Biotechnology Novelty And Nonobviousness 14 Sep10
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This document summarizes the key statutory requirements for patentability in the United States, including novelty, non-obviousness, and disclosure requirements. It discusses how prior art references can anticipate claimed inventions either expressly or inherently, and how multiple references may render a claimed invention obvious. The level of ordinary skill in the art and secondary considerations must be considered for obviousness. Later Supreme Court cases further refined how obviousness is determined.
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COMMIL v. CISCO_Brief of Biotechnology Industry Organization (BIO) as Amicus ...Gary M. Myles, Ph.D.
COMMIL v. CISCO_Brief of Biotechnology Industry Organization (BIO) as Amicus Curiae in Support of Petitioner2017 02-15 uwls-apl_biotech 101
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.
2015-11-4_WSU_Defining a Corporate Structure for a Startup Company
This presentation discusses the key factors that are important in selecting an appropriate corporate entity for a startup company
2015-11-4_WSU_Corp Structure & Formation for Start-ups
This document provides an overview of different corporate structures for startups, including sole proprietorships, general partnerships, limited partnerships, limited liability partnerships, limited liability companies, and corporations (S-Corps and C-Corps). It discusses the key aspects of each structure such as liability, taxation, formation process, and pros and cons. The document recommends that for startups, the primary choices for corporate structure are limited liability companies, S-corporations, and C-corporations, and that the choice depends on factors like financing plans and investment levels. It also discusses considerations around incorporating in the state of the principal office or in Delaware.
Aziz Sancar 2015 Nobel Prize in Chemistry
Gary's Ph.D. adviser, Aziz Sancar, is awarded the Nobel Prize in Chemistry for his work ion nucleotide excision repair.
13-896; tsac; Biotechnology Industry Organization
The Federal Circuit's rule allowing a good-faith belief of patent invalidity to serve as a defense to induced infringement is inconsistent with the text of Section 271(b). Section 271(b) defines inducement based on direct infringement, not invalidity defenses. The Federal Circuit's rule conflates the separate defenses of invalidity and non-infringement and allows an inducer to avoid liability even if the invalidity defense lacks merit, bypassing the presumption of validity and clear and convincing evidence standard. The rule could encourage suits against end users and improper risk-shifting by inducers.
Merchant & Gould Whitepaper: Association of Molecular Pathology v. Myriad Ge...
This Merchant & Gould whitepaper summarizes the holding of the recent Supreme Court Association of Molecular Pathology v. Myriad Genetics decision, outlines its impact, and provides practice tips to those endeavoring to protect nucleic acids, genes, cDNAs, and other biological molecules, including proteins and antibodies as well as diagnostic methods that relate to laws and products of nature.
Protecting the Inventions of Start-ups
This presentation addresses the why, what, and how to protect inventions from the vantage point of the early-stage, pre-financing, start-up company that is interested in patenting its inventions and developing an intellectual property portfolio that maximizes the company's valuation and sets it up for success during the intellectual property due diligence that accompanies financing rounds, corporate partnerships, commercialization, and merger and acquisition.
Preparing for a Financial Audit & Corporate Due Diligence
The document summarizes strategies that biotech companies can take to navigate challenges in obtaining financing. It recommends establishing strong policies and procedures, understanding complex agreements, and working with experts to avoid common pitfalls. Being prepared through measures like "audit-lite" reviews can help companies attract investors and limit risks.
Gary M. Myles, J.D., Ph.D. -- Biotechnology, Life Sciences, and Pharmaceutica...
Gary M. Myles, J.D., Ph.D. -- Biotechnology, Life Sciences, and Pharmaceutica...Gary M. Myles, Ph.D.
