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.
IntOGen, Integrative Oncogenomics for Personal Cancer Genomeschristian.perez
IntOGen was presented September, 11th at the CSHL Meeting on Personal Genomes. The talk was given by Christian Perez-Llamas and he presented the main features of the current version and the advances of IntOGen 2.0 to store, analyze and visualize next generation sequencing data from cancer samples.
CSHL Meeting on Personal Cancer Genomes web: http://meetings.cshl.edu/meetings/person10.shtml
IntOGen, Integrative Oncogenomics for Personal Cancer Genomeschristian.perez
IntOGen was presented September, 11th at the CSHL Meeting on Personal Genomes. The talk was given by Christian Perez-Llamas and he presented the main features of the current version and the advances of IntOGen 2.0 to store, analyze and visualize next generation sequencing data from cancer samples.
CSHL Meeting on Personal Cancer Genomes web: http://meetings.cshl.edu/meetings/person10.shtml
Analysis of Single-Cell Sequencing Data by CLC/Ingenuity: Single Cell Analysi...QIAGEN
Single-cell analysis is useful to study genetic heterogeneity between individual cells and can help in result interpretation by looking at the average behavior of a large number of cells. Applications include circulating tumor cells, cells from small biopsies and cells from in vitro fertilized embryos. In this slidedeck, we show how single cell next-generation sequencing data can be analyzed and what challenges needs to be overcome. One of the examples we use is single cell data from two colorectal cancer cell lines.
Breaking the Status Quo: Using Mass Spectrometry to detect Host Cell ProteinsMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3b3Tbcd
Measurement of host cell proteins is vital to ensuring a biotherapy's purity and a patient's safety. Biotherapies treat diseases with products produced by living organisms, as a result, host cell components must be characterized and controlled. We'll review new methods within product characterization for detection.
Trace amounts of host cell proteins can be present after the production and purification of any biopharmaceutical. Detection of these species requires highly specific techniques to accurately quantify even low levels of contamination. Host cell protein impurities, present at PPM-levels in biotherapies, are a major immunogenicity risk because they can elicit an unpredictable immune response in patients. Their complex and diverse nature makes them challenging to detect or monitor. With acceptance criteria for host residual DNA usually set at a very low level (often =1.0 pg of DNA per mg of drug substance), effective removal techniques and sensitive methods of detection are critical.
Antibody-based techniques, like the enzyme-linked immunosorbent assay (ELISA), have been used to assess the HCP load of biotherapeutics before and after process changes. However, these techniques do not necessarily detect qualitative changes in the HCP population. In this webinar, we will discuss how mass spectrometry (MS)-based approaches coupled with ELISA methods help detect qualitative and quantitative differences in HCP populations.
In this webinar, you will learn:
• Comprehensive HCP ID and semi-quantitation
• HC agnostic process
• Creation of process specific database
• Differential clearance of specific HCPs throughout purification steps
• Monitoring of problematic species e.g. immunogenic (PLBL2), lipases and proteases
• Explanation about why 90% of BLAs filed included this HCP MS data
Biofluid miRNA profiling: from sample to biomarker: miRNA and its Role in Hum...QIAGEN
Circulating miRNAs have great potential as biomarkers due to their aberrant expression in cancer and other diseases. However, miRNAs from body fluids are hard to obtain in amounts sufficient for detailed miRNome profiling. This slideshow describes an integrated, PCR-based system that reduces the amount of sample required for full miRNome profiling by several orders of magnitude and provides unparalleled reproducibility and precision. Detailed protocols are highlighted regarding RNA isolation, real-time quantification and data analysis for the assessment of serum, plasma, urine and cerebrospinal fluid samples. This system enables accurate miRNA analysis on the smallest of samples and opens up new possibilities for biomarker development.
