PATENTABILITY OFSECOND MEDICAL USE IN INDIA

Hari SubramaniamSubramaniam & AssociatesNew DelhiIndia© SNA-2013

AIPPIHelsinki

Sept 2013

Patent Law in Force

The Patents Act, 1970 The Patent Rules, 2003 (with a view to make the law compliant with

TRIPS requirements, a series of reforms took place from 1995 to 2006.

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Brief History

Until 31 December 2004: The following were unpatentable: i) pharmaceutical and chemical substances per

se ii) living organisms including microorganisms iii) methods of treatments iv) use claims

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Brief History

From : January 1, 1995 It became possible to i) file mailbox applications for pharmaceutical

substances per se ii) without fear of summary rejection iii) obtain earliest possible filing date; and iv) obtain patent grant for products post 2005

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Brief History

From : 18 May 2003

It became mandatory to file request for Examination

Term of Patent became 20 years from the date of filing

Brief History

From : January 1, 2005

Chemical and pharmaceutical substances became patentable

Microorganisms became patentable

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Patentability Requirements

Absolute Novelty

Inventive step (non obvious)

Must not fall foul of Sections 3 and 4.

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Patentability RequirementsNegative list

Section 3 lists inventions which are not patentable, even if novel and inventive

Section 4 proscribes Atomic Energy related inventions

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Section 3

Section 3 prohibitions include:

(i) simple admixtures (ii) mere new use of a known substance (iii) new form of a known substance unless

there is significant increase in efficacy (iv) methods of treatment of animals and

humans

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MEDICAL USE

Patent for a new compound would indirectly cover its use as well.

However, no protection for new use of a known compound

Statutorily prohibited. Therefore, “Swiss type” use claims not permitted

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MEDICAL USE

Unlike USA, methods of treatment also statutorily prohibited by Section 3(i). What cannot be achieved directly cannot be

achieved indirectly

However, by skillful articulation, some kind of protection may be achieved.

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MEDICAL USE

New forms such as a polymorph, salt, derivative, crystalline form, pure form, ester, ether, etc., may be patentable provided there is significant increase in efficacy.

Burden of proof is on the applicant© SNA-2013

MEDICAL USE

Synergistic compositions having improved and unexpected properties.

Methods of preparation comprising bringing one substance into contact with another at a particular locus.

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Example

Aspirin First medical use : antipyretic and analgesic Second medical use : anticoagulant Further medical uses: anti stroke; anti ischaemic

None of them patentable in India.

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Example

Thus “use aspirin as an anticoagulant” or“use of aspirin in preparation of a medicament to treat blood clotting” or “ a method treatment…which comprises administering to a patient in need thereof an effective amount of aspirin” would all be rejected in India.

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Example

However, a combination of Aspirin with another known active would be patentable for a new indication upon showing of synergy.

For e.g.: Aspirin + Atorvastain calcium (both known compounds) for treatment of swine flu.

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Example

Queen Mary & Westfield College (IN 7503/DELNP/2007 Invention: administering to a patient

Calcitonin (anti osteoporosis)followed by: Glucocorticoid (anti inflammatory)

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Queen Mary & Westfield College (IN 7503/DELNP/2007-Granted

Rejected because method of treatment unpatentable under Section 3(i)

Claims amended to synergistic composition of Calicitonin and Glucorticoid where the two components come into contact with each other only in human body. Also method of preparing the composition by

bringing the two compounds into contact with each other at a locus.

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Cypress Bioscience, Inc.IN 3183/DELNP/2008

Invention: Method of treatment comprising administering Minacipran (anti fibromyalgia) and Pregabalin (anti epileptic drug) one after another

Claims amended to synergistic composition of Minacipran and Pregabalin where the two components come into contact with each other only in human body.

Also method of preparing the composition by bringing the two compounds into contact with each other at a locus.

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Pfizer, Inc

Invention: Use of Sildenafil citrate (viagra) for correcting sexual dysfunctions not patentable.

Method of treatment not patentable. Combination of sildenafil citrate and nicorandil

patentable as a novel synergistic composition

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PATENTABILITY OFSECOND MEDICAL USE IN INDIA

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