SCIENCE, TECHNOLOGY & LAW: REVISION NOTES

UNIT I: INTRODUCTION TO STL

Science has to be understood from a legal parameter- consider aspects like subject for regulation-
a definition which can be understood without prior scientific knowledge is necessary- science as a
stream adds knowledge- people want to generate and use while facilitating creation and regulating
its use.
1. What is Science and Technology and relation with Law
Not necessarily means creating something new- new ways of using existing knowledge also counts-
Intellectual Property Law comes in to protect these new ways- creates monopoly which can only
be surpassed by licensing- brings in commercial law- if there are environmental effects-
environment law. Essentially lookout for two things- creation (science handles this) and use
(regulated by law, different statutes based on use).
2. Law’s perception of STL
As accumulation, creation, generation and use of knowledge- technology viewed as the method or
process for addressing scientific problems by applying scientific knowledge- this knowledge not
general in nature- has to be specific to the issue- only specific utility and purpose part of
technology- general knowledge is excluded. Lookout for- specificity.
Adding the two- STL Law deals with the facilitation and controlling of the use and application of
scientific knowledge. Science (knowledge) + Technology (Application)= Law (Regulation).
3. Materialisation of Law
Law is an instrument- code of conduct required for a subject- this code can be with or without
sanctions- policy steps in to arrive at the law- can have several approaches- prohibition, regulation,
affirmation, promotion etc.- leads to a multi-model policy framework- has an impact on how the
law looks like- for instance LPG in 90s led to policy being more aligned with LPG- led to law
reflecting the same. Another instance- Brazil and India are biological pools- approach and policy
to the same reflects this position- US and Japan don’t have the same stance. Therefore- approach
to law- depend on traditional background, geographical and geological background.
4. Scope of Governance through Law
Includes protection, prohibition and regulation- job to ensure overall governance- establish a
system for protection, prohibition and regulation. Regulation, protection or prohibition in silos
may not have a system- but in total governance is always happening- brings in the aspect of
conscience and consciousness- Conscience is the ability to be aware of one’s surrounding-
Conscience is being able to distinguish between morally correct and incorrect.

UNIT II: INFORMATION TECHNOLOGY LAW

1. Introduction
Various legal issues come up in IT sector- reliability of information, privacy, liability, use of
technology to commit violations- need to regulate the same to ensure no violation of rights
happens.
Criminal aspect important as well- misuse is common- need for laws for regulating and governance
of the same- this is often divided into smaller ambits (all falling under Science and Technology)-
common legal issues will be identified for science and tech generally and then specifically for each
ambit- each smaller ambit governed according to its specifics.

2. Intellectual Property Aspects of Information Technology

Concerns protection of knowledge developed and its application to solve issues (for example
patents in medical fields being protected)- key legal issues in this domain include:
a) IP Protection: In science and technology- just being novel and innovative and not enough
for protection- has to have commercial value (applicable in real life)- should have market
demand, utility and application- commercial merit along with scientific merit- TRIPS
covers trade related aspects- Paris Convention for industrial property- what about
copyright- unclear if media industry qualified as an industry under Paris convention- Berne
Convention came up to protect media- earlier it had no commercial value- today it does.
b) Relevant IP regime: An overlap of various laws comes into play- let’s consider one piece
of data- would be generally protected under Digital Data Protection Act- if a new way to
utilise the data comes up- covered by patent- specific aspects may be protected by
copyright- list carries on- is then a hierarchy then- patent generally considered the most
important- grants a time-bound monopoly- a step ahead of the rest of the protections and
protects the product as a whole.
c) Digital Sources: Trademark jumps in here- protects domain names and shit- protects
goodwill- regulates usage of digital identity- while patent and copyright is protective in
nature- trademark is regulatory in nature.
IP laws in different forms- offer different sort of protections- identification of the right law
necessary. Refer this table below:
IP Sector Protection Criteria
Patent Provides a monopoly- protects both the Novelty-Inventive-Utility.
product and the process. (Fuck Ordre Public)
Copyright A wide range of fixated works covered- Originality, Fixation.
forms of media- remember animazum
classes.
Trademark Protects goodwill- indicators of a business. Distinctiveness (from all 5
biological senses).
Industrial Design Shape, Pattern, Configuration etc- outlook Novelty, originality and
protected- not the article itself. distinctiveness.
Semiconductors Semiconductor, topography- purely for IT Novelty, originality and
and electronic sector. distinctiveness.
GI 3 products- Natural Products, Unique, coming from one
Manufacturing Products and Agricultural specific geographical area.
Products.
Plant Variety Plant Variety- farmer variety- derived Novel, originality,
variety- extent variety distinctiveness and uniformity
of features over years.
Trade Sectors Sensitive, commercially viable information. Kept it secret- made every
attempt to maintain secrecy-
 commercial value and demand
in market.

