Moot memorial of specific cases ina moot court competition, Cheat Sheet of Law

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(INDIA 2019)

BEFORE

THE HONOURABLE PATENT TRIAL AND APPEAL BOARD

STATE OF PARSINIA

JSA V. OJIBWE INDUSTRIES

JSA (ON BEHALF OF STATE OF TOQOI) --------------------- PETITIONER

OJIBWE INDUSTRIES --------------------- RESPONDENT

WRITTEN SUBMISSION ON BEHALF OF RESPONDENT

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TABLE OF CONTENTS

SL.NO CONTENTS PAGE.NO

1 TITLE PAGE

2 TABLE OF CONTENTS

3 INDEX OF AUTHORITIES

4 STATEMENT OF JURISDICTION

5 STATEMENT OF FACTS

6 SUMMARY OF ARGUMENTS/PLEADINGS

7 ARGUMENTS SUPPORTED BY THE AUTHORITY

8 CONCLUSION/PRAYER

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INDEX OF AUTHORITIES

CASES REFERRED:

SUPEREME COURT

1. NOVARTIS V.UNION OF INDIA & OTHERS - CIVIL APPEAL Nos. 2706-2716 OF 2013
2. BAJAJ AUTOLIMITED V. TVS MOTOR COMPANY LIMITED JT 2009 (12) SC 103 3.F. HOFFMAN-LA ROCHE LTD V.CIPLA LIMITED., MUMBAI CENTRAL
3. BAYER CORPORATION V UNION OF INDIA

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HIGH COURT CASES:

1. CADILA PHARMACEUTICAL LTD.V. INSTACARE LAB.PVT.LTD.,2001 PTC

(GUJ)

2. NATIONAL RESEARCH DEVELOPMENT CORPORATION.V.SILICON CERAMICS

LTD.,AIR DEL 52:1997(2) ARB LR 173:1997(42) DRJ 476

3. IMPERIAL CHEMICAL INDUSTRIES LTD. V. CONTROLLER GENERAL OF

PATENT,DESIGNS & TRDE MARKS,CAL HC

4. BAYER SRTIENGESEUSCHAFT V. CONTROLLER OF PATENTS,CAL HC

5. FRANZ ZAVER V. NEW YASH ENGINEERS,DEL HC

6. AGC FLAT GLASS EUROPE SA V.ANAND MAHAJAN,2009(41)PTC (DEL)

7. K.K.PURI V.M.M INDUSTRIES, 1997 PTC 185 DEL HC

INTERNATIONAL PATENT RELATED CASES REFERRED

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1.BASMATHI RICE CASE US PATENT NUMBER 5663484 ON SEPTEMBER 2 1997

2.MEXICAN BEAN CASE

JOURNALS REFERRED

1. ALL INDIA REPORTERS

2. SUPEREM COURT CASES

3. INTELLECTUAL PROPERTY RIGHTS

4. US PATENT AND TRADEMARK OFFICE(OFFICIAL WEBSITE)

5. INDIAN CONTROLLER GENERAL OF PATENTS(OFFICIAL WEBSITE)

BOOKS REFERREED;-

1. CHARTERED INSTITUTE OF PATENT ATTORNEY,CIPA GUIDE TO PATENT

ACT.12(1980)

2. N.S GOPALAKRISHNAN & T G AGITHA,PRINCIPLES OF INTELLECTUAL

PROPERTY,13(2009)

3. P.NARAYAN ,INTELLECTUAL PROPERTY LAW,7(2017)

4. N.K ACHARYA,TEXTBOOK OF INTELLECTUAL PROPERTY RIGHTS 85(2014)

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5. DR.LILLY SRINIVASAN,LAW AND MEDICINE.415(2013)

6. S.SHANTHAKUMARI,INTRODUCTION TO ENVIRONMENTAL LAW253 (2012)

DATABASE REFEERRED:-

1. http://www.lawoctopus.com
2. http://www.manupathra.com 3.http://www.westlaw.org
3. http://www.indiankannon.com 5.. http://www.european patent trade mark office.org

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STATEMENT OF JURISDICTION

THE COUNCIL REPRESENTING THE RESPONDENT HAVE ENDROSED THE

PLEADINGS BEFORE THE HON’BLE PATENT TRAIL AND APPEAL BOARD , THE

STATE OF PARSINIA UNDER 1 IPR , ENVIRONMENTAL LAW AND BIO PIRACY, IN^2

WHICH THE HON’BLE PPTO HAS THE JURISDICTION.