Identification of antibiotic resistance genes in Klebsiella pneumoniae isolat...QIAGEN
Antibiotic resistant strains of pathogenic bacteria are a growing worldwide health problem. To effectively combat the spread of difficult-to-treat bacterial infections, rapid surveillance methods for detection of antibiotic resistance genes is required to monitor both bacterial isolates and metagenomic samples. Additionally, identification of potential new sources for different antibiotic resistance genes is critical. Both of these goals require tools that can be used for profiling of antibiotic resistance genes from various types of samples. Real-time PCR has proven to be effective for the detection of antibiotic resistance genes. Using PCR array technology, simultaneous detection of 87 prevalent and important antibiotic resistance genes is possible and should prove to be an effective method for antibiotic resistance monitoring. This allows for a more comprehensive profiling of antibiotic resistance genes than is possible using individual PCR assays.
Detection and Surveillance of Antibiotic Resistance Genes From Food and Ferti...QIAGEN
One potential way to acquire antibiotic resistance genes is through the food supply chain. Both livestock and feed may
acquire antibiotic resistant bacteria via different mechanisms. Foodstuffs can be exposed to antibiotic resistant bacteria
through fertilizer originating from waste-water treatment plants. This, in addition to increasing administration of antibiotics
to livestock, can lead to food being a potential source of antibiotic resistance genes. This may lead to horizontal gene
transfer to pathogenic enteropathogens and further to drug resistance in humans. Therefore, the surveillance and prevention
of antibiotic resistance genes in food is important.
To effectively combat the spread of difficult-to-treat bacterial infections, rapid surveillance methods to detect antibiotic
resistance genes are required; in order to monitor both bacterial isolates and metagenomic samples.
Since the gut is known to act as a reservoir for antibiotic resistance genes, a small-scale research study was performed on
5 stool samples isolated from healthy human adults using an antibiotic resistance gene identification PCR array. In addition,
the diversity of antibiotic resistance genes in municipal biosolids was determined using an Antibiotic Resistance Genes
Microbial DNA qPCR Array with DNA extracted from belt-filter, press-cake sewage samples.
22 antibiotic resistance genes were identified from different resistance classifications. Further studies were performed in
beef, chicken, vegetable and pork samples. In conclusion, PCR arrays can be effective tools for detection of antibiotic
resistance genes from food samples and potential fertilizer sources.
Sample Prep Solutions for Microbiome ResearchQIAGEN
An accurate molecular analysis of the microbial constituents of a particular community is contingent upon high-yielding and non-biased nucleic acid extraction methodologies. Only by ensuring that all species and classes of microorganisms present in a sample are effectively lysed during extraction will one be able to reliably assess the composition of that sample. An additional challenge faced in nucleic acid extraction is the presence of persistent, co-purifying polymerase inhibitors endogenous to one’s sample. This presentation will focus on nucleic acid extraction tools developed by MO BIO Laboratories that facilitate accurate non-biased community analysis and eliminate common amplification problems via the depletion of endogenous polymerase inhibitors using our patented Inhibitor Removal Technology.
Analysis and Interpretation of Cell-free DNAQIAGEN
Identification and monitoring of cancer mutations from cell free DNA-Seq data is a key application in liquid biopsy. In this part of the webinar we will show how mutations can be best identified from this type of data and how they can be interpreted. Furthermore, potential challenges when analyzing this type of data will be discussed together with relevant strategies.
Bert Reijmerink (Genalice) - Hoe technologie bijdraagt aan een betere behande...AlmereDataCapital
Presentatie van Bert Reijmerink (Genalice) - 'Hoe technologie bijdraagt aan een betere behandeling van kankerpatiënten' tijdens het Big Data Analytics seminar 14 juni in Almere
Pressure BioSciences, Inc. Launches the Barocycler HUB440 A State-of-the-Art, High Pressure Generator (up to 56K psi) for Multiple Bioscience Applications
Find out more at: www.pressurebiosciences.com
Statistical methods for off-target variant genotyping on Affymetrix' Axiom Ar...Affymetrix
Teresa Webster, Bioinformatics, Affymetrix.Automated clustering and calling of ""Off-Target Variants,"" atypical cluster patterns caused by secondary variants in the probe hybridization region.
