power point presentation

1. By
Pinank Vora
Roll No. 56
MA(E.M.A)-I
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2.  Laws governing copyright are governed by “The Copyright Act, 1957”.
 The objective of the act is to promote and progress of science and useful acts.
 It is for artists, authors composers, designers as well as film producers and
producers of sound recordings
 To safeguard the right to original work or expression of them.
 Also provide them the right to sell these rights to others in return for monetary
gains.
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3. According to the copyright act,1957.
 Any work of visual recording and includes a sound recording accompanying such
visual recording and the expression “cinematograph” shall be construed as
including any work produced by any process analogues to cinematography
including video films
 Visual recording means the recording in any medium by any method including the
storing of it by electronic means, of moving images or of the representations there
of, from which they can be perceived, reproduced or communicated by any method.
 Sound recording means a recording of sounds from which such sounds maybe
produced regardless of the medium on which such recording is the method by
which the sound are produced.
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4. 1. Literary works
2. Computer programmes
3. Dramatic works
4. Musical works
5. Artistic works
6. Cinematograph films
7. Sound recording
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5. Infringements
Direct Indirect Subconscious
1.Works, not
ideas
1.Substantial
taking
1.Themes or
plots
Casual
connection
Copying
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6. R.G Anand vs M/S. Delux Films &
Ors

7.  R.G Anand is a playwright, dramatist and producer of stage plays. The appellant
had written &produced a number of plays.
 Hum Hindustani, a play was written by him in the year 1953 and was enacted in
the year 1954 and thereafter the play proved to be popular.
 R.G Anand received a letter from Mohan Sehgal requesting him to supply a copy
of the play so that he could consider the desirability of making, a film on it.
Thereafter, they met at Delhi.
 In May, 1955 Mohan announced the production of a motion picture entitled "New
Delhi". The picture was released in Delhi in September 1956.
 The appellant filed a suit alleging that the film "New Delhi" was entirely based
upon the play "Hum Hindustani",
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8. Anand young graduate from punjab comes to delhi -
Fights with the girl 'Janaki'- Tries to find a place for
rent but people refuse to give to any one except south
Indians - Disguises as a south indian and gets a place to
stay - Meets the girl Janaki again – falls in love - Boy's
parents come to Delhi - Girl's parents get to know the
identity of Anand - Relations strained - Janaki decides
to commit suicide leaving a letter - Parents realize and
get youngsters married
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9. Plaintiff
 Films is totally copied from the play
 Play was the original idea.
 All characters are based on play
 They covered all the languages of
the country in characters
 Both are based on the similar
location i.e. New Delhi
Defendants
 Films has longer running time and
detail as compared to play
 It just build up on the idea of the
plaintiff
 There is only a few characters which
are based on the play.
 They only covered a Madrasi and
Punjabi language om their
characters.
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10.  Ideas not protected - Only Expression protected.
 It is infringement only if the expression of thought is copied.
 To prove copying it need not be an exact copy, It is enough if the substantial portion
has been copied - Substantial similarity in incidents, scenes and treatment.
 Two works showing the same emotion would not be copies unless the expression has
been copied.
 Colourable imitation amounts to violation.
 Test - affect produced on the mind of a person - If the reader, spectator, person feels
that a subsequent work is a copy of the original.
 There can be no copyright in an idea, subject matter, themes, plots or historical or
legendary facts and violation of the copyright in such cases is confined to the form,
manner and arrangement and expression of the idea by the author of the copyrighted
work.
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11.  The idea or construct of the movie is way different than the play.
 The way for execution of the idea also different given the financials, team and
time period required to develop them also different.
 An idea can’t always be an original until implemented ; an art is the solution of an
idea.
 A play can be basis for the movie doesn’t make it a copy of the play.
 Characters in the movie are far more than that of play which has been improved
the artistic effect of the movie.
 It just copy of the expression of the writer of the play.
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12. Novartis v. Union of India & Others
CASE UNDER THE PATENT ACT,1970

