Post on 20-Dec-2015
transcript
Bioinformatics and Gene DiscoveryCenter for Biological Sequence Analysis, DTU, June 12,
2007
Jens Viktor Nørgaard,Symphogen A/S
Agenda
• Commercials• What is a patent• Patentability basics
• Novelty, inventive step & other criteria• Claims • Inventors • Timelines• Patents as information source• Searching for patent information• Ethics and patent law
Who am I
• MSc in Forestry, PhD in Genetics & Biochemistry (Royal Agricultural University, now University of Copenhagen)
• 10 years of academic research, University of Copenhagen• Patent consultant since 1998• European Patent Attorney 2003• Director of IPR, Symphogen AS• Previously: NsGene (Biotech), Hoiberg (Patent Attorneys)
What is a patent attorney?
• Represents clients/employer before patent authorities• No authorisation requirements in Denmark• Authorisation required in a number of countries: United Kingdom,
Germany, France, United States, Japan, EPO (European Patent Office)
• Qualifications (European patent attorney):• Scientific degree; MSc, PhD or equivalent• Linguistic skills, writing & speaking• Business attitude• Patent training > 3 years• Pass a qualifying exam
What does a patent attorney do
• Writing patent applications• Preparing legal documents• Monitoring dead-lines• Searching for and analysing technical information• Providing legal opinions on patent issues• Preparing and filing responses to patent authorities• Training of scientists/clients/students/trainees• Strategic advice/planning to Universities and Corporations• License negotiations and agreements
Links
• Training of Danish patent attorneys (Certified Danish Patent Attorney): http://www.difi.dk/
• How to become a European Patent Attorney: http://www.european-patent-office.org/epo/pubs/pat_attorney/pdf/patbro_e.pdf
Patents I
• A patent application - ”paid-for publication”, source of information
• A granted patent – a legal document defining an injunction right & a right to claim damages
• A patent does not give the owner any right to exploit the invention• Determined by other’s patents and by legislation
Patents II
• Agreement between inventor and society• Inventor gets a time-limited monopoly• Society gets a description of the invention
• Patenting forces publication• Stimulates exchange of information• Stimulates research and development
• Alternative to patents• Secrecy
Patentability Requirements
• Novelty• Inventive step• Clarity• Conciseness• Enablement• Sufficiency of disclosure• Utility• Industrial applicability• Exceptions to patentability
Novelty
• Novelty = not available to the public on the date of filing
• Available = made available to the public without any confidentiality barriers
• A compound (including proteins and genes) is not known merely because it is found in nature (e.g. an mRNA in a cell, a protein in a plant)
• Compounds can be made available by• decribing the structure of the compound (structural formula
or sequence)• describing a method of producing/synthesising• describing a method of isolating/purifying the compound
The Concept of Novelty
State of the Art (known)1. a cup
2. a cup
3. a cup
4. a cup
5. a cup
Patent Application1. a cup with a handle (novel)
2. a 15 cm tall cup (novel)
3. a cup adapted to hold coffee (non-novel)
4. a red cup (novel)
5. a container for liquid (not novel)
The Concept of Novelty
State of the art1. cells secrete a protein with
activity X2. the protein with acivity X can
be purified from organism Y using method Z
3. protein with sequence ...
4. peptide with sequence: ypskpdnpgedapaedmaryysalrhyinlitrqry (NPY)
5. conservative substitutions can be made in NPY
Patent application1. an isolated protein with
sequence ... having activity X2. an isolated protein with
sequence ... having activity X
3. glycosylated protein with sequence ...
4. peptide with sequence: ypskpdnpgeeapaedmaryysalrhyinlitrqry
5. peptide with sequence: ypskpdnpgeeapaedmaryysalrhyinlitrqry
The Concept of Novelty
State of the art1. gene X was cloned using
primers A and B2. genes 1 to N can be
used for treating diseases 1 to N
3. gene x promotes cell division
Patent application1. gene X having sequence
...........2. gene 5 for treatment of
obesity......3. use of gene x as a
growth factor
Inventive Step/Non-obviousness
• Inventive step/”non-obviousness”• Difference between prior art and invention must be of a
certain ”size”• No patents for trivial inventions• Patents promote technical progress, not stand-still• Non-obvious for the person skilled in the art• Person skilled in the art
• Fictitious person• Not a Nobel prize winner• Average skills• Knows everything (all languages) but is conservative, does not go
against established prejudice, does not try to enter unpredictable areaas nor take uncalculable risks
Inventive Step/Non-obviousness
• Complex arguments• Room for creativeness• Large differences between major patent autorities: EP,
JP, US:• New sequence (new compound, new structure)
• US – any new stucture is non-obvious• JP – a significant and unexpected effect must be associated
with the new structure, or undue difficulty in obtaining new sequence
• EP – was the sequence difficult to make? any unexpected technical effects associated with the new sequence? was it obvious to try and see?