(^3) BIO PIRACY IS THE PRACTISE OF COMMERCIALLY EXPLOITING NATURALLY OCCURING BIO CHEMICAL OR GENETIC MATERIAL , ESPECIALLY OBTAINING PATENTS THAT RESTRICTS ITS FUTURE USE. (^2) ENVIROMENTAL LAW IS A COMMON LAW THAT GOVERNS HOW HUMANS INTERACT WITH THEIR ENVIRONMENT. THE PURPOSE OF ENVIRONMENTAL LAW IS TO PROTECT THE ENVIRONMENT AND CREATE RULES FOR HOW PEOPLE CAN USE NATURAL RESOURCES. (^1) INTELLECTUAL PROPERTY RIGHT IS A CATEGORY OF PROPERTY THAT INCLUDES INTANGIBLE CREATIONS OF THE HUMAN INTELLECT.

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STATEMENT OF FACTS

∙ The eco-social culture of the Kehaur community in Mahagir mountain range has generated a powerful heritage of Kehamani knowledge, which includes the knowledge of plant and genetic resources that has extraordinary medical and commercial value. mahagir mountain range is a wet evergreen forest consisting of 120 endemic plant species and is one of recognized ecologically fragile bio-diversity areas of the state of the democratic republic of toqoi. toqoi, though a developing country in rich ecologically and culturally; in biodiversity it is one of the richest in the world being one among the major countries abounding in biodiversity. ∙ The Democratic Republic of Toqoi, as stated earlier, is a developing country. This range is also designated to be protected as a representative ecosystem and natural/cultural sceneries by the Ministry of Forest and Environment of the State of Toqoi. The Kehuars is a parochial-indigenous community and refrains from any external outreach of mainstreaming activities. The community firmly believes in traditional ethno medicines and treatment methods. ∙ ∙ The members of the community share their ethno medicinal knowledge only through oral traditions. A council of elder community members lead by hereditary chief decides the

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treatment which involves the use of any traditional medicine. The traditional medicines are being prepared by Kehuaras from the medicinal plants which they conserve nurture and preserve for centuries. One of the key traditional medicines the community use is a combination of (i) Strychnos nux-vomica also known as nux vomica; (ii) Rauwolfia serpentine also known as snakeroot and (iii) Limonia Acidissima also known as elephant apple, for curing blood pressure related heart diseases. All three species are endemic to the region where the State of Toqoi is geographically located and are listed in the endangered plant species list of the State of Toqoi. ∙ The concoction is prepared using various parts of the plants by indigenous methods which involve boiling the plant parts in milk, fermenting and cooling processes. The concoction needs to be consumed by the patient immediately as the toxic properties of the plant parts will be active after two hours of its preparation. In the past, during the period between 1990 -2005, 3 MNCs have tried to develop relation with Kehauras and attempted for carrying out certain bio-prospecting to get some lead information relating to Kehauras ethno botanical knowledge and practices. However, Kehauras have neither revealed the secret formula of their concoction nor any knowledge relating to their plants and its various uses.

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∙ In 2005, two young members of the Kehaur community, Ms.Arikara Hopo and Mr.Bannock Hopo, joined the Toqoi Institute of Environment and Bio Diversity studies (TIEBS) to pursue their higher education. TIEBS has some international collaboration with foreign universities for students’ and faculty exchange programmes. Ms.Arikara Hopo and Mr.Bannock Hopo after completing their post graduation from TIEBS, later got admission in a prestigious research programme of Inter University Centre for Bio-diversity and Ethno Medicine (IUCBEM). As a part of an academic exchange programme, ”the Adsila-Ojibwe Scholarship” between the Toqoi University and the Mayford University of State of Parsania, Ms Arikara and Mr Bannock were sent to State of Parsania, in 2010 for a period of two years with a fully funded fellowship. However, as per the TOR of the fellowship, their status would remain as a bonafide student of TIEBS. The State of Parsania is a developed nation and is one of the leading industrialized countries. ∙ The Adsila-Ojibwe Scholarship is one of the ‘Skill Parsania’ efforts of the Ojibwe Industries Inc. (OII), at the Mayford University and the company- OII completely sponsors the scholarship. The Ojibwe Industries Inc is a bio-agro multinational company, with its registered headquarters in Parsania, and had interests in varied corporate sectors

