Unit 1 Patent M.pharm department of pharmaceutics and industry Pharmacy.

1. Patent, Intellectual Property and
Regulatory Affairs.
Mr. Abdallah Abdalmalk
M.Pharm, 1st year IP
Dr. Rashime Mathew
Department of Industry Pharmacy
Karnataka College of Pharmacy
BANGALORE-540064, Karnataka, India
Cell no: 7899406897
E-mail: abdallahabdalmalk@gmail.com
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2.  Contents:
• Definition
• Need for patent
• Type of patent
• Condition to be satisfied by an invention to be patentable
• Introduction to patent search
• Parts of patents.
• Filling of patents.
• Essential element of patents.
• Guideline for preparation of laboratory note book.
• Non-obviousness of patents.
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3. Definition:
• It can be defined as form of intellectual property category of property
that includes intangible creations of the human intellect, that gives it’s
owner legal right to exclude other from making, using selling and
importing and invention provided the invention for limited period of
year.
• i.e. up to 20 years.
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4. Need for patent:
• Patent granted for an invention.
• Invention means product or process which is:
a. New (novel)
b. Involving intensive step (non-obvious)
c. Utility
• Capable of industrial application.
• To ensure the exclusive right over the invention.
• Stop other copying his invention and exploit it commercially.
• To stop other from using, selling, or working out his invention the invention must go for getting
patent.
• Benefit to R&D
• Stop inventioning the wheel.
• Know what is already patent.
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5. • Rewards to inventor.
• Motivate/ stimulate inventive research.
• Encourages maximum disclosure to enable further research and
technology development.
• Transferring into public property after expiry of term or cessation of
patent.
• Encourage for improvement of technology.
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6. Types of patent:
• Patent can be classified as:
1. Independent patent.
• Independent patent claims maybe three types:
A. Claim for thing.
B. Claim for method of making thing.
C. Claim for method of using thing.
2. Patent of an addition ( to some prior patent)
3. Term of patent addition.
• Second type of classification of patent:
A. Process of patent
B. Product patent.
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7. Patent classification:
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8. Types of patent applications:
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9.  Condition to be satisfied by an invention to be
patentable:
• Invention must satisfy the following condition to be patentable
A. Novelty (new)
B. Non-obviousness (intensive step)
C. Usefulness.
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10. A. Novelty:
• An invention will be considered novel if it does not form of the global state of the art.
• Information appearing in magazines, technical journals, books, newspaper etc.
• Oral description of the invention in a seminar/conference can also spoil novelty.
• Novelty is assed in global context.
• An invention will cease the to be novel if it has been disclosed in the public through
any type of publications any where in the world before filling a patent application in
respect of the invention.
• Therefore it’s advisable to fill patent application before publishing a paper if three is
a slight chance that the invention maybe patentable.
• Prior use of the invention in the country of interest before the filling data can also
destroy the novelty.
• Novelty determined through extensive literature and patent searches.
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11. B. Non-obviousness (intensive step)l Ingenuity.
• A patent application involves an intensive step in the proposed invention is
not obvious to a person skilled in the art.
• Inventiveness cannot be decided on the material contained in unpublished
patents.
• The complexity or simplicity of an intensive step doesn’t have any bearing
on the grant of a patent.
• The reason is that it would depend on the interpretative skills of the inventor
and these skill will really be a function of knowledge in the subject area.
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12. C. Usefulness:
• An invention must possess utility for the grant of patent.
• No valid patent can be granted for an invention devoid of utility.
• The patent specification should spell out various uses and manner of
practicing them, even if considered obvious.
• If you are claiming a process, you need not describe the use of the
compound produced thereby.
• Nevertheless it would be safer to do so, but if you claim a compound
without spelling out it’s utility, you maybe denied a patent.
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13. Benefits of patent applications:
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14.  Introduction to patent search:
• Patent search is search and analyze relevant patents in product development
step or prior to patent application process so that you can make sure the
patentability of your invention and get current technology information and
future trend of specific technology area.
• Also it helps you to avoid duplicate research and to invest your money to
safe market having no legal problems related to patent.
• Patent searches are very useful for serval purposes, not only organization
such as universities, but also for researchers.
• In order to performs a good and useful searches it is essential to understand
the structure of patent information, whatever from it can take ( full text or
bibliographies) as well as where and how to use the search tools available.
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15.  Appropriate time for conducting a patent search:
• It’s advisable to ascertain this position at a very early stage of developing later.
• Many a limes the search is conducted alter developing the invention and at the
time of preparing the patent specification.