The capability to anticipate ovulation well in advance, and to then detect ovulation independently of the predictive signals, is unique to the bioZhena technology. This unique capability results from the mode of action, further discussed in the Alphabet of bioZhena under Modus operandi (MO). http://biozhena.wordpress.com/2007/11/28/the-alphabet-of-biozhena
See also under Mysterious conceptions - or the non-existence thereof. From the MO also follows the broad applicability of the technology, which is another feature that distinguishes the Ovulona from any other product addressing fertility status and ovulation monitoring. For a potential impact of the technology on public health, see under Sexually transmitted diseases, and also under Cervical cancer and under Smoking.
It could be argued that the greatest aspect of the bioZhena project is the idea of introducing – via the affordable personal fertility monitoring method – a general, routinely usable, women’s health tracking and diagnostic tool, with the potential to impact on several important areas of public health.
Analysis of Single-Cell Sequencing Data by CLC/Ingenuity: Single Cell Analysi...QIAGEN
Single-cell analysis is useful to study genetic heterogeneity between individual cells and can help in result interpretation by looking at the average behavior of a large number of cells. Applications include circulating tumor cells, cells from small biopsies and cells from in vitro fertilized embryos. In this slidedeck, we show how single cell next-generation sequencing data can be analyzed and what challenges needs to be overcome. One of the examples we use is single cell data from two colorectal cancer cell lines.
Breaking the Status Quo: Using Mass Spectrometry to detect Host Cell ProteinsMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3b3Tbcd
Measurement of host cell proteins is vital to ensuring a biotherapy's purity and a patient's safety. Biotherapies treat diseases with products produced by living organisms, as a result, host cell components must be characterized and controlled. We'll review new methods within product characterization for detection.
Trace amounts of host cell proteins can be present after the production and purification of any biopharmaceutical. Detection of these species requires highly specific techniques to accurately quantify even low levels of contamination. Host cell protein impurities, present at PPM-levels in biotherapies, are a major immunogenicity risk because they can elicit an unpredictable immune response in patients. Their complex and diverse nature makes them challenging to detect or monitor. With acceptance criteria for host residual DNA usually set at a very low level (often =1.0 pg of DNA per mg of drug substance), effective removal techniques and sensitive methods of detection are critical.
Antibody-based techniques, like the enzyme-linked immunosorbent assay (ELISA), have been used to assess the HCP load of biotherapeutics before and after process changes. However, these techniques do not necessarily detect qualitative changes in the HCP population. In this webinar, we will discuss how mass spectrometry (MS)-based approaches coupled with ELISA methods help detect qualitative and quantitative differences in HCP populations.
In this webinar, you will learn:
• Comprehensive HCP ID and semi-quantitation
• HC agnostic process
• Creation of process specific database
• Differential clearance of specific HCPs throughout purification steps
• Monitoring of problematic species e.g. immunogenic (PLBL2), lipases and proteases
• Explanation about why 90% of BLAs filed included this HCP MS data
Biofluid miRNA profiling: from sample to biomarker: miRNA and its Role in Hum...QIAGEN
Circulating miRNAs have great potential as biomarkers due to their aberrant expression in cancer and other diseases. However, miRNAs from body fluids are hard to obtain in amounts sufficient for detailed miRNome profiling. This slideshow describes an integrated, PCR-based system that reduces the amount of sample required for full miRNome profiling by several orders of magnitude and provides unparalleled reproducibility and precision. Detailed protocols are highlighted regarding RNA isolation, real-time quantification and data analysis for the assessment of serum, plasma, urine and cerebrospinal fluid samples. This system enables accurate miRNA analysis on the smallest of samples and opens up new possibilities for biomarker development.
Identification of antibiotic resistance genes in Klebsiella pneumoniae isolat...QIAGEN
Antibiotic resistant strains of pathogenic bacteria are a growing worldwide health problem. To effectively combat the spread of difficult-to-treat bacterial infections, rapid surveillance methods for detection of antibiotic resistance genes is required to monitor both bacterial isolates and metagenomic samples. Additionally, identification of potential new sources for different antibiotic resistance genes is critical. Both of these goals require tools that can be used for profiling of antibiotic resistance genes from various types of samples. Real-time PCR has proven to be effective for the detection of antibiotic resistance genes. Using PCR array technology, simultaneous detection of 87 prevalent and important antibiotic resistance genes is possible and should prove to be an effective method for antibiotic resistance monitoring. This allows for a more comprehensive profiling of antibiotic resistance genes than is possible using individual PCR assays.
