2022-02-26 IPR in Biotechnology (Student)

Alice Yuen-Ting Wong, Ph.D.
26 February 2022
BBMS6300/LSCI5463/BCHE4070
Overview
• Introduction to Intellectual Property
• Trademark
• Copyright
• Basics in Patent
• Trade Secret
• Inventorship & Ownership
© 2022 Alice Wong 2

Intellectual Property

What are Intellectual Property Rights (IPRs)?
• Intellectual assets
§ Intangible
§ Creations of one’s mind, e.g. idea, song, writing
• Positive Right (Right to use) vs Negative Right (Right to exclude others)

• Exclusive Right (Right to use exclusively)
• Four main types

§ Patent (invention)
§ Trademark (product/service identifier)
§ Copyright (expression of ideas)
§ Trade secret (know-how/show-how)
http://www.ipwatchdog.com/images/coke.jpg
http://noonedriving.com/blog/?tag=certificates
http://www.against-the-grain.com/wp-content/uploads/2012/07/copyright-microsoft-clip-art1.jpg
http://www.isqua.org/education/isqua-asqua-tjcha-joint-fellowship/tjcha-content
http://marketing-case-studies.blogspot.hk/2008_05_01_archive.html © 2022 Alice Wong 4
From R&D to commercialization
• High risk business
• Huge capital & running cost
• High failure rate
• Long development time
• Competitors
Technology
Idea Product/
Development Company
Research Advance technology/

Clinical test

Why Intellectual Property Rights (IPRs)?
• Protection
• Prevent undesired/unauthorized exploitation by others
• Business development
• Freedom to operate, minimize risk of infringement
• IP portfolio à investment (funds) / technology transfer (generate revenue)
• Sustain or expand R&D à commercialization
Technology Product/
Idea Seek IP protection IP portfolio
Development Company
Research Evaluate market: Advance technology/ Investment/

Research & marketing Clinical test Licensing
strategy

Drugs – From Discovery to Approval
Discovery
Preclinical testing (cells & animals)
Investigational(IND)
批准新药研究 New Drug Application (IND)
Phase I: Safety & dosage (20-80 healthy subjects)
Phase II：Efficacy & side effects (100-300 patients)
R&D
Phase III: Efficacy & side effects (1,000-3,000 patients)
New Drug Application (NDA)
FDA reviews NDA
FDA approves NDA
Post marketing testing
File US application
File foreign applications
Patents Grant of US application Hatch-Waxman
Extension
Patent Term 20 years Up to 5 years

FDA批准ANDA
推出仿制药
与其他仿制品竞争
http://www.oblon.com/Pub/Gifs/hatchwaxgraphlarge.jpg
Drugs – Regulatory & Market Exclusivity
• 10-15 years from laboratory to patients
• Market exclusivity
• Patent term – 20 years
• Patent term extension for drugs – max 5 years
• Data exclusivity (藥品市場獨佔期) – 5 years after drug approval
IND NDA FDA

Drug discovery (新藥研究) Phase I Phase II Phase III Marketing
(新藥申請) approval
From lab to patients 10-15 years Data exclusivity 5 years
Patent Term (plus extension) 20-25 years

Patent filing Patent granted
No exclusivity
+
Generic drug step in

Expiry of Exclusive Right
• Plavix® (clopidogrel bisulfate)
• Antiplatelet agent – prevents blood clots in heart attack
• Marketed worldwide in nearly 110 countries
• Top / second best-selling drug for years
• May 17, 2012

• US patent expired
• FDA approved generic versions of Plavix
http://articles.mercola.com/sites/articles/archive/2012/10/10/plavix-health-risks.aspx

What Happened to Retail Sales?
Patent expired in May (~Q2)
1.8
1.6
Sales (USD billion)
1.4
1.2
0.8
0.6 ↓ 40% in Q2 to 935 millions

0.4
↓ 96% in Q3 to 64 millions
0.2
↓ 97% in Q4 to 49 millions
0
Q1 2011 Q2 2011 Q3 2011 Q4 2011 Q1 2012 Q2 2012 Q3 2012 Q4 2012
http://www.drugs.com/stats/plavix
http://www.reuters.com/article/2012/10/24/us-bristolmyers-results-idUSBRE89N0NL20121024

