Transcript Document

Procedural Challenges in Opposition
and Revocation proceedings
-Essenese Obhan
MHRD IP Chair Roundtable Symposium
NLU, Jodhpur
17th and 18th March, 2012
Multiple Attacks on Validity of Patent
• Pre-grant opposition
• Post-grant opposition
• Revocation proceedings
Pre-Grant Opposition
• Who?
- Any person
• When?
- Any time after publication of application till grant
• Where?
- Indian patent office
• Appeal?
- No appeal for opponent
Advantages
• Costs: relatively low
• Any person
• Can be quick
• Understand the patentee’s case before a revocation
attack
• Possibility of limiting scope of claims before grant
Disadvantages
• No response to counter-statement
• Cross-examination of experts- generally not allowed
• No additional documents or grounds (?)
Neon Labs. v TroikaaPharma Limited and
Others
• Respondent No. 1 (TroikaaPharma Ltd.) filed the Application no.
96/MUM/2005 for "Injectable preparations of Diclofenac and its
pharmaceutically acceptable salts" on 25.01.2005
• On 29.10.2007, the Petitioner filed a representation by way of opposition
under Section 25(1)
• On 05.02.2008, the Respondent No.1 filed a reply statement to the opposition
of the Petitioner
• During the hearing held on 09.07.2008, Respondent pointed out that they
intended to file an amended set of claims
• the Respondent No. 4 (Asst. Ctrl. Of Patents) sent the amended claims to the
Petitioner after the hearing vide a letter dated 11.09.2008
Neon Labs. v TroikaaPharma Limited
and Others
• Petitioner filed its opposition to the amended claims on 07.10.2008
• The Petitioner requested by its letter dated 30.12.2008 for a personal
hearing in the light of the opposition to the amended claims
• There was no response to these communications and therefore the
Petitioner sent a letter dated 06.05.2009 objecting to the course adopted
by the Respondent No.4, namely, allowing amendment of claims after the
hearing was concluded
Neon Labs. v TroikaaPharma Limited and Others
• “opportunity provided in Section 25(1) is not an empty formality…. Once the
Legislature has devised such a safeguard in public interest and provided for
pregrant opposition, so also, set out the manner in which the same has to be
dealt with, then, we cannot place a narrow interpretation on the said
provision so as to defeat the legislative mandate. The distinction made by Mr.
Kadam that opportunity is restricted only to the contents of the original
application and there is no requirement of giving further hearing; makes the
exercise meaningless and it would be then very easy to defeat Section 25(1).
In this context, it must be understood that the opposition under Section 25(1)
is to the "grant of a patent"....If the opposition is raised to the grant, then,
until the same is dealt with, no patent can be granted. If the original
claim/application is amended, as in this case, and the amendments are also
opposed, then, a personal hearing to the objector on the amended claims is
required to be given if specifically requested. That is the scheme of Section
25(1) and Rule 55 which are to be considered and read together.”
Patent Office:
• Interpreted by patent office
amendment to claims only
to
mean
• treats amendments under section 15 and not
under section 25
Post-Grant Opposition
• Who?
- Person interested
• When?
- Within one year from the date of publication of the grant of
patent
• Where?
- Indian patent office
• Appeal?
- Yes, appealable at Intellectual Property Appellate Board
Revocation
• Who?
- Person interested
• When?
- Any time after the grant of patent
- As a defence in an infringement suit
• Where?
- Intellectual Property Appellate Board (IPAB) Chennai
- High Court
• Appeal?
