Post'1995 Indian patent regime, Loopholes, Advantages, disadvantages, Criticality of sec-3(d), NIB patent war and litigations of foreign nnovator companies, Imatinib, sorafenib, etc...

1. Indian Patent Regime &
“NIB WAR” Litigations
Manasi Vakil
CQA
Torrent Research Center

2. What are IPRs?
“IPRs are legal rights which are granted to a person for CREATION
of the mind or intellect which have COMMERCIAL VALUE.”
 8 well defined mechanisms for protection:

Patents

Copyright

Trademark

Industrial Designs

Layout designs of Integrated Circuits

Geographical indications

Registration of Plant Varieties

Trade Secrets

3. Mechanisms for Protection:
 COPYRIGHT: “exclusive rights granted by the law to the creator of
expressions such as Literary, Music and Cinematographic works”

As got only LIMITED PROTECTION because though one may not
copy a book or audio/video CD, one can still use the
idea/knowledge given in them.

E.g. Induction manual or introductory video of TPL can be
protected under copyright and also as a trade secret.

Term: entire life of an author and 50 years after his/her death.

4. Mechanisms for Protection:
 TRADEMARK: is a word or symbol used by a manufacturer to
identify and distinguish his goods from others.

Nearly all pharmaceutical products bear a distinctive TM.

Term: Initially for 10 years and can be renewed indefinitely.
 INDUSTRIAL
DESIGNS:
refer
to
specific
shape, configuration, surface, pattern or colour or combination
thereof produces an aesthetic impression of the article. Term: 15
years

Design of a Ball pen, design of Packaging Bottle used for
pharmaceutical product.

5. Mechanisms for Protection:
 INTEGRATED CIRCUITS: refer to the specific manner in
which transistors and other circuitry elements are laid
out in a semiconductor IC and includes lead wires
connecting such elements.

Term: 10 years from the date of filing or date of
commercialization whichever is earlier.

6. Mechanisms for Protection:
 TRADE SECRET: refer to proprietary
commercial application and value.
information
having

E.g. formula of the „Coca-Cola‟ which has been preserved as
a family secret, passed from one generation to another.

Some of the highest selling products in Pharma, especially
based on microbial technologies are protected as trade
secrets.

NDA(Non Disclosure Agreement) and CDA(Confidentiality
Agreement) are one of the tools under Trade Secret.

No territorial limits, no expiry, no fee, monopoly for almost
unlimited period are the benefits of this mechanism.

7. Mechanisms for Protection:
 GEOGRAPHICAL INDICATIONS: relate to goodsagricultural, natural r manufactured, originating from a
particular geographical region situated in a particular
country.

E.g.
Darjeeling
Tea,
Petha, Basmati Rice.
Bikaneri
Bhujiya,
Agra

Term: one time registration is valid for 10 years.

Boosts exports

Promotes economic prosperity of local small scale
producers of particular geographical territory.

8. Mechanisms for Protection:
 PLANT BREEDERS‟ RIGHT: legal rights granted by the
govt. for protection of plant varieties, right of farmers
and plant breeders.

Term: 15 years for annual crops and 18 years for trees
and vines.

Promotion of Biodiversity

Better research is encouraged

Easy availability of good quality seeds internationally.
In absence of this mechanism, foreign companies
were hesitant to release their improved seeds for fear
of piracy.

9. Patents:
 Exclusive rights granted by the govt. to an inventor for
protection of his/her work from being illegally copied.

Term: 20 years from the date of filing.
 Patentability Criteria: (N.I.I.)

Novelty

Inventive Step/Non-obviousness

Industrial applicability
 Non-Patentable Articles:

Frivolous, contrary to
society/environment.
public
order
or

Mere discovery

Rearrangement or duplication of known devices
harmful
to

10. Patents:

Substance
produced
by
merely
mixing
of
components, resulting in aggregation of the properties
of the components.

Method
of
agriculture,
horticulture,
treatments, plants and animals as whole.

Mathematical or business methods.

Literary, aesthetic, artistic works, method of playing
games.

Presentation of information.

