ipr & generic pharmaceutical industry by mahendra b. thakre
TRANSCRIPT
-
8/6/2019 IPR & Generic Pharmaceutical Industry by Mahendra B. Thakre
1/26
Intellectual Property Rights
& Generic PharmaceuticalIndustry
By
Dr. Mahendra B. Thakre
IPDO-IPM
St. Peter's Institute of Pharmaceutical
Sciences- 1st July 2011
-
8/6/2019 IPR & Generic Pharmaceutical Industry by Mahendra B. Thakre
2/26
Overview of GATT and WTO
TRIPS and Intellectual Property Rights
Patents and its importance
Developing concept of Patentability
Patents and its enforcement
Status of Patent Act
Pharmaceutical Industry as an case study
ROAD MAP
-
8/6/2019 IPR & Generic Pharmaceutical Industry by Mahendra B. Thakre
3/26
General Agreement on Tariff and Trade(GATT)
It was singed on Oct. 30, 1947 at Geneva
The fundamental principles of GATT includes:-Trade should be carried on non-discriminatory
basis
Domestic industry should be protected by meansof custom tariff and not through commercial means
The aim of consultations should be avoidance ofdamage to members interest
GATT served as a frame work within whichnegotiations could be held to reduce tariff and
other trade barriers
-
8/6/2019 IPR & Generic Pharmaceutical Industry by Mahendra B. Thakre
4/26
WORLD TRADE ORGANISATION (WTO)
WTO came into effect on Jan 1, 1995
Currently 146 countries are membersIt is full fledged international organization
It contains much improved version of the original
GATT rules plus a lot more
It administers a unified package of agreements towhich all members are committed.
TRIPs agreements
-
8/6/2019 IPR & Generic Pharmaceutical Industry by Mahendra B. Thakre
5/26
INTELLECTUAL PROPERTY RIGHTS
Patents
Copyright
Trademark
Design
Trade Secrets
Geographical indicationIntegrated Circuits
-
8/6/2019 IPR & Generic Pharmaceutical Industry by Mahendra B. Thakre
6/26
WHAT IS NOT PATENTABLE
Discoveries are not patentable
Ideas are not patentable
Laws of nature
Physical Phenomena
Abstract ideas
-
8/6/2019 IPR & Generic Pharmaceutical Industry by Mahendra B. Thakre
7/26
WHAT CAN BE PATENTED
New and useful
Process
Machine
Manufacture
Composition of matter
Or any new and useful improvement thereof
-
8/6/2019 IPR & Generic Pharmaceutical Industry by Mahendra B. Thakre
8/26
Developing concept of what can bepatented
Diamond Vs. Chakrabarty, 206 USPQ 193 (1980), held
that microorganisms produced by genetic engineering arenot excluded from patent protection.
Test was not whether they were living, but whether theywere produced by human intervention.
-
8/6/2019 IPR & Generic Pharmaceutical Industry by Mahendra B. Thakre
9/26
PATENT RIGHTS
Right to exclude others
A patent is not a grant of a right to make use or sell.
Quid pro quo of Patent protection- grant of patent in
return for full disclosure
-
8/6/2019 IPR & Generic Pharmaceutical Industry by Mahendra B. Thakre
10/26
Why are patents valuable to an
organization?