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like crop science; horticulture, consumer health; pharmaceuticals; ethnobotany, animal health, animal husbandry, and other business services. ∙ OII has its own specialized R&D wing; the company has more than 100 patents applications pending in multiple jurisdictions relating to various medicinal preparations and processes. As per TOR of the scholarship, the ownership of any intellectual property created during the scholarship period will exclusively vested with the OII., although the individual will be recognized as the inventor/creator as per the law. This mandatory term was also agreed in the Memorandum of Association between the IUCBEM, Toqoi University and the Mayford University. ∙ As part of their academic activities and the terms of Adsila-Ojibwe Scholarship, Ms Arikara and Mr Bannock were required to complete a project in the field of bio-ethnic medicine concoction of their indigenous community, which involved the use of Strychnos nux-vomica, Rauwolfia serpentine and Limonia Acidissima. However, instead of indigenous method of boiling, fermenting and cooling method, they used advanced biochemical distilling method and included tools like genomics, proteomics, and bioinformatics in the process. The biological pathways, such as gene and protein expression, modulation and regulation and cell signaling were also applied by them and they created a drug-Rausilux, which is

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an anticoagulant to be used for Deep Vein Thrombosis (DVT) and helps in preventing blood clots after a stroke or pulmonary embolism, which also makes it a life saving drug. Due to these pharmaceutical processes. The shelf life of the drug increased to 6 months compared to the requirement of immediate consumption of the concoction in its traditional use. The biogenetic materials of the plants were gathered from ex situ collections in three countries where these plants do not exist naturally. These three countries are members of CBD. The Ojibwe Inc. successfully completed the FDA requirements of the State of Parsinia, which also involved multi-phase clinical trials process.OII applied for patent for the drug Rausilux in 2015 in Parsinia. Parsinia Patent and Trademark Office (PPTO) granted patent for the drug Rausilux in February, 2018 to OII. It was an unopposed patent. ∙ Jaiv Sanskruti Avagat(JSA) is a non- profit organization based in State of Toqoi and the organization focuses mainly on the documentation and protection of traditional knowledge, especially that of the indigenous communities in Toqoi. They are in the process of preparing a traditional knowledge library. JSA became aware of the patent grant for Rausilux immediately after its grant by PPTO in 2018 and has accused Ojibwe (OII) of bio- piracy and misappropriation of the traditional knowledge of Kehaur community. ∙

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JSA representing the Kehaur Community decided to file a post grant review at the Patent Trial and Appeal Board of Parsinia. The State of Parsinia’s process for post grant review patent in akin to that of USPTO model. ∙ The State of Toqoi is a party to the United Nations Convention on Biological Diversity (CBD) and has enacted the National Biodiversity Act, which sets the regulation of biological resources in any commercial processes and its transportation and uses in other countries. The authority appointed under the Act grants the permits and licences for the same. However, the State of Parsinia is not a member of CBD. Both Toqoi and Parsinia are parties to the Marrakesh Agreement Establishing the World Trade Organisation(WTO Agreement) and have completed their transition period and compliance obligations. ∙ The Patent Trial and Appeal Board (PTAB) of Parsinia has listed the JSA’S application for the post grant review on 12th^ January, 2019. The State of Toqoi has authorized JSA to represent the State in this matter before the PTAB. **SUMMARY OF ARGUMENTS

1. HOW THE PATENTING OF RAUSILUX WILL NOT AMOUNT TO BIO PIRACY AND MISAPPROPRIATION.OF TRADITIONAL KNOWLEDGE OF KEHAUR**

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COMMUNITY?

A) THE PATENTING OF RAUSILUX WILL NOT AMOUNT TO BIO PIRACY AS THE

EXACT COPYING OF THEPRODUCT IS NOT DONE IN THIS CASE. IT IS EXACLTY A

NEW PRODUCT VERY MUST DIFFERENT FROM KEHAUR COMMUNITY. THE

INVOLOVEMENT OF KEHAURIANS SHOWS THAT THERE IS NO BIO PIRACY.

