Patenting-An introduction

							PATENTABILITY
ASSESSMENT
PHARMAEXCIL-23/05/2012
Srividya Ravi
Gnanlex
SCOPE OF TALK
 Patentability   criteria

 Case   study

 Howto use as an assessment to
 prepare a strong patent draft
PATENTABILITY CRITERIA
Novelty



Utility



Nonobviousness
PATENT ACT – AMENDMENT 2002
EUROPEAN CRITERIA
European patents shall be
granted for any inventions
which are susceptible of
industrial application, which
are new and which involve an
inventive step.
NOVELTY
An invention shall be considered to be new
if it does not form part of the state of the
art.

 (2) The state of the art shall be held to
 comprise everything made available to the
 public by means of a written or oral
 description, by use, or in any other way,
 before the date of filing of the patent
 application
NONOBVIOUSNESS

 A patent may not be obtained if the
 differences between the subject matter
 sought to be patented and the prior art
 are such that the subject matter as a
 whole would have been obvious at the
 time the invention was made to a person
 having ordinary skill in the art to which
 said subject matter pertains.
PERSON HAVING ORDINARY SKILL IN THE ART
 Factors that may be considered in
  determining level of ordinary skill in the art
  include
 the educational level of the inventor;

 type of problems encountered in the art;

 prior art solutions to those problems;

 rapidity with which innovations are made;

 sophistication of the technology; and

 educational level of active workers in the field.
INVENTIVE STEP
 Unanticipated
 Surprising, unexpected, unpredictable
 Long felt, but unresolved need
 Problem in the art hitherto unsolved
 Advantages-Cost, Yield, Conversion
 Adequately supported by examples
 Documentary support
 Support by comparative examples
 Combination of prior arts leading to predictable
  results
OTHER CRITERIA

   Both EU and Indian patent act have specified
    invention not patentable as allowed by TRIPs

   Enablement criteria

   Disclosure

   One year grace period-US and India
A CASE STUDY

 A Process for the preparation of
 Copolymer-A

 Disclaimer: This case study is only meant to illustrate the
 various aspects of patenting such as invention disclosure,
 distinguishing invention with regard to prior art, provisional,
 complete and claims drafting , narrow and broad claims,
 examples etc.
FACT FILE
 Provisional filed with 10 claims
 Lot of prior art
 It was clearly stated in the provisional that the
  process of synthesis is as claimed in US
  6048898
 The provisional did not bring out the novelty
  with regard to this prior art
 Copolymer A is useful in the treatment of
  multiple sclerosis
CLAIMS
What is claimed is :
 Copolymer-1 having molecular weight of about
  8000to 19000Da, made by a process
  comprising:
  Treating trifluroacetyl copolymer-1 with
  piperidine to form a solution of Copolymer-1;
  and
  Purifying copolymer-1, thereby producing
  Copolymer-1 having molecular weight of about
  8000to 19000Da.
THE BACKGROUND
 A provisional application is usually filed to claim
  a priority date for an invention about which
  there is a broad idea and some
  experimentation data is ready, but the data for
  the entire scope of the invention is not yet
  worked up and generated.
 It is useful in areas where number of filings is
  high and more frequent, but its scope cannot
  be widened in future.
THE BACKGROUND

   Therefore, provisional application usually does
    not contain claims-Only a broad description of
    invention, preferably few examples, which
    illustrates enablement of idea.
THE PROCESS
 Process    of patentability assessment
  began with meeting with inventor.
 In the meeting       the novelty of the
  invention was brought out to be the use of
  “polymer supported initiator” which was
  not part of the claims of the provisional
  application.
 Even though this was put in description, it
  was not dwelt into and not claimed at all.
PRIOR ART SEARCH
 Determine prior arts closest to the main claim
  of the invention
 Check if any prior art affects novelty-single
  document detailing all elements of the
  invention
 Check     whether prior arts can affect
  inventiveness of the invention, thus making it
  obvious
 Confirm industrial applicability of invention
THE ASSESSMENT……..

 The assessment cited four prior arts including
  one cited in the provisional.
 The novelty of the invention did lie in the use of
  the polymer supported initiator, since the prior
  arts used the same initiators/catalysts, but not
  supported.
 With    regard to non-obviousness, the
  assessment stated as follows:
THE ASSESSMENT……..

 “Examples supporting the unexpected results
 obtained with polymer supported catalyst as
 initiator in comparison to results of examples
 without catalyst and with non supported
 catalyst will be useful in overcoming
 obviousness type of objections.
  After obtaining all these examples, we can
 review the patentability and redraft claim 1.”
THE ASSESSMENT……..
 Further the inventor was informed that she
  should provide data with regard to the
  effects/benefits/specific advantages obtained
  due to use of supported initiators, apart from
  the narrow range of molecular weight range
  claimed, if any
 Also, details of polymer supported catalyst is to
  be provided while drafting the complete
  specification
PRIOR ARTS COMPARISON
US 3849550             US 5800808             US 6048898

Product with           Only deprotection      Continuation of
15000-25000 KDa        step of process        5800808, method
molecular weight       claimed to obtain      of manufacturing
and use claimed,       molecular weight in    copolymer-1 of
process described,     the range of 5-9 KDa   predetermined
which is followed by                          molecular weight
all subsequent                                claimed, specified in
inventors.                                    description as not >
                                              40 KDa, 75%
                                              between 2-20 KDa
COMPLETE DRAFT
   The draft gave details of polymer supports and
    their process of preparation


   The % of species in the range of 8-19KDa is
    99.25%. Since the amount of copolymer-1
    above 20KDa is less than 1%, the copolymer-1
    is non-toxic as exemplified in example II in US
    6620847 to Konfino et al.
CLAIMS
Provisional                    Complete
Copolymer-1          having    A process for the synthesis
molecular weight of about      of copolymer-1 having a
8000to 19000Da, made by        molecular weight below 20
a process comprising:          KDa , wherein the
  Treating    trifluroacetyl
copolymer-1 with piperidine    polymerization process is
to form a solution of          characterized in using
Copolymer-1; and               polymer supported dialkyl
  Purifying   copolymer-1,     amine as initiator
thereby           producing
Copolymer-1          having
molecular weight of about
8000to 19000Da.
LESSONS WE LEARNT
 The invention/novelty of invention should be
  established even if only provisional is to be filed.
 Inventors may require support of expertise in this
  area to protect their inventions adequately.
 It is advisable to keep the scope of provisional
  broad to cover various aspects of the invention so
  that the priority claimed is not lost. Here the
  polymer supported initiator was part of provisional.
  So the patent office cannot object to the claims
  with regard to same in complete.
INTERNATIONAL SERACH REPORT
WRITTEN OPINION
THANK YOU