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Type: SC Judgements


[op-ed snap] The expanding universe of IP

Context:

  • April 26 is World Intellectual Property (IP) day
  • Over the years, global IP standards have steadily expanded beyond WTO requirements
  • This is because of free trade agreements such as the Regional Comprehensive Economic Partnership (RCEP) which India is currently negotiating with its trading partners

Expanding IP:

  • Data exclusivity is exclusivity over clinical trial data submitted by drug companies to the regulatory authorities for market approval, the grant of which could severely undermine access to medicines
  • The propensity to expand the universe of IP is not new
  • Businesses have demanded patent protection for the way they do business
  • Motorcycle manufacturers have got into dispute over the trademark on the exhaust sound of motorcycles
  • Animal activists have fought for copyright in a selfie taken by a monkey
  • IP in the modern world defies definition, transcends boundaries and has become synonymous with ascribing value to things that we don’t fully understand

Why data exclusivity?

  • The issue of whether India should offer data exclusivity — one of the key issues discussed in the RCEP — is tied to our understanding of what amounts to IP and whether we are obliged to protect it
  • Data exclusivity prevents drug regulators from referring to or relying on data submitted by an originator company relating to a drug’s safety and efficacy while approving bioequivalent versions of the same drug, i.e. therapeutically equivalent generics and biosimilars for a fixed period of time
  • A drug that comes to the market for the first time undergoes extensive preclinical and clinical trials on animals initially and human beings later before it is introduced for public use — a time-consuming and expensive process
  • Developed countries, on behalf of their pharmaceutical lobbies, seek data exclusivity in developing countries arguing that this is necessary to recognise and incentivise the efforts put in to bring a new drug to the market along with recovering the research and development costs incurred
  • However, such exclusivity would prevent market entry of generic versions of the drug, which could be detrimental to the larger public interest

Pharma companies:

  • Pharmaceutical companies have been pushing for data exclusivity to prolong already existing monopoly and delay competition from generics even after the expiry of the 20-year patent term or to gain exclusivity on non- patented drugs
  • In India, such a system may negate the impact of Section 3(d) of the Patents Act, which disallows evergreening patents
  • With data exclusivity, a company could nevertheless gain exclusive rights over such drugs even though they are not patented

Benefits of exclusivity:

  • During the period of exclusivity, regulators are barred from using the originators’ data to grant marketing approval to generics
  • Generic companies would then be required to repeat the entire cycle of clinical trials already conducted instead of merely establishing bioequivalence to prove efficacy
  • As seen in countries where data exclusivity is granted, generic companies do not undertake such clinical trials and their versions of the drug accordingly stay off the market as long as the period of data exclusivity lasts
  • With restricted market entry of generics, artificially high drug prices remain which puts medicines beyond public reach
  • Unlike in the West, India does not offer data exclusivity and allows bioequivalent generics to be registered based on, among other things, trial data available in the public domain

Test data as a public good:

  • The argument that clinical trial data needs exclusivity in the light of the money expended is an untenable one
  • Automotive companies spend millions of dollars on data generated in car crash tests to ensure passenger and pedestrian safety
  • Automotive companies have not made any proprietary claim on the data generated
  • Unlike automotive companies which use crash test dummies, pharmaceutical companies that test their drugs on human subjects have a greater obligation to make the data public and IP-free
  • The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) does not mandate data exclusivity
  • Providing data exclusivity is a TRIPS-plus measure IP-like protection to data exclusivity is not advisable:
  • First, it is an absolute protection granted without any institutional check such as opposition and revocation as available in other forms of IP and ends up as an irrevocable exclusivity to the originator
  • Second, the U.S. Supreme Court in Mayo v. Prometheus, 132 S. Ct. 1289 (2012) has excluded patent protection to biological correlations, terming it as an extension of natural laws
  • Extending IP-like protection to clinical observations will open a window to claim exclusivity in a subject matter traditionally excluded under patent law
  • Third, offering IP-like exclusivity solely on the basis of money spent in regulatory testing will set a bad precedent for other industries that may now claim an IP when there is none

Can’t ban MPs from other professions: SC

Note4students: Note the arguments by petitioner and the SC. Can be used in mains. As a conflict of interest point it can be used in GS2 (governance etc) or GS4 (ethics) papers.


