INTELLECTUAL PROPERTY RIGHTS:
INNOVATION, ECONOMICS AND ACCESS OF
PHARMACEUTICALS
BY SANJAY JAIN
VP, QUALITY MANAGEMENT
AMNEAL PHARMACEUTICALS
DISCLAIMER
The opinions expressed herein are personal and not those of my employer. Information contained herein does not
provides any kind of legal or other opinion. Please consult appropriate expert for business advice.
INTELLECTUAL PROPERTY
 Patents
 Right to exclude other from making, using, import or selling an invention.
 Trademarks
 To protect a logo or name that is used for the purpose of trading goods. E.g. Crocin or Coca-cola
 Copyrights
 Original works of authorship that fall under the categories of literature, drama, musical, painting, sculptures,
software etc. which can be either in published or unpublished form. E.g. Music album, Microsoft licence,
Novel etc.
Copyright protects the form of expression of idea whereas patent protects the idea itself. Eg Article on tablet
manufacturing technologies vs process of preparing tablet.
INTELLECTUAL PROPERTY
Alembic to get milestone payments
 Intangible asset

Considered while valuation of the company

Can be sold
MUMBAI: Alembic has entered into a licensing agreement with the
Brussels-based UCB for its novel drug delivery platform for
Keppra XR (Levetiracetam Extended Release tablets). Under the
terms of the agreement, Alembic will receive milestone payments
of $11 million and royalty on future worldwide net sales of
Keppra XR, subject to necessary legal and regulatory approvals.
Phase III clinical trials on Keppra XR, the once daily formulation of
Keppra, are in progress and results are expected in the fourth
quarter of 2007. Keppra is UCB's leading anti-epileptic drug.
The development of Levetiracetam XR is a milestone for
the Alembic's novel drug delivery system (NDDS)
programme.
Source : The Hindu
PATENTS - FRAMEWORK
 No World patent.
 Right are territorial.
 Governed by respective national laws.
 PCT (Patent co-operation treaty) is international framework for recognizing priorities of every applicants
within member states. Generally 30 months timeline.
 Term - 20 years from the date of filing.
 Regulatory extensions available in US, EU, RU,AU, JP etc.
 Monopoly against complete disclosure of invention.
PATENTS – WHAT DOES IT CONTAINS?
 Title
 Abstract
 Background
 Description
 Examples
 Diagrams
 Claims – Heart of the patent. Decides the
boundaries of the property. Infringement
(Trespassing) is decided based on this
boundaries
Vadodara-based Alembic Pharmaceuticals Ltd is eyeing to capitalise on the recent
approval from the US drug regulator for extended release Desvenlafaxine base
tablets, which is bio-equivalent of Pfizer's popular drug Pristiq (Desvenlafaxine
Succinate) which went off patent recently.
"We have recently received approval from US Food and Drug Administration (USFDA)
for extended release Desvenlafaxine base tablets. This will add significant revenues to
the company in coming months. Presently we are the only player in this segment to have
received approval from the regulator," said Pranav Amin, executive director, Alembic
Phrama.
Analysts, however, pointed out that the benefit to Alembic and Ranbaxy for the product
will be limited as several other players have filed Para IV ANDAs of the same product.
"However, including Alembic Pharma, five to six other players (like, Lupin, Cadila,
Watson) has filed for Para IV ANDAs of the same, which are under litigation
with the innovator. If these players get approval by the end of 2015, then Pristiq will not
remain big opportunity for Ranbaxy and Alembic Pharma," analyst report by IndiaNivesh
Securities Private Limited stated. 'Keeping view the genericisation of Pristiq by the end
of 2015, we anticipate only two years of opportunity for Ranbaxy and Alembic. We
assessed this product to contribute around Rs 90 crore of profit (post tax) in fiscal
2014 and Rs 110 crore in fiscal 2015 for Alembic and Ranbaxy each,' the analyst report
claimed.
Source : Business Standard
PATENTING PROCESS
 Provisional application (PA).
 Complete application/PCT within 12 months of PA.
 Publication of patent application at 18 months from PA.
 Pre-grants opposition.
 Examination starts.
 Examiner issues first examination report (FER) in view of know prior arts.
 Applicant responds on rejections.
 Allowed – Patent granted; Rejected – No rights.
 Post- grant opposition within 1yrs of grant.
 Appellate bodies – Intellectual property appellate board (IPAB); High Court; Supreme court
 Infringement – DC; High Court; Supreme court
HISTORY OF INDIAN PATENT LAW VS % SHARE
Patent Regime Vs % Share
90
Pre - 1970 Product Patent Regime
Act amended (Indira
Gandhi) 1970
Process Patent Regime
India signs WTO
1995
agreement on TRIPS
2005 -
Product Patent regime
80
70
60
50
40
30
20
10
0
1940
1950
1960
1970
MNC
1980
Domestic
1990
2000
2010
INDIAN PATENT ACT - POST – 2005
 Law amended - Product patent regime takes effect.
 India also introduced Section 3(d).
 Section 3 - What are not inventions?
 Section 3(d)

