Consultant F. Hoffmann La Roche AIPPI 2011 Forum/ExCo Protection of new medical uses and exceptions for medical treatment in patent law of India Suja Subramaniam US Patent Counsel Consultant F. Hoffmann La Roche

Copyright- Suja Subramaniam, 2011, IdeeIP Consultants, LLP Agenda Background What is NOT patentable 3(b) 3 (i) Protection of Method of Use and Method of Treatment Conclusion Copyright- Suja Subramaniam, 2011, IdeeIP Consultants, LLP

Background Progress of the Indian Patent System 1856 Act: based on British patent system Provided for a 14 year term Patents Act of 1970 Lengthy examination and opposition procedures Protected methods and processes of manufacture Did not Protect compositions (drugs, food) themselves Copyright- Suja Subramaniam, 2011, IdeeIP Consultants, LLP

Requirements for Patentability Absolute Novelty Inventive step (non obvious) Industrial Applicability Must not fall foul of Sections 3 and 4. Section 3 lists what are NOT inventions within the meaning of the ACT. Section 4 lists Atomic Energy related inventions Copyright- Suja Subramaniam, 2011, IdeeIP Consultants, LLP

WHAT IS NOT PATENTABLE Section 3 Mere Discovery ( non living thing or those occurring in nature) is not patentable Use or commercial exploitation of which will be contrary to public use or public order Causes serious prejudice to human, animal or plant life or health or to the environment New form of a known substance is not patentable 3(d) New use of known substance , process, machine, apparatus. Mere admixtures resulting in the aggregation of properties Mere arrangement and rearrangement of known devices. Process for any medicinal, surgical, curative, prophylactic, diagnostic or therapeutic treatment of human being or animal 3 (i) Traditional knowledge or aggregation or duplication of known properties of traditionally known components Copyright- Suja Subramaniam, 2011, IdeeIP Consultants, LLP

WHAT IS NOT PATENTABLE 3(d) what are not inventions- the following are not inventions within the meaning of this Act,- "(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;". Copyright- Suja Subramaniam, 2011, IdeeIP Consultants, LLP

WHAT IS NOT PATENTABLE 3(d) Under this Section, certain acts are excluded from the definition of “invention” mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance New forms such as a polymorph, salt, derivative, crystalline form, pure form, etc., considered as discovery and same compound may be patentable provided there is significant difference in efficacy. Burden of proof is on the applicant the mere discovery of any new property or new use for a known substance Copyright- Suja Subramaniam, 2011, IdeeIP Consultants, LLP

WHAT IS NOT PATENTABLE 3(i) what are not inventions- the following are not inventions within the meaning of this Act,- "(i) any process for the medicinal, surgical, curative, prophylactic, diagnostics, therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products. Copyright- Suja Subramaniam, 2011, IdeeIP Consultants, LLP

Protection of Method of Use and Method of Treatment Patent for a new compound would indirectly cover all its use as well Second medical Use is not permitted “Swiss type” use claims not permitted methods of treatment also statutorily prohibited by Section 3(i). Copyright- Suja Subramaniam, 2011, IdeeIP Consultants, LLP

Copyright- Suja Subramaniam, 2011, IdeeIP Consultants, LLP Protection of Method of Use and Method of Treatment- Using Aspirin as an Example Aspirin- First medical use : analgesic Second medical use : anti stroke Further medical uses: rheumatoid arthritis ; None of them patentable in India except Aspirin as a compound may be Patentable. The following Claim language would be rejected Use of compound with Formula A (aspirin) as an anticoagulant use of Compound with formula A (aspirin) in preparation of a medicament to treat blood clotting a method treatment...which comprises administering to a patient an effective amount of compound of Formula A (aspirin) Copyright- Suja Subramaniam, 2011, IdeeIP Consultants, LLP

Copyright- Suja Subramaniam, 2011, IdeeIP Consultants, LLP Protection of Method of Use and Method of Treatment- Using Aspirin as an Example The Following May be Patentable: New Form of Aspirin as for use in treatment of Cancer as long as Applicant can show that this “new Form” has enhanced efficacy compared to Aspirin. combination of Aspirin with a new Compound for a new indication Combination of Aspirin with another known active as long as Applicant can new synergy A new process of manufacturing Aspirin Copyright- Suja Subramaniam, 2011, IdeeIP Consultants, LLP

Copyright- Suja Subramaniam, 2011, IdeeIP Consultants, LLP Protection of Method of Use and Method of Treatment- A quick Chart Comparison Category of Claim Patentable or Not New And Novel Compound (A) Yes First Use of A No Second medical use of A Swiss Type Claim New Method of Making Compound A A with Novel Compound B Maybe A with known compound C Copyright- Suja Subramaniam, 2011, IdeeIP Consultants, LLP

Copyright- Suja Subramaniam, 2011, IdeeIP Consultants, LLP Conclusion A Patent for a new Compound will cover all its uses Second Medical use claims are statutorily prohibited Method of treatment or diagnosis are also Prohibited New Form of a known compound may be patentable as long as enhanced efficacy can be shown If a combination of known compounds ensure that it has new synergy not known and not mere aggregation of properties Copyright- Suja Subramaniam, 2011, IdeeIP Consultants, LLP

Copyright- Suja Subramaniam, 2011, IdeeIP Consultants, LLP Questions?? Copyright- Suja Subramaniam, 2011, IdeeIP Consultants, LLP