Transcript Patent presentation from Natalia Giovannini (pptx) - LBNC

Patents in Life
Sciences
Regenerative medicine
Pharma / Medtech
N. Giovannini, EPFL TTO, 21.11 2016
GENERALITIES
WHAT ARE PATENTS USEFUL FOR
WHAT CAN WE PATENT
PREPARING A PATENT APPLICATION
Drug
development,
drug delivery
Medtech, microfluidics,
Diagnostics, Medical imaging,
Implants ..
Personalised medicine
Biomarkers, genomics,
proteomic, epigenetics…
..
STEM CELL
THERAPY
DISEASE
MODELING
REGENERATIVE MEDECINE
CELL BASED THERAPY
GENE THERAPY
TISSUE ENGINEERING
AND BIOMATERIALS,
SYNTHETIC MATERIALS
SMALL MOLECULE
AND BIOLOGICS
“Our working definition of regenerative medicine includes a broad range of products that
leverage the body’s intrinsic abilities to heal itself.”
“Regenerative medicine is the use of cells or entities that stimulate cells to repair or replace
damaged tissues.”
“We define regenerative medicine broadly. We include all technologies that are
regenerative including cells, antibodies, gene therapies, small molecules, biologics,
biomaterials, etc. Our company also considers stem cells for drug screening and safety
toxicology testing as regenerative medicine. Immunotherapy is not positioned within our
regenerative medicine group.”
“Our team views ‘cell-based immunotherapy’as regenerative medicine with a large focus on
oncology.” “Regenerative medicine means any therapy that will repair or restore cells and
physiology leading to improved function.
“Within our venture group we don’t have a specific definition, but from our understanding it
can include a range of technologies including small molecules, biomaterials, cell-based
therapies and stem cells. We would also include gene therapy.”
Preclinical
Clinical Trials
250
5
PHASE
1
PHASE
3
NUMBER OF VOLUNTEERS
20 - 100
3 – 6 Years
PHASE
2
100 - 500
1,000 - 5,000
Years
6 6-8
– 7½
Years
average 10-15 years / 0.5 - 5 BIO
NDA SUBMITTED
5, 000 - 10, 000
Compounds
IND SUBMITTED
PRE- DISCOVERY
Drug Discovery
One drug
approved
(FDA /EMA)
Phase 4: Post Marketing Surveillance
Drug Discovery
The evolution of the costs of pharma output
Medical Devices
Average 2-6 years
Short comparison medtech time to market USA / Europe
USA
mix of sponsor time, FDA, insurance reimbursement
status rapid
EUROPE
CE marking very rapid, insurance reimbursement status
slower
SHORT COMPARISON MEDTECH / PHARMA
MEDTECH
time to market 2-6, more patent coverage in time
Scope of protection usually smaller than pharmaceuticals,
example the stent market (2009):
24 BIO, >10’000 patents
PHARMA
time to market 8-12, less patent coverage in time
Potential for scope of patent protection more important
(average number of patents per drug: 2-3)
CELL THERAPIES
Until 2013, the FDA had approved only one stem cell product, Hemacord, a
cord blood-derived product manufactured by the New York Blood Center
and used for specified indications in patients with disorders affecting the
body’s blood-forming system.
2014, First stem-cell therapy recommended for approval in EU of Holoclar
(New treatment for rare condition caused by burns to the eye, the first
advanced therapy medicinal product (ATMP) containing stem cells, as
treatment for moderate to severe limbal stem cell deficiency (LSCD) due to
physical or chemical burns to the eye(s) in adults.
Estimate 2012 from the Reg. Medicine Annual Report 2012-2013):
60’000 stem cell transplants annually performed (oncology, blood
disorders) for USD900Mio / 160K patients
CELL THERAPIES
cell therapy approvals (through out the world):
2002-2008: none
2008-2011: 5 approvals
2012: 7 approvals
WHAT ARE PATENTS USEFUL FOR
Product income
PROFITABLE CNIES,
PHARMA, BIOTECH
Public, gvnt (no/light strings attached)
Private funding (possible conditions)
UNIVERSITIES
Private investor, ecosystem support,
angels, VC, ..
