US Co Abraxiss patent application on cancer drug refused

Patent application filed by the US firm Abraxis BioSciences for their anti-cancer drug Abraxane, has been refused by the Indian Patent Office on the ground that, it lacks inventive step, and violates Section 3 (d) of the Indian Patent Act. Decision of Indian Patent Office will now be paving the way for generic companies to launch affordable versions in the domestic market.

The US firm Abraxis BioSciences had filed for a patent on the breast cancer drug formulation in 2006, which was opposed by generic company, Natco Pharma. The invention claimed was found to be obvious in light of the prior art that taught antibody therapy using paclitaxel, and in violation of the provision of Section 3(d), legal sources say.

Earlier in a similar case in 2013, Swiss company Novartis lost the patent on its blockbuster cancer drug, Glivec.

Section 3 of the Indian Patent Act speaks about what does not fall under the category of inventions.  Section 3 (d) of the Indian Patent Act, says that the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.

Explanation – For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.

Also Read Novartis AG v. Union of India

Ashoka Kumar Thakur v. Union of India

A curious case of judicial indiscipline

Gautam Mohanty, Student of Law, National Law University, Odissa

The vicissitudes of the law of reservation were duly set about and demarcated in the case of Indira Sawhney v. Union of India ((Indira Sawhney v. Union of India, AIR 1993 SC 477)). The judgment of nine judges collectively with a majority upholding the provision of reservations to the Other Backward Classes to  the  extent of  27%  in central government services, clearly illustrates the acceptance of the Apex Court; that caste is indeed an institution of Indian society. Furthermore the judgment also mentions the very discriminatory nature of the caste hierarchy, the need to overcome it and the role special provisions such as reservations can play in the task of irradicating caste as an institution of the society. Ironical is the fact that reservations have never been viewed by the Indian courts as an instrument for equalizing the status and position of castes in the Indian context. Judicial discipline demands that a judgment can only be reversed by a larger bench of judges and since no bench larger than nine in size has gone into the issue of reservation after Indra Sahwney v. Union of India ((Id.)); the necessary inference that can be drawn is that the matter of reservation has been put to rest.  But it does not appear so; the present case i.e. the case of A K Thakur vs UOI ((A. K. Thakur v. UOI, 2008(56) BLJR1292))has opened up the issue of reservation and all the peripheral questions involved with the same for consideration. The decision by a constitutional bench of the Apex Court in the above mentioned case upholding the constitutional amendment and union legislation which provided for reservations of Other Backward Classes(OBCs) in higher education is a classic one-off example of judicial indiscipline.

DISSECTING THE RATIONALE IN A.K. THAKUR

In A.K. Thakur ((Id.)), the Constitution Ninety-Third Amendment Act, 2005 and the Central Educational Institutions (Reservation in Admission) Act, 2006 were under constitutional scrutiny. The Ninety Third Amendment which happened to insert clause (5) in Article 15 of the constitution reads as follows:

“Nothing in this article or in Sub-clause (g) of Clause (1) of Article 19 shall prevent the state from making any special provision, by law, for the advancement of any socially and educationally backward classes of citizens or for the Scheduled Castes or the Scheduled Tribes in so far as such special provisions relate to their admission to the educational institutions including private educational institutions, whether aided or unaided by the state, other than the minority educational institutions referred to in Clause (1) of Article 30.”

An incisive analysis of the provisions so envisaged in Article 15(5) makes it abundantly clear that it empowers the state to exceed the restrictions so imposed under Articles 15 and 16 so as to allow for special provisions in both state and privately managed educational institutions irrespective of whether they receive state aid or not.

However what is to be taken into consideration at this juncture is that the Central Educational Institution Act(CEI) 2006, enacted by the Parliament under article 15(5), sought to enable greater access to higher education by way of providing 27 percent reservation for “Other Backward Classes” in government controlled educational institutions and had no effect on private education institutions ((For the definition of Central Educational Institution, see Section 2(d), CEI Act (2006).)). The rationale behind such exclusion of privately managed institutions can be found by taking into consideration the objects and reasons of the Act, whereby it has been stated that the state shall undertake all steps necessary for accomplishment of the objectives so enshrined in Article 46 ((As per Article 46, it is the mandate of the state to promote the educational and economic interests of scheduled castes, scheduled  tribes  and  other weaker sections of society.))of the Constitution ((Statement of Objects and Reasons, CEI Act (2006).)).

ASCERTAINING THE CONSTITUTIONAL VALIDITY OF ARTICLE 15(5)

The ground for challenging the constitutionality of the said Article was that it is was in clear and blatant terms a violation of the basic structure doctrine ((The basic structure doctrine, propounded by the Supreme Court in Kesavananda v. State of Kerala, (1973) 4 SCC 225, places substantive and procedural limits on the amending process provided in the Constitution)). Moreover it was argued in the present case that the use of the term “notwithstanding” in Articles 15(3), 15(4) and 15(5) could not be construed as “notwithstanding the declaration of equality principle”. Thus, it was argued that introduction of Article 15(5) into the constitutional machinery destroys the very fabric of equality which is a basic feature of the Constitution ((Supra note 3, at ¶¶ 28, 30 (Balakrishnan CJ).)).

