This presentation discusses the patent application disclosure requirements under 35 U.S.C. Section 112 and relates, in particular, to the Supreme Court and Federal Circuit case law relevant to patent specifications and claims protecting inventions in the life sciences, biotechnology, and pharmaceutical industries
The document discusses the disclosure requirements for biotechnology patents under 35 USC § 112. It covers topics like enablement, written description, and the statutory disclosure requirements. It summarizes several relevant court cases, including In re Wright, UC v. Eli Lilly, Enzo v. Gen-Probe, Chiron v. Genentech, and U. of Rochester v. Searle. The cases discuss how broad claims require broad disclosure, and that the specification must demonstrate possession of the full scope of the claims, including after-arising technologies. Undue experimentation and claims of undue breadth can result in lack of enablement.
Transhumanismo y Mejoramiento Genético mediante CRISPRBioeticared
This document discusses CRISPR gene editing technology, including its origins and development, applications for therapeutic purposes, and debates around its use. It describes how CRISPR uses a guide RNA and Cas9 protein to cut DNA in a targeted way. While promising for treating genetic diseases, some argue its use in human embryos or germline cells raises safety and ethical issues due to risks of uncontrolled errors passing to future generations. Transhumanists support modifying the germline to induce enhanced traits, but this remains controversial.
The document is a United States patent describing methods for producing recombinant coronavirus particles. Specifically, it describes developing a helper cell that contains: 1) a coronavirus permissive cell; 2) a coronavirus replicon RNA containing a heterologous sequence and packaging signal but lacking a structural protein gene; and 3) a separate helper RNA encoding the missing structural protein. When these components are expressed in the cell, coronavirus particles are assembled that contain the heterologous RNA sequence but cannot replicate without the helper RNA. The patent claims compositions and methods for making and using these viral particles to deliver heterologous genes.
Biotechnology Patents: Utility and eligibility requirements under 35 USC 101. This presentation follows the historical development of the utility requirement from the early 19th century case Lowell v. Lewis (MA 1817), the origin of the specific, substantial, and credible standard for a patent disclosure from Brenner v. Manson (SCOTUS 1966), and the modern application of the Brenner standard for biotechnology patents in In re Fisher (Fed. Cir. 2005). Biotechnology eligibility requirements are discussed from the early Supreme Court case Funk Brothers v. Kalo, the seminal biotechnology Supreme Court case Diamond v. Chakrabarty (SCOTUS 1980) where the court holds that statutory subject matter includes "anything under the sun that is made by man," through the recent Supreme Court decision in Myriad v. ACLU (SCOTUS 2013) where the court held that diagnostic method claims and nucleic acid claims that read on products of nature are patent inelibible. Practice tips are provided to ensure that patent claims avoid the exceptions of 35 USC 101 and withstand scrutiny during litigation and business transactions, such as licensing.
Test slide for the lab - Target prioritization Maori Ito
This document discusses candidate gene prioritization for large-scale experiments. It notes that there are challenges in combining available information from different data sources due to lack of annotations for individual genes. The process involves taking many candidate genes as input and applying integrated knowledge discovery to output a smaller number of selected target genes.
Chapter 1 history of genetic engineeringHikmetGeckil1
This document provides a history of genetic engineering from prehistoric times to modern applications. It discusses early discoveries and experiments in genetics from Gregor Mendel in 1865 to James Watson and Francis Crick discovering the DNA structure in 1953. Major milestones included the development of restriction enzymes in 1969 and recombinant DNA techniques in 1972. Since the 1970s, genetic engineering has been commercialized for producing foods, medicines, and other applications. The latest advances include gene editing, RNA interference, and clinical uses of modified cells.
This document discusses genetic engineering and DNA technology. It explains that genetic engineering involves manipulating DNA, such as splicing genes from one organism into another. This allows genes to be mass produced using bacteria or inserted into organisms to improve their traits. Examples are given of inserting human genes into bacteria to produce insulin or "glowing" plants created with bioluminescent genes. Concerns discussed include the debate over GMOs in food, ownership of patented life forms, and long term effects on human health and the environment.
This esteemed panel of leading patent experts, included members of the European Patent Office, addressed U.S. and European perspectives on patenting stem cells, genes, and medical uses, as well as other ethical and legal issues.
The document discusses the disclosure requirements for biotechnology patents under 35 USC § 112. It covers topics like enablement, written description, and the statutory disclosure requirements. It summarizes several relevant court cases, including In re Wright, UC v. Eli Lilly, Enzo v. Gen-Probe, Chiron v. Genentech, and U. of Rochester v. Searle. The cases discuss how broad claims require broad disclosure, and that the specification must demonstrate possession of the full scope of the claims, including after-arising technologies. Undue experimentation and claims of undue breadth can result in lack of enablement.
Transhumanismo y Mejoramiento Genético mediante CRISPRBioeticared
This document discusses CRISPR gene editing technology, including its origins and development, applications for therapeutic purposes, and debates around its use. It describes how CRISPR uses a guide RNA and Cas9 protein to cut DNA in a targeted way. While promising for treating genetic diseases, some argue its use in human embryos or germline cells raises safety and ethical issues due to risks of uncontrolled errors passing to future generations. Transhumanists support modifying the germline to induce enhanced traits, but this remains controversial.
The document is a United States patent describing methods for producing recombinant coronavirus particles. Specifically, it describes developing a helper cell that contains: 1) a coronavirus permissive cell; 2) a coronavirus replicon RNA containing a heterologous sequence and packaging signal but lacking a structural protein gene; and 3) a separate helper RNA encoding the missing structural protein. When these components are expressed in the cell, coronavirus particles are assembled that contain the heterologous RNA sequence but cannot replicate without the helper RNA. The patent claims compositions and methods for making and using these viral particles to deliver heterologous genes.