Patents and IT
Two different components of IT warrant discussion:
a) Physical elements: Visible components- considered as an equipment- hardware- patented
as electronic gadgets.
b) Non-physical elements: software- jurisprudence started in US- software used to derive
performance- mix of math algorithms and binary language- neither are patentable in US
or India- under Sales of Good- it is only the license to use the product which is being sold.
Case Laws: Parker v. Fluke, Groctschel v. Penson, In Re Toma, Diamond v. Dier, State Bank
Trust Company, Arrythrima Technologies.1

Copyright and IT
Codes of computer programs covered as literary work- can be in form of sound recordings-
pictorial representation etc.- covered as per the requirements of copyright Act (Animazum
requirements fixation, literary work and original). In India, computer program/software is eligible
for copyright protection since literary work as per definition.
Case Laws: Apple Computers, Wheelan Associates, Sony Corporations.

IT and Semiconductors
The beginning of any semiconductor would be covered by Copyright since in design stage- would
qualify as artistic work- once the design applied on a specific device- covered by Semiconductor
Act- inner layout covered only- outer layer covered by General Design Act.
Started out in the UK- decided to go beyond just copyright to protect innovations in computer
technology (specifically internal components)- involve not only literary and artistic work- actual
layout has got a specific function- patent also comes in- therefore better to have a specific
mechanism for semiconductors.
The Semiconductor Integrated Circuits Layout Design Act 2000:
a) Came in force in 2014
b) Protection of semiconductors for 10 years (had to be lesser than patent)
c) Requirements: Novel, original and distinctive (has to be distinct from the rest of the
products in the market).
d) Design could be renewed after a period of 10 years.
Case Laws: British Highland, Broo Tree v. A.M.D.

Trademark and IP
Trademark protects the bridge between the producer, seller and the consumer- essentially your
goodwill- for IT- this would mean elements that are accessible to all and used by the public- a
website or webpage- titles- domain name- ensures no other person can copy your domain name
and ergo your goodwill- trademark can be extended to cover physically registered trademarks being
used to in the online domain. Keep in mind, misuse of trademark is a civil wrong but counterfeiting
is a criminal offense.

1 Refer the case list for all case laws mentioned.

Question of how to regulate online domain names and trademarks continues to be a common
theme throughout the cases- S.79 of IT Act comes in regulating the content published on the
websites- makes OSP and ISP responsible.
Case Laws: Toppen v. Panavision, Yahoo v. Akash Arora, Rediff.com v. [Link], Satyam
Computers v. Siffy Net, Mutual [Link] v. Mutual [Link].

3. IT and Criminal Law

Criminal concerns under the IT Act- S.65 to S.74- talks about cybercrimes- digital crimes,
electronic crimes etc.- new criminal laws also make reference of the same- digital evidence also
becomes a relevant consideration- procedural requirements applicable to digital evidence also
applies to digital evidence- keep in mind only crimes with the aid and assistance of IT would be
covered.
S.66- covers acts such as cybercrimes- cyber theft- tampering with electronic evidence- if against
public order- intention is purely irrelevant under S.66. S.67- obscenity through the electronic
format.
The IT Act is an outcome of long series of deliberations-international law adopted a model law on
e-commerce- IT Act on the lines of this- extended the ambit beyond e-commerce to crimes etc.
Case Laws: Shreya Singhal v. UOI, State of Tamil Nadu v. Prakash, [Link] Case, Super
Cassettes Case.