Traditional knowledge

Inventions pertaining to Atomic energy.
medical

11. Definitions:
 Patent: is an exclusive right granted by the govt. to the
original
inventor/developer/researcher
of
an
invention, which prohibits others from making, using or
selling that invention.
 Infringement: is illegal entry into other‟s restricted area.
 Opposition:

Pre-Grant: can be filed by any person after
publication of application to prevent grant of patent
application. (questioning the patentability)

Post-Grant: can be filed by any interested person
within one year from the grant of patents. To revoke
the patent. (questioning the validity)

12. Definitions:
 Voluntary License:

Granted by innovator company to multiple generic companies.

Helps innovator reach newer markets and focus on their core
R&D.

Helps generics to generate revenue.

Facilitates affordable priced drugs supply to public.
 Compulsory License:

Granted to remedy non-affordable drug prices,
emergency, health crisis of public or for govt. use.
national

A royalty is paid by the compulsory licensee to the patent holder

Respective govt. has the right to determine the grounds for
granting compulsory license.

13. Scope:
 NIB WAR:

New Anti-Cancer life saving drugs like
Imatinib(Novartis), Erlotinib(Roche), Sunitinib(Sugen/Pfi
zer), Sorafenib(Bayer) are the subject matters of
ongoing “NIB War” litigations against Indian generic
companies.

These litigations are based on:
Infringement related injunctions and damages
Patent Regulatory Linkages

14. Background:
 Indian Patent Act, 1970

No product patent provision (only process patent)

Lengthy and delayed procedure for patent application and
publication

India having multiple patent offices

Non-uniformity and diverse approaches to implementation of the
policies and provisions of the Patent Act‟1970

Unreasonable delay in resolution of IP-disputes
Such restricted environment destroyed all interests in patenting in
India, during 1970-2005.

During this 35 years under the protected environment of process
patent regime, the Indian generic companies grew
exponentially, by REVERSE ENGINEERING and developing generic
versions of new drugs.

Consequently, India has now emerged as one of the top players
in Global Generic market.

15. Background: (cont...)
 TRIPS: (Trade Related aspects of Intellectual Property
Rights)

Since trade at global level was hindered as the
developed countries were reluctant to sell their products
in the countries where sufficient protection was not given.

Under the 8th round of GATT (General Agreement on
Tariffs and Trade), IPRs were brought within the scope of
GATT.

TRIPS was established under which the rules for protecting
IPs were made uniform in all countries which signed the
Agreement. India was one of them.

Since, the rules for IP protection was governed by
national laws, a 10 year transition period was allowed to
all countries to make their law complaint with TRIPS.

16. Background: (cont...)
 Indian Patent Act was not amended since its first
implementation in 1970.
 India was dragged to the DSB (Dispute Settlement
Board) of the WTO by US and EU, for non-compliance
with TRIPS.
 Thus, 1st Amendment Act of 1999 was unanimously
passed in the Indian Parliament.
 2nd and 3rd amendments were passed in 2003 and
2005 respectively.
 Implementation from 1st January, 2005.

17. Reasons for NIB War and related
litigations in other countries:
 Attractive revenues for generics:

Increase in number of blockbuster drugs during last decade, now
facing patent expiry.

This interests the generic firms to launch their “COPYCAT” version
with very less investment than that of discovery.

Generic entry can be done by 3 ways:
i. Safe Entry – longest duration for approval and more competition.
ii. At-Risk Entry
iii. Licensing options
 Amendments in Indian Patent Act, making it more stringent and
Introduction of Product Patent Regime leading to overflow of
innovators with new drugs.
 Lack of Patent Linkage system in India.

18. At-Risk Entry:

Launching a generic drug (ANDA Filing) involves market
authorization from NDRA of their respective countries.

In countries (e.g USA) following patent linkage system, the generic
drug filer has to prove:
--Patent invalidity
--Confirmation for non-infringement

In countries (e.g. India, EU) not following linkage system, marketing
may be granted on the basis of
--scientific criteria concerning the Quality, Safety and Efficacy of
the drug product.
--without involving any patent law related issues.

The approach to harmonize regulatory and patent system
brought in India by innovators, proved to be very inconsistent and
created contradictions from case to case.