Biotechnology Patents: Utility and eligibility requirements under 35 USC 101. This presentation follows the historical development of the utility requirement from the early 19th century case Lowell v. Lewis (MA 1817), the origin of the specific, substantial, and credible standard for a patent disclosure from Brenner v. Manson (SCOTUS 1966), and the modern application of the Brenner standard for biotechnology patents in In re Fisher (Fed. Cir. 2005). Biotechnology eligibility requirements are discussed from the early Supreme Court case Funk Brothers v. Kalo, the seminal biotechnology Supreme Court case Diamond v. Chakrabarty (SCOTUS 1980) where the court holds that statutory subject matter includes "anything under the sun that is made by man," through the recent Supreme Court decision in Myriad v. ACLU (SCOTUS 2013) where the court held that diagnostic method claims and nucleic acid claims that read on products of nature are patent inelibible. Practice tips are provided to ensure that patent claims avoid the exceptions of 35 USC 101 and withstand scrutiny during litigation and business transactions, such as licensing.
Test slide for the lab - Target prioritization Maori Ito
This document discusses candidate gene prioritization for large-scale experiments. It notes that there are challenges in combining available information from different data sources due to lack of annotations for individual genes. The process involves taking many candidate genes as input and applying integrated knowledge discovery to output a smaller number of selected target genes.
Chapter 1 history of genetic engineeringHikmetGeckil1
This document provides a history of genetic engineering from prehistoric times to modern applications. It discusses early discoveries and experiments in genetics from Gregor Mendel in 1865 to James Watson and Francis Crick discovering the DNA structure in 1953. Major milestones included the development of restriction enzymes in 1969 and recombinant DNA techniques in 1972. Since the 1970s, genetic engineering has been commercialized for producing foods, medicines, and other applications. The latest advances include gene editing, RNA interference, and clinical uses of modified cells.
This document discusses genetic engineering and DNA technology. It explains that genetic engineering involves manipulating DNA, such as splicing genes from one organism into another. This allows genes to be mass produced using bacteria or inserted into organisms to improve their traits. Examples are given of inserting human genes into bacteria to produce insulin or "glowing" plants created with bioluminescent genes. Concerns discussed include the debate over GMOs in food, ownership of patented life forms, and long term effects on human health and the environment.
This esteemed panel of leading patent experts, included members of the European Patent Office, addressed U.S. and European perspectives on patenting stem cells, genes, and medical uses, as well as other ethical and legal issues.
DNA Technology 2 genetic engineering notesRobin Seamon
This document provides an overview of genetic engineering and biotechnology concepts through a series of slides. It discusses how DNA from different organisms can be spliced together, and how genetic engineering involves manipulating genes. Examples are given of inserting select genes into organisms to improve traits or have them mass produce certain proteins. The document also summarizes gene cloning techniques like PCR and discusses applications of genetic engineering in medicine, agriculture, and animal science. Ethical considerations around topics like patenting life forms and conducting safety research are also briefly outlined.
This patent document describes the isolation and characterization of a novel human coronavirus (SARS-CoV) that is the causative agent of severe acute respiratory syndrome (SARS). It provides the nucleic acid sequence of the SARS-CoV genome and the amino acid sequences of its open reading frames. Methods are described for using these molecules to detect SARS-CoV and detect infections. Immune stimulatory compositions are also provided, along with methods for their use.
Cure Lab is developing novel anti-cancer vaccines and oncolytic viruses to treat cancer. They have a pipeline of products including an oncolytic virus and immunostimulant that have competitive advantages over existing treatments. With $10M of investment, they aim to finalize clinical testing in the Former USSR and license their products to big pharma for over $1B, valuing the company at over $1B. Cure Lab has collaborations with universities worldwide and plans to conduct pre-clinical and clinical testing in the Former USSR while developing future products in the US.
This document summarizes research on the immune response to Lassa virus (LASV) infection. It finds that LASV is able to impair the immune system through several mechanisms. Antibody profiles show an early IgM response directed mostly at the LASV nucleoprotein, while the IgG response is delayed. Cytokine levels are dysregulated early in infection but become quiescent once antibodies develop. LASV's nucleoprotein exhibits exonuclease activity that impacts immune signaling pathways like TLR3. These immune evasion mechanisms allow LASV to establish infection and cause Lassa fever.
This document discusses genetic engineering and DNA technology. It explains that genetic engineering involves manipulating DNA from different organisms by splicing genes together or inserting select genes. This allows genes to be engineered for mass production in organisms like bacteria. Examples given include producing human insulin in E. coli and creating glowing plants. The document also discusses genetic modification of crops, animal cloning, stem cells, and debates around genetic engineering.
- All primer sets were able to successfully amplify mtDNA from ancient goose samples into the correct size fragments. Two samples were identified as specific bird species.
- Universal primer sets were designed that could identify over 97% of North American bird species from mtDNA, through amplifying variable regions of the COI gene. Four primer sets allow for sequential testing to identify unknown samples.
- The primers were tested on ancient goose and other unknown bird samples, identifying several to the species level through DNA sequencing and BLAST searches. The primers provide a tool for identifying bird remains when morphology alone is insufficient.