IPRs – International Aspect & Timing
• Important features:
• Right to exclude
• IPRs are territorial in nature
• Time is of the essence
1. Paris Convention
• Right to claim the priority of a prior application within 6 (TM/industrial designs) or 12
months (patents/utility models) (177 regions)
2. Patent Cooperation Treaty (PCT)

• One PCT application à reserve right to file applications in up to 154 regions
• File, prosecute, grant and maintain independently in each region of interest
3. Madrid System
• One existing TM application à simultaneously seek registration in up to 125 regions
• Save costs & procedures for individual national filings
• No protection if, during the first 5 years, the initial TM application is finally withdrawn,
refused, or the registered TM is cancelled

PCT – International & National Stage
National Entry
United States
18 months
Japan
12 months
Europe
Prior Application PCT Application Publication

Up to 154 Regions
in China
30 or 31 months
“Priority Application”
ü Buy time/delay filing

ü Preserve priority date
Note: Countries/regions that are not members to the PCT are not
covered by the PCT scheme, e.g. Hong Kong, Taiwan, Argentina

Trademark

Trademark
• A sign capable of distinguishing the goods (or services) of one enterprise
from those of other enterprises
• Right to use & exclude others from using the mark in relation to certain
categories of goods/services
• Protection arises from

• Actual use (common law) – first-to-use, protected in the place of use (™)
• Registration®
• China – mandatory, first-to-file
• HK – extra protection under TM Ordinance
• U.S. – national protection; sue against infringement
• Term of protection – everlasting; renew usually every 10 years
www.apple.com/
www3.gehealthcare.com/en/Global_Gateway
Protection of Brand with Trademark & Design Patent
www.trademarkologist.com/2013/11/build-your-brand-using-frequent-filer-lessons-from-coca-cola/

Trademark – Two Prime Requirements
• Distinctiveness (Capacity to distinguish)
• i.e. clearly set your goods/services apart from others’
• Same/similar marks for same/similar goods/services exist?
• Purely descriptive of goods/services? (IVORY – jewelry vs soap)
• Become generic description through usage?
e.g. ASPIRIN = acetylsalicylic acidà No longer distinctive
e.g. Google = search the internet?
• Use in commerce
• Non-use for 3 (e.g. HK, China, U.S.) to 5 (e.g. Europe) consecutive years after
registration – mark vulnerable to non-use cancellation
• 3rd party can request trademark office to cancel non-used or generic TM
• May require evidence to prove use or sufficient reason for non-use

Trademark – Distinctiveness – Strength
More distinctive & registrable
Merely
Fanciful Arbitrary Suggestive Generic
Descriptive
• Xerox • Apple on iPod • 7-11 on stores • Raisin-Bran® • Apple on
• Kodak • Shell on • At-A-Glance on • Food Fair on apple
gasoline calendars supermarkets
v No meaning v An existing v Meaning v Just describe v Common
v Non-existing term being associated the goods e.g. name of a
terms applied on a with goods features, class of thing
thing a new v Not directly quality, v Incapable of
way describe purpose of distinguishing
v No prior goods but goods source of
association somehow goods
with goods suggesting
BRILLIANT
• Diamond – descriptive
Relative concept • Furniture polish – suggestive
• Applesauce – arbitrary

Trademark – Infringement
l Hong Kong
l Identical mark on identical goods/services
l Identical mark on similar goods/services + Likelihood of confusion
l Similar mark (appearance, meaning, sound, or overall commercial impression)
on identical or similar goods/services + Likelihood of confusion
l Likelihood of confusion
Whether the customer will be confused by the mark as to the source of the goods/services?
www.neb.com
www.enterprise.com
l Well-known trademark (e.g. GOOGLE, APPLE) (Paris Convention &