19. At-Risk Entry: (US)
Generic files ANDA along with Para-IV
FDA has 60 days to accept this application
Generic filer sends a notice to each of the patent owner and to the
approved NDA holder
Once the notice has been served, the patent holder has 45 days to
sue the generic manufacturer
This automatically triggers the 30 months stay of FDA approval to the
ANDA
If ANDA applicant/generic manufacturer prevails the litigation
ANDA applicant receives a 180-day period of marketing exclusivity

20. Licensing Option:

US Patent law does not explicitly provide for a CL
(Compulsory License), but more than 100 licenses
have been granted in special cases.

Provisions for CL were incorporated as amendment in
2002 in Indian Patent Act.

India granted its 1st CL on 9th March 2012 to Natco for
Bayer‟s Anti-Cancer drug Nexavar.

21. Amendments in Patents
Act, 1970

Provisions of TRIPS agreements was implemented in 10 years in stages:

Jan 1 1995: (1999)
Filing of Black Box applications
Provision of Exclusive Marketing Rights

May 20, 2003:
Uniform Patent term of 20 years from filing

Jan 01, 2005
Grant of product patents in all fields of technology including drugs, food and
chemical substances

Procedural amendments

Patentability related amendments

Amendments related to remedial options for third parties at IPO

Administrative and other amendments

22. Procedural amendments:
 Time to file complete specification after provisional
patent application – 12 months without extension.
 Requirements under Section 8
 Statement and undertaking regarding foreign filing and
details of corresponding application till its grant.
 Disclosure of details about objections issued by other
patent offices in other countries.
 Example:
Cipla)
Sutent case
for Sunitinib (Pfizer/Sugen Vs

23. Patentability related
Amendments
 Definition of Inventive step and Novelty inserted
“Inventive step” means a feature of an invention that
involves technical advancement 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;

“New invention” means any invention or technology
which has not been anticipated by publication in any
document or used in the country or elsewhere in the
world before the date of filing of patent application with
complete specification, i.e., the subject matter has not
fallen in public domain or that t does not form part of the
state of the art;

Example: Sutent case for Sunitinib (Pfizer/Sugen Vs Cipla)
Tarceva for Erlotinib (Roche Vs Cipla)

24. Patentability related
Amendments
 Section 3(d): Non Patentability Criteria:

The mere discovery of a new form of a substance which does not
result in enhancement of a known efficacy of that substance or
the mere discovery of a new property or new 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
purpose
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 prior arts.

Examples: Glivec case for Imatinib mesylate (Novartis Vs Cipla)

25. Amendments related to
remedial options for third parties
at IPO:
 Pre-Grant or Post-Grant Oppositions
 Grounds of Pre and Post Grant opposition are same.
 Compulsory license:

At any time after the expiration of three years from the date of
grant of a patent, any person interested may make an
application to the Controller for grant of compulsory license
on patent on any of the following grounds, namely: Non-availability or
 Over priced or
 Non-working in India

Example: Nexavar case for Sorafenib Tosylate (Bayer Vs
Natco)

26. Administrative and other
amendments:
 Enactment of IPAB- Specialized IP board
(Intellectual Property Appellate Board)
 Residents not to apply for patents outside India
without prior permission and intimation.

27. Landmark Litigations:
1.
Glivec/ Imatinib mesylate – Novartis Vs Cipla
2.
Nexavar/ Sorafenib – Bayer Vs Natco
3.
Nexavar/ Sorafenib – Bayer Vs Cipla
4.
Tarceva/ Erlotinib – Roche Vs Cipla
5.
Sutent/ Sunitinib – Pfizer/Sugen Vs Cipla

28. 1. Glivec/Imatinib mesylate

Indian Patent application #: 1602/MAS/1998

Date of filing: 17th July 1998 (via Black Box application)

Specification: this patent claimed β-crystalline form of
Imatinib mesylate.

It distinguished the only physical properties of the β
form as superior to that of α form.

According to sec-3(d), this is not patentable. (refer
slide#24)

Though the claims were to focus on β form, a separate
Divisional Patent Application was filed specifically
claiming α form.