129 andrew z. fire - 8283329 - genetic inhibition of double-stranded rnaMello_Patent_Registry
Andrew Z. Fire, Stephen A. Kostas, Mary K. Montgomer, Lisa Timmons, SiQun Xu, Hiroaki Tabara, Samuel E. Driver, Craig C. Mello - Genetic Inhibition of Double-Stranded RNA
THE FRONTIERS OF MONOPOLIZATION OF HUMAN GENESSaravanan A
This document outlines and discusses issues around the patenting of human genes. It begins with a brief history of genetics and gene patenting. Gene patents are controversial as genes are part of nature but are also seen as innovations that deserve intellectual property protection. The document then examines some of the most controversial gene patents granted, such as for the BRCA1 and BRCA2 genes linked to breast cancer. Both pros and cons of gene patents are presented around whether they encourage research and development or pose ethical issues. Statistics on the large number of human genes patented are also provided. The document concludes that the debate around gene patenting will continue as courts and society discuss the legal and moral implications.
Discovering my research interest by eric garson sheffield university 2017Eric Garson
1) The document describes the author's process of discovering his research interest in targeting specific cell types in the brain using viral vectors and manipulating their tropism.
2) It outlines experiments using organotypic slice cultures of rat cerebellum to test the ability of cathepsin K and its inhibitor to shift the tropism of lentiviral vectors toward Bergmann glia or Purkinje neurons, but the results were inconclusive.
3) Going forward, the author is interested in developing more targeted approaches using cell-type specific pseudotyping, promoters, or microRNA sequences to modify viral tropism and enable gene delivery to specific cells involved in diseases
This document provides an overview of the history and development of biotechnology from ancient times to the present. It discusses how biotechnology has evolved from traditional techniques like selective breeding and fermentation used since ancient civilizations to the modern use of recombinant DNA and genetic engineering. It outlines major milestones like the discovery of DNA's structure, development of techniques like PCR and monoclonal antibodies, and completion of the Human Genome Project. The document serves to give context around the field of biotechnology and how it has advanced over time.
This document summarizes key concepts regarding the enablement and written description requirements under 35 U.S.C. 112 for biotechnology patent applications. It discusses the level of disclosure needed to enable various claim scopes, such as claims to protein families defined by percent identity. It also analyzes several court cases that have shaped the written description doctrine, including the establishment of written description as a separate validity requirement from enablement.
Life science patents have grown increasingly vulnerable to rejection and invalidation due to subject matter eligibility and enablement interpretations. The implications are staggering with over 80% of abandoned life science applications having a final rejection stating that the innovation did not include patentable subject matter. In this talk, we’ll explore how to avoid these rejections, understand the implications for new drugs, and provide practical tips for creating robust life science patents.
The document summarizes new patent issues surrounding therapeutic antibodies. It discusses how antibodies have become a major class of therapeutic drugs and outlines key cases that have shaped patent law in this area. The document focuses on issues of enablement, written description, obviousness, and anticipation as the law has evolved to address emerging antibody technologies. It analyzes several important court cases and how they have impacted what can be claimed and whether certain claims have adequate support or are invalid. The document also raises questions about current issues like subgeneric claims and selection of antibody leads during research.
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.
Think your innovation is sufficiently enabled to secure, defend, and assert your patent rights? If it’s a biological, chemical, or emerging technology invention then you might want to think again. In today’s episode we’re looking into how to get more predictable results from the unpredictable arts.
Some technologies, like those rooted in physics and mechanics, are considered “predictable” by the US Patent Office, while others, like biological and chemical technologies, are generally considered “unpredictable.” It follows that the amount of disclosure required to enable an invention is related to the predictability of the technology, and so-called unpredictable arts require more description to teach a reader how to “make and use” the technology. Similarly, emerging technologies, being less well known, also require more disclosure to be fully enabled.
In this month’s episode, David Jackrel, President of Jackrel Consulting, leads a discussion along with our all star patent panel, exploring enablement for the unpredictable arts and emerging technologies. The panel discusses peculiarities of patenting unpredictable art and emerging technologies, with a focus on modern case law and statutes to arrive at a set of best practices for getting more predictable results when patenting these technologies.
Dave is also joined today by our always exceptional group of IP experts including:
⦿ Dr. Ashley Sloat, President and Director of Patent Strategy at Aurora
⦿ Kristen Hansen, Patent Strategist at Aurora
⦿ Shelley Couturier, Patent Strategist and Search Specialist
Before joining the group, as we often do, we’d like to provide a short primer on some key concepts in this episode for those newer to the world of patenting. This primer covers:
⦿ Section 112
⦿ What is the MPEP?
⦿ Specification vs. Claims
⦿ Genus vs. Species Claims
⦿ Markush Groups
The document discusses the implications of the Federal Circuit's decision in Ariad v. Eli Lilly, which reaffirmed that 35 U.S.C. 112 contains both a written description requirement and an enablement requirement. The decision clarifies that the written description requirement mandates that the inventor demonstrate possession of the full scope of the claimed invention by sufficiently describing it within the specification. For broad claims encompassing genera, the specification must describe a sufficient variety of species to evidence possession.
We’re leading off Season 3 with a close look at a Supreme Court patent case that could have profound impacts on the invention enablement problems we covered heavily in Season 2. SCOTUS is set to hear opening arguments in Amgen v Sanofi on March 27th. For the first time in over 75 years, the Supreme Court is evaluating the meaning and scope of the enablement requirement. For those who’ve been following along, you’ll know that this has become one of the bigger issues plaguing patenting and especially so in the life sciences.
Dr. Ashley Sloat, President and Director of Patent Strategy at Aurora, leads our discussion today along with our all star patent panel, exploring the scientific background around antibodies necessary to understand the claims, a brief case history of Amgen v Sanofi, an overview of the enablement factors and tests that have been historically applied in courts and how they might apply to this case, and a discussion around open questions and the potential unintended consequences of the Supreme Court only taking up one-half of the two-sided enablement coin. This ends up being a really great, spirited conversation with panel members coming down strongly on both sides of the case with very compelling arguments – really highlighting the complexities and fundamental issues the court will have to face.
