Intellectual property rights: innovation, Economics and Ac - PowerPoint Presentation

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which can be either in published or unpublished form.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