,JC Industrial Estate,
Kanakapura Road,Bangalore – 560 062.
Email: contact@bananaip.com
Telephone: +91-80-26860414 /24/34
Luke Lightning presented on pre-clinical drug development and ADME (absorption, distribution, metabolism, excretion) studies. He discussed why ADME is important for assessing a compound's developability. He provided examples of his experience conducting ADME studies at Alquest Therapeutics and a previous company. The presentation covered regulatory considerations for ADME studies, in vitro and in vivo study types and costs, and options for conducting studies in-house or outsourcing them. An example ADME work plan was presented, along with a summary of key points and future directions for ADME research.
U.S. Regulation of Biosimilars: Key IssuesMichael Swit
September 2014 Presentation at the Regulatory Affairs Professionals Society Regulatory Convergence Conference in Austin, Texas, with a focus on:
• The “Good” News –351(k) BLAs Have Been Filed at FDA
• Interchangeability
• State Substitution Laws
• Naming
• Where FDA Stands on Biosimilars
Biosimilars are biologic medicines that are developed to be similar to existing approved biologic medicines known as reference medicines. Biosimilars must demonstrate similarity to the reference medicine in terms of quality, safety and efficacy through comprehensive testing and analysis. While biosimilars may provide reduced costs and increased access to biologic treatments, they are more complex than traditional small molecule drugs due to differences in size, structure, manufacturing processes, and potential for immunogenicity. Thorough evaluation and regulation is required to ensure biosimilars are interchangeable for the reference product without compromising patient safety.
Drug discovery clinical evaluation of new drugsKedar Bandekar
The document discusses the process of new drug development from initial idea to market launch. It takes 12-15 years and over $1 billion. The process involves identifying a biological target, screening compounds to find hits, optimizing hits to develop leads, and conducting preclinical and clinical trials. Key steps include target identification and validation, high-throughput screening to find initial hits, hit-to-lead and lead optimization processes to improve properties, and three phases of clinical trials to test safety and efficacy in humans. Characteristics of ideal lead compounds include high target affinity and selectivity, drug-like properties, and favorable absorption and toxicity profiles.
Drug discovery clinical evaluation of new drugsKedar Bandekar
The document discusses the process of new drug development from initial idea to market launch. It takes 12-15 years and over $1 billion. The process involves identifying a biological target, screening compounds to find hits, optimizing hits to develop leads, and conducting preclinical and clinical trials. Key steps include target identification and validation, high-throughput screening to find initial hits, hit-to-lead and lead optimization processes to improve properties, and progression through preclinical and clinical phases of drug development. Characteristics of ideal lead compounds include high target affinity and selectivity, efficacy, appropriate physicochemical properties, and favorable ADME profile.
Assn. for molecular pathology vs. mtriad genetics case studyAltacit Global
This document summarizes a case study on the lawsuit between the Association for Molecular Pathology and Myriad Genetics regarding patents on the BRCA1 and BRCA2 genes. Myriad's scientists discovered the genes linked to breast cancer in 1994 and were granted patents. However, a lawsuit challenged the patents, arguing that genes cannot be patented. While a district court invalidated Myriad's patents, an appeals court upheld them. Ultimately, the US Supreme Court ruled that isolated DNA is not patentable subject matter, invalidating Myriad's patents.
In view of the U.S. approval process for biosimilars, companies are gearing up to either produce their own biosimilar products, or to defend against their entry onto the market. While the Biologics Price Competition and Innovation Act (BPCIA) spells out many of the requirements, the pathway for approval is complicated. Our panel of experts discuss the features of the BPCIA and how it operates for both approved biologics as well as biosimilar entrants. They also make some predictions on its impact for life science companies.
The webinar is 60 minutes, complete with Q&A.
Scientific Validity of Replacements for Animal-Derived AntibodiesRebeccaClewell
Summary of the recommendations by the EURL-ECVAM Scientific Advisory Committee (ESAC) on the Scientific Validity of Replacements for Animal-Derived Antibodies. Presented at the ICCVAM Communities of Practice Webinar 2020, "Use of Animal-free Affinity Reagents", January 2020.