Ashley is joined today by our always exceptional group of IP experts including:
⦿ David Cohen, Principal at Cohen Sciences
⦿ Kristen Hansen, Patent Strategist at Aurora
⦿ David Jackrel, President of Jackrel Consulting
⦿ Ty Davis, Patent Strategy Associate at Aurora
The document discusses the past, present, and future of patenting antibodies. It summarizes key court cases around patenting antibodies and the technologies involved. Additionally, it addresses current issues regarding freedom-to-operate for antibody technologies and explores how antibody patenting may evolve in the future as the technology continues to advance. Therapeutic antibodies have become a major market but also face increasing competition, so maintaining a strong patent portfolio is important to protect investments and maximize value.
The document discusses biotechnology patents and subject matter exclusions. It provides learning objectives about how biotechnology has helped develop innovative products and the role of patents. It examines the origins of biotech patenting, patent eligibility under TRIPS, and provisions in Indian patent law regarding biotech subject matter eligibility. It describes modern biotechnology applications, biotech products, and challenges in distinguishing discoveries from inventions eligible for patents. It discusses early biotech patent cases from the US and EPO regarding gene sequences, mixed bacterial cultures, and transgenic animals.
The intellectual property landscape of the human genomeKyle Jensen
The document analyzes the intellectual property landscape of the human genome. It finds that over 4,000 of the approximately 23,000 genes in the human genome are claimed in granted U.S. patents. Most patented genes are involved in cancer and cellular processes, and the institutions holding the most gene-related patents are biotech companies and research institutes rather than large pharmaceutical firms.
The Federal Circuit ruled that isolated DNA sequences are patent eligible under Section 101. The court found that isolated DNA sequences are distinct chemical molecules compared to DNA in nature. However, the court ruled that method claims covering abstract mental processes of comparing DNA sequences were not patent eligible. The decision maintains that isolated DNA can be patented but limits the patentability of certain diagnostic method claims.
1) Incyte Genomics pursued an ambitious business model and patent strategy in the late 1990s and early 2000s that involved sequencing the human genome, patenting gene sequences, and selling subscriptions to genomic databases and licensing the patents.
2) A key part of the strategy was filing over 2,000 patent applications covering about 11,000 human gene sequences to generate licensing revenues, but this strategy faced challenges from the US Patent Office's utility requirement.
3) In 2004, Incyte abandoned its original business model and patent strategy after the US Patent Office rejected many of its patent applications for lack of demonstrating utility and specific and substantial real world use for the gene sequences.
DNA Technology 2 genetic engineering notesRobin Seamon
This document provides an overview of genetic engineering and biotechnology concepts through a series of slides. It discusses how DNA from different organisms can be spliced together, and how genetic engineering involves manipulating genes. Examples are given of inserting select genes into organisms to improve traits or have them mass produce certain proteins. The document also summarizes gene cloning techniques like PCR and discusses applications of genetic engineering in medicine, agriculture, and animal science. Ethical considerations around topics like patenting life forms and conducting safety research are also briefly outlined.
This patent document describes the isolation and characterization of a novel human coronavirus (SARS-CoV) that is the causative agent of severe acute respiratory syndrome (SARS). It provides the nucleic acid sequence of the SARS-CoV genome and the amino acid sequences of its open reading frames. Methods are described for using these molecules to detect SARS-CoV and detect infections. Immune stimulatory compositions are also provided, along with methods for their use.
Cure Lab is developing novel anti-cancer vaccines and oncolytic viruses to treat cancer. They have a pipeline of products including an oncolytic virus and immunostimulant that have competitive advantages over existing treatments. With $10M of investment, they aim to finalize clinical testing in the Former USSR and license their products to big pharma for over $1B, valuing the company at over $1B. Cure Lab has collaborations with universities worldwide and plans to conduct pre-clinical and clinical testing in the Former USSR while developing future products in the US.
This document summarizes research on the immune response to Lassa virus (LASV) infection. It finds that LASV is able to impair the immune system through several mechanisms. Antibody profiles show an early IgM response directed mostly at the LASV nucleoprotein, while the IgG response is delayed. Cytokine levels are dysregulated early in infection but become quiescent once antibodies develop. LASV's nucleoprotein exhibits exonuclease activity that impacts immune signaling pathways like TLR3. These immune evasion mechanisms allow LASV to establish infection and cause Lassa fever.
This document discusses genetic engineering and DNA technology. It explains that genetic engineering involves manipulating DNA from different organisms by splicing genes together or inserting select genes. This allows genes to be engineered for mass production in organisms like bacteria. Examples given include producing human insulin in E. coli and creating glowing plants. The document also discusses genetic modification of crops, animal cloning, stem cells, and debates around genetic engineering.
- All primer sets were able to successfully amplify mtDNA from ancient goose samples into the correct size fragments. Two samples were identified as specific bird species.
- Universal primer sets were designed that could identify over 97% of North American bird species from mtDNA, through amplifying variable regions of the COI gene. Four primer sets allow for sequential testing to identify unknown samples.
- The primers were tested on ancient goose and other unknown bird samples, identifying several to the species level through DNA sequencing and BLAST searches. The primers provide a tool for identifying bird remains when morphology alone is insufficient.
