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What is IP, Patents in PharmaWhat is IP, Patents in Pharma
IndustryIndustry
by
DR ANTHONY CRASTO
JAN 2015
01/28/15 1
◦ What is innovation ?
◦ What is intellectual property ?
01/28/15 2
http://drugpatentsint.blogspot.in/
http://fdazilla.com/drugs/generic/
http://ep.espacenet.com
http://www.druglead.com/
http://www.accessdata.fda.gov/scripts/cder/ob/
http://chem.sis.nlm.nih.gov/chemidplus/
◦ Think
◦ Imagine
◦ Create (Creations of the mind)
 WHAT WE CREATE OUT OF THIS PROCESS
IS INTELLECTUAL PROPERTY – VALUE
01/28/15 3
Innovation and Intellectual Property
Knowledge (IP – Intangible property) is
cumulative with each idea building upon
the last,
whereas
Machines (Tangible property) deteriorate
and must be replaced
01/28/15 4
Property
Patents
Copy Rights©
Trade marks®
Geographic Indications
Protection of undisclosed
information
Layout designs of integrated circuits
Industrial designs
01/28/15 5
Types of IP
6
What does IP mean?What does IP mean?
Trademarks
Patents
Designs
Utility models
Includes also:
Copyright
Unfair Competition
Business Secrets
Manuals
Domain names
etc…
That’s all very interesting…That’s all very interesting…
But how does IP help
my research?
Why should I invest in
protecting my IP?
BUNDLE OFBUNDLE OF IPIP ASSETSASSETS
 A marketing tool
 A source of revenue through licensing/acquisition
 A crucial component of franchising agreements
 Useful for obtaining banks or third party financing
 A valuable business asset
BUSINESS AND YOUR IPBUSINESS AND YOUR IP
Be proactive: Invest in protecting your
bundle of business assets.
Be vigilant: Watch for potential
infringers – license, acquire
Be assertive: Protect your business
assets
Forms of Intellectual PropertyForms of Intellectual Property
Term
Life + 70 years
14 years
20 years
10 years * X
∞
01/28/15 11
PATENTS ACT 1970PATENTS ACT 1970
PATENT- DEFINITION
Exclusive right for being the true and first
inventor of a product or process, granted by the
govt. for a limited period, to exclude others from
making, using, selling or importing the patented
product or process without his consent, in
exchange of full disclosure of his invention .
Term- 20 years from the Date of Filing(S.53)
Patent JurisdictionsPatent Jurisdictions
A patent is only valid in the jurisdiction in
which it is granted
World Intellectual Property Organization
(WIPO)
◦ Patent Cooperation Treaty (PCT)
◦ Provides World filing for Patent Application
What is a patent?What is a patent?
Is grant by a government or
government agency.
To an inventor
Right to exclude others from
◦ Making
◦ Using
◦ Selling
◦ Offering for sale
◦ importing
01/28/15 13
PatentPatent
Exclusive monopoly in exchange for
disclosure of invention
Disclosure
Time-limited Monopoly
Anatomy of a PatentAnatomy of a Patent
01/28/15 16
Lifecycle of a patentLifecycle of a patent
Publication Vs. PatentPublication Vs. Patent
Scholarly Publication
 Authorship somewhat
negotiable
 Must have done the work
 Effort paramount
 Future ideas can interfere
with subsequent patentability
 Only directly comparable
results can lead to loss in
priority
Patent
 Inventorship a matter of law
 “Constructive reduction to
practice” encouraged
 Conception paramount
 Disclosure of ideas for as
many future uses as possible
strengthens the patent
 Results from analogous
systems can result in prior art
and obviousness rejections
Documenting InventionsDocumenting Inventions
Keep a notebook!
Keep the pages sequential
and clearly dated.
Documenting InventionsDocumenting Inventions
Write down your experiments!
(especially the ones showing
structure of the invention and how
to make the invention) = “reduction
to practice”
Also write down significant ideas!
(ditto!) = “conception”
Documenting InventionsDocumenting Inventions
Periodically show your notebook to
someone else in the lab who is not an
inventor (but who has an obligation of
confidentiality and can understand what
you are telling them).
Have that witness sign and date the
pages and indicate that they have “read
and understood”the content.
01/28/15 22
Patents are granted for inventions
which are technical, that is inventions
which are capable of being
industrially exploitable
What is patentable?
01/28/15 23
A Product
The apparatus for producing the product
The process
The use
What can be patented?
01/28/15 24
What cannot be patented?
Computer programmes
Medical and surgical treatments
Mathematical methods
Business methods
Discoveries
Aesthetic creations
New species of plant or animal
Inventions which are contrary to moral standards
and public order (e.g. instruments of torture)
The human body and any non-separate part/s
thereof
InfringementInfringement
“Infringement” of a patent occurs when a
competitor makes, uses, sells, offers to sell
or
imports an embodiment of the invention
without the permission of the patent
owner.
Direct infringementDirect infringement
A person directly infringes a patent by making, using,
offering to sell, selling, or importing into the US any
patented invention, without authority, during the term of the
patent.
Unlike direct infringement, which does not require
knowledge of the patent or any intent to infringe.
While the United States Patent Act does not directly
distinguish "direct" and "indirect" infringement, it has
become customary to refer to describe infringement under 35
U.S.C. § 271(a) as direct infringement, while grouping 35
U.S.C. § 271(b) and 35 U.S.C. § 271(c) together as "indirect"
ways of infringing a patent.,
28/01/15 26
Indirect InfringementIndirect Infringement
Accused has some knowledge and intent
35 U.S.C. § 271(b) "active inducement of infringement “by
encouraging, aiding, or otherwise causing another person to
infringe. Inducer must be aware of the patent and intend.
35 U.S.C. § 271(c) "contributory infringement," is triggered
when a seller provides a part or component that, while not
itself infringing of any patent, has a particular use as part of
some other machine or composition that is covered by a
patent.[3]
If there are other valid uses for the product.
Only occurs when there has actually been a direct
infringement of the patent. There must have been at least one
instance where the inducement or contribution resulted in the
practice of the patented art. 28/01/15 27
28
Consequences of infringingConsequences of infringing
If you infringe someone else’s patent, you
may risk:
Injunction, which means that all your
products may be removed from the
market
Destruction of your products
Paying damages to the patent owner
Being given a fine, e.g. the Kodak vs.
Polaroid case
Being sentenced to imprisonment (in
gross cases)
Type of patents?Type of patents?
Utility patents
Plant patents
Design registration
01/28/15 29
Utility patentsUtility patents
Structural or functional aspects of
◦ Products
◦ Composition
◦ Process
01/28/15 30
Utility PatentUtility Patent
01/28/15 31
Plant patentsPlant patents
New variety of living plants
01/28/15 32
Plant PatentPlant Patent
01/28/15 33
Design PatentDesign Patent
01/28/15 34
Design registrationDesign registration
Ornamental designs of useful objects
In US designs are patentable.
01/28/15 35
Is this gives right to marketIs this gives right to market
No
A separate permission is required to
make use
◦ DCA or DCGI approval is required to market
pharmaceutical products.
01/28/15 36
01/28/15 37
The Patent ProcessThe Patent Process
Allowance
Approach to Obtaining a Patent &Approach to Obtaining a Patent &
CommercializationCommercialization
 Disclosure: Ideally when you can describe both what the invention is and
what it accomplishes
 Evaluation:
◦ Can this invention be patented?
 Is there any prior art? Is this invention new, useful, & non-obvious?
◦ Is it worthwhile to patent this invention?
 What product could come from this patent? Is there a market for said product?