The Concept of Inventive Step
State of the art (known)1. a cup
2. a cup
3. a cup
4. a cup
5. a cup
Patent application1. a cup with a handle
(inventive?)
2. a 15 cm tall cup (inventive?)
3. a cup adapted to hold coffee (non-novel)
4. a red cup (inventive?)
5. a container for liquid (not novel)
The Concept of Inventive Step
State of the art1. cells secrete a protein with
activity X2. the protein with acivity X can
be purified from organism Y using method Z
3. protein with sequence ...
4. peptide with sequence: ypskpdnpgedapaedmaryysalrhyinlitrqry (NPY)
5. conservative substitutions can be made in NPY
Patent application1. an isolated protein with
sequence ... having activity X2. an isolated protein with
sequence ... having activity X
3. glycosylated protein with sequence ...
4. peptide with sequence: ypskpdnpgeeapaedmaryysalrhyinlitrqry
5. peptide with sequence: ypskpdnpgeeapaedmaryysalrhyinlitrqry
The Concept of Inventive Step
State of the art1. gene X was cloned using
primers A and B2. genes 1 to N can be used for
treating diseases 1 to N3. gene x promotes cell division4. an EST annotated as having
homology to an enzyme with activity Y
Patent application1. gene X having
sequence ...........2. gene 5 for treatment of
obesity......3. use of gene x as a growth
factor4. isolated and purified protein
having sequence X and enzyme activity Y
Clarity, Sufficiency, Enablement
• ”Quality requirements”• No short cuts by trying to keep part of the invention
secret• No short cuts by filing too early – before invention
is complete• Legal certainty (possible for 3rd party to determine
scope of claims)
Clarity, Conciseness
• The claims must be clear and concise• Results in many definitions:
• Sequence homology • Binding specificity• Competition for antigen/epitope• Binding affinities• Alignment • Hybridisation • High stringency
Sufficiency, Written Description
• Description must be sufficient• Sufficiency – when the skilled person can carry out the
invention – don’t try to leave anything out• Also a question of credibility• Written description – you must show that you were in
possession of the invention upon filing – do not file before you completed the invention
Utility
• Industrial applicability/”utility”• USA – credible, substantial and specific utility (a
use for the invention) – high hurdle, used by the Patent Office to refuse trivial or premature applications
• EPO – the industrial applicability of a sequence must be given in the application (Biotekdirektivet) – low hurdle
Patent Claims
• The claim defines the invention• The claim must satisfy the patentability requirements• The description may only be used to interpret the
features of the claims
Rights arising from Patent I
• Productpatent – forbid others to: • make, use, offer for sale, sell, import
• Claims• 1. An isolated polypeptide comprising the amino acid
sequence of SEQ ID No. 2, or a biologically active sequence variant having at least 70% sequence identity to SEQ ID No. 2.
• 2. A pharmaceutical composition comprising protein X.• 3. An expression vector comprising a sequence coding for
protein X.
Rights arising from Patent II
• Method patent – forbid others to • Use the method• Method of manufacture also protects the products
• Claims:1. Use of protein X for the preparation of a pharmaceutical
composition.2. Use of protein X for the preparation of a medicament for the
treatment of disease Y.3. A method for identifying a compound with activity X,
comprising testing the compound in screening assay Y. 4. A method of producing protein X, comprising culturing a host
cell transfected with vector Y and recovering protein X from the culture medium.
Claim Types, Product
• Nucleic acid• Polypeptide• Antibody• Expression vector• Screening assay (kit)• Array• Pharmaceutical composition• Cells• Data carrier
Claim Types, Methods
• Method of treatment (of disorder)• Medical use (any therapeutic use)• Second medical use (disease specific therapeutic use)• Diagnostic use• Method of preparing compound/protein• Method of identifying modulator of activity• Method of isolating compound/protein/gene
Why??
• European Patent Convention (Art 60)• The right to a European Patent belongs to the
inventor or his successor in title.