START UPS
Healthcare industry has low
advantage to invest in
product development costs
without a patent protection
because
Healthcare companies bear
the high costs of obtaining
approval (FDA, EMA,..) only
because they can charge
high prices for PATENTED
drugs
USA
EP
• Assignee is protected by the priority date, as a
counterpart he must disclose its invention (18
months)
• Assignee is deciding about the commercial
rights in the exploitation
IMPORTANT
a granted patent is not a market approval
• Leverage for company investment
• Research exemption
Commercialisation and exploitation of licence
revenues (revenue source)
Asset value (negotiation tool)
Licensing or cross-licensing (exchange of value, aera
of collaborations)
Blocking / Defensive uses (dissuasion weapon)
Innovative image (marketing of a product, a
company)
PATENT APPLICATIONS ARE AHEAD
One example of IP display
Derwent pat database:
Stem cell and medical device:
Ab. 66 patents filed (quick search 2015) , owners inventors / institutions and a few
cnies:
MEDTRONIC
TISSUETECH INC (1)
MITRALIGN INC (1)
MIT CAPITAL PARTNERS LLC
IMRICOR MEDICAL SYSTEMS INC (1)
BOSTON SCI SCIMED INC (1)
CARDIO INC (1)
Medtronic inc (1)
BUT only one stem cell therapy approved by FDA (cord blood, for certain indications)
GLOBAL STEM CELL PATENT APPLICATIONS / PATENTS
Applications filed and patents granted at each office are shown for years 1986–2005.
(Nature Biotechnology 2007)
WHAT CAN YOU PATENT ?
«AN INVENTION THAT PROVIDES A NEW
TECHNICAL SOLUTION TO A TECHNICAL PROBLEM»
PATENTABILITY CRITERIA
An invention must be
NEW
never described before («prior art»)
INVENTIVE (Europe) or NON-OBVIOUS (US)
ENABLED
Described sufficiently to enable the skilled artisan
to reproduce the invention without undue burden
USEFUL (US) or have an INDUSTRIAL APPLICATION (Europe)
PATENTABILITY CRITERIA
An invention must be STATUTORY SUBJECT MATTER, not
excluded by law (f (territory)
Excluded subject matter is independent of novelty or
inventiveness.
“The categories of exclusions and exceptions may, depending
on one’s moral, social or other point of view, appear acceptable
or unacceptable, quixotic or outdated, liberal or conservative…”
(Board of Appeal of the European Patent Office ).
PATENTABILITY CRITERIA
SIGNIFICANT DEGREE OF UNCERTAINTY AT THE
MOMENT IF FILING FOR OBTAINING A PATENT
APPLICATION, WHICH TYPES CLAIMS, WHICH
SCOPE, ETC.
Evolution of the legal context, evolution of case
law,
PREPARING A PATENT APPLICATION
THE PRIOR ART
Get a good knowledge of the field of your invention
Be able to cite a certain number of publications,
scientific and patent applications / patents
PREPARING A PATENT APPLICATION
PUBLIC DATABASES
http://patentscope.wipo.int/search/en/result.jsf
http://worldwide.espacenet.com/?locale=en_EP
www.google.com/patents
http://www.uspto.gov/patents/index.jsp
https://www.lens.org/lens/
IPI subject search
https://www.ip-search.ch/fileadmin/user_upload/ip-
search/e/search_request_form_patentsearches_e.pdf
PREPARING A PATENT APPLICATION
THE PRIOR ART SEARCH
Allows you to feel the landscape
Allows you to bette interact with the patent
attorney, raises the potential quality of the
patent application
Allow you to make business decisions
Allow you to prepare and launch a patent
monitoring
PREPARING A PATENT APPLICATION
THE PRIOR ART SEARCH – STARTER KIT
A - Search with familiar names (authors, universities,
companies)
B - Get familiar with the scientific and technical language
C - Search extension via classifications, ..
With a view to analyze the patent trends in the field of regenerative medicine, it
is important to note that the above-mentioned patent application pertains to
the major international patent classification (IPC) of C12N 11/16, which
generally relates to enzymes or microbial cells being immobilised on or in a
biological cell. A quick search at the WIPO patent database reveals that there
are 164 WIPO Patent Applications that include C12N 11/16 as primary patent
classification. the following graph illustrates major players filing patents in this
field.
PATENT MONITORING
YOU IDENTIFY POTENTIAL PARTNERS / COMPETITORS
YOU IDENTIFY / FOLLOW THE ACTIVITIES OF YOUR
PARTNERS / COMPETITORS
GET A FEELING ON THE FREEDOM TO OPERATE
..
IMPORTANT SUPPORT TO (BUSINESS) DECISIONS
PREPARING A PATENT APPLICATION
INVENTION DEFINITION - DECLARATION
Background of the invention
description, references
Definition of the invention
detailed description, reference to figures
Embodiments of the invention
Material and methods, detailed description,
reference to figures
Claims
indicate types of claims (methods, device, new use,
composition of matter,..)