29. 1. Glivec/Imatinib mesylate
 Divisional Patent: is filed when a patent application
contains more than one invention.

This divisional patent leads to EVERGREENING of
patent, which keeps extending the term of patent, for
every new divisional patent.

Evergreening is not preferred practice, since it hinders
the technological advancement of developing
countries.

Thus, both the patents were subjected to Pre-Grant
opposition by Sun, Ranbaxy, Natco Cipla and Cancer
Patients Aids Association.

30. 1. Glivec/Imatinib mesylate

Controller of IPO rejected both the patent
applications of Novartis being non-patentable under
sec-3(d).

Novartis filed its improved efficacy data later, which
was rejected on the basis of the Patents Act provision
for „non-acceptance of later submitted data‟.

Novartis filed a WRIT petition against the controller‟s
decision.

Case was transferred to IPAB, which also held the
controller‟s decision and rejected the petition.

At present, Cipla is manufacturing its generic named
„IMATIB‟.

31. 1. Glivec/Imatinib mesylate

Current status: pending at supreme Court against
interpretation of section-3(d).

Meaning of term „Efficacy‟ has been defined as
„Therapeutic Efficacy‟.

Grant of patent applications of polymorph, salt etc
has become tougher in India.

Later submitted data would not be accepted for
overcoming Rejections under sec-3(d) subject matters.

For sec-3(d), data comparison is required which should
be between known (improved) form of substance and
claimed form of substance.

32. 2. Nexavar/Sorafenib
tosylate (Bayer Vs Natco)
 Granted Patent #: IN215758
 Post-Grant opposition by: Natco
 1st CL was granted on 9th March 2012 to Natco.
 Grounds on which CL can be granted:

Non-availability [sec-83(a)]

Over priced [sec-83(g)]

Non-working in India [sec-83(b)]

33. 2. Nexavar/Sorafenib
tosylate (Bayer Vs Natco)
 In this case:

The patentee claimed to have manufacturing facilities
in India for several products, including anti-cancer
drugs.

Bayer imported in India a small quantity (only 2% of
patient population) of Sorafenib and did not produce
any pill in India. (non compliance to sec-83-(b))

Bayer could have granted voluntary license also.

Bayer also argued for low quantities requirement of
the product in India, which was rejected by the
controller.

34. 2. Nexavar/Sorafenib
tosylate (Bayer Vs Natco)

Bayer‟s Nexavar was priced 2,80,000 INR for monthly
dose, which is obviously out of reach of any middle
class man in India and where there is 40% population is
living below poverty line.

On the basis of above reasons, the controller
countered every objection raised by Bayer and
granted CL to Natco under specific terms:
> A sale price of 8,800 INR per month dose
> Royalty to Bayer at rate of 6% on net sales.

35. 2. Nexavar/Sorafenib
tosylate (Bayer Vs Natco)
 Though India amended its Patent act, didn‟t go
accordingly with the TRIPS in this case.
TRIPS
Indian Patent Act
According to article-27(1),
there is no compulsion on
patentee for local working
to enjoy its right in the
territory.
There is non-discrimination
between importation and
local production.
India amended its sec83(a) and (b) stating that,
“the patentee shall be
working in India and patent
can not be granted for
merely importing the
product.

36. 3. Nexavar/Sorafenib
tosylate (Bayer Vs Cipla)
 Date of filing: 5th July, 2001
 Date of grant: 3rd March, 2008
 Title: Carboxylated substituted Diphenyl Urea

Cipla announced its probable launch of generic Nexavar
(Soranib) in April 2010. (because of no patent linkage system in
India)

Bayer sued Cipla for patent infringement.

Cipla defended the case by arguing that Bayer‟s patent is
invalid.

[Note: in most patent litigations, the defendant doesn‟t waste
time on asserting non-infringement. Their line of defense is ONLY
limited to challenging the VALIDITY of Patent.]

37. 3. Nexavar/Sorafenib
tosylate (Bayer Vs Cipla)
 Grounds on which Cipla challenged the validity :
1.
Lack of inventive step: there are 2 prior art
documents filed by SUGEN and provide motivation to
arrive at compounds structurally similar to Sorafenib.

