Indo German Investment Summit 2011

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Transcript Indo German Investment Summit 2011

The Enduring Enigma of section 3(d): Will the Supreme Court Prune the Evergreen Tree?

“These are only my personal and academic views”

Coverage

•

Current status before the Supreme Court of India

•

Important Issues to be settled

•

Recollecting the IPAB and the Madras High Court

•

Law and Policy

Coverage

…Contd.

“

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

for a known substance

or ….

new use

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 to Section 3(d).

—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.

Coverage

…Contd.

•

Imatinib (free base)

•

Imatinib mesylate salt

•

Patent relating to Beta crystalline form of Imatinib mesylate salt

•

IPAB rejected patent application under Section 3(d) [Held to be Novel and Inventive]

Novartis before Supreme Court

Novartis AG v. UOI & Ors.

September 2011 Recusal of Hon’ble Mr. Justice Dalveer Bhandari …Contd.

Important Issues to be Settled

 Defining and Proving ‘efficacy’ Bio-availability and Efficacy.

Clarify on evidence issues  Relationship with “Inventive Step”  Defining ‘known substance’  Defining ‘Derivatives’ in the Explanation to Section 3(d)?

Recollecting the Madras High Court

Constitutionality of Section 3(d)

Novartis v. UOI & Ors.

 Section 3(d) held constitutional  Question relating to alleged non-compliance with TRIPs held not maintainable Concept from Pvt. Int’l. Law applied.

Novartis v. UOI & Ors.

 High Court recognizes limited scope of applicability of first part of Section 3(d) …Contd.

“…we are clear in our mind the portions of the amended section and Explanation under attack is definitely referable only to the pharmacology field, namely, drugs”

Novartis v. UOI & Ors.

…Contd.

 High Court recognizes that Explanation applies only to first part of Section 3(d)

“…therefore, we have no doubt at all that the Explanation would operate only when discovery is made in the pharmacology field”

Novartis v. UOI & Ors.

…Contd.

Novartis v. UOI & Ors.

…Contd.

 Ordinary meaning of ‘efficacy’

“…ability therapeutic to produce the effect ……healing desired of a disease ….having a good effect on the body”

Recollecting the IPAB

The Gleevec Patent

Novartis - IPAB

Novartis – IPAB

…Contd.

 Test for novelty, inventive step, Section 3(d) are distinct Novartis’ patent held to be novel and inventive, but rejected under Section 3(d).

Novartis – IPAB

 IPAB follows Madras High Court on ‘efficacy’ …Contd.

Better thermodynamic stability (facilitating storage), lower hygroscopicity (increased shelf life), better flow properties (more processable) held irrelevant to Section 3(d).

Novartis – IPAB

…Contd.

 Increased ‘bioavailability’ of 30% also held insufficient to overcome Section 3(d)

in the fact of this case

“…Binding is the crucial step that determines effect …Therefore, binding and not absorption is the key to healing the disease …Bio-availability is related to availability and not binding …Appellant

has neither responded to this argument nor contradicted

…….Thus, we are convinced that

bioavailability and efficacy are generally not one and the same

”

Novartis – IPAB

…Contd.

 Factual inquiry as to “enhanced efficacy” to be decided

based on original disclosure in the specification

“…Appellant is not entitled to make out a case for [a] patent in its favour by importing a new matter in the specification[,] which discovered / established” was later

But IPAB seems to have allowed new evidence?!

Law and Policy

What the Supreme Court may have to handle

Law and Policy



Ipso facto

Law and Policy

…Contd.

8-11 Years Basic Research Prototype Design Preclinical IND 4-6 Years Clinical Development Phase 1 Phase 2 Phase 3 Launch

CRITICAL PATH Patent Filing (Case-law relating to evidence for utility)

Ipso facto

implications

 General logic - no R&D in pharma w/o patent Innovation Cost : Imitation Cost is very high One estimate suggests (approx. USD 800 mil.), with almost 60% towards regulatory approval.