Detection and Surveillance of Antibiotic Resistance Genes From Food and Ferti...QIAGEN
One potential way to acquire antibiotic resistance genes is through the food supply chain. Both livestock and feed may
acquire antibiotic resistant bacteria via different mechanisms. Foodstuffs can be exposed to antibiotic resistant bacteria
through fertilizer originating from waste-water treatment plants. This, in addition to increasing administration of antibiotics
to livestock, can lead to food being a potential source of antibiotic resistance genes. This may lead to horizontal gene
transfer to pathogenic enteropathogens and further to drug resistance in humans. Therefore, the surveillance and prevention
of antibiotic resistance genes in food is important.
To effectively combat the spread of difficult-to-treat bacterial infections, rapid surveillance methods to detect antibiotic
resistance genes are required; in order to monitor both bacterial isolates and metagenomic samples.
Since the gut is known to act as a reservoir for antibiotic resistance genes, a small-scale research study was performed on
5 stool samples isolated from healthy human adults using an antibiotic resistance gene identification PCR array. In addition,
the diversity of antibiotic resistance genes in municipal biosolids was determined using an Antibiotic Resistance Genes
Microbial DNA qPCR Array with DNA extracted from belt-filter, press-cake sewage samples.
22 antibiotic resistance genes were identified from different resistance classifications. Further studies were performed in
beef, chicken, vegetable and pork samples. In conclusion, PCR arrays can be effective tools for detection of antibiotic
resistance genes from food samples and potential fertilizer sources.
Sample Prep Solutions for Microbiome ResearchQIAGEN
An accurate molecular analysis of the microbial constituents of a particular community is contingent upon high-yielding and non-biased nucleic acid extraction methodologies. Only by ensuring that all species and classes of microorganisms present in a sample are effectively lysed during extraction will one be able to reliably assess the composition of that sample. An additional challenge faced in nucleic acid extraction is the presence of persistent, co-purifying polymerase inhibitors endogenous to one’s sample. This presentation will focus on nucleic acid extraction tools developed by MO BIO Laboratories that facilitate accurate non-biased community analysis and eliminate common amplification problems via the depletion of endogenous polymerase inhibitors using our patented Inhibitor Removal Technology.
Analysis and Interpretation of Cell-free DNAQIAGEN
Identification and monitoring of cancer mutations from cell free DNA-Seq data is a key application in liquid biopsy. In this part of the webinar we will show how mutations can be best identified from this type of data and how they can be interpreted. Furthermore, potential challenges when analyzing this type of data will be discussed together with relevant strategies.
Bert Reijmerink (Genalice) - Hoe technologie bijdraagt aan een betere behande...AlmereDataCapital
Presentatie van Bert Reijmerink (Genalice) - 'Hoe technologie bijdraagt aan een betere behandeling van kankerpatiënten' tijdens het Big Data Analytics seminar 14 juni in Almere
Pressure BioSciences, Inc. Launches the Barocycler HUB440 A State-of-the-Art, High Pressure Generator (up to 56K psi) for Multiple Bioscience Applications
Find out more at: www.pressurebiosciences.com
Statistical methods for off-target variant genotyping on Affymetrix' Axiom Ar...Affymetrix
Teresa Webster, Bioinformatics, Affymetrix.Automated clustering and calling of ""Off-Target Variants,"" atypical cluster patterns caused by secondary variants in the probe hybridization region.
The capability to anticipate ovulation well in advance, and to then detect ovulation independently of the predictive signals, is unique to the bioZhena technology. This unique capability results from the mode of action, further discussed in the Alphabet of bioZhena under Modus operandi (MO). http://biozhena.wordpress.com/2007/11/28/the-alphabet-of-biozhena
See also under Mysterious conceptions - or the non-existence thereof. From the MO also follows the broad applicability of the technology, which is another feature that distinguishes the Ovulona from any other product addressing fertility status and ovulation monitoring. For a potential impact of the technology on public health, see under Sexually transmitted diseases, and also under Cervical cancer and under Smoking.