Furthermore the constitutionality of Article 15(5) was also challenged on the ground that it was in direct conflict with Article 15(4) as both Articles exclude the remaining provisions of Article 15. Whereas Article 15(5) excludes Article 15 and Article 19(1)(g); Article 15(4) excludes Article 15 and Article 29(2). Hence, it was argued that Article 15(5) could not be read in conformity with the principles in Articles 14 and 15 and thus it was in clear violation of the principle of equality so enshrined in the Constitution ((There were other grounds of challenge as well to the validity of Article 15(5). For example, whether the exclusion of minority educational institutions from Article 15(5) violated Article 14 of Constitution? This paper has, however, concentrated only on Article 15(5).)). The Supreme Court did ultimately conclude that Article 15(5), insofar as it dealt with state maintained and aided institutions, did not violate the basic structure of the constitution.

Furthermore the bench indulged into the exercise of harmoniously construing both Articles 15(4) and 15(5) and clarified that the meaning of “nothing in this article” in Article 15(5) would encompass within itself the grounds so mentioned in Article 15(1) and exclude Article 15[4] ((Supra note 3, note 1 at ¶ 95 (Balakrishnan CJ).)). What is to be taken into due notice here is the very fact that this textual analysis done by the esteemed bench is not properly directed and lacks conviction. It is so because even though the Court held that Article 15(5) did not negate Article 15(4), there is no clear majority on the scope and ambit of the phrase “nothing in this article” in Article 15(5). Furthermore the crux of the basic structure review is about compliance with basic features of the Constitution. Surprisingly, the counsels representing both the parties and the esteemed court itself happen to misconstrue the context of the discussion and indulge into the discussion as if Article 15(5) had to be in conformity with other textual provisions of the Constitution. The analysis of the court seems to be misdirected in the present case as basic structure review does not confine itself to a particular expression in the text of the Constitution.

THE CURIOUS CASE OF JUDICIAL INDISCIPLINE

The case of A.K. Thakur ((Supra note 3))is a textbook case of judicial indiscipline; the order of reference by the two judge bench of Arijit Pasayat and Lokeshwar Singh Panta sought out to answer a whole list of questions which were previously with great assertion laid to rest in the Mandal Commission Case ((Supra note 1)). The only question that might have sufficient ground to stand this accusation is whether the Parliament by an enacted legislation is vested with the appropriate power to direct private educational institutions to give reservations to the OBCs?, the irony being this question was never answered on the ground that there was no challenge from private educational institutions.

After coming to the above mentioned conclusion the bench should have in all probability reverted the reference back instead of answering it; because there was never any doubt regarding the fact that the government could provide for reservations under the Constitution to OBCs in educational institutions owned or financially aided by it. In spite of such clear clarity the blanket order of reference was used by three of the five judges to read the Mandal Commission ((Id.))judgment tendentiously, genuflecting with due respect, but glossing it  in  a  manner  that leaves the door open for a reversal in good time ((44.43 K. Balagopal, Ideology and Adjudication: The Supreme Court and OBC Reservations EPW 16-19 (2009).)).

After the decision of the court in the Mandal Commission Case ((Supra note 1)), caste as a social category had come to be accepted by the courts as a class of a kind, eligible for reservations if it is backward. But A.K.Thakur ((Supra note 3))introduces a new revision to this criteria; the revision being caste becomes a class only after the creamy layer is removed. Thus, the elimination of the creamy layer from the benefits of reservation is no longer an issue of purported justice within the community as between the more backward and the less backward amongst it, as it was in the Mandal Commission case ((Supra note 1)), but a necessary prerequisite for the caste to at all be a class, and a fortiori a backward class ((Supra note 15)). The revision so undertaken happens to be conceptual in nature brought into effect without anyone’s notice by a majority of the five judge bench in a reference that was unnecessary in the first place.

The smuggling in of the “economic criterion” is another instance where there has been unnecessary interference by the five judge bench. Unnecessary for the very reason that the bench was not constituted for the purpose of determining as to whether or not caste could be the sole basis for determining backwardness. Ultimately what this uncalled for intervention has resulted in is a shift from the stand-point that caste can be only one of the criteria taken into account to identify backwardness to the entire caste being declared backward on the sole criteria of backwardness, though there can be other ways of identifying classes too.

What is altogether more ironical is the fact that three judges out of five judges duly approve the above mentioned opinion of the Mandal Commission case ((Supra note 1))but nevertheless proceed gamely to pose and answer the same question notwithstanding its finality and express different opinions while declaring themselves to be bound by the Mandal Commission Judgement.

