Petitioners' Memorial

3RD AACL NATIONAL LEVEL MOOT COURT COMPETITION - 2018
College Code - NMC:331
3RD NATIONAL LEVEL MOOT COURT COMPETITION – 2018
MEMORIAL ON BEHALF OF PETITIONERS
Before
THE HON’BLE SUPREME COURT OF BHARATH
1. Mrs.Sowmya……………..……….……………………………Petitioner-1
2. Pro-Right NGO…………….……...…………………..………Petitioner-2
3. Richie Bio-Tech Research Institute……….………………….Petitioner-3
1. Cradles……………….……………………………………….Respondent-1
2. Florey Research Institute rep by Mr.Raghavan…….……..Respondent-2
3. Santaana Fertility Research Centre………………………...Respondent-3
4. Union of India………………………………………………..Respondent-4
[MEMORIAL ON BEHALF OF PETITIONERS]

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3RD NATIONAL LEVEL MOOT COURT COMPETITION – 2018
MEMORIAL ON BEHALF OF PETITIONERS
TABLE OF CONTENTS_
PARTICULARS Pg. No.
Index of Authorities 3
Constitutions …………………………………………………………………………… 3
Statutes …………………………………………………………………………………. 3
Cases ……………………………………………………………………………………. 4
Books …………………………………………………………………………………… 5
Articles and Journals ………………………………………………………………….. 6
Rules ……………………………………………………………………………………. 6
Lexicons ………………………………………………………………………………… 7
Other Authorities ……………………………………………………………………… 7
List of Abbreviations 9
Statement of Jurisdiction 11
Statement of Facts 12
Issues Presented 15
Summary of Arguments 16
Arguments in Detail 19
Prayer 38

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INDEX OF AUTHORITIES
CONSTITUTIONS
1. The Constitution of India

2. The Constitution of Bharath
(as all laws of RoB are pari materia to India)
STATUTES
1. The Patents Act 1970

2. The Patents (Amendments) Act 2005
3. Biological Diversity Act 2002 an Patenting of Biological Inventions in India
4. Human Fertilization and Embryology Act 1990 [UK]
5. Human Fertilization and Embryology (Amendment)Act 2008 [UK]
6. Stem Cell Laws [EU]
7. Human Rights Act 1993 (With Amendment Act, 2006), NHRC India
8. Indian Penal Code 1860
9. Law of Torts
10. Companies Act 1956
11. Companies(Amendment) Act 2013
12. Indian Limitation Act 1980
13. The Medical Termination of Pregnancy Act 1971 and Rules
14. The Bio-Medical Waste (Management & Handling) Rules 1998
15. The Bio Medical Waste ( Management &Handling) Rules 2016
16. The Drugs & Cosmetics Act 1940
17. The Drugs & Cosmetics (Amendment) Act 2008
18. The Indian Contract Act 1872
19. Consumer Protection Act 1986 & Medical Profession
20. The Indian Medical Council Act 1956 and (Amendment) Act 2010
21. Monopoly and Restrictive Trade Policies Act 1970
22. The competition Act 2002

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CASES
1. Consumer Education and Research Centre v. Union of India 1995 AIR 922, 1995 SCC (3)
42
2. Mid Essex Hospital Services NHS Trust v Compass Group. [2013] EWCA Civ 200.
3. Walford v Miles [1992] 2 AC 128.
4. Unikol Bottlers Ltd. v. Dhillon Kool Drinks, reported in 1994 (28) DRJ 483. Paragraph 32
5. Kusum Sharma And Others v. Batra Hospital And Medical Research Centre And Others.
30 August, 2000
6. Bharathi Knitting Company v. DHL Worldwide Express; JT 1996 (6) SC 254
7. E.P Royappa v. State of Tamil Nadu; AIR 1974 SC 555,
8. State of Haryana v. Raj Rani 2005 7 SCC 22

9. State of Punjab v. Shiv Ram 2005 7 SCC 1.
10. State of Haryana v. Santra AIR 2000 SC 1888
11. Lawson, Dominic (11 March 2008). "Of course a deaf couple want a deaf child". The
Independent. London. Retrieved 12 November 2009.
12. Ajay Madan and another vs St.of Haryana.

13. Laxman Balkrishna Joshi (Dr.) v. Dr. TrimbakBapuGodbole AIR 1969 SC 122
14. Hamadard Davakhana case 23 May, 1985.
15. Suresh Gupta (Dr.) v. Govt. of NCT of Delhi AIR 2004 SC 4091
16. Nihal Kaur v. Post Graduate Institute of Medical Sciences & Research 1996 3 CPJ 112
State Comm.
17. Sr. Louie (Dr.) v. KannolilPathumma 1993 1 CPJ 30 NC
18. Mumbai-based Sun Pharmaceutical Industries Ltd. CASE 2015
19. “Nilabati Behera V State of Orrissa”, 1993 AIR 1960, 1993 SCR (2) 581
20. K.Basu V State of West Bengal” 1997 1 SCC 416
21. Chairman Railway Board and others v Chandrima Das 2000 2SCC 465
22. Sri Gajalakshmi Ginning Factory Ltd. v. CIT (1952) 22 ITR 502 (Mad).
23. In Ram NarainKher v. Ambassador Industries PTC (Suppl.) (1) 180 (Del).

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24. In 1985, in a classic case, Windsufing International v. Taburmarine

25. Dr. AloysWobben&Anr. Vs. Yogesh Mehra&Ors. APPEAL NO. 6718 OF 2013
26. Avesthagen Ltdcase 1988
27. Union of India V/s Pflizer Ltd And others 15 December, 2017 ... 22972 OF 2017 (Arising
out of SLP (C) NO.7061 OF 2017)
28. ParmanandaKatara v. Union of India 1989 AIR 2039, 1989 SCR (3) 997
29. Olmstead v United States, 277 U.S. 438, 478.
30. Bandhua Mukti Morcha v. Union of India (1997) 10 SCC 549
31. Paschim Banga Khet Mazdoor Samiti v State of West Bengal (1996) AIR SC 2426/ (1996)
4 SCC 37.
32. Nilabati Behera v State of Orissa 1993 AIR 1960, 1993 SCR (2) 581
33. Delhi Transport Corporation D.T.C v. Mazdoor Congress and Others ILR 1986 Delhi 158
34. State of Punjab v. M.S. Chawla 18 April, 2001
35. Vincent v. Union of India 1987 AIR 990, 1987 SCR (2) 468
36. Justice KS Puttaswamy v. Union of India" 15 December, 2017
37. Griswold v. Connecticut, 381 U.S. 479 (1965)
38. Kharak Singh v State of Tamil Nadu (AIR 1963 SC 129)
BOOKS
1. Mallik Vijay (2014) – Law relating to Drugs and Cosmetics 24th edition
2. Surendra (2014) – Supreme Court on Drugs and Medical Laws, Medical Negligence 1st
Edition
3. Dr.Sujith battacharya – Work on Biological Gene Invention In India
4. Lutgens SP, Nellissen EC – Its notes on Reproduction and IVF

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ARTICLES AND JOURNALS
Article 27(2), TRIPs Agreement Inventions whose primary or intended use or commercial
exploitation is contrary to public order or morality or which causes serious prejudice to human,
animal or plant life or health or to the environment are not patentable.
2) National Abortion Assessment Project, a nationwide study on abortion and abortion services in
the public and private sectors in six Indian states. According to the study, most abortions were
opted for as a family planning measure. It is estimated that 40-60 million abortions take place
throughout the world and half of them performed by unauthorized person mostly in developing
countries with grave consequences (WHO, 1990). Health education and community awareness are
the basic aspects of its prevention.
3) “The Medical Tourism Market Report 2015”, This reports In India the cost of medical treatment
is lowest and with Highest quality, as Indian medical facilities offers wide varieties of procedure,
which cost lesser then compared to others countries.
4) The Article 9 of UDHR provides for ‘protection of life and personal liberty’ of every person.
Art 25 of the universal declaration of Human Rights defines that everyone has a right to health and
medical care.
5) Art 12 of the International covenant on economic Social and cultural rights directs the member
states to recognized and accepts the rights of everyone to the enjoyment of highest attainable
standards of physical and mental health.
6) The Indian Council of Medical Research (ICMR) first published detailed guidelines for
biomedical research11 in 2000. These include guidelines for ethical review. Revised
guidelines published in 2006, state that the ethics review committee is also responsible for
monitoring trials.
RULES
1. A term is unfair if, contrary to the requirement of good faith, it causes a significant
imbalance in the parties’ rights and obligations to the detriment of the consumer.
2. Unfair Terms in Consumer Contracts Regulations 1999 (“UTCCR”) and Section 62(4) of
the Consumer Rights Act 2015.

