Transcript LESSONS FROM EMR LITIGATION

Patent Law In India:
Questions Outstanding
Ms. Arpita Sawhney
This presentation comprises of the following:
1. Background;
2. Critical appraisal of Section 3 (d) of the Patents Act, 1970
vis-à-vis TRIPS-Defaults at legislative level;
3. Analysis of Section 3(d);
4. Novartis case- An insight; ; and
5. Burning topic “Patent Linkage”
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Background
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WTO/TRIPS AND INDIA’S
OBLIGATIONS
o
India became a member of WTO/TRIPS Agreement effective,
January 01, 1995
o
India, being a developing country was given ten years’ transition
period to fully comply with TRIPS
o
This was done in three stages effective:
o January 01, 1995
• Filing of Black-Box applications
• Provision for Exclusive Marketing Rights
o May 20, 2003
• Uniform patent term of 20 years
o January 01, 2005
• Grant of product patents in all fields of
technology including drugs, food and chemical
substances
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PRODUCT PATENTS ALLOWABLE
interalia FOR
 Drug Molecules
 Pharmaceutical preparations
 Synergistic Combinations
 Agrochemicals
 Chemical products i.e., resulting from chemical, biotechnological, microbiological or biochemical processes
 Microorganisms
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Critical appraisal of Section 3 (d)
vis-à-vis TRIPS
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IT’S ALL ABOUT TRIPS
• India’s obligation to TRIPS is recorded in the final amending Act passed
by the Indian Parliament effective January 1, 2005:
“While considering the third set of amendments to the Act, efforts have
been made not only to fulfill our final obligation under the TRIPS
Agreement but also to simplify and rationalize the procedure..”
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Pre- amendment- How Section 3(d)
read?
“The mere discovery of any new property or mere new use for
a known substance or of the mere use of a known process,
machine or apparatus unless such known process results in a
new product or employs at least one new reactant”
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India defaults at the legislative levelYEAR 2005
Post-amendment of Section 3(d) : Road Block:
“The mere discovery of a new form of a known substance which
does not result in the enhancement of the known efficacy of
that substance …”
Explanation: “For the purposes of this clause, salts, esters,
ethers, polymorphs, metabolites, pure form, particle size,
isomers, mixtures of isomers, complexes, combinations and
other derivatives of known substance shall be considered to be
the same substance, unless they differ significantly in
properties with regard to efficacy.”
This clause is of a great significance (The Pharma Industry)
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Therefore, Article 27 of TRIPS lays down following criteria for
patentability:
Patents shall be available for any inventions, whether products or
processes, in all fields of technology, provided
• They are new;
• Involve an inventive step; and
• Are capable of industrial application.”
The Indian Patents Act almost follows this definition.
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ARTICLE 27-EXHUSTIVE-EXCEPTIONS
PROVIDED THEREIN
Exception to patentability on the basis of –
1. ordre public or morality, including to protect human, animal or plant life or health
or to avoid serious prejudice to the environment, provided that such exclusion is not
made merely because the exploitation is prohibited by their law.
2. diagnostic, therapeutic and surgical methods for the treatment of humans or
animals;
3. plants and animals other than micro-organisms
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Unfortunately- in giving legislative effect to TRIPS,
for certain inventions such as chemicals, India has
laid down an additional condition of proving
“enhanced efficacy” over and above three known
standards of patentability- Novelty, inventive step and
industrial applicability and has thereby contravened
the provisions of TRIPS.
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WORTH NOTING
Article 28 (1) (a) of the TRIPs Agreement and Section 48 (a) of the Act,
dealing with the exclusive rights being conferred on grant of a patent, are
identical;
also
while defining the term “invention”, Article 27 of the TRIPS and Section
2(1) (j) of the Act are identical;
but
Indian legislation did not stop at that.
It made the definition of “invention” under Section 2(1) (j) restrictive by
amending Section 3(d).
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Analysis of Section 3(d)
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 “Mere” Discovery + Enhanced Efficacy = Invention
 Invention- Enhanced Efficacy = “Mere” Discovery
•
•
As per section 3(d):
Discovery of a new form of a known substance would not come within the purview
of an invention, if it does not result in enhancement of a known efficacy of that
substance. In other words, mere discovery qualified by enhancement of known
efficacy of the substance, is an invention or to put it otherwise, invention devoid of
enhanced efficacy boils down to a “mere” discovery.
Another limb of the argument:
If a new product satisfies the conditions laid down in section 2(1)(j) of the Act,
(new, involvement of an inventive step and capable of an industrial application), it
is an invention and in that event, term “enhanced efficacy” appearing in Section
3(d) of the Act still is another hurdle for an applicant to cross and overrides Section
2(1) (j) of the Act.
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Explanation of Section 3(d):
KNOWN
SUBSTANCE
•
•
•
•
•
•
•
•
•
•
Salts
Esters
Ethers
Polymorphs
Metabolites
Pure form particle size isomers
Mixtures of isomers
Combinations
Complexes
Other derivatives
SAME
SUBSTANCE
Unless they differ
significantly in properties
with regard to efficacy
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ENHANCED EFFICACY?????
o Not defined
o Touchstone elements:
• Increased Stability
• Increased bioavailability
• Faster response time
• Reduction in treatment period
• Wider spectrum of activity
• Lesser side effects
o Evidence necessary:
• Clinical data/Experimental
trials
• Technical affidavit
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Section 3(d)- A closer look
a)
Section 3 (d) allows patenting of a new form of a
known substance only if it results in the significant
enhancement of known efficacy of that substance.
b)
CONTRADICTION- “Mere” discovery of a new form
is a contradiction in terms in that new form requires
human intervention. By the same token – every
derivative is the product of human intervention.
c)
ILLOGICAL- Concept of a “mere” discovery
graduating into a patentable invention on the basis of
enhanced efficacy defies logic.