Experience has shown that rivals are less likely to go to
court when they know that their opponent can also wield
a patent
IPR protection is key for companies to recoup costs and
generate returns (active ingredient, formulation, process)
Asserting your patent back in an infringement action
A good patent portfolio can affect the market valuation of
a company and used as a bargaining chip
-
8/6/2019 IPR & Generic Pharmaceutical Industry by Mahendra B. Thakre
11/26
COCEPTS OF PATENTABILITY
Utility
AnticipationObviousness
Enablement
Best mode
-
8/6/2019 IPR & Generic Pharmaceutical Industry by Mahendra B. Thakre
12/26
UTILITYLevel of utility to be disclosed by pharmaceuticals
patents
In vitro activity
Animal tests
Does not have to prove safety or efficacy of the drug in
human beings
Reasonable correlation between the activity in question
and the asserted utility
Function of the FDA and patent office are distinct
-
8/6/2019 IPR & Generic Pharmaceutical Industry by Mahendra B. Thakre
13/26
-
8/6/2019 IPR & Generic Pharmaceutical Industry by Mahendra B. Thakre
14/26
OBVIOUSNESSIf the difference between the subject matter sought to patented
and the prior art are such that the subject matter as a whole
would have been obvious at the time the invention was made
to a person having ordinary skill in the art to which said subject
matter pertains
Definition of one of Ordinary skill in the art
Combining two or more prior art references
Motivation to combine
Some teaching, suggestions, or motivation to modify or combinefound either in the references themselves or in the knowledge
generally available to one of ordinary skill in the art
-
8/6/2019 IPR & Generic Pharmaceutical Industry by Mahendra B. Thakre
15/26
ENABLEMENT
35 U.S.C. 112
The specification shall contain a written description ofthe invention, and of the manner and process of
making and using it, in such full, clear, concise, and
exact terms as to enable any person skilled in the art
to which it pertains, or with which it is most nearly
connected, to make and use the same, and shall setfor the the best mode contemplated by the inventor of
carrying out his invention
-
8/6/2019 IPR & Generic Pharmaceutical Industry by Mahendra B. Thakre
16/26
-
8/6/2019 IPR & Generic Pharmaceutical Industry by Mahendra B. Thakre
17/26
-
8/6/2019 IPR & Generic Pharmaceutical Industry by Mahendra B. Thakre
18/26
INFRINGEMENT
Making, using, selling or offering for sale
Importing
Experimental use defense
Bolar exemption is not an experimental use defense
-
8/6/2019 IPR & Generic Pharmaceutical Industry by Mahendra B. Thakre
19/26
STATUS OF PATENT ACT
In India
Recognition of Product
20 years from date of filing
In US
Patent filed before June 8th 1995 20 years from
the date of filing or 17 years from the date ofgranting whichever is more
After 1995 20 years form the date of filing
-
8/6/2019 IPR & Generic Pharmaceutical Industry by Mahendra B. Thakre
20/26
FDA
Regulatory approval-time and cost
Focus of FDA approval process-safety and efficacyDifference between the conditions for patentability
and approval
Only one out of every 2,500 patents make it to the
market
-
8/6/2019 IPR & Generic Pharmaceutical Industry by Mahendra B. Thakre
21/26
HATCHW
AXMAN ACT
Commonly known as The Drug price competition and
patent term restoration Act of 1984.
The Act deals with approval of generic drugs and
conditions for getting approvals from FDA, market
exclusivity, Patent term extension and orange book listing
-
8/6/2019 IPR & Generic Pharmaceutical Industry by Mahendra B. Thakre
22/26
Patent challenges and generic exclusivityOverview of the legal process
ANDA Requirements:
i. Information to show that the listed drug is
approved;
ii. That the listed drug has the same active ingredient as
the new drug;
iii. That the route of administration, the dosage
forms, the strength of new drug etc. Are the same asthe listed drug;
iv.That the new drug is bio-equivalentto the listed drug.
-
8/6/2019 IPR & Generic Pharmaceutical Industry by Mahendra B. Thakre
23/26
PARA CERTIFICATIONSSection 505(j)(2)(A)(vii)
(I) That such patent information has not been filed;
(II) That such patent has expired;
(III) That the proposed drug will not be marketed until
expiration of the patent.
(IV) That either the proposed generic drug does not infringe
the patent or the patent is invalid (known as
Paragraphs IV certification)
-
8/6/2019 IPR & Generic Pharmaceutical Industry by Mahendra B. Thakre
24/26
CONCLUSION
Protection of Intellectual property is at most
important for knowledge based industry
Exploitation of patent landscape would be a
driving factor for expanding business.
-
8/6/2019 IPR & Generic Pharmaceutical Industry by Mahendra B. Thakre
25/26
CARRIER OPPORTUNITIES IN IP
Intellectual Property Management Generic
business IPM - Drug discovery
Business Development
Strategic Development
IP Law firms
KPO (Knowledge Processing Organization)
-
8/6/2019 IPR & Generic Pharmaceutical Industry by Mahendra B. Thakre
26/26
THANKS ..