UNIT III: ARTIFICIAL INTELLIGENCE

1. Introduction
Machine’s art of intelligence-acts like an artist while learning things on its own- increases its
knowledge base- initial design by humans- further evolution by its own- does the same things that
humans do but better- increased efficiency, time management and accuracy- generates knowledge
on its own based on context provided- lack of emotional quotient.
AI Regulation hinges on the fact that they do human functions without possessing this key
emotional quotient- has to be determined if AI is a program, machine or set of instruments- who
will have the rights to the products created by the AI- AI or the creator of the AI? These are some
considerations of AI
2. Personhood of Artificial Intelligence
One interesting aspect here- while all biological persons are legal persons, with the advent of AI,
the same cannot be held vice versa- how will law treat AI? What kind of an entity would it be?
Corporations are already treated as legal persons without having any biological life- this shows an
expansion in the understanding of legal person from the initial notion of a biological person- also
shows that the definition of person has also expanded- question is whether AI can also be clubbed
together with corporations and thereby be treated as persons- key difference between a company
and AI is that AI is artificial while a company has a fictitious presence- AI runs on its own unlike
a company- better than a person in that circumstance- liability could also be imposed on AI in
such a case- granting of legal status of robot Sofia in Saudi- the AI can now enter into contracts,
have IP rights etc- this means all rights that a legal person is entitled to can also now be extended
to AI.
The key consideration then becomes is- where the does the liability of the coder end and where
does the AI’s liability start? Law of torts would use strict, absolute and vicarious liability to fix
liability- concept laid down in Ryland v. Fletcher of strict liability would also extend to AI- third-
party damage due to a non-natural use- the absence of regulations also allows courts to have a
larger playing field with respect to liability- the status of AI would be the deciding factor for
liability- in case of strict liability who will it be pinned on is still vague.
Liability imposed by EU, USA and Saudi has been different- Saudi used strict liability imposed on
the AI- EU used vicarious liability due to the negligence of the one who crafted the AI and failed
to do their share of due diligence in the development of the AI- US used strict joint liability.
S.72 IT Act- falls within the definition of a “Digital Article Running in digital codes”- when AI
does something wrong- could be attributed to wrong calculations- scope for 72 to be altered in a
manner to cover misuse of info.
Case Laws: Ryland v. Fletcher, Donoghue v. Stevenson.

2. Human Rights, IP and Tax Issues with AI

Can AI violate Human rights? This aspect has to focus both on racial discrimination in US and
violation of privacy in India- US, issue of AI being used to perpetrate racial discrimination- AI
found to be biased against black folks based on the information provided- this is because open
source being relied upon by AI which contains information that tends to favour one section-
contains habitual offenders of specific group (often blacks)- invariably affects the functioning of
the AI- data not actually being created by AI but just mined by AI- to prove actual racial bias-
would have to be shown that the creator fed the AI racially biased set of data- since AI is often
self-generating- open source is to be blamed- reliance on AI in policing and judiciary would lead
to discrimination due to its reliance on open source- reliance on AI in such key areas has to be
reduced.
What about Privacy- the fact that one is always connected to the internet- means always under
surveillance- violated privacy which is a fundamental right- AI tracks preferences, nature, needs
etc.- guidelines are a must to ensure that privacy is protected.

IP and AI
Who shall own the IP rights to an AI- one who makes the AI- in such a case, if AI makes
something, who would the creator- one who crafted the AI or the AI itself- any difference if the
AI is self-generative?
Reference point- Sofia from Saudi- legal status- therefore can hold IP rights- India’s IP laws do
not have an explicit bar on machine learning and becoming inventors- since the machine has been
developed by a person- both AI and the inventor can be given joint IP rights- same way they can
be held jointly liable for any damages- IP rights would then hinge on approach taken by individua
states- India has a lack of jurisprudential development on the matter- therefore cannot conclusively
comment at this stage about the IP rights of AI.

Tax and AI
Can tax be imposed on AI- again the status of AI would come into play- US currently developing
some principles for global tax assessment of AI- if AI taxed as a corporation earning money- or
would the creator get taxed on behalf of the AI- or would they be jointly taxed- also currently
unclear- not enough developments.
 UNIT IV: SPACE LAW

1. Introduction
“Common Heritage of Mankind”- space falls within the ambit of this- it is not a common property
everyone has access no- for betterment of common heritage no one tries to use it- another example
is high seas- areas beyond 200 nautical miles where no one exercises control- nations only enjoy
control over their air space till a certain extent- no state can control space- keep in mind focus is
on outer space and not aviation laws- the benefits should be available for mass distribution and
no misuse should be allowed- no one can enjoy a monopoly over space- commercialisation of
space has commenced though- satellites of states as well as private players being sent- Space
Activities Bill, 2022 allows private players to operate in India- marks a departure from common
heritage.
Space Research Activities Bill- focuses on four main aspects- International aspect of space law- IP
aspect of space law (let’s say a satellite has been manufactured in one country and launched from
another while signals sent to a third country and the satellite makes some innovation- whose IP
laws will apply?)- commercialisation of space law- liability in case of space debris.
Licensing also plays a crucial role here- use of government launch pads for private satellites- private
players would be licensees of the government.
Case Law: Doordarshan v. BCCI

