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 ID: 278900
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Slide1
Intellectual property rights: innovation, Economics and Access of Pharmaceuticals
By Sanjay Jain
VP,
Quality
Management
Amneal
PharmaceuticalsSlide2
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.Slide3
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which can be either in published or unpublished form.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.Slide4
Intellectual property
Intangible asset
Considered while valuation of the company
Can be sold
Alembic to get milestone
payments
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 HinduSlide5
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.Slide6
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 StandardSlide7
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 courtSlide8
History of Indian Patent Law Vs % Share
Pre -
1970
Product Patent Regime
1970
Act amended
(Indira Gandhi) -
Process Patent
Regime
1995
India signs
WTO
agreement on TRIPS
2005 -
Product Patent
regimeSlide9
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;
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)
Beta crystalline form of
Imatinib
mesylate
– Patent denied. Novartis challenged it till Supreme court and lost. No enhancement of known efficacy.Slide10
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
.Slide11
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
.
Natco Pharma wins cancer drug caseBayer's plea dismissed by the Intellectual Property Appellate BoardThe 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
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.Slide12
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.Slide13
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
)Slide14
Let’s INNOVATE
Thank you