TRADE SECRETS Trade Secret A trade secret can be any - - PowerPoint PPT Presentation

TRADE SECRETS

Trade Secret

A trade secret can be any formula,pattern,idea,process,physical device

• r a compilation of information which

provides its owner a competitive advantage in the market. A trade secret is expected to be treated in such a way that it is not available to others unless

• btained by theft or by improper acquisition.

Examples

• Recipe, chemical formula, survey methods,

confidential data, computer programmes, manufacturing process, marketing strategies, financial strategies or a new invention for which patent application is not yet filed.

• Generally information is usually ptotected as

trade secret when the other forms of IPR protection can not be used ( eg. Idea, a negative know-how)

TRIPS

• The information must be secret
• It must have a commercial value
• Subjected to reasonable steps by the holder of

the information to keep it secret

Steps

• Limited number of people have access and are

aware that it is confidential

• Signing confidentiality agreement with

buisness partners whenever disclosing confidential information

• Confidentiality agreements with employees
• Physical restrictions (access, repository)
• Security in digital era

Laws related to Trade Secret

USA-Uniform Trade Secret Act Injunctive Relief, damages France- Manufacturing trade secrets, Know-how and confidential buisness information UK- Breach of Confidence-injunctive relief,damages and third party liability,search and seizure India- No trade secret law- like UK

Indian Situation

• Trade secrets are more likely to be used for

process innovation and for innovations in services.

• Strong price competition is typical of

commodity type markets, where opportunities for product differentiation/innovation are scant, and margins may be enhanced with cost/process innovation.

How is a trade secret evalauted?

• The extent to which information is known to

public or within particular trade

• The amount of effort and money expended in

developing the secret information

• The value of the information to holder & his

competitors

• The extent of measures taken to guard the

secrecy of the information

• The ease or difficulty with which the information

could be properly acquired by others

Trade Secret Vs Patent

Patent

• 20 years + Fees

Trade Secret

• Ability to keep secret for longer period
• Reverse Engineering / Independent creation
• Enforcement

Intellectual Property Rights and Traditional Knowledge

R.R.HIRWANI Head CSIR-URDIP Pune

What is meant by Traditional Knowledge? TK refers to tradition-based literary, artistic

• r scientific works, performances,

inventions, scientific discoveries, designs, marks, names and symbols, undisclosed information, and all other tradition-based innovations and creations resulting from intellectual activity in the industrial, scientific, literary or artistic fields.

• What is meant by tradition-based?

Knowledge systems, creations, innovations and cultural expressions which : have generally been transmitted from generation to generation; are generally regarded as pertaining to a particular people or its territory; and, are constantly evolving in response to changing environment.

What does TK include?

• Agricultural Knowledge
• Scientific knowledge
• Technical knowledge
• Ecological Knowledge
• Medicinal Knowledge
• Bio-diversity Knowledge
• Expression of Folklore

Traditional Medicinal Knowledge Definition

• The sum total of all the knowledge and

practices,

• whether explicable or not, used for diagnosis,

prevention and elimination of physical, mental, and social imbalance, and

• relying exclusively on practical experience and
• bservations handed down from generation to

generation, whether verbally or in writing.

• TRADITIONAL KNOWLEDGE IS-
• Largely based on medicinal plants.
• The most important systems of traditional

medicines in the world belong to the following countries

• African,
• American,
• South East Asian
• The western pacific regions.

• Classification of Traditional Medicinal

Knowledge

• Non-Codified
• Codified

Non-Codified Medicinal Knowledge

• The knowledge that is handed over orally

from generation to generation, & based

• n traditional beliefs norms & practices

based on centuries old experience of, trials and errors, success & failure at the house hold level

• Folk
• Rural
• Tribal
• Indigenous Traditional Medicinal

Remedies

Codified Medicinal Knowledge

• To represent knowledge in forms that can be

shared, stored, combined, and manipulated in a variety of ways is called as codification of knowledge.

• Codified tradition consists of medicinal

knowledge and sophisticated foundations expressed in thousands of manuscripts covering all branches of medicine. E.g.:

• Ayurveda.
• Siddha,Unani,
• Tibetan tradition.

Need to Protect Traditional Medicinal Knowledge

• Essential to health of millions of people in

developing country.

