Healthcare Marketplace

17B1NBT732
ODD Sem 2022
Open Elective for B Tech and integrated students of
CSE, ECE and IT

Department of Biotechnology
JIIT NOIDA

Faculty: Prof Shweta Dang and Prof Indira P Sarethy

JAYPEE INSTITUTE OF INFORMATION TECHNOLOGY

VISION
To become a Centre of Excellence in the field of IT & related emerging areas education,
training and research comparable to the best in the world for producing professionals
who shall be leaders in innovation, entrepreneurship, creativity and management.
 
MISSION

MISSION 1: To develop as a benchmark University in emerging technologies.

MISSION 2: To provide state of the art teaching learning process and R&D environment.
MISSION 3: To harness human capital for sustainable competitive edge and social
relevance.
 
 

 
 
 
 
 
DEPARTMENT OF BIOTECHNOLOGY

VISION
 
To be a centre of excellence in Biotechnology for providing quality education and
carrying out cutting edge research to produce professionals,  innovators,
researchers and entrepreneurs.

MISSION
 
MISSION 1: To offer contemporary, futuristic and flexible curricula of Biotechnology
for teaching and training.
 
MISSION 2: To carry out globally acceptable cutting edge research through
sponsored projects and to provide state of art laboratories for experimental work.
 
MISSION 3: To develop bio-safe, socially, ethically and environmentally acceptable
solutions to address health, environmental, industrial, entrepreneurial and societal
concerns.
Programme Name: B. Tech BIOTECHNOLOGY
 
PROGRAMME EDUCATIONAL OBJECTIVES
 
PEO 1: To provide fundamental and practical knowledge in the field of Biotechnology for
pursuing research career in industry and academia.
 
PEO 2: To impart analytical and research skills and nurture entrepreneurial
endeavours. 
 
PEO 3: To develop biotechnologists with professional ethics to address global and societal
issues for sustainable development.
 
 Programme Name: M. Tech. BIOTECHNOLOGY
 
PROGRAMME EDUCATIONAL OBJECTIVES
PEO 1: To impart advanced theoretical and practical knowledge in Biotechnology and allied
fields.
PEO2: To provide domain knowledge and expertise for successful career in academics,
research and industry.
 
PEO3: To develop ethically and socially responsible professionals with leadership and
entrepreneurship skills.
Course Name & Code: Healthcare Marketplace, 17B1NBT732 (C401-14)
•Course Outcomes:
At the completion of the course, students will be able to,

COURSE OUTCOMES COGNITIVE LEVELS

C401-
Explain healthcare market, drugs and devices, role of various stakeholders Understand Level (C2)
14.1
C401-
Apply related intellectual property laws and regulatory approvals for healthcare sector Apply Level (C3)
14.2
C401-
Analyze the various business models/ innovations in the healthcare industry Analyze Level (C4)
14.3
C401-
Compare economic aspects pertaining to the sector Analyze Level (C4)
14.4

•CO-PO and CO-PSO Mapping:

COs PO 1 PO 2 PO 3 PO 4 PO 5 PO 6 PO 7 PO 8 PO 9 PO 10 PO 11 PO 12 PSO1 PSO2

C401-14.1 2 1 1     2   2   2   2    
C401-14.2 2 1 1     2   2   1   1    
C401-14.3 2 1 2 2 1 2   2 1 1   1    
C401-14.4 2 2 1     2       1   2    
Avg.
2 1 1 2 1 2   2 1 1   2    
C401-14
 Assessment Tools for CO Attainments

Course Name & Code

  Course Outcome Direct Assessment Tools (80%) In-Direct Assessment Tools
(20%)
CO1 Explain healthcare market, drugs and devices, T1, T2, End Semester Course Exit Survey
role of various stakeholders
CO2 Apply related intellectual property laws and T1, End Semester, Assignment-1 Course Exit Survey
regulatory approvals for healthcare sector
CO3 Analyze the various business models/ innovations T2, End Semester, Assignment-2 Course Exit Survey
in the healthcare industry
CO4 Compare economic aspects pertaining to the T1, T2, End Semester, Assignment-3 Course Exit Survey
sector
•PATENTS/IPR’s
•Indian patents and Generics
•Regulatory approval pathways
•Pre-clinical trials
•IND application
•Clinical Trials
•NDA application
•What are Generics
•ANDA application
•Hatch Wax man Act
•Pricing of Drugs and Devices
•Non-Patent Exclusivities
•Orphan Drugs
•Drug Pharmacokinetics and Pharmcodynamics
 NATURE OF IPRs

Essentially negative rights

– Stop others from copying or counterfeiting

Statutory rights = legally enforceable

Limiting periods of monopoly with obligation to disclose

(except trade secrets)

Territorial in nature/ PCT: patent cooperation

treaty/TRIPS/WTO
https://health.economictimes.indiatimes.com/news/industry/how-patents-have-transfor
med-the-health-care-sector/68721028#:~:text=All%20in%20all%2C%20it%20can,the%20o
ther%2C%20by%20allowing%20only
 What is patentable??

