Transcript Patents_and_Trademar..

CRA-UD 2013-2014
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Intellectual property
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Framework
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Patents
Monopoly granted to the inventor monopoly of working for
20 years, -in exchange for the disclosure of the invention
Patent = contract between the company and the inventor
Not all creation can be patented
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Advantage / Disadvantage
Disadvantage: no protection by society and researchers
will not know the architecture of the invention.
A patent: is an economic exploitation monopoly for 20
years, it's a giving – giving contract.
We can not make a patent of everything, some creations
are not patentable for various reasons.
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Discoveries in: Pharmaceutical Industries
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Development of the chemical industry
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Development of biotechnology
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Example of HIV
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Dr. Robert Gallo case
He is an ex-discoverer of the AIDS virus.
As a lab chief at the NIH, in Bethesda, Gallo is probably the bestknown AIDS researcher in the world. He is usually called, albeit
erroneously, ''co-discoverer of the AIDS virus.
The virus that Gallo put forth in 1984 as the cause of AIDS was
not an independent discovery but merely a copy of a virus sample
sent to him nine months earlier by cooperative French scientists
at the Pasteur Institute in Paris.
In the three-year battle for credit and patents that followed, the
French were shown to be the rightful discoverers, despite the
politically maneuvered "amicable" agreement to split the credit
for the discovery between the two countries.
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Development of the computer industry
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The most important point
 Commercial profit
 Taking benefices
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Evolution of Industrial Property
Evolution with the evolution of society and discoveries
Still lags behind the evolution of research and development
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What is the economic logic?
 Secret V / S Patent
-secret:
 advantage if:
-Small group of researchers
-Limited number of intervening
-Possibility of secrecy
-cheap
 disadvantage if:
-Several speakers to produce the finished product
-Need a collaborative work
 example:
-The chemical formula of Coca Cola
-Steak sauce of Paris (transmitted from father to son)
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What is the economic logic (2)?
Secret V/S Brevet
Patent (obstacle for free competition )
 advantage:
-State and legal protection of inventions
-Investment protection
-Opportunity to share with others the invention (as validations
of patents)
 disadvantage:
-Implementation very complicated
-There is no single international protection
-Preparation of a file into several languages
-High cost
 examples:
Patent active drugs
Patents filed by technology companies like Apple, Intel, Sharp,
Sony, BMW ...
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What is the economic logic (3)?
Investment V / S Return on Investment (1/3):
The discovery of a drug is expensive: European
investments in R & D:
 1980:
€ 2.3 billion
 1990: € 7.7 billion
 1997: € 12 billion
 2009: € 26 billion
 Investment in the U.S. in R & Din 2009: $ 34.8 billion
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Most important R&D investment is in
USA
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Number of new molecules / Innovative
drugs
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Cycle de financement d’un médicament
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Return on investment:
between yesterday and today
Acceleration of diffusion
Faster generic
entry
Flux financiers
10 ans
20 ans
Cost increase
of R & D
Development is increasingly long
Approximately 70% of drugs on the market do not provide companies that have marketed
the return on investment, it is provided by Slide
a limited
number of drugs.
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What is the economic logic?
Investment V / S Return on Investment (2/3)
-The discovery of a drug is expensive
-Laboratories to make an investment must earn sufficient income
from the marketing of a drug
 20-year monopoly
-No copy of the same drug can reach the market during this
period of protection
-However possibility of arriving competitors on the market
(different molecule with identical efficiency)
 Exclusivity for orphan drugs
-7-year monopoly over the U.S.
-10 years in Europe and Japan
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What is the economic logic?
 Investment V / S Return on Investment (3/3)
injustice:
 Rich countries can invest, but this is not the case in poor
countries
 The patent reinforces the imbalance between the north and
south
 Importance of the Doha Declaration = easy access to essential
drugs in poor countries
 An obstacle to free competition
As a result of patents, pharmaceutical companies are investing
heavily in research and development and take financial risks in order
to respond to the growing therapeuticSlide
needs
25 of the population.
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Lebanon- patent law
OJ 14 August 2000: Act No. 240
-Protection of Pharmaceutical Products
-Protection of 20 years from the filing date
-Filing language: Arabic
-Description and claims in Arabic, French or English
-cost:
• The first year: 50,000 LL fee + 100 000 LL
• Annual cost = cost year (n-1) + 50 000 LL
-Compulsory license held under certain conditions:
• Public health purposes
• Reasons vital to the economy
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Conditions of patency – Liban
Article 2 de la loi n°240
 novelty
-It is an invention that has not been previously described
-Any oral disclosure (communication at a conference) or
written (poster, abstract, article ...) destroys the novelty
 innovation
-A skilled artisan can ( not) achieve in the current
knowledge of the state of the art
 industrial application
-Invention can be manufactured by any type of industry
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Are not patentable - Lebanon?