• Only affordable treatment to poor people.
• 80% population depends on it, for health

care needs

• Healing properties of plants, minerals and

animal products have been the source of many modern medicines

Need to Protect Traditional Knowledge

TK is sometimes appropriated, adapted and patented by scientists and industry, for the most part from developed countries, with little or no compensation to the custodian of this knowledge and without their concern for a fair and equitable sharing of benefits

Why the Debate ?

• Advancement of biotechnology/CBD (1992)

GATT/TRIPS(1994)

• Important source of income, food & health

(Commercial applications)

• It is linked to genetic resources.
• Useful for environmental benefits and

sustainable development

BACKGROUND RESEARCH

• Medicinal Plants – Major Source of medicines
• Extensive research on Natural Products and Plant

Chemistry

• Isolation and characterization of chemical constituents
• Study of structure - activity relationships
• Knowledge useful for Life Science Industry
• Being appropriated, adapted and patented by

commercial entities

• PROJECT SUPPORTED BY DBT
• EMPHASI S ON TECHNOLOGI ES AND

APPLI CATI ONS

• I NPUT FOR CONSERVATI ON AND

DEVELOPMENT OF BI ODI VERSI TY

• STUDY PATENTS ON 2000+ PLANTS
• 12,000+ PATENTS ON 500+ PLANTS

PATENTS ON AROMATI C,MEDI CI NAL AND ECONOMI C PLANTS(PAMEP)

.

• Plant Breeding, Propagation and Cultivation
• Formulations and their methods of preparation
• Food Applications
• I ndustrial Uses
• Active Components
• Agrochemical uses
• Dietary Supplements
• Processing
• Traditional Usage
• New Medicinal Usage
• Harvesting and post-harvest processing
• Other Misc. Uses

PAMEP

IPR ISSUES

• IP Protection beyond TK on Medicinal Plants
• Active ingredients / chemical constituents
• Combination of constituents of Natural Products

and Synthetic compounds

• Minor variants of naturally occurring compounds
• Physical Form/Metabolites
• Emphasis on ‘Patentability’ and ‘Validity’

INDIAN INITIATIVES

• CSIR
• Health Heritage Database (2000)-WIPO PORTAL
• Traditional Knowledge Digital Library (TKDL)
• INDIAN PATENT ACT
• Traditional knowledge excluded from patentability
• BIODIVERSITY ACT
• Permission of authority required if bioresource is

subject matter of patent

CURRENT FOCUS

• Validation of Ayurveda concepts on Modern

Scientific Principles

• Create Value by Synthesis between Ancient

Insights and Modern Discoveries

• Innovation by Scientification of Traditional

Knowledge

• CLASSIFICATION OF MEDICINAL PLANTS BASED

ON MECHANISM OF ACTION

• CASE STUDIES
• THERAPEUTICS : DIABETES

VALIDATION OF AYURVEDA CONCEPTS

MECHANISMS FOR DIABETES

• BETA CELL ACTIVATION
• BETA CELL REGENERATION
• PANCREATIC TONING/ PROTECTION
• INSULIN MIMICKING
• IMPROVEMENT OF GLUCOSE TOLERANCE/

INSULIN EFFICIENCY

• REDUCTION OF GLUCOSE ABSORPTION
• IMPROVEMENT IN CARBOHYDRATE

METABOLISM

• IMPROVEMENT OF FAT METABOLISM
• OTHER MECHANISM

PATENT MAPPING FOR RESEARCH PLANNING

IS THE ACETYLCHOLINE RECEPTOR A RABIES VIRUS RECEPTOR ?

ABSTRACT

Rabies virus was found on mouse diaphragms and on cultured chick myotubes in a distribution coinciding with that of the acetylcholine

• receptor. Treatment of the myotubes with

α-bungarotoxin and d- tubocurarine before the addition of the virus reduced the number of myotubes that became infected with rabies virus. These findings together suggest that acetylcholine receptors may serve as receptors for rabies virus. The binding of virus to acetylcholine receptors, which are present in high density at the neuromuscular junction, would provide a mechanism whereby the virus could be locally concentrated at sites in proximity to peripheral nerves facilitating subsequent uptake and transfer to the central nervous system.

Lentz et. al.

