DR.

RAM MAHOHAR LOHIYA NATIONAL LAW UNIVERSITY

2015-2020

IPR IN PHARMACEUTICALS SECTOR

(FINAL DRAFT)

REVOCATION OF PATENT IN PUBLIC INTEREST

SUBMITTED BY: UNDER THE GUIDANCE OF:

SHAILESH KUMAR / VIKASH RAJ MS. PRIYA ANURAGANI

ENROLL NO. - 150101120/150101159

SECTION ‘B’ ASSITANT PROFESSOR (LAW)

SEMESTER IX DR. RMLNLU, LUCKNOW

OBJECTIVE OF THE STUDY

The objective of this paper is to analyze and understand the role and impact of Intellectual
Property Rights with regard to the pharmaceuticals sector in India, focusing on the small and
medium scale enterprises.

RESEARCH QUESTIONS

1. Can the Central Government review the grant of a patent under Section 66 of the Patent Act,
1970?
2. How are intellectual property rights important to small and medium enterprises in the
pharmaceuticals sector in India?

LITERATURE REVIEW

Under Section 66, if the Central Government is of the opinion that a patent or the mode in which it is
exercised was mischievous to the State or prejudicial to the public, after giving an opportunity to the
patentee to be heard, it may make such declaration in the Official Gazette and the patent shall stand
revoked. The struggle between innovator pharmaceutical companies (mostly in the Western world) and
developing world Generic companies has been lately played out in India and especially for the last 2-3
years in the form of litigations and oppositions. Here I would be discussing the specific cases and laws
which deal with the revocation in public interest.

INTRODUCTION

When a patent has been sealed or granted, it is not always the case that the patent shall stay
unhindered by any third party till the life of the patent. The patent can be challenged by certain
people on different grounds, and a method to cause the same is by filing a revocation petition/
post-grant opposition proceedings. As the patent act does not presume patents granted to be
valid, rights granted on such patents cannot be absolute. Third parties which are required to seek
permission from patentee for practicing any of the exclusive rights bestowed upon him are also
given a chance to challenge the validity of the patents. This challenge can be instituted on own as
well as on patentee asserting infringement of patent rights.
Revocation of patents section 64 deals with revocation of patents. Revocation of patents can be
understood in the context of opposition of patents, because opposition is a proceeding similar to
revocation, but the proceeding happens at the patent office and we saw that there are two types of
oppositions. The opposition could be to an application what we call a patent application. That is
opposed before its grant and it is also called pre-grant opposition or the opposition could be one
year after the grant what is known as the opposition after the grant or the post-grant opposition.
Now, these two types of opposition are proceedings by which you can challenge the validity of
the patent before the patent office.

The Indian patent act, 1970 empowers the central government to revoke any patent granted by
the Indian patent office if it feels that the said patent is prejudicial to public interest. There are
two provisions in the patent act, 1970 which empowers the central government to revoke granted
patents. One is section 65 of the act which gives power to the government to give directions to
the controller to revoke a patent if the government is satisfied that the invention is one relating to
atomic energy for which no patent shall be granted. Another important provision related to the
central government’s power is section 66 which empowers the government to revoke the patent
if it feels that the mode in which it is exercised is mischievous to the state or generally
prejudicial to the public. In such cases, the central government has the power to revoke the patent
but only after giving an opportunity to the patentee to explain why his patent should not be
revoked. After such hearing, if the government feels that the patentee could not explain why the
invention does not affect public interest, it can revoke the patent by making a declaration in the
official gazette. 

COMPLIANCE OF SECTION 66 WITH TRIPs –

As India is a WTO member and TRIPs compliance nation the Indian patent regulations should be
formulated in letter and spirit of TRIPs agreement. In order to understand how section 66 of Indian patent
act complies with TRIPs provisions a critical analysis of section 66 and Article 7 and Article 8 of TRIPs
needs to be done.

Revocation of patent in public interest (Article 66)-

Where the Central Government is of opinion that a patent or the mode in which it is exercised is
mischievous to the State or generally prejudicial to the public, it may, after giving the patentee an
opportunity to be heard, make a declaration to that effect in the Official Gazette and thereupon the patent
shall be deemed to be revoked.

This section clearly states that the central government can in the interest of public, revoke the patent
granted to any person and establish concept of public good over exclusivity of rights one can observe
similar provisions in TRIPs.

In TRIPs, public interest reflected in

Article 7: The protection and enforcement of intellectual property rights should contribute to the
promotion of technological innovation and to the transfer and dissemination of technology, to the mutual
advantage of producers and users of technological knowledge and in a manner conducive to social and
economic welfare, and to a balance of rights and obligations.

This Article reflects the existence of public interest through the emphasis on the protection and
enforcement of intellectual property rights should contribute to the transfer and dissemination technology
by considering the balanced interest between producers and users of technology, and in manner conducive
to social and economic welfare, and to a balance of rights and obligations.

Another article of TRIPs agreement also enshrines the spirit of public interest and shares similarity with
section 66 of the Indian patent act.

