NOVARTIS AG SCHWARZWALDALLE 215 4058 BASEL AND LICHSTRASSE 35 4002 BASEL SWITZERLAND Vs. UNION OF INDIA

JUDGEMENT

(1.) )

(2.) THE writ petitioner in both the writ petitions is one and the same. In the first writ petition, Novartis " a foreign company represented by it's Indian Power of Attorney holder, is the writ petitioner. In the second writ petition, Novartis India represented by it's power agent is the writ petitioner. THE respondents in both the writ petitions are one and the same. THE prayer in both the writ petitions is one and the same namely, for a declaration that section 3(d) of the Patents Act, 1970, amended by Patents (Amendment) Act 15/2005, is unconstitutional. However, in the first writ petition there was an additional prayer in addition to the relief asked for. THE additional prayer was to direct the second respondent in that writ petition namely, the Controller General of Patents and Designs, to allow the patent application bearing No.1602/NAS/98 filed by the petitioner seeking patent. However at a later stage, during the pendency of the writ petitions, M.P.No.1/2007 came to be filed in that writ petition seeking to delete the prayer for a direction to the Patent Controller to allow the application and it was accordingly ordered. THErefore as on date in the two writ petitions, the Constitutional validity of section 3(d) alone is in challenge, both on the ground that it violates not only Article 14 of the Constitution of India but also on the ground that it is not in compliance to "TRIPS". Both the writ petitions along with the connected miscellaneous petitions were admitted by a learned Judge of this court and before the very same learned Judge, at a later stage, all the miscellaneous petitions came up for disposal. We are informed that elaborate arguments were advanced by the learned senior counsels on either side at that stage and on 26.09.2006 learned Judge, who heard these writ petitions with the connected miscellaneous petitions, came to the conclusion that the writ petitions require the attention of a Division Bench of this court, as according to the learned single Judge, the writ petitions involve substantial questions of law. THErefore learned single Judge passed an order directing the Registry to place the entire material papers before the Hon'ble Chief Justice for disposal by a Division Bench. Subsequently, by orders of the Hon'ble Chief Justice, these writ petitions are listed before us. Heard Mr.Soli Sorabji, Mr.Shanthi Bhushan and Mr.Habibulla Badsha, learned senior counsels appearing for the petitioners; Mr.V.T.Gopalan, learned Additional Solicitor General for the Government of India and the Controller of Patents and Designs; Mr.Anand Grover, learned counsel; Mr.P.S.Raman learned senior counsel; Mr.Aravind P Datar learned senior counsel; Mr.K.M.Vijayan learned senior counsel and Mr.Lakshmi Kumaran, learned counsel appearing for the various respondents.

(3.) LEARNED senior counsels on the opposite side would vehemently contend that the amended section is definitely compatible to "TRIPS". Even assuming that it is not so, the remedy to have the "TRIPS" agreement complied with in letter and spirit available to the member countries does not lie before the Indian courts but only before the Dispute Settlement Board, hereinafter referred to as "DSB" created under "TRIPS" itself. According to them, even assuming if "TRIPS" confers rights on any citizen/legal entity of a member country, then such person should also approach "DSB" only. "DSB" had been constituted to address all disputes that may arise between member countries and their citizens/legal entity in implementing or not implementing "TRIPS" and that is the exclusive authority to go into those controversies. Therefore the challenge to the validity of the amended section on the ground that it is not compatible to "TRIPS", cannot be legally sustained before Indian courts. It is contended by learned senior counsels and the other counsels on the opposite side that in discharging their obligations under "TRIPS", Government of India had brought in several amendments to the Parent Act and the amended section is one such provision. Every member country is given enough elbow room to bring in a local law in discharging their obligation under "TRIPS" having regard to the various needs of their citizens. India is a welfare country and it's first obligation under the Constitution is to provide good health care to it's citizens. When that is it's priority commitment under the Constitution of India, the Union of India has every right to bring in any local law in discharging their obligations under "TRIPS" to suit to the needs and welfare of it's citizens. On the attack to the amended section that it is vague, arbitrary and therefore unconstitutional, it is argued by learned senior counsels and the other counsels in the opposite camp that the amended section as it stands is workable. The Patent Controllers are all experts having undergone considerable training abroad in this field. The petitioner is not a novice to the field but on the other hand it is one of the pharmaceutical giants in the world. The efficacy of a known substance is well-known and it is definitely known to everyone in the pharmaceutical field. When the efficacy of that substance would stand enhanced could also be clinically found by those in the field. The petitioner is not a common man but it is having the expertise behind it. When does the properties in a derivative differ significantly with regard to efficacy could also be scientifically established by the people in the field. Therefore when everyone in the pharmaceutical field understands what is meant by enhancement in the known efficacy of a substance or when it can be said that the derivatives differ significantly in properties with regard to efficacy and the Patent Controller also understands it, the amended section cannot be struck down on the ground of arbitrariness and vagueness. If the Patent Controller, exercising his Statutory power, wrongly rejects the patent application on the ground that the drug is excluded under the amended section, then such a decision could always be corrected by the Appellate Authority and then by the higher forums. In other words, a wrong decision arrived at by the Patent Controller based on wrong application of the amended section cannot be a ground to strike down the said amended section which is otherwise in order. Case law was cited at the Bar by learned counsel Mr.Lakshmikumaran appearing for the opposite party that Indian courts have no jurisdiction to test the validity of a municipal law on the ground that it is in violation of an International Treaty, assuming it is so. It is argued by Mr.Lakshmikumaran, learned counsel, by citing an English Court decision, that a member has a right to make a Law of it's own by breaking an International Treaty, if making such a Law is warranted, to meet the welfare of it's citizens. Responding to the arguments advanced by the learned senior counsels and the other counsels for the opposite party that Indian courts cannot test the validity of the amended section on the ground that it is in violation of an International Treaty, learned senior counsels appearing for the petitioner in each case contended, by showing a precedent, that Indian courts do have the power. It is also argued by them that even assuming for a moment without conceding that an Indian Law cannot be struck down on the ground that it is in violation of an International Treaty, yet, there is no bar, either express or implied, disabling Indian courts to give a declaration that the amended section is in violation of the International Treaty. After broadly stating their respective contentions, R3, R4, R5 & R7, R6, R8 and R9 filed their respective written submissions.