• This is wrong one has to start doing the search from the time an invention is
conceived and through the development stage of the invention.
• Finally the details of the search already in hand will be helpful to make the
reference in patent specification by way of prior art.
• Such procedure will safe considerable amount of time and more important that
any later stage embracement by realizing that the invention has already been in
the prior art.
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16.  Conduction of patent search:
• The patents are classified under the national patent systems of every country
like( Indian patent classification system, US patent classification etc.).
• As well as under international patent classification system (IPC).
• The IPC classification system classifies the entire science and technology into
eight main heading, each heading further classified minutely into about 95000
subheading.
• There are available through various websites like USPTO website, website of
WIPO (world intellectual property organization).
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17.  Parts of patent:
I. Theme search: it provides the overview of patents related to your filed of
interest. These search are helpful to detect the recent trend of your technology
area and to establish your R&D direction.
II. Patentability search: it’s first step of patenting process a patentability search
surveys patents filled in each national intellectual property office to check
whether there exists inventions similar to yours.
III. Infringement search: its to check whether patents which can be infringed by
your products launched newly in a certain country exist or not in that country.
IV. Invalidity search: when you intend to make some claims of a particular patent
invalid, the invalid search can provide some prior at references that disclose
claims that are infringed by the subject disclosure.
V. Legal status search/ family patent: patent family search provides a list of
country in which a particular patent filled. Legal status gives the legal
progressing status of a particular patent.
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18.  Process of patent search:
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19.  Process of patent search:
Searching and reviewing
Reform search Search result and extracting data
Select key word
Make search queries
Clarify the purpose of search
Decide the extent of search
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20.  Where to search patent information:
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Original published document (article, technical
study, patent, standard, market study…)
Database
Bibliographic reference
Summarized indexed
Search
Question?
Fig: Access to information.

21.  Filling of patent:
• Patent filling can be defined as: process of submitting an application in patent
office requesting grant of patent to your invention.
• To protect the invention in different countries, then submit a patent
application in each of those countries.
• How to fill patent application:
Document can be filled in the patent office.
Through online ( e-filling).
www.indiaonline.gov.in/online
Can be submitted by hand.
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22.  Steps involved in the patent process in India:
• Check the patentability of the invention by performing a search for similar
technology.
• Drafting patent application (professional or complete).
• Provisional patent specification.
• Content of specification.
• Filling the patent application in India.
• Publication of patent application.
• Examination of patent application.
• Final decision on grant of patent
• renewal
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23. General procedure for obtaining patent/ main
steps of patenting procedure:
• Filling patent application.
• Publication after 18 months.
• Pre grant opposition.
• Request for examination.
• Examination grant or refusal.
• Publication of grant of patent.
• Post grant opposition to grant of patent.
• Decision by controller.
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24.  Filling of patent application:
• A patent application shall be filled on along with professional or complete
specification, with the prescribed fee as given in first schedule as an appropriate office.
• Normal fee should be applicable for application contain up to 20 pages in specification
and up to 10 claims.
• If application exceeds 30pages or claims are more than 10 in number additional fee as
given in first schedule is payable.
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25. Essential elements of patent:
1. Description
2. File No
3. Claims
4. Abstract
5. Drawings
6. Fees
7. Depositories
8. Disclosure
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26. Description
• The description of the invention in the International Application must disclose the
invention in a manner sufficiently clear and complete for the invention to be
carried out by a person skilled in the art.
• The description first repeats the title of the invention. It then specifies the
technical field to which the invention relates. It indicates the so-called
“background art,” that is, the technical and, in particular, patent literature,
pertaining to that technical field, constituting the “prior art” or “state of the art”
or known technology for the newly filed application.
• It discloses the intention in a way which allows the technical problem and its
solution to be understood. It states the advantageous effects of the invention as
compared with the known technology. It briefly describes the figures in the
drawings. It sets forth the best mode contemplated by the applicant for carrying
out the invention and any other mode he wants to include. Finally, it indicates the
way in which the invention is capable of exploitation in industry. Explains the
inventive step and how it works.
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27. Claims:
• Claims are the parts of a patent which define the boundaries of patent
protection. Patent claims are the legal basis for your patent protection.
They form a protective boundary line around your patent that lets
others know when they are infringing on your rights. The limits of this
line are defined by the words and phrasing of your claims.
• As the claims are key to receiving complete protection for your
invention, you may wish to seek professional help to ensure that they
are properly drafted. When writing this section you should consider
the scope, characteristics, and structure of the claims.