Perhaps the only time courts in our country have taken into due recognition the division of the country into rich and poor and deplored it is when people have approached the forum of the apex court seeking to enforce their caste based reservations or rights. It is remarkable to note that the courts are otherwise normally indifferent to economic cleavages in society. In A.K. Thakur ((Supra note 3))the majority has given the astonishing direction that “to  strike  the  constitutional balance, it  is necessary  and  desirable  to earmark  certain percentage of  seats  out  of permissible limit  of 27% for socially and economically backward  classes”. And a concurring opinion from a judge of the same bench directs that after a brief period of ten years the criterion for reservation must indeed shift to the economically backward. Wanting in discipline or not, the effect of such a decision is that a majority of three out of the five judges can be seen indulging into the unwarranted exercise of pushing for the economic criterion in determining backwardness.

Moreover the judgment focuses on putting forth answers to questions which were never asked in the first place. It must be recalled at this juncture that the bench was supposed to be adjudging the constitutional validity of the 93rd Amendment which was introduced into the Constitutional fabric via Article 15(5) which sought out to enable the government to make a special provision by law for the advancement of backward classes and the validity of the consequential law made by the Parliament, namely, the Central Educational Institutions (Reservations in Admissions) Act, 2006. But as is clearly evident the bench digressed to a very large extent from the core issue and attempted to answer questions which were never really asked in the first instance. By putting forth answers to questions which were never asked in the first place the court has indeed indulged in the act of judicial indiscipline.

THE UNCALLED AND UNWARRANTED RELAXING CRITERIA

The “Relaxing Criteria” is the result of the uncalled and unwarranted intervention of the court into the question as to what extent the government or the educational institutions may relax the qualifying marks to enable the students belonging to the OBC category to access the benefits of reservations. And what is to be done if the seats so allocated for the very purpose of providing the benefits of reservation to OBCs go unfilled? The above mentioned questions are questions to which answers were never sought out in the first place.

The questions so answered in the judgment happen to be a matter pertaining to government policy and while the courts may be called upon to adjudicate the validity of a policy once it is formulated it is not for them to say what it should be. But the majority of the bench thought otherwise and Arijit Pasayat and C.K.  Thakker begin their opinion on this issue by asking the central government to “examine the desirability of fixing cut-off marks in respect of candidates belonging to OBC”. And then they further mandate in respect of the allotment of unfilled up seats that they shall be filled up by “candidates from general categories”. This order clearly overstep the powers so vested with the judiciary and furthermore is a direct encroachment of the power so vested with the executive or with the legislature when it comes to policy decision.

THE THREE FATAL SINS OF A.K. THAKUR

The First fatal sin is that the judgment creates a deep cleavage between various castes present in India based on an improper understanding of the text and context of the Supreme Court ruling in Indra Sawhney. The bench in Indra Sawhney did not under any form of interpretation state that caste was supposed to be the most important criteria in identifying backwardness; it merely acknowledged the fact that caste as an institution is prevalent in the society of India and it should be taken into account as one of the factors while determining backwardness.

The second fatal sin is that the bench fails to understand that the term “backward class” under Article 15(5) and Article 16(4) connote two different meanings. Under Article 15(5) majority in terms of numbers is irrelevant as a section of the society even though comprising of 80% of the total population can still be marked as backward for the purposes of Article 15(5). But the scenario is not so under Article 16(4) where apart from being backward the section of the societymust be “inadequately represented”. Being “inadequately represented” is an additional criteria which can only be found in Article 16(4) and not in Article 15(5). Furthermore what is to be taken into account is that it is only in Article 16(4) that representation of the population per se attains much significance and not under Article 15(4) and Article 15(5).

The third fatal sin is in the nature of poor constitutional advice given in the context of reconciling Article 15(5) and Article 15(4). Under Article 15(4) the state could provide for reservations for OBC’s in state-aided institutions. The sole purpose for introducing Article 15(5) into the Constitution was for providing reservations for OBC’s in private institutions. Hence with such diverse purposes it is remarkable how the bench in A.K. Thakur ((Supra note 3))insisted on reconciling both the Articles. Before Article 15(5), reservation for OBC’s in state aided institutions could be provided under Article 15(4). In case of unaided or private institutions the judgment of the Apex Court in the case of T.M.A. Pai and Inamdar ((T.M.A. Pai Foundation and Ors. v. State of Karnataka and Ors, AIR 2003 SC 355))is to be taken into due consideration where the Court observed that coercing admissions in private institutions on the basis of reservation was an unreasonable restriction under Article 19(1)(g). Instead of recognizing this simple constitutional history, the bench indulged themselves into an uncalled exercise of reconciling Article 15(5) and Article 15(4).