• Vol. 215 8.1.1982

SYNTHESIS BETWEEN TK AND MODERN SCIENCE

The affected person be made to drink the essence of Arka tree. This will clear his stomach of poison, if any, by vomiting. Sveta, Punarnava or Datura be administered. Palala, Oilseeds of Tila and essence of Rupika with Joggery drain the poison of Alarka (mad dog) as the wind drives away the clouds.

SYNTHESIS BETWEEN TK AND MODERN SCIENCE

Datura as a prophylaxis for rabies

This cake be eaten by a person, who is bitten by Alarka and poisoned. Whatever the ills caused by the bite of mad dog are cured by this medicine. Karsa measure of root of Sarapunkha along with a half of Datura measure be mixed with the rice-water be ground with wet rice - this paste be wrapped by Unmattaka leaves and cooked as a cake.

DATURA AS A PROPHYLAXIS FOR RABIES

• Chemical constituents of Datura are Scopolamine,

Atropine and many other alkaloids

• These alkaloids predominantly block the muscarnie

action of acetylchlorine

• Datura for rabies treatment represents the first

documented example of prophylaxis by receptor blockade

MI NERALI A MEDI CA

• MEDICINES OF MINERAL ORIGIN WERE WIDELY USED
• BHASMAS ARE STILL IN USE
• HAS REMAINED AS NEGLETED AREA OF RESEARCH DUE TO

PERCEPTION OF TOXICITY

• NO MENTION OF BHASMAS IN THE CHEMICAL ABSTRACTS FROM

VOL.1 (1906) TO TILL DATE

• ON INTERNET ONLY COMMERCIAL INFORMATION AVAILABLE
• NO CLASSICAL WORK TRANSLATED IN ENGLISH LANGUAGE
• COMPILED ALL THE LITERATURE ON BHASMAS, TRANSLATED IN

ENGLISH,COLLECTED SCIENTIFIC LITERATURE

• PCT APPLICATION ON ONE PARTICULAR BHASMA ALREADY BEEN

FILED

METALLOPHARMACEUTI CALS

• METAL BASED DRUGS
• CANCER (Pt)
• ANTI-INFLAMMATORY DRUGS
• Cu OR Zn
• ANTIDIABETIC DRUG
• Cr AND V
• ANTIMICROBIALS
• Zn, Bi, METAL CLUSTERS
• DEGENERATIVE DISEASES
• Cu, Zn AND Fe
• EMERGING TECHNOLOGIES
• NANOTECHNOLOGY (Au)

