Dr. amit gangwal ka pharmaceutical patent presentation highly exhaustive and updated ppt on pharmaceutical patents, a must watch by all those concerned with the same.

1. Pharmaceutical
Patents and
Paraphernalia
Amit ka PPT
Amit Ratn Gangwal Jain
Smriti college of Pharmaceutical Education, Indore

2. Disclaimer
Views expressed in this PPT are fairminded. Proprietary names used in this
article are of respective firms. Efforts
have been made to make this PPT
comprehensive but owing to space
limitations and continuous development
and case studies in the field, PPT can
not be termed highly exhaustive.)

3. Amit ka PPT
• Where language per se is used, original
reference/source/photos of personality have
been mentioned at appropriate place.
• This PPT of mine (Amit ka PPT) is not to
make money; this I have prepare to spread
right information for various readers.
• All the images are taken from internet.
Thanks

4. This world is being
driven by
R & D,
which is being
incentivized by patent.

5. Requirements for Patentability
USEFUL
– Must have some utility;
achieve some objective;
not against public policy,
must be disclosed
NOVEL
– Must be new, i.e., different
from available information
– Subject matter as a whole
would not have been
obvious at the time to
person of ordinary skill in
the art
NON-OBVIOUSNESS

6. What is not patentable
•Naturally occurring things
•Generally you cannot patent living things,
although you can patent certain live matter,
such as genetically engineered animals, plants,
etc., or the process of extracting a natural
product.
•You cannot patent laws of nature,
mathematical formulas and abstract ideas.
•Idea

7. Patents
Exclusive
rights
two decades

9. Patents
• There is provision for pre-grant rejection.
• May be revoked any time, if something foul is
reported. (post grant opposition)
• Product and process patent (from 2005) both
are in force
– Closing down
chapters
various
reverse
engineering
• Before 2005 reverse engineering was
flourishing (Much to the dissatisfaction of
overseas player).

10. Types of patent application
(1)Ordinary patent application- It is a simple application for
patent without any priority claim and not being convention or
National phase application .It should be accompanied by a
provisional or complete specification at the time of filling.
(2)Convention Application- An application who files an
application for patent in a convention country can make
convention application in India within 12 months from the date of
basic application
(3)National phase application under PCT- PCT stands for the
patent co-operation treaty. It is a sister treaty of the Paris
convection administered by the world intellectual property
organization. The PCT system facilitated filing of patent
application under a single umbrella and provide for simplified
procedure for the search and examination of application

11. National, regional and international applications
National applications
generally filed at a national patent office.
Regional applications
A regional patent application is one which may have effect in a
range of countries. The European Patent Office (EPO) is an
example of a Regional patent office. The EPO grants patents
which can take effect in some or all countries contracting to the
European Patent Convention, following a single application
process.
(Taken from Wikipedia)

12. Patent of
addition
is granted for
additional
information
in original
application,
if found
adhering to
the laws.

13. WIPO
The World Trade Organization's Trade-Related
Aspects of Intellectual Property Rights (TRIPS)
Agreement establishes minimum standards for
intellectual property rights, including patent
protection for pharmaceuticals; therefore, it may
make it difficult for developing countries to gain
access to medicines, especially those countries that
are the least developed. This study aims to
determine whether implementation of the TRIPS
Agreement in Latin American and Caribbean
countries has generated patent legislation that is
sensitive to public health needs. (Taken from
Wikipedia)

14. PTC
• The Patent Cooperation Treaty (PCT) is
an international patent law treaty, concluded
in 1970. It provides a unified procedure for
filing
patent
applications
to
protect inventions in each of its contracting
states. A patent application filed under the
PCT is called an international application,
or PCT
application.
(Taken
from
Wikipedia)

15. TRIPS
• The Agreement on Trade Related Aspects
of Intellectual Property Rights (TRIPS) is
an international agreement administered by
the world trade organization (WTO) that sets
down minimum standards for many forms
of intellectual property (IP) regulation as
applied to nationals of other WTO
Members. It was negotiated at the end of
the Uruguay round of the general agreement
on tarrifs and trade (GATT) in 1994. (Taken
from Wikipedia)

16. Generic versions
(ANDA)
• If products goes off patent, molecule/product
goes to public domain.
• Its open for generic players.
• F2F (first to file) will get the green signal to
launch first generic version in world/chosen
area/protected area.
• F2F will get exclusive rights for 6 months.
• Then anybody may launch with permission.

