Title: Patents, Patentability and Infringement
1Patents, Patentability and Infringement
- B. Vijayaraghavan
- Director, IP
- Ranbaxy Laboratories Limited
2The Cycle of Innovation and Competition
Branded Company Innovates, Creating Value for the
Healthcare System via Breakthroughs
Branded Company Rewarded with Monopoly Position
Branded Company Loses Revenue on Older Products,
Necessitating Plan to Replace s
Patent Expiration Generic Industry Opportunity
to Create Value via Competition
RANBAXY
3Some Quotable Patent Quotes
- A country without a patent office and good
patent laws is just a crab and can't travel any
way but sideways and backwards - Mark Twain
- The patent system added the fuel of interest to
the fire of genius - Abraham Lincoln (the only US president with a
granted patent) - Everything that can be invented has been
invented - Charles H. Duell, Commissioner, U.S. patent
office, 1899 (attributed)
4NOTIONS OF INTELLECTUAL PROPERTY
- MOVABLE PROPERTY
- Owner has legal and exclusive rights to use his
property. - Owner may authorize others to use his property
but requires legal authorization. - Can be possessed, owned, donated, stolen.
- IMMOVABLE PROPERTY
- Land and property
- Limit to use of such property
- INTELLECTUAL PROPERTY (Creation of human
intellect) - An asset that can be possessed, owned, bought,
sold, donated, and - stolen.
- An asset that is cognizable under the basic laws
governing the ownership and the monetary value.
5MODES OF PROTECTING INTELLECTUAL PROPERTY
- PATENTS
- Process
- Products
- Apparatus
- Capable of Industrial application
- DESIGNS
- Shapes
- Ornamental
- TRADE MARKS
- Marks used to distinguish goods - words, signs or
combination - An asset that is cognizable under the basic laws
governing the ownership and the monetary value
6MODES OF PROTECTING INTELLECTUAL PROPERTY
- COPY RIGHTS
- Musical work
- Artistic work
- Literary work e.g. Books, periodicals, lectures,
plays, maps, art reproductions and models
7WHY PATENT INVENTIONS ?
- To reserve for oneself rights on a short term
basis. - To be recognized as being the inventor or being
an - innovative company.
- To prevent third parties from obtaining patents
for the same invention (defensive patent). - To obtain a complete monopoly on the invention
to - exclude potential infringer
(offensive patent).
8CAN I PUBLICLY DISCLOSE MY INVENTION?
- If you are thinking of applying for a patent you
should not publicly disclose the invention
before you file an application because this
could be counted as prior art of your invention - Any type of disclosure (whether by word of
mouth, demonstration, advertisement or article
in a journal), by the applicant or any one
acting for them could prevent the applicant from
getting a patent. - It could also be a reason for having the patent
revoked if one was obtained - It is essential that the applicant only makes
any disclosure under conditions of strict
confidence
9WHEN SHOULD I FILE MY PATENT APPLICATION
- ADVANTAGES OF EARLY FILING
- You establish a priority date for your
invention - A disclosure of the invention either by
yourself or - someone else, can not now prevent you
from getting - the patent
- It maximizes the chance of beating
competitors who - may also file a patent application on
the same invention - If you delay, you run the risk of losing
your ability to - get a patent
-
10WHEN SHOULD I FILE MY PATENT APPLICATION
- ADVANTAGES OF DELAYED FILING
-
- You will have time to add refinements to your
inventions - You will have time to assess and broaden the
scope (limits) of the invention - You can discuss the commercial significance of
your invention with a potential licensee who may
be ready to make funds available to do more
extensive research on the invention
11KEY STEPS INVOLVED IN OBTAINING A PATENT
IDEA (Conception)
INVENTION (Reduction to Practice)
- FILE PATENT APPLICATION
- Novel
- Non obvious
- Useful
Average Time 1. 5 3 Years
EXAMINED BY PATENT OFFICE
PATENT ALLOWED
PATENT REJECTED
OR
ISSUE PATENT
OR
ABONDON
RE-FILE
APPEAL
12STATUS IN 2006
- Countries in the world
200 - Countries having patent laws
157 - Country members of Patent Cooperation Treaty
130
13WHAT IS A PATENT ?