It could be argued that the greatest aspect of the bioZhena project is the idea of introducing – via the affordable personal fertility monitoring method – a general, routinely usable, women’s health tracking and diagnostic tool, with the potential to impact on several important areas of public health.
Breast Cancer Patents Research - Myriad Genetics in US | Trastuzumab in India...Rahul Dev
Breast Cancer – Patents
Executive Summary
Introduction
Breast cancer is a malignancy that effects women across the world and is most prevalent among various types of cancers. Patents are jurisdiction specific exclusive rights that are sought by innovators across various technological fields.
breast-cancer-ribbon
However, patent rights become questionable and debatable when these are sought in respect of pharmaceutical drugs, medical devices, surgical techniques, diagnostic tests, personalized medicines and research tools related to healthcare. Across Western jurisdictions, patents have been sought for artificial plant varieties (hybrid plants, genetically modified plants etc.), animal species created with human intervention (Harvard Oncomouse, Dolly the Sheep etc.), and methods of human treatment. Due to the presence of numerous patents in the field of healthcare, it imminently results in the requirement of large number of licenses to access patented technology, which subsequently leads to increased cost of treatment because of accumulation of royalties (royalty stacking) to be paid to the patent holders. Therefore, in developing countries like India, it becomes highly controversial as to whether to grant such patents to protect Intellectual Property Rights (IPR) or to focus on affordable healthcare by rejecting such patents.
Strategy, Scope and Focus
With a view to discuss implications of patents specifically related to breast cancer, we have researched and analyzed the breast cancer patent landscape in India and US, in light of latest legal developments, with special focus on Trastuzumab (a medicine which treats a form of breast cancer) and US Supreme Court judgement to overturn Myriad Genetics’ patents on the “breast cancer genes - BRCA1 and BRCA2”.
Breast Cancer and Patents
Basics of Patent Rights
As it is well known that patent protection is granted for a limited period of 20 years, wherein the patent holder holds exclusive rights for exploitation of the patented invention. Generally, patents are aimed at encouraging innovations by providing incentives to the patent holders by offering them recognition for their creativity.
Biotechnology Patents
In the field of biotechnology and healthcare, the cost of reparation is crucial, as the research in these fields is highly expensive. The financial investments can only be paid off if the companies can protect results by exclusive rights (patents) and gain the competitive advantage.
Gene Therapy Patents
Historically, there has been a close relation between gene therapy, patents and scientific advancements. Large pharmaceutical companies have invested huge amount of capital in patenting genes, either on their own or by acquiring small biotech companies. For example, Swiss pharmaceutical company Sandoz (subsidiary of Novartis) acquired Genetic Therapy Inc. of Gaithersburg, Md. In 1995, for about $295 million. At that point of time, Genetic Therapy held e
This presentation discusses the historical context for the recent court decisions that affect the patent eligibility of biotechnology inventions, including those directed to genes, cDNAs, proteins, antibodies, and diagnostic methods. Discussed are the early Funk Brothers and Chakrabarty decisions as well as the Lab Corp, Bilski, Prometheus, Classen, and Myriad court opinions. The impact of the court holdings on the future development of biotechnology inventions, in particular personalized medicine inventions, is analyzed as is the erosion of the requisite incentives of innovative companies to invent and commercialize in areas where patent protection is less certain.
After Myriad: Where next for gene patents in the US? by Patent Attorney Dr Mi...Jeremy M. Ben-David
Following the recent Supreme Court decision regarding Myriad, Dr. Hammer has sided with those who declare that "the sky has not fallen." He analyses the decision and points to the way forward. Dr. Hammer heads the "US Direct" patent prosecution practice at JMB Davis Ben-David, a US and Israel Intellectual Property Boutique located in the Har-Hotzvim high tech park in Jerusalem, Israel.
In addition to filing and prosecuting patent and trademark applications worldwide for their Israeli clients, JMB Davis Ben-David files and prosecutes patent and trademark applications for clients the world over, both in the Israeli and US Patent and Trademark Offices.
1 (Slip Opinion) OCTOBER TERM, 2012
Syllabus
NOTE: Where it is feasible, a syllabus (headnote) will be released, as is
being done in connection with this case, at the time the opinion is issued.
