Transcript Document

at
Pharmexcil, Chennai
24th August, 2012
by
Dr. Gopakumar G. Nair
Advisor to Pharmexcil, India
Gopakumar Nair Associates
Url: www.gnaipr.net
Email: [email protected]
Product Patents In India
Patents Act, 1970
Came into force on 20th April, 1972
Abolished Product Patents for
substances intended for use as
Food, Drugs And Agrochemicals
Patents (Amendment) Act, 1999
Came into force retrospectively from
1st January, 1995
Provided for filing of Product Patent Applns
in the field of Food, Drugs & Agrochemicals
u/s 5 (2) of the Patents Act, but,

no Grant, only EMR


Patents (Amendment) Act, 2002
Came into force on 20th May, 2003
Extension of Term of Patent from 5/7 years to 20 years
across all fields of technology.
Deletion of License of Right (Automatic CL)
Insertion of Section 3(j)
Exception: Microorganisms &
Microbiological processes made
Patentable
Deletion of Section 3(g)
Method of Testing during
manufacture made Patentable
Patents (Amendment) Act, 2005
Came into force on 1st January, 2005
Deletion of Section 5(2)
Filing and Grant of Product Patent across all
fields of technology including
Food, Drugs & Agrochemicals
1st Product Patent Granted in India for Pharma,
IN198952 granted for Pegasus (Peinterferon apha-2a) to
F. Hoffmann-la Roche AG on 21st February, 2006
Currently, under Opposition at IPAB, Chennai
TRIPS – Article 27
Patentable Subject Matter
1. Subject to the provisions of paragraphs 2 and 3, patents shall be
available for any inventions, whether products or processes, in all
fields of technology, provided that they are new, involve an
inventive step and are capable of industrial application.
[1] Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and
paragraph 3 of this Article, patents shall be available and patent
rights enjoyable without discrimination as to the place of invention,
the field of technology and whether products are imported or
locally produced.
2. Members may exclude from patentability inventions, the prevention
within their territory of the commercial exploitation of which is
necessary to protect 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.
TRIPS – Article 27
Patentable Subject Matter
3. Members may also exclude from patentability:
(a) diagnostic, therapeutic and surgical methods for the treatment of
humans or animals;
(b) plants and animals other than micro-organisms, and essentially
biological processes for the production of plants or animals other
than non-biological and microbiological processes. However,
Members shall provide for the protection of plant varieties either
by patents or by an effective sui generis system or by any
combination thereof. The provisions of this subparagraph shall be
reviewed four years after the date of entry into force of the WTO
Agreement.
[1] For the purposes of this Article, the terms "inventive step" and
"capable of industrial application" may be deemed by a Member to
be synonymous with the terms "non-obvious" and "useful"
respectively.
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Three Statutory Pillars of
PATENTABILITY
1. Novelty (new)
2. Inventive Step (non-obvious) (Sec 2(1)(ja))
3. Industrial Applicability (utility) (Sec 2(1)(ac))
 Must not be covered by Sec. 3 or Sec. 4
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Patent - Patentability
An invention can be patented if it is
 NOVEL: Must be New,
Must DISTINGUISH from “State of the Art”
(PRIOR ART)
 Must have INVENTIVE STEP
Non-obvious to a person “Skilled in the Art”
 Must have INDUSTRIAL APPLICATION
Must be Useful
Must have Utility
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Invention
Section 2(1)(j)
“invention” means a new product or
process involving an inventive step and
capable of industrial application.
Invention vs. Discovery
Discovery adds to the human knowledge by
disclosing
something,
not
seen
before,
whereas,
Invention adds to human
knowledge by suggesting an
act to do which results in a
new product or new process.
Novelty