CONCLUSION

The blunder so made by the judiciary in the case of A.K. Thakur is a textbook classic of judicial indiscipline. The bench never took into consideration the issue of proportionality. The concept of affirmative action has been borrowed from United States where the main objective of introducing such a concept unlike India was to promote diversity. The rationale behind introduction of affirmative action in the Indian context is clearly to compensate for past discrimination and not to promote diversity unlike the United States. In such a case, the compensation must be proportional to the deprivation suffered; which is clearly not the case in the present context. Hence it is about time the matter in regards of reservation is laid to rest and strict accountability enforced in order to discourage judicial indiscipline.

Madras Bar Association v. Union of India

The recent trend of setting up tribunals in various sectors to lighten High Courts’ burden and speed up decisions suffered a setback again when the Supreme Court struck down the National Tax Tribunal Act on grounds that it encroached upon the power of the judiciary and the principle of separation of powers.

Madras Bar Association v. Union of India

Issue arises before the Court pertains to the constitutional validity of the National Tax Tribunal Act, 2005 (hereinafter referred to as, the NTT Act). Simultaneously, the constitutional validity of the Constitution (Forty-second Amendment) Act, 1976 has been assailed, by asserting, that the same violates the basic structure of the Constitution of India (hereinafter referred to as, the Constitution), by impinging on the power of “judicial review” vested in the High Court. In the event of this Court not acceding to the aforementioned prayers, a challenge in the alternative has been raised to various provisions of the NTT Act, which has led to the constitution of the National Tax Tribunal (hereinafter referred to as, the NTT). The NTT, according to the learned counsel for the petitioners, is styled as a quasi-judicial appellate tribunal. It has been vested with the power of adjudicating appeals arising from orders passed by Appellate Tribunals (constituted under the Income Tax Act, the Customs Act, 1962, and the Central Excise Act, 1944). Hitherto before, the instant jurisdiction was vested with High Courts. The pointed issue canvassed in this behalf is, that High Courts which discharge judicial functions, cannot be substituted by an extra-judicial body. Additionally, it is maintained that the NTT in the manner of its constitution undermines a process of independence and fairness, which are sine qua non of an adjudicatory authority.

Supreme Court struck down the National Tax Tribunal Act on grounds that it encroached upon the power of the judiciary and the principle of separation of powers.

Read the Judgment

Common Cause v. Union of India

The most resonant judgment which the Apex Courtdelivered in the year 2014 was the one which cancelled around 200 coal mining licences, in Common Cause v. Union of India. It is the most important decision since its earlier judgment cancelling 2G spectrum licences.

Brief Fact

Coal is king and paramount Lord of industry is an old saying in the industrial world. Industrial greatness has been built up on coal by many countries. In India, coal is the most important indigenous energy resource and remains the dominant fuel for power generation and many industrial applications. A number of major industrial sectors including iron and steel production depend on coal as a source of energy. The cement industry is also a major coal user. Coal’s potential as a feedstock for producing liquid transport fuels is huge in India. Coal can help significant economic growth. India’s energy future and prosperity are integrally dependent upon mining and using its most abundant, affordable and dependant energy supply – which is coal. Coal is extremely important element in the industrial life of developing India. In power, iron and steel, coal is used as an input and in cement; coal is used both as fuel and an input. It is no exaggeration that coal is regarded by many as the black diamond.

Being such a significant, valuable and important natural resource, the allocation of coal blocks for the period 1993 to 2010 is the subject matter of this group of writ petitions filed in the nature of Public Interest Litigation, principally one by Manohar Lal Sharma and the other by the Common Cause. The allocation of coal blocks made during the above period by the Central Government, according to petitioners, is illegal and unconstitutional inter alia on the following grounds:

  1. Non-compliance of the mandatory legal procedure under the Mines and Minerals (Development and Regulation) Act, 1957 (for short, ‘1957 Act’).
  2. Breach of Section 3(3)(a)(iii) of the Coal Mines (Nationalisation) Act, 1973 (for short, ‘CMN Act’).
  3. Violation of the principle of Trusteeship of natural resources by gifting away precious resources as largesse.
  4. Arbitrariness, lack of transparency, lack of objectivity and non-application of mind; and
  5. Allotment tainted with mala fides and corruption and made in favour of ineligible companies tainted with mala fides and corruption.

Principally, two prayers have been made in these matters, first, for quashing the entire allocation of coal blocks made to private companies by the Central Government between 1993 and 2012 and second, a court monitored investigation by the Central Bureau of Investigation (CBI) and Enforcement Directorate (ED) or by a Special Investigation Team (SIT) into the entire allocation of coal blocks by the Central Government made between the above period covering all aspects.

However, the present consideration of the matter in this case is confined to the first prayer, i.e., for quashing the allocation of coal blocks to private companies made by the Central Government between the above period.