TRIPS)?
Copyright

Copyright !!!
• Three prime requirements

• Expression of idea (vs idea itself)
• Originality (so independent creation not precluded)
• Fixation xxxxx
xxxxx
• Copyrightable works
• Literary, dramatic, musical, artistic work
• Sound recordings, films, TV broadcasts, cable programs
• Works made available to the public on the Internet
e.g. genomic database, images of fluorescent-labeled cells, source/object code of software
• Automatic right
• As soon as the work is created
• Not necessarily be disclosed or registered
• U.S. – work first published in U.S. or created by U.S. nationals must be registered to
bring an infringement lawsuit

Copyright – A Bundle of Rights
• Economic & exclusive rights (HK)
• Reproduction, i.e. copying
• Distribution
• Rental
• Making available online
• Public performance
• Broadcasting
• Adaptation, i.e. production of derivative works
• Individual rights are transferable/licensable, e.g.

l To publish or exhibit a painting
l To perform a song
l To lease a DVD of a movie
l To produce derivative works e.g. from a novel to a movie

Copyright – Authorship
• Authorship
• Author – a person who makes sufficient contribution to the original expression of
the work
• “Work for hire” in U.S. – Author is the body corporate (e.g. employer is the author
of work created by its employee’s)
Monkey Selfie?
Naruto v. Slater (USDC, N.D. California, 2016)

Copyright – Ownership & Duration
• Ownership
l Creator, e.g. writer, composer (most types of work)
l Employer/contractor (“work for hire”)
l HK – Author of a commissioned work is presumed to be the owner; Hirer
enjoys exclusive license in using the work (subject to parties’ contrary
agreement)
• Term of protection
l Expire after a fixed period from the year of creation/publication or death
of authors, e.g. in HK
- 50 years plus lifetime of the author
- 50 years after publication/creation (unknown authorship)

Copyright Infringement – Reproducing a Work
Oscar statue Film poster vs Magazine cover
Photo vs Graphic
? Access
Tattoo ü Access
? Substantially similar
ü Substantially similar
Photo vs Sculpture
ü Access
© 2022 Alice Wong ü Substantially similar 24
Copyright – Non-infringing Uses
• Fair dealing (e.g. HK & China)
Ø China – Twelve exemptions provided by the law
Private study or research
Quote of a small portion of a work in a scholarly article
Report of current events
• Fair use principle (U.S.)

Ø Nature of the use (e.g. non-profit educational or non-commercial uses)
Ø Nature of the copyrighted work (creative or factual; published or not)
Ø Amount and substantiality of the portion taken (quantitative & qualitative;
factual or expressive element)
Ø Effect of the use upon the value of the copyrighted work (personal gain by
copyright owner vs public benefit)

Hong Kong – Fair Dealings with Fair-use Considerations
Fair Dealings
Research and Private Study

+ Four fair-use factors
Education
Criticism, Review, News Reporting
• Research and Private Study

√ Copy for your own purpose
X Copy for the whole class
• Education
e.g. Teachers who distribute copies of work via school network must limit the
access and cannot store the copies in the network > 12 months

Basics in Patent

Questions…
• Q1 – Can everything new be patented?
• Q2 – Mary presented her experimental findings at a conference held

in HK, can she later patent her invention in Europe?
• Q3 – Peter invented a coffee maker and put it on sale. Can he get a

patent for his coffee maker?
• Q4 – I got a Chinese patent for my infant milk formula. Company A

reproduced and sold my product in HK. Can I sue company A for
patent infringement?
http://analytical-skills.amanet.org/ © 2022 Alice Wong 28

Patents & Biotechnology

http://www.sciencedirect.com/science/article/pii/S0092867413005710
Patent - Biotechnology
Process/Method Machine
• Treating/diagnosing diseases • DNA sequencer
• Preparing a composition • Cell incubator
• Drug screening • Balloon catheter
• Culturing cells • Surgery robot
Manufacture Composition of matter

• Gene, protein • Compounds
• Vector, vaccine, antibody • Mixtures
• Microorganism, cell line
• Transgenic animal

Patent
• A right granted by the government to an inventor to exclude others, for a
fixed period of time, from making, using, selling, importing, or offering for
sale the patented products, or using the patented method, or using, offering
for sale, selling or importing the products made by the patented method
• Granted by the Government, but policed by the right holders
• Territorial protection
§ No international protection
§ US ¹ CN ¹ HK
• “First-to-File”
• Biotech invention: typically takes 3-5 years from beginning to end

