In its petition before the M adras High Court, Novartis heavily relied upon the argum ent
that Section 3(d) o f the Patent Act 1970 (India) violated Article 14 o f the C onstitution
o f India because it was vague, arbitrary and conferred un-canalised pow ers upon the statutory authority. The litigation raises three distinct questions o f constitutional law. The first set o f issues is related to the question o f contravention o f A rticle 14 o f the Constitution which concerns equality before the law. The second set o f issues is about the discussions associated with the possibility o f granting a declaratory relief under Article 32 o f the Constitution o f India. The third set o f issues is about the right to life and its interpretation and application in this case.
A. Article 14 o f the Constitution o f India
Article 14 o f the Constitution o f India states:
266 Council Directive of2004/27/EC o f 31 March 2004 amending Directive 2001/83/EC on the Community’ Code Relating to Medicinal Products fo r Human Use [[2004] OJ L/ 136, 34 at http://europa.eu.int/eur-lex/lex/LexUriServ/LexUriSe»v.do?uri=CHLBX:32004L0027:EN:HTML.
14. Equality before law.—The State shall not deny to any person equality before the law or the equal protection of the laws within the territory of India.
The main grounds of the attack to the validity of the Section 3(d) of the Patents Act 1970 (India) were that, it was vague, arbitrary, and confers un-canalised powers on the statutory authority i.e. the patent office which was assigned quasi-judicial functions under the statute. Therefore, it should be struck down under the ‘equality’ clause enshrined in Article 14 of the Constitution. The petitioners submitted overlapping arguments in favour of their position to establish a case of contravention of the basis of the three grounds stated earlier. The petitioner argued that through the amended Section 3(d) under the Patents (Amendment) Act 2005 (India) ‘a further clause was added to the effect that the discovery of a new form of a known substance should result in the enhancement of a known efficacy of that substance and if it does not, then, it is not an invention’.267 Such a clause, according to the petitioners, was not part of the Patents Ordinance 2004 (India) and it had been added later without due deliberations.
Novartis alleged that in the absence of any guidelines in the Patents (Amendment) Act 2005 (India) regarding the exact interpretation and scope of terms such as ‘efficacy’ and ‘the enhancement of known efficacy’, an unguided discretion was vested with the statutory authority and therefore the amended section was bad in law. Furthermore, the explanation added at the end of Section 3(d) was also attacked on the same ground as it had also limited the scope of patentability. It was submitted that:
In other words, the submission is that, both the amended section as well as the Explanation to the amended section must prescribe in clear terms for the Authority constituted under the Act, the guidelines to decide in what circumstances it can be held that the discovery of a new form of a known
substance had resulted in the enhancem ent o f the known efficacy o f that substance and when the derivatives are found to differ significantly in properties with regard to efficacy. Though the expression “efficacy” has a definite m eaning, yet, no definite m eaning could be attributed to the expression “enhancem ent o f the known efficacy” and “differ significantly in properties with regard to efficacy” . These expressions are am biguous.268
In response to this contention, respondents submitted that in view o f advancem ent o f technology and rapid developm ents in scientific research, the legislators adopted a general expression and the statutory authority was left free to apply its mind to determ ine the interpretation o f an im pugned section in different cases. Therefore it w ould be unwise to insist upon a statutory interpretation o f these term s as having regard to individual inventions; the patent office would determine w hether the new form o f a known substance had resulted in the enhancement o f known efficacy.266
W hile deciding the matter, the court agreed with the petitioners that the am ended
Section 3(d) under the Patents (Amendment) Act 2005 (India) was substantially
different from the one originally incorporated in the Patents (Amendment) Ordinance
2004 (India) and thus from the Patents Bill 2005 submitted to the parliam ent. The court
also declared that the scope o f Section 3(d) was w ider and in no w ay w as it limited to pharm aceutical products. However, the exception stated with this section was specifically designed for inventions related to the pharm acology field, nam ely drugs.270
A fter a careful exam ination o f relevant facts the and arguments o f the parties, the court rejected the plea o f the petitioners that amended Section 3(d) was in violation o f A rticle
268 Ibid. 40. 269 Ibid. 41.
270
14 of the Constitution of India. It was declared that the speeches made during the parliamentary debates and a statement of objectives and reasons associated with legislation was of less significance in the interpretation of a legal provision. The court relied upon an earlier judgment of the Supreme Court of India in Aswini Kumar v.
Arabinda Boss11', which held: ‘The Statement of Objects and Reasons appended to the Bill should be ruled out as an aid to the construction of a statute.’272
Therefore, the court rejected the contention of Novartis that the while adopting the amended Section 3(d), the legislator had ignored the spirit behind the introduction of this law contained in the Minister’s statement of objectives.