Cipla said that plaintiff‟s invention is OBVIOUS to a
person skilled in the art, to carry out trial and error
with different substitutes.

Cipla would have to be careful about raising such
defense so that it doesn‟t look like HINDSIGHT
reconstruction or BIAS.

38. 3. Nexavar/Sorafenib
tosylate (Bayer Vs Cipla)
2. False suggestion/mis-representation: Cipla said that
Bayer had suppressed 2 prior arts which disclose the
similar compounds, from Patent Office.
3. Objection on Working the invention: Cipla said that
Bayer did not manufacture the product in India.
4.
Over Priced: Bayer‟s
Nexavar costs
2,330
Rs/tablet, while Cipla‟s Soranib costs 230 Rs/tablet.

39. 3. Nexavar/Sorafenib
tosylate (Bayer Vs Cipla)
5. No technical advancement:

Cipla said that there is no technical advancement shown
by the invention over what was already known. (sec-3d)

For fulfillment of sec-3(d), there must be a previously
known compound with which one can compare the NEW
FORM. E.g. new polymorph or a new salt with the same
parent molecule.

But here Sorafenib
compound.

Here, Cipla‟s argument is totally absurd, as sec-3(d) does
not apply to this case.
tosylate
is
altogether
a
new

40. 3. Nexavar/Sorafenib
tosylate (Bayer Vs Cipla)
 The case is still in court.
 Court rejected the permanent injunction on Cipla and
permitted to manufacture and market its generic
Soranib.
 Decision is pending on validity of the patent.

41. 4. Sutent/Sunitinib
(Pfizer/Sugen Vs Cipla)
 Patent #: IN209251
 Grounds for Post-Grant opposition:
1. Invention is obvious and didn‟t include inventive step.

Cipla cited 3 prior arts
US5886020, WO/9850356, WO/99/61422, disclosing very
similar compounds, except for one difference in
substitution and activity of all was same.

42. 4. Sutent/Sunitinib
(Pfizer/Sugen Vs Cipla)
2. Patentee failed to disclose information as required under
sec-8.

This patent was identified in media as Pfizer Patent, while
Pfizer is only the licensee.

Patent is actually owned by Sugen Inc. and Pharmacia &
Upjohn.

Sugen failed to disclose before IPO, that the patent was
licensed to Pfizer.
3. Non-availability:

Sugen imported only a mere 7000 units into India, where
500,000 people die of cancer every year.

43. 4. Sutent/Sunitinib
(Pfizer/Sugen Vs Cipla)
 Controller ruled that “where there is a case based
upon closeness of structure, then it is mandatory for
the patentee to demonstrate that there are actual
differences between the claimed compound and the
prior art such that the invention as a whole is nonobvious.
 Revocation of product patent of Sunitinib.
 Final decision as per 29/11/2012:

SC returned the case to patent authorities to reexamine the patent.

SC also lifted the injunction granted by HC against
restraining Cipla from launching its generic in market.

44. 5. Tarceva/Erlotinib (Roche
Vs Cipla)
 Patent #: IN196774
 Date of grant: September 2007
 Tarceva by Roche: 4,800 Rs/Tablet
 Erlocip by Cipla: 1,600 Rs/Tablet

Roche sued Cipla for infringement of their Tarceva
Patent and demanded interim injunction on Cipla.

Cipla (again!!) challenged validity of the Tarceva
patent.

45. 5. Tarceva/Erlotinib (Roche
Vs Cipla)
 Interim injunction was refused by Delhi HC on the
ground of public interest by decision. (mainly due to
cost difference)
 HC ordered Cipla not to export their generic to he
countries where Roche has the Patent.
 Final Verdict:

HC upheld the Tarceva patent valid.

At the same time, Cipla won the infringement case
against Roche, as polymorphic form used by Cipla
(Polymorph-B) was different than the Roche‟s Tarceva
(A+B).

46. Conclusions:
 Examination of patents including product patent wrt
inventive step would become more strict.
 At the time of filing of patents, it would be required to
incorporate data for substantial improvement over the
known substance.
 Provisional application provides priority to the
disclosed subject matter only – Maximum disclosure is
beneficial.
 Non-disclosure of required subject matter and its
supportive data within 12 months from provisional
application may lead to loss of rights.

