This document discusses several patent cases in India between foreign pharmaceutical companies and Indian generic drug manufacturers. It summarizes key patent cases such as Novartis vs. India regarding Glivec, Bayer vs. Natco regarding Nexavar, Roche vs. Cipla regarding Tarceva. It also discusses India's patent laws including sections 3(d) and compulsory licensing. Many foreign drug patents were revoked by Indian courts based on lack of innovation or in the interest of public health and making medicines more affordable in India. The document supports India's stance on promoting generic competition and ensuring access to healthcare.

1. PRESENTED BY
KAVITA YADAV
M.PHARM 2nd SEM

2.  for an invention
 by the government
 to the inventor
 in exchange for full disclosure of the invention

3.  Novelty
 Inventive step
 Industrially applicable

4. a) Frivolous invention
b) Use for commercial exploitation
c) Mere discovery
d) New form of known substance which does not result
in the enhancement of the efficacy
e) Mere admixture
f) Mere arrangement or rearrangement
g) Agricultrure or horticulture
h) Medicinal,surgical,curative,prophylactic,diagnostic,t
herapeutic or other treatments for human beings and
animals

5. i) Production and propagation of plants and animals
j) Mathmatical or business process or a computer
programme
k) A literary,dramatic,musical or artistic work
l) Mere scheme or rule
m) Presentation of information
n) Topography
o) Traditional knowledge

6.  Patent evergreening
 Cost
 Compulsory liscence
 Patent linkage

7.  Pregrant opposition-
Application of patent has been published but a patent
has not been granted.
 Postgrant opposition-
Anytime after the grant of patent but before the expiry
of a period of one year from the date of publication

8.  Novartis applied for patent in India on July 17,1998.
 Indian patent office rejected the application on January
25,2006 based on 3(d) of the Indian
Patent(amendment)Act 2005.
 Pregrant opposition by Cancer Patient Aid Association
and domestic drug maker like Cipla and Natco.
 Glivec cost Rs.1,20,000 per patient per month &
generic cost Rs.8000 per patient per month.

9. On 17,may 2006 Novartis filed two cases in Chennai
Patent Office-
 First against the pregrant opposition.
 Second to challenge the constitutionality of section
3(d) of Indian Patent Act,2005.
 Court rejected patent application of Novartis on
„Glivec‟ as it is not able to prove therapeutic efficacy
on 1 april 2013.
 Court also rejected the argument of petitioner that sec
3(d) is not compliant to TRIPS agreement.

10.  Bayer obtained a patent in India in 2008 for Nexavar.
 The Controller of Patents, Mumbai, granted the first-
ever compulsory licence to Natco in march 2012 to
make „sorofenib tosylate‟.
 Bayer has filed an appeal against an Indian Patents
Office's order, with the Intellectual Property Appellate
Board.
 Natco argued on high price and limited availability.

11.  On 14 september 2012 IPAB rejected a petition by
Bayer.
 In a separate case, Bayer has accused Cipla of
infringing its patent on Nexavar in march 15, 2010 at
the Delhi High Court.
 The Delhi High Court on dismissed an appeal by Bayer
that sought to stop Cipla from obtaining a marketing
approval.

12.  February 23, 2007 patent granted to Roche.
 2008, Cipla launch generic version erlocip.
 Roche had sued Cipla in 2008.
 Case filed by Cipla on basis of section 3(d) and section
8 of Indian Patent Act.
 Cipla Ltd won in the Delhi high court on 7 sptember
2012.

13.  Also Cipla was selling the erlocip at 1/3rd of the price
of Roche therefore “public interest”demanded that no
injunction be granted.
 Natco then arguing variously as follows-
 That Roche had suppressed material facts.
 That the Indian patent specification made no mention
that the patent cured Non-Small Cell Lung Cancer.
 That the Division Bench had specifically asked Roche
to disclose X-ray diffraction data.

14.  Sugen was granted a patent for Sutent in 2007 and
licensed to Pfizer for marketing it globally.
 Cipla filed a post-grant opposition in 2008, arguing
based on section 3(d) and section 8 of Indian Patent
Act.
 The Patent Controller had revoked the patent on
Sutent, 4 october 2012.

15.  Roche was granted patent no. 198952 by Indian Patent
Office on 21stFebruary, 2006.
 This patent was immediately challenged by local
generic drug maker Wockhardt and Sankalp
Rehabilitation Trust.
 The technology of combining interferon and other
biologically active proteins with PEG has been known
for many years.

16.  In 2009 the IPO rejected their challenge and upheld
Roche's patent.
 Sankalp subsequently appealed to IPAB, which
announced its decision in favour of the group's
challenge on November 2, 2012.

17.  In 2004, Merk in India claiming a product patent on
an aerosol suspension formulation containing two
active drugs mometasone furoate and formoterol
fumarate.
 The grant of the patent was published in the Patent
Office Journal on 4th March 2011.
 Cipla,that produces COPD/asthma medicines
particularly inhalers, filed a post grant opposition.

18.  The patent has been revoked on 12 december 2012.
 The decision also states that there is no inventive step
in the selection of non-CFCs for the preparation of the
aerosol suspension formulation.
 There is no inventive concept on selecting HFA 227
and/or HFA 134a from known non-CFCs.

19.  On 30,November 2011 Lipitor patent expired.
 Ranbaxy, has been fighting the anti-cholesterol Lipitor
battle with Pfizer in about 17 countries since 2002.
 Patent office rejected all 14 claims of re issue
application.
 Pfizer and Ranbaxy settled their Lipitor ANDA
litigation in 2008, agreeing that Ranbaxy would not
market its generic version of Lipitor until November
30, 2011.

20.  Cost
 Proper healthcare
 Drug export
 Growth of Indian generic companies
 Avoid patent evergreening

21.  Effect on economy
 Harmful for innovation
 MNC‟s moved away from R&D investment
 MNC‟S threatened India

22.  Patent wars in India between the foreign innovator
companies and the Indian generics seem to be
spreading over life management disease segment.
 Court‟s decision against the patent linkage and
compulsory licence will encourage the generic
companies and it is in the favour of public healthcare.

23.  http://www.ipindia.nic.in/ipr/patent_Act_1970_28012013_book.pdf
 http://articles.economictimes.indiatimes.com/2013-04-
09/news/38404857_1_indian-patent-act-glivec-protection
 http://www.thehindu.com/buisness/companies/natco-pharma-wins-
cancer-drug-case/article4475762
 http://www.financialexpress.com/news/cipla-gets-hc-relief-in-tarceva-
case/450858
 http://timesofindia.indiatimes.com/business/india/supreme-court-sends-
pfizer-cipla-case-back-to-patent-office/articleshow/17409961.cms
 http://www.pharmatimes.com/article/12/11/05/india_revoke_Roche_on_
pegasy
 http://timesofindia.indiatimes.com/business/Merk -v/s- Glenmark-case-
revives-patent-linkage-issue/articleshow/19484055
 http://articles.timesofindia.indiatimes.com/2011-9-15/india-
buisness/30159441_generic-version-market-exclusitivity-patent-
protection