Inventions in all fields of technology, whether

products or processes, if they meet the criteria of
• Being patentable subject matter;

• Novelty; / NO PRIOR ART/ Prior art search

• Non-obviousness (inventive step);/ person skilled
in the art
• Industrial application (utility).
Types of patents

• Product (end product)

• Process

Enablement
Priority dates
Provisional vs Complete specification applications

Patent non-infringing strategy

Difference between prior art search and FTO search

VLSI v. Intel Case

On March 2, 2021, Intel Corporation was ordered to pay US$2.18 billion for patent-
infringement to VLSI Technology LLC, a well-known court opponent, by the Western
District Court of Texas.

The two patents involved are U.S. Pat. No.: 7,523,373 and U.S. Pat. No.: 7,725,759.

Both of them cover inventions that increase the power and speed of processors, a key
issue for competition.

Both were granted before 2006 and transferred to VLSI Technology LLC in 2019. VLSI
filed complaints in April 2019 immediately after acquiring the patents.

The court determined Intel had literally infringed claims 1,5,6,9 and 11 of US’373 and
infringed claims 14, 17, 18, and 24 of  US’759 under the Doctrine of Equivalents.

https://portal.uspto.gov/pair/PublicPair

Introduction to Patent Search, Dr Shweta Dang, 20.04.2021 15

Introduction to Patent Search, Dr Shweta Dang, 20.04.2021 16
Types of Patent Applications

Patent of Addition/ Continuation applications

Divisional Applications
Patents with Terminal Disclaimer
Double patenting
Secondary patenting/Evergreening

Revenues from Patenting

Licensing (Exclusive and Non exclusive)
Compulsory Licensing
Assigning

Parallel Imports
Rights of Exhaustion (international and National)
TYPES OF PATENT APPLICATIONS
Ordinary/ Domestic Application
Patent of addition
Divisional Application
PCT application
Convention application
Application for Patent of Addition
Patent of addition is an application made for a patent in respect of any
improvement or modification of an invention described or disclosed in the
complete specification already applied for or has a patent.

In order to be patentable an improvement, should be something more than

a mere workshop improvement and must independently satisfy the test of
invention.

The major benefit is the exemption of renewal fee so long as the main
patent is renewed.

A patent of addition lapses with the cessation of the main patent.

PARIS CONVENTION-Treaty

India is a member

Convention Application

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COMPARING Priority dates

PCT- 30 M
Convention Application: 12 M
Provisional Application: 12 M

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suppose you filed the following patent applications:

1.Provisional filed on Jan. 20, 2016 disclosing features A and B of an

invention;

2.Non-provisional filed on Jan. 20, 2017 claiming priority to the 1/20/16

provisional and adding new feature C (i.e., disclosing A, B & C); and

3.Patent of addition or CIP  filed on Aug. 20, 2017 adding new feature D (i.e.,
disclosing A, B, C & D).

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25
Divisional Application

A divisional application is one which has been "divided" from an existing

application.
The applicant, at any time before the grant of a patent can file a further
application, if he so desires or if an objection is raised by the
examiner on the ground that the claims disclosed in the complete
specification relates to more than one invention.

A divisional application can only contain subject matter in the

application from which it is divided (its parent),

but retains the filing and priority date of that parent.

A divisional application is useful if a unity of invention objection is

issued, in which case the second invention can be protected as a
divisional application.

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Restriction requirements occur when a patent examiner at the USPTO
deems that an inventor has included more than one invention in a
patent application.

With the recent increase in filing fees, there may be a strong desire to
include patent claims directed to a plurality of related, but separate
inventions into one patent application.

However, due do the USPTO count system (how the examiner’s at the
USPTO are graded/paid), having the Examiner perform multiple
searches for different inventions within the time limit they are given
for a single invention put an “undue burden” on the Examiner. 