Presentation at the Biosimilars and Follow-On Biologics 2014 Americas Conference, sponsored by Paradigm Global Events, February 12, 2014. Presentation focused on:
•Interchangeability
•State Substitution Laws
•Naming
•Risk Evaluation & Mitigation Strategies (REMS) and Their Impact on Biosimilars
•Where FDA Stands on Biosimilars
Similar to Issac Patent Eligibility Presentation Mid Winter Orlando 2015 (20)
1. 11
AIPLA
Firm Logo
American Intellectual Property Law Association
More Fun with §101 – A Prosecution Perspective
for Biotechnology Derived Innovation
Roy P. Issac, Ph.D., J.D.
IP Practice in Japan – Pre-Meeting at AIPLA Mid-Winter Institute
Orlando, Florida
January 27, 2015
2. 22
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Disclaimer
This presentation is intended for educational
purposes only. It is not intended to convey legal
advice pertaining to any particular situation and is
not a substitute for legal advice.
3. 33
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USPTO Guidance: A Streamlined Approach
• Product claims– Apply the markedly different
characteristics test (Chakrabarty test)
– If the claims do not meet the Chakrabarty test, apply the
significantly more test from Myriad.
• Process/Method claims–Apply the Mayo/ Alice test
Well-understood
Routine
Conventional
Inventive concept
Significantly more
4. 44
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Myriad v. Ambry Uses the Same Bifurcated Approach
• Soon after the PTO Guidance was published, the Federal
Circuit’s opinion in Myriad v. Ambry was issued.
• Case involved product claims directed to primers and
method claims directed to screening for BRCA1 mutation
by comparing a patient’s gene sequence with a germline
BRCA sequence.
• Both sets of claims were held patent ineligible.
• The Court applied the Chakrabarty approach for primers
and the Mayo/Alice approach for the method claims.
5. 55
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PTO Guidance: Focus on pre-emption
• Determine whether an element in the claim
directed to a law of nature, natural phenomenon or
abstract idea will tie-up the subject matter and pre-
empt others from using the judicial exception.
• Argue how the additional elements in the claim
limit the law of nature, natural phenomenon or
abstract idea such that not all uses are pre-
empted.
6. 66
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PTO Guidance: For products, apply the markedly
different characteristics test
• Dissection Analysis: The markedly different characteristics test
is applied to the nature-based product limitations, not for the
claim as a whole.
• However, care should be taken not to overly extend the
markedly different characteristics analysis to products that when
viewed as a whole are not nature-based.
• Changes that are incidental to isolation is not enough.
• E.g. A claim directed to an artificial hip prosthesis coated with a
naturally occurring mineral is not an attempt to tie up the mineral.
Here, the claim is analyzed as a whole and determined that the
prosthesis when viewed as a whole is not nature-based.
7. 77
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PTO Guidance: Markedly Different Characteristics
• Difference in structure, function and/or other properties
• Even a small change can result in markedly different
characteristics.
• Purified or isolated products will be eligible when there is a
resultant change in characteristics sufficient to show a marked
difference.
• Biological/ pharmaceutical function or activities
• Chemical or physical properties
• Phenotype including functional and structural characteristics
8. 88
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Examples of Nature-Based Products That Will Likely Meet
the Markedly Different Characteristics Test
• Genetically modified organisms (Diamond v. Chakrabarty)
– Organisms that have been modified to be genetically different from
any natural organism such as e.g. insertion of vectors encoding and
expressing one or more exogenous genes.
– Organisms that have been modified to be biologically or
phenotypically different from any natural organism in the absence of
genetic engineering e.g. organisms subjected to different growth
conditions resulting in some phenotypic difference or cloned
animals having a phenotypic difference such as altered telomeres.
9. 99
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Examples of Nature-Based Products That Will Likely Meet
the Markedly Different Characteristics Test
• cDNA (AMP v. Myriad Sup. Ct. 2013)
– Nucleic Acids
• Non-naturally occurring nucleic acid sequences of a native
sequence wherein one or more nucleotides have been modified
(e.g. tagged nucleic acids, modified bases), deleted, inserted,
substituted) such that there is no naturally occurring counterpart.