 Provisional application: Preserves worldwide rights against initial
disclosure; gives you 1 year to decide whether or not to pursue patent
 Initial publication: If you publish prior to filing a provisional application you
lose the rights to file internationally
DISCLOSURE INITIAL PUBLICATION
~3 MONTHS
FILE PROVISIONAL
APPLICATION (~$10k)
EVALUATE
 Patent Cooperation Treaty (PCT): an international application which
claims priority to a provisional US application & have option for protection
for up to 111 countries.
RE-EVALUATION
FILE PCT
(~$25K)
PCT
PUBLICATION
12 MONTHS
8 MONTHS
6 MONTHS
Approach to Obtaining a Patent
& Commercialization
12 MONTHS
RE-EVALUATE RE-EVALUATE
Approach to Obtaining a Patent &
Commercialization
ENTER NATIONAL PHASE
& PROSECUTION(~$20K)
 Continuation of marketing/finding a licensee as well as additional
publications
 National stage applications with expensive examination rounds
DISCLOSURE INITIAL
PUBLICATION
RE-EVALUATION RE-EVALUATIONRE-EVALUATION
Overview of Pathway to Commercialization
FILE PROVISIONAL
APPLICATION (~$10k)
EVALUATION
3 MONTHS
FILE PCT
(~$25K)
PCT
PUBLICATION
8 MONTHS
12 MONTHS 6 MONTHS 12 MONTHS
ENTER NATIONAL PHASE
& PROSECUTION (~$20k)
RARELY GET
THIS FAR
W/O LICENSEE
PATENTABILITY &
MARKETING EVALUATION
MARKETING/SEARCH FOR LICENSEE
GENERATE NCD
ADDITIONAL PUBLICATIONS W/
INTERESTING ANIMAL DATA,
PROTOTYPING, FURTHER
COMMERCIALIZATION
Some common termsSome common terms
Application
Best mode
Claims
Conception
Dependent claim
Examiner
Failure of others
01/28/15 42
Some common terms …contSome common terms …cont
How to make
Independent claim
Invention
Novelty
Obviousness
Preferred embodiment
01/28/15 43
Some common terms …contSome common terms …cont
Prior art
Provisional application
Specification
01/28/15 44
Some common terms …contSome common terms …cont
Application
◦ A written document seeking patent
protection filed with patent office.
Best mode
◦ A patent application is required to disclose
the best means known to the applicant of
practicing the invention as of the date of filing
the application
01/28/15 45
Some common terms …contSome common terms …cont
Claims
◦ A claim is one of the numbered paragraphs that
appear at the end of a patent and defines the scope of
protection given to the owner of the patent
◦ Each claim is treated separately for purposes of
determining validity and infringement. For example,
claims may be directed toward apparatus, methods,
products, and compositions of matter and new and
useful improvements thereof.
01/28/15 46
Some common terms …contSome common terms …cont
Conception
◦ is the creation of the mental concept of the
invention.
Dependent claim
◦ is a Claim+ that makes express reference to
and depends on a prior claim
◦ thereby, incorporates by reference all of the
recitals of the prior claim
01/28/15 47
+http://www.tms.org/pubs/journals/JOM/matters/matters-9609.html#claim
Some common terms …contSome common terms …cont
Examiner
◦ An employee of a patent office to whom an
application is assigned for handling prosecution.
Failure of others
◦ A secondary test of patentability relevant to the issue
of whether an invention is obvious is whether others
have failed to come up with the solution previously.
01/28/15 48
Some common terms …contSome common terms …cont
How to make
◦ This is part of the obligation to provide a
disclosure in the patent application that
would enable one skilled in the art to practice
the invention without engaging in undue
experimentation.
01/28/15 49
Some common terms …contSome common terms …cont
Independent claim
◦ is a claim that stands by itself and must be so
read in terms of infringement and validity
evaluations. This is contrasted with a
dependent claim.
01/28/15 50
Some common terms …contSome common terms …cont
Invention
◦ in order to have a patentable invention, one
must have a development that is
 useful,
 novel (no single prior art reference shows the
identical development), and
 unobvious to one skilled in the art
at the time the invention was made,
01/28/15 51
Some common terms …contSome common terms …cont
Novelty
◦ is present if no single piece of prior art
discloses every element of the claimed
invention.
01/28/15 52
Some common terms …contSome common terms …cont
Obviousness
◦ If the invention could readily be deduced at the time
the invention was made from publicly available
information (prior art) by a person of ordinary skill in
that art, it is obvious.
◦ Prior art may be combined to show that an invention
would have been obvious.
01/28/15 53
Some common terms …contSome common terms …cont
Preferred embodiment
◦ The preferred embodiment of an invention
can usually be interpreted as being recited as
the best mode known to the inventor of
carrying out the invention.
01/28/15 54
Some common terms …contSome common terms …cont
Prior art
◦ The existing body of technological
information against which an invention is
judged to determine if it is patentable as being
novel and unobvious.
◦ It must be early enough in time to be cited
against the application.
01/28/15 55
Some common terms …contSome common terms …cont
Provisional application
◦ an applicant can file a patent specification
complying with standards and get the filing
date as a priority date.
◦ for a complete patent application filed within
one year thereafter claiming the benefit.
01/28/15 56
Some common terms …contSome common terms …cont
Provisional application
◦ The provisional application does not
have to contain claims.
◦ The effective filing date of the full
application for purposes of avoiding
prior art will be the filing date of the
provisional application.
◦ but will have the benefit of the date of
filing the full application for purposes of
the 20 year patent term.
01/28/15 57
Some common terms …contSome common terms …cont
Specification
◦ The part of the patent application that
precedes the claims and in which the
inventor specifies, describes, illustrates,
and discloses the invention in detail.
01/28/15 58
Intellectual Property
◦It Starts With An IDEA
01/28/15 59
An invention can only be protected by
patent if it is novel
(no prior publication of the invention).
Therefore, it is essential not to disclose the
invention publicly until after a formal patent
application has been filed.
01/28/15 60
Any printed publication in
a newspaper,
scientific journal,
or
other written form
available on an unrestricted basis is considered a public
disclosure,
as is an oral presentation at a public meeting.
Note that an abstract and, in some cases,
even a title may act to bar patentability if it discloses all
the necessary elements of the invention.
01/28/15 61
Rights and responsibilitiesRights and responsibilities
Obtaining and maintaining IP, especially patents
require many actions and funds.
Patent search
Patent filing
Handle opposition and objections
Renewal of patents
Handle infringement
Licensing and transfer of IP
01/28/15 62
IP policyIP policy
Will IP policy make a difference?
Institutes ought to generate their own
resources.
Hence management will drive research
programmes accordingly.
Clarity will help faculty in making choices.
Who doesn’t like money?01/28/15 63
01/28/15 64
Patent Filing ProcessPatent Filing Process
01/28/15 65
66
Patent Application ProcessPatent Application Process
(2-5 Years on Average?)(2-5 Years on Average?)
1. Conceive the invention
2. Write the application
3. File the application
4. Meet the application formalities – e.g., declaration, formal
drawings
5. Examination process begins
6. Restriction requirement issued – sometimes
7. Substantive Office Action issued
8. Reply filed (usually there will be multiple iterations of this
and the above step before an allowance is obtained)
9. Appeal filed
10. Application Allowed
11. Pay necessary fees – file continuations?
12. Patent issues
13. Pay Maintenance Fees
01/28/15 67
Filing processFiling process
Provisional application
Non provisional application
01/28/15 68
Provisional applicationProvisional application
Specifications
◦ Title
◦ Introduction to the invention
◦ Drawings (if required)
◦ Model (upon request from PO)
01/28/15 69
Non provisional applicationNon provisional application
Specifications
◦ Title
◦ Introduction to the invention
◦ Drawings (if required)
◦ Model (upon request from PO)
01/28/15 70
71
What is a Provisional Application?What is a Provisional Application?
