You can't escape CCI !!

Author: Prigya Arora, 1st year student of RGSOIPL, IIT Kharagpur Law School.

The pharmaceutical industry of India has matured over the years into a major producer of bulk drugs, rated among the top five in the world[1]. With the escalating number of diseases, more resistant bacteria and constantly evolving viruses, there is a constant increase in the demand of drugs in market. But making new drugs and taking them into the market is a hellacious task. It includes a lot of research and development and trials and rejections that leads to enormous costs.

A new analysis conducted at Forbes puts grim numbers on these costs. A company hoping to get a single drug to market can expect to have spent $350 million before the medicine is available for sale. In part because so many drugs fail, large pharmaceutical companies that are working on dozens of drug projects at once spend $5 billion per new medicine[2].

To acknowledge the efforts and costs put up by the pharmaceutical companies for this R&D, the novel drugs are given patents so that these companies can get the exclusive rights to manufacture that drug under The Patents Act, 1970. But once the patent expires, the formula of the drug becomes open (generic) and anyone is free to produce and manufacture it. The core issues for most drug companies are pricing, patent expiration of number of drugs and increasing legal and regulatory concern. To recover these high costs, the pharmaceutical companies try to maintain the monopoly in the market by paying off small local cheap generic drug producers for keeping them off the market. Some companies alter the compound and sell at much lower prices which surely upsets the comparatively larger companies.

Such issues can be observed as in the case of F. Hoffmann-La Roche Ltd. v. Cipla Ltd.[3]In 2008, Roche sued Cipla before Delhi High Court claiming that Cipla’s generic product Erlocip violates Roche’s patent rights over the Erlotinib Hydrochloride (EH); Indian Patent No. IN '774. Moreover, Cipla’s generic version costs about 1/3rd of Roche’s patented drug. The Court dismissed Roche's patent infringement suit in 2012. To counter such problems, the Competition Commission of India (CCI) which regulates country’s competition may now examine the details of patent settlements being negotiated between foreign branded medicine companies and local generic drug makers as these agreements may restrict the access of cheaper drugs to the unwell.

The other cases which CCI is likely to examine includes patent infringement battle between Swiss drug maker Novartis and Indian biotech firm Biocon, and the other between US-drug multinational Merck Sharp and Dohme Corp. (MSD) and India’s Glenmark Pharmaceuticals Ltd., both these cases are based on patent infringements of anti-diabetic drug of different kinds.

The argument is not that MNCs should be stopped from coming to India; the real concern is to guarantee that if they potentially harm competition, then steps are taken to ensure that the harmful effect is diluted. Generic drugs on the other hand, have become a necessity for the availability of cheap medicine to the poor class of India. With the involvement of CCI in the pharmaceutical sector, it is expected to bring a positive impact on the distribution of medicines in India as well as a check on prices charged to the customers.

In the past, until the passage of the CCI’s involvement, these issues were managed by administrative decisions of ministries and the Foreign Investment Promotion Board (FIPB) route. This approach had the impression of arbitrariness of government decisions. On the contrary, CCI operates within a well defined structure, providing legal certainty and transparency to the parties with clearly defined appellate processes. The Competition Act, 2002 empowers the Commission to evaluate all aspect of the proposed deal such as reduction of capacities for production or R&D and market distorting issues related to ownership of IPR. Further, this structure has in-built systems for consultation with appropriate sources, including ministries, department of government and designated persons or cells in these organizations[4].

Government of India has taken a very optimistic decision to allow CCI to be the watchdog of pharmaceutical settlements. As the role and powers of the CCI have been notified very recently, the ultimate test of their efficacy lies in the implementation. Both domestic and foreign pharmaceutical companies must realize the importance of public health and the need for affordable and accessible medicines to all consumers in a densely populated country like India and must rearrange their business models to serve the larger purpose.

 Disclaimer: This blog or any post thereof is not to be considered to be in any way associated with the official stand of IIT kharagpur or RGSOIPL on the issues being discussed in the said post. The opinions on the blog are the authors own and should not be considered as legal advice.

