PATENTABILITY OF SECOND MEDICAL USE IN INDIA

Transcription

1 PATENTABILITY OF SECOND MEDICAL USE IN INDIA AIPPI Helsinki Sept 2013 Hari Subramaniam Subramaniam & Associates New Delhi India

2 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.

3 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

4 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

5 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 5

6 Brief History From : January 1, 2005 Chemical and pharmaceutical substances became patentable Microorganisms became patentable

7 Patentability Requirements Absolute Novelty Inventive step (non obvious) Must not fall foul of Sections 3 and 4.

8 Patentability Requirements Negative list Section 3 lists inventions which are not patentable, even if novel and inventive Section 4 proscribes Atomic Energy related inventions

9 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

10 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

11 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.

12 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

13 MEDICAL USE Synergistic compositions having improved and unexpected properties. Methods of preparation comprising bringing one substance into contact with another at a particular locus.

14 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.

15 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.

16 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.

17 Example Queen Mary & Westfield College (IN 7503/DELNP/2007 Invention: administering to a patient Calcitonin (anti osteoporosis) followed by: Glucocorticoid (anti inflammatory)

18 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.

19 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.

20 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

21 PATENTABILITY OF SECOND MEDICAL USE IN INDIA X