U.S. Patent
• Utility (= Invention)
§ Process
§ Machine
§ Manufacture
§ Composition of matter
• Design
• Visual ornamental characteristics on
an article of manufacture
e.g. Apps icon, Coca-Cola bottle
• Plant
http://www.fort-myers-patent.com/
• Asexually reproduced plant

Utility Patent Design Patent
• US 7,869,206 (issued Jan 11, 2011) • US D593,087 (issued May 26, 2009)
Functionality and configuration Appearance

Plant vs Utility Patent (U.S.)
Plant itself (asexually reproduced plant only)
Plant patent PP 25,647 - Heuchera plant named ‘Brown Sugar’
1. A new and distinct cultivar of hybrid Heuchera plant named ‘Brown Sugar’ as herein illustrated and
described.
Different aspects of the plant (other types of plants)

Utility patent US 9,040,779 - Soybean variety A1035446
1. A plant of soybean variety A1035446, wherein a sample of seed of said variety has been deposited under
ATCC Accession No. PTA-13306.
4. A seed of soybean variety A1035446, wherein a sample of seed of said variety has been deposited under
ATCC Accession No. PTA-13306.
5. A soybean plant that expresses all of the physiological and morphological characteristics of soybean
variety A1035446, wherein a sample of seed of said variety has been deposited under ATCC Accession No.
PTA-13306.
6. A method of producing soybean seed, wherein the method comprises crossing the plant of claim 1 with
itself or a second soybean plant.
19. A method of producing a commodity plant product comprising collecting the commodity plant product
from a plant of soybean variety A1035446, wherein a sample of seed of said variety has been deposited
under ATCC Accession No. PTA-13306.

Patent – U.S. vs China
U.S. China
Utility 20 years Invention 20 years
Design 15 years Design 15 years
Plant 20 years /
/ Utility model 10 years
U.S. China
Utility Patent 發明專利 Invention Patent 發明專利 Utility Model 實用新型
Any new and useful process, Any new technical solution

machine, manufacture, or Any new technical solution relating to the shape, the
composition of matter, or any relating to a product, a process structure, or their
new and useful improvements or improvement thereof combination, of a product,
thereof which is fit for practical use
http://www.uspto.gov/
http://www.sipo.gov.cn/ © 2022 Alice Wong 35
Patent – Hong Kong
http://www.ipd.gov.hk/chi/home.htm
• Design – 25 years
• Short Term Patent & Standard Patent

Short-term Standard
Term 8 years 20 years
Registration Apply directly to HK Re-registration: Original grant:
Patents Registrar • First apply to • Apply directly to
designated patent HK Patents
offices (UK/EU/CN) Registrar
• Then file request to
record & register with
HK Patents Registrar
Examination Formality only Formality Substantive +

(Substantive matters Formality
only arise in
infringement
proceedings)
"Under section 101, a person may have invented a
machine or a manufacture, which may include
anything under the sun that is made by man. . . .”
Diamond v. Chakrabarty, 447 U.S. 303 (1980)
Chief Justice Warren E. Burger

What Cannot be Patented?
U.S. China
Abstract idea Rules and methods for mental activities
Laws of nature Scientific discoveries
Natural phenomena /
Natural products
/
e.g. Purified protein, gene, chemical etc.
Methods for diagnosis or treatment of diseases

/ √ Products/devices for treating/diagnosing diseases
√ Uses of composition to prepare drugs
Human organisms Animal and plant* varieties

Sole utilization of special nuclear material or Substances obtained by means of nuclear
atomic energy in an atomic weapon transformation
Invention violating laws, social ethics or harms

the public interest e.g. human embryonic stem
cells
* Protected by other systems

© 2013 Law Offices of Albert Wai-Kit Chan, PLLC
What are Claims?
• Define the scope of your rights
“Consisting of” vs “Comprising” A, B and C
Independent claim
§ Broadest, stand alone
Claim 1: A composition comprising a calcium compound and vitamin D.
Dependent claim
§ Narrower: further limits a claim, or incorporates extra features into the
claim
The composition of claim 1, wherein the calcium compound is calcium acetate, calcium
carbonate, or calcium citrate.
The composition of claim 1, further comprising magnesium acetate.

