Patents Trade Marks Copyrights Generic Labelling Role of NGO to fight for patient’s right against Patent’s Right. Leading Cases of IPRs that shows ramifications in Indian IPR system.

1. An Analysis of Pre-Grant & Post- Grant
Opposition to IPRs in India
Department of Pharmaceutical Sciences
Maharshi Dayanand University
Presented
By: Bindu Supervised By:
Dr Arun Nanda Co-Supervised By:
Dr Rahul Taneja

2. � Pharmaceutical Industry is burgeoning in terms of
investments, innovations, qualities, educational scope
and thereby aiding to the economic development.
� If these inventions passes the essential criteria for IPR
protection, monopoly rights can be obtained.
� When an entity exercise the monopoly rights for profit
only, there may be opposition to the IPRs.
� But not to exercise these monopoly rights in the
interest of profit only, there comes opposition into
role.
Opposition to IPRs

3. � Patents
� Trade Marks
� Copyrights
� Role of NGO to fight for patient’s right against
Patent’s Right.
� Leading Cases of IPRs that shows ramifications in
Opposition: Trend Setter of IPR

4. Opposition to Patents
Opposition can be made
on the grounds listed
under section 25(1)(a) to
(k) and 25 (2)(a) to (k) of
the Patent Amendment
Act, 2005:
Pre Grant
Oppositions
Post Grant
Oppositions

5. Pre Grant Opposition
Can be filed by any person within 6 months from the
date of publication along with the statements and
evidences.
Controller will consider the opposition procedure
only along with report of examiner.
Pre-grant opposition acts as a defensive shield to
confirm the validity of the patent applications
before patents are granted to them

6. Post Grant Opposition

7. Procedural Differences Between Pre Grant And Post Grant Patent Opposition In
India:
o Pre grant proceedings may be initiated by
"any person", while only a "person
interested" can introduce a post grant
opposition.
o Infringement proceedings can not be
started during pre grant opposition
prosecution as the patent is still in the
application stage, where as infringement
proceedings may be introduced in post
grant opposition.
o Section 25(1) of the Act does not openly
allow the patent applicant an opportunity
to be heard in a pre-grant opposition.

8. oMoreover, the Indian Patents Act does not explicitly allow the opponent to be heard
in a pre-grant opposition. The opponent has to make a request for hearing and the
rules do not detail how a hearing is to be conducted. The opponent's right to be heard
solely depends upon the discretion of the Controller, who decides the same based
upon the merit of the opposition. Additionally, the rules are also not clear whether the
opponent will be heard in the presence of the applicant. In contrast, the opponent in a
post-grant opposition can proceed with the case irrespective of the merit of the notice
of opposition.

11. COPYRIGHTS IN PHARMACEUTICALS
Generic Labeling

12. Generic Labeling
One important area the fields do overlap in is
drug labeling. Suffice it to state that copyright
protection can only be achieved for labels if
something is added to the labels which is
creative and which is beyond FDA
requirements. Although copyright does protect
labeling to the extent it contains more than just
data that may be sufficient for a brand owner
that is creative in making its labels

13. Limitations & Exceptions in IPR
System
Compulsory
License Research Section 49
Exhaustion
of Patent
Rights

14. 1. I-MAK
2. SANKALP
3. KNP+
4. DNP+
5. PWN
6. MNP+
7. INP
8. MSF
9. ANP+
10. HEPCON
11. ICR
12. AIDAN
13. LOCOST
14. ARV
15. SAHARA
16. PLHAS
17. PRAYAS
18. JAN SWASTHYA ABHIYAN
19. COMMUNITY DEVELOPMENT MEDICAL UNIT
Pool Players of Indian IP System

15. Success Area of NGOs
Ofloxacin
31—3.20
Amlodipine
6—1.51
Atenolol
2.45—0.40
Zidovudine
20.40—7.70
Glimepride
5.30—0.80
Valsartan
41—5.90
Azithromycin
39.14—8.50
Levofloxacin
95--6.82
Extent of Price Reduction

16. Ciprofloxacin
8.90—3.90
Tamoxifen
20-2.70
Albendazole
9—1.10
Letrozole
181.50—9.9
Leflunomide
44--8
Pioglitazone
6—0.99
Enalapril
1.60—0.30
Cetrizine
0.50—0.20
Fluconazole
28—3.50
Risedronate
500-50.12

17. Case Study: IPR Opposition Cases

18. Plaintiff: Monsanto Company
Defendant: Coramandal Indag Products ℗ Ltd.
Patent Claim: Butachlor- Herbicide
Sections Involved: 64 (1) (a) (b) (c) (d) (e) (f) (g) (h) (i) (j) (k) (l) (m)
Status: Patent Revoked dated 4-01-1986
De Panning v/s Coramandal Indag
Pvt Ltd

19. Applicant: Novartis
Defendant: Cipla
Patent Claim: Onbrez- A Treatment for COPD
Sections Involved: 92(3), 66
Status: Interim Injunction was posed.
Novartis vs Cipla (Onbrenz- A Treatment for
COPD)

20. Roche Vs Cipla (Tarceva- A Treatment for Lung Cancer)
Erlotinib Case
Applicant: Roche
Defendant: Cipla
Patent Claim: Tarceva- A Treatment for Lung Cancer
Sections Involved: 5(2), 2(1) (t) (a), 3(d)
Status: Roche patent was found to be valid

21. Godrej Soaps (P) Ltd. Vs. Dora Cosmetics Co
Crowning
Glory
Glory
M/s. Chaitra Advertising Private Ltd. created the carton
for the plaintiffs and the carton so created was assigned
to the plaintiffs by virtue of a Deed of Assignment for a
consideration of Rs. 20,000/- Consequently the plaintiff is
the owner of the copyright in the said carton. The
defendant indefensibly adopted the trade mark GLORY
and a visually similar box in respect of similar product
leading to infringement of plaintiff's rights and filing of the
present suit.