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3. Indian Council for Medical Research (ICMR) has a set of strict guidelines to be followed
by any fertility/ IVF centre. Currently, though this is not a law, it is a bill pending in the parliament
to be passed. So, it is definitely mandatory for an IVF Centre to be registered with
ICMR.Restrictions on availability of IVF include costs and age to carry a healthy pregnancy to
term. IVF is mostly attempted if less invasive or expensive options have failed or are unlikely to
work. This process most often amounts to negligent act.
4. Rule 122 DAA of Drugs & Cosmetics Rules, 1945 (“D & C Rules”) defines clinical trials
as a “systematic study of new drug(s) in human subject(s) to generate data for discovering and/or
verifying the clinical, pharmacological (including pharmacodynamics and pharmacokinetic)
and/or adverse effects with the objective of determining safety and / or efficacy of the new drug”.
5. Clinical study design aims to ensure the scientific validity and reproducibility of the results.
Only 10 percent of all drugs started in human clinical trials become an approved.
LEXICONS
1. Intellectual Property Rights (Black Laws Dictionary) – 10th Edition 2014

2. Charles Anton (Classical Dictionary on
3. Battacharya, S Garg, KC Sharma, Bharvi, Indian Patent Activity in International and
Domestic Patent System (Biological Patenting in India)
4. M/s Minusmitha Ray, a Senior Patent Consultant in the Institute of Intellectual Property
Research and development (Gene Patenting in India)
OTHER AUTHORITIES
1. WTO.
2. TRIPS Agreement.
3. WIPO.
A) General Assembly of WIPO (2004)
B) Handbook on Human Rights and Intellectual Property Rights
4. Universal Declaration on Human Rights(UDHR) – Article 27.

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5. Paris Convention(Article 1(2).

6. Human Geno Project.
7. BUDAPEST Treaty.
8. European Patent Convention (EPC).

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LIST OF ABBREVIATIONS
1. RoB - Republic of Bharath
2. FRI - Florey Research Institute
3. BCMR - Bharath Council Medical Research
4. SFRC - Santaana Fertility Research Centre
5. DNA - Deoxyribonucleic acid
6. RNA - Ribonucleic Acid
7. GB - Golden Bullet
8. HnGT - Hyponeuclic Genome theropia
9. IPAB - Intellectual Property Appellate Board
10. SC - Supreme Court
11. HC - High Court
12. RBRI - Richie Bio-tech Research Institute
13. PRNGO - Pro-Rights Non Governmental Organization
14. PIL - Public Interest Litigation
15. MTP Act - The Medical Termination of Pregnancy Act
16. BMWM Act - The Bio Medical Waste Management Act
17. DC Act - The Drugs and Cosmetics Act
18. WHO - World Health Organization
19. UN - United Nations
20. IPC - Indian Penal Code
21. CRPC - Criminal Procedure Code
22. C.I.T - Commissioner of Income Tax
23. TRIPS - Trade related Intellectual Property Rights

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24. PIL - Public Interest Litigation
25. LTD - Limited
26. USA - United States Of America
27. HTEP - Human Tissue Engineered Product
28. DTAB - Drug Technical Advisory board
29. NGO - Non Government organization
30. UNDHR - United Nation Declaration on Human Rights
31. WTO - World Trade Organization
32. UTCCR - Unfair term in Consumer Contract Regulation
33. ART - Assisted reproductive technology
34. ICMR - Indian Council of Medical research
35. PGD - Pre Implementation Genetic Diagnosis
36. D& C Rules - Drug And Cosmetics Rules
37. ASCI - Advertisement Standarad Council of India
38. IICPR - International convention on Civil and Political Right
39. CIOMS - Council for International Organizations of Medical Sciences
40. IMA - Indian Medical Association.

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STATEMENT OF JURISDICTION
The Petitioners humbly submits memorandum for the petition filed before this Hon’ble
Supreme Court of Bharath. The petition invokes its writ jurisdiction under Article 32 of The
Constitution of India, 1950. It sets forth the facts and laws on which the claims are based.

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STATEMENT OF FACTS
BACKGROUND
1. Florey Research Institute, being the holder of highest number of Patents in the field of
Biotechnology in Malaipur, the Capital city of RoB, has invented a vaccine by name ‘Golden
Bullet- which could eradicate major non genetic diseases and obtained Patent for the same in
the year 2003 and invented a germ line gene editing technique called HnGT- Hyponeuclic
Genome Theropia, which is able to find the specific gene of interest and replace it with desired
traits and this was Patented in the year 2005.
2. Mr.Raghavan, Head Scientist in the Genetic Research Dept. of FRI approached SFRC-
Santaana Fertility Research Centre and later on, both in collaboration started ‘Cradles-
Fertility Clinic’ to impart the benefits of the research work and to bring about changes in the
mankind by making human race free from any kind of impediments, thru eradication of
allergies, diseases, and genetic disorders and also to create highly intellectual designer human
beings. Cradles gave advertisement in different media, stating their expertise and experience
in fertility treatment at minimal cost and free follow up care.
3. 110 couples approached Cradles but 77 qualified for the IVF Procedure to be done. Among
them 45 couple had genetic disorder or were hereditary carriers. Agreement was entered
between the Couples qualified for IVF procedure and Cradles, that “IVF shall be done at
minimal cost, and in the event of unfortunate miscarriage, Cradles may use the biological and
genetic material resulting from the miscarriage for the purposes determined by Cradles to be
in the interest of science or otherwise useful and beneficial and thereafter Couples shall not
claim any interest in the scientific activities or in the business of Cradles.”
4. Mrs.Sowmya a citizen of RoB, was a genetic carrier and was among the couples who
underwent IVF Procedure at Cradles. She had come to Cradles on seeing Visual advertisement
given by Cradles, in Hrudaya- a leading Kannada TV Channel. On visiting Cradles she was

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explained about the advantages of IVF treatment, cost of treatment and was assured for full
safety for mother and child, and of further follow up care ‘free of charge’.
5. After entering into agreement, the IVF procedure was commenced by Cradles- Eggs and
sperms were collected, fertilized, later on they treated the fertilized embryos with HnGT to
tweak the genetic disorder, as intended and also to give High IQ, 20/20 vision and muscle
power to unborn. Not only those embryos with disorder were treated but also the healthy
embryos were treated the same way to avoid the possible chances of other diseases. Regular
checkup was conducted. After thorough study of results of anomaly scan and other necessary
scans of the mothers, among 77 cases 48 foetus were found to be abnormal. As agreed before,
after informing the parents the possible consequences of continuation of abnormal foetus, it
was elected to be terminated. After termination treatment and necessary counseling too was
provided.
WRIT PETITION FILED BY MRS.SOWMYA

6. Whereas During 25th week Mrs.Sowmya experienced discomfort in lower abdomen, after
thorough check ups and tests conducted by Dr.Arjun, a friend of Sowmy’s husband, it was
found that the fertility procedure done had disoriented. Sowmy brought it to the notice of
Cradles, Cradles tried to pacify her and took the reports for its consideration. Couple got
discontented that Cradles had deceived them, and approached before Hon’ble SC of RoB
seeking constitutional remedy, on the grounds that; a)Cradles had done such an act without the
consent of the couple. b) Such an act has endangered the life of both mother and child.
WRIT PETITION FILED BY PRNGO

