This ppt is about how to obtain patent for drugs

1. SUBMITTED BY-
ASUPRITA PATEL
M.PHARM 1ST SEM
REGD NO.-1661611012
SCHOOL OF PHARMACEUTICAL SCIENCE
SIKSHA O ANUSANDHAN UNIVERSITY

2. CONTENTS…
WHAT IS PATENT?
WHAT CAN BE PATENTED?
NEED OF PATENT.
MAJOR TYPES OF PATENTS.
PATENT OFFICES IN INDIA.
PATENT OFFICES IN US.
PATENT OFFICES IN EUROPE.
INTERNATIONAL REGISTRATION OF PATENTS.
HOW PATENTS ARE OBTAINED FOR DRUGS?
PATENT TERM & EXTENSION.
PATENT ACT 1970.

3. WHAT IS PATENT?
 The term patent usually refers to the right
granted to anyone who invents any new,
useful & non-obvious process, machine,
manufactured article, or composition of
matter.
 Simply it’s the exclusive rights granted by a
government to an inventor to manufacture,
use or sell an invention for a limited period
of time.

4. WHAT CAN BE PATENTED?
 To obtain a patent, following 4
requirements must be satisfied…
 The subject matter must be patentable.
 The invention must be novel.
 The invention must have some utility or
usefulness.
 The invention must be non obvious.

5. NEED OF PATENT…
• A patent gives certain legal rights to the patentee
which can deter rival businesses from using or
copying the product or inventions or the formula.
There are many good reasons to
apply for a patent including…
1.Legal right of ownership of the invention.
2.Often required when applying for
investment.
3.Protection of the product from the time the
patent application is filed.

6. MAJOR TYPES OF PATENT…
 Generally there are 3 types of patents.
1. Utility patents.
2. Design patents.
3. Plant patents.
UTILITY PATENTS:-
It is the most common type of patent. It covers inventions that
function in a unique manner to produce a useful result.
Utility patents are grouped in 5 categories:-
1. A process
2. A machine
3. A manufactured article
4. A composition of matter
5. An improvement of an existing idea.
 A Utility patent last for 20 years from the date when the patent application is
filed.

7. CONT…..
DESIGN PATENT :-
 Design patent protect virtually any new and non-obvious
ornamentation of a useful object.
EX- From the flickering icon on the computer screen to the shape of the
iPhone4.
 A person can enforce his/her design patent for only 14 years
after it’s issued.
PLANT PATENT:-
 The least frequently issued type of patent are plant patents –
granted for any novel, asexually reproducible plants etc.
 The patent protects the owner by keeping other individuals or
businesses from creating the type of plant or profiting from the
plant for at least 20 years from the date of the application.

8. PATENT OFFICES IN INDIA:-
 The Indian Patent Office is administered by the office of the
Controller General of Patents, Design & Trade
Mark(CGPDTM).
 The CGPDTM reports to the Department of Industrial Policy
& Promotion(DIPP) under the ministry of Commerce &
Industry.
 It has 5 main administrative sections:-
1. Patent Office
2. Trademark Registry
3. Geographical Indications Registry
4. Rajiv Gandhi National Institute of Intellectual Property
Management(NIIPM).
5. Patent Information System.

9. CONTD…
 Head quarter of the patent office – Kolkata.
 Branches in – Chennai, New Delhi, Mumbai.
 Office of the CGPDTM – Mumbai
 Office of the Patent Information System & NIIPM –
Nagpur.
 O.P. Gupta is the current CG & took charge on 16
Nov 2015.
 The Indian Patent Office has:-
75 patent examiners, 70 assistant controllers, 7
deputy controllers, 1 joint controller & 1 senior joint
controller.