• US-statute• Applications are filed in the name of the inventors• Inventorship is required to be accurate
Conception
• ”the formation in the mind of the inventor of a definite and permanent idea of the complete and operative invention”
• Conception is more than a goal• Must include how to make and use without undue
experimentation• Reduction to practise (=testing an invention
conceived by another) does not make you an inventor• Is the mental part of the invention, not the
constructive part
Joint inventions
• Joint conceivers are joint inventors• Do not need to work together• Do not need to make the same type or
amount of work• Do not need to contribute to every claim
PCT Patent Application Process
THE INVENTIO
N
PRIORIT
Y PATENT
APPLICATIO
N
FILIN
G AN U
PDATED PCT
APLICATIO
N
NOVELTY S
EARCH
PUBLICATIO
N OF P
CT
APPLICATIO
N
PRELIM
INARY
EXAMIN
ATION
FILIN
G NATIO
NAL OR
REGIONAL
APPLICATIO
NS
MONTHS0 12 16 18 28 30
Patenting Process
PRIORIT
Y PATENT
APPLICATIO
N
• First filing– timing• Early filing –
• Easier to get novelty• Enablement, sufficiency, utility?
• Later filing –• More time to prove function (of a gene or protein)• Longer patent term (evergreening of Pharmaceutical
products)
THE INVENTIO
N
Patenting Process
FILIN
G AN
UPDATED PCT
APPLICATIO
N
0 12 16 18 28 30
• Filing of updated PCT-application• Filed within 12 months of the first filing• Claims priority from the earlier filing => prior art is
anything published before the priority date• One single application in one language can give
patents in 130+ countries (1 May, 2007, 137 countries)
Patenting Process
NOVELTY
SEARCH
0 12 16 18 28 30
• Novelty search (database search)• Identification and classification of publications (patent
applications and scientific papers)• Possibility to evaluate the fate of the patent
application
Patenting Process
PUBLICATIO
N
0 12 16 18 28 30
• Publication of the application 18 months from first filing
Patenting Process
PRELIM
INARY
EXAMIN
ATION
0 12 16 18 28 30
• Preliminary examination –• A possibility to evaluate the patentability• Dialog with examiner at EPO or PRV (Swedish PTO);
written procedure, but possibilty for interview• International preliminary report on patentability
• Report on the patentability • Preliminary, so not binding on national authorities
Patenting Process
NATIONAL,
REGIONAL
APPLICATIO
NS
0 12 16 18 28 30
• Entry into national phase (US, JP, CA, AU, IN, CN, etc) or regional phase (Europe, Eurasia, Africa).• Selection of countries• Geographic strategy• Language - translations• Costs
Patenting Process
NATIONAL
PHASE
0 12 16 18 28 30
• The application is adjusted to national law• Patent grant/refusal• Possibility for opposition from third parties• Can be maintained up to 20 years from PCT filing date
Patent Applications Layout I
• Frontpage• Bibliographic information
• Background of the invention • Corresponds to introduction
• Summary of the invention • Copy of the indpendent claims, perhaps arguments
• Brief description of the drawings • Figure legends
• Detailed description • Definitions, description of alternatives, variations, uses• Supports sub-claims, fall-back positions, enablement, how to
make and use the invention
Layout II
• Examples • Materials & methods, results, rarely any discussion
• Claims• Main claims and independent claims
• Drawings (not Figures!)• Always at the end of the application
• Sequence listing• Amino acid and nucleotide sequences• Made according to special formal requirements
International (PCT) Applications
• APPLICATIONS!! NOT PATENTS• Filed locally (e.g. Denmark)• Treated and published centrally (WIPO, EPO, USPTO,
PRV, JPO).• Potentially covers 137 countries (holes in South
America and the Arab world)
PCT-applications
• Filed, searched, published, examined• Timeline: priority year, published after 18
months, PCT phase ends after 2½ years• Example: WO 2006/007853 (Symphogen)
US-applications/Patents
• US-applications published at 18 months• Long numbers, US2007020279 A1 (Johnson et al)
• US-patents, published at issue• Granted patents• Short numbers, fx US 5,824,307 (Johnson et al)
EP-patents
• Applications published at 18 months • Most are published as PCT applications (WO number)• Published as B1 publication at grant
Finding Patent Information – for Free
• espacenet• Link: http://ep.espacenet.com• Simple search functions• Abstract from the application• OCR text available for English, French and German language
applications• Publication as pdf-file – full document/page by page
• USPTO• Link: http://www.uspto.gov/patft/index.html• Simple and advanced search tools• Patent number search• Free text search• OCR text available• Publication available in Tiff format, page by page
Finding Patent Information – for Free
• Patentscope (WIPO)• Link: http://www.wipo.int/pctdb/en/• Advanced, simple, or structured search functions• Abstract from the application• OCR text available for English, French and German
language applications• Publication as pdf-file• Other documents (priority documents etc) as pdf-
file
Downloading Patent Documents for Free
• pdf’s of European patents and applications (since 2004): https://publications.european-patent-office.org/PublicationServer/search.jsp
• pdf’s of PCT applications from Patentscope (WIPO): http://www.wipo.int/pctdb/en/
• pdf’s of PCT applications file inspection at EPO: http://www.epoline.org/portal/public/!ut/p/kcxml/04_Sj9SPykssy0xPLMnMz0vM0Y_QjzKLN4i3dAHJgFjGpvqRqCKOcAFvfV-P_NxU_QD9gtzQiHJHRUUA43OWZA!!/delta/base64xml/L3dJdyEvUUd3QndNQSEvNElVRS82XzBfOUc!