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[1] Dr. Geeta Gouri (Member: Competition Commission of India), Competition Issues in the Generic Pharmaceuticals Industry in India,http://www.cci.gov.in/images/media/presentations/ComIssGenPharmIndusIndia_20100401142

346.pdf

[2] http://www.forbes.com/sites/matthewherper/2013/08/11/how-the-staggering-cost-of-inventing-new-drugs-is-shaping-the-future-of-medicine/

[3] 159(2009)DLT243

[4] “Foreign Direct Investment in Indian Pharmaceutical industry”,http://cci.gov.in/images/media/ResearchReports/shahbaazInternreportdec2011.pdf

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Every Monkey has its day!!! I mean litrally …

Author: Suraj Badrayan, 3rd Year student of RGSOIPL, IIT Kharagpur Law School.

Imagine yourself owning a DSLR camera, and trek the forests in the hopes of capturing one of those rare photographs. You put down your camera and take break. Little do you know, lurking in the bushes, whoosh..!!! A monkey grabs your camera, manhandles the camera and then dropping it down and running away. Ordinarily, all you would do is just hope that your expensive camera is not damaged and scratched. But, then you find out  that you are in the possession of one of the rarest photographs ever captured. A rare shot of a monkey taking a selfie!! That photograph could make you a lot of money.

Little do you realise that you would be actually be mixed up with a bizarre copyright ownership issue about that photograph. Apparently, the monkey owns copyright over the photograph. Surprised..!!! Well you shouldn’t be, because that is exactly what has happened to Mr Slater. The story can be viewed here.

Well, let’s examine the legal position in this regard. Section 17 of the Indian Copyright Act, 1957 says that “the author of the work” shall be the first owner of the copyright. Section 2(d) subclause (iv) of the same Act, defines author of the photograph as the person taking the photograph. So by bare reading of the provisions of the Act, you will actually realise that the monkey is  the true owner of the copyright.

Ok, in order to make things more complicated, the Black’s Law Dictionary and General Clauses Act, 1897 defines person as a human being or a legal entity. So, the monkey cannot hold the copyright in the photograph.

THE QUESTION IS WHO OWNS THE PHOTOGRAPH?

There are three arguments that can be put forward. Let’s look at them.

1. The owner of the camera is the owner of the photograph. He spent, time, money and resources. He meant to take photographs, but the monkey took and camera and clicked it. Since, monkey is not a person, naturally the only person over there, the owner of the camera owns the copyright.

2. The government owns the photograph: The concept of animals as “property” of person is not new. To the law, animals are property, they are goods to be bought and sold, acquired and maintained.   This principle is deeply interwoven into the law. Imagine, the monkey is owned by a person, say Mr. X. Then, if the monkey clicks the photograph, then it can be said that the copyright is owned by Mr. X. As common law says that, rights and liabilities of acts done by the animal can be traced back to the owner itself.

Section 39 of the Wildlife Protection Act, 1972 specifies that all wild animals are to be government property. Section 17 clause (d) of the Copyright Act, says that in case of government work, the government shall be the first owner of the copyright. Hence, above analogy, the government shall be the first owner of the copyright of the photograph.

3. The photograph is in public domain: Here it can be said that, no one owns the copyright, and the photograph is public domain under the principle of res communes. The term res commune was defined as "things that could be commonly enjoyed by mankind, such as air, sunlight and ocean”. Common law describes public domain material as publici juris or propriétépublique to describe works that were not covered by copyright law. Legal scholars such as Patterson and Lindberg describe “public domain” not as a "territory", but rather as a concept: "There are certain materials—the air we breathe, sunlight, rain, space, life, creations, thoughts, feelings, ideas, words, numbers—not subject to private ownership. The materials that compose our cultural heritage must be free for all living to use no less than matter necessary for biological survival.^[1]

Hence, copyright to photograph may not exist at all due to publici juris principle. An alternative interpretation to this would be taking the philosophy of section 52 of the Copyright Act, which are copyright exceptions and limitations. Hence, such content which (but for Section 52) would have fallen squarely within the scope of the definition of a protectable work under the Copyright Act may also, in a manner, be considered to be in the public domain, if one were to use the term loosely. Consider particular sub clauses of:

 52(1)(a): as fair dealing

52(1)(h): for bona-fide instructional use

52(1)(m): for reproduction in any newspaper, periodical, magazine of an article on economic, political, social or religious topics.