10. PATENT OFFICES IN U.S.
 The United States Patent & Trade Mark Office
(USPTO) is an agency in the U.S. Dept. of
commerce that issues patents to inventors &
businessmen for their inventions & trademark
registration for product & Intellectual Property
Identification.
 The USTPO is based in ALEXANDRIA, VERGINIA.
 The head of the USTPO is Michelle K.Lee(Director)
 Russell Slifer is the Deputy Director.
 Vikrum Aiyer is the Chief of the staff.

11. PATENT OFFICES IN EUROPE:-
 The European Patent Office(EPO) is one of the two
organizations of the European Patent
Organization(EPorg), the other being the
Administrative Council.
 The EPO headquarter is located at Munich, Germany.
 The EPO also includes a branch in Rijswik,
Netherlands.
 Sub-offices in:-
1.Berlin,Germany
2. Vienna,Austria
3.Brussels,Belgium

12. INTERNATIONAL REGISTRATION OF PATENTS…
 International registration of patents are done through
the PCT(Patent Cooperation Treaty).
 A patent application filed under the PCT is called an
international application or PCT application.
 A PCT application has 2 phases:-
1.1st phase(International phase):-
In this phase patent protection is pending under a single
patent application filed with the patent office of a
contracting state of PCT.
2. 2nd phase(National phase):-
It follows the international phase in which rights are
continued by filing necessary documents with the patent
offices of separate contracting states of the PCT.

13. CONTD…
 The PCT procedures includes:-
1.Filing
2.International Search
3.International Publication
4.Supplementary International Search(optional)
5.International Preliminary Examination(optional)
6.National Phase

14. HOW PATENTS ARE OBTAINED FOR
DRUGS???
 In the pharmaceutical industry, the patent
protection of drugs & medicines is much more
important because drugs can be easily copied &
because of the significant research &
development spending and the high risks
associated with the development of a new drug.
 Procedures of obtaining a patent for a drug:-
1. IND Application to CDER(Center For Drug
Evaluation & Research).
2. NDA Application .
3. Application to ANDA.

15. CONTD…
1.IND APPLICATION:-
 After obtaining data from lab studies the drug
developers submit an Investigational New Drug(IND)
application to CDER.
 Once the IND application is in effect, the drug
sponsor could begin the clinical trials.
 After a sponsor submits an IND application, it must
wait till 30 days before starting a clinical trial to allow
FDA time to review the prospective study .
 If FDA finds a problem, it can order clinical hold to
delay an investigation.

16. CONTD….
2.NDA APPLICATION:-
 Then after getting the clinical trials data,
the sponsor submits a New Drug
Application(NDA) with full information on
manufacturing, stability & bioavailability
data, method of analysis of each of the
dosage forms the sponsor intended to
market & the result of any additional
toxicological studies not already
submitted in the IND application.

17. CONTD…
3.ANDA:-
 When the patents or other periods of exclusivity on
brand name of drugs expire, manufacturers can submit
an Abbreviated New Drug Application(ANDA) to sell
generic drug.
 An ANDA is an application for a U.S generic drug
approval for an existing licensed medication or
approved drug.
 The ANDA is submitted to FDA’s CDER, office of
generic drugs, which provides for the review and
ultimate approval of a generic drug product.
 Once approved, an applicant may manufacturer and
market the generic drug product to provide a safe,
effective, low cost alternative to the public.

18. PATENT TERM AND EXTENSION

19. PATENT TERM AND EXTENSION….

21. THE INDIAN PATENT ACT :-
 In INDIA the grant of patent is governed by the
Patent Act 1970 and Rules 1972.
 The patents granted under the act are operative in
the whole of India.
HISTORY:-
The Patent and Design Act, 1911.
The Patent Act,1970 & Rules1972.
The patent amendment act 2005.

22. REFERENCE…
Journal of International Economics 39
(1995) 227-248.
 Journal of World Patent Information(2012),
ISSN:0172-2190
Journal of the Patent and Trademark
Office society(2014)
https://www.uspto.gov>offices>ous
https://www.libraries.psu.edu>docume
nts

23. THANK YOU…