DO NOT BOTHER WRITE CLAIMS YOURSELF
EPFL - TTO
Technology transfer office
Innovation Park Bât. J
CH 1015 Lausanne
Natalia Giovannini
[email protected]
+21 693 35 90 / +21 693 70 73
THANK YOU FOR YOUR ATTENTION
Trade Related Aspects of
Intellectual Property Rights (TRIPS)
(1996)
Members must grant patents for "inventions" in all "fields of
technology" provided they meet all other patentability
requirements
MINTT
(TRIPS) (1996) - Article 27(3) –
exclusions
Members may also exclude from patentability:
a) the one "necessary to protect ordre public or
morality"including when intended to protect human, animal or
plant life or health or to avoid serious prejudice to the
environment, provided that necessity is at stake, and not just
convenience; and
(b) a second group including: (i) diagnostic, therapeutic and
surgical methods for the treatment of humans or animals, as
well as (ii) plants and animals other than microorganisms, and
(iii) plant or animal production essentially biological processes
other than non-biological and microbiological processes”
MINTT
70
60
50
40
30
20
Number of countries
(TRIPS) (1996) – Country specific
exclusions
Article 27(3) – exclusions
90
80
10
0
Biotechnological inventions which can be
used solely for one particular plant or
animal variety
Agricultural and horticultural methods
Plant products
Inventions Contrary to Laws of Nature
Contrary to Sharia law
Inventions for the protection of human,
animal or plant health or life or the
preservation of the environment
New uses
Processes for modifying the genetic
identity of animals which are likely to
cause them suffering without any…
The human body and processes related to
it
Materials occurring in nature
Inventions detrimental to human, animal
or plant life or health and/or the
environment
Essentially biological processes for the
production of plants and/or animals
Plant and animal varieties
Schemes, rules, methods etc for
performing mental acts and/or
intellectual activities
Therapeutic, surgical and diagnostic
methods for treating humans or animals
Inventions contrary to law, public order,
public policy, public interest and/or
morality
MINTT
Patentable subject matter in US and
Europe
EPC art 52 (1)
European patents shall be granted for
any inventions, in all fields of
technology, provided that they are
new, involve an inventive step and are
susceptible of industrial application.
35 U.S.C. 101.
“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
MINTT
Biopatents-Subject matter exclusions
Europe (Directive 98/44/EC)*
-
any invention whose commercial exploitation would
be contrary to ordre public or morality (Art. 53(a)
EPC) e.g. cloning in humans, modification of human
germ lines, genetic identity, modification of animals
causing them great harm; commercialisation human
embryos
-
Invention concerning plant and animal varieties (Art.
53(b) EPC).
-
essentially biological processes for the production of
plants and animals (Art. 53(b) EPC), i.e. classical
breeding comprising crossing and selection
-
methods for treatment of the human or animal body
by surgery or therapy, and diagnostic methods
practiced on the human or animal body (Art. 53(c)
EPC)
-
Discoveries (e.g. the mere discovery of natural
substances, such as the sequence or partial sequence
of a gene) are not patentable.
* Implementation in European Patent Convention (EPC)
USA (U.S. Code Title 35)
35 U.S.C. 101.
“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
Implicit judicial exceptions:
- Abstract ideas
- Laws of Nature/Natural principles
- Natural phenomena
- Natural products
Leahy-Smith America Invents Act (2012)
Notwithstanding any other provision of law,
no patent may issue on a claim directed to
or encompassing a human organism.
MINTT
Eligibility test of subject matter –
US law
process, machine,
manufacture, or
composition of
matter?
- Abstract ideas
- Laws of
Nature/Natural
principles
- Natural phenomena
- Natural products
Identify marked
difference?
MINTT
US patent law balancing act in assessing subject
matter
«All inventions at some level embody, use, reflect, rest upon or
apply laws of nature, natural phenomena, or abstract ideas»
Avoid
Unwarranted monopoly
…
Promote
Usefulness
Social benefit
…
MINTT
Basic differences in assessing subject
matter
• Must be a «process, machine, manufacture or
composition»
• Have a marked difference with what exists in nature
or add something that is significantly different from
Nature
• Any biological material and/or process that has
industrial applications + couple of exceptions
• Biological material isolated from its natural
environment or produced by a technical process
even if it previously occured in nature is patentable .
MINTT
patentable subject matter
methods for treatment by surgery,
therapy and diagnostic methods on
human/animals
Europe
USA
Excluded except for
products, in particular substances or
compositions, for use in any of these
methods
Still accepted
MINTT
Non-biologicals for medical
treatment/diagnosis
MINTT
Basic parts- human and other organisms
DNA
e.g.
Genes, SNPs,
introns*
Recombinant
DNA
RNA
lipids
e.g.
Therapeutic
siRNAs
e.g.
Lipid
encapsulation
mRNA
expression
profile
proteins
glycans
e.g.
Antibodies
e.g.