Or reading of  the general exceptions within section 52 one can come to a conclusion that the photograph can be fitting loosely in the definition of public domain.

CONCLUSION:

If the matter ever comes to court and if I was ever the judge hearing that case, I would rather apply the Golden rule of interpretation^[2] to the definition of author in section 2(d) sub clause (iv) of the Copyright Act in order to remedy the absurd result arising from the section.

The interpretation would be that in particular cases when author of the camera is not able to be determined or is absurd in law, then the author is in fact the owner of the camera.

This would be the most simple, more logical and common sense thought to do. For if a court would try to resolve it otherwise, he would end up writing a whole lot of absurd nonsense like the one I have written above.

Disclaimer: This blog or any post thereof is not to be considered to be in any way associated with the official stand of IIT kharagpur or RGSOIPL on the issues being discussed in the said post. The opinions on the blog are the authors own and should not be considered as legal advice.

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[1]Ronan, Deazley (2006). Rethinking copyright: history, theory, language.Edward Elgar Publishing.p. 105.ISBN 978-1-84542-282-0.

[2]The golden rule of statutory interpretation may be applied where an application of the literal rule would lead to an absurdity. The courts may then apply a secondary meaning.

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Transfer of a Judge

Author :  Pulkit Gopalkrishan Popli, 1st Year student of IIT Kharagpur Law School.

Often the judgments delivered by various courts receive various responses on the basis of credibility, justice served, equitable grounds etc. But recently a judgment delivered by Chief Justice of Kerala High Court sparked a controversy. The reason of the controversy was that Hon'ble Judge Manjula Chellur has been transferred to the Kolkata High Court where she assumed the charge on 5th of August. The transfer warrant was signed by the Honorable President on July 21 while the verdict on case was delivered on July 25. The verdict declared the 2007 eviction-drive in Munnar as illegal. The question arises, could a judge still deliver judgments after a transfer warrant was issued?

As per Article 222(1) the President may, after consultation with the Chief Justice of India, transfer a Judge from one High Court to any other High Court. According to the Delhi High court rules,

“Every District Judge or Sub-Judge proceeding on leave or transfer, must, before making over the charge, sign a certificate that he has written judgments in all cases in which he has heard arguments. Should an officer be forced to lay down his charge suddenly, he shall, nevertheless, write the judgments in such cases, and send them for pronouncement to his successor.[1]”

This article along with article 217 has been the center of controversies. Article 217 states that 

“Every Judge of a High Court shall be appointed by the President by warrant under his hand and seal after consultation with the Chief Justice of India, the Governor of the State, and, in the case of appointment of a Judge other than the chief Justice, the chief Justice of the High court, and shall hold office, in the case of an additional or acting Judge, as provided in Article 224, and in any other case, until he attains the age of sixty two years Provided that-

              (a) a Judge may, by writing under his hand addressed to the President, resign his office;

             (b) a Judge may be removed from his office by the President in the manner provided in clause ( 4 ) of Article 124 for the removal of a Judge of the Supreme Court;

           (c) the office of a Judge shall be vacated by his being appointed by the President to be a Judge of the Supreme Court or by his being transferred by the President to any other High Court within the territory of India”

In the Landmark Judgment of, S.P.Gupta v. Union of India case^[2] which is the last judgment of judge’s case trilogy, could be used to answer various queries regarding the transfer of judges.

In paragraph-900 at page 543 it was discussed whether how court views the transfer of judges? It was said that it is a transaction that takes place in two parts, the first is termination from the original high court and the second is the simultaneous appointment in the other high court.

This view is supported by the circumstance that the power of transfer is vested in the President. It is significant in this connection that the President is also the appointing authority in the case of appointment made under Clause (1) of Article 217 and is also vested with the power of removal in cases falling under Article 218 read with Clause (4) of Article 124. Therefore, it was necessary that the authority who has been otherwise vested with the power to appoint a Judge and to terminate his appointment should also be the authority to transfer him. It may be added that inasmuch as the transfer constitutes an appointment of the Judge to the other High Court. Article 219 comes into play and, therefore, the transferred Judge must, before he enters upon his office in that High Court, make or subscribe an oath or affirmation according to the prescribed Form.