“Shot-gun approach” –

5000 : 1

Ipso facto

implications

…Contd.

 But this is normally assessed w.r.t New Chemical Entities (NCEs) Section 3(d) is concerned with type of IMPs (Incrementally modified products) and not NCEs Unclear whether the cost analysis applies equally well here –

same regulatory approval process may not apply.

Ipso facto

implications

…Contd.

 Contd. (US FDA example) E.g., if new form is bio-equivalent (similar bio availability), then only ANDA and no significant costs (what generics normally do w.r.t NCEs) E.g., if new form has different bioavailability, trials may be required by the US FDA - fact specific (includes a 505(b)(2) application or a paper ‘NDA’)

Ipso facto

implications

…Contd.

 Novartis case – not an ideal test case for innovator companies?

US 5521184 disclosed imatinib mesylate salt US FDA approval for Gleevec imatinib mesylate salt (not crystalline form) – only mentions limited to any Orange book listing for Gleevec – lists both 5521184 and 6894051 ( ᵝ crystalline form) 31 CFR 314.53

– cannot list polymorph patent unless bio-equivalent!

‘Efficacy’ and Evidence

 Bio-availability (BA) and efficacy  General definition of ‘efficacy’?

BA and Efficacy

 Increased BA ≠ increased efficacy may not always be incorrect E.g.

Omeprazole increase in BA, v/s S-Omeprazole – 80% but inconsistent results viz. increase in healing ability on a milligram-to-milligram comparison (data submitted with FDA) © COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN

BA and Efficacy

 Drug action is a complex science – mechanism is not clearly understood …Contd.

E.g. noradrenaline – difference between in-vitro and in-vivo effect Generally accepted that the effect” graph is a hyperbolic curve “concentration “Signal Transduction” at a cellular level is not very clearly understood © COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN

BA and Efficacy

…Contd.

 Having a

per se

rule makes little sense – PHOSITA’s perspective for each therapeutic class / disease concerned  But without a clear

per se

Efficacy and Evidence

…Contd.

 What about reduced side effects?

Ind Swift

Cadila

(Review Petition – August 2010) – factor that polymorph may have been less cardiotoxic seems to have played a significant role.

 Same efficacy – but contributes to a class of patients not covered under earlier form?

 Quicker responses?

‘Efficacy’ and Evidence

…Contd.

 Existing definition [“having a good effect on the body”] seems broad enough to cover all the above possibilities  Reduce length of treatment?

‘Efficacy’ and Evidence

…Contd.

 IPAB’s ruling as to evidence – significant policy lever in determining the timing of application  Broadly, data relating to drugs are of two kinds Pharmacokinetics (PK) – ADME (Absorption, Distribution, Metabolism, Excretion) Pharmacodynamic (PD) – “concentration– effect” studies © COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN

‘Efficacy’ and Evidence

…Contd.

Basic Research Prototype Design Preclinical IND Clinical Development Phase 1 Phase 2 Phase 3 Launch

PK / PD Studies in vitro / animal; Sometimes, scaled models for humans PK in humans / sometimes PD PD Studies PD Studies

What data will be sufficient in the original specification?

‘Efficacy’ and Evidence

 No

per se

rule …Contd.

Question to be viewed from perspective of PHOSITA What Evidence?

May vary from case-to-case (class of drugs, other scientific parameters) What about subsequent evidence?

‘Efficacy’ and Evidence

 Contd.

…Contd.

Analogy from case-law relating to “new subject matter” and case-law on selection invention What Evidence?

Whether the information presented in the original specification was “beyond speculation”?

‘Inventive step’ and Section 3(d)

 T 777/08 – May 24, 2011 

Novartis

case [Polymorph patent] – crystalline form claimed (drug) Inventive step / technical feature argued to be based on improved filtration and drying properties Held not to be inventive since improved filtration and drying properties – expected properties for crystalline forms [Polymorph patent] – crystalline form claimed (drug) Arguments against Section 3(d) – better stability, flow properties, processability and increased bio-availability (due to better increased dissolution properties) - Are these expected properties for crystalline forms?