17. If products goes off patent,
molecule/product goes to
public domain.

18. Paragraph IV filing
Patent listings are important in the generic drug approval
process because challenges to listed patents can lead to stays
in approval of generic versions of original molecule. As per the
FD&C Act, a generic drug applicant need to include in its
application; a certification for each patent listed in the Orange
Book for the innovator drug. Similar information is required for
applicants filing 505(b)(2) applications under section 505(b)(2)
of the FD&C Act. This certification must state one of the
following:
 Para I: that the required patent information relating to such patent has
not been filed;
 Para II: that such patent has expired;
 Para II:I that the patent will expire on a particular date; or
 Para IV: that such patent is invalid or will not be infringed by the drug, for
which approval is being sought.

19. 30 month stay provisions
If the generic counterpart of a branded product is
intended to be marketed before expiration of the
patent, then applicant is liable for legal action
against him and the ANDA applicant, filing an
application citing a paragraph IV certification, may
be tried for patent infringement. Within 45 days the
NDA holder or patentee can file a patent
infringement suit against the ANDA applicant after
receiving notice from FDA which may be followed
by disapproval (of ANDA application) by FDA. This
disapproval remains in force for at least 30 months
from the date of that notice.

20. Recent never-before announcement by Indian
courts
There has been series of pronouncements by Indian courts,
including the Apex Court (Supreme Court). Most of these were
not in favour of MNC. Few notable cases are: Nexavar and
Gleevac. Moreover, both these products are used in treatment
of rare cancers for which these are the most successful
medicaments so far.
• Nexavar ruling was historical in that, it became the first product
in pharmaceutical realm in India, which is now being produced
and sold (other than the innovator company) by Indian
company using compulsory license provision.
• Gleevac became the historical brand in the sense that first time
in India, Apex Court rejected the ground (minor change in drug
form) furnished by defendant MNC and not granted the fresh
patent to milder modification in the molecule present in
Gleevac.

21. Historical decrees by indian court
Glivec/Gleevec was
already in the
market, however
company decided to
seek a patent on a
slightly modified
version potentially
giving it longer period
of market exclusivity.

22. Such was the
need and
success
of Imitanib
that this was
featured on
the
cover of Time
magazine in
2001

23. Dr. Brian J. Druker
Dr. Brian J. Druker an
oncologist at Oregon Health and
Sciences University and a
Howard
Hughes
Medical
Investigator, played a major role
in discovering Imitanib.

24. Section 3(d) of the Indian Patents
Act does not allow
patents of new version of known drug
molecules if they don’t make it more effective
than before. In the mean time many Indian
companies produced generic drugs at very
cheap rate which was consumed by 300000
people . Whereas 16000 people use glivec.
(Generic versions can be manufactured when
the
product
expires
the
patent).
http://www.slideshare.net/BizandLegis/patent-

25. Word
efficacy is important.
Until efficacy is increased
and proved, new patents
are not granted in India,
after slight/bigger change in
existing molecule/product

26. Patent evergreening
What is Patent evergreening?
Patent evergreening is a potentially dubious and
sometimes derogatory term that generally refers to the
strategy of obtaining multiple patent that covers different
aspects of the same product, typically by obtaining
patents on improved versions of existing products.

27. What has accelerated is not so much
patenting or innovation but evergreening,
the effort to extend patents.

28. Historical decrees by
indian court
natco
Sorafenib
tosylate

29. Compulsory license
In certain cases, without patentee’s consent and with state
intercession, generic version can be produced and sold through the
provision of compulsory license. A compulsory license, also known
as statutory license or mandatory collective management, provides
owner of a patent patentee) the rights against payment either set by
act or determined through some form of negotiation. Government
intervention is indispensable. It is one of the flexibilities in patent
rules mentioned in the world trade organization (WTO)’s agreement
on intellectual property, the TRIPS (Trade Related Aspects of
Intellectual Property Rights) agreement. The TRIPS agreement does
not specifically list the reasons that might be used to justify
compulsory licensing. However, the Doha declaration on TRIPS
confirms that countries have liberty to decide the basis on which
compulsory licenses could be granted. The TRIPS agreement lists a
number of conditions for issuing compulsory licenses, in Article 31.
In particular:

30. Nexavar became a blockbuster with $1 billion in sales in
2011 for Bayer. The revenue growth was 7% over the 2010
sales of $934 million. Bayer holds Indian patent (215758)
for this chemotherapeutic agent. But all that changed on
March 13, 2012, when India's patent office accepted a
request from Hyderabad-based Natco Pharma and granted
permission to compulsorily make Bayer's patented drug and
make it available to patients at 97 percent discounted price
of 8,800 rupees for a month's dose (while Bayer charges
284,428). Of course, Natco has been ordered to pay 6
percent royalty on Nexavar’s sales to Bayer.