Petition:

  • Beedi or liquor barons eventually become MPs and sit on committees to influence the destiny of their businesses and this is a serious conflict of interest
  • Many legislators who doubled up as advocates were even retainers of big corporate bodies’ entities
  • It thus giving rise to a situation of conflict of interest between their constitutional duties as legislator and lawyer meant to vouchsafe the private interests of their clients
  • The restriction imposed on public servants and judges against engaging in other professions should apply to lawmakers
  • With 543 Lok Sabha MPs representing more than 1.3 billion people, a Member of Parliament on an average represents more than 2.25 million people
  • Similarly, a Rajya Sabha MP is the voice of his State in Parliament and, as such, has a very important role in our federal political system
  • The primary role of an MP is as a legislatorThus, MPs must attend Parliament every day and dedicate themselves full-time for the welfare of people
  • SC verdict: Found no merit in a petition to ban legislators from practising other professions, especially law
  • There are doctors who became IAS officials and engineers who are diplomats
  • Petitioner has a valid point, but the court cannot not frame policies

 

Citizenship and related issues Constitution

National anthem must be played before screening of films: Supreme Court

  1. What: The SC has ordered all cinema halls across the country to play the national anthem before the screening of films
  2. It said that all present must “stand up in respect” till the anthem ended
  3. Furthermore, it said the practice would “instill a feeling within one a sense of committed patriotism and nationalism”
  4. Cinema halls should also display the national flag on screen when the anthem is played
  5. The Bench said it is the duty of every person to show respect when the national anthem is played or recited or sung under the Prevention of Insults to National Honour Act of 1951
  6. In its interim order, the SC issued a complete ban on the commercial exploitation of the national anthem and the flag
  7. It banned dramatisation of the anthem or it to be used in any part of any variety shows or for entertainment purposes
  8. The court banned the display of the national anthem on any undesirable or disgraceful places
  9. It also banned the display, recitation or use of the abridged version of the national anthem
  10. The SC was hearing a plea to clarify when the national anthem should be sung
  11. Background: The SC’s decision to consider this PIL followed after a wheelchair-bound man was assaulted by a couple at a cinema hall in Panaji for not standing up during the rendition of the anthem

Back2basics:

The Prevention of Insults to National Honour Act, 1971 is an Act of the Parliament of India which prohibits desecration of or insult to the country’s national symbols, including

  1. The National Flag,
  2. The Constitution,
  3. Indian map and
  4. The National Anthem.

Significant amendments were added in 2003 and 2005, which prohibited many previously common uses of the flag, such as draping it over a podium during a speech, using it as decoration, or incorporating it into clothing designs.

Note4students:

Any SC judgment is important from the mains perspective. Note the judgment down, it will be useful for questions on patriotism, nationalism etc.

Lodha committee’s recommendations on the BCCI Governance

Appoint Pillai as BCCI observer, Lodha panel tells SC

  1. Who: Former CJI R.M. Lodha-led SC committee
  2. What: It reiterated its recommendation to remove office-bearers who are 70 years old
  3. And also Ministers and those who have already served at the Board’s helm for nine years
  4. This was its third report filed in the apex court, and the panel reiterated that the SC had upheld its recommendations in a July 18, 2016 judgment
  5. It said the time has come to implement them so that work on reforming the Board could go ahead
  6. The panel sought the disqualification of the following: BCCI office bearers who are not Indian citizens
  7. Those who hold any office or post in a sports or athletic association or federation apart from cricket
  8. Those declared insolvent or of unsound mind and administrators charged with a crime
Jallikattu Debate Constitution

[op-ed snap] SC declined to review Jallikattu ban

  1. Jallikattu: a popular bull-taming sport held alongside annual harvest festivities in rural Tamil Nadu
  2. A macho sport in which young men demonstrate their valour by pouncing on fleeing bulls
  3. Why banned? Need to prevent cruelty to animals overrides the consideration that conducting the sport was necessary to preserve culture and tradition
  4. The game caused distress and pain to the animals, and led to injuries and occasional fatalities
  5. Cultural and religious significance for Tamil community: Over the years, tradition was kept alive in many villages
  6. This was due to a belief that not conducting jallikattu would invite divine wrath
  7. The court sticks to the stand that it would not allow any cruelty in the name of holding a rural sport
Judicial Appointments Conundrum Post-NJAC Verdict Constitution

SC Collegium refuses to accept govt.’s rejection of 43 names for HC judges

  1. What: The SC Collegium has refused to accept the govt’s rejection of 43 names of the 77 it had hand-picked for judicial appointments in HCs
  2. The SC informed the govt that it had reiterated every one of the 43 names that was sent back by the Centre to the Collegium for re-consideration
  3. Prevalent procedure: If the Collegium reiterates the names sent back to them, the govt is bound to accept them and clear them for appointment as judges
  4. The govt had sent back the names after CJI Thakur told the Centre to send back names in case of any difference of opinion rather than keep the entire process of judicial appointments hanging
NPA Crisis : Major Surgery Needed Finance and Banking

