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© COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN The Enduring Enigma of section 3(d): Will the Supreme Court Prune the Evergreen Tree? Adarsh Ramanujan, Associate MHRD-IP Chair Symposium on IP and Pharmaceutical Policy, NLU- Jodhpur 17 th and 18 th March, 2012
2 © COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN 2 “These are only my personal and academic views”
3 © COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN 3 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
4 © COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN 4 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 new use for a known substance or …. 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.
5 © COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN 5 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] Coverage …Contd.
Novartis before Supreme Court 1
6 © COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN 6 August 2011 Part-heard by the Supreme Court August 2009 Recusal of Hon’ble Mr. Justice Katju August 2009 Appeal filed against order of the IPAB Novartis AG v. UOI & Ors.
6 © COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN 6 February –March 2012 Expected to be decided shortly September – October 2011 Preliminary Issue – maintainability of the appeal September 2011 Recusal of Hon’ble Mr. Justice Dalveer Bhandari Novartis AG v. UOI & Ors. …Contd.
Important Issues to be Settled 2
6 © COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN 6 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)? Important Issues to be Settled
Recollecting the Madras High Court Constitutionality of Section 3(d) 3
6 © COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN 6 Section 3(d) held constitutional Question relating to alleged non-compliance with TRIPs held not maintainable Concept from Pvt. Int’l. Law applied. No comments on merits of the patent But dealing with Article 14 issue necessitated the High Court to interpret Section 3(d) Novartis v. UOI & Ors. Four important take-aways
6 © COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN 6 High Court recognizes limited scope of applicability of first part of Section 3(d) “…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.
6 © COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN 6 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.
6 © COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN 6 High Court recognizes alleged mischief to be remedied from Parliamentary debates prevent “evergreening” and enable access to life saving drugs Novartis v. UOI & Ors. …Contd.
6 © COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN 6 Ordinary meaning of ‘efficacy’ “…ability to produce the desired therapeutic effect……healing of a disease….having a good effect on the body” Court holds that it is possible to provide comparative details to prove enhancement Novartis v. UOI & Ors. …Contd.
Recollecting the IPAB The Gleevec Patent 2
6 © COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN 6 Appeal from Controller’s decision rejecting Novartis’ patent for beta crystalline form of imatinib mesylate Novartis - IPAB Four important take-aways
6 © COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN 6 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 …Contd.
6 © COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN 6 IPAB follows Madras High Court on ‘efficacy’ Better thermodynamic stability (facilitating storage), lower hygroscopicity (increased shelf life), better flow properties (more processable) held irrelevant to Section 3(d). Novartis – IPAB …Contd.
6 © COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN 6 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” (Emphasis Supplied) Novartis – IPAB …Contd.
6 © COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN 6 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 was later discovered / established” But IPAB seems to have allowed new evidence?! Novartis – IPAB …Contd.
Law and Policy What the Supreme Court may have to handle 4
6 © COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN 6 Ipso facto implications (“the incentive to innovate” conundrum) Defining and proving increased ‘efficacy’ Relationship between inventive step and Section 3(d) Law and Policy
6 © COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN 6 Law and Policy …Contd. Basic Research Prototype Design Phase 1 Phase 2 Phase 3 Clinical Development Preclinical Launch CRITICAL PATH IND Patent Filing (Case-law relating to evidence for utility) 4-6 Years 8-11 Years
6 © COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN 6 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 success rate “Blockbuster drug” business model – recover costs of failure as well Ipso facto implications
6 © COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN 6 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.
6 © COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN 6 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 bio- availability, trials may be required by the US FDA - fact- specific (includes a 505(b)(2) application or a paper ‘NDA’). Section 3(d) reducing incentive to innovate? – not too clear Ipso facto implications …Contd.
6 © COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN 6 Novartis case – not an ideal test case for innovator companies? US disclosed imatinib mesylate salt US FDA approval for Gleevec – only mentions imatinib mesylate salt (not limited to any crystalline form) Orange book listing for Gleevec – lists both and ( crystalline form) 31 CFR – cannot list polymorph patent unless bio-equivalent! Ipso facto implications …Contd.
6 © COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN 6 Bio-availability (BA) and efficacy General definition of ‘efficacy’? ‘Efficacy’ and Evidence
6 © COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN 6 Increased BA ≠ increased efficacy may not always be incorrect E.g. Omeprazole v/s S-Omeprazole – 80% increase in BA, but inconsistent results viz. increase in healing ability on a milligram-to-milligram comparison (data submitted with FDA) BA and Efficacy
6 © COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN 6 Drug action is a complex science – mechanism is not clearly understood E.g. noradrenaline – difference between in-vitro and in-vivo effect Generally accepted that the “concentration- effect” graph is a hyperbolic curve “Signal Transduction” at a cellular level is not very clearly understood BA and Efficacy …Contd.
6 © COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN 6 Having a per se rule makes little sense – PHOSITA’s perspective for each therapeutic class / disease concerned But without a clear per se rule, ex ante planning seems impossible Implications in terms of temporal effect (next slides) BA and Efficacy …Contd.
6 © COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN 6 What about reduced side effects? Ind Swift v. 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.
6 © COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN 6 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.
6 © COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN 6 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 ‘Efficacy’ and Evidence …Contd.
© COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN ‘Efficacy’ and Evidence …Contd. Basic Research Prototype Design Phase 1 Phase 2 Phase 3 Clinical Development Preclinical Launch IND PK / PD Studies in vitro / animal; Sometimes, scaled models for humans PK in humans / sometimes PD PD Studies What data will be sufficient in the original specification?
6 © COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN 6 No per se rule Question to be viewed from perspective of PHOSITA May vary from case-to-case (class of drugs, other scientific parameters) What about subsequent evidence? ‘Efficacy’ and Evidence …Contd. What Evidence?
6 © COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN 6 Contd. Analogy from case-law relating to “new subject- matter” and case-law on selection invention Whether the information presented in the original specification was “beyond speculation”? ‘Efficacy’ and Evidence …Contd. What Evidence?
40 © COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN 40 ‘Inventive step’ and Section 3(d) T 777/08 – May 24, 2011 [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 Novartis case [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?
© COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN Discussion
© COPYRIGHT 2011, LAKSHMI KUMARAN & SRIDHARAN New Delhi Mumbai Bengaluru Chennai Hyderabad Ahmedabad Pune About Us
© COPYRIGHT 2012, 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 Lakshmi Kumaran & Sridharan
© COPYRIGHT 2012, LAKSHMI KUMARAN & SRIDHARAN Contact Details New Delhi B-6/10, Safdarjung Enclave New Delhi Phone Bangalore , 5th Floor, Brigade Plaza (North) 71/1, Subedar Chetram Road, Anand Rao Circle Bangalore Phone Mumbai , Kakad Chamber 132, Dr. Annie Besant Road Worli, Mumbai Phone Hyderabad Hastigiri, , Chapel Road Opp. Methodist Church, Nampally Hyderabad Phone Ahmedabad B-334, SAKAR-VIII, Nehru Bridge Corner, Ashram Road, Ahmedabad Phone Chennai 2, Wallace Garden, 2nd Street Chennai Phone Pune Ebony Meeting Room 1st Floor, Apartment Section Hyatt Regency Weikfield IT Park, Nagar Road Pune , Maharashtra Phone
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