Discussion

Lakshmi Kumaran & Sridharan

Lakshmi Kumaran & Sridharan (L&S) is an Indian law firm specializing in the areas of International Trade, Taxation, Intellectual Property and Corporate law.

Founded by V. Lakshmi Kumaran and V. Sridharan in 1985, the firm has seven offices across India in New Delhi, Mumbai, Chennai, Bengaluru, Hyderabad, Pune and Ahmedabad.

The firm is well-known for its high ethical standards, quality work and transparency in all business dealings. It supports its clients by providing litigation, dispute resolution and advisory services and compliance reviews across each of its divisions of Tax, International Trade, Intellectual Property and Corporate.

For more information, visit us at http://www.lslaw.in

Contact Details

New Delhi

B-6/10, Safdarjung Enclave New Delhi - 110 029 Phone - +91-11-4129 9811 E-mail - [email protected]

Bangalore

505-508, 5th Floor, Brigade Plaza (North) 71/1, Subedar Chetram Road, Anand Rao Circle Bangalore - 560 009 Phone - +91-80-4171 7777 E-mail - [email protected]

Mumbai

401-404, Kakad Chamber 132, Dr. Annie Besant Road Worli, Mumbai - 400 018 Phone - +91-22-2491 4382 E-mail - [email protected]

Hyderabad

Hastigiri, 5-9-163, Chapel Road Opp. Methodist Church, Nampally Hyderabad - 500 001 Phone - +91-11-4129 9811 E-mail - [email protected]

Ahmedabad

B-334, SAKAR-VIII, Nehru Bridge Corner, Ashram Road, Ahmedabad - 380 009001 Phone - +91-79-4001 4500 E-mail - [email protected]

Chennai

2, Wallace Garden, 2nd Street Chennai - 600 006 Phone - +91-44-4396 1600 E-mail - [email protected]

Pune

Ebony Meeting Room 1st Floor, Apartment Section Hyatt Regency Weikfield IT Park, Nagar Road Pune - 411 014, Maharashtra Phone - +91-20-6641 1234 E-mail - [email protected]

Thank you

For more information visit http://www.lslaw.in

Indo German Investment Summit 2011

Transcript Indo German Investment Summit 2011

The Enduring Enigma of section 3(d): Will the Supreme Court Prune the Evergreen Tree?

“These are only my personal and academic views”

Coverage

Current status before the Supreme Court of India

Important Issues to be settled

Recollecting the IPAB and the Madras High Court

Law and Policy

Coverage

Coverage

Imatinib (free base)

Imatinib mesylate salt

Patent relating to Beta crystalline form of Imatinib mesylate salt

IPAB rejected patent application under Section 3(d) [Held to be Novel and Inventive]

Novartis before Supreme Court

Novartis AG v. UOI & Ors.

Novartis AG v. UOI & Ors.

Important Issues to be Settled

Important Issues to be Settled

Recollecting the Madras High Court

Novartis v. UOI & Ors.

Novartis v. UOI & Ors.

Novartis v. UOI & Ors.

Novartis v. UOI & Ors.

Novartis v. UOI & Ors.

Recollecting the IPAB

Novartis - IPAB

Novartis – IPAB

Novartis – IPAB

Novartis – IPAB

Novartis – IPAB

Law and Policy

Law and Policy

Law and Policy

Ipso facto

implications

Ipso facto

implications

Ipso facto

implications

Ipso facto

implications

‘Efficacy’ and Evidence

BA and Efficacy

BA and Efficacy

BA and Efficacy

Efficacy and Evidence

‘Efficacy’ and Evidence

‘Efficacy’ and Evidence

‘Efficacy’ and Evidence

‘Efficacy’ and Evidence

‘Efficacy’ and Evidence

‘Inventive step’ and Section 3(d)

Discussion

Lakshmi Kumaran & Sridharan

Contact Details

Thank you

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