PATENTABILITY OF SECOND MEDICAL USE IN INDIA · 2019-07-22 · Queen Mary & Westfield College (IN...
Transcript of PATENTABILITY OF SECOND MEDICAL USE IN INDIA · 2019-07-22 · Queen Mary & Westfield College (IN...
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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