Article 8, TRIPs firmly stipulates public interest consideration in IPR protection, stipulating that: 1.
Members may, in formulating or amending their laws and regulations, adopt measures necessary to
protect public health and nutrition, and to promote the public interest in sectors of vital importance to
their socio-economic and technological development, provided that such measures are consistent with the
provisions of this Agreement. 2. Appropriate measures, provided that they are consistent with the
provisions of this Agreement, may be needed to prevent the abuse of intellectual property rights by right
holders or the resort to practices which unreasonably restrain trade or adversely affect the international
transfer of technology It is clear that this Article gives each member of WTO have a possibility to adapt
measures necessary to protect health and nutrition’s, and to promote the public interest in sectors of vital
importance to its socioeconomic and technological development, as long as that such measures do not
contravene the provisions of the Agreement. Despite all measures should be conducted consistent with the
provisions of the TRIPs Agreement, this provision constitutes a firm recognition of rights of each WTO’s
member to protect public interest in its national IPR laws.
AGRACERUS’s PATENT CASE

The first instance was when a process patent was granted to Agracetus, a U.S. company, for genetically
engineered cotton cell lines. Around the year 1994, this patent was revoked in public interest because it
was viewed as being prejudicial to farmers’ rights. The Govt. was of the view that Cotton is an important
crop essential to national economy and should not be the subject matter of patents.

Indian Patent Number 168950 titled “A method of producing transformed Cotton Cells by tissue culture”
was granted to Agracetus of USA based on the patent application number 919 Cal 87 (filed on
24/11/1987) by the Indian Patent Office.

The main claim of the patent stated:

A method of producing transformed cotton cells by method of tissue culture of immature cotton plants for
generation into mature cotton plants, the process comprising exposing hypocotyls tissue of the same
immature cotton plant on a medium to a culture to transformation component non-oncogenic
Agrobacterium tumefaciens and harbouring a TI plasmid having a T-DNA region, including both foreign
chimerix and a selection agent resistant gene.

No “pre grant” opposition was filed by any party and the Patent Office ended up granting the patent. The
implications of granting such a patent was realized later and there was mounting criticism from the farmer
community that this patent was prejudicial to their interests as it would impact the farming of a major
crop of national importance and have negative ramifications on the Indian economy. After China and the
US, India is the world’s third largest cotton producing nation. At least 190 million people in the
developing world drive all or part of their cash income from cotton growing and handling.

Government Action

In October, 1994, the Indian Government revoked Agracetus’s controversial patent on transgenic cotton.
The Indian Government under Section 66 of the Patent Act decided to summarily revoke the patent,
“because of its far-reaching implications for India’s Cotton economy”. The government observed that the
patent would affect the farmers and the cotton industry which would eventually result in negative
ramifications on the Indian Economy. Later the United States also followed suit and revoked Agracetus’s
patent.
Can the Central Government review the grant of a patent under Section 66 of
the Patent Act, 1970?
As stated in section 66 central government has laid upon itself quasi judicial powers to review the grant of
patent and to revoke it based on its own opinions. This self delegated quasi judicial power of central
government has become a controversial sensation in intellectual property regime.

Admist the entire controversy of frivolous patents being granted to innovator companies the Controller
General of Patents recently made the following statement to the press: “At the present law, there is no
provision to review already granted patents by the patent office once the post-grant opposition period (one
year after the grant) is over. But it can be revoked by moving the Intellectual Property Appellate Board or
courts of law against the wrongly granted patents.
Image from here.

While this statement is almost correct I would like to point out to Section 66 of the Patents Act, 1970
which allows for “Revocation of patent in public interest”. In particular the Section states that

Where the Central Government is of opinion that a patent or the mode in which it is exercised is
mischievous to the State or generally prejudicial to the public, it may, after giving the patentee an
opportunity to be heard, make a declaration to that effect in the Official Gazette and thereupon the patent
shall be deemed to be revoked.

It appears to me that this Section provides the Patent Office or the DIPP, Ministry of Commerce with a
power to review the grant of patents. A frivolous pharmaceutical patent would be greatly prejudicial to
the public and should therefore be revoked under this provision. Since the Act does not define Central
Government it would appear to me that as long as the Order is made under the seal of the President of
India it would lead to a revocation of the patent.

.
Implications of section 66

1- Lowering the burden on judiciary-

If we look at the history of Section 66, it can be observed that the Government of India has invoked its
powers to revoke patents only twice. In both situations, the Government ensured that public interest is not
disturbed due to grant of those patents. The section acts as a correctional provision and the Government is
considered as the adjudicating authority, which ensures that interest of public is given more priority than
personal interests. The public at large need not approach the Court every time for striking down every
such patent. The presence of such provision hence lowers the burden on the Judiciary. Now that
the Traditional Knowledge Digital Library is accessible to the Government, it is being anticipated by
many that the Government may try to weed out more of such patents.

2- Allows the scope of arbitrariness.

The self assigned power of quasi judicial review delegated by central government upon itself
has given central government an unchallenged power of revocation. This power could lead to
an arbitrarily exercise of revoking patents which in turn could lead to violation of TRIPs
provisions. Thus an efficient mechanism of checks and balance in case of public good is need
of an hour.

Recommendations

1- ‘Opinion’ term used in section should be clearly defined i.e. the opinion on which central
government applies article 66 should be legal opinion that should be based on data gathered
through different agencies.
2- Patentee whose license central government is intending to revoke should be allowed to appeal
before Honorable Supreme Court, so as to get easy disposal of the suit.
REFERENCES

1. http://www.ipindia.nic.in/writereaddata/Portal/IPOAct/1_113_1_The_Patents_Act_1970_-
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3. http://www.mondaq.com/india/x/740652/Patent/Revocation+Of+Patents+Patents+Act+1970
4. https://nptel.ac.in/content/storage2/nptel_data3/html/mhrd/ict/text/110106081/lec54.pdf
5. https://www.thehindubusinessline.com/specials/pulse/make-pharmaceutical-patents-work-in-the-
public-interest/article22637313.ece#
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Original
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