B)THERE IS NO MISAPPROPRIATION OF TRADITIONAL KNOWLEDEGE AS THIS

MEDICINE WILL BE A LIFE SAVING DRUG TO THE ENTIRE WORLD AND THIS

CONCEPT IS NOT UTILIZSED WRONGFULLY.

2)WHY CANT THE GRANTED PATENT OF RAUSILUX BE REVOKED ON THE

BASIS OF ANTICIPATION AND PRIOR -ART?

A) THERE IS NO PROBLEM REGARDING THE POINT OF ANTICIPATION AS THEY

HAD PASSED ALL CLINICAL TRIALS AND SUCCESSFULLY BROUGHT TO MARKET.

B) PRIOR -ART MEANS ANY ART WHICH WAS DONE IN ANY WHERE IN THE

WORLD. HERE THERE IS NOTHING REGARDING PRIOR –ART AS MEDICINE BY

KEAHURIANS AND MEDICINES BY OJIBWE INDUSTRIES ARE DIFFERENT IN MANY

ASPECTS. SO THERE IS NO PROBLEM REGARDING PRIOR-ART.

AGUMENTS SUPPORTED BY AUTHORITIES.

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1)HOW THE PATENTING OF RAUSILUX WILL NOT AMOUNT TO BIOPIRACY

AND MISAPPROPRIATION OF TRADITIONAL KNOWLEDGE OF KEHAUR

COMMUNITY?

2)WHY CANT THE GRANTED PATENT FOR RAUSILUX BE REVOKED ON THE

BASIS OF ANTICIPATION AND PRIOR ART?

∙ THE STUDENT INVENTORS INVENTED A CONCOCTION BASED ON THE

KNOWLEDGE WHICH THEY HAD , MODIFIED THE CONCOCTION BY

INCREASING THE SHELF-LIFE FROM TWO HOURS TO SIX MONTHS

AND BETTER AVAILABILITY TO THE PEOPLE AS AN ANTI-COAGULANT

OF DVT AND IT HAS NO RELATIONSHIP WITH THE MEDICINE USED BY

THE KEHAUR COMMUNITY FOR THE TREATMENT OF BLOOD

PRESSURE RELATED HEART PROBLEMS. THE ONLY SIMILARITY

BETWEEN THEM IS THE PLANTS THEY USED, BUT SIMILAR

INGREDIENTS THEY USED WILL NOT LEAD TO THE SAME MEDICINE.

∙ THERE ARE MANY MEDICINES WHICH CURES MORE THAN ONE

DISEASES, SUCH AS ECOSPRIN 75mg TABLET IS AN ANTI-PLATELENT DRUG WHICH IS USED TO PREVENT CLOT IN BLOOD VESSELS AND ALSO RELIEVES PAIN AND INFLAMMATION. IT CAN BE TAKEN IN COMBINATION WITH OTHER ANTI-PLATLETS FOR BETTER ACTION. HERE

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SAME MEDICINE IS USED FOR MORE THAN ONE PURPOSE. ECOSPRINE

35mg TABLET WHICH IS USED AS AN ANTI-COAGULANT FOR STROKE. EVEN THOUGH THESE MEDICINES SOUNDS THE SAME BUT THEY DIFFER IN THEIR PURPOSE. 1 PARACETAMOL ALSO KNOWN AS ACETAMINOPHEN AND APAP, IS A MEDICINE USED TO TREAT PAIN AND FEVER. IT IS TYPICALLY USED FOR MILD TO MODERATE PAIN RELIEF, EVIDENCE FOR ITS USE TO RELIEVE FEVER IN CHILDREN IS MIXED. IT IS OFTEN SOLD IN COMBINATION WITH OTHER MEDICATIONS SUCH AS COLD,COUGH, ETC. THERE ARE VARIOUS MEDICINES USED FOR TREATMENT OF PAIN RELIEF COUGH, COLD,ETC SPECIFICALLY. PARACETAMOL BEING A MEDICINE THAT COVERS THE TREATMENT OF FORMER DISEASES DOESN’T MEAN THAT THOSE MEDICINES WHICH ARE SPECIFICALLY MADE WITH SIMILAR INGREDIENTS SHOULD NOT GET PATENT. ∙ THE MEDICINE CREATED BY THE INVENTORS AND THE MEDICINE USED BY THE KEAHUR COMMUNITY FOR CENTURIES DIFFER IN THEIR PROCESS, EFFECT AS WELL AS THEY USED BIO-GENETIC MATERIALS FROM THE SAME SPECIES OF PLANTS. THUS, THIS PATENT SHOULD NOT BE REVOKED ON THE BASIS OF BIO-PIRACY AS THESE YOUNG INVENTORS INVENTED A

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NEW MEDICINE CONCENTRATED ON DVT WITH INCREASED SHELF-LIFE.