Finding Patent Information
• Blast searches in patent database at NCBI: http://www.ncbi.nlm.nih.gov/BLAST/
• Example:• Find US patents covering persephin: http://www.ncbi.nlm.nih.gov
/entrez/viewer.fcgi?db=protein&val=2935710• Copy sequence• Paste into NCBI Blast (pat) http://www.ncbi.nlm.nih.gov
/BLAST/• Searching.....• Copy patent number• Go to http://www.uspto.gov/patft/index.html• Go to Patent Number Search• Paste number - search
Limitations of NCBI Blast
• Accession policy appears inconsistent / random• Only a small fraction of patented sequences are found at NCBI• Alternatives:
• Search for gene names• Commercial sequence databases (Chemical Abstracts
Registry, PCT-gen (WIPO), DGene (Derwent))
Ethics and Patent Law
• Why ethics?• Controversial issues:
• Patents on life (Dolly the Sheep, Harvard Onco-mouse)• Plant patents• Human genes• Stem cells• Human embryos (cryopreserved embryos)• Breast cancer diagnostics (brca genes)• Computer programs
Ethics and patent law
• ”Non-controversial” issues:• Patents on weapons• Patents on nuclear power plants/weapons• Patents on chain-saws• Industrial fishing equipment
Greenpeace
• Greenpeace believes the EPO is abusing patent law for the benefit of the few multinational giants that control the genetic engineering industry.
• Over 150 patents on human and animal genes and over 50 patents on seeds have been granted by the EPO since it started applying the EU Patents Directive in 1999.
• Greenpeace opposes the wording of the EU Patents Directive and calls for a re-negotiation of the Directive at the EU level.
• Greenpeace opposes patents on life. The sell-out of biological diversity and intellectual property rights that restrict access to plant genetic resources must stop. (source: Greenpeace Web-site)
Greenpeace reports
• http://www.greenpeace.org/raw/content/international/press/reports/greenpeace-patents-on-life-in.pdf
• http://www.greenpeace.org/international/press/reports/the-true-cost-of-gene-patents
For & Against Patents on Genes
• Not novel – but novel in isolated (=available) form• Not invented by the inventor – but isolated by the
inventor• Isolation is no invention – but the isolated gene can
solve a technical problem and has utility• Immoral to patent life – why? – living creatures
(animals, plants, microorganisms) have been regarded as goods for centuries
• Patenting genes is contrary to development – mere allegation, do not confuse patent applications with valid patents
Ethics
• Allegation: gene claims are way too broad• Cover all uses (product claims)• Gene claims should be restricted to use (Biotechnology directive as
implented in France and Germany)• Stops research
• My answer: gene claims should have same scope as all other claims
• Traditional compound claims cover all uses• Why should gene patent stop development and research while
patents in other fields enhance research?• Again: do not confuse patent applications with valid granted claims
• Part of the problem:• Backlog of human gene patent applications results in uncertainty• Sequence non-obviousness in the US• USPTO grants invalid patents• Very limited research exemption in the US
Human Gene Patent Applications
• The result of high-througput sequencing• Genes predicted with software• No biological data• Limited expression data (rarely quantitative)• Long list of genes (several 1000)• Laundry list of possible functions• Laundry list of possible uses
• Diagnostics• Therapeutics• Screening