The document discusses various topics related to patents and scientific articles in pharmaceutical research. It provides details on forms of patent applications, requirements for different types of specifications, priority dates, sections that should be included in specifications according to different jurisdictions, and types of patent claims such as independent, dependent, Markush, and product-by-process claims.

1. Patents and art of writing scientific articles n
pharmaceutical research conducted on conducted on 9th
Oct. 2013 at MIT Pune, India.
Dr. Pravin B. Shejul
M.Sc., Ph.D., LL.B.
Wanbury Ltd.

2. Form of application
Section 7 ,
Sub section (1) , single invention only.
1A PCT applications designating India.
1B Date of filing as basic application.
(2) assignments of the right to apply should furnish
proof of right (form 1 or separate assignment).
(3) Declaration that applicant if true and first
inventor.
(4) application for patents shall be accompanied by
provisional / complete specification.

3. Application for patents
Section 6 , Person entitled to apply
 1 (a) true and first inventor,
 (b) assignee,
 (c) legal representatives,
2 any one or alone can apply,

4. Provisional and Complete specification
Section 9 of IPA 1970
Sub section (1) Application for patent where
provisional specification , a complete specification
shall be filed with in 12 months,
(2) Cognate applications.
(3)Purporting to be a complete specification such
specification shall be treated as provisional
specification.
(4) Post-dating of an application.

5. Contents of specifications
Section 10 Sub section (1) Title indicating
sufficiently the subject matter.
(2)Drawings ,
(3) Model or sample ,
(4) Specification shall
(A) Invention
(B) Best method of performing
(C ) claims
(D) Abstract.

6. Contents of specifications
Section 10 (4) (d) Abstract ,
Controller may amended it ,
If applicant mentions a biological material in the
specification such materials not available public , the
application shall be completed by depositing the
material to an international depository authority.
(a) deposition shall be prior than date of filing of an
application.
(b) characteristics of the material or No. of the
depositary
(c ) accesses to the material
(d) geographical origin

7. Contents of specifications
Section 10 (4) (a) International application,
(5) claims of invention shall relate to single
inventive concept.
(6) Declaration of inventorship
(7) additional applicant shall be added as per
provisions of section 6 of IPA 1970

8. Priority Date of claims of a complete
specification
Section 11 Subsection (1) there shall be priority
date for each claim.
(2) complete specification filed in pursuance of
 1, Provisional specification.
2, a specification which is treated
by virtue of complete section (3) .

9. Under 37 CFR 1.77 The specification should
include following Sections
 Title of invention
 Cross reference to related applications
 The statement regarding federally sponsored or
development project.
 The name of the parties to joint research
agreement.
 Reference to a ‘ sequence listing’ a table or a
computer program listing
 Background of the invention.
 Brief summary of the invention.

10. Under 37 CFR 1.77 The specification
should include following Sections
Brief description of the several view of the
drawings.
Detailed description of the invention.
A claim or claims .
Abstract of the disclosures.
Sequence listing if on paper,
US patent prosecution
IDS play a major role in prosecution

11. What is mean by Patent Claim
“Patent Claims are usually in the form of a series of
numbered expressions following description of the
invention in a patent application and define, in
technical terms , the extend of protection conferred
by a patent application when applicable . They are
of utmost importance both in examination
proceedings and litigation , for instance during
infringement actions”

12. What is mean by Patent Claim
Patent claims are not an explanation of invention or an
attempt of verbalizing what might be called as heart of
invention,
In US Practice claims are check list of components or
method steps that all need to be present in accused device or
method.
Each component listed in claims ( or element)must also be
verbally linked, functionally or structurally , to at least one
other component specified in the claim.
The requirement of such verbal connection between the
components or method steps is not same as a requirement
for a narrative explanation in the claim of how the
invention works .

13. Types of claiming
The US employs ‘peripheral claiming’ where claim
defines the outer limits of or boundary of an
invention and the issue during a lawsuit for
infringement is whether the accused device fall
inside the boundary or outside.
The central claiming system , claims identify the
center of the invention . The exact scope of
protection depends on the actual nature of
inventors contribution to the art in concerned
technology.

14. Anatomy of a claim
Patent claims build up of the following
constituents,
‘Preamble’ it’s main function is to introduce what
follows by providing name or brief description , of
the invention that will be defined in the main claim
portion of claim.
The ‘Transition word’ The transition word marks
end of the preamble ,
“COMPRISING” is understood to mean “including at
least” the following ,and possibly other things are in
addition.

15. Anatomy of a claim
“CONSISTING OF ” be sued in claims directed to
mechanical or electrical inventions , or also used for
chemical inventions which stands mean that
“ including what follows but little or nothing else ”
“Which Consist of ” or “Essentially consist of ”

16. Anatomy of a claim
The main portion of claim is what the transition. It
is known as body,
It is by listing of the elements of the invention and,
for each element , at least one relationship between
that elements in claims.
These elements provides checklist for gauging
patentability and infringement. The elements and
relations in a claim are called “limitations”