Independent claim
Dependent claim

Example 1
(Claims 11-12 skipped)

Use
Product

Example 2

Example 2
Product
Manufacturing
method
© 2022 Alice Wong Use45

Example 3
Device

How to Circumvent a Claim?
• Example 1
A food/dietary supplement …, which comprises:
(a) an alkanoyl L-carnitine selected from the group consisting of
isovaleryl L-carnitine, and propionyl L-carnitine or the
pharmacologically acceptable salts thereof or mixtures thereof; and
(b) ribose,
wherein the weight ratio of ingredients (a):(b) ranges from 1:1 to 1:10.
• Product A: L-carnitine & ribose at 1:1 weight ratio

Product B: Propionyl L-carnitine & ribose at 1:12 weight ratio
• Example 2
A supplement consisting of (a) and (b).
• Product C: (a) and (b)

Product D: (a), (b) and (c)

Five Basic Patentability Requirements
• Statutory requirements for patentability (U.S.):
§ Utility (35 U.S.C. §101)
§ Novelty (35 U.S.C. §102)
§ Non-obviousness (35 U.S.C. §103)
§ Written Description (35 U.S.C. §112)
§ Enablement (35 U.S.C. §112)
• 授予專利權的條件 (中華人民共和國)
§ 授予專利權的發明和實用新型，應當具備新穎性、創造性和實用性。(專利法第
二十二條)
§ 說明書應當對發明或者實用新型作出清楚、完整的說明，以所屬技術領域的技術
人員能夠實現為準。(專利法第二十六條)

Utility
• Useful
• Specific and substantial utility (U.S.)
• Industrial applicability 實用性 (China)
§ Exclude methods for treatment, surgery, and diagnosis practised on human or
animal body

Novelty
• Not novel when an invention is:
§ Described in a patent/application publication
§ Described in a printed publication
§ In public use Prior Art
§ On sale
§ Otherwise available to the public (e.g. oral presentation)
First to file!
• Anywhere in the world!
A and B disclosed the same C filed a patent application

composition. for the same composition.
A disclosed B disclosed C filed

April 28, 2017 January 29, 2018 March 1, 2018

Novelty - Grace Period (U.S.)
• 1 year grace period
§ Inventors can file a patent application after disclosure made by the
inventors, or others who obtained the invention directly/indirectly from the
inventors
C filed a patent application

for the same composition.
A and B disclosed the same A also filed an application

composition. for the same composition.
April 28, 2017 January 29, 2018 March 1, 2018 April 27, 2018
A disclosed B disclosed C filed A filed
NOT prior art against NOT Prior art against

A’s application A’s application

Non-obviousness (Inventiveness)
• Teaching or motivation in a combination of disclosures and/or common
knowledge in the field
• An invention is obvious if, without inventiveness, a person having ordinary skill
in the field would have achieved the same invention with the existing
knowledge
• “Obvious to try” with a reasonable expectation of success
www.jafarilawgroup.com

Novelty vs Non-obviousness
NOVELTY NON-OBVIOUSNESS
Looks at similarities between the invention Assesses differences between the invention and
and prior art prior art
The invention must not be anticipated by a Presupposes that no single piece of prior art
single piece of prior art contains all the elements of a claim, but a
combination
An invention is novel if no single piece of prior Involves a qualitative judgement that the
art contains each and every element of the differences between the prior art and the
claim invention are sufficiently inventive or substantial

