Opportunities and Challenges for Pharma SMEs in the current Patent regime Deepak Padia Managing Director – Octavius Pharma Pvt. Ltd.

Current Issues

Awareness about Patents Overall awareness about Patents is low amongst employees in Pharma SMEs at all levels Increase Patent awareness, its implications and the exclusivity rights offered by Patents amongst Employees at all levels R&D / Production / QA / QC - staff should have sufficient knowledge for Patent Searching and Patent interpretation

Knowledge of Prior Art Lot of research which is done at SME level is repetition of work done by other research scientists To avoid duplication of research work, proper search of Patents and published articles is required before start of research work Free Patent database search is provided by WIPO, USPTO, EPO, IPO, etc.

Opportunities for SMEs

Selection of Right Product Product for research should be selected after proper Prior art search and Market research Identify Existing products with big market but having areas of improvement Research for NCE (New Chemical Entity) is a very costly affair and SMEs should avoid unless they have complete knowledge of cost involved and revenue to be generated

Case Studies Metformin Side-effect: Vit B12 impairment on chronic use Improvement: Formulation can be supplied as combination with Vit B12 Vitamin D3 Scope for improvement in Bio-availability Improvement: Nano-sizing of Active to increase bio- availability API To check the stability of different polymorphs Increasing yield Changing Route of Synthesis

Application for Patent Maintain secrecy of research work throughout development Take help of Patent experts inorder to secure patent with maximum available claims in targeted countries Identifying right markets to apply for Patent and understanding cost involved for the same

Other opportunities Out-licensing of Patented product or partnering with large sized companies to market patented products and establish the brand (Eg. Research products of CSIR are out-licensed for marketing) In-licensing of Patented products from research firms outside India (Can be considered by SMEs with good marketing team) (Eg. Galvus-met of Novartis is marketed by Abbott) Government offers benefit in Income-tax for expense done on R&D as well as expense done on Patent application by various schemes

Challenges for SMEs

Cost of R&D High cost of Finance, Reasearch Facilities, HR and time taken for research Clinical trials, BE studies is also a costly affair Patent application cost in developed countries is also very high

Patentability of Innovation Innovation has to prove Novelty, Inventive Step (non-obviousness) and Industrial Applicability Section 3(d) of Indian Patent Act has requirement for Pharma Products to prove “significant increase in efficacy” from previous product which has to be proved through clinical studies Section 3 (e) A substance obtained by mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance is not patentable eg. Para+Ibu vs Ison+Rifa

Other Challenges Not easy to trace infringement of Patent. Burden of proof for infringement lies on Patent Holder Product can any time come under Price control or compulsory licensing, which may lead to significant dent in profitability Marketing of the product on large scale to reach maximum customers

Section 3 – What are not Inventions Subsection – 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

Case of Novartis Novartis applied for its “Beta form of Imatinibe mesilate” (anti-cancer drug GLIVEC) via “Drop box” application in 1998 at Madras-PTO During prosecution of application in 2006, CGPDTM, Mumbai, Dr. Chandrashekhran; rejected application by citing section 3 (d) that this molecule is nothing but polymorphic form of its parent molecule & did not differ in efficacy point of view Novartis already launched its parent molecule “Imatinibe mesilate” (racemic form) in different foreign markets before 1st Jan (Also having US patent on it) Number of Indian Generic firms viz. Cipla, Sun already have generic version of “Imatinibe” in India and also having process patent on it

Novartis claimed that this new molecule possess 30% more efficacy than the parent molecule (and already patented in more than 40 countries) Novartis challenged the decision of Controller to IPAB, Chennai IPAB constitutes a committee of 3 members in which one of the member was Dr. Chandrashekhar as an technical expert Novartis filed request to IPAB to substitute Dr. Chandrashekhar, but it was rejected Novartis filed a case in Chennai high-court in this matter and court give judgment to substitute him Case of Novartis

Novartis again file a case in Chennai high court, challenging section 3(d) of Patent Act by stating that it is not compliance to TRIPs. Chennai high court gave judgment by stating that, section 3(d) is in compliance with TRIPs Novartis filed a case in Supreme court to intervene the case for validity of section 3(d) Supreme court ruled out that WTO-Dispute Resolution Cell will be the right place to take a judgment Novartis filed a compliant to WTO to challenge the section 3(d) ; Result is still pending Finally Novartis lost the case as per the verdict of Supreme court in March 2013.