129 andrew z. fire - 8283329 - genetic inhibition of double-stranded rnaMello_Patent_Registry
Andrew Z. Fire, Stephen A. Kostas, Mary K. Montgomer, Lisa Timmons, SiQun Xu, Hiroaki Tabara, Samuel E. Driver, Craig C. Mello - Genetic Inhibition of Double-Stranded RNA
THE FRONTIERS OF MONOPOLIZATION OF HUMAN GENESSaravanan A
This document outlines and discusses issues around the patenting of human genes. It begins with a brief history of genetics and gene patenting. Gene patents are controversial as genes are part of nature but are also seen as innovations that deserve intellectual property protection. The document then examines some of the most controversial gene patents granted, such as for the BRCA1 and BRCA2 genes linked to breast cancer. Both pros and cons of gene patents are presented around whether they encourage research and development or pose ethical issues. Statistics on the large number of human genes patented are also provided. The document concludes that the debate around gene patenting will continue as courts and society discuss the legal and moral implications.
Discovering my research interest by eric garson sheffield university 2017Eric Garson
1) The document describes the author's process of discovering his research interest in targeting specific cell types in the brain using viral vectors and manipulating their tropism.
2) It outlines experiments using organotypic slice cultures of rat cerebellum to test the ability of cathepsin K and its inhibitor to shift the tropism of lentiviral vectors toward Bergmann glia or Purkinje neurons, but the results were inconclusive.
3) Going forward, the author is interested in developing more targeted approaches using cell-type specific pseudotyping, promoters, or microRNA sequences to modify viral tropism and enable gene delivery to specific cells involved in diseases
This document provides an overview of the history and development of biotechnology from ancient times to the present. It discusses how biotechnology has evolved from traditional techniques like selective breeding and fermentation used since ancient civilizations to the modern use of recombinant DNA and genetic engineering. It outlines major milestones like the discovery of DNA's structure, development of techniques like PCR and monoclonal antibodies, and completion of the Human Genome Project. The document serves to give context around the field of biotechnology and how it has advanced over time.
This document summarizes key concepts regarding the enablement and written description requirements under 35 U.S.C. 112 for biotechnology patent applications. It discusses the level of disclosure needed to enable various claim scopes, such as claims to protein families defined by percent identity. It also analyzes several court cases that have shaped the written description doctrine, including the establishment of written description as a separate validity requirement from enablement.
Life science patents have grown increasingly vulnerable to rejection and invalidation due to subject matter eligibility and enablement interpretations. The implications are staggering with over 80% of abandoned life science applications having a final rejection stating that the innovation did not include patentable subject matter. In this talk, we’ll explore how to avoid these rejections, understand the implications for new drugs, and provide practical tips for creating robust life science patents.
The document summarizes new patent issues surrounding therapeutic antibodies. It discusses how antibodies have become a major class of therapeutic drugs and outlines key cases that have shaped patent law in this area. The document focuses on issues of enablement, written description, obviousness, and anticipation as the law has evolved to address emerging antibody technologies. It analyzes several important court cases and how they have impacted what can be claimed and whether certain claims have adequate support or are invalid. The document also raises questions about current issues like subgeneric claims and selection of antibody leads during research.
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.
Think your innovation is sufficiently enabled to secure, defend, and assert your patent rights? If it’s a biological, chemical, or emerging technology invention then you might want to think again. In today’s episode we’re looking into how to get more predictable results from the unpredictable arts.
Some technologies, like those rooted in physics and mechanics, are considered “predictable” by the US Patent Office, while others, like biological and chemical technologies, are generally considered “unpredictable.” It follows that the amount of disclosure required to enable an invention is related to the predictability of the technology, and so-called unpredictable arts require more description to teach a reader how to “make and use” the technology. Similarly, emerging technologies, being less well known, also require more disclosure to be fully enabled.
In this month’s episode, David Jackrel, President of Jackrel Consulting, leads a discussion along with our all star patent panel, exploring enablement for the unpredictable arts and emerging technologies. The panel discusses peculiarities of patenting unpredictable art and emerging technologies, with a focus on modern case law and statutes to arrive at a set of best practices for getting more predictable results when patenting these technologies.
Dave is also joined today by our always exceptional group of IP experts including:
⦿ Dr. Ashley Sloat, President and Director of Patent Strategy at Aurora
⦿ Kristen Hansen, Patent Strategist at Aurora
⦿ Shelley Couturier, Patent Strategist and Search Specialist
Before joining the group, as we often do, we’d like to provide a short primer on some key concepts in this episode for those newer to the world of patenting. This primer covers:
⦿ Section 112
⦿ What is the MPEP?
⦿ Specification vs. Claims
⦿ Genus vs. Species Claims
⦿ Markush Groups
The document discusses the implications of the Federal Circuit's decision in Ariad v. Eli Lilly, which reaffirmed that 35 U.S.C. 112 contains both a written description requirement and an enablement requirement. The decision clarifies that the written description requirement mandates that the inventor demonstrate possession of the full scope of the claimed invention by sufficiently describing it within the specification. For broad claims encompassing genera, the specification must describe a sufficient variety of species to evidence possession.
We’re leading off Season 3 with a close look at a Supreme Court patent case that could have profound impacts on the invention enablement problems we covered heavily in Season 2. SCOTUS is set to hear opening arguments in Amgen v Sanofi on March 27th. For the first time in over 75 years, the Supreme Court is evaluating the meaning and scope of the enablement requirement. For those who’ve been following along, you’ll know that this has become one of the bigger issues plaguing patenting and especially so in the life sciences.
Dr. Ashley Sloat, President and Director of Patent Strategy at Aurora, leads our discussion today along with our all star patent panel, exploring the scientific background around antibodies necessary to understand the claims, a brief case history of Amgen v Sanofi, an overview of the enablement factors and tests that have been historically applied in courts and how they might apply to this case, and a discussion around open questions and the potential unintended consequences of the Supreme Court only taking up one-half of the two-sided enablement coin. This ends up being a really great, spirited conversation with panel members coming down strongly on both sides of the case with very compelling arguments – really highlighting the complexities and fundamental issues the court will have to face.