• Codon optimized nucleic acid sequences of native nucleic acid
sequences so long as the codon optimized sequence is not
identical to any native sequence.
• Nucleic acids having modified internucleotide linkages (e.g.
phosphorothioate internucleotide linkages).
• Vectors that are not identical to naturally occurring plasmids.
10. 1010
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– Proteins
• Non-naturally occurring crystal structures of natural proteins
• Non-naturally occurring glycosylation of natural proteins
• Unglycosylated forms of natural proteins (such as a eukaryotic protein
produced in a prokaryotic cell).
• Non-naturally occurring amino acid sequences of natural proteins
resulting from e.g. amino acid substitution, insertion deletion, or
presence of a non-naturally occurring or chemical modified amino acid.
• Non-naturally occurring fusion proteins (e.g. recombinantly produced
fusion proteins of two different genes not otherwise found fused
together in nature).
• Circularly permuted proteins (e.g. wherein the amino acid structure of a
proteins is altered to provide a new N- and C-terminus).
Examples of Nature-Based Products That Will Likely Meet
the Markedly Different Characteristics Test
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Examples of Nature-Based Products That Will Likely Meet
the Markedly Different Characteristics Test
– Cells
• Cells that are genotypically different from any naturally occurring
cell
• Cells that are phenotypically different from any naturally occurring
cell
• Combinations of naturally occurring cells and unnaturally
occurring cells resulting in different biological properties of the
combination.
• Hybrid plants (J. E. M. Ag Supply v. Pioneer Hi-Bred Sup. Ct. 2001)
12. 1212
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PTO Guidance: Significantly More
• If the markedly different characteristics test cannot be met
for the claim element directed to nature-based product,
apply the significantly more test from Myriad.
• Do additional elements add significantly more?
• Is there an element or a combination of elements sufficient
to ensure that the claims amount to significantly more than
the judicial exception?
13. 1313
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PTO Guidance: Significantly More
• What types of additional elements will be considered
sufficient to meet the significantly more test is not clear.
• It is also not clear whether conventional elements can meet
the significantly more standard.
– For instance, will buffers or carriers in a pharmaceutical formulation
be considered sufficient to meet the significantly more standard for
a formulation containing a nature-based product.
14. 1414
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• Does any element, or combination of elements, in the claim
is sufficient to ensure that the claim amounts to significantly
more than the judicial exception.
– Here the claim elements are analyzed by dissecting the judicial
exception out of the claim and determining if the additional elements
add sufficiently more.
• Inventive concept: Does the claim as a whole amount to
significantly more than the exception itself?
– Claim is analyzed as a whole.
– “It is important to consider the claim as a whole. Individual
elements viewed on their own may not appear to add significantly
more to the claim, but when combined may amount to significantly
more than the exception.”
PTO Guidance: Method Claims
15. 1515
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Back to the Myriad v. Ambry Decision
• The Court held that claims directed to short single stranded
DNA primers were not patent eligible since they were
“structurally identical to the ends of DNA strands found in
nature.”
• In case of screening method claims, the Court determined
that the additional elements apart from the DNA sequence
itself were directed to “well-understood, routine and
conventional activity.”
16. 1616
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Myriad v. Ambry: Primers
• Primers are not distinguishable from the isolated DNA
found patent-ineligible in Myriad.
• Structurally identical to the ends of DNA strands found in
nature.
• No weight given to the fact that the sequences are
synthetically replicated.
• Separating DNA from its surrounding genetic material is not
an act of invention.
• Myriad argued that primers have fundamentally different
function than when the sequence is part of the DNA strand.
17. 1717
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• However, the Court found that the naturally occurring
sequences do not perform a significantly new function.
• “A DNA structure with a function similar to that found in
nature can only be patent eligible as a composition of
matter if it has a unique structure, different from anything
found in nature.”