∙ THE CONCOCTION PREPARED BY THE INVENTORS WILL BE AVAILABLE

WORLDWIDELY IF THE PATENT IS NOT REVOKED. IT WILL BE A HUGE

RELIEF TO THE PEOPLE WHO ARE AFFECTED BY THE DVT AND IT WILL BE

A BOON TO THEM SINCE IT IS AVAILABLE IN THE MARKET. THE KEHAUR

COMMUNITY’S MEDICINE IS NOT WORLD WIDELY AVAILABLE AND

PEOPLE CANNOT HAVE AN EASY ACCESS TO IT, THIS IS AN INJUSTICE TO

PEOPLE WHO ARE SUFFERING FROM DVT.

∙ AND THIS MODIFICATION FOCUSES ON THIS PARTICULAR DISEASE. THE

PREPARATION OF THE CONCOTION BY THE SCIENTIST IS NOT A THREAT

TO THE INDIGENIOUS PLANT SPECIES INSTEAD ITS A COMPLETE

UTILISATION OF THE MEDICINAL QUALITIES THAT THESE PLANTS POSSES.

AS THIS PATENT WAS ACQUIRED BY GOING THROUGH MANY CLINICAL

TRIALS THIS SHOWS THAT THIS MEDICINE IS APT FOR CONSUMPTION.

∙ RAUSILUX IS PREPARED USING BIO-GENERTIC MATERIALS FROM

RAUWOLFIA SERPENTINA, LIMONIA ACIDISSIMA, STRYCHNOS NUX-VOMICA

. AMONG THESE THREE PLANTS AN INCREASE IN THE CONTENT OF

STRYCHNOS NUX-VOMICA WOULD LEAD TO RAT POISON. THE KEHAUR

COMMUNITY’S MEDICINE HAS NO VALID PROOF THAT THE CONTENTS ARE

MIXED IN A PROPOTIONATE WAY. BUT THE MODIFIED MEDICINE

PREPARED BY THE YOUNG INVENTORS CAN ASSURE ADVANCED

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BIOCHEMICAL DISTILLING METHODS AND INCLUDED TOOLS LIKE

GENOMICS, PROTEOMICS, AND BIOINFORMATICS IN THE PROCESS. IT IS A

LIFE THAT RAUSILUX CAN STAY FOR SIX MONTHS AS WELL AS NO HARM

WOULD BE CAUSED TO PATIENTS. THE REVOCATION OF PATENT WOULD

RESULT IN A TRAGIC LOSS. ITS A CONTRIBUTION TO THE MEDICINAL

FIELD, IT IS PREPARED USING SAVING DRUG.

∙ IT IS STATED IN THE FACT THAT THE STATE OF TOQOI IS A PARTY TO THE

UNITED NATIONS CONVENTION ON BIOLOGICAL DIVERSITY (CBD) AND

HAS INACTED THE NATIONAL BIODIVERSITY ACT, WHICH SETS THE

REGULATION OF BIOLOGICAL RESOURCES IN ANY COMMERCIAL

PROCESS, AND IN TRANSPORTATION AND USES IN OTHER COUNTRIES.THE

AUTHORITY APPOINTED UNDER THE ACT GRANTS THE PERMITS AND

LICENCES FOR THE SAME.THE BIOGENETIC MATERIALS WERE GATHERED

FROM EX SITU COLLECTIONS IN THREE COUNTRIES.

∙ THUS THE AUTHORITY ITSELF GRANTED PERMIT FOR COLLECTING

BIOGENETIC MATERIALS OF THE PLANT FROM THE THREE COUNTRIES.