17. Anatomy of a claim
Example: US 7,671,030 (VYVANSE)
A composition1
comprising2
an amount of from 25 to 75 mg of L-lysine-d-amphetamine or a salt
thereof and having an amphetamine base amount of from 7.37 to
22.1 mg of said amphetamine3
, said L-lysine-d-amphetamine or a
salt thereof
providing a mean AUC0-12h(ng h/mL) from 205.4±42.5 to 611.5±104.53
,
a mean AUClast(ng h/mL) from 396.7±84.8 to 1237.0±194.03
,
a mean AUCinf(ng h/mL) from 415.0±80.1 to 1259.5±191.33
,
a mean Cmax(ng/mL) from 25.0±5.6 to 74.0±12.93
,
a mean Tmax(hours) from 3.1±0.876 to 3.9±1.03
, and
a mean T1/2(hours) from 9.68±1.43 to 10.3±1.7 of amphetamine3
when orally administered to a human subject3
.
1. Preamble
2. Transitional phrase

18. Types of claims
There are two basic types of claims,
Independent claims
Dependent claims
Independent claims stands on their own
Dependent claims which depends in single claim or
on several claims and generally expressed as fall-
back positions ,
The expressions “in one embodiment”, “ in a
preferred embodiment” “ in a particular
embodiment” , “in a advantageous embodiment”
are used to correspond dependent claim.

19. Types of claims
Dependent claims refers to another claims and
builds on it.
Example Claim 1 ‘ A tool comprising of an element
A an element B connected to element B and
element C connected to element B.’
Claim 2 , The tool of claim 1 further comprising an
element D.

20. Means and Functions
Functional language is frequently used in patent
claims
Means – plus-function claim is including a technical
feature expressed in functional terms of type , ‘
means for converting a digital electrical signal into
an analog electric signal’ A variant known as a "step-
plus-function" claim style may be used to describe
the steps of a method invention ("step for
converting... step for storing...")

21. Other claims format
Jepson-Type claim is an independent format claim , a
Jepson claim is a method or product claim where one or
more limitations are specifically identified as point of
novelty or distinguishable over at least the contents of
the preamble. Example , “ A System for storing
information having …….. Wherein the improvement
comprises
 “ An improved – ( name of device) that includes
(element present in prior art of this type, such as a frame,
wheel rotatable mounted on the frame , a peddle
assembly that is…”
 The preamble is followed by improvement comprises as
a transition.
The body of claim then specifies what is new,
12:23

22. Other claims format
“Markush Claim” Used in chemistry or structure is
claim with multiple functionally equivalent chemical
entities allowed in one or more parts of the
compound.
“In claims that recites --- comprises of compositions ,
it is sometimes important to claim , as alternative . A
group of constituents that are equivalent for the
purpose of invention…..This has been permissible to
claim such an artificial group referred to as a
Markush group ”

23. Markush Claim
 If a compound being patented as includes several Markush
groups , the number of possible compounds it covers could
be vast . No patent database generates all possible
permutations and index them separately .
State whether substituent's are the same or identical
Example:
 “1 to 3 substituent's selected from hydroxyl, methyl, fluoro,
chloro, and bromo.”
 Can you have a 1 methyl and 1 fluoro substituent?
• Better:
“1 to 3 substituent's independently selected from
hydroxyl, methyl, fluoro, chloro, and bromo.”

24. Other claims format
Omnibus claim (EU, US –no 35 USC 112)
Omnibus claim including a reference to the
description or the drawings without stating any
technical features of the product or process claimed.
For ex. Apparatus as described in the description" or
"An x as shown in Figure y".
Product-by-process claims –
A product by process claim is a product claim where
the product is identified by its process of
manufacture ,

25. Product-by-process claims
Chemical inventions claimed by this ,
“ Product obtained by the process of claim ”
As per EP practice it is interpreted as
“ product obtainable by the process of claim” in this
case only product is allowed to be patented .

26. Swiss Types of Claims
A Swiss Types of Claims or Swiss type of use claims
is claim intended to cover the second use or
subsequent medical use or indication of a known
substance or composition.

27. Other form of claims
Reach-through claims, this type of claims are
protect things which have not discovered by an
inventor , but might be discovered in future by
making use of their invention, For example, someone who discovers a
new protein which might be suitable for use as a drug target may not be satisfied to obtain
protection only for the isolated drug target and methods of screening for drugs which act as
inhibitors or agonists (as appropriate) for that drug target. They may also want to obtain
explicit protection for all drugs which act as inhibitors or agonists (as appropriate) for that
drug target (or all gene therapies which modulate levels of the protein in vivo). Someone who
discovers a drug screening process may wish to claim all drugs discovered through that
process. The devisor of a peptide-display library or a new combinatorial chemistry technique
may wish to protect specific molecules within the library that are later found to have practical
applications. In these cases, the inventor would like to reach-through from their invention to
protect other products which could follow on from performing their invention, but which they
have not as yet actually discovered.

28. Special Problems
There are number of words or expressions to be
inherently indefinite when used in patent claims,
“or ” Invention claimed as ‘ an element C
connected to the element A or element B’
“Negative limitations ” claims should specify what is
present in an invention rather than what is not
present.
Example “ A wall” and “a hole in the wall” it shall be
“a wall having hole”

29. Special Problems
Words such as ‘about’ ‘Substantially’
‘Approximately are frequently used in claims to
permit degree of variation when numbers or
mathematical relationship are recited
Example ‘ A approximately three times as wide as B’
‘A substantially extends in direction perpendicular to
element B.

30. Special Problems
Relative terms such as “long” ‘Heavy’ “narrow” , “
Thick ” are source of trouble ,
Words such as , wherein , whereby are frequently
used.
Specification----Enablement---claims

31. 12:23
Thank you….