- A patent for an invention is granted by the
Government to the inventor, giving the inventor
the right to stop others from making, using or
selling the invention without the permission of
the inventor for a limited period. - Owning a patent does not of itself give the
patent owner the right to practice his own
invention because practicing ones own invention
may infringe some one elses patent. - When a patent is granted for an invention , it
becomes the property of the inventor or its
assignee. Patents are territorial rights - US patent will give the holder rights within the
United States and rights to stop others from
importing the patented products into the United
States
14CONDITIONS OF PATENTABILITY
- An invention must meet the following criteria if
it is to be eligible for patent protection.
These include - 1 Patentable subject Matter (Statutory
requirement) - 2 Novelty
- 3 Inventive step ( Non Obviousness)
- 4 Industrial applicability (Utility)
15POTENTIAL CHEMICAL INVENTIONS
- Compound per se .
- Pharmaceutical composition of new compounds.
- New pharmaceutical compositions of old
compounds. - Method of treatment or method of use.
- Compound for use (broad first use).
- New medical use for old compound (second use).
- Process per se. (when novel and inventive).
- Intermediates .
- Processes for preparing composition.
- Different salt forms,hydrates,or polymorphs
- Drug non specific patents (platform technology)
16NOVELTY
- Fundamental requirement for patentability.
- Novelty is not something which can be proved or
established, only its absence can be proved. - An invention is new if it is not anticipated by
the prior art. - Novelty exists if there is any difference between
the invention and the prior art.
17INVENTIVE STEP (NON - OBVIOUSNESS
- Establishing the non-obviousness or the inventive
stepis the most difficult task in the examination
as to the substance. - Invention should not be obvious to a person
having - ordinary skill in the art.
- The person having ordinary skill in the art is a
person with appropriate training and practical
experience but "ordinary skill" intends to
exclude the "best expert" in that field in the
country concerned. - "Inventive" implies result of "creative idea" and
"step" means there is noticeable difference
between the state of the art and the claimed
invention. This gives the progress or advance
over the prior art and this progress should be
significant.
18INVENTIVE STEP (NON OBVIOUSNESS) contd
- During the evaluation of the difference
between the invention under examination and the
prior art, an account has to be taken as a whole
i.e. the invention is compared not only with
each publication or other disclosure
separately, but with the combinations thereof. - In the nut shell not only the combination,
but also the choice of the combined elements
should not be obvious.
19INDUSTRIAL APPLICABILITY (UTILITY)
- In order to be patentable,the invention must be
of the kind - - which can be applied for practical
purposes - - which can be carried out in practice
- - which can not be purely theoretical
-
- In common language, an "industrial" activity
means a technical activity on a certain scale
while in the terminology of patent laws
industrial applicability of an invention means
the application (making,use)
20PRIOR ART
- All knowledge that existed prior to the relevant
filing or priority date of a patent application,
by way of written or oral disclosures or
disclosures by use. - Written disclosures Physical carriers for
information like publications e.g. patents,
published patent applications, writings
(manuscript, typescript, printed matter),
pictures, including photographs, drawings,
films, recordings (discs or tapes) in either
spoken or coded language. - Oral disclosure Words or form of the disclosure
which are not necessarily recorded as such and
includes lectures and radio broadcasts - Disclosure by use Public visual disclosure by
display, sale, demonstration, unrecorded
television broadcasts and actual public use
21LIFE OF A PATENT
- EUROPE
- - 20 years from date of filing.
- USA
-
- - Before GATT (June 08, 1995)20 years from
date of filing or 17 years from date of
grant whichever is longer - - After GATT 20 Years from date of
filing. - INDIA
- Till May,2003
- (a) Pharmaceuticals / Food 7 years from date
of filing, - (b) others like engineering etc 14 years from
date of filing - - After May, 2003 20 years from filing
date. -
22INFRINGEMENT
- A patent prevents others from utilizing the
invention without the consent of the patentee or
its licensee. - Any act of trespassing this property constitutes
an act of infringement, which is a tort in the
sense of direct invasion of the right of the
patentee or its licensee. - A patentee or its licensee approaches the court
of the country where the patent is in force for
legal redress for invasion of one or more claims
of the patent by the infringer.
23LITERAL INFRINGEMENT(ALL ELEMENTS RULE)
- A claim with several elements is infringed if
every element is found in the accused device /
product / process. For literal infringement, all
elements present in the claims must be present in
the accused product /process.