Disclosure of names of big loan defaulters pointless: SC

  1. What: The SC said public disclosure of names of defaulters who owe banks over Rs. 500 crore in bad loans is pointless
  2. Background: The observation from the Bench gains significance as it was on the SC’s order that the govt filed a confidential list of 57 defaulters
  3. These defaulters owe the banks about Rs. 85,000 crore in bad loans
  4. The previous hearings had seen the SC turn the heat on the RBI for expressing reluctance in making public the names of big loan defaulters
  5. It had said the RBI should bring the names of defaulters into the public domain through the Right to Information (RTI) Act
Jallikattu Debate Constitution

Jallikattu ban: SC dismisses T.N. plea

  1. What: The SC dismissed a review petition filed by Tamil Nadu to review a 2014 apex court judgment banning Jallikattu
  2. Why: The Bench said “taming a bull” to perform in an event runs counter to the concept of welfare of the animal
  3. Animal welfare is the basic foundation of the Prevention of Cruelty to Animals Act of 1960
  4. The court threw out Tamil Nadu’s argument that the ban affected the fundamental right to religion under Article 25
  5. Previous judgement: In 2014 the SC had banned Jallikattu after declaring it to be an act of “inherent cruelty”

Supreme Court refuses to stay demonetisation notification

  1. What: The SC refused to stay the November 8 government notification demonetising Rs. 500 and Rs. 1,000 currency
  2. But it asked the Centre to take immediate measures to alleviate the hardships and sufferings of the common man
  3. The Bench asked the Centre to file an affidavit by Nov 25 detailing the various measures it can take to lessen the hardship
  4. The A-G said 3.25 lakh crore in Rs. 500/1000 notes was deposited out of 15 or 16 lakh in circulation. At least, Rs. 10 to 11 lakh crore is expected to come in

Punjab law to stop sharing Ravi, Beas waters illegal: SC III

  1. To implement this notification and for water to flow into the State, Haryana began its construction of SYL Canal
  2. The same year while Punjab delayed it till the early 1980s
  3. An agreement in 1981 saw the States mutually agree to the re-allocation of water, this time taking into consideration the needs of Haryana
  4. The SYL canal was supposed to be completed in the next two years
  5. However, work came to stop after militant attacks on senior canal staffers
  6. In 2002, the SC ordered Punjab to complete the canal in a year, Punjab filed suits and delayed the case
  7. Punjab Assembly responded by passing the 2004 Act, terminating all its obligations under the 1981 Act despite the Supreme Court judgments

Punjab law to stop sharing Ravi, Beas waters illegal: SC II

  1. History: The dispute over the rivers can be traced back to Indus Water Treaty of 1960 between India and Pakistan
  2. It allowed the former “free and unrestricted use” of Ravi, Beas and Sutlej
  3. Subsequently, Haryana was carved out of Punjab through the Punjab Re-organisation Act of 1966
  4. The Centre went on to allot Haryana with 3 M.A.F. quantity of water under a notification issued in March 1976

Punjab law to stop sharing Ravi, Beas waters illegal: SC I

  1. What: The SC declared that Punjab reneged on its promise to share the waters of rivers Ravi and Beas with neighbouring States like Haryana
  2. How: By unilaterally enacting the controversial Punjab Termination of Water Agreements Act of 2004
  3. A 5-judge Constitution Bench gave its opinion on a Presidential Reference made to it twelve years ago questioning the constitutional validity of the Act
  4. Previous judgement: The SC referred to its 2006 Mullaperiyar dam judgment
  5. The SC held that a State Legislative Assembly “cannot through legislation do an act in conflict with the judgment of the highest court which has attained finality”

NDTV India moves SC against ban

  1. What: NDTV India has moved the Supreme Court against the government’s order banning its telecast for a day on November 9
  2. Reason for ban: Its coverage of the Pathankot terror attack
  3. The petition challenges the Constitutional validity of the government order
  4. The channel said that the ban has been widely condemned by journalists and editors

Voter has right to know candidate’s qualification: SC

  1. SC judgment: Every voter has a fundamental right to know the educational qualification of a candidate
  2. Furthermore the candidate has a duty not to lie about his or her academic past
  3. The verdict came on appeals challenging the judgment of the Manipur HC
  4. The HC had declared as “void” the election of Mr. Prithviraj in the 2012 polls for claiming in his nomination papers, had said he was an MBA, which was found to be incorrect
Labour Reforms In India Industries

Lesser wages for equal work is violation of human dignity: SC

  1. SC judgment: It terming the denial of equal pay for equal work to daily wagers, temporary, casual and contractual employees “exploitative enslavement,”
  2. The SC has held that they should be paid at par with regular employees doing the same job as them
  3. Such classifications resulting in disparity and denial of the principle of “equal pay for equal work” is esseantially oppressive, suppressive and coercive conduct by employers
  4. It is also antithetical to the ideal of a Welfare State
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