The syllabus constitutes no part of the opinion of the Court but has been
prepared by the Reporter of Decisions for the convenience of the reader.
See United States v. Detroit Timber & Lumber Co., 200 U. S. 321, 337.
SUPREME COURT OF THE UNITED STATES
Syllabus
ASSOCIATION FOR MOLECULAR PATHOLOGY ET AL.
v. MYRIAD GENETICS, INC., ET AL.
CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR
THE FEDERAL CIRCUIT
No. 12–398. Argued April 15, 2013—Decided June 13, 2013
Each human gene is encoded as deoxyribonucleic acid (DNA), which
takes the shape of a “double helix.” Each “cross-bar” in that helix
consists of two chemically joined nucleotides. Sequences of DNA nu-
cleotides contain the information necessary to create strings of amino
acids used to build proteins in the body. The nucleotides that code
for amino acids are “exons,” and those that do not are “introns.” Sci-
entists can extract DNA from cells to isolate specific segments for
study. They can also synthetically create exons-only strands of nu-
cleotides known as complementary DNA (cDNA). cDNA contains only the
exons that occur in DNA, omitting the intervening introns.
Respondent Myriad Genetics, Inc. (Myriad), obtained several pa-
tents after discovering the precise location and sequence of the
BRCA1 and BRCA2 genes, mutations of which can dramatically in-
crease the risk of breast and ovarian cancer. This knowledge allowed
Myriad to determine the genes’ typical nucleotide sequence, which, in
turn, enabled it to develop medical tests useful for detecting muta-
tions in these genes in a particular patient to assess the patient’s
cancer risk. If valid, Myriad’s patents would give it the exclusive
right to isolate an individual’s BRCA1 and BRCA2 genes, and would
give Myriad the exclusive right to synthetically create BRCA cDNA.
Petitioners filed suit, seeking a declaration that Myriad’s patents are
invalid under 35 U. S. C. §101. As relevant here, the District Court
granted summary judgment to petitioners, concluding that Myriad’s
claims were invalid because they covered products of nature. The
Federal Circuit initially reversed, but on remand in light of Mayo
Collaborative Services v. Prometheus Laboratories, Inc., 566 U. S. ___,
the Circuit found both isolated DNA and cDNA patent eligible.
2 ASSOCIATION FOR MOLECULAR PATHOLOGY v.
MYRIAD GENETICS, INC.
Syllabus
Held: A naturally occurring DNA segment is a product of nature and
not patent eligible merely because it has been isolated, but cDNA is
patent eligible because it is not naturally occurring. Pp. 10–18.
(a) The Patent Act permits patents to be issued to “[w]hoever in-
vents or discovers any new and useful . . . composition of matter,”
§101, but “laws of nature ...
Merchant & Gould Whitepaper: Association of Molecular Pathology v. Myriad Ge...Gary M. Myles, Ph.D.
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.
Ethics and the Law: The Case of Myriad Genetics, Ethics in Patenting and Eth...Kirby Drake
This presentation provides an overview of gene patents and discusses the case of Myriad Genetics and ethics in patenting and licensing and commercializing innovations.
Discusses the available scope of patent protection for advances in diagnostics as well as the types of claims available in different jurisdictions. Additionally covers "support", i.e. the enabling teaching that is the trade-off for the patent monopoly, in the context of diagnostic patent applications. Finally, considers the enforcement and exploitation of patents directed to diagnostics.
Presenters: Anna Wilkinson and Cynthia Tape, Ogilvy Renault
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
2. 案件歷程
Federal District Court of
Southern District of New
York (S.D.N.Y.) Mayo Collaborative Services v.
Prometheus Laboratories, Inc.
(C.A.F.C)
Federal Court of
Appeals, Federal Circuit
(C.A.F.C.)
Petition for Certiorari
Mayo Collaborative Services v.
Certiorari granted in light
Prometheus
of Prometheus Laboratories, Inc.(S.C)
2
3. 故事是這麼發生的…
BRCA 1 BRCA 2
Chromosome 17
創業
Breast,
Ovarian
cancer
Gene sequencing & diagnose
Founded in 1991
3
4. 接著…
Univ. of Utah
Myriad
3,000 USD./test
競爭
vs.