24 INFRINGEMENT UNDER DOCTRINE OF
EQUIVALENTS (DOE)
- Infringement beyond claim boundaries
- It is judicially constructed equivalence and
non- statutory - Designed to prevent injustice to patent holder
to catch a would be infringer who escapes the
literal language of the claim by making cosmetic
changes to the claim - Equivalent of each element / feature of claim
must be found in the accused device / product /
process - To determine whether equivalence is actually
present, one method is to see whether
replacement achieves substantially the same
function in substantially the same way to give
substantially the result, known as the
function - way result test first codified in
Graver tank v Linde Air Prods (1950)
25INFRINGEMENT UNDER DOCTRINE OF EQUIVALENTS (DOE)
contd.
- Prosecution History Estoppel(PHE) is one tool
that prevents the doctrine of equivalents(DOE)
i.e.if during the patent prosecution applicant
narrows the claim for any reason except to
correct the typo he is barred from asserting
infringement under DOE - In Glaxo vs. Ranbaxy, CAFC held Glaxo estopped to
assert DOE as it had narrowed the claims during
the prosecution of the 181 patent , therefore,
infringement under DOE in the present case is
precluded by Prosecution History Estoppel
26THE MOST EXPENSIVE EXAMPLE OF IP MISMANAGEMENT
(POLAROID VS EASTMAN KODAK)
- 1948, Erwin H. Land invented a Camera that would
develop the picture almost immediately after it
was taken - First film was made by Kodak for Polaroid
- Instant camera technology had been developed
largely by Polaroid supported number of patents - Kodak entered into an agreement to produce the
colour negative for Polaroid. The agreement
lasted till 1969 - In 1976 Kodak decided to move on its own into
instant camera and film by working around the
Polaroid patents
27THE MOST EXPENSIVE EXAMPLE OF IP MISMANAGEMENT
(POLAROID VS EASTMAN KODAK)
- Immediately after Kodak entered the market in
April, 1976, Polaroid filed an infringement suit
on Kodak for 12 of its instant camera patents. - On October 12, 1990 the court ordered Kodak to
pay Polaroid 454,205,801 in compensation for 10
years its instant camera products were in the
market. An additional 455,251,761 was added on
as interest, (total - approx. 920 million). - Total cost to Kodak of its misguided patent
strategy was about 920 million. - Kodak was forced to shut down its 1.5 billion
manufacturing plant and lay off 700 workers. -
28MAINTENANCE OF LABORATORY NOTE BOOKS
- SOME USEFUL GUIDELINES
- Laboratory records of inventive work can be
used to prove the date of - invention.
- Two concepts that need to be understood are
- (a) Evidence
- (b) Diligence
-
- EVIDENCE
- Evidence goes to establish the date of
conception of the invention which can - be achieved by instituting a formal system of
recording who conceived the - idea and when
- Ideas should be documented as minutes of a
research review meeting / - project planning exercise, recordings of a
brain storming session, etc. - The evidence should be singed and dated by both
the inventor and a - corroborating witness.
29MAINTENANCE OF LABORATORY NOTE BOOKS
- Ø DILIGENCE
- Is used to prove that the idea was actually put
into practice - Requires one to keep records of the progress or
even gaps in the activity in - the well established laboratory note -books.
- Laboratory note book must be hardbound (so that
it can not be tampered) - and the pages numbered.
- Every Laboratory Note Book should also be
numbered which should be - followed by "Preface recording relevant
details of the inventor such as his - name, department, project name, etc.
- The title page lists the contents and a page
listing the abbreviations being - used in the note book is also recommended
30MAINTENANCE OF LABORATORY NOTE BOOKS
- Every page has to be dated and the entries signed
by the inventor, with each page countersigned by
an independent witness. - Experimental results, their interpretations,
experimental strategy, development of ideas are
expected to be documented in the Note Book with
appropriate signatures and counter signatures - Analytical data such as IR, NMR, UV, Mass
spectra, HPLC, GLC graphs, XRD, DSC data should
be kept in a separate file which is
systematically indexed, allowing easy retrieval - There should be a central laboratory note-books
issuing authority which is responsible for
maintaining records of the issues. - A system should also be created to archive the
complete note books when these are required at a
future date to serve as legal document for any
patent related litigation.
31 The only thing that keeps us alive
is our brilliance The only
thing protecting our brilliance
is our patents.
Edwin H. Land, 1976
32Thank you