Pharma Patent Law and Recent Trends - India / A presentation by Dr. Kalyan C Kankanala and Mr. Vikram Pratap Singh Thakur Contact Us for Intellectual Property Services BananaIP Counsels Regd Office No.40,3rd Main Road,JC Industrial Estate, Kanakapura Road,Bangalore – 560 062. Email: contact@bananaip.com Telephone: +91-80-26860414 /24/34

1. Dr. Kalyan C. Kankanala Vikram Pratap Singh Thakur
© 2011 BananaIP

2.  Patent Act
 First Patent legislation - Act VI of 1856
 Patent Act, 1970 (brought into force w.e.f. 20th April, 1972)
 Patents (Amendment) Act, 1999
 Patents (Amendment) Act, 2002
 Patents (Amendment) Act, 2005
 Patent Rules
 Patents Rules, 1972 (brought into force w.e.f. 20th April, 1972)
 Patents (Amendment) Rules, 2005
 Patents (Amendment) Rules, 2006
 Patent Manual
 Draft Patent Manual 2010
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3.  From 1.1.1995
 Mail-Box for pharmaceutical and agrochemicals products
 Exclusive Marketing Rights
 From 1.1.2000
 Patent term increased to 20 years
 Definition of invention – inclusion of inventive step
 Right of patentee (importation also included)
 From 1.1.2005
 Product patents for food, chemical and pharmaceutical
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4.  Subject matter
 Industrial applicability
 Novelty
 Inventive step
 Specification
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5.  Patentable Subject Matter
 Product or process
 Non Patentable subject matter
 3 (d)
 New form
 Efficacy
 New property or new use
 Mere use of a known process
 New product
 New reactant
 Explanation- 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.
 efficacy
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6.  Imatinib Masylate
 beta crystal form of Imatinib Masylate, which is non-needle
shaped, having better flow properties, thus better processible,
less hygroscopic and more thermodynamically stable, thus
better storable than its needle shaped, alpha crystal form,
 Pre grant opposition
 Increased efficacy (therapeutic effect in healing a disease)
 Challenged constitutional validity of sec. 3(d)
 Not vague, ambiguous and arbitrary
 Section along with explanation – clear and has inbuilt measures to guide
controller
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7.  Non Patentable subject matter
 3 (e)
 Mere admixture
 Aggregation of properties
 Synergistic effect
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8.  capable of industrial application
 Test
 Make
 Repeat
 Use
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9.  Anticipation:
 Public knowledge or public use
 Exemption - Secret use
 Prior publication
 Wrongful obtainment
 Govt.
 Learned society
 Grace period
 On sale
 Reasonable trial
 Public display
 Central govt. notified exhibition
 Grace period
 Public working
 Reasonable trial
 Grace period
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10.  Technical advance as compared to the existing
knowledge ; or
 having economic significance; or
 both
 not obvious to a person skilled in the art
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11.  Human epidermal growth factor type 1 / epidermal growth
factor receptor (Her/Egfr) inhibitor popularly known as
Erlotinib
 Clarified the concept of inventive step
 Test of obviousness– whether in light of prior art, it was
possible for a normal but unimaginative person skilled in the
art to discern the inventive step of the invention on the basis
of general common knowledge of the art at the priority date.
 Whether the differences between the prior art would,
without knowledge of the alleged invention, constitute steps
which could have been obvious to the skilled man or whether
they required any degree of invention
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12.  Written Description
 Enablement
 Best mode
 Claims
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13.  Novartis patent IN212199 claiming single-pill
combination of aliskiren and valsartan marketed as
Valturna rejected
 Post grant opposition by Sun pharma
 lack of inventive step, insufficient disclosure, not an invention
and non-patentable under the Act
 Claims amended
 None of examples exemplified the compositions of
amended claims.
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14. Filing
Publication
18 months
FER
Putting app in order for grant
6 months
12 months
Request for
Examination
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15.  Pre grant
 Post grant
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16.  Bayer’s IN/PCT/2002/410/CHE claiming contraceptive
formulation of drospirenone and ethinylestradiol (EE)
marketed as Yasmin and Yaz/Yasminelle in Europe and
the US refused
 Opposed by cipla and natco
 The decision was more or less influenced by the
District Court and the CAFC decisions in Bayer
Schering Pharma AG v. Barr Laboratories, Inc.
which held US6787531 obvious and invalid.
 Equivalent of ‘531 patent
 “obvious-to-try” test
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17.  Literal infringement
 Infringement by equivalence
 Substantial equivalence test
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18.  Lallubhai Cakubhai Jariwala v. Chimanlal Chunilal
 Process of treating dry fruits
 Sulphuric acid – washing soda
 3% bleaching solution – 4 and 2 % bleaching solution
 Acetic acid – Muriatic acid
 Sulphur dioxide fumes under presssure – sulphur dioxide fumes
without pressure
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19.  Patent invalid
 Govt. use
 Research exemption
 Parallel imports
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20.  Section 84
 Application for compulsory license
 (a) that the reasonable requirements of the public not been
satisfied, or
 (b) that the patented invention is not available to the public at a
 reasonably affordable price, or
 (c) that the patented invention is not worked in the territory of
India.
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21.  Compulsory license for export
 Country having Insufficient or no manufacturing capacity in
pharma sector to address public health problem
 Such Country
 Granted compulsory
 Allowed importation
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22. © 2011 BananaIP