(d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known
efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of
a known process, machine or apparatus unless such known process results in a new product or employs at least one new
reactant.

Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers,
mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same
substance, unless they differ significantly in properties with regard to efficacy;
 Beta crystalline form of Imatinib mesylate – Patent
denied. Novartis challenged it till Supreme court and
lost. No enhancement of known efficacy.
Novartis Loses Glivec Patent Battle in India
NEW DELHI—India's Supreme Court rejected Novartis AG's attempt to win patent
protection for a major cancer drug, a landmark judgment roundly criticized by
pharmaceutical companies but praised by public-health activists, who said it
would protect India's ability to make inexpensive generics for the
developing world. (Source : The Wall street Journal)
ACCESS - COMPULSORY LICENSING (CL)
 Section 84 - Compulsory licences
(1) At any time after the expiration of three years from the date of the grant of a patent, any person interested may
make an application to the Controller for grant of compulsory licence on patent on any of the following grounds,
namely:—
(a) that 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 in the territory of India.
ACCESS - COMPULSORY LICENSING (CL)
 Sorafenib – Carcinoma.

Bayer’s Nexavar for Rs. 2,84,000 per patient per month.

Natco’s therapy - Rs. 8, 800 per patient per year.

Question – Return on investment for research vs Access to
medicine for life saving drugs.

Patent office granted CL to Natco.

Later on decision upheld by IPAB, Bombay high court and Supreme
court.
 BDR’s CL for Dasatinib and Lee Pharma’s – Saxagliptin
denied
 US - 2001 anthrax attacks through the US Postal Service,
the US Government threatened to issue a compulsory
license for the antibiotic drug ciprofloxacin, if the patent
owner, Bayer, didn't lower the price to the government.
Bayer lowered the price and the government backed
down on the threat.
Natco Pharma wins cancer drug case
Bayer's plea dismissed by the Intellectual Property Appellate Board
The Intellectual Property Appellate Board (IPAB) on Monday upheld the
grant of compulsory licence (CL) to the Hyderabad-based Natco Pharma
Limited, a generic drug maker, to produce and market Nexavar, a patented
cancer drug of multinational pharma major Bayer Corporation. The order
will pave the way for reduction in the prices of costly life saving
drugs.
Disposing an appeal filed by Bayer Corporation, the Board held that various
international conventions and Indian laws allowed the member countries to
grant such compulsory licence in order to make medicine cheaply
available to the public.
Declining to interfere with the order of compulsory licence, the Board said,
“We are not inclined to interfere with the order of Controller General in
the interest of the public. The invention must be available to the public
at reasonable and affordable price if not compulsory licence is
given.”
“We must bear in the mind of public interest but neither the investor nor
the compulsory licence applicant. Patents are granted to benefit the
inventions to the public.”
Source :The Hindu
ACCESS AND INNOVATION – WAY FORWARD
 Innovation
 India pharmaceutical Industry – Mainly generic
 Blockbuster drugs are going off patent in coming years.
 Generic Competition across the globe within Indian players and from companies in other countries
 Positives – High Quality

(Sofosbuvir, Gilead signed agreement with 7 Indian generic manufacturer to sale the product in 91 countries)
 To manage economics well innovation is inevitable. Many Indian companies are already onto this path.
 Access – Possible options
 CL applications in appropriate case for life saving drugs.
 By third party under Section 84.
 By government under Section 92.
ACCESS AND INNOVATION – WAY FORWARD
 Strategy
 New Chemical Entity
 Innovative formulations
 New Dosage form of existing DP
 Changes in release pattern
 Drug repurposing, (new Indication)
 New strength
 Digital Medicine (e.g.Aripiprazole ANDA by Otsuka)
Let’s INNOVATE
Thank you