The court declared that such interpretation could not be construed to invalidate a provision of law which was duly approved by the legislator. Many cases were cited in this regard to reject the Novartis stance on this issue.272 It was then concluded that ‘it is not possible to sustain the arguments advanced by the learned senior counsels that having shown section 3(d) in a particular form in Ordinance 7/2004 and bringing it in a totally different form in Amending Act 15/2005, the amending section ex-facie stands in violation of Article 14 of the Constitution of India’.274
The court went further with the issue of interpretation and scope of the terms ‘efficacy’ and ‘the enhancement of known efficacy’, as it was a major argument of Novartis. The Madras High Court resolved this matter in terms of therapeutic efficacy by referring to the simple meanings of terms in different medical dictionaries. After determining the
1 Aswini Kumar v. Arabinda Boss AIR 1952 SC, 369.
2 2 Judgment of the High Court of Judicature at Madras in Novartis AG v Union o f India (2006), 44-45. 273 P.S. Narasimha Rao v. State (CBI/SPE), (1998) 4 SCC, 622; K.S. Paripoornan v. State o f Kerala, (1994) 5 SCC, 593.
statutory scope o f an ‘explanation’ in view o f the established case law, the court declared that scientifically it was possible to show with certainty the properties o f a substance. The court endorsed the opinion o f the Additional Solicitor G eneral, India: ‘The writ petitioner is not a novice to the pharm acology field but it, being pharm aceutical giant in the whole o f the world, cannot plead that they do not know what is m eant by enhancem ent o f a known efficacy and they cannot show that the derivatives differ significantly in properties with regard to efficacy.’27''
The court also scrutinised the argument o f N ovartis that the Parliam ent should have provided and disputed terms in Section 3(d) in the light o f previous case law and
statutory interpretations. In view o f Benilal v. State o f Maharashtra21* and the Registrar
o f Co-operative Societies v. K.Kunjabmu211, parliam ent could not foresee things that
m ay arise in the future and ‘parliament expresses its object and puipose in general terms when enacting Statute’.27* Thus, the court concluded that the petitioners could not make a case under Article 14 o f the Constitution:
It is not shown by the learned senior counsels appearing for the petitioners before us that in the exercise o f the discretionary pow er by the Patent controller, any o f the petitioner’s fundamental rights are violated nam ely, to carry on the trade or the petitioner stand singularly discrim inated.279
Finally on the issue o f invalidity on the basis o f Article 14 o f the C onstitution, the court differentiated the w ay in which both economic and social legislations could be
275 Ibid. 59.
~76 Benilal v. State o f Maharashtra 1995 Supp. (1) SCC 238.
27 Registrar o f Co-operative Societies v K.Kunjabmu 1980 (1) SCC 340.
2 s Judgment of the High Court of Judicature at Madras in Novartis AG v Union o f India (2006), 60. 279 Ibid. 73.
construed. In light of R.K. Garg v. Union o f India2*0 the rule was highlighted that the laws relating to economic activities could be viewed with greater latitude than laws about civil rights such as freedom of speech. The Patents Act 1970 (India) could only be construed in this context as it had been amended over the periods keeping in view the economic conditions of the country. Therefore from the very beginning, the Parliament was aware about the change in the economic conditions of the country, which made them amend the earlier laws to suit the prevailing economic conditions. It was held that the petitioners failed to demonstrate any legal ground relating to equality before the law to invalidate the amended section.281
B. Declaratory Relief under Article 226
Another dimension of the Constitutional debate was the possibility of issuing a declaration in this case which was filed under Article 226 of the Indian Constitution. Novartis presented a case that if the court could not strike down Section 3(d) of the
Patents Act 1970 (India) on the basis of contravention of the TRIPS Agreement 1994
then at least, as an alternative remedy, a declaratory relief could be pronounced to the effect that the impugned Section was inconsistent with the obligations of the agreement. The Petitioners stated that Section 3(d) of the Patents Act 1970 (India) as amended by the Patents (Amendment) Act (India), was invalid, illegal and unconstitutional on the grounds of contravention of Article 14 of the Constitution of India and the petitioners were entitled to a declaration.
The court addressed this issue mainly from a Constitutional perspective and it declared that the scope of declaratory relief in proceedings under Article 226 of the Constitution of India was limited to the situations where such relief could actually provide real
280 R.K. Garg v. Union o f India (1981) 4 SCC 675.
benefit to a party. Thus, in other cases where such relief has a mere notional value, the court should abstain from exercising its Constitutional jurisdiction.282 The Court established through the case law that the scope of declaration under Article 226 was quite limited; however, a court exercising its jurisdiction under the provisions of the Constitution could rely upon Article 32 to afford such a relief.283
Then the High Court analysed the case law under Article 32 to determine whether a declaration could be issued on the Novartis application and noted that the Supreme Court of India had held that it would not hesitate to grant a declaratory relief under Article 32 of the Constitution of India where fundamental rights had been violated. After elaborating this standard, the court held that the amended Section 3(d) did not totally take away the right of the petitioner to carry out the business and trade in India and thus a case for declaration could not be established. Furthermore, petitioners were not satisfied with the amendments in a statute but ‘it is a settled position in law that nobody can compel the Parliament to enact a law’.284 Based upon this settled point, the court questioned the usefulness and utility of such a declaration even if the court could consider declaring that the amended provision was not in the discharge of India’s obligations under Article 27 of the TRIPS Agreement 1994. Thus, in view of Katakis v.
Union o f Indicr85, a declaration could not be given where it would serve no useful purpose to the petitioner.
