1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

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