2. Issues and Challenges of Copyright in relation to Space Law

The main focus here is copyright of satellites and signals- right now TRIPS dictates a lot of it- two
main doctrines come into play here- Doctrine of Territoriality and Doctrine of Exclusive Use-
Understand the two in terms of utilisation of resources- one has the freedom to use and access
resources of the outer space- however, this comes with the obligation that it cannot be exploited
for one’s individual gains- some view this as a hindrance to the creation of IP- goes against Locke’s
labour theory which requires appropriation of a property for creation of a IP- but appropriation
for one’s gain is forbidden.
Copyright could be used for outer space- this is contingent on it not being used as a source but as
a medium to generate resources- for instance using a satellite in space (space being the source) to
enable broadcasting and remote sensing (being the resource). Data in general would not be eligible
for protection- the final product after processing of the data (the weather report) could be
protected- two forms of data emerge- raw data and final processed data.
Remote Data Sensing Policy, 2020- data created by a satellite- ownership would be with the
government of the organisation- to access this data consent will have to be taken from the
government by the third party [Self note: kinda goes against the whole aspect that data cannot be
monopolised].
Case Study: Direct Broadcasting Satellite- Two stations- one to send the signal0 one to receive and
broadcast on out devices- broadcasted content protect under IP laws (since it is final processed
data).
Case Law: EBC v. DB Modak

2. International Law’s stance on regulation of space

Following treaties of importance:
 a) Outer Space Treaty, 1967: Constitution of International Space Law framework- ICJ enjoys
exclusive jurisdiction over any disputes pertaining to the outer space- recognises space
activism and acknowledges that spaces disputes can be adjudicated by the ICJ- recognises
space exploration by nations considering space as a common heritage of mankind-
recognises peaceful use of space- principle of Peaceful use of space- talks about the
importance of maintaining peace and normalcy among states when they are into space
exploration- emphasises that space has to be used in a peaceful manner.
b) Rescue Convention, 1968: Facilitates the safe return of astronauts from space- inclusive of
space objects and shuttles- states did not care what happened once the satellite was
launched- equally important to take care of return- where would it land- how would it stay
etc.- satellites should not be left around to roam in space once they accomplish their
purpose like debris- technology to help them return- any astronaut sent out for research
has to be returned back to Earth safe and sound.
c) Registration Convention, 1975: Talks about registration of space objections- UN has to be
informed- requires disclosures and details- does not matter if public or private entity
launching it- space centre from where it being launched has to furnish this information-
helps decide liability in case of mishaps.
d) Liability Convention, 1972: Talks about two types of liabilities for states venturing into
space- whichever nation is sending the satellite- whoever owns the satellite- whose purpose
the satellite is serving would be liable for consequences- At the same time, liability will only
be imposed when any damage caused (to not deter corporate entities from entering this
domain thereby promoting commercialisation)- no pre-fixation of liability- once you
inform UN about entering space- you are liable for the damage- acceptance of the liability
is a choice for nations (lmaoooooo).
e) Moon Agreement, 1979: Moon is an identified natural satellite- regulates space activities
on moon- Moon is of common heritage of mankind and therefore space exploration of
moon has to be done in a peaceful manner without damaging its heritage.

4. Indian Law
ISRO biggest player- recently private players have also come in- Govt. brought a legislation to
allow the use of Geo-Spatial data- info collected from satellites orbiting space- collected by the
receiving station and broadcasted- Geo-Spatial Data Regulation Act, 2021- Once Doordarshan v.
BCCI happened, private players jumped in and started using the Act- emphasises that data cannot
be used in a manner that cause privacy violations, public disturbance etc.
Remote Sensing Data Policy, 2011: Sensing data from a remote region- primarily used for weather
forecasts- also allows scientists to understand what is inside a celestial body without digging- this
policy dealt with the disclosure of such information.
Govt. of India has already recognised Space Exploration Activities Bill for private players-
reintroduced in 2023- yet to be passed- would be restricted to social welfare purposes but
commercial enterprising based on specific business of private parties.
Indian Space Policy of 2023: Promotes entrepreneurship in space exploration and research for
both public and private- government no longer enjoys a monopoly over space exploration.
Highlights how we have moved past “Common Heritage of Mankind” to “Common Platform of
Commercial Entrepreneurship”
5. Science, Technology and Law vis-à-vis Space Law
Principles of torts may become relevant in determining liability. Ryland v. Fletcher and strict
liability will apply since non-natural objects are being sent out- if cause mischief Liability
Convention kicks in and liability would be decided- while pre-fixation is not allowed questions of
the cause behind the damage become very important- if one launched satellite comes in way of
the other causing a clash- liability becomes particularly tricky to determine- factors like act of god,
change in climate would then find place.
There is a need for specific liability for space law- common liability fixed for all the Common
Heritage of Mankind does not fit into various specific situations- especially space- control is
required to fix liability- but in absence of this control- it becomes very difficult.
Another important factor for liability- it is not determined on the basis of the damage in space but
in terms of damage to Earth- if a satellite from a nation crashes and damages another nation- the
satellite manufacturers, controllers would be held liable for the damage and the fixation of liability
would happen accordingly- this is a commercially drive liability fixation.