7. Meanwhile after termination of pregnancy of mothers, Cradles sold the aborted fetuses and
placentas to leading cosmetic companies throughout RoB. By this Cradles got Crores of
money. Pro-Rights NGO a nonprofit organization on research found the fact that Cradles were
selling the foetus and placentas without the consent of the concerned parents and making huge
money grossing crores. Pro-Rights then filed a PIL before the Hon’ble SC on the grounds that;
a) Abortion is against State law and selling the aborted foetus and placentas is against public
policy and unethical. b) Mothers were induced to undergo abortion. c) Creating demand for

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foetus is unethical and dangerous to mankind. d) Mothers were not made aware of the fact that
aborted foetus were sold. e) usage of such substance in cosmetic industries is against
regulations of manufacturing of cosmetics.
PETITION FILED BY RBRI FOR REVOCATION OF PATENTS

8. Side by side RBRI - Richie Bio-tech Research Institute, which was in the same line of
business or research, filed for revocation of Patents on 21/08/2008, on the grounds that –
Golden Bullet is contrary to or injurious to public health and HnGT is not a patentable
invention. IPAB after hearing revoked the Patents. Aggrieved FRI appealed before HC, which
reversed the decision of IPAB, later RBRI appealed to the Hon’ble SC.

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ISSUES PRESENTED
1.
Whether the following petitions filed are maintainable?
- Richie Bio-tech for revocation of Patents
- Pro-Rights’ PIL
- Sowmya’s contention for seeking Constitutional remedy
2.
Whether the Pregnant women’s “Right to Health and Privacy” under Article 21
is violated by Cradles?
3.
Whether Cradles’ intention of the agreement with the couples was bonafide?
4.
Whether Cradles’ personnel (Doctors and Staff) had the expertise and
experience to conduct the IVF Procedure involving GB and HnGT?
5.
Whether Cradles had taken necessary permission from the concerned
authorities to conduct “Clinical Trail” and necessary “Future Medical and
Procedural Precautions” before conducting Trial?

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SUMMARY OF ARGUMENTS
[1] THE WRIT PETITION FILED BEFORE THE SUPREME COURT ARE
MAINTAINABLE
PETITION FILED BY RBRIFOR REVOCATION OF PATENTS

1. The petition filed by the RBRI is not maintainable. Firstly, the GB cannot be invalidated
because the vaccine , by altering the DNA it prevents potentially fatal diseases and HNGT cannot
be held non patentable as this gene mutation is in the nature of preventing genetic disorder and
ethical view point should not cease the advancement of bio technology which is on the whole for
the betterment of human beings. Secondly,post-grant opposition under section 25(2) can be filed
by any person interested within 12 months from the date of publication of grant. Whereas in this
case the opposition filed was after competition of almost 3years with professional grudge.
2. The writ petition filed by the PRNGO is not maintainable. Firstly, due consent of the
couples were taken before conducting the IVF procedure and for the usage of aborted foetus and
placentas for the scientific and business purpose of Cradles, thru a valid contract. Secondly, foetus
were not sold any cosmetic companies but on the contrary were sent to FRI for further research.
Thirdly, abortion was done with the consent of the mothers after obtaining their permission for the
same and for the reason that the foetus were abnormal and if the continuation of abnormal foetus
was allowed, it would endangered the life of those respective mothers. Fourthly, on understanding
the cause for abortion, consequences of abortion mothers have expressed their free consent for
conducting the abortion process and their consent are not influenced.
3. The writ petition filed by the Mrs.Sowmya is not maintainable. Firstly, without the consent
of Cradles, Sowmya had visited to a Doctor outside Cradles and just on the opinion of a Doctor
outside Cradles cannot be relied to come to a conclusion that the foetus in her womb in abnormal
or the IVF procedure done at Cradles has disoriented the DNA of foetus. Secondly,Cradles had
not been given time to reconsider the reports of Dr.Arjun, for further analysis and
interpretation.Without verification of Dr.Arjun’s Reports, it cannot be presumed that the life of the
mothers are endangered.
[2] THE PREGNANT WOMEN’S “RIGHT TOHEALTH(LIFE) AND PRIVACY”

UNDER ARTICLE 21 IS NOT VOILATED BY CRADLES

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The pregnant women’s “Right to Life(Health) and Privacy” under Article 21 is not violated by
Cradles. Firstly, lower abdomen pain experienced by Mrs.Sowmya is common in the normal cases
of pregnant women and abnormality of foetus cannot be assumed with the lower abdomen
pain.Secondly, the ‘necessary after abortion medical care and counseling facility’ were given to
those mothers who underwent abortion.Thirdly, the whole IVF procedure conducted by Cradles
were provided at minimal costs to avoid economical burden on those under privileged and those
who cannot afford to make their parenting dream come true.
[3] CRADLES’ INTENTION OF AGREEMENT WITH THE COUPLES WAS

BONAFIDE
Cradles’ intention of agreement with the couples was bonafide. Firstly, the intention of
inventions namely, GB is to eradicate the non genetic disorders and HnGT is to edit the gene line
and replace it with the desired traits, are bonafide and noble as it is for the betterment of mankind.
Secondly, the intention of IVF procedure is to make the dreams of those couples to become parents,
who are unable to, by natural reproductive process due to individual causes, come true. Thirdly,
foetus were not sold but were sent to FRI for further research that is to enhance the performance
and results of both GB and HnGT to fetch 100% results. Fourthly, without any undue influence
the consent of the couples were obtained to use the foetus and placentas for further research by
Cradles, in case of unfortunate miscarriage.
[4] CRADLES’ PERSONNEL(DOCTORS AND STAFF) HAD THE EXPERIENCE

AND EXPERTISE TO CONDUCT IVF PROCEDURE INVOLVING GB AND HnGT
Cradles’ personnel (Doctors and Staff) had the experience and expertise to conduct the IVF
Procedure involving GB and HnGT. Firstly, FRI is one of the leading research institute in
Malaipur, in conducting genetic and genome research and also holds highest no. of Patents in the
field of Bio-technology. SFRC was also an exclusive fertility research institute, having years of
experience in fertility research and treatment.Both in collaboration established ‘Cradles’, which is
a clear indication of FRI ad SFRC’s experience in their respective field. Secondly, the FRI and
SFRC had well experienced and efficient doctors and staff to carry on the intended acts of the
organizations and they were employed in Cradles. Thirdly, because of the availability and
employment of well experienced and efficient personnel, advertisement in media were given which
states the experience and expertise of Cradles’. Fourthly, GB and HnGT are firstly experimented
on animals and only after the 100% success it was administered on human beings.
[5] CRADLES HAD TAKEN NECESSARY PERMISSION FROM THE

CONCERNED AUTHORITIES TO CONDUCT CLINICAL TRIAL AND

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NECESSARY ‘FUTURE MEDICAL AND PROCEDURAL PRECAUTIONS’

BEFORE CONDUCTING CLINICAL TRIAL
Cradles had taken necessary permission from the concerned authorities to conduct the Clinical
Trial and necessary ‘Future Medical and Procedure Precautions’ before conducting the Clinical
Trial.Firstly, Permission to conduct the Trial was obtained from DCGI and all necessary
formalities have been completed. Secondly, while handling the IVF procedure on couples and in
administering GB and HnGT on the embryos, due care has been taken. Administering GB and
HnGT on the embryos itself was to make sure that the foetus are not born with any genetic or non
genetic disorders. Thirdly, after the termination of pregnancy due medical care and counseling
were too provided free of cost. Thirdly, insurance too has been taken to cover the damages
contingent in nature.