47. Conclusions:
 Improvement of the invention from prior art should be
convincingly incorporated in patent application.
 Compared to US and EP laws, Indian Patent Act is
more stringent wrt subject matter and criteria of
patentability.
 If a patent application complies with all the
requirements of Indian Patent Act, chances of the
grant of patent in other countries become higher.
 India govt. should provide subsidiaries and health
insurance reimbursement to all patients for life saving
and/or non-affordable dugs.

48. Conclusions:
 E.g. Alexion Pharma (USA) sells a drug – SOLIRIS that
treats a very rare disease called PNH (Paroxysmal
Noctural Haemoglobinurea).
 Price: US$ 400,000 per patient per year
 National Health Services (UK) agreed to reimburse the
price of the drug.
 Similarly, Australian govt. agreed to reimburse full price
of the drug.
 This led to increased productivity and life-quality of
patients.
 WIN-WIN situation for both Innovators and Patients.

49. Post TRIPS Effects:
 Contrary to negative perception, India survived the
Post-TRIPS „Rough Weather‟ period most successfully.
 The law-makers are making best use of the flexibilities
permitted in TRIPS.
 India acquired patent proficiency and Indian Pharma
companies have moved onto globally dominant
position at least as the leader of generic medicines.
 Domestic Pharma industries are taking preventive and
defensive measures as well as offensive where the
patents are vulnerable.

50. Post TRIPS Effects:
 The practice of new Patent Regime directed the
Indian Pharma companies to regulated markets with
Largest number of USFDA and EMA approved
manufacturing sites.
 Large number of DMF/ANDA filings and approvals.
 With increased govt. funds, the Indian Pharma industry
is gearing up for entering the Drug Discovery Band
Wagon.
 Pharma MNCs are facing increased competition for
new molecules from India-based generic companies.

51. Post TRIPS Effects:
 Indian Pharma companies have generated „Largest
New Drug Pipeline‟ among generic companies
worldwide.
 Innovators are witnessing growth in generic drug
industry and possible decline in revenue due to some
blockbuster drug patent nearing expiry.
 Thus, innovators have turned towards M&A activities to
retain their monopoly also in the generic market. E.g.
Pfizer with Aurobindo and Novartis with Sandoz.
 Few Contract Drug Discovery initiatives have been
triggered: ADVINUS, SUVEN…

52. Post TRIPS Effects:
 Availability of new life saving drugs in developing
countries and LDCs.
 Availability of affordable generic drugs of the same
life saving innovators‟ drugs due to best use of
flexibilities under TRIPS.
 Due to „Working‟ provision for the innovators for their
patented drugs, technology transfer has been
triggered to less developed nations, leading to
technological development.
 Establishment of TKDL (Traditional Knowledge Digital
Library)

53.  84. Compulsory licences.(1) At any time after the expiration of
three years from the date of the sealing of a patent, any person
interested may make an application to the Controller alleging
that the reasonable requirements of the public with respect to
the patented invention have not been satisfied or that the
patented invention is not available to the public at a reasonable
price and praying for the grant of a compulsory licence to work
the patented invention.
 (2) An application under this section may be made by any
person notwithstanding that he is already the holder of a licence
under the patent and no person shall be estopped from alleging
that the reasonable requirements of the public with respect to
the patented invention are not satisfied or that the patented
invention is not available to the public at a reasonable price by
reason of any admission made by him, whether in such licence or
otherwise or by reason of his having accepted such a licence.

54.  (3) Every application under sub- section (1) shall contain a
statement setting out the nature of the applicant' s interest
together with such particulars as may be prescribed and the
facts upon which the application is based.
 (4) In considering the application filed under this section the
Controller shall take into account the matters set out in section
85.
 (5) The Controller, if satisfied that the reasonable requirements of
the public with respect to the patented invention have not been
satisfied or that the patented invention is not available to the
public at a reasonable price, may order the patentee to grant a
licence upon such terms as he may deem fit.
 (6) Where the Controller directs the patentee to grant a licence
he may as incidental thereto exercise the powers set out in
section 93.