23.  Traditionally this communication was treated by the
patent office as confidential
 Complete Specifications of only granted patents
were available
 As per notification of April 15, 2010; patent office to
supply upon request all correspondence between the
applicant and patent office
 Helpful for pre grant opposition
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24.  Well accepted principle internationally
 No case supporting the principle in India
 Making available the entire prosecution history on
request may lead towards PHE
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25.  Patent application for a molecule used in the
treatment of diabetes
 First Examination Report
 “…The molecule lacks novelty and inventive step because it
forms part of a publication in a text that discloses a herbal
extract for diabetes treatment.”
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26.  Applicant responds by giving a detailed explanation
of differences between the extract disclosed in the
text and the molecule.
 Applicant further states that a hearing must be
given before making an adverse decision.
 Second Examination Report-
 “…The molecule lacks novelty and inventive step because it
forms part of a publication in a text that discloses a herbal
extract for diabetes treatment.”
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27.  First Examination Report
 “…The molecule lacks novelty and inventive step because it
forms part of a publication in a text that discloses a herbal
extract for diabetes treatment.”
 Second Examination Report-
 “…The molecule lacks novelty and inventive step because it
forms part of a publication in a text that discloses a herbal
extract for diabetes treatment.”
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28.  Not a speaking Order
 Hearing must be given- adherence to principles of
natural justice
 Magical Sentence- “Kindly provide hearing in case of
adverse decision on the application.”
 Valencia CTT v. Union of India (decided on 26th Feb 2010)
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29.  Abandonment
 Application considered abandoned if all requirements not
complied with
 Cannot be appealed
 Refusal
 General power of the Controller to Refuse
 Can be appealed
 Patent Office Practice-
 Application abandoned whether reply to examination report
filed or not.
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30.  Ericsson v. UOI (Decided on March 11, 2010)
 29th July 2005- Ericsson filed national phase patent
application
 8th October 2007- First Examination report issued and
defects pointed out which was replied on 10th Dec. 2007
 25th July 2008- Another examination report sent by
controller restating points already mentioned in first
information report. Replied on 22nd Sept 2008
 10th October 2008- Patent office wrote a letter to the
petitioner stating that despite response of the petitioner on
22nd September 2008, the specification of the petitioner was
still defective on various grounds and the application was
deemed to be abandoned under section 21(1).
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31. Delhi High Court Held:
Abandonment-
When reply to examination report is not filed at all.
Refusal-
If reply is filed then the application cannot be abandoned and has
to be refused.
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32.  Bayer Corporation v. Union of India
 Decided on 9th Feb 2010
 CIPLA filed for a drug license for the generic drug
‘Soranib’.
 Bayer corporation sent a letter to the drug
controller requesting him not to grant approval as
Bayer holds a patent on ‘Sorafenib Tosylate’ and
Soranib is a substitute of their patented drug.
 Drug Controller granted the drug license.
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33.  Bayer filed a petition in the Delhi High Court against
the approval granted by the Drug Controller.
 Bayer’s contention- If drug controller had previous
knowledge of potential patent violation he should not
grant approval.
 Decision- Drug Controller doesn’t have to travel
beyond the scope of Drugs & Cosmetics Act and rules.
Shouldn’t refuse license on the pretext of possible
violation of a patent.
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34.  2010 Patent draft manual released
 Scientific advisors
 Application status search available
 TKDL involved in rejection and withdrawal of patent
application
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35. © 2011 BananaIP