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ARGUMENTS IN DETAIL
[1] THE PETITIONS FILED BEFORE THE SUPREME COURT ARE MAINTAINABLE
PETITION FILED BY RBRI FOR REVOCATION OF PATENTS

9. The petition filed by the RBRI under Art 32 of Constitution of India is maintainable.
Firstly, according to the Patents Act 1970.
Section 2(1)(j) in The Patents Act, 1970
"Invention" means a new product or process involving an inventive step and capable of industrial
application;1 "inventive step" means a feature of an invention that involves technical advance as
compared to the existing knowledge or having economic significance or both2 and that makes the
invention not obvious to a person skilled in the art.3
10. Sec 2(1)(j) defines any invention in the field of Medicals, drugs, food items and chemicals
its process of manufacturing can be patented which is also called as “Licenses of Rights”, RBRI
has objection for grant of patents to FRI4 as invention of Golden Bullet to eradicate non genetic
disorders. As per Section 64 of the Patents Act, revocation can be sought by either a counter claim
in suit for infringement OR by filing a revocation petition before the IPAB, the challenger cannot
attempt to simultaneously proceed against the patentee in both the matters. Attempting to seek one
of the remedies would bar him from availing the other.
11. As this invention is contrary and injurious to the public health5 which has been proved in
several occasions, as per Section 64 of the Patents Act, revocation can be sought by either a counter
claim in suit for infringement OR by filing a revocation petition before the IPAB, the challenger
cannot attempt to simultaneously proceed against the patentee in both the matters. Attempting to
seek one of the remedies would bar him from availing the other. The statistics reports of pregnant
1
Sri Gajalakshmi Ginning Factory Ltd. v. CIT (1952) 22 ITR 502 (Mad).
2
In Ram NarainKher v. Ambassador Industries PTC (Suppl.) (1) 180 (Del).
3
In 1985, in a classic case, Windsufing International v. Taburmarine, the Court propounded four-step test to determine
the inventive step in an invention.
4
Dr. AloysWobben&Anr. Vs. Yogesh Mehra&Ors.
5
Avesthagen Ltd case. And Section 66 of the Indian Patents Act, i.e. on the patent being prejudicial to the interests of
the public and being mischievous.

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woman aborted itself is evidence which is beyond any reasonable doubt. Patents Act clearly states
that “even if there is no opposition or when opposition is not filed, the Controller will have the
power to take consideration of opposition on its own in the Interest of Public”. 6
12. The RBRI had dully collected disclosed specification from patent authority official Gazette
and here by make submission that RBRI also conducted research of this medicine manufacture
process, since 2002 and earlier, during 2008 RBRI had a breakthrough in their research and there
research was found this Golden Bullet and HnGT will disorient DNA and adversely affect healthy
embryos and health of pregnant women which resulted in miscarriage of pregnancy woman. The
FRI intention behind this invention is not to fulfill the dreams of couples who are childless, but
only in the foetus which has a Diamond value in Research arena.
13. HnGT is a non patentable invention. Sec 3 and 4 of the Patents Act clearly states that
“inventions are not patentable if the process of any drug, medicines, surgical, curative,
prophylactic, diagnostic, therapeutic, or other treatment of human beings or animals or plants that
would render them free from disease or to increase their economic values”. Publication and
examination of application chapter IV and Section 11A to 21 deals with the publication and
examination of the applications for patents filed before the competent authority. Sec 15 after
considering the application and finding that the applications or any specification does not comply
the requirement of the act the controller may either refuse to proceed with application or demand
further information’s.
14. Biotechnology patents: Biotechnology involves the use of living organisms or biological
materials in the preparation of pharmaceutical products. Biotechnology patents cover a wide range
of diagnostic, therapeutic and immunological products. For example, Indian patent no. 234072
claims an aqueous, human serum albumin-free Interferon solution containing an interferon-alpha,
a non-ionic detergent, a buffer for adjusting pH 4.5-5.5, benzyl alcohol and optionally an
6
Section 3(b), Patents Act 1970 & Article 27(2), TRIPs Agreement. Inventions whose primary or intended use or
commercial exploitation is contrary to public order or morality or which causes serious prejudice to human, animal or
plant life or health or to the environment are not patentable.

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isochronizing agent. Incidentally, above Indian patent no. 234072 was the first product patent
granted by the Indian Patent office after the enactment of product patent regime in 2005. 7

15. The writ petition filed by PRNGO is maintainable. Pro Right NGO had filed this PIL in
the interest of public, The Golden Bullet and HnGT is used to cause abortion with capitalization
interest by Cradles, medical practitioner is unethical and against State policy. Cradles after causing
abortion, the aborted foetus and placentas were sold to cosmetic companies throughout RoB
grossing crores of money, which may create unethical demand for such substance in future which
is dangerous to mankind.
16. Cradles has done an act without the free consent of the concerned Pregnant woman or there
Guardian, The Cradle has violated all human Rights norms, International Obligations, Treaties,
they even had not made compensation for such loss. Cradle has sold human tissues8 to several
pharmaceutical companies for their research, according those pharmaceutical companies had used
foetus9 and done research, got patents registered
17. Pregnant woman consent is not a free consent; they had been threatened of birth of
abnormal child, in case if they don’t agree for elective abortion. The offence done by Cradle is
Punishable Under IPC 312, Causing Miscarriage, which the act done is only with the intention to
have foetus collection for the purpose of research and commercial activities. As there is no good
faith about to save the life of pregnant woman., this case they had not taken the free consent of
Pregnant woman or Guardian, as mentioned in Paragraph 14 in moot proposition FRI and SFRC
had decided to “elective abortion”10.The decision of “elective abortion” by FRI & SFRC clearly
7
The patent is owned by F. Hoffmann-La Roche Ltd., Switzerland.
8
Human tissues such as bone, skin and heart valves are usually removed from cadavers in hospitals, morturies or even
funeral homes and, these organs, can be stored for years—in tissue banks.
9
‘Pro-life’ is a term most commonly used to oppose abortion and support foetal rights. foetuses are human beings, and
therefore have a right to live.
10
An abortion is referred to as an elective or voluntary abortion when it is performed at the request of the woman for
non-medical reasons. There is difference between elective abortion and elective surgery, Confusion sometimes arises
over the term "elective" because "elective surgery" generally refers to all scheduled surgery, whether medically
necessary or not.

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proves as the conduct of Coercing or Pressurization of pregnant woman to choose option of

abortion. It is estimated that 40-60 million abortions take place throughout the world and half of
them performed by unauthorized person mostly in developing countries with grave
consequences.11
Section 312 in The Indian Penal Code

18. 312. Causing miscarriage - Whoever voluntarily causes a woman with child to miscarry,
shall, if such miscarriage be not caused in good faith for the purpose of saving the life of the
woman, be punished with imprisonment of either description for a term which may extend to three
years, or with fine, or with both; and, if the woman be quick with child, shall be punished with
imprisonment of either description for a term which may extend to seven years, and shall also be
liable to fine. Explanation. - A woman who causes herself to miscarry, is within the meaning of
this section.
19. Cradles intention is only to create market for placenta and foetus and not of deliver of
desired babies for couples; this tendency has increased medical termination of pregnant woman.
The patent owned by F. Hoffmann-La Roche Ltd., Switzerland. Wide Indian patent no. 234072,
In this preparation of pharmaceutical products foetus which is an Human tissue has been used as
is used for research involving Biotechnology. These tissues can be used in numerous recipients as
and when they are needed. In the early days of human tissue banking was not for-profit, those
banks are mostly located in hospitals dominated the field. Human tissues for research are said to
be worth more than diamonds, being valued at US$500/g.
20. Since the 1980s, the demand for human tissues has increased dramatically. The first tissue
in significant demand was human bone for use in allograft in orthopedic surgery. In the 1990s, the
emerging field of regenerative medicine, which generates human tissue-engineered products
(HTEPs), began to require access to human tissues. Eventually, pharmaceutical companies began
WHO Report 1990.