Establishes a filing date (earliest priority
date)
Examination process does not begin
Clock does not start running on lifetime
of patent
Has simpler filing requirements
Lower filing fees
Claims are not required
Non provisional applicationNon provisional application
Specifications
◦ Detailed description
◦ Examples (best mode)
◦ Claim(s)
◦ Abstract
01/28/15 72
Prior art searchPrior art search
Patents
Literature articles
Journals
Scientific Presentations
01/28/15 73
Prior art searchPrior art search
Patents
◦ US ……….http://www.uspto.gov/
◦ EU……http://ep.espacenet.com/
◦ WIPO….http://www.wipo.int/ipdl/en/search/p
ct/search-simp.jsp
Japan Patent Office
http://www.jpo.go.jp/
01/28/15 74
USPTO WebsiteUSPTO Website
www.uspto.gov
PATENTS Tab
© Copyright 2014 75
Prior art searchPrior art search
Patents & Published literature
◦ Scifinder
◦ Prous integrity
◦ Reaxys
◦ Thomson cortellis
◦ Google
01/28/15 76
Prior art searchPrior art search
Published literature
◦ www.sciencedirect.com (for elsevier journals)
◦ www.tandf.co.uk/journals/online.asp (for journals of
dekker and taylor and francis publishing)
◦ www.ncbi.nlm.nih.gov/entrez/query.fcgi (med line-
gives elsevier journals also)
01/28/15 77
Prior art searchPrior art search
Published literature
◦ www.aapspharmscitech.org (free full text articles
published in AAPS Pharm Sci Tech, an online journal)
◦ http://pubwww.srce.hr/acphee/ (acta pharmaceutica-
full text for last 2 years and abst for older journals)
01/28/15 78
http://www.ingentaconnect.com/content;jsessionid=1
3rvsr25ic2q1.victoria (many journals esp british)
pubs.acs.org/journals (journals of American
Chemical Society)
www.blackwell-synergy.com (Blackwell Synergy
Publications
01/28/15 79
Applicant’s expectationsApplicant’s expectations
Applicant is always interested in
◦ Low cost to file
◦ Less time in prosecution
◦ Less time in granting
◦ Minimum cost in maintainance
All of this is only possible with PCT filing
process
01/28/15 80
01/28/15 81
01/28/15 82
What is PCTWhat is PCT
Patent cooperation treaty
A United Nations treaty
◦ Signed in June 1970
◦ Became operational in June 1978
◦ Administered by the International Bureau (IB)
of the World Intellectual Property
Organization (WIPO) in Geneva, Switzerland
01/28/15 83
Purpose of PCTPurpose of PCT
To simplify the process of filing foreign
patent applications
To give every regional and national
patent office the benefit of a search and a
preliminary report on patentability by a
major patent office
01/28/15 84
PCTPCT
This system provides
◦ A common filing process.
◦ Minimizes the expenses in filing process.
◦ Gives enough time for an applicant to think
and choose the territory he would like to
cover.
01/28/15 85
What PCT providesWhat PCT provides
There is no “international patent.”
The Patent Cooperation Treaty (PCT)
functions as a patent application filing system.
The applicant must still prosecute the
international application in each national or
regional office in order to obtain a patent.
01/28/15 86
Traditional filingTraditional filing
01/28/15 87
0 12
File Application
Locally
File Applications
Abroad
(Months)
PCT FilingPCT Filing
01/28/15 88
File Demand
File First
Application
File
PCT
International
Search
Report/
Written
Opinion
International
Publication
0 12 16 18
International
Preliminary
Examination
(Months)
OR
30
20
Enter
National
Phase
Chapter I
Chapter II
30
01/28/15 89
01/28/15 90
Patent Time LinePatent Time Line
© Copyright 2014 91
File
Provisional Patent
Application
$
File
US Nonprovisonal
and/or PCT
Application
$$
Patent
Application
Publishes
Enter National
Stage
$$$
0 1 yr 18 mo 30 mo
21 yrs
(20 from PCT Appl.)
25 yrs
Patent
Issues
Patent
Expires
Up to 5 years
Patent Term
Restoration
(drugs)
35 USC §156
23 yrs
Up to 3 years
Patent Term
Adjustment for
USPTO Delays
35 USC §154
30 mo0
01/28/15 92
93
Patent Cooperation Treaty (PCT)Patent Cooperation Treaty (PCT)
 Single place of filing
 International novelty and
patentability search
 Final decision for countries
TILL 30 MONTHS ONE IS SAFE
94
International patent systemsInternational patent systems
Basic principle:
 Patent in each country
The systems:
 Patent Cooperation Treaty (PCT)
 European Patent Convention (EPC)
 Other regional systems (OAPI,ARIPO,
EURASIAN)
01/28/15 95
96
Active PharmaceuticalsActive Pharmaceuticals
01/28/15 97
Five basic patent searchesFive basic patent searches
Application number
Patent number
Assignee name
Inventor name
Subject search
 By Chemical structure or chemical name
 Solid/crystalline/hydrated forms (Physical form)
 Purity of the API
 Alternate salts
 Process
 Physicochemical characteristics
 Technology
01/28/15 99
Claims..
01/28/15 100
1. By Chemical structure or Name:
1.1. Claim by large Markush structure – Atorvastatin (US 4,681,893)
Atorvastatin
• Generally possible for innovators
• Entire genus is novel
• No clarity on the final target.
• Broadest claim possible. • No design around possible.
• Invalidation is the only option
01/28/15 101
1. By Chemical structure or Name:
1.2. Claiming by simple structure – Paroxetine intermediate
• Covers limited no of novel compounds.
• Covers possible protecting groups and derivatives.
• Generally possible when a novel scheme is designed for a known
product.
Markush claimsMarkush claims
Typically in chemical cases
Allows broad claiming of many species of
related compounds
Markush groupMarkush group
Markush claimMarkush claim
DETAILED DESCRIPTION - 2,3-benzodiazepine
derivatives of formula (I) and their acid addition
salts are new.
X=H, Cl or OCH3;
Y=H or halo;
Z=methyl or Cl;
R=1-4C alkyl or NR1R2; and
R1, R2 =H, 1-4C alkyl, 1-4C alkoxy or
3-6C cycloalkyl.
01/28/15 105
01/28/15 106
1. By Chemical structure or Name:
1.3. Claiming by Chemical name– Atorvastatin Calcium (US 5,273,995)
• Covers one or two specific compounds and its salts.
• Narrow in scope
• Covers the actual commercial product.
• Highly difficult to invalidate the patent.
• Generally extends the life cycle of the product.
01/28/15 107
2. By physical form:
2.1. By Solid form– Montelukast Acid (US 2005/107426)
• Broad claim possible, if the compound is already known in a non-
solid state.
• Provide great value if some of the impurities are washable only by
purification of the solid intermediate.
01/28/15 108
2. By physical form:
2.2. By Crystalline form– Amlodipine free base (US 6680334)
• Broad claim possible, if the compound is already known in a non-
crystalline form.
• Provide great value if non-crystalline form is significantly
unstable for processing and pure product can be obtained only from
crystalline material.
• Can be used as alternate to API salt form if possible.
• Generally stands in the litigation even-if the genus claim of compound claim is
invalidated.
01/28/15 109
2. By physical form:
2.3. By Specific parameters– Alfuzosin Base (WO 2006/090268)
• Considered as the narrow claim.
• Has value only if the known solid forms are protected or all of
them are unstable for processing.
01/28/15 110
3. By Purity:
3.1. By Purity of the API– Candesartan (US 20050250827 A1)
3.1. By Chiral Purity of the API–Armodafinil (WO 2007/103221)
• API is known but with less purity.
• Provide value if the impurity is a critical & difficult to remove or forms in
stability.