THE ACT WAS ENACTED TO MEET OBLIGATIONS UNDER CBD.AS THE

PERMIT WAS GRANTED THESE MATERIALS WERE COLLECTED. THE OII

HAS PUT A LOT OF EFFORT TO MAKE RAUSILUX FOR THE BENEFIT OF THE

PEOPLE.

∙ WITH REFERANCE TO THE JEEVANI CASE (2003) IT IS STATED IN THE FACTS

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OF THIS CASE THAT, THE AROGYAPAACHA LEAVES WERE USED BY THE

KANI TRIBE PEOPLE AND THE RESEARCHERS USED

∙ FOR AN INVENTION TO BE PATENTABLE, IT MUST BE DIFFERENT FROM

ALL PUBLISHED ARTICLES, KNOWN TECHINIQUES AND MARKETED

PRODUCTS. HERE, AN INVENTION LITERALLY MEANS “FINDING OUT

SOMETHING WHICH HAS NOT BEEN FOUND BY OTHERS”.A PATENT

REPRESENTS QUID PRO QUO (A FAVOUR OR ADVANTAGE GRANTED IN

RETURN FOR SOMETHING).

∙ TALKING ABOUT THE PATENT LAW , HERE ANTICIPATION TALKS ABOUT

THE PRIOR INVENTION OR DISCLOSURE OF THE CLAIMED INVENTION BY

ANOTHER, OR THE INVENTOR’S ON DISCLOSURE OF THE CLAIMED

INVENTION , SALE, PUBLICATION OR OFFER TO SELL PRIOR TO THE

INVESTOR’S APPLICATION FOR A PATENT. IN SIMPLE WORDS, IF SOMEONE

ELSE KNOWS ABOUT OR USED THE INVENTION BEFORE THE PATENT

APPLICANT APPLIES FOR A PATENT THEN THE PATENT APPLICANT WILL

NOT BE ELIGIBLE FOR PATENT.

∙ 4 A PATENT IS AN EXCLUSIVE RIGHT GRANTED TO A PERSON WHO HAS

INVENTED A NEW AND USEFUL ARTICLE OR AN IMPROVEMENT OF AN

EXISTING ARTICLE OR A NEW PROCESS OF MAKING AN ARTICLE. IT

CONSISTS OF AN EXCLUSIVE RIGHT TO MANUFACTURE THE NEW ARTICLE

(^4) Intellectual Property Law, Authored by P. Narayanan Pg-

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INVENTED OR MANYUFACTURED AN ARTICLE ACCORDING TO THE

INVENTED PROCESS FOR A LIMITED PERIOD. AFTER THE EXPIRY TO THE

DURATION OF THE PATENT, ANYBODY CAN MAKE USE OF THE INVENTION.

∙ THE GRANTED patent for Rausilux be revoked on the basis of anticipation and prior- art. ∙ The granted patent of Rausilux can’t be revoked on the basis of anticipation and prior art as this drug passed all clinical test and their will be no technical problem regarding the technical side of Rausilux .Considering the side of prior-art as the term prior art refers to any art which is previously invented or used anywhere but in this case both medicines that is the medicines by kehuarians and the medicine invented by ojibwe industries are different in many aspects the medicines by the people of kehuar community can be used only for two hours and the medicine by the ojibwe industries can be used up to 6 month thus it becomes a life saving drug since the contents are same the essences and the entire process differs so there is no prior-art. PRAYER FOR RELIEF

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WHEREFORE, IN LIGHT OF THE FACTS STATED,ISSUES RAISED,AUTHORITIES

CITED& ARGUMENTS ADVANCED MAY THIS HON’BLE COURT BE PLEASED

TO ADJUDGE &DECLARE THAT :

1. THE PATENT SHOULD NOT BE REVOKED ON THE BASIS OF BIO –PIRACY

2.THE RESPODENT DID NOT MISSAPROPRIATED TRADITIONAL KNOWLEDGE

3.THE PATENT MADE AVAILABLE A LIFE SAVING DRUG TO ALL PEOPLE WIDELY

AND

PASS ANY OTHER ORDER THAT IT MAY DEEM FIT IN THE INTEREST OF JUSTICE,

EQUITY AND GOOD CONSCIENCE.ALL WHICH IS MOST HUMBLY PRAYED

ON BEHALF OF

RESPONDENT

COUNSEL OF THE RESPONDENT

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