UNIT V: FINANCIAL TECHNOLOGY LAW (FINTECH)

Currency a tool for value exchange- traditionally currency has always been in the physical form-
digital currency has emerged- crypto- unlike traditional money- digital money and crypto’s value
denomination does not remain stable (1 rupee will always be 1 rupee in India not true for digital
currency)- varies from time to time- valuation is not determined from when one paid for the
currency- current value- Negotiable Instrument Act would apply.
Digital Currency is now seen as a lucrative investment- once that is done it becomes a stock and
thereby something in lieu of money- NIA applies- RBI grants licences to deal with digital
cryptocurrency- RBI’s guidelines which apply very strictly to banks (to protect the consumer) do
not apply similarly to NBFCs- means crypto is safe from stringent RBI regulations- calls for new
regulations to be made- Copyright also gets involved- face of the crypto is made via coding and
algorithm.
Digital currency comes with a very high amount of authentication and security as compared to
physical currency- can be used to purchase further stocks- reputation and goodwill also has an
impact on the crypto when introduced- often not true for physical currency.
Digital Money Lending Guidelines- RBI- if not lending but only taking and investing it in stocks-
guidelines won’t apply- only entities lending crypto would be covered under DMLG- Crypto and
Digital Currency Bill, 2021 never became a reality.
Since digital currency is not issued by the state- legality is always in question- traditional money
always issued by the state- no need for identity- no KYC- no one-on-one interactions like in banks
while issuing currency- no stringent documentation requirements- Prevention of Money
Laundering Act’s restriction of deposit of money does not apply to crypto- gives digital money a
very large playground.
RBI banned crypto in 2018- challenged in SC- held that such a blanket ban cannot be imposed-
counts as a restriction on trade and profession since crypto is a tradable commodity and a stock-
ban was lifted in 2020 and crypto was held to be legal tender- once this was done- fell right within
the ambit of the Banking Act- now can be taxed under the Income Tax Act as well.
Case Law: Internet and Mobile Networks v. RBI
 UNIT VI: BIO-TECHONOLOGY
1. Introduction
Combination of Bios and Technology- application of knowledge on bios and with reference to
life- also known as bios-engineering- most common development is the engineering of life- not
only construction of new things but modifying existing living beings- does not cover alterations
made in between life cycles- changes made at the zygote level covered- Biotech concerned only to
the extent of gestation period of bios and not beyond- it is inherently commercial in nature and
laws required to regulate- it does not have to be intra species can be inter species too- US scientists
developed half human half monkey.
Bio-chemicals have started being commercialised by pharma- used to develop medicines-
commercialisation kicks in when biotech is able to draw more yield from existing organisms- this
is not a quick process- takes generations- for instance Louis Pasture observed how bacteria in bios
could be used to develop cheese and yogurt.
There exists a hierarchy in organisms based of their biology- lowest form of life is micro-organisms
highest is humans- the lack of ability to think and feel makes humans higher ranking- initial biotech
was around the lowest life forms- use of micro-organisms for curd, bread etc.- next gen was around
life lower than humans but higher than micro-organisms- stem culture, cell culture etc.- helped
commercialise agriculture by introducing new tech- third gen was around the highest life forms-
in case of animals it focused on milk, meat production and also on increasing efficiency-
hybridisation brought in to commercialise animal husbandry- in case of humans it was altering of
genetic identity-fingerprints, DNA etc- ethics and morality become a large part of this aspect since
public interest comes in.
2. Applications of Bio-Technology
Commercial application depends on organism- biotech policy is more specific and beyond general
science policy- majorly applications have some utility in industries- not necessarily true for all-
biggest chunks of industry application is in medical and food industry- therefore, law and policy
came in to regulate these two sectors in addition to general law.
Agriculture sector: botanical research led to organic and inorganic farming- pesticides, insecticides
also came into the picture- inorganic method allowed for a quicker and more efficient farming
process- at the same time, the makeup of a plant was also changed internally- genetic engineering
led to transformation- this change was at the single cell stage- cannot happen at the seed level-
gave better results without any adverse impact- genetic revolution of agriculture- no public interest
concerns since harm was not being done to the public through this.
Medicine and Pharma Sector: use of bio-tech to treat genetic and hereditary diseases- correction
of gene- furthered right to health- usage of bio-chemicals to improve drugs-insulin to aid diabetic
patients was a. product of usage of bio-chemicals- large change in the industry due to this.
3. Legal Implications
5 Major implications to take note of:
Concern of dealing with Bios: raw material in biotech is bios (life)- biological diversity law exists-
Convention on Biological Diversity- establishes sovereign rights over biological resources present
in any state- consent required to use biological resources of any state- half of the benefits arising
from the usage has to be shared with the local community that conserved the biology.
India has two main biological pools- Western and Eastern Ghats- enough resources to aid
commercialisation- America came up with their version of basmati rice (Textmati) through this-
through genetic engineering it was made possible to increase the length of the grain, change in
aroma and less water during growth- claim of bio-piracy came up in the light of this- WTO verdict
led to the introduction of Biodiversity Act and the GI Act.
Keep in mind no patent over elements claimable by everyone can be allowed- a transformative
usage of the same would only be patentable- neem and turmeric as examples- any usage of the
same would-be bio-prospecting- since the usage would always stem back to India- product of
India’s naturally bestowed biological resource- permission has to be taken and profits have to be
shared.
Genetically Modified Organisms
Since aim is to commercialise in biotech- IP laws come in again to decide if something is entitled
to protection if it is creative, novel and innovative- a new organism which may be commercially
viable- patent, copyright etc. comes in here.
Copyright law talks about creativity- DNA sequences would be considered literary work in
scientific language- US granted copyright protection to DNA sequences in 2012- since there is a
re-compilation of DNA sequences from the existing knowledge so it is copyrightable.
For the most bit- biotech protection is offered by Patent Law- long series of cases dealing with
patent of genetically modified organisms. In Humans- genetic modification can only be done for
public or health purposes- DNA and genes have to be identified in such a manner that could help
achieve this.
Case Law: India v. USA, Diamond v. Chakraborty, Genetech v. Poly Peptide, Pioneer Hibbert
(Plants), Plant Genetic Systems, Ex Parte Allen, Harvard Onco Mouse, In Re Bel, Biogen v.
Medeva, Pioneet Hibbert Int. (Humans), Dominico v. Patent Controller, Novartis v. UOI.

