COMPULSORY LICENCES
held that importation from manufacturing facilities outside India did not satisfy the mandatory requirement of working the patent in India. The IPAB, on the other hand, held that working should be decided on a case- by-case basis and it may be proved that in a given case, the ‘working’ may be done by way of ‘import’, but this cannot apply to all cases. The patentee should show why it could not be locally manufactured. A mere statement to that effect is not sufficient and evidence must be shown.
Te IPAB also made it clear that the grant of a compulsory licence is not to favour the licensee, but to make the medicine reasonably affordable and accessible to the public. Te IPAB further emphasised that these proceedings are neither against the inventor, nor against the compulsory licence applicant, but purely based on public interest.
Patent-price linkage
It seems that the compulsory licence is based on public interest which is in turn related to the price of
the drug. Tis seems to link
patents to price control. A similar attempt at ‘patent linkage’ was made in 2009 when Bayer attempted to link the Patent Act with the Drugs and Cosmetics Act.
Incidentally, the drug product in both cases
was the same (sorafenib tosylate). In the patent linkage matter, it was stated that the nodal ministry for the administration of the Drug and Cosmetics Act is the Ministry of Health and Family Welfare whereas for the Patents Act it is the Ministry of Industry and Commerce. The court held against this attempt at bringing in patent linkage.
On similar lines, the price of a drug in India is decided by the National Pharmaceutical Pricing Authority (NPPA) which is under the Department of Pharmaceuticals in the Ministry of Chemicals and Fertilisers. It is a matter of debate whether this could also be considered as patent-price linkage and on how the courts react to it.
A further development relating to compulsory licences is that a committee set up by the Department of Pharmaceuticals to examine the issues of price negotiations for patented drugs, has recently submitted its report. Tis report
110 World Intellectual Property Review Annual 2013
R. Muralidharan is an advocate, mediator, law lecturer and a registered patent agent. He has a Bachelor’s degree in biology and a Master’s degree in
international law and constitutional law. He has participated in some of the leading patent and trademark litigations in India. He
also specialises in competition law
compliance and acts as a resource person regularly in professional skill improvement programmes.
Ashima Katara has about eight years of experience in the biotech and pharma IP rights practice. Her key practice areas include patent drafting, search
and analysis opinions, patent prosecution, litigation and patent portfolio management.
mentions that once a government-appointed committee fixes a price for medicines which is accepted by the government, this fixed price would be supposed to be reasonable and therefore it won’t be possible for the government to use the tool of compulsory licences on grounds related to the price of the patented medicine.
Bayer is said to have disagreed with the
conclusions of the IPAB and is likely to approach the court. Te case is set to be a crucial milestone in deciding the fate of pharmaceutical business in India in the wake of price control measures by the government.
R. Muralidharan is a patent attorney at Krishna & Saurastri Associates. He can be contacted at:
murali@krishnaandsaurastri.com
Ashima Katara is an associate, advocate and patent agent in the life sciences department of Krishna & Saurastri Associates. She can be contacted at:
ashima@krishnaandsaurastri.com
www.worldipreview.com
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99 |
Page 100 |
Page 101 |
Page 102 |
Page 103 |
Page 104 |
Page 105 |
Page 106 |
Page 107 |
Page 108 |
Page 109 |
Page 110 |
Page 111 |
Page 112 |
Page 113 |
Page 114 |
Page 115 |
Page 116 |
Page 117 |
Page 118 |
Page 119 |
Page 120 |
Page 121 |
Page 122 |
Page 123 |
Page 124 |
Page 125 |
Page 126 |
Page 127 |
Page 128 |
Page 129 |
Page 130 |
Page 131 |
Page 132 |
Page 133 |
Page 134 |
Page 135 |
Page 136 |
Page 137 |
Page 138 |
Page 139 |
Page 140 |
Page 141 |
Page 142 |
Page 143 |
Page 144 |
Page 145 |
Page 146 |
Page 147 |
Page 148 |
Page 149 |
Page 150 |
Page 151 |
Page 152 |
Page 153 |
Page 154 |
Page 155 |
Page 156 |
Page 157 |
Page 158 |
Page 159 |
Page 160 |
Page 161 |
Page 162 |
Page 163 |
Page 164 |
Page 165 |
Page 166 |
Page 167 |
Page 168