22
using human tissue instead of animals in the early stages of medical product testing. Human tissues
for research are said to be worth more than diamonds,
21. Inevitably, commercial tissue banks were set up to capitalize on this demand, starting in
the USA. Most US tissue bank companies obtain their material through Willed Body Donation
programs, run by the bank itself or through hospitals like Cradles. The demand for Human tissues
is the motive behind the Cradles for coercing or pressurizing the pregnant woman to go for elective
abortion.
22. Medical Tourism: is seriously affected as Cradle has failed in its mission of safe delivery,
Medical tourism is a growing sector in India ,according to Confederation of Indian Industries in
its report “The Medical Tourism Market Report 2015”This reports In India the cost of medical
treatment is lowest and with Highest quality, as Indian medical facilities offers wide varieties of
procedure, which cost lesser then compared to others countries.
23. Pro right NGO appeal Hon’ble court for permanent Injunction to Cradles from further
conduct of this treatment, as it would sabotages countries reputation in International market, which
may lead to financial crises as more people suffer would file for compensation. Cadaver Donation
Program, its only applicable for Human anatomical waste and not for aborted foetus, the Cradle
sold foetus for commercial purpose in the name of Research, they gives reason as there donation
could go research that prevents miscarriage helps treatment, abnormalities of fetal development
contribute to generate therapies to treat conditions and a varieties of other medical advances
24. Indian Contract Act 1872, The contract agreement is not of Bonafide interest, agreement
states fertility services would be provided at minimal cost, these agreement is not of Bonafide
interest, as this specifies about unfortunate miscarriage, they also mention about rights about
biological and genetic material caused from miscarriage, this agreement also impose restriction on
agreement holders to claim any interest in the scientific or business of cradles or even from
associates enterprises such as FRI and SFRC.

23
25. Ban of Drugs, In It was held Govt. need not Mandatorily consult DTAB before banning
drugs under Sec 26A of the Drugs and Cosmetics Act The Drug Technical Advisory Board
(DTAB) need not be mandatorily consulted by the government in order to be convinced of reasons
for banning medicines12
26. This petition is filed by Petitioner as there is urgency, violation of her Right to Health,
Danger to the life of pregnant mother and health of fetus. Her plaint for issue of writs, such as
Mandamus ,may be accepted, and necessary order be issued to Union of Bharath, for amendment
of “The Medical Termination Of Pregnancy Act,1971”, to make necessary changes in the length
of period necessary for termination of pregnancy, The said act place restriction as 12 to 20 weeks.
27. Mrs.Sowmya Has filed this petition on advice of another Doctor Arjun, who was a
gynecologist. this petition is maintainable, according to Sec 5 its says”Sec5 (1)The provisions of
Sec 4 and so much of the provisions of sub-section(2) of Sec 3 as relate to the length of the
pregnancy, the opinion of two registered medical practitioner does not apply for termination of
pregnancy , when the registered medical practitioner in good faith opinion for termination of
pregnancy to save the life of pregnant woman,
28. In this case Sec 3 and does not apply Mrs.Sowmya health as advise by Dr Arjun, is in
dangerous condition, there is expected substantial risk and danger of child to be born with physical
and mental abnormalities and handicapped.
29. Sowmya is worried about abnormality of 48 foetuses, in fact there was only 45 people had
genetic disorder, there was 77 couples tested i.e. 154 people, out of these 154 people only 45
persons had genetic disorder and were hereditary carrier by birth. other 109 persons were healthy
and did not have any genetic disorder, if each couple had one person genetic disorder so 154-
90=64, i.e. 64/2=32 couples were of good health, according to these statics there shall by only 45
12
Union of India V/s Pflizer Ltd and others

24
foetus with abnormality, were as there is 48 foetus mean even foetus of healthy 3 couple has been
found to aborted, was one of the reason to approach Hon’ble for writs to permanent injunction
towards continuation of HnGT treatment.
[2] THE PREGNANT WOMEN’S “RIGHT TO HEALTH (LIFE) AND PRIVACY

(PERSONAL LIBERTY)” UNDER ARTICLE 21 IS NOT VOILATED BY CRADLES
30. Fundamental Rights as contained in Part III (Article 12 to 35) of Constitution of India. It
guarantees civil liberties such that all Indians can lead their lives in peace and harmony as citizens
of India. The framers of Indian constitution were deeply influenced by the international document
i.e. Universal Declaration of Human Right (UDHR) 1948 which had a great impact on the drafting
of Indian constitution.
31. “No person shall be deprived of his life or personal liberty except according to a procedure
established by law.” And it embodies a constitutional value of supreme importance in a democratic
society and of the procedural magna carta protective of life and liberty.13
32. As per the provisions of ‘The Medical Termination of Pregnancy Act 1971” Sec 3
defines when Pregnancies may be terminated by registered medical practitioners the act says even
unwanted pregnancy may be presumed to constitute as a gravy injury to the mental health of the
pregnant woman to choose for abortion as a result of failure of any device,14the termination of a
pregnancy is only permitted when the conditions specified in the applicable statute have been
fulfilled. Hence, the provisions of the MTP Act, 1971 can also be viewed as reasonable restrictions
that have been placed on the exercise of reproductive choices.
33. (2b)There is also conspiracy behind the decision of FRI & SFRC to do elective abortion,
which is not only the violation of unborn person rights,15 it’s also effects the Transfer of Property
Acts. According to the advertisement of fulfillment of desired baby is also violation of The Pre
Natal diagnostic technique act 1984, which shall cause severe gender ration differences,
13
Article 21 of Indian Constitution and Olmstead v United States, 277 U.S. 438, 478.
14
ParmanandaKatara v. Union of India
15
Bandhua Mukti Morcha v. Union of India and Jurisprudence

25
34. Right to Privacy there shall be no doubt that a woman right to make reproductive choices
is also a one of the essential of personal liberty as understood under Article 21 of the Constitution
of India. It is important to recognize that reproductive choices can be exercised to procreate as well
as to abstain from procreating. They direct the member states to recognize and accept the rights of
everyone to the enjoyment of highest attainable standards of physical and mental health.16
35. The crucial consideration is that a women right to privacy, dignity and bodily integrity
should be respected. No person can make advantages from the ignorance of others17 knowledge,
Sowmya’s had limited knowledge on IVF treatment, she had totally depended on Cradles
Advertisement as expertise and experience, Cradle had committer the breach of Trust which
Sowmya had trusted with Cradle, this not only violated her Right to Health but also Right to
Privacy.18
36. (2d).India has changed its Patent law in 2005 for pharmaceutal products, to enforce its
obligation under the TRIPS Agreements. The Trade Related Aspects of Intellectual Property rights
should not prevent member country to take measures for protections of Public health, This
act/agreement should be interpreted and implemented by WTO members towards rights to protect
public health and in particular to promote access to medicines for all.
37. It has been held that- the right to life guaranteed under Article 21 includes within its ambit
the right to health19 and medical care and emphasized that a healthy body is the very foundation
of all human activities.Art.47, a directive Principle of State Policy in this regard lays stress note
on improvement of public health and prohibition of drugs injurious to health as one of primary
duties of the state20."Right to Privacy is an integral part of Right to Life and Personal Liberty
guaranteed in Article 21 of the Constitution," 21 .A nine-judge bench of the Supreme Court
16
International covenants on Socio-Cultural and Econoimic Council
17
Paschim Banga Khet Mazdoor Samiti v State of West Bengal r/w Nilabati Behera v State of Orissa
18
Delhi Transport Corporation D.T.C v. Mazdoor Congress and Others
19
State of Punjab v. M.S. Chawla
20
Vincent v. Union of India and Art. 21 of Directive principles of State policy r/w Art. 46 and 47 of Indian Constitution.
21
"Justice KS Puttaswamy v. Union of India" and Griswold v. Connecticut, 381 U.S. 479 (1965).