- Yes
Advantages- IPAB
• Adjournments/delays strongly discouraged
• Additional documents can be submitted
• More structured
Disadvantages- IPAB
• No cross examination of witnesses
• Single technical member for all technologies
Grounds of opposition/revocation:
• Novelty
• Inventive Step
• Insufficiency
• Not an invention/not patentable
Inventive Step:
• Section (2)(1) (ja): “inventive step” means a feature
of a invention that involves technical advance as
compared to the existing knowledge or having
economic significance or both and that makes the
invention not obvious to a person skilled in the art
Not Inventive:
• Section 64(1) (f): That the invention so far as claimed
in any claim of the complete specification is obvious
or does not involve any inventive step, having regard
to what was publicly known or publicly used in India
or what was published in India or elsewhere before
the priority date of the claim
Windsurfer test:
• First: identify the “inventive concept” embodied in the patent
• Second: the court has to assume the mantle of the normally skilled
but unimaginative addressee in the art at the priority date and to
impute to him what was, at that date, common general knowledge
in the art in question
• Third: identify what, if any, differences exist between the mater
cited as being “known or used” and the alleged invention
• Finally, the court has to ask itself whether, viewed without any
knowledge of the alleged invention, those differences constitute
steps which would have been obvious to the skilled man or whether
they require any degree of invention
Routes to proving obviousness
• Route 1: Mosaic of prior art documents
• Route 2: Missing element provided by Common
General Knowledge
Insufficiency
• Section 64 (1)(h): that the complete specification does not
sufficiently and fairly describe the invention and the method
by which it is to be performed, that is to say, that the
description of the method or the instructions for the working
of the invention as contained in the complete specification are
not by themselves sufficient to enable a person in India
possessing average skill in, and average knowledge of, the art
to which the invention relates, to work the invention, or that
it does not disclose the best method of performing it which
was known to the applicant for the patent and for which he
was entitled to claim protection
Need to Determine:
• State of the Art – Publicly known or used in India;
published anywhere
• Person of Skill in the Art (PoSITA)
• Common General Knowledge of the PoSITA
Common General Knowledge:
• “The information which at the date of the patent in question is common
knowledge in the art or science to which the alleged invention relates, so
as to be known to duly qualified persons engaged in that art or science.”
[British Thomson – Houston Co. Ltd v Taylor Electrical Co. Ltd (1916) 33 R.P.C. 166
at 171]
in other words,
• “it is part of the mental equipment necessary for competency in that art
or science concerned, such as every worker in the art may be expected to
have as a part of his technical equipment.”[Automatic Coil Winder, etc., Co Ltd
v Taylor Electrical Instruments Ltd (1944) 61 R.P.C. 41]
Common General Knowledge:
What is not:
‘In my judgement it is not sufficient to prove common general knowledge that
a particular disclosure is made in an article, or series of articles, in a scientific
journal, no matter how wide the circulation of that journal may be, in the
absence of any evidence that the disclosure is accepted generally by those
who are engaged in the art to which the disclosure relates. A piece of
particular knowledge as disclosed in a scientific paper does not become
common general knowledge merely because it is widely read, and still less
because it is widely circulated. Such a piece of knowledge only becomes
general knowledge when it is generally known and accepted without question
by the bulk of those who are engaged in the particular art; in other words,
when it becomes part of their common stock of knowledge relating to the
art.’ [British Acoustic Films 53 R.P.C 221at 250]
Common General Knowledge:
•
“It has never been easy to differentiate between common general knowledge and
that which is known by some. It has become particularly difficult with the modern
ability to circulate and retrieve information. Employees of some companies, with
the use of libraries and patent departments, will become aware of information
soon after it is published in a whole variety of documents; whereas others,
without such advantages, may never do so until that information is accepted
generally and put into practice. The notional skilled addressee is the ordinary man
who may not have the advantages that some employees of large companies may
have. The information in a patent specification is addressed to such a man and
must contain sufficient details for him to understand and apply the invention. It
will only lack an inventive step if it is obvious to such a man. It follows that
evidence that a fact is known or even well-known to a witness does not establish
that that fact forms part of the common general knowledge.” [Court of Appeal in
Beloit Technologies Inc V Valmet Paper machinery Inc (1997) RPC 489 at pages 494-495; also
referred to in K. Manivannan v. M. Mani IPAB Order No. 55/2009]
Common General Knowledge in Pharma matters:
• Different types of dosage forms and their properties
• Dissolution rate of a drug affects its bioavailability
• Dissolution rate affected by particle size (surface area)
• Differing properties of different polymorphs can include
different solubilities (and therefore bioavailability)
Person of Skill in the Art (PoSITA)
• Notional Person
• Average Skill in the Art to whom the patent is addressed
• Has read all the prior art (but does not remember any of
it)
• Has no inventive capability
• Knows all the Common General Knowledge in the art
• Could be different for construction/ sufficiency and
obviousness
PoSITA
Art: Vehicular Cargo transportation (TRUCKS)
•
•
•
•
Use: drives a truck? Repairs a truck?