Others
1000 USD./test
4
5. 當事人
• Plaintiffs
• Researchers
Drs. Kazazian, Ganguly (University of Pennsylvania School of medicine, Genetic
Diagnostic Lab.), Ostrer (New York University)…
• Organizations
AMP (Association for Molecular Pathology), ACMG (American College of Medical
Genetics), ASCP (American Society for Clinical Pathology), CAP (College of
American Pathologists)
• Patients
• Defendants
• USPTO
• Myriad Genetics, Inc. (Salt Lake City)
former co owner and exclusive licensee
• UURF (The University of Utah Research Foundation)
an owner or part owner of each patent.
• Amici
• American Civil Liberty Union (ACLU) , Public Patent
Foundation (PUBPAT)
9. 專利內容-基因序列
• Claim 1 of the „282 patent
An isolated DNA coding for a BCRA1 polypeptide, said
polypeptide having the amino acid sequence set forth in
SEQ. ID. NO: 2.
9
10. 專利內容-診斷方法(1)
• Claim 1 of the ‟ 999 patent
– A method for detecting a germline alteration in a BRCA1
gene, said alterations set forth in Table 12A, 14, 18 or 19 in
a human which comprises
• analyzing a sequence of a BRCA 1 gene or BRCA1
RNA from a human sample or
• analyzing a sequence of BRCA1 cDNA made from
mRNA from said human sample with the proviso that
said germline alteration is not a deletion of 4
nucleotides corresponding to base numbers 4184-4187
of SEQ ID. NO:1.
10
11. 專利內容-診斷方法(2)
• Claim 2 of „857 patent
– A method for diagnosing a predisposition for
breast cancer in a human subject which comprises
• comparing the germline sequence of the BRCA2 gene
or the sequence of its mRNA in a tissue sample from
said subject with
• the germline sequence of the wild- type BRCA2 gene or
the sequence of its mRNA,
wherein an alteration in the germline sequence of the
BRCA2 gene or the sequence of its mRNA of the subject
indicates a predisposition to said cancer.
11
12. 專利內容-診斷方法(3)
• Claim 20 of the „282 patent
– A method for screening potential cancer therapeutics
which comprises
• growing a transformed eukaryotic host cell containing an
altered BRCA1 gene causing cancer and the presence of a
compound suspected of being a cancer therapeutic,
• growing said transformed eukaryotic host cell in the absence
of said compound,
• determining the rate of growth of said host cell in the
presence of said compound and the rate of growth of said
host cell in the absence of the said compound and
comparing the growth rate of said host cells,
wherein a slower rate of said host cell in the presence of said
compound is indicative of a cancer therapeutic.
12
15. 專利的例外?
Whoever invents or discovers any new and useful process,
machine, manufacture, or composition of matter, or any
new and useful improvement thereof, may obtain a patent therefor,
subject to the conditions and requirements of this title.
-35 USC § 101 - Inventions patentable
Statutory Subject Matter
Not products of nature
Not natural phenomena
Not abstract ideas
15
16. 過去判決-否定
In American Fruit Growers, the Supreme Court
rejected patent claims covering fruit whose skin
had beer treated with mold-resistant borax.
In Funk Brothers, a mixture of bacteria couldn‟t
be patented, since it “did not create a state of
inhibition or of non- inhibition.”
In General Electronic, a purified tungsten couldn‟t
be patented, since it ”existed in nature and
doubtless has existed for centuries.”
16
17. 過去判決- 肯定
In Chakrabarty, the micro-organism in question
was a bacterium that had been genetically
engineered to break down multiple components
of crude oil.
In Merck, the Fourth Circuit considered the
validity of a patent claiming a Vitamin B12
composition useful for treating pernicious
anemia.
17
18. 過去判決-結論
This requirement that an invention possess
“markedly different” characteristics for purpose
of section 101 reflects the oft- repeated
requirement that an invention have “a new or
distinctive from, quality, or property” from a
product of nature…
18
19. 法院說法比一比
D.C. C.A.F.C.