Exemplary rationales that may support a conclusion of obviousness include:
1. Combining prior art elements according to known methods to yield predictable results;
2. Simple substitution of one known element for another to obtain predictable results;
3. Use of known technique to improve similar devices (methods, or products) in the same way;
4. Applying a known technique to a known device (method, or product) ready for

improvement to yield predictable results;
5. “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a
reasonable expectation of success;
6. Known work in one field of endeavor may prompt variations of it for use in either the same
field or a different one based on design incentives or other market forces if the variations
are predictable to one of ordinary skill in the art;
7. Some teaching, suggestion, or motivation in the prior art that would have led one of
ordinary skill to modify the prior art reference or to combine prior art reference teachings to
arrive at the claimed invention.
Secondary Considerations – Infer that an Invention
is NOT Obvious
1. Commercial success
2. Long-felt but unmet need
3. Failure of others
4. Copying
5. Adoption by the industry
6. Licensing and acquiescence by others
7. Professional approval or skepticism
8. Unexpected results
Reference 1: Calcium reduces bone loss.
Reference 2: Vitamin D promotes calcium absorption in the gut.
Claim 1: A method of treating osteoporosis in a subject using calcium and vitamin D.
www.ipwatchdog.com

KNOWN in the field (Reference)
DNA ––XXX-XXX-XXX-TCA-XXX-XXX-XXX––
Protein ––X–X–X–S–X–X–X–– [Active site residues]
Invention 1
A DNA ––XXX-XXX-XXX-TCC-XXX-XXX-XXX––
encoding a polypeptide ––X–X–X–S–X–X–X––
Examiner: DNA is novel but obvious variation [identical polypeptide].
Invention 2
A DNA of ––XXX-XXX-XXX-TTA-XXX-XXX-XXX––
encoding a polypeptide ––X–X–X–L–X–X–X––
Examiner: Obvious, absent any unexpected property.
Invention 3
A DNA ––XXX-XXX-XXX-TAA-XXX-XXX-XXX
––X–X–X–END
Examiner: maybe allowed if the protein is still functional.

Written Description and Enablement
• Quid Pro Quo (Something for Something):
• Patentee gets the right to exclude others for a period of time
• Public gets full disclosure of the inventor’s best ideas about how to make and use
the invention
• CANNOT withhold necessary details of your invention to prevent others from
copying
• Three distinct disclosure requirements (35 U.S.C. §112)
Written Description Enablement

• Enable one skilled in the art to make and use the
• Describe in full, clear, concise and exact terms claimed invention without undue experimentation
• Show possession of full scope of an invention • Working example(s) and methodology
Best Mode
• Must disclosure the best mode of making and
using the invention as contemplate
• Do NOT need to point it out

Support for a Broad claim - Unpredictability
What you have:
Saccharomyces cerevisiae secreting human growth factor X.
Claim 1. A microorganism capable of secreting a human growth factor.
Claim 2. The microorganism of claim 1, wherein the microorganism is a

protozoan, a fungus, a yeast or a bacterium.
Claim 3. The microorganism of claim 1, wherein the microorganism is a yeast.
Claim 4. The microorganism of claim 3, wherein the human growth factor is

human growth factor X.
Claim 5. The microorganism of claim 1, wherein the microorganism belongs to

the genus Saccharomyces and the human growth factor is human growth
factor X.
Qs: (1) Adequacy of data & description provided, (2) Predictability of the technology

Broad Claims - Unpredictability
• We all want the broadest protection

• Whether the claim
• has gone beyond what is disclosed in the written description?
• is adequately supported by the written description?
• WHY DEPENDENT CLAIMS?

• Independent claims: reasonable scope
• Dependent claims: cover individual variants described in the specification

Trade Secret

Trade Secret
• Kept confidential
• Used in a business
• Beneficial to the owner
e.g. “Know-how”, “Show-how” www.the-patent-attorney.com
http://www.unemed.com/blog/how-trade-secrets-work

Patent Trade Secret
Subject matter Patentable items or methods Virtually everything
Disclosure Full disclosure Confidential
Effective time for Upon approval of patent Immediate protection

protection
www.mhc.ie
Protection 20 years Unlimited
Cost Higher - Filing, prosecution, Lower(?) - Costs for maintaining

maintenance and attorney fees secrecy
Risks Loss of right if patent is invalidated Right lost upon disclosure; has no
or held unenforceable control in reverse engineering and
independent development
Which should you opt for?