• Competitors will have to use impure materials and end up regulatory issues
01/28/15 111
4. Alternate salts:
4.1. Alternate salts: (Desvenlafaxine – US7001920)
4.1. Alternate salts: (Sitagliptin – US2005032804)
• Narrow in scope
• Covers the actual salt of product.
• Considered as easy to invalidate the patent if other salts are already
known.
• Generally extends the life cycle of the product.
01/28/15 112
4. Diasteriomer salts:
4.1. Diasteriomer as compound (Eszopiclone -WO07/088073)
4.1. Diasteriomer with purity (Duloxetine-WO06/099459)
4.1. Diasteriomer in crystalline form (Eszopiclone -WO07/088073)
01/28/15 113
5. Process for Preparation of API :
5.1. Generic process (Ramelteon)
01/28/15 114
5. Process for Preparation of API :
5.2. Simple process (Paroxetine)
01/28/15 115
5. Preparation of API :
5.3. Specific process (Duloxetine HCl)
01/28/15 116
5. Preparation of API :
5.4. Specific process (Ziprasidone HCl)
01/28/15 117
6. Physicochemical properties :
6.1. PSD of API compound (Ziprasidone HCl -US6150366)
1. A composition comprising crystalline ziprasidone free base or
crystalline ziprasidone hydrochloride particles having a mean
particle size equal to or less than about 85 μ and a
pharmaceutically acceptable diluent or carrier.
6.2. PSD of API compound (Escitalopram -US6916941)
Covers non-crystalline solid Atorvastatin salt having bulk density from about 0.05
to 0.4 g/ml; and mean particle size of about 0.5 to 50 microns
6.3. PSD & BD of API compound (Atorvastatin -WO2007100614)
01/28/15 118
7. Technology:
Synthesis of Piperizine ring (Mirtzapine-US 6852855)
01/28/15 119
7. Technology :
Synthesis of Amino acid amides (Levitiracetum-US 2005/0182262)
Patent Grant Procedure (In Brief)
Filing of PATENT APPLICATION
EXAMINATION & NOVELTY SEARCH
ACCEPTANCE OR REFUSAL
NOTIFICATION OF “ACCEPTANCE”
IN THE GAZETTE OF INDIA (part III section 2)
OPPOSITION (if any)
GRANT OF A PATENT
Thank You
01/28/15 121Extras…
01/28/15 122
US patents vs. non-US patentsUS patents vs. non-US patents
Foreign patent applications published 18-36
months before US patents issue.
After 29 November 2000, the US has published
some applications over a range of dates.
US will still be a slow publishing country for
many applications
Tracking foreign patents give insight to what
will be publishing in the US as all are part of the
same patent family.
A patent familyA patent family
Contains all patents/applications that are linked
by a common priority application number
Includes divisionals, continuations, CIPs
Includes members from other countries or
treaties
Are very useful when answering the most asked
question in patents: “Find an English equivalent
of this non-English patent.”
1) Set a goal, dream, imagine!
2) Write it down!
3) Experiment, develop, modify and
construct your invention.
4) It’s a SECRET!
So...how do you “invent”?
Why would you want one?Why would you want one?
Powerful form of protection
Protects the idea rather than the implementation
No need to show copying. Even an “innocent”
infringer can be stopped
Patents act as a deterrent to a competitor
developing a similar product
May strengthen your negotiating position if you
infringe someone else’s patent
May be a valuable asset in its own right: patents can
be licensed and assigned
NoveltyNovelty
 An invention is new if it does not form part of the
“state of the art”
 The state of the art includes all disclosures that were
made available to the public before the filing date
 This includes written and oral disclosures. Anything
that has been sold and anything published online. In
other words, the entire stock of publicly available
knowledge
 A grace period is applicable in the US. So - Sometimes
patent protection is viable in the US when it is no
longer available in Europe
Inventive StepInventive Step
 An invention involves an inventive step if it is not
obvious (with regard to the state of the art)
 There may be an inventive step if the invention solves a
problem, provides a surprising result, provides an
increase in speed, efficiency etc..
 There must be a technical solution to a technical
problem: a divergence from existing technology that
would not be developed by routine experimentation or
applying known principles
Conclusion
◦ File
◦ File early
◦ Disclose everything that you know
◦ Be ready to negotiate
Commercial exploitationCommercial exploitation
Various strategies can be used to extract value from
patents:
 Exclude your competitors from using the invention
 Develop a thicket of patents to deter competitors from
even considering your technology
 Licensing
 Use the patents to participate in a cross-licensing patent
pool
 Patents as marketing tools
 Patents as defensive disclosures
01/28/15 131
Patent Examining ProcessPatent Examining Process
1. Read1. Read 2. Search2. Search
3. Determine3. Determine
PatentabilityPatentability 4. Communicate4. Communicate
A global perspectiveA global perspective
Patents are territorial: there is no such thing as
an international patent
A UK patent can give you the right to stop
others from making, selling, using and importing
the invention in the UK. It gives no rights in
other countries
A separate patent is required in each country
where protection is required
In practice, it is usually sufficient to obtain
patents in key territories
133
PatentsPatents
Famous Patents – TheFamous Patents – The
TelephoneTelephone
US Patent 174,465 – Alexander Graham
Bell “Improvement in Telegraphy” (1876)
© Copyright 2014 134
Famous Patents – The Light BulbFamous Patents – The Light Bulb
US Patent 223,898 – Thomas A. Edison
“The Electric Light Bulb” (1880)
© Copyright 2014 135
136
INDIA….Regional Patent office’sINDIA….Regional Patent office’s
JurisdictionJurisdiction
Office Territorial Jurisdiction
Patent Office Branch,
Chennai
The States of Andhra Pradesh, Karnataka, Kerala,
Tamil Nadu and the Union Territories of
Pondicherry and Lakshadweep
Patent Office Branch
Mumbai
The States of Maharashtra, Gujarat, Madhya
Pradesh, Goa and Chhattisgarh and the Union
Territories of Daman and Diu & Dadra and Nagar
Haveli.
Patent Office Branch,
New Delhi
The States of Haryana, Himachal Pradesh, Jammu
and Kashmir, Punjab, Rajasthan, Uttar Pradesh,
Uttaranchal, Delhi and the Union Territory of
Chandigarh.
Patent Office, HO
Kolkata
The rest of India
137
INDIA……..How to file a patentINDIA……..How to file a patent
application?application?
 Documents can be filed in the patent office
 through online( e-filing) or
 www.ipindiaonline.gov.in/online
 through post or
 can be submitted by hand
138
GENERAL PROCEDURE FORGENERAL PROCEDURE FOR
OBTAINING A PATENTOBTAINING A PATENT
 Filing of patent application
 Publication after 18 months
 Pre Grant Opposition /Representation by any
person.
 Request for examination
 Examination: Grant or Refusal
 Publication of Grant of patent
 Post Grant Opposition to grant of patent
 Decision By Controller
01/28/15 139
140
INDIA….Statutory Fees:INDIA….Statutory Fees:
Particular Natural person
(Rs)
Other than natural
person (Rs)
For filing patent application 1000 4000
For each sheet of specification
in addition to 30
100 400
For each claim in addition to 10 200 800
01/28/15 141
01/28/15 142
01/28/15 143
01/28/15 144

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What is IP, Patents in Pharma Industry

  • 1. What is IP, Patents in PharmaWhat is IP, Patents in Pharma IndustryIndustry by DR ANTHONY CRASTO JAN 2015 01/28/15 1
  • 2. ◦ What is innovation ? ◦ What is intellectual property ? 01/28/15 2 http://drugpatentsint.blogspot.in/ http://fdazilla.com/drugs/generic/ http://ep.espacenet.com http://www.druglead.com/ http://www.accessdata.fda.gov/scripts/cder/ob/ http://chem.sis.nlm.nih.gov/chemidplus/
  • 3. ◦ Think ◦ Imagine ◦ Create (Creations of the mind)  WHAT WE CREATE OUT OF THIS PROCESS IS INTELLECTUAL PROPERTY – VALUE 01/28/15 3 Innovation and Intellectual Property
  • 4. Knowledge (IP – Intangible property) is cumulative with each idea building upon the last, whereas Machines (Tangible property) deteriorate and must be replaced 01/28/15 4 Property
  • 5. Patents Copy Rights© Trade marks® Geographic Indications Protection of undisclosed information Layout designs of integrated circuits Industrial designs 01/28/15 5 Types of IP
  • 6. 6 What does IP mean?What does IP mean? Trademarks Patents Designs Utility models Includes also: Copyright Unfair Competition Business Secrets Manuals Domain names etc…
  • 7. That’s all very interesting…That’s all very interesting… But how does IP help my research? Why should I invest in protecting my IP?