Now the question that arises that the article stated that the office of the judge will be vacated by him while being transferred by the President to other high courts. So can we say that the judge that has been issued the transfer warrant can no longer work as a judge until he has joined the new high court? One of such questions arose in a case M.K. Sasidharan, Advocate Supreme Court and President v. The Hon'ble Chief Justice of India, Supreme Court of India and Ors.^[3]The Petitioner, an advocate practicing in the Supreme Court filed the Original Petition praying for the issue of a writ of Quo Warranto calling upon the 5th Respondent, a Judge of this High Court who has been transferred to the High Court of Gujarat, under what authority he has been discharging the functions as an Additional Judge of the High Court of Kerala. The 5th Respondent was appointed as an Additional Judge of the High Court of Kerala under Article 217 of the Constitution of India. He had sworn as a Judge of this Court on 11th April 1996. By virtue of powers vested in the President of India under Article 222 of the Constitution, the 5th Respondent was transferred to the High Court of Gujarat. He was given time till 9th May 1996 to assume charge as Judge of the Gujarat High Court. Later the President of India in consultation with the Chief Justice of India had granted extension of time from time to time up to 22nd July 1996. In the meanwhile the 5th Respondent was functioning as a Judge of this Court, hearing and disposing of cases. It was contended by the Petitioner that on his transfer to the Gujarat High Court, the 5th Respondent was ceased to be a Judge of this High Court and that he has no right or authority to discharge the duties of a Judge of this Court

In the judgement to this case, the court also said in paragraph 18:

“The prayer of the petitioner to issue a writ of quo warranto is not maintainable as the 5th respondent was appointed as an Additional Judge of the High Court of Kerala by the President of India in consultation with the Chief Justice of India and the warrant of appointment still holds good and he had been given time to assume office till 22-7-1996. He continues to be a Judge of this Court for all practical purposes.”

Thus from this case we can easily conclude that a judge continues to remain judge until she/he gets relieved from the previous court, not when she gets the transfer warrant but in order to maintain the spirit of the constitution it is preferred that they vacate it as soon as possible. So applying same standards in the case of Judge Manjula Chellur, it was duteous of her to deliver the judgment which and her authority of deliverance is not dubitable under law and complies with the spirit of constitution.

Disclaimer: This blog or any post thereof is not to be considered to be in any way associated with the official stand of IIT kharagpur or RGSOIPL on the issues being discussed in the said post. The opinions on the blog are the authors own and should not be considered as legal advice.

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[1]http://delhihighcourt.nic.in/writereaddata/upload/CourtRules/CourtRuleFile_AF9J1IE4.PDF

[2](AIR 1982 SC 149)

[3]AIR1997Ker35

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Parallel Judiciary in India

Author - Abhishek Chansoria, 1st Year student of IIT Law School (RGSOIPL).

The governance of our country rests on three pillars: the legislature, the executive and the judiciary. It is the Constitution which has bestowed these separate powers on the three. The same Constitution has left some elbow-space for the personal laws of an individual providing for non-intervention of the State in the personal issue of an individual, namely religion. But, what happens when this personal religious institution takes up the job of any of the three? Will the policy of non-intervention still hold its importance? If it doesn’t, then when does the need of such intervention arise?

The major personal laws in force in India are the Hindu and the Muslim laws. Every common law has been formed and subsequently evolved according to the comforts of the society. Be it the patriarchal northern India based on Aryan lines, or be it matriarchal southern and eastern India influenced by the Dravidian society, both have been churned with time to suit the ever growing society. Whereas it is evident that the Muslim laws have a heavy bias towards the male counterparts, the Hindu polygamy practices before the Srinivasa Aiyar v. Saraswathi Ammal, 1951 and the subsequent Hindu Marriage Act 1955 also reflect the plight of women. The government’s stance to abolish polygamy in Hindus was a blazing example of a legislation driving a social change.