Ashley is joined today by our always exceptional group of IP experts including:
⦿ David Cohen, Principal at Cohen Sciences
⦿ Kristen Hansen, Patent Strategist at Aurora
⦿ David Jackrel, President of Jackrel Consulting
⦿ Ty Davis, Patent Strategy Associate at Aurora
The document discusses the past, present, and future of patenting antibodies. It summarizes key court cases around patenting antibodies and the technologies involved. Additionally, it addresses current issues regarding freedom-to-operate for antibody technologies and explores how antibody patenting may evolve in the future as the technology continues to advance. Therapeutic antibodies have become a major market but also face increasing competition, so maintaining a strong patent portfolio is important to protect investments and maximize value.
The document discusses biotechnology patents and subject matter exclusions. It provides learning objectives about how biotechnology has helped develop innovative products and the role of patents. It examines the origins of biotech patenting, patent eligibility under TRIPS, and provisions in Indian patent law regarding biotech subject matter eligibility. It describes modern biotechnology applications, biotech products, and challenges in distinguishing discoveries from inventions eligible for patents. It discusses early biotech patent cases from the US and EPO regarding gene sequences, mixed bacterial cultures, and transgenic animals.
The intellectual property landscape of the human genomeKyle Jensen
The document analyzes the intellectual property landscape of the human genome. It finds that over 4,000 of the approximately 23,000 genes in the human genome are claimed in granted U.S. patents. Most patented genes are involved in cancer and cellular processes, and the institutions holding the most gene-related patents are biotech companies and research institutes rather than large pharmaceutical firms.
The Federal Circuit ruled that isolated DNA sequences are patent eligible under Section 101. The court found that isolated DNA sequences are distinct chemical molecules compared to DNA in nature. However, the court ruled that method claims covering abstract mental processes of comparing DNA sequences were not patent eligible. The decision maintains that isolated DNA can be patented but limits the patentability of certain diagnostic method claims.
1) Incyte Genomics pursued an ambitious business model and patent strategy in the late 1990s and early 2000s that involved sequencing the human genome, patenting gene sequences, and selling subscriptions to genomic databases and licensing the patents.
2) A key part of the strategy was filing over 2,000 patent applications covering about 11,000 human gene sequences to generate licensing revenues, but this strategy faced challenges from the US Patent Office's utility requirement.
3) In 2004, Incyte abandoned its original business model and patent strategy after the US Patent Office rejected many of its patent applications for lack of demonstrating utility and specific and substantial real world use for the gene sequences.
The US Court of Appeals for the Federal Circuit issued a decision regarding the utility requirement for patents of expressed sequence tags (ESTs). The court affirmed the Patent and Trademark Office's rejection of a patent application for ESTs from corn plants. The majority found that the ESTs lacked a specific, substantial utility as required, as the application disclosed no information about the corresponding genes' structure or function. The court determined the disclosed potential uses for the ESTs, such as gene markers, were too generic and did not demonstrate real-world utility for the particular claimed ESTs. The decision confirmed that the utility standard under US patent law requires disclosure of a specific, practical benefit to satisfy the usefulness requirement.
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.
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Biotech Patentable Subject Matter After Bilskiwardjohn1346
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2. 35 U.S.C. § 112
Enablement and Written Description
• In Re Wright (Fed. Cir. 1993)
• U. of California v. Eli Lilly (Fed. Cir. 1997)
• Enzo v. Gen-Probe (Fed. Cir. 2002), Rader Dissent
• Chiron v. Genentech (Fed. Cir. 2004)
• Rochester v. Searle (Fed. Cir. 2004)
• Ariad v. Lilly (Fed. Cir. 2009), (Fed. Cir., en banc,
2010)
3. • 35 U.S.C. § 112, Specification
– Enablement
– Written Description
– Best Mode
The Statutory Patent Disclosure
Requirements
4. POST-AIA
35 U.S.C. § 112(a)
(a) In General.— The SPECIFICATION shall contain
a written description of the invention, and of
the manner and process of making and using it,
in such full, clear, concise, and exact terms as
to enable any person skilled in the art to
which it pertains … to make and use the same,
and shall set forth the best mode contemplated
by the inventor or joint inventor of carrying out
[[his]] the invention.
5. Enablement – Basic Concepts
A patent application must provide sufficient
disclosure to enable a person skilled in the art
to make and use the claimed invention
One skilled in the art would be enabled to
practice the claimed invention if:
• It would NOT require “undue experimentation” to
make and use the claimed invention
• The claims are NOT of “undue breadth” in view of
the scope of the disclosure provided by the
specification
6. Enablement – Basic Concepts
In re Wands (Fed. Cir. 1988): “The key word is
‘undue,’ not ‘experimentation’ ” Quoting In re
Angstadt (CCPA 1976)
• Quantity of experimentation
• Amount of direction and guidance provided
• Presence or absence of working examples
• Nature of the invention
• State of the prior art
• Relative skill of those in the art
• Predictability of the art
• Breadth of the claims
7. The Problem of Enablement in
Biotechnology
What is the scope of protection afforded by these
claims?
• A cDNA encoding Protein X, comprising the
nucleotide sequence of SEQ ID NO: 1.
(wherein SEQ ID NO: 1 encodes full-length Protein
X)
• A cDNA encoding Protein X, comprising a nucleotide
sequence that is at least 70% identical to the
nucleotide sequence of SEQ ID NO: 1.