4. Trade and Environment Law and Biotech

WTO’s establishment led to formal rules for trade law- biotech is a part of trade law- acknowledged
there are certain risks associated with this- safety mechanisms were required to ensure natural
environment is not destroyed- ensure that genetically modified products do not affect the health
of the people- environment and trade law have to be put together to ensure this- environment law
will have to ensure that biodiversity is preserved- A.20 of FATT ensured that safety and health of
environment is maintained.
Technical Barriers to Trade Agreement: establishes the requirement of proper labelling of
products- circulation of information- in India FSSAI requires labelling food on packaging- risk
assessments have to be carried out for two years.
Sanitary and Phyto-Sanitary Measures Agreement- conducting risk assessment in international
state- exporting country has the obligation to do so- liability would be extended past the threshold
of Ryland v. Fletcher.
Case Law: Monarch Butterfly Case, Terminator Technology Case, Beef’s Hormone Case, EC
Biotech Case.

5. Human Rights and Biotech

Two schools of thought- one considers it violation of human rights- other considers it as a
facilitator.
First school: Biotech challenges nature- changing biological genetic structure given by nature-
people have the right to self-integrity and is a part of life and dignity- any change in this is a
violation of right to life- stem cell research facilitating abortions- destroys potential life- organ
cloning has also come in which is a violation of human values.
Second School: Successful research and caters to right to food and right to health- more of a liberal
standpoint as compared to first school.
Indian stance on human rights and Biotech can be understood through cases.
Case Law: Aruna Roudricks v. UOI (in line with first school), Parmanand Katara v. UOI (in
line with second school).