In the Muslim communities, the practice of issuing Fatwa is a grave over-exercise of jurisdiction by an institution. In the judgment given by the Supreme Court of India in Vishwa LochanMadan v. Union of India, fundamental rights given to the people are considered to be above personal and religious norms. Article 13 of the Constitution states that every law which is in contravention with the Constitution is void. From the very first day of the enactment of the Constitution, certain fundamental rights have been recognized. Hence, every action violating our rights is void. A fatwa is not given a legal mandate and hence it has been left at the choice of the individual to follow the same. The authorities issuing Fatwa do not draw its power from any legislation, hence, the concept of deductive reasoning simply tells us that the Fatwa also do not hold any legal sanctity. In the words of the Supreme Court- “The power to adjudicate a provision must flow from a ‘validly made law’”, which involves the legislature. The religious institution should exercise advisory actions pertaining to the need for a balanced solution approach.

The khap panchayats are infamous for their orthodox and conservative stand in inter-caste marriages. A myriad of cases of honor killings are coming forward with every passing day.

Along with the analysis of the need to check certain authorities from over-stepping actions, it is imperative to acknowledge the social evils addressed by the same authorities. As we know that a Muslim community in Pakistan and a Muslim community in India have the same religious genesis but what is different between the two societies is the political will which has driven them further. On one hand, the handful amendments in the Muslim personal law show the political escapism in our country, and on the other hand, the drive to acknowledge social changes which is a proof of political desperation is surfacing in Pakistan.

In the last week of May, 2014 the religious leaders of Pakistan issued a Fatwa stating honor killings as an "Un-Islamic" act. The leaders opined that daughters are the gifts by Allah and being dishonored by them is forbidden in Islam. There is a need to look at our neighbour’s religious approach to the common laws.

A fatwa which is issued for curbing the practice of honor killing, hence upholding the right to life, liberty, free will of women and men shows the institutional responsiveness to address the social evil. Whereas, the authorities in India issue a fatwa, which is prima facie so retrograde, "advising" a rape victim to marry the rapist, who is her father-in-law. The fatwa also stated that her husband can no longer keep any physical relationship with her as it is written in Quran that "Marry not the women whom your father copulated".   

 

Talking about the khap panchayat’s involvement in evils like honor killing, a question on the authority of the Khap needs to be answered. From where do they draw the power to adjudicate such draconian laws? The Supreme Court of India has used the term “kangaroo courts” for such institutions. But, a critical point of analysis remains that, though we have a well written Constitution along with its machinery, still the provisions dictated by such authorities are recognized by a large part of the population under them. Doesn’t it show the social status and acceptance enjoyed by them?

As it is well evident that the three pillars of our democracy have somewhere lacked in filling this lacuna between the people (affected by such Fatwa and Khap) and their constitutional rights, hence it will be prudent to use the authorities already present on the ground for the constitutional realization. This can be done by strict and careful regulation on such institutions and there powers. The khappanchayats have been blamed for the honor killings, but recently a Khap namely, 'Satrol KhapPanchayat' in Narnid village, Haryana, has come forward with its ideology which is far from conservatism. The Khap hasagreed with the truth that interaction between men and women has increased andstopping it is not possible. The decision given by the five-member committee has loosened the knot by allowing marriages in 42 villages which were earlier banned. Also, it has shown desperation is curbing female foeticide, bride sharing and dowry.

We can conclude that whatever be the laws; personal or statutory, should not go against the Constitution. The Constitution is above every personal law as it ensures happiness for all not on the basis of religion but on the lines of individual dignity.

Disclaimer: This blog or any post thereof is not to be considered to be in any way associated with the official stand of IIT kharagpur or RGSOIPL on the issues being discussed in the said post. The opinions on the blog are the authors own and should not be considered as legal advice.

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Effect of TRIPS on Public Health

Author: Sutapa Jana , 3rd Year student of RGSOIPL, IIT-Kharagpur.

       

Health is one of the basic fundamental needs of all human beings. Health policies encompass a number of elements, from prevention to cure and access to drugs.[1] Access is now defined by both availability and affordability which clearly establishes the economic link between this “access” and poverty.

The scenario of HIV/AIDS in the African continent clearly illustrates this relationship. The epidemic which is going on ruining countries has brought in limelight the utterly inhuman face of the Multi National Companies (MNCs), as they continued to sell the drugs to treat HIV-AIDS at 20-50 times their actual cost by seeking shelter under laws mandated by the TRIPS agreement. A kind of relief was given to those deprived people when the Indian companies like Cipla offered these drugs at very low prices by March 2001.