How easy would it be for a third-party competitor to
escape the literal scope of these claims by “designing
around” with insubstantial nucleotide substitutions?
8. Amgen v. Chugai (Fed. Cir. 1991)
Teach how to make and use the claimed
invention such that it can be practiced by a
person of skill in the art without undue
experimentation
• Disclosure that is commensurate in scope
with the breadth of the claims
• Multiple working examples within the claim
scope
• Teaching of how to test additional
undisclosed variants within the claim scope
9. Amgen v. Chugai (Fed. Cir. 1991)
Make and Use Without Undue Experimentation
• Structural Limitations
−Provide algorithms for computing percent
identity
−Describe conservative amino acid
substitutions
• Functional Limitations
−Disclose assay systems and methodologies
for confirming claimed functionality
10. In Re Wright (Fed. Cir. 1993)
Claim 11
A live, non-pathogenic vaccine for a pathogenic
RNA virus, comprising an immunologically effective
amount of a viral antigenic, genomic expression
having an antigenic determinant region of the RNA
virus, but no pathogenic properties.
11. In Re Wright (Fed. Cir. 1993)
One Working Example
• A recombinant vaccine that confers
immunity in chickens against Prague Avian
Sarcoma Virus (PrASV), which is an RNA virus
that is a member of the Rous Associated
Virus (RAV) family
12. In Re Wright (Fed. Cir. 1993)
Federal Circuit
• “… claims are directed to vaccines, and
methods of making and using these
vaccines, which must by definition trigger
an immunoprotective response in the host
vaccinated; mere antigenic response is not
enough”
13. Enablement
General Rules
• Broad scope requires broad disclosure
• Working examples not required
• Not required to teach “and preferably omits”
what is well known in the art”
(Hybritech v. Monoclonal Antibodies (Fed.
Cir. 1986))
15. UCalifornia v. Eli Lilly (Fed. Cir. 1997)
UC disclosed:
• Cloned a cDNA encoding rat insulin
• Determined the rat cDNA nucleotide
sequence
• Amino acid sequence of human insulin protein
• General method for obtaining the human
cDNA
16. UC v. Eli Lilly (Fed. Cir. 1997)
UC claimed:
1. A recombinant plasmid replicable in
procaryotic host containing within its
nucleotide sequence a subsequence having the
structure of the reverse transcript of an mRNA
of a vertebrate, which mRNA encodes insulin.
5. A recombinant procaryotic microorganism
modified so that it contains a nucleotide
sequence having the structure of the reverse
transcript of an mRNA of a human, which
mRNA encodes insulin.
17. UC v. Lilly (Fed. Cir. 1997)
Federal Circuit Upholds District Court
• Claim 1 invalid
−A description of rat insulin cDNA is not a
description of the broad classes [genra] of
vertebrate or mammalian insulin cDNA
−A description of a chemical genus ‘requires a
precise definition, such as by structure,
formula, [or] chemical name.’ Quoting, Fiers
v. Revel 984 F.2d at 1171
• Claim 5 invalid
−“whether or not [Example 6] provides an
enabling disclosure, it does not provide a
written description of the cDNA encoding
human insulin.”
18. UC v. Lilly (Fed. Cir. 1997)
Written description becomes a super-
enablement requirement, which is
separate and apart from the enablement
requirement
19. Enzo v. Gen-Probe (Fed. Cir. 2002)
Rader dissent
• UC v. Lilly (1997) was a “deviation from 30
years of precedent”
• Fed. Cir., for the first time, “purported to
apply WD as a general disclosure doctrine in
place of enablement, rather than as a
priority doctrine.”
20. Enzo v. Gen-Probe (Fed. Cir. 2002)
Rader Dissent
• History of the Written Description
Requirement
−“Written description” first appears in
Patent Act of 1793
−Evans v. Eaton (1822), S. Ct. construed
description requirement to be an
enablement requirement
−JEM AG Supply (2001), S. Ct.
acknowledged only enablement as the
disclosure quid pro quo of Patent Act
21. Chiron v. Genentech (Fed. Cir. 2004)
Feb. 1984 Parent
App. Filed
Discl. 1 MAb
No Chimeric
No Humanized
May 1984
First Chimeric
Antibody
Publication
1985 CIP
App. Filed
Discl. 6 MAb
No Chimeric
No Humanized
1986 CIP
App. Filed
Discl. 6 MAb
No Chimeric
No Humanized
1995 CIP
App. Filed
Discl. 1 MAb
Chimeric & Humanized
Ab Technology
May 1986
First Humanized
Antibody
Publication
Intervening Art
1977
First Monoclonal
Antibody
Publication
22. Chiron v. Genentech (Fed. Cir. 2004)
‘561 patent issues with claims directed to
monoclonal antibodies that bind to HER-2
(an antigen associated with breast cancer)
Chiron sues Genentech for infringement over
sales of Herceptin®, a humanized Ab that
binds to HER-2
24. Chiron v. Genentech (Fed. Cir. 2004)
Claims construed to encompass chimeric
and humanized antibodies to HER-2, in
addition to the murine antibodies
disclosed in the 1984, 1985, 1986, and
1995 applications
Parties stipulate that if Chiron is not
entitled to a priority claim under 35
U.S.C § 120, the intervening art
anticipates the ‘561 patent claims
25. Chiron v. Genentech (Fed. Cir. 2004)
Feb. 1984 Parent
App. Filed
Discl. 1 MAb
No Chimeric
No Humanized
(HELD: NO WD)
May 1984
First Chimeric
Antibody
Publication
1985 CIP
App. Filed
Discl. 6 MAb
No Chimeric
No Humanized
(HELD:
NON-ENABLED)
1986 CIP
App. Filed
Discl. 6 MAb
No Chimeric
No Humanized
(HELD:
NON-ENABLED)
1995 CIP (‘561 Patent)
App. Filed
Discl. 1 MAb
Chimeric & Humanized
Ab Technology
(HELD:
ANTICIPATED)
May 1986
First Humanized
Antibody
Publication
Chiron sues Genentech
For Infringement
based on
sale of Herceptin
(Humanized Ab)
Intervening Art
1977
First Monoclonal
Antibody
Publication
26. Chiron v. Genentech (Fed. Cir. 2004)
Fed. Cir.’s Reasoning
• The 1985 and 1986 applications do not enable
the ‘561 patent claims because:
−Chimeric Abs were “nascent technology
requiring a ‘specific and useful teaching.’ ”
−Undue experimentation required to make and
use the claimed chimeric antibodies
−Enabling disclosure must be commensurate in
scope with claims
◦ Claim reads on chimeric and murine Abs,
yet applications do not disclose chimeric
Abs
27. Chiron v. Genentech (Fed. Cir. 2004)
Fed. Cir.’s Reasoning, cont.