13.  Novartis International AG is a
Swiss multinational pharmaceutical
company based
in Basel, Switzerland.
 It is one of the largest
pharmaceutical companies by both
market capitalization and sales.
 An IMS Health report ranked
Novartis as the biggest pharma
company in 2012 when the case was
going on.
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14.  The patent application at the center of the case was filed by Novartis in India in
1998, after India had agreed to enter the World Trade Organization and to abide
by worldwide intellectual property standards under the TRIPS agreement.
 As part of this agreement, India made changes to its patent law; the biggest of
which was that prior to these changes, patents on products were not allowed,
while afterwards they were, albeit with restrictions.
 These changes came into effect in 2005, so Novartis' patent application waited in a
"mailbox" with others until then, under procedures that India instituted to
manage the transition.
 India also passed certain amendments to its patent law in 2005, just before the
laws came into effect, which played a key role in the rejection of the patent
application.
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15.  When examination of Novartis' patent application began in 2005, it came under
immediate attack from oppositions initiated by generic companies that were
already selling Gleevec in India and by advocacy groups.
 The application was rejected by the patent office and by an appeal board. The key
basis for the rejection was the part of Indian patent law that was created by
amendment in 2005, describing the patentability of new uses for known drugs and
modifications of known drugs.
 Section 3(d) of the amended Act, specified that such inventions are patentable only
if "they differ significantly in properties with regard to efficacy." At one point,
Novartis went to court to try to invalidate section 3(d); it argued that the provision
was unconstitutionally vague and that it violated TRIPS.
 Novartis lost that case and did not appeal. Novartis did appeal the rejection by the
patent office to India's Supreme Court, which took the case.
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16.  Novartis had attempted to patent imatinib mesylate in beta crystalline form
(rather than imatinib or imatinib mesylate), thus they sought to prevent extant
literature on imatinib or imatininb mesylate from being considered as prior art.
 The thrust of the arguments by Novartis' legal team was two-fold:
1. that the Zimmerman patents and the journal articles published by Zimmerman
et al. do not constitute prior art for the beta crystalline form as it is only
one polymorph of imatinib mesylate, thereby providing the required novelty
and inventive step
2. that imatinib mesylate in beta crystalline form has enhanced efficacy over
imatinib or imatinib mesylate to pass the test of section 3(d)
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17.  Zimmermann patent did not teach or suggest to a person skilled in the art to select the
beta crystalline form in preference to other compounds of which examples were given
in the Zimmermann patent. Further, even if the beta crystalline form was selected, the
Zimmermann patent did not teach a person to how to prepare that particular
polymorph of the salt. Having arrived at the beta crystal form of methane sulfonic
acid addition salt (mesylate salt) of imatinib.
 The inventors had to further research to be able to ensure that particular salt form of
imatinib was suitable for administration in a solid oral dosage form. Hence, the
coming into being of the beta crystalline form of imatinib mesylate from the free base
of imatinib was the result of an invention that involved technical advance as compared
to the existing knowledge and brought into existence a new substance. Research was
required to define and optimise the process parameters to selectively prepare the beta
crystalline form of imatinib mesylate.
 As the Zimmermann patent contains no mention of polymorphism or crystalline
structure, the relevant crystalline form that was synthesized needed to be invented.
There was no way of predicting that the beta crystalline form of imatinib mesylate
would possess the characteristics that would make it orally administrable to humans
without going through the inventive steps
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18. The beta crystalline form enhanced efficacy over other polymorphs, it was stated
that beta crystalline form has
I. more beneficial flow properties
II. better thermodynamic stability
III. lower hygroscopicity
IV. increased bioavailability
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19.  The argument was primarily focused on proving imatinib mesylate in beta
crystalline form is neither novel nor is it non-obvious due to publications about
imatinib mesylate in Cancer Research and Nature in 1996, disclosures in
Zimmerman patents, disclosures to FDA and finally that efficacy as referred to in
section 3(d) should be interpreted as therapeutic efficacy and not merely a
physical efficacy.
 It also quoted extensively from Doha Declaration, excerpts from parliamentary
debates, petitions from NGOs, WHO, etc. to highlight the public policy dimension
of arguments in regards to easy affordability and availability of life saving drugs.
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20.  It was clear from the Zimmerman patent that imatinib mesylate itself was not new and did not
qualify the test of invention as laid down in section 2(1)(j) and section 2(1)(ja) of the Patents Act,
1970. The court then examined the beta crystalline form of imatinib mesylate and wrote that it,
"for the sake of argument, may be accepted to be new, in the sense that it is not known from the
Zimmermann patent. (Whether or not it involves an “inventive step” is another matter, and
there is no need to go into that aspect of the matter now). Now, the beta crystalline form of
Imatinib Mesylate being a pharmaceutical substance and moreover a polymorph of Imatinib
Mesylate, it directly runs into section 3(d) of the Act with the explanation appended to the
provision".
 In applying 3(d) of the Act, the Court decided to interpret "efficacy" as "therapeutic efficacy"
because the subject matter of the patent is a compound of medicinal value. Court acknowledged
that physical efficacy of imatinib mesylate in beta crystalline form is enhanced in comparison to
other forms and that the beta crystalline form of imatinib mesylate has 30 per cent increased
bioavailability as compared to imatinib in free base form. However, as no material had been
offered to indicate that the beta crystalline form of imatinib mesylate will produce an enhanced
or superior efficacy (therapeutic) on molecular basis than what could be achieved with imatinib
free base in vivo animal model, the court opined that the beta crystalline form of imatinib
mesylate, does not qualify the test of Section 3(d)
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21.  Thus in effect, Indian Supreme Court upheld the view that under Indian Patent
Act for grant of pharmaceutical patents apart from proving the traditional tests of
novelty, inventive step and application, there is a new test of enhanced
therapeutic efficacy for claims that cover incremental changes to existing drugs.
 The Court took pains to point out that the subject patent application was filed
during a time of transition in Indian patent law, especially with regard to striking
Section 5, which had barred product patents and adding section 3(d), for which
there was no case law yet.
 The Court also took care to state the decision was intended to be narrow: "We
have held that the subject product, the beta crystalline form of Imatinib Mesylate,
does not qualify the test of Section 3(d) of the Act but that is not to say that
Section 3(d) bars patent protection for all incremental inventions of chemical and
pharmaceutical substances.
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22.  Glivec is peculiar and unlikely to be representative going forward. Had it been
invented a few years later (or TRIPS implemented a few years earlier), Glivec
likely would be patented in India. Newly discovered compounds are likely to
receive basic patents and to be less vulnerable.
 It was a very limited ruling in most aspects and very fact-specific. Although the
Court has interpreted efficacy to mean only therapeutic efficacy, it has left the
exact scope of therapeutic efficacy to be defined in future cases.
 Most importantly, the Court made the nuanced distinction between the rent-
seeking practice of evergreening and the beneficial practice of incremental
innovation, and has clarified that Indian patent law forbids only the former
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24. 1. Book referred law relating to intellectual property rights 2nd edition by V K
Ahuja.
2. Indiankanoon.com for case law
3. Google.com for images and research
4. Hindu Business Line for the new clipping.
5. Bare acts of The Copyright Act,1957 and The Patent Law, 1970.
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25. For providing us with such a inciteful project