  • 8. BUNDLE OFBUNDLE OF IPIP ASSETSASSETS  A marketing tool  A source of revenue through licensing/acquisition  A crucial component of franchising agreements  Useful for obtaining banks or third party financing  A valuable business asset
  • 9. BUSINESS AND YOUR IPBUSINESS AND YOUR IP Be proactive: Invest in protecting your bundle of business assets. Be vigilant: Watch for potential infringers – license, acquire Be assertive: Protect your business assets
  • 10. Forms of Intellectual PropertyForms of Intellectual Property Term Life + 70 years 14 years 20 years 10 years * X ∞
  • 11. 01/28/15 11 PATENTS ACT 1970PATENTS ACT 1970 PATENT- DEFINITION Exclusive right for being the true and first inventor of a product or process, granted by the govt. for a limited period, to exclude others from making, using, selling or importing the patented product or process without his consent, in exchange of full disclosure of his invention . Term- 20 years from the Date of Filing(S.53)
  • 12. Patent JurisdictionsPatent Jurisdictions A patent is only valid in the jurisdiction in which it is granted World Intellectual Property Organization (WIPO) ◦ Patent Cooperation Treaty (PCT) ◦ Provides World filing for Patent Application
  • 13. What is a patent?What is a patent? Is grant by a government or government agency. To an inventor Right to exclude others from ◦ Making ◦ Using ◦ Selling ◦ Offering for sale ◦ importing 01/28/15 13
  • 14. PatentPatent Exclusive monopoly in exchange for disclosure of invention Disclosure Time-limited Monopoly
  • 15. Anatomy of a PatentAnatomy of a Patent
  • 17. Lifecycle of a patentLifecycle of a patent
  • 18. Publication Vs. PatentPublication Vs. Patent Scholarly Publication  Authorship somewhat negotiable  Must have done the work  Effort paramount  Future ideas can interfere with subsequent patentability  Only directly comparable results can lead to loss in priority Patent  Inventorship a matter of law  “Constructive reduction to practice” encouraged  Conception paramount  Disclosure of ideas for as many future uses as possible strengthens the patent  Results from analogous systems can result in prior art and obviousness rejections
  • 19. Documenting InventionsDocumenting Inventions Keep a notebook! Keep the pages sequential and clearly dated.
  • 20. Documenting InventionsDocumenting Inventions Write down your experiments! (especially the ones showing structure of the invention and how to make the invention) = “reduction to practice” Also write down significant ideas! (ditto!) = “conception”
  • 21. Documenting InventionsDocumenting Inventions Periodically show your notebook to someone else in the lab who is not an inventor (but who has an obligation of confidentiality and can understand what you are telling them). Have that witness sign and date the pages and indicate that they have “read and understood”the content.
  • 22. 01/28/15 22 Patents are granted for inventions which are technical, that is inventions which are capable of being industrially exploitable What is patentable?
  • 23. 01/28/15 23 A Product The apparatus for producing the product The process The use What can be patented?
  • 24. 01/28/15 24 What cannot be patented? Computer programmes Medical and surgical treatments Mathematical methods Business methods Discoveries Aesthetic creations New species of plant or animal Inventions which are contrary to moral standards and public order (e.g. instruments of torture) The human body and any non-separate part/s thereof
  • 25. InfringementInfringement “Infringement” of a patent occurs when a competitor makes, uses, sells, offers to sell or imports an embodiment of the invention without the permission of the patent owner.
  • 26. Direct infringementDirect infringement A person directly infringes a patent by making, using, offering to sell, selling, or importing into the US any patented invention, without authority, during the term of the patent. Unlike direct infringement, which does not require knowledge of the patent or any intent to infringe. While the United States Patent Act does not directly distinguish "direct" and "indirect" infringement, it has become customary to refer to describe infringement under 35 U.S.C. § 271(a) as direct infringement, while grouping 35 U.S.C. § 271(b) and 35 U.S.C. § 271(c) together as "indirect" ways of infringing a patent., 28/01/15 26
  • 27. Indirect InfringementIndirect Infringement Accused has some knowledge and intent 35 U.S.C. § 271(b) "active inducement of infringement “by encouraging, aiding, or otherwise causing another person to infringe. Inducer must be aware of the patent and intend. 35 U.S.C. § 271(c) "contributory infringement," is triggered when a seller provides a part or component that, while not itself infringing of any patent, has a particular use as part of some other machine or composition that is covered by a patent.[3] If there are other valid uses for the product. Only occurs when there has actually been a direct infringement of the patent. There must have been at least one instance where the inducement or contribution resulted in the practice of the patented art. 28/01/15 27
  • 28. 28 Consequences of infringingConsequences of infringing If you infringe someone else’s patent, you may risk: Injunction, which means that all your products may be removed from the market Destruction of your products Paying damages to the patent owner Being given a fine, e.g. the Kodak vs. Polaroid case Being sentenced to imprisonment (in gross cases)
  • 29. Type of patents?Type of patents? Utility patents Plant patents Design registration 01/28/15 29
  • 30. Utility patentsUtility patents Structural or functional aspects of ◦ Products ◦ Composition ◦ Process 01/28/15 30
  • 32. Plant patentsPlant patents New variety of living plants 01/28/15 32
  • 35. Design registrationDesign registration Ornamental designs of useful objects In US designs are patentable. 01/28/15 35
  • 36. Is this gives right to marketIs this gives right to market No A separate permission is required to make use ◦ DCA or DCGI approval is required to market pharmaceutical products. 01/28/15 36
  • 37. 01/28/15 37 The Patent ProcessThe Patent Process Allowance
  • 38. Approach to Obtaining a Patent &Approach to Obtaining a Patent & CommercializationCommercialization  Disclosure: Ideally when you can describe both what the invention is and what it accomplishes  Evaluation: ◦ Can this invention be patented?  Is there any prior art? Is this invention new, useful, & non-obvious? ◦ Is it worthwhile to patent this invention?  What product could come from this patent? Is there a market for said product?  Provisional application: Preserves worldwide rights against initial disclosure; gives you 1 year to decide whether or not to pursue patent  Initial publication: If you publish prior to filing a provisional application you lose the rights to file internationally DISCLOSURE INITIAL PUBLICATION ~3 MONTHS FILE PROVISIONAL APPLICATION (~$10k) EVALUATE
  • 39.  Patent Cooperation Treaty (PCT): an international application which claims priority to a provisional US application & have option for protection for up to 111 countries. RE-EVALUATION FILE PCT (~$25K) PCT PUBLICATION 12 MONTHS 8 MONTHS 6 MONTHS Approach to Obtaining a Patent & Commercialization
  • 40. 12 MONTHS RE-EVALUATE RE-EVALUATE Approach to Obtaining a Patent & Commercialization ENTER NATIONAL PHASE & PROSECUTION(~$20K)  Continuation of marketing/finding a licensee as well as additional publications  National stage applications with expensive examination rounds