Articles 3 and 4 of Act No. 240
 Any scientific discovery, theory or mathematical
program without industrial application
 Any concept or method in connection with
intellectual, economic, financial or in connection with
the field of toy.
 Any diagnostic or therapeutic method for the
treatment of humans or animals with the exception of
products or equipment used to carry out these
methods.
 Any invention against public order or moral
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Category
Regulatory Data
Protection
Length
• 5 years
• 7 yrs for orphan drugs
Legal
Hatch -Waxman
When it’s granted
1.
2.
3.
NDA Approval
for NME
sNDA
Pediatric
exclusivity
Patent Protection
• 8 years (+ 2 + 1) NME
•10 years (orphan)
•12 years (orphanPUMA)
•1 year (new indication for
well-established)
1.
Directive 2001/83
amended by
2004/27
1.
2.
MAA approval
Significant
medical
advancement
20 years from filing
(Orange Book)
Patent and Trademark
Office
1.
2.
After review
by Patent and
Trademark
Office
Pediatric
exclusivity
20 years from filing
(country specific and
not posted) + 5y SPC
Country specific
SPC: Regulation No
1798/92/EC
Pediatric reward: (+ 6
months)
NDA – New Drug Application; NME - New Molecular Entity; sNDA – supplemental New Drug Application; SPC – Supplementary protection
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certificate
Autres différences en E-U et
Europe
 United States:
No possibility to register generic prior to the expiration of
all patents of the reference molecule
 Europe:
-Ability to register a molecule generic if the registration
data of the reference molecule are no longer protected
(expires 10 years of protection)
-No opportunity to market a generic (even if an
authorization for placing on the market) if there is a patent
valid
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RDP (years)
Paediatric data
US
7
+ 6 months
EU
10
+ 2 years
Australia
5
Similar to other drugs
Japan
10
+ 4 years (max 10 years)
Canada
No Orphan drug status
Russia
No Orphan drug status
Turkey
Israel
No Orphan drug status
Let’s see if I can find more countries…
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1.
NEW molecular entity: “old” product introduced in United States
2.
3.
NEW product: combination products
NEW formulation: extended release
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RDP 10 years
File never updated to EU standards
1963
Nivalin 1st MA
in Austria
Treatment
of polio
2000
1995
Alzheimer
indication
approved
2001
Nivalin
withdrawal
2005
Generic
galantamin MAA
submitted to
MHRA
BE vs. Remnyl
MA for Alzheimer via
MRP to Cilag Janssen
(full application)
MHRA rejected the
application (RDP
not expired)
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2009
2010
RDP Expiry
ECJ:
Nivalin
can’t be
used a
Referenc
Medicinal
Product
1990-1999
2000
2005
2007
Jan 14, 2005
RDP Expired
Foreign Approvals
Jan 14, 2000
Approved in US
October 9, 2007
First Generic Approved
Source: Electronic Orange Book: http://www.accessdata.fda.gov/scripts/cder/ob/docs/tempai.cfm (June 9, 2009)
Source: Drugs@FDA: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Search_Drug_Name (June 9, 2009)
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1.
NEW molecular entity: “old” product introduced in United States
2.
NEW product: combination products
3.
NEW formulation: extended release
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December
Diovan
(valsartan)
Approved
1992
July
Norvasc
(amlodipine)
Approved
1996
June
Exforge
(valsartan/amlodipine)
Approved
2003
September
Amlodipine
generic
Approved
2007
October
Tentative
Approved
valsartan
generic
March
Diovan patent
Expires
2011-12
June
RDP Expires for
Exforge
Source: Electronic Orange Book: http://www.accessdata.fda.gov/scripts/cder/ob/docs/tempai.cfm (June 9, 2009)
Source: Drugs@FDA:
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Search_Drug_Name
(June 9, 2009)
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Products
Exforge® 160/5
Diovan® 160 mg
Amlodipine 5 mg
Exforge® 320/10
Diovan® 320 mg
Amlodipine 10 mg
90 day supply
$246.61
Total
$246.61
$220.28
$22.99
$338.28
$243.27
$338.28
$311.72
$23.99
$335.71
Source: http://www.drugstore.com/pharmacy/prices/drugprice.asp?ndc=00078049115&trx=1Z5006; accessed June 2, 2009
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1.