26
headed by Chief Justice JS Khehar, ruled on August 24, 2017 that the Right to Privacy is a
fundamental right for Indian citizens under the Constitution of India.22
38. The Supreme Court laid down that:“Social justice which is device to ensure life to be
meaningful and livable with human dignity requires the State to provide to workmen facilities and
opportunities to reach at least minimum standard of health, economic security and civilized living.
The health and strength of worker, the court said, was an important facet of right to life. Denial
thereof denudes the workmen the finer facets of life violating Art. 21.”23
39. The preamble of the 1946 World Health Organization (WHO) Constitution defines
health broadly as "a state of complete physical, mental and social well-being and not merely
the absence of disease or infirmity."24
40. “It is the fundamental right of everyone in this country… to live with human dignity
free from exploitation. This right to live with human dignity enshrined in Article 21 derives
its life breath from the Directive Principles of State Policy and particularly clauses (e) and
(f) of Article 39 and Articles 41 and 42 and at the least, therefore, it must include protection
of the health and strength of workers, men and women, and of the tender age of children
against abuse, opportunities and facilities for children to develop in a healthy manner and in
conditions of freedom and dignity, educational facilities, just and humane conditions of work
and maternity relief”.
41. The Hon’ble Court shall also to take note of the provision of the termination of the
pregnancy in case of rape or failure of birth control methods as same, since both of these
eventualities shall have been equated with a grave injury to the mental health of a woman. The
22
Kharak Singh v State of Tamil Nadu.
23
Consumer Education and Research Centre v. Union of India.
24
Enumerated in international agreements which include the UNDHR and Article 12 of UN Convention on the
Elimination of All Forms of Discrimination against Women.

27
hon’ble Court may emphasized that in all such circumstances, the consent of the pregnant woman
is an essential requirement for proceeding with the termination of pregnancy.
[3] CRADLES’ INTENTION OF AGREEMENT WITH THE COUPLES WAS

BONAFIDE
42. Agreement signed by Cradles is unambiguous terms and conditions, 25 the cradle had
inserted an agreement point, about unfortunate miscarriage, this it self proves that the IVF
procedure to be conducted by Cradle would lead to abnormal condition of foetus or would lead to
abortion.
43. The cradle also define in the agreement26 as in case of any miscarriage, the cradle would
have and authority to dispose the foetus, dispose human tissue according tho Bio medical waste
management act 2016 or even use the foetus which is against the disposal procedure of biological
waste and send for further research., interest of science or for further beneficial.
44. The cradles further makes an agreement and restricts the couple from claim of any benefits
accured from the disposal of foetus or by sale of foetus or any benefits from scientific and business
of cradles. The above reasons defines that there was no bonafide intention behind the agreement.27
45. A term is unfair if, contrary to the requirement of good faith, it causes a significant
imbalance in the parties’ rights and obligations to the detriment of the consumer.28
46. In contract law, the implied covenant of good faith and fair dealing is a general
presumption that the parties to a contract will deal with each other honestly, fairly, and in
good faith, so as to not destroy the right of the other party or parties to receive the benefits
of the contract. It is implied in every contract in order to reinforce the express covenants or
25
Mid Essex Hospital Services NHS Trust v Compass Group
26
Walford v Miles [1992] 2 AC 128.
27
Kusum Sharma And Others v. Batra Hospital And Medical Research Centre And Others.
28
The Unfair Terms in Consumer Contracts Regulations 1999 (“UTCCR”) and Section 62(4) of the Consumer Rights
Act 2015.

28
promises of the contract. A lawsuit (or a cause of action) based upon the breach of the
covenant may arise when one party to the contract attempts to claim the benefit of a technical
excuse for breaching the contract, or when he or she uses specific contractual terms in
isolation in order to refuse to perform his or her contractual obligations, despite the general
circumstances and understandings between the parties. When a court or trial or fact
interprets a contract, there is always an "implied covenant of good faith and fair dealing" in
every written agreement
47. In U.S. law, the legal concept of implied covenant of good faith and fair dealing arose
in the mid-19th century because contemporary legal interpretations of “the express contract
language, interpreted strictly, appeared to grant unbridled discretion to one of the parties”.
Paragraph 32 of the said judgment being relevant for my purpose is extracted below:—
48. “For a valid contract it is essential that the parties have given their free consent for it.
Section 10 of the contract act statutorily recognizes the requirement of free consent for a valid
contract. Section 13 of the contract act defines consent as follows:—‘two or more persons are said
to consent when they agree upon the same thing in the same sense’.29
Paragraph 37 of the judgment in Unikol Bottlers Ltd. (Supra.) it has been held thus:—
49. “The contracts are meant to be performed and not to be avoided. Justice requires that men
who have negotiated at arm's length, be held to their bargains unless it can be shown that their
consent was vitiated by fraud, mistake or duress.
50. To the similar effect is also the decision of the Supreme Court held that the parties to an
agreement are bound by the terms of the agreement.30
29
Unikol Bottlers Ltd. v. Dhillon Kool Drinks, reported in 1994 (28) DRJ 483.
30
in Bharathi Knitting Company v. DHL Worldwide Express; JT 1996 (6) SC 254 wherein it has been

29
51. The Supreme Court has held that the burden of establishing malafide intention is very
heavy on the person who alleges it arid the very seriousness of such allegations demands proof of
a high order of credibility. The evidence on record has been carefully perused by me on this issue.31
[4] CRADLES’ PERSONNEL(DOCTORS AND STAFF) HAD THE EXPERIENCE

AND EXPERTISE TO CONDUCT IVF PROCEDURE INVOLVING GB AND HnGT
52. In vitro fertilization (IVF) is a process of fertilization where an egg is combined with sperm
outside the body, in vitro .The fertilized egg (zygote) undergoes embryo culture for 2–6 days, and
is then transferred to the same or another woman's uterus, with the intention of establishing a
successful pregnancy, IVF is a type of assisted reproductive technology used for infertility
treatment and gestational surrogacy, in which a fertilized egg is implanted into a surrogate's uterus,
and the resulting child is genetically unrelated to the surrogate.
53. Although the law in India does not regulate egg donation and surrogacy, most clinics follow
good practices established by experts’ organizations and international medical society. Each state
in this country has come up with their own legal approach to this relatively new method of
procreation.
54. Rules of acting for IVF centers and egg banks are still discussed in India. The Assisted
Reproductive Technology (ART) Bill was drafted in 2010 to govern the grey area of infertility
treatment. It has specific regulations on egg donation. The Bill has failed to make it through
Parliament but it drafted guidelines for ART clinics and professionals.
55. The Indian Council for Medical Research (ICMR) has a set of strict guidelines to be
followed by any fertility/ IVF centre. Currently, though this is not a law, it is a bill pending in the
parliament to be passed. So, it is definitely mandatory for an IVF Centre to be registered with
ICMR. Restrictions on availability of IVF include costs and age to carry a healthy pregnancy to
31
In E.P Royappa v. State of Tamil Nadu; AIR 1974 SC 555,

30
term. IVF is mostly attempted if less invasive or expensive options have failed or are unlikely to
work.32This process most often amounts to negligent act.33
56. Since the Cradle is newly formed company: By Joint venture between FRI and SFRC,
this newly formed company has no cumulative experience and expertise 34 as mention in there
advertisement, this is also shall be considered as misleading advertisement. Another concern is
that people will screen in or out for particular traits, using Pre-implantation Genetic Diagnosis
(PGD) or Pre-implantation Genetic Screening. For example, a deaf British couple, Tom and Paula
Lichy, have petitioned to create a deaf baby using IVF.35
57. Moreover, only a registered medical practitioner who is defined in Sec.2 (d) of the Act
as "a medical practitioner who possess any recognize medical qualification as defined in
Cl.(h) of sec.2 of the Indian Medical Register and who has such experience or training in
gynecology and Obstetrics as may be prescribed by rules made under this Act" is permitted
to conduct the termination of pregnancy.36
58. The cradle has committed a serious fraud by their advertisement in all leading news paper
and media. These offence amounts to Criminal Act under IPC, There misleading Advertisements
caused confusing among the public, by advertising unfair37 , the petition is open to file complaint
against such misleading advertisement for unfair trade practice.
59. And the act which against the codes and norms of ASCI.38 The Act under Prohibits the
advertisement of any diagnosis cure, mitigation, treatment or prevention of certain diseases,
disorder, condition tested under the schedule to this act. Misleading advertisement also misleads
32
State of Haryana v. Raj Rani 2005 7 SCC 22.
33
State of Punjab v. Shiv Ram 2005 7 SCC 1.
34
State of Haryana v. Santra AIR 2000 SC 1888.
35
Lawson, Dominic (11 March 2008). "Of course a deaf couple wants a deaf child". The Independent. London.
Retrieved 12 November 2009.
36
Ajay Madan & othr vs St. of Haryana.
37
Under Sec 2(1)(r ) of Consumer protection Act 1986.
38
The Hon’ble Supreme court in the Drug and Magic Remedies (objectionable Advertisement) Act 1954.