• Patentable subject matter?
• Can the invention be easily circumvented?
• Information can be obtained by reverse-engineering of a product on market?
• Will disclosure facilitate your competitor?
• Will it be difficult to keep it as trade secret?
• Hot area – everyone races to find the solution to the same problem?

Inventorship vs. Ownership

Inventorship vs. Ownership
• I am a research student
• I created an idea
• I worked hard & obtained promising data
• I kept secrets on the data
• I patented my invention
• Investors coming in
• I going to commercialize the invention & get rich!!
Wait - Who OWNS the invention?
www.patentacademyonline.com

Who is an Inventor??
Inventor
1. Conceive a complete and definite
idea of the invention
à Mental act of coming up with the
invention
AND
2. Reduce to practice of the conceived

idea
à Physical step of bringing the idea to
physical fruition
• Actual – Experiments/Prototypes, or
• Constructive – Filing patent app’l

Inventorship Determination
• Determined by patent attorney/agent based on one’s contributions to the claimed invention.
Labour
• A pen comprising A, B and C.

v X conceived A, B & C and built the
prototype.
General
Inventor? v Y contributed the money to build the
Money
ideas
prototype.
v Z built the prototype with X under
Supervision
X’s instruction.
of routine
experiments
• U.S. – false inventorship with deceptive intent may render a patent unenforceable.
• Always identify the right inventors & never omit a true inventor!

What if I Co-write the Paper or Patent App’l?
• Inventorship ≠ Authorship on scientific publication

Inventor Author
• An author is a person who makes sufficient contribution to the

original expression of the work (writing, drawing etc.)
• Author may or may not be relevant to the “inventing” process
• e.g. write-up introduction/conclusion/findings
• Title of paper, proofreading?

Ownership
• Owners – Right to possess
l Employers or employees? Inventor
l University or researchers?
l Check university policy, employment contract etc.
Created/made in the course of employment and responsibilities? Author Owner
Made significant use of the university’s resources?
• Transferrable (cf Inventorship/authorship)

• Co-owner can freely practice or license a patent without other co-
owners’ consent
• Standing to sue against infringement
http://www.cuhk.edu.hk/chinese/aboutus/message.html

THANK YOU!
Email: alicewonginss@gmail.com

2022-02-26 IPR in Biotechnology (Student)

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Alice Yuen-Ting Wong, Ph.D.

© 2022 Alice Wong 2

© 2022 Alice Wong 3

• Positive Right (Right to use) vs Negative Right (Right to exclude others)

• Four main types

Research Advance technology/

© 2022 Alice Wong 5

Research Evaluate market: Advance technology/ Investment/

© 2022 Alice Wong 6

Patent Term 20 years Up to 5 years

IND NDA FDA

From lab to patients 10-15 years Data exclusivity 5 years

Patent Term (plus extension) 20-25 years

© 2022 Alice Wong 8

• May 17, 2012

© 2022 Alice Wong 9

0.6 ↓ 40% in Q2 to 935 millions

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2. Patent Cooperation Treaty (PCT)

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Prior Application PCT Application Publication

ü Buy time/delay filing

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• Protection arises from

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l Well-known trademark (e.g. GOOGLE, APPLE) (Paris Convention &

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• Three prime requirements

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• Individual rights are transferable/licensable, e.g.

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Naruto v. Slater (USDC, N.D. California, 2016)

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• Fair use principle (U.S.)

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Research and Private Study

Criticism, Review, News Reporting

• Research and Private Study

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• Q2 – Mary presented her experimental findings at a conference held

• Q3 – Peter invented a coffee maker and put it on sale. Can he get a

• Q4 – I got a Chinese patent for my infant milk formula. Company A

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Manufacture Composition of matter

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• Granted by the Government, but policed by the right holders

• Biotech invention: typically takes 3-5 years from beginning to end

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Functionality and configuration Appearance

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Different aspects of the plant (other types of plants)

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Any new and useful process, Any new technical solution

• Short Term Patent & Standard Patent

Examination Formality only Formality Substantive +

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Methods for diagnosis or treatment of diseases

Human organisms Animal and plant* varieties