NEW molecular entity: “old” product introduced in United States
2.
NEW product: combination products
3.
NEW formulation: extended release
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September
IR Approved
(low doses)
1997
May
XR Approved
2002
September
Data
Exclusivity
Ends (IR)
2007
April
Data
Exclusivity
Ends (XR)
December
Generic
Tentative
Approval (IR)
Rejected
2008
April
FDA Advisory
Committee Meeting
for MDD and GAD for
XR formulation
2009
2012
2017
March
Patent
Expires (IR)
November
Patent
Expires (XR)
IR – Immediate Release, XR – Extended Release, MDD- Major Depressive Disorder; GAD-General Anxiety Disorder
Source: Electronic Orange Book: http://www.accessdata.fda.gov/scripts/cder/ob/docs/tempai.cfm (June 9, 2009)
Source: Drugs@FDA: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Search_Drug_Name (June 9, 2009)
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A new formulation RDP
Global Marketing Authorisation contains the initial
authorisation and all variations and extensions thereof, as well as
any additional strengths, pharmaceutical forms, administration
route or presentations authorized through separate procedures
and under a different name, granted to a MA holder of the initial
authorisation
All presentations of a given product are considered as part of the
same MA.
The start of the data exclusivity period is the date when the first
MA was granted in the EU Community.
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The brand
 "The brand is ... a non-negligible value of business
assets"
Brand = Quality Assurance
Brand = Fight against generic
Brand = Fight against counterfeiting
Brand = Fight against parallel trade
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Anti-brand health authorities
 Right of substitution by the pharmacist
 DCI prescription
 Framework agreements with prescribers
 Limiting medical prescribers in the
TFR
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Criteria for the validity of a trade
mark - Absolute Criteria
A brand must not contain any prohibited sign and it must
be distinctive.
Article L711-3
of the ICC
 forbidden signs
-Signs reserved for official or semi-official (Red Cross,
pharmaceutical caduceus, caduceus medical ...)
-Misleading signs on the nature, quality or
geographical origin of a product ("pharm" and
"pharma" are reserved for pharmaceutical product)
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Criteria for the validity of a trade
mark - Absolute Criteria
A brand must not contain any prohibited sign and it must
be distinctive.
article L711-3 du CPI
 Distinctive signs
 A generic term (by ex.une DCI) is not a valid trademark
 Ordinary terms or necessary in the current language or
professional for identity of the product are not valid
trademarks
 mark consists of a name or a sign which may serve to
designate a characteristic of the product is not valid
 signs which consist exclusively of the shape imposed by the
nature or function of the product are not considered valid
 it is possible to make a shape as a trade mark, provided that it
does not present a functional and technical character.
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Criteria of validity of a mark –
Relative criteria
mark must not infringe (harm) prior rights held by
third parties (brand name, trade name, brand,
domain names ...), that is to say they should not be
identical or similar.
 Assessing the availability of a mark before deposition
 Research is conducted at least in principle in Class 5 of
the Nice International Classification
 Right to object to the use by third
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Brand Control
In France: Double control
INPI:
 verifies the absolute criteria for the validity of a
trademark
 In France, the criteria must be supervised by trademark
owners => right to object => increases the risk of conflict
AFSSAPS:
 the brand is part of the Marketing Authorization
 Brand Refusal = Refusal of the Marketing Authorization
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Contrôle de la Marque par
l’AFSSAPS
Article L 5111-2 of the CSP:
"Any medicinal product prepared in advance in a special pack and
characterized by a special name“
Article R. 5121-2 of the CSP:
"The name of a drug can be either an invented name or a common or
scientific name accompanied by a trade mark or name of the
manufacturer. The fancy name can not be confused with the common
name “
Article R. 5121-21 of the CSP:
"... The fancy name must be chosen to avoid confusion with other
medicinal products and not misleading as to the quality or properties of
the specialty“
 Link between brand control and protection of public health
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Contrôle de la Marque par
l’AFSSAPS
Recommendation for the choice of a drug name:
 Preferably one word
 No hyphen
 No diminutive or superlative (HIGH, LOW, RETARD, PLUS, MINUS ...)
 No syllable that resembles a diminutive or superlative
Attention to the likelihood of confusion:
 With another drug
 With a cosmetic product or foodstuff
 No trivialization of drug
Major points of comparison with another name
 The position of letters
 The first letters of distinct preference
 The confusion associated with handwriting
 The number of letter in common with respect to all of the letters of the name
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En résumé – Quel type de protection?
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