Must not be Anticipated by
Prior Publication
Prior Claiming
Prior Public Use
Prior Public Knowledge
The anticipatory disclosure must be entirely contained within
a single document (no Mosaicing). If more than one document
is cited, each must stand on its own. The cumulative effect of the
disclosures cannot be taken into consideration nor can the lack of
novelty be established by forming a mosaic of elements taken from
several documents. This may be done only when arguing
obviousness. (Ammonia's Application, 49 RPC 409).
Inventive Step
Section 2(1)(ja):
"inventive step" means a feature of an
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.
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Non-Obvious
THE DIFFERENCES BETWEEN THE
CLAIMED INVENTION and the PRIOR
ART are such that the subject matter as a
whole
WOULD
NOT
HAVE
BEEN
OBVIOUS at the time the invention was
made to a PERSON SKILLED IN THE ART,
to which the subject matter pertains.
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Utility / Industrial Application
• Be Useful
• Must work / be workable
• At least one recognized, verifiable
and practical end-use
Test of Utility: Whether the invention will work
and whether it will do what is claimed for it.
Lakhapati Rai & Ors. v. Srikissen Dass & Ors. (1917)
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Patentability Filter
Prior use/ prior publication/ prior disclosure
Industrial applicability
Novelty
Non-obviousness: inventiveness
Sec. 3 - Not patentable
Written description / enablement
requirements
 Application/ specification/ claims
 Patent prosecution
 Maintenance / Defense after grant






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Famotidine
18
 NCE/NME
 API
 Product Patent
Tiotidine
 Process Patent
 ‘Me too’ derivatives – Imatinib, Erlotinib
 Formulation
 Dosage Forms – Tablet, Capsule, etc
 Release Profile – Controlled, Slow etc.
 NDDS – ex. Transdermal Patches,
Transmucosal Drug Delivery.
 New Use – Aspirin (analgesic & blood
thinner)
Inventions Not Patentable
Section 3 . What are not inventions.3(a) Frivolous Or Obviously Contrary
To Well Established Natural Laws;
 A machine purporting to produce perpetual
motion.
 A machine allegedly giving 100% performance.
3(b) Contrary To Public Order Or Morality,
Prejudice To Human, Animal Or Plant Life Or
Health Or To The Environment;
 Device, method for committing theft/burglary
 Biological warfare material
Inventions Not Patentable
3(c) Mere Discovery Of Scientific Principle,
Abstract Theory, Living Thing Or Non- living
Substances
 Discovery of any living thing,
micro-organism,
naturally occurring material.
3(d)Mere Discovery Of New Form, New Property,
New Use Of A Known Process, Machine Or
Apparatus (EFFICACY)
Explanation: salts, esters, ethers, etc.
 New use of Aspirin in heart ailments
Inventions Not Patentable
3(e) Mere Admixture (SYNERGY)
 mixture of sugar and some colorants in
water to produce a soft drink.
3(f) Mere Arrangement, Re-arrangement,
Duplication of known devices.
 Umbrella cum Torch
3(g) Omitted (Testing Methods)
3(h) Method Of Agriculture Or Horticulture
 method of producing mushroom plant.
 method of producing improved soil
Inventions Not Patentable
3(i) Method Of Treatment.
 Treatment of malignant tumour cells
 However, Patent can be obtained for surgical,
therapeutic or diagnostic instrument or apparatus.
3(j)Plants, Animals, Including Seeds Varieties,
Species, Biological Processes.
Exception: Microorganisms
 Protection of Plant Varieties &
Farmers’ Rights Act, 2002.
Inventions Not Patentable
3(k) Mathematical Or Business Method
Or A Computer Program Per Se
Or Algorithms;
3(l) Literary, Dramatic, Musical Or Artistic Work,
Other Aesthetic Work
 Copyright Act, 1957.
3(m) Mere Scheme, Rule, Method Of Performing
Mental Act, Playing Game;
 Method of learning a language.
 Method of playing chess.
Inventions Not Patentable
3(n) A Presentation Of Information;
 Method of expressing information.
 Business methods
3(o) Topography Of Integrated Circuits;
 Semiconductor Integrated Circuit
Lay-out Designs Act, 2000
3(p) Traditional Knowledge
 Pesticidal / insecticidal
properties of neem.
Inventions Not Patentable
Section 4: “No Patent shall be granted in respect of
an
INVENTION
RELATING
TO
ATOMIC
ENERGY falling within subsection (1) of section
20 of the Atomic Energy Act, 1962 (33 of 1962)”
 Radioactive Substances or Radioactive Material
 Nuclear
Materials.
Materials,
Nuclear-related
other
Distinguishing
Indian Patentability vis-à-vis US & EU
India
US
EU
Method of Treatment