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28. Scope:
• Each claim should have only one meaning which can be either broad or
narrow, but not both at the same time. In general a narrow claim specifies
more details than a broader claim. Having many claims, where each one
is a different scope allows you to have legal title to several aspects of
your invention.
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29. Important characteristics
• Three criteria to take note of when drafting your claims are that they should clear, complete, and supported.
Every claim must be one sentence, as long or as short a sentence as required to be complete.
• Be Clear
Your claim must be clear so that you do not cause the reader to speculate about the claim. If you find yourself
using words such as "thin", "strong", "a major part", "such as", "when required", then you are probably not
being clear enough. These words force the reader to make a subjective judgment, not an objective
observation.
• Be Complete
Each claim should be complete, so that it covers the inventive feature and enough elements around it to put
the invention in the proper context.
• Be Supported
The claims have to be supported by the description. This means that all the characteristics of your invention
that form part of the claims must be fully explained in the description. In addition, any terms you use in the
claims must be either found in the description or clearly inferred from the description.
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30. Abstract
• The abstract is intended to serve the purpose of technical information. The
treaty says clearly that it cannot be taken into account for any other purpose.
This means in particular that it cannot be used for the purpose of interpreting
the scope of the protection sought.
• The abstract consists of a concise summary of the disclosure of the Invention
as contained in the description, claims & drawing in within 50 to 150 words.
It must be drafted in a way, which Allow the clear understanding of the
technical problem, the general idea of the solution of that problem through
the invention, and the principal use of the invention.
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31. • The abstract is the concise summary of the invention preferably within 150
words. It shall commence with the title of the invention, preferably within 15
words. It should be prepared in such a way that one can understand the
technical problem and solution with its usefulness. If necessary, most
relevant drawing should also be included in the abstract, particularly, in
mechanical type inventions.
• Each main feature mentioned in the abstract and illustrated by a drawing
should be indicated by reference numerals. In case of Chemical invention, it
should contain the Chemical Formula for understanding the invention.
However, it cannot be used for the purpose of interpreting the scope of
protection in legal proceeding.
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32. drawing
• The drawings are only required where they are necessary for the
understanding of the invention. This will be the case for a mechanical
invention. It will not be the case when an invention cannot be drawn, as is the
case for a chemical product. Here again, the requirements are similar to those
of most patent Offices Drawings are preferred because it is typically easier to
show the novel, claimed Elements in solid lines and to show the non-
essential elements in dotted lines.
• However, photographs, both black and white and color, can be submitted as
informal drawings to obtain a filing date. Further, black and white
Photographs are now acceptable as formal drawings.
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33. fees
• 1) There shall be paid in respect of the grant of patents and applications there for,
and in respect of other Matters in relation to the grant of patents under this Act,
such fees as may be prescribed by the Central Government.
• 2) Where a fee is payable in respect of the doing of an act by the Controller, the
Controller shall not do that act until the fee has been paid.
• 3) Where a fee is payable in respect of the filing of a document at the patent office,
the document shall be deemed not to have been filed at the office until the fee
has been paid.
• 4) Where a principal patent is granted later than two years from the date of filing of
the complete specification, the fees which have become due in the meantime may
be paid within a term of three months from the date of the recording of the
patent in the register.
• 5) International Application filing fees can be paid in the national currency and to
one Office, the Receiving Office. They may all be paid within one month after
filing.
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34. Guideline for preparation of notebook:
• Laboratory notebooks should be provided to each researcher.
• Each notebook should have a number and be assigned to an individual
researcher, who is the only person who should enter data in the book. Only
one project should be entered in each notebook. Pages should not be removed
or replaced.
Signing for the book
The researcher should sign and date receipt of the book on the inside cover.
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35. • Signing daily entries and witness signatures
a) Entries should be dated and signed by the researchers on the day the work is
conducted.
b) All entries require witness signatures on a weekly basis (signature to be
dated).
The witness should understand the work but should not be directly involved in
the project so that he/she would not be deemed a co-inventor on any patent(s)
arising from the research.
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36. • Recording data
a) Enter all research data directly into the laboratory notebook where possible.
b) Explain any unusual abbreviations.
c) Entries should be legible and understandable to a co-worker.
d) Entries must be in permanent black or blue ink to facilitate legibility,
photocopying, etc.
e) Leave at least a half-inch margin at the inside (bound) edge of each page, to
facilitate photocopying. Keep entries inside the printed margins of each page.
f) Do not erase or use correction fluid. Strike out errors with a single line through
the mistake so that it is still legible; enter the corrected word(s) or value(s) above
the error, indicating the reason for the correction. Initial and date all corrections.
g) Any unused pages or portions of pages must be closed out with a diagonal line
and dated with the researcher’s initials. Do not skip pages with the intention of
filling in data at a later date.