• What makes DNA unique not only • The claim covers molecules that
its chemical structure, but also the hardly exist in natural status.
information it conveys.
• The isolated DNA is free of some
• Even defined by polypeptides, the other components in the cell.
functional structure remain the same.
For example, BRCA2 without
• The different chemical structure are introns shrink to just 80,000
just the result of purification. nucleotides in comparison with
those normal with introns can
have near 102,000 nucleotides.
Not Patentable Patentable
19
21. 「方法」可以專利嗎?
• In Biliski, claim 1 of „892 patent
• A method for managing the consumption risk costs of a commodity
sold by a commodity provider at a fixed price comprising the steps
of:
– (a) initiating a series of transactions between said commodity provider
and consumers of said commodity wherein said consumers purchase
said commodity at a fixed rate based upon historical averages, said
fixed rate corresponding to a risk position of said consumer;
– (b) identifying market participants for said commodity having a
counter-risk position to said consumers;and
– (c) initiating a series of transactions between said commodity provider
and said market participants at a second fixed rate such that said series
of market participant transactions balances the risk position of said
series of consumer transactions.
21
22. Machine and Transformation Test
(1) it is tied to a particular machine or apparatus, or
(2) it transforms a particular article into a different
state or thing.”
(3) In addition, “the use of a specific machine or
transformation of an article must impose meaningful
limits on the claim„s scope to impart patent-
eligibility,” and “ the involvement of the machine or
transformation in the claimed process must not
merely be insignificant extra-solution activity.”
22
23. 診斷方法的例子-Prometheus
• In Prometheus, a method of optimizing therapeutic efficacy for
treatment of an immune- mediated gastrointestinal disorder,
comprising:
(a) administering a drug providing 6- thioguanine to a subject having said
immune- mediated gastrointestinal disorder, and
(b) determining the level of 6- thioguanine in said subject having said
immune- mediated gastrointestinal disorder,
• wherein the level of 6- thioguanine less than about 230 per mole per 8x108 red
blood cells indicates a need to increase the amount of said drug subsequently
administered to said subject and
• wherein the level of 6- thioguanine greater than about 400 per mole per 8x108
red blood cells indicates a need to decrease the amount of said drug
subsequently administered to said subject.
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24. 診斷方法的例子-Prometheus
• The “determining” step was itself construed to include the
extraction and measurement of metabolite concentrations,
such as high pressure liquid chromatography.
• Transformation exist as human body as well as the chemical
and physical changes of the drug‟s metabolites.
• The “determining” step alone was transformative and central
to the claimed method since determining the levels of the
metabolites in a subject necessarily involves a transformation,
for those levels can’t be determined by mere inspection.
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25. 法院說法比一比
D.C. / C.A.F.C
• The words “analyzing and comparing”, in contrast to
“determining the metabolite level ”, refers to only
abstract mental process.
• Without specifying how about the words “analyzing
and comparing” impose no meaningful limitation on
the claim.
Not Patentable
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26. 法院說法比一比
D.C. C.A.F.C.
• Viewed in entirety, the essence of the • Specific host cells transformed with
claim is to compare the cell growth BCRA gene.
rate.
• Satisfying the transformation test,
• To compare is just a basic scientific including these transformative steps:
rule that slower growth rate of the • 1. host cells growing with a
cell. Inserting DNA or compound into altered BCRA1 gene
host cells can only be regarded as • 2. to determine growth rate with
preparatory data gathering step. or without the compound, which
can’t be merely speculated.
• If the compound shows no • 3. these steps are central to the
effect, transformation won’t happen. claimed process
Not Patentable Patentable
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27. 最高法院重新考慮Prometheus一案…
• A well- understood, routine, conventional
activity previously engaged in by researchers
in the field.
• Granting patent would risk disproportionately
tying up the use of natural law, inhibiting
their use in the making of further discoveries.
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29. 專利對生技業的重要性?
Startup
• Market Power
• Market Value
Mature Company
• IP fences
• Prevent substitutes
Sales • Stream revenue
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30. 專利與創新的關係?
Alternatives
Backup compounds
Preventing new tech. from
selling, manufacturing…only
Core to prolong old products’ life
Substitute
Invention cycle…
competition
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