Regarding patent information

1. Drug Patency
Pharmaceutical Marketing
2017-2018
Iman Ajami
Rawan Sabra
Lebanese University
Faculty of Pharmacy
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2. Did you know that “Patent” and
“Exclusivity” are two of the most
commonly searched terms on the
FDA website?
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3. Patent Definition
• Patent: is a property right issued to an
inventor “to exclude others from making,
using, offering for sale, selling or importing
the invention for a limited time, in exchange
for public disclosure of the invention when
the patent is granted.
• Generally, the term of a new patent is 20
years from the date on which the
application for the patent was filed.
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4. The Contract of Patency
Reveal invention Get exclusivity
So that others can learn from it
and improve upon it! 4

5. Key facts about Patents
Isn't a permit to put a
product on the market
Says nothing about
whether the product is
safe
still have to go through
rigorous testing and
approval
5

6. Territoriality of Patency
The exclusive rights are only applicable in the
country or region in which a patent has been
filed and granted, in accordance with the law
of that country or region.
Country A
Country B
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7. Why do we need a
Patent Law?
Rewards time, money & effort
associated with research
Stimulates further research as
competitors invent alternatives
Encourages innovation and
research by permitting
companies to recover R&D
costs during period of exclusive
rights
Limited term encourages quick
commercialization.
Patents allow exchange of
information between research
groups:
Avoiding duplicate efforts
Increasing general pool of
public information
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8. Patentability Requirements
Novelty
• The invention
does not form
part of the
prior art.
• Prior art = any
knowledge
made
available to
the public
before the
filing date of
the relevant
patent
application
Inventive
step
• The invention
could not
“easily have
been made”
by “a person
with ordinary
skill in the
art” on the
basis of the
prior art.
Industrial
Applicability
• The invention
could be
manufactured
or utilized in
any type of
industry.
Sufficiency
of
disclosure
• An applicant
must disclose
the invention
in a
sufficiently
clear and
complete
manner for
the invention
to be carried
out by a
person skilled
in the art
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9. Manufacturing a Generic Drug
This encourages competition and results in a
significant drop in drug costs, which ensures that life-
saving and important drugs reach the general
population at comparative prices.
Its patent has
expired.
Patents held on
the drug are
either
unenforceable,
are invalid or
would not be
infringed upon.
There has never
been any
patents on the
drug before.
In countries
where the drug
has no patent
protection.
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10. Higher returns
on
investments
Strong
market
position
Exclusive
rights
Opportunity
to license or
sell the
invention
Increase in
negotiating
power
Positive
image for
your
enterprise
Advantages of patent (Innovator)
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11. Disadvantages of patents (Innovator)
Technical information about
invention publicly available
High Cost (application,
searches for existing patents,
patent attorney's fees, annual
fee)
Application time-consuming
and lengthy process
(typically 3 to 4 years)
You'll need to be prepared to
defend your patent. Taking
action against an infringer can
be very expensive
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12. Patents Bad Impact (on the market)
Products patents restricts the ability of local firms to manufacture
copies of new drugs leading in developing countries to:
Less Competition
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Higher Drug Prices Lower Welfare

13. • Ever Greening: When brand-name companies patent “new
inventions” that are really just slight modifications of old
drugs.
• No significant therapeutic advantage, but for company’s
economic advantage.
The Ever Greening problem
13

14. Patent Protection Strategies
Pharmaceutical companies can employ
a number of strategies to maximize
patent protection on important
compounds, thereby maximizing the
commercial lifecycle.
STRATEGIES
• New Formulations
• New route of administration
• Stereoselectivity/Chiral Switches
• New Uses
• Combinations
• polymorphism
14

15. Patent Law Can Block Lifesaving Drugs
Pharmaceutical
companies
systematically screen
their drug candidates
to exclude the ones
lacking strong patent
protection.
Patents can be denied for
great drugs that might not
come to market because
they are:
• Disclosed in the past
(not novel)
• Naturally extended
existing knowledge
(obvious)
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16. We don’t want to provide patent protection
for profit-increasing activities that do not benefit
patients, like “me too” drugs.
But some things that are obvious might be beneficial,
and for those we want to encourage development. 16

17. Patent Process Overview:
In order to protect your drug in multiple countries:
Direct or Paris route:
• File separate patent applications at the
same time in all countries in national or
regional offices.
• File in a Paris Convention country
within 12 months from the filing date
giving you benefit of claiming this date.
PCT route:
• File an application under the PCT
directly or within 12 months period
provided by Paris Convention from
the filing date which is valid in all
Contracting States of PCT.
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18. WTO AND THE TRIPS AGREEMENT
Of these agreements, TRIPS
have the greatest impact on
the pharmaceutical sector and
access to medicines and
members adapt their laws to
the minimum standards of IPR
protection.
The World Trade Organization (WTO):
international organization dealing with the
rules of trade between nations.
In becoming Members of the WTO,
countries undertake to adhere to the 18
specific agreements.
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19. WTO AND THE TRIPS AGREEMENT
Laws in all countries that belong to WTO require
permission from a current patent-holder, not only to
use the patented technology, but also to import
products embodying or produced by this technology.
The definition of novelty,
non‐obviousness, and
usefulness of inventions may
vary from country to country.
The TRIPS Agreement is flexible
in national patent‐protection
system design.
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20. WTO Waiver
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The countries that will benefit from the
waiver are the 49 poorest nations, classified
by the United Nations as “Least Developed
Countries” or LDCs.
All other countries, including developing
countries such as India and China, are still
bound by the WTO’s agreement on TRIPS with
respect to drug patents.
Waiver
2033