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37. • Organising data
a) Only one project may be recorded in each book. Researchers should
maintain a current table of contents or running index within the book, including
date, experiment number, objective, subject and page number.
b) When a book is closed out, a cross-reference to the succeeding notebook
should be entered (e.g. Continued to notebook number).
• c) With each new book, the researcher should cross-reference the previous
notebook (e.g. Continued from notebook number).
d) For each new page, enter the title, project name/number and date.
e) Only one date should be used per page.
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38. f) For patent purposes, records of new experiments should always be started on
anew page and dated at the onset of each experiment. The purpose/objective of
the experiment must be stated clearly.
g) If the experiment continues over more than one day, each entry must be dated
and continuation pages must be clearly annotated. For patent purposes, each page
should not contain entries for more than one day.
h) Only if absolutely necessary should new entries be added to previous pages,
when subsequent work of later date is already recorded on succeeding pages.
Backdating of these entries is strictly prohibited – the actual date of entry should
be used.
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39. Organising ancillary documentation
a) Where possible, supporting data should be affixed to the notebook.
b) Attach inserts (folded graphs, raw data tables, or computer printouts) with
transparent tape, glue or staples.
Care should be taken that the tape does not cover data and that inserts are not affixed in
a manner that would hinder photocopying.
Sign and date the insert and notebook page (along the seam).
c) A form of binder, notebook, folder, or envelope must be used for organization
and traceability of ancillary documentation (raw data sheets and other supporting
documentation) that cannot feasibly be incorporated into bound notebooks, but are
needed as permanent records of specific experiments.
d) In all cases, ancillary documentation must be cross-referenced to the appropriate
notebook number and page and vice versa. Additional information, such as the project
name/number, study name, device used to collect data, date of collection, researcher’s
name, etc., should also be included where relevant.
e) Specify computer programs (not fully described in the study protocol or method)
used to perform calculations on raw data. Source codes are not necessary, but indicate
the nature of the calculations.
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40. Records for patent purposes
• The importance of keeping careful, accurate records of laboratory work, to
prove inventor ship and to assist in preparing the patent specifications which,
by law, must describe the invention, cannot be over-emphasised.
• Dependence on memory or scanty notes for this purpose may result in an
invalid patent. Any record may serve as evidence to prove inventor ship, but
the laboratory notebook is the most important.
a) Describe methods in detail or by reference to an approved protocol,
standard operating procedure or method of the date of a previous notebook
entry at the beginning of the experiment.
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41. • b) Keep entries factual when reporting an experiment. Note and record unusual or
interesting observations during an experiment separately, under a heading of
‘Observations’. Premature or hasty statements such as “an experiment was
unsuccessful” should be avoided. If recording an idea to be worked on later, be
full in your discussion; use general language, state equivalents, etc.
c) Keep entries up-to-date. Advance attention to planning the experiment will give a
clearer, more intelligible record.
d) Make the entries complete, so that one skilled in the art would be able to repeat
the work. The procedure should be clearly stated in words or by reference.
e) Record the findings regarding a compound’s/cell line/molecule/other reagents etc.
activity in the notebook at the end of each experiment. The result, clearly set
forth, should be supported with analytical data.
f) Do not describe an invention or name an inventor in the findings.
g) Enter a conception on a separate page in the notebook, or keep a conception
notebook.
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42. Closing out notebooks
Notebooks that are not used for frequent reference should be returned to
the supervising senior researcher unless otherwise advised.
If a notebook is returned with unmarked pages, write ‘Notebook closed;
no further entries’, following the last recorded data. Date and sign the
page.
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43.  Non-obviousness of patent:
• The purpose of the intensive or non-obviousness requirement is to
avoid granting patent for invention which only follow from normal
product design and development to achieve proper balance between
the incentive provided by patent system, namely encouraging
innovation, and its social cost namely conferring temporary
monopolies the non-obviousness bar in thus a measure of what society
accepts as available discovery.
• Additional reason for non-obviousness requirement are providing
incentive for fundamental research rather than for incremental
improvement and minimizing the proliferation of an economically
insignificant patents that are expensive to search and to license.
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44. THE END …
THANK YOU FOR YOUR TIME…
HOPE YOU ENJOYED THE PRESENTATION.
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