6. Biotech Regulation in India

First legal attempt by govt to regulate was in 1989- Environment Protect Act- GMOs to be used
in a manner that does not impact environment.
DNA Safety Guidelines- while indulging in genetic engineering, safety is important- a case-to-case
basis being followed in India- no umbrella framework.
Bio-Technology Regulatory Authority of India Bill was the first consolidated effort in regulation-
never was passed- we still follow a piece meal basis- DNA proofing bill came in 2007- again has
not been introduced- dealt with crime detection- concern of genetic identity of citizens would be
kept in public domain.
A four-tier regulation system in India- GMO Rules, 1989- Genetic Engineering Approval
Committee, Recombinant DNA Committee, Genetic Manipulation and Bio-Safety Committee-
permission has to be taken when indulging in genetic engineering.

UNIT VII: MEDICINE SCIENCE AND LAW

Discussion surrounding IP- patenting of medical methods, drugs etc and underlying Human rights
concerns- ethics considered as well- liability in case of negligence. Medical Council of India
regulates this field- patient and doctor relation has now become more of a producer and consumer
relation instead of the traditional doctor and patient relationship.
To invoke right to health grounds- look at whether a particular aid qualifies as service or medical
assistance- if it is a service- no argument of right to health- because consumer and contract law
deals with this- for instance services like hair transplant- if assistance- right to health can be
invoked.
MCI introduced- Medical, Professional Ethics and Code of Conduct, 2022- requirement to register
as a doctor individually- if you start a clinic- clinic has to be registered.
Liability of doctors- civil or criminal- covered within the ambit of law of tort- if mens rea present-
criminal law- if negligence and an accident- medical negligence- Jacob Matthew v State of Punjab
opened doors for civil prosecution.
Case Laws: Desai Case, Kusum Sharma v. Vasant Nair, V.P Shanta Case, IMA v. Shanta, P.K
Gandhi v. Bar Association, Keshavam v. Harish Balla, Jacob Matthews v. State of Punjab.

Human rights and IP vis-à-vis Medicine Science and Law

The first aspect deals with Right to Life. Already covered above that right to life includes right to
health- cases bring to light the expanding scope of the right to life.
Second aspect is IP. Patents creating monopoly would be a hindrance in ensuring right to health-
surgical methods cannot be patented in India- US and EU allows this- US allows a more
discretionary stance balanced with public interest- depending upon the circumstances, drugs and
vaccines have been denied patent protection in India- market rights are granted but no monopoly-
balance has to be created between interests- control would ensure that masses aren’t
disadvantaged- another good example is COVID- heavy exports of vaccines without allowing
monopoly.
Case Laws: Aruna Ramchandra Shanbaug case, Bhopal Gas Tragedy Case, Cipla Case.

UNIT VIII: FORENSIC TECHNOLOGY AND LAW

Forensic evidence is only corroborative in nature- cannot be relied upon solely for conviction-
S.27 of Evidence Act provides this- used for crime detection and identification of individuals in
case of disaster- five tools of forensic science- biometrics, finger prints, polygraph, narco-analysis
and DNA brain mapping- biometrics entails retina and iris scanning- first gen of forensic science
was finger prints- second gen more advanced like DNA and brain mapping.
All of this qualifies as personal data- forms a part of A.21 and cannot be used to violate the rights
of person- generally used in the digital platforms- Digital Personal Data Protection Act comes into
play- all of this is a direct aftermath of Puttaswamy- a person’s past and future generations can
also be stored- privacy concerns became very relevant-an offence against the society at large.
Fingerprints: First gen- biological fingerprint- second gen- DNA fingerprinting- storage is in a
digital format so DPDP also applies- the risk of private data becoming accessible to everyone at
large is big concern- initially used as a signature of a person- traditional forensic tools are becoming
less relevant now since crime has also benefitted from the advent in technology- would usage of
finger print in crime detection be self-incrimination- if the accused that knowledge of the
fingerprint being taken then no- if they did not have knowledge then against the principle of self-
incrimination.
Polygraph: Machine measures heartbeat, blood pressure etc while questions are asked- to
determine if a person is lying or not- drug admission does not take place- while lying a particular
enzyme is released which helps detect it.
Narco Analysis: First usage in Telgi case- controversial means of collecting evidence- drug
administered which has sodium in it- neutralises brain function and slows it down- essentially
forces the person to tell the truth- also known as the serum test- here right against self-
incrimination becomes squarely applicable- potential violations of A.21- underlying concerns
makes it a less popular means- a doctor has to be present while the test is carried out along with
the local magistrate for the evidence to be valid.
Brain Mapping: No administration of drugs- brain reaction is mapped- first stage is asking normal
questions to ease the brain- followed by actual questions- reactions to both will be compared- this
can be done multiple times in order to confuse the person being subjected to the test- the reactions
are recorded with audio- harms of this are way lesser than Narco-Analysis-Selvi guidelines applies-
subject has to be informed in advance about the details, purpose, consequence of the test- doctor
has to be present- a family member, friend or advocate has to be present from the accused’s side-
the entire test has to be reduced to writing and given to the subject- they can consent to it, reject
it or object to it.
Case Laws: Kuppuswamy Gounder v. Palaniappan, Badshah Khan v. State of Madhya Pradesh,
Selvi v. State of Karnataka, Telgi Case.
 UNIT IX: NANOTECHNOLOGY LAW