Produce: Manufacture the truck
Design: Aesthetics/Capacity of the truck
Research/Invent: Involved in creating new technologies for
trucks
PoSITA in Pharma Cases:
• In the Pharma Industry – interested in formulating drugs
• Has a degree in Chemistry/ Pharmaceutical sciences/
Formulation science
• A few years experience in a lab with:
– Experience in formulation and development of solid
dosage forms intended for oral administration
• Assisted by a team of graduates and technicians
• Access to analytical laboratories
EP1307131
EP1307131
Verathon Medical (Canada) ULC v Aircraft
Medical Limited [2011] CSOH 19
• Verathon Medical – proprietor of EP1307131
• Verathon Medical alleged infringement of
EP1307131 by Aircraft Medical’s product McGrath
Series 5 laryngoscope
• Aircraft Medical counterclaims for revocation of
patent
PoSITA according to Verathon Medical-Patentee
• Clinicianinvolved in carrying out and supervising the
intubation of patients and a Medical Device Engineer
and
• Medical Device Engineer- a clinical technologist
employed in a hospital rather than a graduate
medical engineer; or
if in industry: no training in anatomy and physiology;
would not have used a laryngoscope and would have
no design experience for it.
PoSITA according to Aircraft Medical-Defendant
• Clinician- newly qualified consultant anaesthetist having
interest in the management of difficult airways
• Medical Device Engineer: works in industry with either
physics, mechanical or electrical degree followed by a
MSc + product design degree followed by experience in a
design house + a degree in biophysics or biomedical
engineering
• Camera technician: would know of CMOS and CCD
products and how to use and position them
PoSITA as determined
• Not a clinical user of a laryngoscope: newly-qualified
consultant anaesthetist who has an interest in airway
management;
• medical device engineer working in industry with some
knowledge of electronics and camera technology or along
with a camera engineer; would know of use of cameras in
some medical devices
Common General Knowledge according to
Verathon Medical -Patentee
• Clinician: knowledge of very limited number of conventional
laryngoscope blades. In UK would know macintosh blade and
in the US would also know a few other blades.
• Not aware / experienced of other laryngoscope blade
including Belscope, Bullard or other rigid fibre-optic
laryngoscopes
• Not aware of specialist textbooks
• Not aware of patents, concept of indirect laryngoscopes,
camera and lens in endoscopy
Common General Knowledge of a PoSITA
according to Aircraft Medical-Defendant
• Clinician: knowledge that there had been attempts to obtain
an indirect view of the glottis from the pharynx, behind the
tongue
• Would know of Bullard and other laryngoscope,
• New devices discussed in meetings of DAS (Difficult Airway
Society)
• Use of video chips at the distal end of endoscopes for
gastrointestinal investigations
Common General Knowledge of a PoSITA as
determined
• Consultant anaesthetist
laryngoscopes
in
UK/US
–skills/use
:direct
– Leading text books contributed to “awareness” of Bullard and other
anatomically-shaped rigid fibre-optic laryngoscopes;
– DAS Meetings contributed to awareness of new laryngoscopes
including indirect laryngoscopes;
• Medical device engineer would be aware of use of video chips
in endoscopy
EP0042723
EP0042723
• Claim 1:
A vacuum cleaning appliance including:
– cyclone units of successively higher efficiency in
the capability of depositing fine dust;
– in series connection;
– the highest efficiency cyclone having frustoconical part tapered away from entry;
– lower efficiency cyclone unit upstream of the
highest efficiency unit.
Dyson Appliances Ltd v Hoover Ltd [2001]
RPC 26
• First patent by Dyson had two high efficiency
cyclones
• Huge profits in selling filter bags-industry bias
• Hoover product: Three parts:
– SU1: cylindrical cyclone
– SU2: intermediate channel-no dust collection
– SU3: frusto-conical cyclone
PoSITA according to Dyson
• General engineer in vacuum cleaning industry with a
“practical turn of mind”
• Post graduate
• Must be working in “domestic” product field
Amended to:
“Agree that engineer must have limited knowledge of
large scale industrial cyclones”
PoSITA according to Hoover
• Engineer in vacuum cleaning industry with
considerable time spent in familiarizing himself with
the manufacture and operation of both gas cyclones
and vacuum cleaning appliances
Amended to:
• “designer and manufacturer of vacuum cleaning
appliances” (not only domestic) + knowledge of
theory and working of cyclones: hands on experience
of cyclones including commercial cyclones
PoSITA as determined
• “The evidence has not proved to be of much assistance in
getting a clear picture of the workings of what I believe to be
the relevant field, that is, vacuum cleaner industry alone”
PoSITA:
• Graduate in mechanical or electrical or both
• Few years practical experience in vacuum cleaner industry
• Not limited to only domestic appliances
• Does not have to possess hands on experience with cyclones
and their working
• But will have some knowledge of cyclones as part of general
engineering background including commercial cyclones
Challenges:
• Determining the PoSITA
• Identify the Common General Knowledge of the
PoSITA
• Balancing Obviousness and Insufficiency
• Expert Evidence: Important not to portray the expert
as person skilled in the art
Thank you
• Questions?
• Email - [email protected]