22. Emami Ltd Vs Arbaaz Khan Productions Pvt.
Emami Ltd. has asked the production house to give
them the right to use the song for their advertisements
as barter for use of the word in the song. However the
production house demanded for the royalties on the
song. Thereafter Emami has sent them the legal
notice alleging the production house for violation of
their copyright in the word Zandu. Very surprisingly,
this objection comes in a stage when Dabangg has
scored big at the box office and the music album is
the highest selling currently. Reports have also
suggested that the sales of Zandu Balm have actually
shot up after the release of the movie. However,
Zandu claims that they also launched a new ad-
campaign around that time and thus the sales figure
could be a consequence of that.

23. SBL LTD VS HIMALAYAN DRUG
High Court: Ordered the Defendant to amend it’s
mark accordingly to a mark which will not be
similar to the mark of the Plaintiff.
Liv.52 Liv.T
District Court: dismissed the suit of the Appellants holding that the mark ‘LIV’ is
publici juris and there is no similarity between the two trademarks. ‘Liv’ will be
considered as the generic on account of the fact that it is used in respect of
medicine used for treatment of ailment of ‘LIVER’

24. Cadila Healthcare Ltd Vs Cadila Pharmaceutical Ltd
SC: INFRINGEMENT OF FALCIGO WAS PROVED.
Falcigo Falcitab
District Court Conclusion: Both the drugs in question differed in their appearance, chemical
formulation and price. And since they could only be sold to hospitals and clinics and not to the general
public, there was no chance of any deception or confusion. Hence, he dismissed the injunction
application of the petitioner.

25. Pfizer Ireland Pharmaceuticals vs. Intas Pharmaceuticals and Another
TEMPORARY INJUNCTION WAS
GRANTED
Lipitor Lipicor

26. WYETH HOLDINGS CORP. & ANR. VS. SUN PHARMACEUTICALS
INDUSTRIES LTD
Pacitane Parkitane
The Court held that in both the cases the goods are similar, being
pharmaceutical preparations for treatment of Parkinson’s disease, the
customers buying these goods are the same and the trade channels are
the same. Since the defendants did not show any search of the Register
before adopting the impugned mark, prima facie adoption of the mark was
not honest.

27. Ranbaxy Laboratories Limited Vs. Anand Prasad & 4 Others
It was further held that since the rival
goods are also pharmaceutical goods it
might lead to serious consequences due
to deception or confusion in the minds of
the public. Hence on the possibility of
harm being caused to common person the
appeal was allowed.
Fortwin Ostwin

28. Beecham Group Plc. Vs. S.R.K. Pharmaceuticals
IPAB held that the respondent dishonestly adopted the
mark by copying it from the appellant who had got the
mark registered long ago. Hence the respondent cannot
claim honest concurrent use, by virtue of earlier use. The
Appellate Board delivered a judgment prohibiting
registration of the Trade Mark ‘LYMOXYL’.
Amoxil Lymoxil
The respondents filed their counter statement denying all the allegations and contentions stated in the notice of
opposition and contended that the suffix 'MOXIL' or 'MOXIN' is common to a number of marks registered in respect
of 'AMOXYCILLIN' preparations in the name of different manufacturers and that 'AMOXIL' is an abbreviation form of
'AMOXICILLIN' and being a generic term the opponents cannot claim its exclusive rights.

29. Ranbaxy Laboratories Limited v/s Universal Twin Labs
It was held that the defendant adopted a clever disguise for passing off its own product VONIGEL, by infringing
the registered trade mark of the plaintiff. There was deceptively similar color combination. The word mark,
color scheme layout and get up adopted by the defendant were held to be deceptively similar. So it was
concluded that adoption of mark was not honest.
Volini Vonigel

30. Raymond Limited v/s Raymond Pharmaceuticals Private Ltd
Defendant was using the mark as part of its corporate name since 1983. No action taken till 2005.
The name 'Raymond' found to be a common name .There was no attempt by defendant to take
unfair advantage of the plaintiff. Both companies in different business and goods. No association
between the products of the two companies. Held that plaintiff is not entitled to Interim injunction
Raymond
Raymond
Pharma

31. In Lakme ltd. v. Subhash Trading
Defendant was using the trade mark ‘Like- me’ for the same class of products. It was held that there
was striking similarity between the words. The two words are phonetically similar. There is every
possibility of deception and confusion being caused in the minds of the prospective buyers of the
plaintiff’s products. Injunction was made permanent.
Lak
me
Like
me

32. United Decorative Pvt. Ltd v. Prem Traders
Plaintiffs were a reputed manufacturer of dental
cream COLGATE. Defendants used the mark
COLLEGIATE which is phonetically similar to the
plaintiff’s mark with deceptively similar letters in
white with the red background so as to cause
confusion in the minds of the customers as pass
off its products as COLGATE. Hence the mark was
restrained through injunction.
Colgate Collegiate

33. The IPR policy attempts to strike a balance between individual
rights over innovation and societal good in making available the
benefits of innovation to the large public. One can conclude the
benefits of IPRs as:
� Protection of invention.
� Economic growth & competitiveness.
� Protect consumers and families as main interest of IPRs lies in
public safety.
� Generate solution to global challenge.
� Encourage innovation & reward entrepreneur .
Summary