Some experts, however, view it differently. If a court is exercising discretionary powers under writ jurisdiction then it should keep in view the treaty obligations and make orders accordingly. In the words of Justice R. K. Abichandani: ‘While the role of
Ibid. 35. 283 Ibid. 30. 284 Ibid. 34.
285
judiciary is confined to the four comers o f the statutory provisions governing the intellectual property rights, its discretionary powers enable it to legitimately take into account the ramifications that its discretionary orders would have in the context o f the wider horizons o f the intellectual property rights.’286
C. Right to Health under Article 21
The human rights based approach adopted in and around the Gleevec patent litigation had intensified the importance o f the case throughout the world. Novartis claimed that its intellectual property right had been abridged and the case was filed to protect its strategic assets. The patient groups argued that an attempt to get a patent on imatinib would threaten their right to health by narrowing down the options to access affordable medicines. The submissions o f one respondent, the Cancer Patients Aid Association, were quite conspicuous in this regard and they heavily relied upon the related provisions o f the Indian Constitution and other international instruments.
In its written reply to the Novartis petition, the Cancer Patients Aid Association maintained that India was bound by a Constitutional duty to comply with the positive obligations o f the right to health o f its citizens including those affected by Chronic Myelogenous Leukemia (CML). In this regard reference was made to the right to life guaranteed under Article 2 1287 o f the Constitution of India. It was also submitted that the non-availability and non-affordability of any form of Imanitib Mesylate to CML
~S6 Justice R.K. Abichandani, 'Role of Judiciary in the Effective Protection of Intellectual Property Right’, (undated) 11, at
http://vvwvv.ccstat.gov.in/Articles?/o20bv0/o20Prcsident/Role%20ot%20Judiciary%20in%20thc%20Effecti ve%2QProtection%20of\,T2(.)lntellectual%20Propertv%20Ri tiht.doc
Article 21. Protection of life and personal liberty.—No person shall be deprived of his life or personal liberty except according to procedure established by law.
patients would also violate the rights of the CML patients under Articles 14 and 21 of the Constitution.288
It is worthwhile mentioning that the Indian Constitution does not recognise the right to health as a fundamental right per se. However, the Supreme Court of India in Vincent Panikurlangara v. Union o f India2*9 recognised the enforceability of the right to health within the scope of Article 21 of the Indian Constitution. Later, the Supreme Court through an expansive interpretation of Article 21 (right to life) in its landmark judgment of Paschim Banag Khet Samity v. State o f West Bengal, declared that the right to life included the right to health and the right to emergency medical care.2 '0
In addition to their reliance upon the Constitutional provisions, the Cancer Patients Aid Association also referred to various international instruments to highlight India’s commitments and obligations to protect the health of its citizen’s by adopting favourable administrative and legislative measures. In this regard, Article 3 of the
Universal Declaration o f Human Rights states: ‘Everyone has the right to life, liberty and security of person.’ Article 25 (1) of the Universal Declaration o f Human Rights,
Article 6 of the International Covenant in Civil and Political Rights (ICCPR) to which India is a party and Article 12.1 of the International Covenant on Economic, Social and Cultural Rights, 1976 (ICESCR) were specifically mentioned to establish India’s obligations in this regard. In Vishakha v. State o f Rajasthan, the Supreme Court also declared that Article 21 of the Constitution of India had to be interpreted in the light of international instruments.201 Respondents also referred to the poverty profile of India
288 Affidavit for the Respondents No. 6 in the High Court of Judicature at Madras, Writ Petition No. 24759 of 2006, 12.
284 Vincent Panikurlangara v Union o f India (1987 (2) SCC 165. 290 Paschim Banag Khet Samity’ v State o f West Bengal (1996) 4 SCC 37. 291 Vishakha v. State o f Rajasthan (1997) 6 SCC 241.
and the need to devise an intellectual property policy to stimulate the research and development in the best interests of poor and marginalised groups who are badly in need of affordable quality medicines.292
The judgment of the Madras High Court mainly deals with the legal and technical aspects of the dispute. However, the court could not fully avoid the appeal of such analysis and it had sporadically reflected upon those arguments by upholding the use of policy style reasoning to validate the contentious provision of a law. The court observed that:
Lengthy arguments have been advanced ... that India, being a welfare and a developing country, which is pre-dominantly occupied by people below poverty line, has a constitutional duty to provide good health care to its citizens by giving them easy access to life saving drugs. In so doing, the Union of India would be right, it is argued, to take into account the various factual aspects prevailing in this big country and prevent evergreening by allowing generic medicine to be available in the market. As rightly contended by the learned Additional Solicitor General of India, the Parliamentary debates show that welfare of the people of the country was in the mind of the Parliamentarians when Ordinance 7/2004 was in the House.293
Finally, concluding in its own words, the court stated that: ‘We have borne in mind the object which the Amending Act wanted to achieve namely, to prevent evergreening; to
212 Affidavit for the Respondents No. 6 in the High Court of Judicature at Madras, Writ Petition No. 24759 of 2006, 12-13.
provide easy access to the citizens of this country to life saving drugs and to discharge their Constitutional obligation of providing good health care to its citizens.’294