Specifically, 37 CFR 1.142(a) states:

If two or more independent and distinct inventions are claimed in a single
application, the examiner in an Office action will require the applicant in th
e reply to that action to elect an invention to
which the claims will be restricted,
this official action being called a requirement for restriction (also known as
a requirement for division). Such requirement will normally be made befor
e any action on the merits; however, it may be made at any time before fin
al action.
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DOUBLE PATENTING

Double patenting is the granting of two patents for a single invention to

the same proprietor and in the same country or countries. 

As per USPTO
1. Statutory Double patenting (Identical claims)/ rejected
2. Non-Statutory patenting (Obviousness type Double patenting)

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 Free Public Use of the
Filing Issue Patent Expiration
Invention and Obvious
Date Date Date
Original Modifications Thereof
Application
Possible Unjust Extension
Of Original Patent Term
Second
Application Filing Issue Patent Expiration
By Applicant Date Date Date Free Public Use of the
Or Assignee Invention and Obvious
Modifications Thereof

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Terminal Disclaimer: to get away ODP based rejections!!

When an inventor already has a patent issued on an invention

and files another patent application on essentially the same
invention, only making changes deemed obvious, the USPTO will
likely require that the applicant sign a binding agreement to limit
the second patent, referred to as a “terminal disclaimer.”  

1. Applicant’s affirmative disclaimer of any term of the second

patent beyond the term of the first.

2. Acknowledgement that patents linked by a terminal disclaimer will

only be enforceable while co-owned.

3. Obviates an OTDP rejection during prosecution.

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ELI LILY vs Barr
War over anti depressant Prosac
Platform patent
lead would still be patentable as long as the platform patent did not
disclose the lead or render it obvious

Eli Lilly’s earlier platform patent covered the use of a large class of
compounds to treat mental depression. The platform patent covered the use
of Prosac®, but did not specifically disclose the compound.

Eli Lilly’s later patent covered the use of Prosac® to inhibit seratonin
uptake (a conditionimplicated in mental depression).

 Eli Lilly argued that the specific claim to Prosac® was patentable over the
platform patent because Prosac® was not disclosed in the earlier patent,
and it would not have been obvious to select Prosac® from the class of
compounds disclosed in the platform patent.
TRADE SECRETS/ confidential Information

formula,
pattern,
physical device,
idea,
process,
compilation of information

Some examples:

machining processes,
blueprints,
stock-picking formulae,
customer lists,
pricing information, and
non-public financial data
Data for which patent has not been filed yet

35
Coco-cola
KFC-11 herbs
Maggi

Hotmail- Sabeer Bhatia

Google's famous algorithm that directs internet travelers to relevant

search engine results is an extremely valuable trade secret

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Trade secret Eligibility:

 Economical Value

 Maintained as a secret

NDA: Non Disclosure agreement

Access controls
Non compete agreenment

37
PROS & CONS OF A TRADE SECRET
Involves no registration costs
Is not limited in time
Is immediately effective
Does not require disclosure or registration with the government
 inventions which Are NOT PATENTABLE

If the secret is embodied in a product, others may be able to discover the
underlying secret and use it legally by "reverse engineering" it
Protection is not granted if the secret is publicly disclosed
Protection is only effective against improper acquisition and use or
disclosure of the confidential information
Protection is weaker than the protection granted to patents
A trade secret does not protect against those who independently
come up with the same confidential idea.
EXPENSIVE
ENFORCEMENT IS DIFFICULT

Ref:http://www.wipo.int/sme/en/ip_business/trade_secrets/
patent_trade.htm
 Trade secrets Apply to

Softwares? Reverse engg? EULA?

Healthcare?

Reverse Engg… Allowed?

https://www.crowelltradesecretstrends.com/2020/05/ip-and-the-novel-cor
onavirus-developing-a-vaccine/

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Microsoft End User License Agreement SCOPE OF LICENSE.

The software is licensed, not sold.

This agreement only gives you some rights to use the software.

Microsoft reserves all other rights, Unless applicable law gives you more rights despite
this limitation, you may use the software only as expressly permitted in this
agreement.

In doing so, you must comply with any technical limitations in the software that only
allow you to use it in certain ways.
You may not·
• work around any technical limitations in the software;·
• reverse engineer, decompile or disassemble the software,
• except and only to the extent that applicable law expressly permits, despite this
limitation;·
• make more copies of the software than specified in this agreement or allowed by
applicable law, despite this limitation;·
• publish the software for others to copy;·
• rent, lease or lend the software; or·
• transfer the software or this agreement to any third party.
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