  • 41. DISCLOSURE INITIAL PUBLICATION RE-EVALUATION RE-EVALUATIONRE-EVALUATION Overview of Pathway to Commercialization FILE PROVISIONAL APPLICATION (~$10k) EVALUATION 3 MONTHS FILE PCT (~$25K) PCT PUBLICATION 8 MONTHS 12 MONTHS 6 MONTHS 12 MONTHS ENTER NATIONAL PHASE & PROSECUTION (~$20k) RARELY GET THIS FAR W/O LICENSEE PATENTABILITY & MARKETING EVALUATION MARKETING/SEARCH FOR LICENSEE GENERATE NCD ADDITIONAL PUBLICATIONS W/ INTERESTING ANIMAL DATA, PROTOTYPING, FURTHER COMMERCIALIZATION
  • 42. Some common termsSome common terms Application Best mode Claims Conception Dependent claim Examiner Failure of others 01/28/15 42
  • 43. Some common terms …contSome common terms …cont How to make Independent claim Invention Novelty Obviousness Preferred embodiment 01/28/15 43
  • 44. Some common terms …contSome common terms …cont Prior art Provisional application Specification 01/28/15 44
  • 45. Some common terms …contSome common terms …cont Application ◦ A written document seeking patent protection filed with patent office. Best mode ◦ A patent application is required to disclose the best means known to the applicant of practicing the invention as of the date of filing the application 01/28/15 45
  • 46. Some common terms …contSome common terms …cont Claims ◦ A claim is one of the numbered paragraphs that appear at the end of a patent and defines the scope of protection given to the owner of the patent ◦ Each claim is treated separately for purposes of determining validity and infringement. For example, claims may be directed toward apparatus, methods, products, and compositions of matter and new and useful improvements thereof. 01/28/15 46
  • 47. Some common terms …contSome common terms …cont Conception ◦ is the creation of the mental concept of the invention. Dependent claim ◦ is a Claim+ that makes express reference to and depends on a prior claim ◦ thereby, incorporates by reference all of the recitals of the prior claim 01/28/15 47 +http://www.tms.org/pubs/journals/JOM/matters/matters-9609.html#claim
  • 48. Some common terms …contSome common terms …cont Examiner ◦ An employee of a patent office to whom an application is assigned for handling prosecution. Failure of others ◦ A secondary test of patentability relevant to the issue of whether an invention is obvious is whether others have failed to come up with the solution previously. 01/28/15 48
  • 49. Some common terms …contSome common terms …cont How to make ◦ This is part of the obligation to provide a disclosure in the patent application that would enable one skilled in the art to practice the invention without engaging in undue experimentation. 01/28/15 49
  • 50. Some common terms …contSome common terms …cont Independent claim ◦ is a claim that stands by itself and must be so read in terms of infringement and validity evaluations. This is contrasted with a dependent claim. 01/28/15 50
  • 51. Some common terms …contSome common terms …cont Invention ◦ in order to have a patentable invention, one must have a development that is  useful,  novel (no single prior art reference shows the identical development), and  unobvious to one skilled in the art at the time the invention was made, 01/28/15 51
  • 52. Some common terms …contSome common terms …cont Novelty ◦ is present if no single piece of prior art discloses every element of the claimed invention. 01/28/15 52
  • 53. Some common terms …contSome common terms …cont Obviousness ◦ If the invention could readily be deduced at the time the invention was made from publicly available information (prior art) by a person of ordinary skill in that art, it is obvious. ◦ Prior art may be combined to show that an invention would have been obvious. 01/28/15 53
  • 54. Some common terms …contSome common terms …cont Preferred embodiment ◦ The preferred embodiment of an invention can usually be interpreted as being recited as the best mode known to the inventor of carrying out the invention. 01/28/15 54
  • 55. Some common terms …contSome common terms …cont Prior art ◦ The existing body of technological information against which an invention is judged to determine if it is patentable as being novel and unobvious. ◦ It must be early enough in time to be cited against the application. 01/28/15 55
  • 56. Some common terms …contSome common terms …cont Provisional application ◦ an applicant can file a patent specification complying with standards and get the filing date as a priority date. ◦ for a complete patent application filed within one year thereafter claiming the benefit. 01/28/15 56
  • 57. Some common terms …contSome common terms …cont Provisional application ◦ The provisional application does not have to contain claims. ◦ The effective filing date of the full application for purposes of avoiding prior art will be the filing date of the provisional application. ◦ but will have the benefit of the date of filing the full application for purposes of the 20 year patent term. 01/28/15 57
  • 58. Some common terms …contSome common terms …cont Specification ◦ The part of the patent application that precedes the claims and in which the inventor specifies, describes, illustrates, and discloses the invention in detail. 01/28/15 58
  • 59. Intellectual Property ◦It Starts With An IDEA 01/28/15 59
  • 60. An invention can only be protected by patent if it is novel (no prior publication of the invention). Therefore, it is essential not to disclose the invention publicly until after a formal patent application has been filed. 01/28/15 60
  • 61. Any printed publication in a newspaper, scientific journal, or other written form available on an unrestricted basis is considered a public disclosure, as is an oral presentation at a public meeting. Note that an abstract and, in some cases, even a title may act to bar patentability if it discloses all the necessary elements of the invention. 01/28/15 61
  • 62. Rights and responsibilitiesRights and responsibilities Obtaining and maintaining IP, especially patents require many actions and funds. Patent search Patent filing Handle opposition and objections Renewal of patents Handle infringement Licensing and transfer of IP 01/28/15 62
  • 63. IP policyIP policy Will IP policy make a difference? Institutes ought to generate their own resources. Hence management will drive research programmes accordingly. Clarity will help faculty in making choices. Who doesn’t like money?01/28/15 63
  • 65. Patent Filing ProcessPatent Filing Process 01/28/15 65
  • 66. 66 Patent Application ProcessPatent Application Process (2-5 Years on Average?)(2-5 Years on Average?) 1. Conceive the invention 2. Write the application 3. File the application 4. Meet the application formalities – e.g., declaration, formal drawings 5. Examination process begins 6. Restriction requirement issued – sometimes 7. Substantive Office Action issued 8. Reply filed (usually there will be multiple iterations of this and the above step before an allowance is obtained) 9. Appeal filed 10. Application Allowed 11. Pay necessary fees – file continuations? 12. Patent issues 13. Pay Maintenance Fees
  • 68. Filing processFiling process Provisional application Non provisional application 01/28/15 68
  • 69. Provisional applicationProvisional application Specifications ◦ Title ◦ Introduction to the invention ◦ Drawings (if required) ◦ Model (upon request from PO) 01/28/15 69
  • 70. Non provisional applicationNon provisional application Specifications ◦ Title ◦ Introduction to the invention ◦ Drawings (if required) ◦ Model (upon request from PO) 01/28/15 70