Myriad v. Ambry: Primers
18. 1818
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Claim 7: A method for screening germline of a human subject for an alteration of a BRCA1 gene which
comprises comparing germline sequence of a BRCA1 gene or BRCA1 RNA from a tissue sample from
said subject or a sequence of BRCA1 cDNA made from mRNA from said sample with germline sequences
of wild-type BRCA1 gene, wild-type BRCA1 RNA or wild-type BRCA1 cDNA, wherein a difference in the
sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA of the subject from wild-type indicates an
alteration in the BRCA1 gene in said subject[,]
wherein a germline nucleic acid sequence is compared by hybridizing a BRCA1 gene probe which
specifically hybridizes to a BRCA1 allele to genomic DNA isolated from said sample and detecting the
presence of a hybridization product wherein a presence of said product indicates the presence of said
allele in the subject.
“Do the patent claims add enough to their statements of the
correlations to allow the processes they describe to qualify as
patent-eligible processes that apply natural laws?”
Myriad v. Ambry: Screening Method Claims
19. 1919
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• Are “the remaining elements, either in isolation or
combination with the other non-patent-ineligible elements,
sufficient to “transform the nature of the claim” into a
patent-eligible application.”
• Abstract mental steps are not enough.
– Compare
– Analyze
– Determine
• The first paragraph of the claim is directed to patent
ineligible abstract idea of comparing BRCA sequences and
determining the existence of alterations.
Myriad v. Ambry: Screening Method Claims
20. 2020
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• Methods directed to identification of alterations of the gene,
require merely comparing the patient’s gene with the wild-
type and identifying any differences.
• The number of covered comparisons is unlimited.
• The covered comparisons are not restricted by the purpose
of the comparison or the alteration detected.
Myriad v. Ambry: Screening Method Claims
21. 2121
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• The second paragraph of the claim adding particular
mechanisms of comparison are analyzed to see if they
transform the claim into a patent-eligible application.
• Additional elements
– Hybridizing a BRCA gene probe
– Detecting the presence of a hybridization product
– Amplification of BRCA1 gene
– Sequencing amplified nucleic acids
• Additional elements “do not add enough to make the claims
as a whole patent-eligible.”
Myriad v. Ambry: Screening Method Claims
22. 2222
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• Additional elements are not enough because, they “set
forth well-understood, routine and conventional activity
engaged in by scientists at the time of Myriad’s
applications.”
Myriad v. Ambry: Screening Method Claims
23. 2323
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Back to PTO Guidance: Examples of Nature-Based
Products That Meet Patent Eligibility Requirements
• Combinations of nature-based products that exhibit new
functionality or characteristics
– Gunpowder where new functional characteristics of explosiveness
is not present in individual ingredients.
• Combinations of nature-based product with additional
agents that provide additional characteristics
– E.g. Pomelo juice with added preservatives.
• Formulations with nature-based product
– E.g., Amazonic acid with solubilizing agent
• Method of treating cancer with nature-based product
– E.g., Treating cancer with amazonic acid.
24. 2424
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Back to PTO Guidance: Examples of Nature-Based
Products That Meet Patent Eligibility Requirements
• Purified proteins
– Purified antibiotics
– Proteins expressed in recombinant yeast
– Proteins with point mutations
• Genetically modified bacterium
• Bacterial mixtures
– If the combination provides a mixture with additional
functional properties.
• Nucleic acids
– At least one substitution or modification compared to that
exists in nature.
25. 2525
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Back to PTO Guidance: Examples of Nature-Based
Products That Meet Patent Eligibility Requirements
• Antibodies
– E.g. Human antibodies to bacterial protein.
• Cells
– E.g. Isolated human pacemaker cell expressing marker Z
26. 2626
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Take Home Points
• Product claims are largely governed by the “markedly different
characteristics” test.
• Determine when to analyze the claim as a whole and when to
focus on the nature-based product element.
• Have a series of narrow claims that add additional claim
elements that specify methods of characterizing, comparing etc.
• Determine if the changes to a nature-based product is “merely
incidental to isolation.”
• AMP v. Myriad may be limited to cases where the changes for a
nature-based product are those “merely incidental to isolation.”
28. 2828
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Questions?
Roy P. Issac, Ph.D., J.D.
Elmore Patent Law Group, P.C.
484 Groton Rd.
Westford, MA 01886
978.251.3501
rissac@elmorepatents.com
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