This has been the spark for an upsurge in the public opinion against the ruthless practices of MNCs, questioning the rationale of TRIPS, particularly in public health. These developments ultimately resulted in the Doha Declaration on TRIPS Agreement and Public Health (November 2001) seeking to limit, to some extent, the damage done by the TRIPS agreement and its underlying philosophy.[2]

The Doha Declaration does not open new avenues within TRIPS but confirms the legitimacy of measures seeking to use to the largest extent possible the in-built flexibility found in TRIPS. This emphasizes that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health and reaffirms the rights of Members to fully use the flexibilities available in the TRIPS Agreement for this purpose. The TRIPS Agreement has to be interpreted in a manner which is supportive to safeguard the public health of Member countries and to promote access to medicines to all ("interpreted and implemented in a manner supportive of WTO members right to protect public health and, in particular, to promote access to medicines for all" ). In other words, the declaration does not open new avenues within TRIPS but confirms the legitimacy of measures seeking to use to the largest extent possible the in-built flexibility found in TRIPS.

It also clarified the provisions for the flexibilities granted under TRIPS, i.e. Compulsory licensing. Compulsory licensing has long been used as a tool to regulate the exclusive rights conferred by patents. In the case of health, the rationale is to make sure that the existence of a patent does not create a situation where a protected medicine is not available to the public because of non-health related factors. The Patents Act, 1970 provided an elaborate regime that included both compulsory licenses and licenses of right. The TRIPS Agreement has not explicitly mentioned the word compulsory licensing but that does not mean it has done away with the notion of compulsory licenses but provides a more restrictive framework than the current regime in force in India. It explained that each member has the right to grant compulsory licenses and has the discretion to determine the grounds upon which such licenses are to be given. The recognition in the Doha Declaration that TRIPS member-states can use the flexibility provided in the agreement and can, thus be understood in the context of a generally increasingly restrictive international patent regime. It was also mentioned that compulsory licenses can be issued for importation as well as for domestic production.

In regard to exhaustion of IPRs, the Declaration has clearly mentioned that each Member is free to establish its own regime without challenge if they are subject to provisions of TRIPS, prohibiting discrimination on the basis of nationality of the right holder. In the declaration it was reaffirmed that the developed countries are committed to the provisions of providing incentives to their enterprises and institutions to promote technology transfer to LDCs under Article 66.2 of TRIPS.

The declaration has been hailed as a giant leap in the direction for making the TRIPS Agreement more responsive to the needs of developing countries and more specifically to the individuals who are unable to afford the cost of patented drugs. In fact, it tries to address a number of important issues related to the implementation of medical patents. However, it fails to take up the much more fundamental questions of the scope of patentability and the duration of patents in the health sector. The Doha Declaration acts an important instrument in India for two main reasons. Firstly, at a political level, India was among the most vocal and one of the leading developing countries at the ministerial conference in putting forward developing Countries' interests. Secondly, the declaration was adopted while the joint committee of Parliament was finalizing its report.

The major goals identified in this millennium which are of immense importance include reducing poverty and hunger, improving health and education and ensuring environmental sustainability. There has been arguments in favor as well as  against the implementation of  IPR regime. Some strongly recommend the implementation of IPRs will reduce the poverty by stimulating economic growth. As protection for new innovation increases this will in turn increase the production calling for both domestic and foreign investment which will ultimately lead to availability of medicines to combat diseases. People who vehemently oppose this argue that it stimulates innovation to only a limited extent, on the other hand developed countries use it as a tool to ouster the domestic competitors from the market and encourage importing of medicines instead of manufacturing which in turn increases the price of essential drugs. 

Hence, even if those drugs are available they are beyond the reach of the destitute.  IP rights are not conferred to only attain profits but also to provide affordable health care for long term. Such rights must therefore be closely monitored to ensure that they do actually promote healthcare objectives and, above all, should not act as barrier in promoting access to healthcare.

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[1] Prachi Pallavi; Patent Regime and Right to Health: National and International Perspective; : http://www.legalservicesindia.com/articles/pg.htm

[2] Prachi Pallavi; Patent Regime and Right to Health: National and International Perspective; http://www.legalservicesindia.com/articles/pg.htm

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