  • 71. 71 What is a Provisional Application?What is a Provisional Application? Establishes a filing date (earliest priority date) Examination process does not begin Clock does not start running on lifetime of patent Has simpler filing requirements Lower filing fees Claims are not required
  • 72. Non provisional applicationNon provisional application Specifications ◦ Detailed description ◦ Examples (best mode) ◦ Claim(s) ◦ Abstract 01/28/15 72
  • 73. Prior art searchPrior art search Patents Literature articles Journals Scientific Presentations 01/28/15 73
  • 74. Prior art searchPrior art search Patents ◦ US ……….http://www.uspto.gov/ ◦ EU……http://ep.espacenet.com/ ◦ WIPO….http://www.wipo.int/ipdl/en/search/p ct/search-simp.jsp Japan Patent Office http://www.jpo.go.jp/ 01/28/15 74
  • 76. Prior art searchPrior art search Patents & Published literature ◦ Scifinder ◦ Prous integrity ◦ Reaxys ◦ Thomson cortellis ◦ Google 01/28/15 76
  • 77. Prior art searchPrior art search Published literature ◦ www.sciencedirect.com (for elsevier journals) ◦ www.tandf.co.uk/journals/online.asp (for journals of dekker and taylor and francis publishing) ◦ www.ncbi.nlm.nih.gov/entrez/query.fcgi (med line- gives elsevier journals also) 01/28/15 77
  • 78. Prior art searchPrior art search Published literature ◦ www.aapspharmscitech.org (free full text articles published in AAPS Pharm Sci Tech, an online journal) ◦ http://pubwww.srce.hr/acphee/ (acta pharmaceutica- full text for last 2 years and abst for older journals) 01/28/15 78 http://www.ingentaconnect.com/content;jsessionid=1 3rvsr25ic2q1.victoria (many journals esp british) pubs.acs.org/journals (journals of American Chemical Society) www.blackwell-synergy.com (Blackwell Synergy Publications
  • 80. Applicant’s expectationsApplicant’s expectations Applicant is always interested in ◦ Low cost to file ◦ Less time in prosecution ◦ Less time in granting ◦ Minimum cost in maintainance All of this is only possible with PCT filing process 01/28/15 80
  • 83. What is PCTWhat is PCT Patent cooperation treaty A United Nations treaty ◦ Signed in June 1970 ◦ Became operational in June 1978 ◦ Administered by the International Bureau (IB) of the World Intellectual Property Organization (WIPO) in Geneva, Switzerland 01/28/15 83
  • 84. Purpose of PCTPurpose of PCT To simplify the process of filing foreign patent applications To give every regional and national patent office the benefit of a search and a preliminary report on patentability by a major patent office 01/28/15 84
  • 85. PCTPCT This system provides ◦ A common filing process. ◦ Minimizes the expenses in filing process. ◦ Gives enough time for an applicant to think and choose the territory he would like to cover. 01/28/15 85
  • 86. What PCT providesWhat PCT provides There is no “international patent.” The Patent Cooperation Treaty (PCT) functions as a patent application filing system. The applicant must still prosecute the international application in each national or regional office in order to obtain a patent. 01/28/15 86
  • 87. Traditional filingTraditional filing 01/28/15 87 0 12 File Application Locally File Applications Abroad (Months)
  • 88. PCT FilingPCT Filing 01/28/15 88 File Demand File First Application File PCT International Search Report/ Written Opinion International Publication 0 12 16 18 International Preliminary Examination (Months) OR 30 20 Enter National Phase Chapter I Chapter II 30
  • 91. Patent Time LinePatent Time Line © Copyright 2014 91 File Provisional Patent Application $ File US Nonprovisonal and/or PCT Application $$ Patent Application Publishes Enter National Stage $$$ 0 1 yr 18 mo 30 mo 21 yrs (20 from PCT Appl.) 25 yrs Patent Issues Patent Expires Up to 5 years Patent Term Restoration (drugs) 35 USC §156 23 yrs Up to 3 years Patent Term Adjustment for USPTO Delays 35 USC §154 30 mo0
  • 93. 93 Patent Cooperation Treaty (PCT)Patent Cooperation Treaty (PCT)  Single place of filing  International novelty and patentability search  Final decision for countries TILL 30 MONTHS ONE IS SAFE
  • 94. 94 International patent systemsInternational patent systems Basic principle:  Patent in each country The systems:  Patent Cooperation Treaty (PCT)  European Patent Convention (EPC)  Other regional systems (OAPI,ARIPO, EURASIAN)
  • 96. 96
  • 98. Five basic patent searchesFive basic patent searches Application number Patent number Assignee name Inventor name Subject search
  • 99.  By Chemical structure or chemical name  Solid/crystalline/hydrated forms (Physical form)  Purity of the API  Alternate salts  Process  Physicochemical characteristics  Technology 01/28/15 99 Claims..
  • 100. 01/28/15 100 1. By Chemical structure or Name: 1.1. Claim by large Markush structure – Atorvastatin (US 4,681,893) Atorvastatin • Generally possible for innovators • Entire genus is novel • No clarity on the final target. • Broadest claim possible. • No design around possible. • Invalidation is the only option
  • 101. 01/28/15 101 1. By Chemical structure or Name: 1.2. Claiming by simple structure – Paroxetine intermediate • Covers limited no of novel compounds. • Covers possible protecting groups and derivatives. • Generally possible when a novel scheme is designed for a known product.
  • 102. Markush claimsMarkush claims Typically in chemical cases Allows broad claiming of many species of related compounds
  • 104. Markush claimMarkush claim DETAILED DESCRIPTION - 2,3-benzodiazepine derivatives of formula (I) and their acid addition salts are new. X=H, Cl or OCH3; Y=H or halo; Z=methyl or Cl; R=1-4C alkyl or NR1R2; and R1, R2 =H, 1-4C alkyl, 1-4C alkoxy or 3-6C cycloalkyl.
  • 106. 01/28/15 106 1. By Chemical structure or Name: 1.3. Claiming by Chemical name– Atorvastatin Calcium (US 5,273,995) • Covers one or two specific compounds and its salts. • Narrow in scope • Covers the actual commercial product. • Highly difficult to invalidate the patent. • Generally extends the life cycle of the product.
  • 107. 01/28/15 107 2. By physical form: 2.1. By Solid form– Montelukast Acid (US 2005/107426) • Broad claim possible, if the compound is already known in a non- solid state. • Provide great value if some of the impurities are washable only by purification of the solid intermediate.
  • 108. 01/28/15 108 2. By physical form: 2.2. By Crystalline form– Amlodipine free base (US 6680334) • Broad claim possible, if the compound is already known in a non- crystalline form. • Provide great value if non-crystalline form is significantly unstable for processing and pure product can be obtained only from crystalline material. • Can be used as alternate to API salt form if possible. • Generally stands in the litigation even-if the genus claim of compound claim is invalidated.
  • 109. 01/28/15 109 2. By physical form: 2.3. By Specific parameters– Alfuzosin Base (WO 2006/090268) • Considered as the narrow claim. • Has value only if the known solid forms are protected or all of them are unstable for processing.
  • 110. 01/28/15 110 3. By Purity: 3.1. By Purity of the API– Candesartan (US 20050250827 A1) 3.1. By Chiral Purity of the API–Armodafinil (WO 2007/103221) • API is known but with less purity. • Provide value if the impurity is a critical & difficult to remove or forms in stability. • Competitors will have to use impure materials and end up regulatory issues
  • 111. 01/28/15 111 4. Alternate salts: 4.1. Alternate salts: (Desvenlafaxine – US7001920) 4.1. Alternate salts: (Sitagliptin – US2005032804) • Narrow in scope • Covers the actual salt of product. • Considered as easy to invalidate the patent if other salts are already known. • Generally extends the life cycle of the product.