LEECH

LEECH

• LEECHES HAVE BEEN USED AS AN ALTERNATIVE

TREATMENT TO BLOOD LETTING AND AMPUTATION FOR SEVERAL THOUSAND YEARS

• IT WAS USED FIRST FOR MEDICINE IN ANCIENT

INDIA ABOUT 1000 BC

• IN AYURVEDA LEECH THERAPY IS CALLED AS

JALOUKA PRAYOGA

• LEECH SALIVA HAS ANALGESTIC AND ANASTHETIC

EFFECT

• MAJOR SPECIES USED IN MEDICINE

Ø HIRUDINARIA MANILLENSIS - ASIAN Ø HAEMENTERIA GHILIANII - AMAZON Ø HIRUDO MEDICINALIS

• EUROPEAN

US FDA APPROVAL

• IN JUNE 2004, US FOOD AND DRUG ADMINISTRATION

CLEARED THE FIRST APPLICATION FOR LEECHES TO BE

USED FOR COMMERCIAL MARKETING IN MODERN MEDICINE AS MEDICAL DEVICES

• RICARIMPEX SAS , A FRENCH FIRM, WAS THE FIRST

COMPANY TO REQUEST AND RECEIVE FDA CLEARANCE TO MARKET LEECHES AS MEDICAL DEVICE

• FDA DETERMINED THAT LEECHES ARE MEDICAL

DEVICES BECAUSE THEY MEET THE DEFINATION OF A MEDICAL DEVICE UNDER THE FOOD, DRUG AND COSMETICS ACT

LEECH THERAPY

• SKIN GRAFTING AND REATTACHMENT SURGERY
• APPLICATION ON ARTHRITIC KEEN REDUCES JOINT

PAIN AND SWELLING

• PLASTIC AND RECONSTRUCTIVE SURGERY –

PROVIDES CRITICAL VENOUS OUTFLOW FOR TISSUE REPLANTATION

• BREAST RECONSTRUCTION
• REDUCES POST SURGERICAL VENOUS

ENGORGEMENT

• CONTINUOUS VENOVENOUS HEMODIALYSIS IN LIVER

TRANSPLANTATION

• LEECHES APPLIED ON THE TIP OF THE TONGUE TO

REMOVE THE SYMPTOMS CHARACTERISTIC FOR GLOSSALGIA

HIRUDIN

• HIRUDIN-NATURALLY OCCURRING PEPTIDE IN THE

SALIVARY GLANDS OF LEECHES

• ANTICOAGULANT
• INHIBIT THE THROMBIN CATALYTIC SITE
• DOES NOT INTERFERE WITH OTHER SERUM

PROTEINS AND CAN ACT ALSO ON BOUND THROMBIN

• RELIEVES ACUTE VENOUS CONGESTION
• REDUCES THE RISK OF NONFATAL MYOCARDIAL

INFARCTION IN ACUTE CORONARY SYNDROME

MODERN RESEARCH

• INHIBITOR HUMAN TRYPTASE ISOLATED FROM LEECHES
• BIVALIRUDIN (HIRULOG) INHIBITS THROMBOSIS
• HIRULLIN POLYPEPTIDE SHOWS STRONG ANTITHROMBIC

ACTIVITY

• ANTIMETASTATIC FACTOR COMPRISING A PROTEIN

SUBSTANCE HAVING FACTOR XA INHIBITORY ACTIVITY ISOLATED FROM SALIVARY GLAND OF HAEMENTERIA GHILIANII

• HEMENTIN, A POLYPEPTIDE DERIVED FROM LEECH

SALIVARY GLANDS FOR PREVENTS FORMATION AND DEAGGREGATION OF PLATELET-RICH CLOTS OR THROMBUS

• HIRUDIN (OR RELATED CHEMICALS) HAVE BEEN

SYNTHESISED USING RECOMBINANT-DNA TECHNOLOGY.

MODERN RESEARCH

• A RECOMBINANT ANTISTASIN TYPE SERINE PROTEINASE

INHIBITORS

• POLYPEPTIDE INHIBITING C1 ESTERASE AND /OR FACTOR XII

USED IN GENE THERAPY FOR CARDIOVASCULAR, INFLAMMATORY OR AUTO IMMUME DISORDES

• PROTEIN BLOCKS STIMULATION OF PLATELET AGGREGATION

BY COLLAGEN USEFUL IN TREATMENT OF THROMBOTIC DISEASES

• NEW THROMBOLYTIC ENZYME DESTABILASE, ENDO-

EPSI(GAMMA-GLU)-LYS-ISOPEPTIDASE, SHOWING EXO- EPSI(GAMMA-GLU)-LYS-ISOPEPTIDASE AND AMIDOLYTIC ACTIVITY OBTAINED FROM HIRUDINIDAE

• RECOMBINANT PROTEIN HAVING FIBRINOLYTIC AND

COAGULATION-FACTOR XA-INHIBITING AMINO ACID SEQUENCE- INHIBITING PROPERTIES

CONTD..

I NTO THE FUTURE

• LINK BETWEEN PHARMACOGENOMICS AND TMK
• PERSONALISED MEDICINE
• CONVERT CONCEPTS INTO

PRODUCTS,DEVICES,MACHINE

• Diagnostic apparatus for analyzing arterial pulse waves -

Seiko Epson Corporation (USP 6,364,842)

• WIPO working Group on TK- Treaty Possible

Licensing Issues

Forms of Licensing

• Licensing Vs. Assignment
• Basic Patent License Vs. Complete license

covering know-how and patents

• Difference between Licensing and Technology

Transfer

What is being licensed?

• Field of use
• Territory (Geographical)
• Site
• Production Capacity (Quantity)
• Duration
• Exclusive/Non-Exclusive
• Sub-licensing rights?

Terms and conditions

• Pricing
• Lumpsum ,Milestone Payments, Down –Payment

+ Royalties

• Royalties- % of price, unit sale, sliding scale
• Period of royalty payment
• Know-how from others
• Purchases from and sale to others
• Resale of licensed products

Terms and Conditions

• Limitations on disclosure of Know-how
• Improvements made by licensee ( grant-backs)
• Licensor responsible in case of third party

infringement

• Challenge to validity of patent
• Termination/post-termination
• Dispute resolution
• Applicable law