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 InventionsSubsection – 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