  • 112. 01/28/15 112 4. Diasteriomer salts: 4.1. Diasteriomer as compound (Eszopiclone -WO07/088073) 4.1. Diasteriomer with purity (Duloxetine-WO06/099459) 4.1. Diasteriomer in crystalline form (Eszopiclone -WO07/088073)
  • 113. 01/28/15 113 5. Process for Preparation of API : 5.1. Generic process (Ramelteon)
  • 114. 01/28/15 114 5. Process for Preparation of API : 5.2. Simple process (Paroxetine)
  • 115. 01/28/15 115 5. Preparation of API : 5.3. Specific process (Duloxetine HCl)
  • 116. 01/28/15 116 5. Preparation of API : 5.4. Specific process (Ziprasidone HCl)
  • 117. 01/28/15 117 6. Physicochemical properties : 6.1. PSD of API compound (Ziprasidone HCl -US6150366) 1. A composition comprising crystalline ziprasidone free base or crystalline ziprasidone hydrochloride particles having a mean particle size equal to or less than about 85 μ and a pharmaceutically acceptable diluent or carrier. 6.2. PSD of API compound (Escitalopram -US6916941) Covers non-crystalline solid Atorvastatin salt having bulk density from about 0.05 to 0.4 g/ml; and mean particle size of about 0.5 to 50 microns 6.3. PSD & BD of API compound (Atorvastatin -WO2007100614)
  • 118. 01/28/15 118 7. Technology: Synthesis of Piperizine ring (Mirtzapine-US 6852855)
  • 119. 01/28/15 119 7. Technology : Synthesis of Amino acid amides (Levitiracetum-US 2005/0182262)
  • 120. Patent Grant Procedure (In Brief) Filing of PATENT APPLICATION EXAMINATION & NOVELTY SEARCH ACCEPTANCE OR REFUSAL NOTIFICATION OF “ACCEPTANCE” IN THE GAZETTE OF INDIA (part III section 2) OPPOSITION (if any) GRANT OF A PATENT
  • 123. US patents vs. non-US patentsUS patents vs. non-US patents Foreign patent applications published 18-36 months before US patents issue. After 29 November 2000, the US has published some applications over a range of dates. US will still be a slow publishing country for many applications Tracking foreign patents give insight to what will be publishing in the US as all are part of the same patent family.
  • 124. A patent familyA patent family Contains all patents/applications that are linked by a common priority application number Includes divisionals, continuations, CIPs Includes members from other countries or treaties Are very useful when answering the most asked question in patents: “Find an English equivalent of this non-English patent.”
  • 125. 1) Set a goal, dream, imagine! 2) Write it down! 3) Experiment, develop, modify and construct your invention. 4) It’s a SECRET! So...how do you “invent”?
  • 126. Why would you want one?Why would you want one? Powerful form of protection Protects the idea rather than the implementation No need to show copying. Even an “innocent” infringer can be stopped Patents act as a deterrent to a competitor developing a similar product May strengthen your negotiating position if you infringe someone else’s patent May be a valuable asset in its own right: patents can be licensed and assigned
  • 127. NoveltyNovelty  An invention is new if it does not form part of the “state of the art”  The state of the art includes all disclosures that were made available to the public before the filing date  This includes written and oral disclosures. Anything that has been sold and anything published online. In other words, the entire stock of publicly available knowledge  A grace period is applicable in the US. So - Sometimes patent protection is viable in the US when it is no longer available in Europe
  • 128. Inventive StepInventive Step  An invention involves an inventive step if it is not obvious (with regard to the state of the art)  There may be an inventive step if the invention solves a problem, provides a surprising result, provides an increase in speed, efficiency etc..  There must be a technical solution to a technical problem: a divergence from existing technology that would not be developed by routine experimentation or applying known principles
  • 129. Conclusion ◦ File ◦ File early ◦ Disclose everything that you know ◦ Be ready to negotiate
  • 130. Commercial exploitationCommercial exploitation Various strategies can be used to extract value from patents:  Exclude your competitors from using the invention  Develop a thicket of patents to deter competitors from even considering your technology  Licensing  Use the patents to participate in a cross-licensing patent pool  Patents as marketing tools  Patents as defensive disclosures
  • 131. 01/28/15 131 Patent Examining ProcessPatent Examining Process 1. Read1. Read 2. Search2. Search 3. Determine3. Determine PatentabilityPatentability 4. Communicate4. Communicate
  • 132. A global perspectiveA global perspective Patents are territorial: there is no such thing as an international patent A UK patent can give you the right to stop others from making, selling, using and importing the invention in the UK. It gives no rights in other countries A separate patent is required in each country where protection is required In practice, it is usually sufficient to obtain patents in key territories
  • 134. Famous Patents – TheFamous Patents – The TelephoneTelephone US Patent 174,465 – Alexander Graham Bell “Improvement in Telegraphy” (1876) © Copyright 2014 134
  • 135. Famous Patents – The Light BulbFamous Patents – The Light Bulb US Patent 223,898 – Thomas A. Edison “The Electric Light Bulb” (1880) © Copyright 2014 135
  • 136. 136 INDIA….Regional Patent office’sINDIA….Regional Patent office’s JurisdictionJurisdiction Office Territorial Jurisdiction Patent Office Branch, Chennai The States of Andhra Pradesh, Karnataka, Kerala, Tamil Nadu and the Union Territories of Pondicherry and Lakshadweep Patent Office Branch Mumbai The States of Maharashtra, Gujarat, Madhya Pradesh, Goa and Chhattisgarh and the Union Territories of Daman and Diu & Dadra and Nagar Haveli. Patent Office Branch, New Delhi The States of Haryana, Himachal Pradesh, Jammu and Kashmir, Punjab, Rajasthan, Uttar Pradesh, Uttaranchal, Delhi and the Union Territory of Chandigarh. Patent Office, HO Kolkata The rest of India
  • 137. 137 INDIA……..How to file a patentINDIA……..How to file a patent application?application?  Documents can be filed in the patent office  through online( e-filing) or  www.ipindiaonline.gov.in/online  through post or  can be submitted by hand
  • 138. 138 GENERAL PROCEDURE FORGENERAL PROCEDURE FOR OBTAINING A PATENTOBTAINING A PATENT  Filing of patent application  Publication after 18 months  Pre Grant Opposition /Representation by any person.  Request for examination  Examination: Grant or Refusal  Publication of Grant of patent  Post Grant Opposition to grant of patent  Decision By Controller
  • 140. 140 INDIA….Statutory Fees:INDIA….Statutory Fees: Particular Natural person (Rs) Other than natural person (Rs) For filing patent application 1000 4000 For each sheet of specification in addition to 30 100 400 For each claim in addition to 10 200 800

Editor's Notes

  1. Today we concentrate on the rights mentioned on the left side
  2. The damages can be calculated to the amount of lost of fore example royalty for the period the infringement has been going on. In the 80´Kodak was found to have infringed seven Polaroid patents directed to improvements in instant photography. As a result, Kodak paid Polaroid nearly $1 billion in damages. In addition, Kodak was enjoined from any further infringement and was ordered to pull all of its instant photography cameras off the market, forcing Kodak completely out of the instant photography business. The largste damages in the history.
  3. This is a pure rationalization arrangement or an extension of the priority period
  4. Patent is a territorial exclusive right, filed in the language of the country. Another person can easily produce a product in Sweden if you only have the patent right in Denmark. If you wish to have protection in several countries => regional patent or PCT This is possible, because patent laws are very much harmonised => international systems are possible OAPI = Africa, former French colonies ARIPO = Africa, former English speaking countries EURASIAN = Former USSR and some Asian countries
  5. Link side: EPO fees Right side: National fees
  6. Remember – your imagination is even better than most adults imaginations You can even keep a journal or a special notebook with your goals and ideas. Continue to think about your idea – experiment – try and make it – change it if you need to. However – don’t tell anyone about your inventions! Keep them secret! Of course, you can tell your Mom and Dad!
  7. Other issues to consider: Secrecy better than a patent? (example: Vodka, Whisky) Prophylaxis better than patent? (in newspapers, internet etc.). Example: A pharmaceutical company develops a new medicine. This consists of a number of development steps, where some of the steps are uninteresting to protect. However, the pharmaceutical company would not like other companies to be able to protect the technology, so a profylaxis is chosen Infringement: Example: Danish wind mill industry and USA. A large DK wind mill company erected a number of mills in the USA, but was stopped because of infringement of patent rights. After this, the wind mill industry began using the patent system! Licence agreement – dependent patents: Example: Grammophone and pick-up