• The 1984 application does not provide
written description support for the ‘561
patent claims because:
− No disclosure, hence possession, of chimeric or
humanized Ab technologies
− Enablement requirement does not apply to after-
arising technologies
28. U. of Rochester v. Searle (Fed. Cir. 2004)
Rochester Discloses
• COX-2 gene and protein
• COX-2 is expressed in response to
inflammatory stimuli and is associated with
arthritis
• Screening of compounds to see if they are
capable of selectively inhibiting COX-2
• No actual disclosure of any COX-2 inhibitors
29. U. of Rochester v. Searle (Fed. Cir. 2004)
Rochester claims
• Methods for selectively inhibiting [COX-2]
activity in a human host, comprising
administering a non-steroidal compound that
selectively inhibits activity of the [COX-2]
gene product to a human host in need of
such treatment
Searle sued for sale of COX-2 inhibitors
Celebrex® and Bextra®, marketed for
treatment of inflammation
31. U. of Rochester v. Searle (Fed. Cir. 2004)
Fed. Cir. upholds invalidity of claims for lack of
written description.
• “[T]he ‘850 patent does not disclose any
compounds that can be used in its claimed
methods. The claimed methods thus cannot
be practiced based on the patent’s
specification, even considering the
knowledge of one skilled in the art.”
32. Ariad v. Lilly (Fed. Cir. 2009)
Ariad Claims:
95. [A method for reducing, in eukaryotic
cells, the level of expression of genes which
are activated by extracellular influences
which induce NF-κB-mediated intracellular
signaling, the method comprising reducing
NF-κB activity in the cells such that
expression of said genes is reduced], carried
out on human cells.
33.
34. Ariad v. Lilly (Fed. Cir. 2009)
Ariad Disclosed:
• Three classes of molecules
(by function, not structure)
−Specific Inhibitors
−Dominantly interfering molecules
−Decoy molecules
35. Ariad v. Lilly (Fed. Cir. 2009)
Federal Circuit
• “Regardless of whether the asserted claims
recite a compound, Ariad still must describe
some way of performing the claimed
methods. … the specification suggests
only the use of the three classes of
molecules*** to achieve NF-κB reduction.”
*** The three classes of molecules include
−Specific Inhibitors
−Dominantly interfering molecules
−Decoy molecules
36. Ariad v. Lilly (Fed. Cir. 2009)
Federal Circuit
“Thus, to satisfy the written description
requirement for the asserted claims, the
specification must demonstrate that Ariad
possessed the claimed methods by sufficiently
disclosing molecules capable of reducing NF-κB
activity.” Citing, Capon v. Eshhar (Fed. Cir. 2005)
37. Ariad v. Lilly (Fed. Cir. 2009)
Federal Circuit
“A vague functional description and an
invitation for further research does not
constitute written disclosure of a specific
inhibitor.
* * *
written description requires more than a
‘mere wish or plan for obtaining the
claimed chemical invention.’ ” UC v. Eli Lilly
38. Ariad v. Lilly (Fed. Cir. 2009)
Federal Circuit
• Judge Linn’s Concurrance
“I write separately to emphasize … my belief
that our engrafting of a separate written
description requirement onto 35 USC 112,
paragraph 1 is misguided.
* * *
[S]ection 112, paragraph 1 requires no more
of the specification than a disclosure that is
sufficient to enable a person having
ordinary skill in the art to make and use the
invention.”
39. Ariad v. Lilly (Fed. Cir. 2010) (en banc)
Federal Circuit
• Opinion joined by every member of the
Court except Linn and Rader
• Reaffirms that there is a separate written
description and enablement requirement
under 35 USC § 112, first paragraph
40. Ariad v. Lilly (Fed. Cir. 2010) (en banc)
“Particularly for the biological arts,” having a
separate written description requirement
“ensures that when a patent claims a genus by
its function or result, the specification recites
sufficient materials to accomplish that
function.”
41. In Summary …
35 U.S.C. § 112 (a) -- Specification
• Enablement
− Teach one skilled in the art
− Make and use the claimed invention
− Without undue experimentation
− Disclose nascent technology
• Written Description
− Demonstrate Applicant’s possession of the
claimed invention
− Provide disclosure of structure, formula,
chemical name, or physical properties
42. Practice Tip
Disclosure of Single Embodiments is Risky
Claim Construction
35 U.S.C. § 112 (a)
OK if construed reads on:
· Your commercial product
· Competitor’s commercial product
“Invalid”