Swiss Claim
(New Use of Known Subs)

?

Composition of Matter
?

?
Product by Process
?


PVPFA

Both
Plant Patents
Research & Other Exemptions

Biological Matter
(other than Micro-organisms)


(?)
Stem Cells / Cloning
(?)
(?)

 (?)  (?)
Compulsory License
India’s 1st CL granted, u/s 84 of the Patents
Act, 1970, to Natco Ltd. for Sorafenib
(Nexavar®) by Former Controller General of
Patents, Trademarks and Design, Mr. P. H.
Kurian vide order dated 9th March, 2012.
http://ipindia.nic.in/ipoNew/compulsory_Licens
e_12032012.pdf
…..contd
Grounds for Grant of CL
1. Reasonable Requirements of the Public were
not satisfied,
– Drug was accessible to only 2% of Patients
2. Patented invention was not available to the
public at a reasonably affordable price,
– Rs.2,80,428/- per month
3. Patented invention was not worked in India.
– Mere importation of the drug into India.
Section 3(d)
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 or the mere discovery of any new property or
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.
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.
Section 3(d)
Gleevec (Imatinib Mesylate)
…..contd
Hearing re-scheduled for 22nd August , 2012
Madras High Court order dtd 06/08/2007
…..if the discovery of a new form of a known substance
must be treated as an invention, then the Patent applicant should
show that the substance so discovered has a better therapeutic
effect - enhanced efficacy …..
all derivatives of a known substance would be deemed to
be the same substance unless it differ significantly in properties
with regard to efficacy.
the Patent applicant should show the discovery has
resulted in the enhancement of the known efficacy of that
substance and if the discovery is nothing other than the
derivative of a known substance, then, it must be shown that the
properties in the derivatives differ significantly with regard to
efficacy.
Landmark Indian Cases Related to
Pharmaceuticals
1) Patent Linkage
(a) Bayer Corp vs. UOI (Sorafenib) 2008 to 2010
Division Bench & Supreme Court upheld
decision of Single Bench that Patents Act and the
Drugs &
Cosmetic Act are distinct and separate.
Attempt to establish a linkage was not permitted.
(b) BMS Company vs. Hetero (Dasatinib) in 2008
Justice Rajiv Sahai Endlaw prevented the Drug
Controller General of India in allowing marketing
approval of generic drug in view of a granted Patent.
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….. contd
3) Public Interest & Temporary Injunction
(Erlotinib)
F. Hoffmann-La Roche Ltd. v Cipla Ltd. in 2008
Justice S. Ravindra Bhat while rejecting application for
ad-interim injunction held that the injury to the public
which would be deprived of the defendant’s product,
which may lead to shortening of lives of several
unknown persons, who are not parties to the suit, and
which damage cannot be restituted in monetary terms,
is not only uncompensatable, it is irreparable.
Exemptions In Indian Patents Act, 1970
Relevant to Pharma Patents
 Sec. 3(d), Sec. 3(e), Sec. 3(i), Sec. 3(p).
 Sec. 47(3), Sec. 47(4), etc.
 Sec. 84 to Sec. 90: Compulsory Licence (CL)
 Sec. 92-A: CL for Export of Patented Pharma
products
 Sec.107(A)(a): Research for Regulatory
Exemption.
 Sec. 107(A)(b): Parallel Import Exemption.
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