This resume provides a summary of Gary Myles legal and scientific background, education, publications, presentations, board memberships, and honors.CASRIP 2012 -- Patenting of Human DNA and Embryos
This document summarizes recent developments in US patent law as it relates to patenting human DNA, embryos, and organs. It discusses Supreme Court cases that established that isolated DNA sequences and genetically modified organisms can be patented, but products of nature cannot. It describes the ongoing Myriad Genetics case regarding patents on human genes and recent legislation restricting patents on claims directed to human organisms. It concludes with an overview of developments in patenting stem cells and induced pluripotent stem cells.
America Invents Act: Recent Changes to US Patent Law and Practice
The document summarizes changes brought by the America Invents Act to U.S. patent law and practice. Some key changes include transitioning from a first-to-invent system to a first-inventor-to-file system, expanding the definition of prior art, creating new post-grant review proceedings like post-grant review and inter partes review, expanding prior user rights, and changing treatment of errors in inventorship. The changes aim to harmonize the U.S. system with other countries and improve patent quality and challenge procedures.
Biotechnology Patent Eligibility
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.
Patenting In The Biotech Industry 21 Sep10
This document summarizes the agenda for a two-day symposium celebrating the 30th anniversary of the landmark Supreme Court decision in Diamond v. Chakrabarty. The symposium includes presentations and panels on September 21st and 22nd discussing the implications of the decision. The decision found that genetically modified life forms can be patented and helped launch the modern biotechnology industry. Speakers include the original plaintiff in the case, Dr. Ananda Chakrabarty, as well as legal and business experts discussing the impact on innovation, university research, and patent law.
Career Options Life Scientist 04Jun10
The document discusses career options for life scientists with PhDs. It begins with a brief history of biotechnology, noting 1980 as a seminal year when the Bayh-Dole Act and a Supreme Court ruling enabled university patenting and commercialization of research. This shifted the focus from solely publishing to also patenting and technology transfer. The document outlines traditional career paths for PhDs but notes a disconnect between university education and non-academic options. It encourages cross-disciplinary training and developing unique qualifications to work at the interfaces of science, business, law, and technology.
Biotechnology Written Description, Enablement, and Patent Eligibility
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.
More from Gary M. Myles, Ph.D. (20)
2020 01-28 uwls-apl_biotech_disclosure under 35_usc112
2020 01-28 uwls-apl_biotech_disclosure under 35_usc112
Commil v. Cisco: Brief of Biotechnology Industry Organization as Amicus Curi...
Commil v. Cisco: Brief of Biotechnology Industry Organization as Amicus Curi...
COMMIL v. CISCO_Brief of Biotechnology Industry Organization (BIO) as Amicus ...
COMMIL v. CISCO_Brief of Biotechnology Industry Organization (BIO) as Amicus ...
2015-11-4_WSU_Defining a Corporate Structure for a Startup Company
2015-11-4_WSU_Defining a Corporate Structure for a Startup Company
2015-11-4_WSU_Corp Structure & Formation for Start-ups
2015-11-4_WSU_Corp Structure & Formation for Start-ups
Merchant & Gould Whitepaper: Association of Molecular Pathology v. Myriad Ge...
Merchant & Gould Whitepaper: Association of Molecular Pathology v. Myriad Ge...
Preparing for a Financial Audit & Corporate Due Diligence
Preparing for a Financial Audit & Corporate Due Diligence
Gary M. Myles, J.D., Ph.D. -- Biotechnology, Life Sciences, and Pharmaceutica...
Gary M. Myles, J.D., Ph.D. -- Biotechnology, Life Sciences, and Pharmaceutica...
America Invents Act: Recent Changes to US Patent Law and Practice
America Invents Act: Recent Changes to US Patent Law and Practice
Biotechnology Written Description, Enablement, and Patent Eligibility
Biotechnology Written Description, Enablement, and Patent Eligibility
Biotechnology Novelty And Nonobviousness 14 Sep10
- 1. Biotechnology Patent Prosecution – Part 1 Novelty and Nonobviousness Gary M. Myles, Ph.D. Biotechnology and the Law Seattle University School of Law September 14, 2010