31. When Natco’s approach for voluntary license [{s. 84(6) (IV)}] was
turned down by Bayer then state intervention lead to historical
verdict on March 12, 2012 in favour of Natco. Bayer had appealed
against this order. This ruling was further upheld by Chennaibased Indian patent appellate board (IPAB). The earlier order had
relied on Section 84 (1) (a, b and c) of the Patents Act, which
states that “after three years of grant of a patent, a compulsory
license can be granted to any applicant on any of the following
justifications:
(a) the reasonable requirements of the public with
respect to the patented invention have not been satisfied, or
(b) that the patented invention is
not available to the public at a reasonably affordable price, or
(c) that the patented invention is not ‘worked’ (manufactured to
some satisfactory extent) in the territory of India18

32. Specimen
copy of
notification
to innovator
company at
USA by
Government
of Zambia,
regarding
compulsory
license.

33. Western world raises eyebrows
on
• the issuance of unwarranted compulsory
licenses
• the unfair revocation of valid patents, and
• the denial of patentability of inventions in India

34. What lies ahead
Is very clear only three things will get cheaper
molecules
–Either compulsory license
–Free to all policy
–Rigorous R and D by most of the pharma organization

35. While addressing at Government
College of Pharmacy, Bangalore,
former President of India APJ Abdul
Kalam suggested concept of open
source, introduced by CSIR (Council
of
Scientific
and
Industrial
Research). Open source drug
delivery
(OSDD)
focuses
on
collaborative effort to achieve
breakthroughs in the world of
medicines and bringing down cost of
medicines. This concept would
provide
medicines
free
from
monopoly and only generics would
be produced.

36. What research and
development brings to the
organization
•It brings name and fame to product
•Product then becomes brand
•Brand then makes brand range
•Ultimately people purchase product
of that category by your brand name.

37. Importance of being pioneer

38. An ITC product
Bhaiya ak lal wali
maggi dena
(though its not a
maggy).

44. • Most of the people demand for packed
water bottle by asking
bhaiya ak
bislery dena.
• Bhaiya ak xerox kar dena.

45. Uncle Sam’s nation
U.S. is now “first to
file”/first to publish

46. The process of "negotiating" or "arguing“ (or
putting one’s point) with a patent office by
patentee, and interaction with a patent office
with regard to a patent after its grant, is known
as
patent prosecution.
Patent prosecution is distinct from
litigation,
patent
which relates to legal
proceedings for infringement of a patent after it
is granted.

48. • Leading scientist, Padma Bhushan
awardee and chairman of pharma major
Cipla, Yusuf Hamied shot to
global fame in early 2001 when he
announced that his company, Cipla,
would supply a combination of AIDS
drugs to developing countries for less
than $1 a day, at a time when first-line
antiretroviral (ARV) medication sold for
up to more than $15,000 per patient per
year. (October 20, 2013, Times of India 11
page)

49. In other words, the drug companies in
the USA who were charging $15,000 a
year for this medication were saying
that without their brand name, these
generic medications were simply not
the same despite the fact they were
both made with the same cheap active
ingredients, as pointed out by Cipla’s
Hamied.

50. India is committing selective genocide in healthcare.
• Drugs for cancer, HIV/AIDS, TB, Malaria
should be free from clutches of patents law.
• There should be provision for compulsory
licensing.
• There must be policy for compulsory license
; presently system varies case to case.
• In canada there is system of obligatory
licenses ; which allows Canadians to copy
any drug and pay the patent holder 4 %
royalty.

51. India cannot afford a monopoly in drugs. If
there is a monopoly, people won't be able to
afford drugs, like the cancer drugs sold today.
For example, the top-selling AIDS drug in the
world, Atripla, costs $20,000 per patient per
year in the US. Cipla's US FDA-approved
equivalent product, is being sold for less than
$100 per patient per year in Africa where it is
not under patent. If they block India, they are
essentially blocking the Third World's supply of
newer cheaper anti-AIDS drugs and other
newer medicine.

52. Many countries like Malaysia, Indonesia,
Thailand, Brazil have already brought in
compulsory licensing. Look at the world's topselling drugs; 70% of them are made and
marketed by companies that haven't invented
them. They are all in-licensed products. They are
paying royalty to the guy who did the invention.
So in-licensing is on all the time, but now, it is a
specific in-licensing on exclusive basis to one
company. I want non-exclusive in-licensing. I
want the obligatory licensing system. I don't mind
paying royalty.

53. Fire in the
blood: A heart
touching
documentary
on patent
issues
http://www.frontrowreviews.co.uk/reviews/fireintheblood/21252

54. Heavy inputs from my earlier
published article
“PHARMACEUTICAL PATENTS: THE
HATCH
–
WAXMAN
AMENDMENTS,
EVERGREENING, 180 DAYS EXCLUSIVITY,
LISTING IN ORANGE BOOK AND FEW
RECENT UNPRECEDENTED DECREES BY
INDIAN COURTS”

55. Thanks