In nanotech- particles are so small they cannot be represented in terms of mini or micro-
engineering at the ultra-microscopic level- not limited to bio-based sciences but physical sciences
too.
Food sector uses nanotech a lot- food and chemicals come into play- chemical and fertilizers has
also depended on nanotech- so three main sectors- agriculture and food- medicine and pharma-
chemical and fertilizers.
Nanotech deals with the alteration and compilation at the ultra-microscopic level- if one can
modify a molecule or come up with a new molecule at this level- entitled to IP protection.
Internationally nanotech is regulated by UN Pharmaceutical Collaborations- asymmetry between
bio and nano-bio only deals with bios and conversion to pharma- nano deals with other aspects
as well- anything under the sun would have its chemical value at which nanotech takes place-
nanotech’s ambit is therefore much wider.
Pharma was initially based on just natural chemicals- with advent in biotech reliance increased on
other developments- these changes partly happen due to nanotech- modifications at the molecular
level.
There is no specific protection for innovation in nanotech- it relies heavily on re-compiling and
recombination- does not meet the innovation threshold- a process patent for devising the method
of alteration of nano tech is the most that can happen- product patents cannot happen- strict
liability will be the applicable standard and Ryland v. Fletcher would apply.

UNIT X: TRANSFER OF TECHNOLOGY

Two means through which technology transfers happens:

On the basis of domain
a) Private: Commercial in nature- between private parties- covered under TRIPS- states
transferring for commercial benefit also falls here.
b) Public: Non-commercial in nature- covered by TRIPS and CBD- public in nature.

Transboundary Transfers- between two states through a contract would be covered by contract
law- between more than two states through multilateral contracts- during COVID multilateral
contracts were facilitated by WHO to transfer vaccines to Africa- public transfer that was non-
commercial- India and SA did not demand IP protection of vaccines.
On the basis of structure
a) Vertical: Same country same industry
b) Horizontal: Same/Different countries- different industries.

Right to Development- CBD states that technology transfer is mandatory where there is a bio-
based transfer- when US made Textmati- had to be transferred to India- TRIPS also has something
to say- if done for a commercial purpose- private companies have no capacity to enter into
contracts- government enters on their behalf and subsidizes cost- for instance COVID vaccines.
Cross Border measures under TRIPS: Talks about cross border transfer recognition and protection
of IP- except in situations when the government can acquire IP rights- compulsory licensing is the
norm. Two ways to go about this:
a) Before the development, government can announce- through a vertical transfer get hands
on it and through a horizontal transfer provide to other countries
b) Compulsory licensing- vertical transfer to the government pharma prospects.
Cross border transfers come with the problem of territoriality of IP- what happens when cross
border transfer is affected when there already exists a protected IP in the home country- one can
only respect the protection and move on- only exception is trademark law that does not have a
territorial application- the other country would have enforced protection given to the IP as well-
the patent would become reciprocally applicable on the same- allows for a smooth transfer-
demanded by TRIPS.
Technology transfer between two private players- no government intervention- licensing and
assignment becomes applicable- international trade law becomes applicable- barriers and risk
assessment tests would have to be carried out- therefore, governing law will be transnational
international law.
The requisites for a cross border technology transfer are:
a) IP has been obtained
b) The country where the technology is being transferred is allowed protection
c) If the party is investing in improving the tech or purchasing it (becomes relevant from an
FDI/FEMA perspective).