21. 21

22. WTO Waiver Necessity
Critical due to higher
disease burden, especially
infectious diseases such
as HIV and malaria which
drugs are still under
patent
Developing and
strengthening the
manufacturing capacities
of developing countries as
these countries are often
unable to import cheap
copies of patent
protected drugs from
countries like India
Patents not effective
incentive in countries
which haven’t reached an
adequate level of
economic development
because they have no IP
to protect
22

23. Patent Laws in the Developing Countries
Why developing countries are
concerned about embracing the
patent protection?
Without implementing legal,
economic, and political structures
associated with free‐trade systems,
developing countries may not reap
the economic benefits of patent
protection.
Economic
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24. Patent Laws in the Developing Countries
Stronger patent protection system will allow developing
countries to:
Attract foreign direct
investment (FDI)
Increase investments
in research and
development (R&D)
Encourage national
scientists to invent
new drugs and invest
in their national
economies
Improve the overall
quality of health
Enhance
competitiveness in
the world market
Accelerate economic
development for
developing countries
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25. Patent Laws in the Developing Countries
1988 1995
425 billion
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Economic Growth
Developing countries that have
embraced the TRIPS Agreement:

26. Japan Experience
After it strengthened pharmaceutical patent
protection in 1978, Japan experienced a
substantial increase in U.S. pharmaceutical
R&D investment: $135.8
million
$505.5
million
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27. Lebanon's accession to the World Trade
Organization
Until today,
Lebanon didn’t get
the approval to
become a member,
noting that, the
period of
negotiations usually
varies between 2 to
5 years.
Preparation of the
basic documents
needed began in
late 2000, and
Lebanon proceeded
to submit the
documents and
negotiate their
content.
The first efforts for
Lebanon’s accession
to the WTO began
in 1998 with the
aim to
“Put Lebanon on
the world trade
map“.
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28. TRIPS compatible Patent Law
was enacted on August 7,
2000, and entered into force
on August 14, 2000
Paris Convention membership
accession on June 18, 1924,
and entered into force on
September 1, 1924 28

29. Conclusion
• Patents and other forms of intellectual
property protection play essential roles
in encouraging innovation.
• However, countries should always have
certain amount of freedom in modifying
their regulations and various options in
formulating their national legislation.
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Goal of providing
incentives for
future inventions
of new drugs
Goal of
affordable access
to existing
medicines

30. References:
National Center for Biotechnology Information (2013.). Drug patents: the evergreening problem. Retrieved Jan 22, 2018, from
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3680578/
AIPLA QUARTERLY JOURNAL (2005.). HOW PATENT PROTECTION HELPS DEVELOPING COUNTRIES. Retrieved Jan 22, 2018, from
http://developmentstudio.bskb.com/news/articles/documents/Ali_Imam_s_AIPLA_Quarterly_journal1.pdf
World intellectual property organization. Legal Requirements for Patentability. Retrieved Jan 23, 2018, from
http://www.wipo.int/edocs/mdocs/africa/en/wipo_pat_hre_15/wipo_pat_hre_15_t_3.pdf
The Conversation (2015.). World’s poorest countries allowed to keep copying patent-protected drugs. Retrieved Jan 22, 2018, from
https://theconversation.com/worlds-poorest-countries-allowed-to-keep-copying-patent-protected-drugs-50799
The new health care ( 2015.). How Patent Law Can Block Even Lifesaving Drugs.Retrieved Jan 23, 2018, from https://www.nytimes.com/2015/09/29/upshot/how-
patent-law-can-block-even-lifesaving-drugs.html
New Medical Life Sciences (2014.). Drug Patents and Generic Pharmaceutical Drugs. Retrieved Jan 18, 2018, from https://www.news-medical.net/health/Drug-Patents-
and-Generics.aspx
National Center for Biotechnology Information (2010.). Patent protection strategies. Retrieved Jan 23, 2018, from
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3146086/
NIBUSINESS INFO .CO.UK. Get patent protection for your business. Retrieved Jan 18, 2018 , from https://www.nibusinessinfo.co.uk/content/get-patent-protection-your-
business 30

31. References:
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• FDA/CDER SBIA CHRONICLES(2015.). Patents and exclusivity. Retrieved Jan 19, 2018,
fromhttps://www.fda.gov/downloads/drugs/developmentapprovalprocess/smallbusinessassistance/ucm447307.pdf
• Ministry of Economy & Trade (2000.). Patents law of Lebanon. Retrieved Jan 23,2018, from
http://www.economy.gov.lb/public/uploads/files/6061_8660_6573.pdf
• United Nations. LDC list. Retrieved Jan 23, 2018, from https://www.un.org/development/desa/dpad/least-developed-country-category/ldcs-at-a-glance.html

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