31
to unfair trade practice or unfair competition under the Monopolies and Restrictive Trade
practices Act 1969, which is now merged with competition Act 2002, “Sec 36a” of this Act
prohibits making any statements , whether orally or writing or by visible representation which
falsely represents that the goods are of a particular standard quality and makes a false or misleading
representation concerning the need for ,or services
The said act caused to misunderstanding or in correct decisions.
60. This concept of decisively altering genes has coined the concept of the Designer Baby. But
this activity or an invention has resulted in many negligent acts by experts.39Projections for societal
repercussions include changing the realm of athletics, creating human weapons, and exchanging
autonomy over one’s life course for pre designation.40Also, with a limited view of the future, it is
difficult to alter a human’s genetic makeup without knowing full repercussions. For example,
through gene therapy, a lab was able to make rats lose weight, but the long-term effects of the gene
manipulation lead to worry of toxin production and too much weight loss.41
61. Many people do not oppose the IVF practice itself (i.e. the creating of a pregnancy through
"artificial" ways) but are highly critical of the current state of the present day industry. Such
individuals argue that the industry has now become a multibillion-dollar industry, which is widely
unregulated and prone to serious abuses in the desire of practitioners to obtain profit.
62. For instance, in 2008, a California physician transferred 12 embryos to a woman who
gave birth to octuplets (see Suleman octuplets). This has made international news, and had
led to accusations that many doctors are willing to seriously endanger the health and even
life of women in order to gain money.
39
Laxman Balkrishna Joshi (Dr.) v. Dr. Trimbak Bapu Godbole AIR 1969 SC 128
40
Sandel M (2004). "The Case Against Perfection". Atlantic Monthly. 293 (3): 51–62.
41
Ahima RS (2003). "Obesity gene therapy: slimming immature rats". Gene Therapy. 10: 196–197.

32
63. Robert Winston, professor of fertility studies at Imperial College London, had called
the industry "corrupt" and "greedy" saying that "One of the major problems facing us in healthcare
is that IVF has become a massive commercial industry," and that "What has happened, of course,
is that money is corrupting this whole technology", and accused authorities42 of failing to protect
couples from exploitation "The regulatory authority has done a consistently bad job. It's not
prevented the exploitation of women,43 it's not put out very good information to couples, it's not
limited the number of unscientific treatments people have access to".44
64. The IVF industry can thus be seen as an example of what social scientists are describing
as an increasing trend towards a market-driven construction of health, medicine and the human
body.45
65. In Hon’ble Supreme court held as violation of Art 14, the fact of these case was a drug
was advertised it have the quality to magically cure certain types of disease, which in fact was not
correct. the court further held that these are misleading advertisement and the defendant are held
liable.46
[5] CRADLES HAD TAKEN NECESSARY PERMISSION FROM THE
CONCERNED AUTHORITIES TO CONDUCT CLINICAL TRIAL AND
NECESSARY ‘FUTURE MEDICAL AND PROCEDURAL PRECAUTIONS’
66. (5a)Rule 122 DAA of Drugs & Cosmetics Rules, 1945 (“D & C Rules”) defines clinical
trials as a “systematic study of new drug(s) in human subject(s) to generate data for discovering
and/or verifying the clinical, pharmacological (including pharmaco dynamics and
42
Laxman Balkrishna Joshi (Dr.) v. Dr. TrimbakBapu Godbole AIR 1969 SC 128
43
Suresh Gupta (Dr.) v. Govt. of NCT of Delhi AIR 2004 SC 4091 r/w Nihal Kaur v. Post Graduate Institute of Medical
Sciences & Research 1996 3 CPJ 112 State Comm.
44
Sr. Louie (Dr.) v. Kannolil Pathumma 1993 1 CPJ 30 NC.
45
Dumit, J. (2012) Drugs for Life: How Pharmaceutical Companies Define Our Health. Duke University Press:
Durham.
46
Hamadard Davakhana .

33
pharmacokinetic) and/or adverse effects with the objective of determining safety and / or efficacy
of the new drug”.47
67. "No one shall be subjected to torture or to cruel, inhuman or degrading treatment or
punishment. In particular, no one shall be subjected without his free consent to medical or scientific
experimentation."The Article prohibits experiments that violate the integrity of the person by cruel,
undignified or inhuman treatment.48. Clinical study design aims to ensure the scientific validity
and reproducibility of the results. Only 10 percent of all drugs started in human clinical trials
become an approved49
68. "The fundamental document in the field of ethics in biomedical research." The recent
version also enunciates the laudable goal that "the research is responsive to the health needs and
the priorities of the population or community in which it is to be carried out; and any intervention
or product developed, or knowledge generated, will be made reasonably available for the benefit
of that population or community."50Nevertheless, as stated in the Declaration of Helsinki51, human
rights issues are coming to be seen as within the proper domain of public law and private law
remedies such as negligence and the tort of trespass do not constitute a potent deterrent for
unscrupulous researchers operating in under-developed countries where access to legal advice is
scarce and/or prohibitively expensive. But in reality a strong civil law52 is helping effected people
at the end of the trials.
69. Clinical trials recruit study subjects to sign a document representing their "informed
consent". The document includes details such as its purpose, duration, required procedures, risks,
potential benefits, key contacts and institutional requirements.53
47
Medical Council of India Act, 1956 and the Central Council for Indian Medicine Act, 1970 also regulate the conduct
of clinical trials in India.
48
Article 7 of ICCPR.
49
Ezekiel J. Emanuel. "The Solution to Drug Prices". New York Times.
50
CIOMS guidelines make some reference to the Declaration of Helsinki.
51
The Declaration of Helsinki is accepted as an international standard for biomedical research.
52
As per the Bulletin of WHO titled Clinical trials in India: ethical concerns
53
Maloney, Dennis M (1984). Protection of Human Research Subjects: A Practical Guide to Federal Laws and
Regulations. Boston.