Glycan biogels
enzymes
Drug target
receptor for drug
screening
DNA carriers
Recombinant
protein
MINTT
Examples
MINTT
Cellular parts: human and other
organisms
Isolated cancer
cells
Adult stem
cells
Immortalized cells
MINTT
But not human embryonic cells
(at least in Europe)
MINTT
No restrictions for Gene therapy
except for germ cells
MINTT
No restriction for bioengineering
patentable both US and EP
MINTT
Animals and plants: transgenics
In Europe: only if technical feasibility is
not confined to one variety
MINTT
Animals and plants: classical breeding
Only allowed in
the US
Dairy cattle breeding for improved milk production
traits in cattle
MINTT
Micro-organisms (Bacteria, viruses, ye
Pure culture or transgenics now patentable
only in Europe
MINTT
Synthetic Micro-organisms
Allowed both in Europe and the United States
MINTT
Subject matter patentability - recap
•
Must be a «process, machine, manufacture or composition»
•
Have a marked difference with what exists in nature or add something that is significantly
different from Nature
•
Essentially biologically processes (plant and animal breeding)
•
Not Isolated biological material
•
Any biological material and/or process that has industrial applications
•
Biological material isolated from its natural environment or produced by a technical
process even if it previously occured in nature is patentable .
•
Inventions concerning animals and plants (e.g. transgenics) for which the technical
feasibility is not confined to one species
•
microorganisms
•
Not Animal an plant varieties and essentially biological processes such as breeding
•
Not human germ and ES cells
•
Not methods of surgical and therapeutic treatment or diagnostics on human or any animal
•
Not inventions that are contrary to morality or public order
MINTT
Subject matter patentability - summary
Europe :
- Any isolated part of an organism or micro-organism
- Inventions concerning animals and plants (e.g. transgenics) for which the
technical feasibility is not confined to one species
- microorganisms
- Not Animal an plant varieties and essentially biological processes such as
breeding
- Not human germ and ES cells
- Not methods of surgical and therapeutic treatment or diagnostics on human
or any animal
- Not inventions that are contrary to morality or public order
USA:
-
Any invention that represents a process, machine, manufacture or
composition
Essentially biologically processes (plant and animal breeding)
Not Isolated biological material – except for isolated micro-organisms
MINTT
Some history
Take home messages

-
The patentability of an invention may
differ from one country to another
change during time
change with the state of knowledge
still not be covered by patent law
 If in doubt, don’t hesitate to contact the TTO (has a good
network of Patent Attorneys)
MINTT
New use – Medical device
Pain indication
Neurorehabilitation
paraplegics
MINTT
New use – Biomaterials
Treatment of congestive heart
failure
Self-gelling alginate
= Medical device
is primarily physical in contrast to pharma
exerting biochemical effect
 intended purpose is physical – does not
achieve primary intended purpose by
chemical action or being metabolized
Encapsulation of Islet cells for
injection into kidney
MINTT
1. A method for inducing differentiation in stem cells,
comprising,
a) providing:
i) a cell culture comprising human pluripotent stem cells,
ii) a first inhibitor of Small Mothers Against
Decapentaplegic (SMAD) protein signaling, wherein said
first inhibitor is selected from the group consisting of
Noggin, a disulfide-linked homodimer of Noggin,
Dorsomorphin, LDN-193189, and mixtures thereof, and
iii) a second inhibitor of Small Mothers Against
Decapentaplegic (SMAD) protein signaling, wherein said
second inhibitor is 4-[4-(1,3-benzodioxol-5-yl)-5-(2pyridinyl)-1H-imidazol-2-yl] benzamide (SB431542), and
b) plating said stem cells in a culture medium,
Example 13
c) contacting said plated pluripotent stem cells
within 24-36 hours of said plating with said first
inhibitor of Small Mothers Against Decapentaplegic
(SMAD) protein signaling and said second inhibitor
of Small Mothers Against Decapentaplegic (SMAD)
protein signaling, and
d) inducing differentiation of said contacted
pluripotent stem cells into a population of cultured
neuroectodermal precursor cells.
7. The method of claim 1, wherein said population of
neuroectodermal precursor cells further
differentiate into cells selected from the group
consisting of central nervous system (CNS)
progenitor cells, pattemable neuronal cells,
dopamine positive neurons and motoneurons.
US8642334 B2 (2014)
MINTT
Three related patents filed by
Stanford
• 400 licenses to apply the
technique to commercial
ends.
• revenues of more than
$255 million for the
university,
• creation of more than
2400 commercial products
with aggregate sales
exceeding $35 billion.
MINTT
In 1975, Boyer meets Silicon
Valley venture capitalist
Robert Swanson
Genentech founded in
1976
MINTT
Example of MRC / Institution X (2002)
* Institution X grants the MRC a non-exclusive license under any
and all of its intellectual property rights in vector X to manufacture
and distribute HIV vaccine which incorporates the said vector or
parts thereof together with the MRC HIV gene sequences.
* For Developing Countries The license shall be world-wide and
royalty-free for (World Bank classification).
* For Developed Countries the license granted to MRC shall be
world-wide and provide a royalty to Institution X (the royalty is only
payable once the MRC has recovered all its reasonable direct costs
expended on the development, manufacture and distribution of the
HIV vaccine).
MINTT