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d)
UNIQUE- Criterion of efficacy is not found in Patent
Legislation of any other country.
d)
VAGUE- Efficacy has not been defined in our Act as well.
This has led to arbitrary decisions.
d)
UNEQUAL TREATMENT- Patent protection abroad for
subject matter prohibited in India, obtainable- resulting in an
uneven playing field.
d)
CONTRARY TO TRIPS- Article 27 of the TRIPS
Agreement provides for uniform conditions of patentability.
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Novartis case- An insight
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Novartis AG & Anr. Vs Union of India & Ors.
ISSUES BEFORE THE COURT:
(a) Whether amended Section 3(d) is in compliance with Article
27 of “TRIPS”?;
(b) Whether amended Section 3(d) is arbitrary and vague and
therefore unconstitutional under Article 14 of the
Constitution of India?; and
(c) Whether a declaratory relief from the Court can be availed to
the effect that the amended Section 3(d) is not in
compliance of Article 27 of “TRIPS”?
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The Court observed:
• With regard to (a) - the issue may be agitated before the
Dispute Settlement Body under WTO/TRIPS.
• With regard to (b) - Article 14 can be invoked only when it is
shown that in the exercise of a discretionary power there is a
possibility of a real and substantial discrimination and such
exercise interferes with the fundamental rights guaranteed by
the Constitution.
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A wrong decision arrived at by the Patent Controller
based on wrong application of the amended Section
cannot be a ground to strike down the said amended
Section which was otherwise in order.
•
With regard to (c) - the
declaratory relief, even
if
granted, would be only on paper, as on the
basis of
which, the petitioner cannot claim any
further relief in the Indian Courts.
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WHAT COURT SAID ON
“EFFICACY”?
“going by the meaning of the word “efficacy” and “therapeutic” ... …, what
the patent applicant is expected to show is, how effective the new discovery
made would be in healing a disease/having a good effect on the body. In
other words, the patent applicant is definitely aware as to what is the
“therapeutic effect” of the drug for which he had already got a patent and
what is the difference between the therapeutic effect of the patented drug
and the drug in respect of which patent is asked for.”
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WHAT DRAFT MANUAL HAS TO
SAY ON “EFFICACY”?
In the attempt to define the ‘efficacy’, the Draft Manual cites Novartis case,
which seeks to define ‘efficacy’ as therapeutic efficacy. This is restrictive.
The definition of ‘enhanced efficacy’ should include other parameters such
as faster response time, lesser side effects, increased stability, increased
bioavailability, reduction in treatment period, wider spectrum of activity,
etc.
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EFFECT OF SECTION 3(d)
• Situation of ambiguity – Arbitrary decisions by the Patent Office due to
non-definitive term “Enhanced Efficacy”
• Increased rejections of applications under Section 3(d)
• Increased pre-grant oppositions
• What a hit to Black-Box applications?
Amended Section 3(d) requires: Enhanced efficacy data-means‘Black-Box’ applicants to have completed clinical studies when Section
3(d) in its present form was non-existent. Now requiring completed studies
for allowance of those applications would be a retroactive denial of
patentability
• A state of bewilderment
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WHAT TO DO TODAY?
AT THE DOMESTIC LEVEL:
• Applicants need to be pro-active in taking up the matter with higher forumPrecedents need to be laid down
• Reform in the system- Patent Office needs to be trained
• Laying down uniform, detailed and unambiguous guidelines to reduce the
area of conflict.
AT THE GLOBAL LEVEL:
Government(s) of developing and developed countries to approach the
Dispute Settlement Body under TRIPS – for necessary modification of
Section 3(d).
We appreciate that perfection is not easy to achieve
BUT
One can always strive for it.
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Patent linkage
Another burning topic in India
“Patent Linkage” is the practice that creates a link between the patent status
of a product and its application for marketing authorization which prevents
approval of marketing generic/infringing medicines.
The Drugs & Cosmetics law read with the Patents Act, 1970 provides the
concept of “Patent Linkage”.
In an unprecedented litigation, Bayer Corporation Vs Union of India, our
Firm had a privilege of bringing this concept into limelight.
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The Court framed the following issues:
•
Whether the DGCI can grant marketing approval under the DCA to generic
versions of patented drugs?;
•
Whether the grant of such marketing approvals to generic versions of a patented
drug is in derogation of the Patents Act?; and
•
Whether generic drugs are spurious drugs in terms of the DCA?
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Regarding issues (1) & (2), the Court observed that the scheme of the Patents Act
and the Drugs Act had distinct and disparate objectives. The Drugs Act was a
public regulatory measure, prescribing, amongst other things, standards of safety
and manufacturing practices which were to be followed by the pharmaceutical
industry. The Patents Act on the other hand conferred private monopoly rights in
favour of inventors which were certainly subject to the satisfaction of certain
conditions prescribed therein.
Accordingly, unless there are express provisions in the DCA requiring the DCGI
not to grant marketing approval to a generic manufacturer in respect of a patented
drug, it is not possible for this Court to read such a requirement into the law.
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Regarding issue (3), the Court observed that the terms “imitation” and “substitute”
occurring in the definition of “spurious drug” are to be read in conjunction with the
other words “in a manner likely to deceive”. This envisages a situation where a
generic manufacturer is passing off its drug as that of the patent holder by way of
deception. It would be stretching the language of the definition of “spurious drug”
to an impermissible limit to hold that all generic versions of patented drugs, for
which marketing approval is sought from the DGCI in terms of the DCA, should be
considered “spurious drugs”.
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CONCLUSION
LAWYERS TO HAVE A FIELD DAY
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THANK YOU
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