34
70. In 2003 and 2005 FRI got patent rights for Golden Bullets and HnGT, ,in initial it was
tested on lab mouse ant monkeys after ethnic committee permission , however there is not clear
about permission granted to conduct test of newly invented Golden Bullet and HnGT on human
beings.
71. In 2008 RBRI has filed for revocation of patent on the grounds of invention of Golden
Bullet and HnGT is injurious to health, The Patent authorities after hearing both parties according
to natural justice procedure, revoked the patent on the grounds of Dangerous to health. Before
2005, the Drugs and Cosmetics Rules suggested, but did not require, that clinical trial
72. Documents be reviewed by an ethics review committee. The Rules as amended in January
2005 require that the clinical study report include a statement that the trial was conducted
according to the principles of the Declaration of Helsinki, Indian Good Clinical Practice
guidelines, and the Indian Council of Medical Research’s ethical guidelines 54 for biomedical
research on humans.55
73. Confidentiality is an important part of clinical research 56 and ensures that personal
information is seen only by those authorized to have access. It also means that the personal identity
and all medical information of clinical trial participants is known only to the individual patient and
researchers.57Results from a study will usually be presented only in terms of trends or overall
findings and will not mention specific participants. As of January 2005, it is mandatory for clinical
trials in India to conform to the ICMR’s guidelines and to the guidelines in the Declaration of
Helsinki.58 The guidelines state that: “persons who are economically or socially disadvantaged
should not be used to benefit those who are better off than them.”
54
In 2000 it issued a Policy Statement “’Ethical .Guidelines for Biomedical Research on Human Subjects’ (“Ethical
Guidelines”) in terms of which all clinical trials in India must be conducted in compliance with the Ethical Guidelines.
55
The Indian Council of Medical Research (ICMR) first published detailed guidelines for biomedical research11 in
2000. These include guidelines for ethical review. Revised guidelines published in 2006, state that the ethics review
committee is also responsible for monitoring trials.
56
In 2003, Mumbai-based Sun Pharmaceutical Industries Ltd case.
57
The US National Institutes of Health The Clinical Center Patients' Bill of Rights.
58
Section III b in ICMR, 2000 and Section IV iii b in ICMR, 2006.

35
74. In an appeal to High court of Malaipur set aside the decision of Patent authorities, The
RBRI has challenged again the decision before Hon’ble Supreme court of Bharath in the month of
January 2018 dated 09.01.2018 for permanent injunction on Golden Bullet and HnGT.
75. Indian clinical trials cannot get recognition unless there is a culture of quality clinical
research among physicians. A recent review of research publications between 2005 and 2014
reported that research output from Indian medical institutions was poor and 57.3% of the medical
colleges did not have a single publication during this period.
76. It is shameful that Indian arbors a significant quantum of major illnesses that are not seen
in other parts of the world. In the recent Global Burden of Disease study published in Lancet, India
ranked 154th out of 195 countries as far as access to healthcare and quality are concerned. Despite
there being a large number of patients with varied conditions in the country, most clinical trials,
unfortunately, still focus on ailments they have a western bias to their origin or numbers. 59
77. The Hon;ble court shall be please to grant Injunction to avoid further miscarriage of
Pregnant woman . Compensation to be given for all pregnent woman60 who had already been
aborted. By elective abortion, as they had been passed by sever turma and mental In support her
case refered similar cases “Nilabati Behera V State of Orrissa”,D.K.Basu V State of West
Bengal”,Chairman Railway Board and others v Chandrima Das.
59
Dr. Chandra Gulhati, Editor of the Monthly Index of Medical Specialities.
60
Crpc Sec 357.

36
Seeking Relief:
Wherefore in the light of the issues raised, arguments advanced and authorities cited, it is humbly
prayed that this Hon‟ble Court may be pleased to adjudge and declare for the following reliefs:
1] Compensation for ‘Deficiency in service’ may be granted under Consumer Protection Act
1986.
2] Order may be passed for the recovery of Medical expenses borne by Mrs.Sowmya and
Compensation for physical and mental health upset caused by the negligence of Personnel of
Cradles, under The Drugs and Cosmetics Act, 1940.
3] Cradles and its Personnel may be criminally made liable for Causing Miscarriage U/S 312, for
the Criminal Breach of Trust U/S 406 and 417(Punishment), for the offence Cheating U/S 418 and
420
4] Cradles and its Personnel may be made liable for the offence of Medical Negligence and be
punished.
5] The License of Cradles to practice medical may be cancelled and Doctors Registration in IMA
may be cancelled.

37
PRAYER
Wherefore in the light of the issues raised, arguments advanced and authorities cited, it is humbly
prayed that this Hon‟ble Court may be pleased to adjudge and declare that:
[1] THE WRIT PETITION FILED BEFORE THE SUPREME COURT ARE
MAINTAINABLE
[2] THE PREGNANT WOMEN’S “RIGHT TO HEALTH AND PRIVACY” UNDER

ARTICLE 21 IS VOILATED BY CRADLES
[3] CRADLES’ INTENTION OF AGREEMENT WITH THE COUPLES WAS NOT

BONAFIDE
[4] CRADLES’ PERSONNEL(DOCTORS AND STAFF) HAD NO EXPERIENCE AND

EXPERTISE TO CONDUCT IVF PROCEDURE INVOLVING GB AND HnGT
[5] CRADLES HAD NOT TAKEN NECESSARY PERMISSION FROM THE

CONCERNED AUTHORITIES TO CONDUCT CLINICAL TRIAL AND NO
NECESSARY ‘FUTURE MEDICAL AND PROCEDURAL PRECAUTIONS’ TAKEN
And pass any other order, direction, or relief that this Hon‟ble Court may deem fit in the interests
of justice, equity and good conscience.
All of which is humbly prayed,

NMC:331,
Counsel for the Petitioners.

38

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3RD AACL NATIONAL LEVEL MOOT COURT COMPETITION - 2018

College Code - NMC:331

3RD NATIONAL LEVEL MOOT COURT COMPETITION – 2018

MEMORIAL ON BEHALF OF PETITIONERS

THE HON’BLE SUPREME COURT OF BHARATH

[MEMORIAL ON BEHALF OF PETITIONERS]

3RD NATIONAL LEVEL MOOT COURT COMPETITION – 2018

MEMORIAL ON BEHALF OF PETITIONERS

PARTICULARS Pg. No.

[MEMORIAL ON BEHALF OF PETITIONERS]

1. The Constitution of India

1. The Patents Act 1970

[MEMORIAL ON BEHALF OF PETITIONERS]

8. State of Haryana v. Raj Rani 2005 7 SCC 22

12. Ajay Madan and another vs St.of Haryana.

[MEMORIAL ON BEHALF OF PETITIONERS]

24. In 1985, in a classic case, Windsufing International v. Taburmarine

[MEMORIAL ON BEHALF OF PETITIONERS]

ARTICLES AND JOURNALS

[MEMORIAL ON BEHALF OF PETITIONERS]

1. Intellectual Property Rights (Black Laws Dictionary) – 10th Edition 2014

[MEMORIAL ON BEHALF OF PETITIONERS]

5. Paris Convention(Article 1(2).

[MEMORIAL ON BEHALF OF PETITIONERS]

1. RoB - Republic of Bharath

2. FRI - Florey Research Institute

3. BCMR - Bharath Council Medical Research

4. SFRC - Santaana Fertility Research Centre

5. DNA - Deoxyribonucleic acid

6. RNA - Ribonucleic Acid

8. HnGT - Hyponeuclic Genome theropia

9. IPAB - Intellectual Property Appellate Board

10. SC - Supreme Court

11. HC - High Court

12. RBRI - Richie Bio-tech Research Institute

13. PRNGO - Pro-Rights Non Governmental Organization

14. PIL - Public Interest Litigation

15. MTP Act - The Medical Termination of Pregnancy Act

16. BMWM Act - The Bio Medical Waste Management Act

17. DC Act - The Drugs and Cosmetics Act

18. WHO - World Health Organization

19. UN - United Nations

20. IPC - Indian Penal Code

21. CRPC - Criminal Procedure Code

22. C.I.T - Commissioner of Income Tax

23. TRIPS - Trade related Intellectual Property Rights

[MEMORIAL ON BEHALF OF PETITIONERS]

24. PIL - Public Interest Litigation

25. LTD - Limited

26. USA - United States Of America

27. HTEP - Human Tissue Engineered Product

28. DTAB - Drug Technical Advisory board

29. NGO - Non Government organization

30. UNDHR - United Nation Declaration on Human Rights

31. WTO - World Trade Organization

32. UTCCR - Unfair term in Consumer Contract Regulation

33. ART - Assisted reproductive technology

34. ICMR - Indian Council of Medical research

35. PGD - Pre Implementation Genetic Diagnosis