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Revocation of Patents and Compulsory Licensing

Revocation of Patents and Compulsory Licensing notes

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Diksha Arora
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50 views24 pages

Revocation of Patents and Compulsory Licensing

Revocation of Patents and Compulsory Licensing notes

Uploaded by

Diksha Arora
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© © All Rights Reserved
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UNIT 3

REVOCATION AND COMPULSORY


LICENSING
 Revocation: Request to revoke a granted
patent

 Opposition: Right to oppose grant


of a patent.

2
 Pre grant Right to oppose grant of a
Opposition: patent

 Post grant Opposition: Request to revoke a


granted patent within one year of grant of patent.

• Revocation: Terms beyond post-grant opposition.


Description Pre-grant Opposition 25(1) Post-grant Opposition 25(2)

Hearing No procedure for Hearing Procedure as detailed in R. 62

Relief Rejection of Application Revocation of Patent

Form No prescribed form Form 7

Fee No Fee Rs.1500/- for Individuals and


Rs.6,000/- for Legal Entity
Time limit Within 3 month after publication One year within grant of patent

Costs No provision for costs Cost can be awarded under


R.63
Appeal In IPAB In IPAB
Patent Opposition
 Opportunity to public

 Kinds Pre-grant representation and Post grant


opposition

 Pre grant representation to be filed before grant

 Post grant opposition to be filed within 1 year from


date of grant
Revocation of patents
 Apart from challenging the grant of patent or opposing the
granted patent under sections 25 (1) and 25 (2), another
opportunity to file petition- Revocation of patent.
 Section 64, (36) Indian Patent Act, 1970.

 Patent may be revoked anytime during the life of patent by


any person interested.

 Unlike post grant opposition, revocation of patent is not a


time bound procedure
Who can file revocation
 Person interested in the appellate board

 The Central Government

 The High Court has the power to settle disputes between the
patentee and the central government.

 Form 19

7
Revocation

 Revocation means "cancellation” Revocation of an offer means its withdrawal


by the offer or An offer may be revoked at any time before the offeree accepts it.

 Revocation of an offer after acceptance will be ineffective. If it is to be effective, it


must be communicated before the dispatch of the letter of acceptance.
Grounds of revocation-
Prior claiming .

Wrongfully obtained patent.

Subject of claim not invention.

Lack of novelty in invention.

Invention is obvious or no
inventive step.
Grounds of revocation-
Complete specification doesn’t sufficiently
or fairly describe invention & method of it .

Claims not clearly or sufficiently defined.

Patent obtained on false suggestion or


representation.

Inventions anticipated by traditional


knowledge.

Failure to disclose - foreign


application.
Revocation of patent in public interest
[section 66]

• Central government is of opinion that patent or

its mode is mischievous to the state or

prejudicial to the public , after giving patentee

an opportunity to be heard.
Revocation of patent non working
According to section 85 of patents act the Central
Government or any interested person after
expiration of 2 years from date of order granting
the first compulsory license apply to controller for
an order of revoking patent on ground that

 Patented invention not worked in territory of India

 Reasonable requirements of public – not satisfied

 Patented invention – not available at reasonably


affordable price
Restoration of lapsed patent [section
60]
Patent has ceased to have effect
under section 53[2] – because of
non payment of renewal fees
within prescribed period ,the
patent & any specified patent of
addition

Restored
If an application is made within 18
months of date on which patent
lapsed
• Application that failure to pay
renewal fee was unintentional
• Supporting evidence
COMPOLSORY LICENSING

Introductionof Compulsory licensing


Indian perspective
Bayer vs. Natco case
Global perspective
Impact of Compulsory licensing
Conclusion
Introduction:
The Intellectual Property Rights across the world
abide by a common agreement named Trade
Related Aspects of Intellectual Property
(TRIPS) which is a part of the WTO agreement.
TRIPS covers Compulsory License in detail.

Compulsory licenses came into force when the


developing countries couldn’t afford the cost of
technology to produce medicines and high price
of the patented medicines.
Compulsory Licensing is defined by the WTO as
“Compulsory licensing is when a government
allows someone else to
produce the patented product or process without the
consent of the patent owner.”

Compulsory license can be granted, at any time after


the expiration of three years from the date of
grant of a patent, by making an application to the
Controller of patents.
Indian Perspective:
Chapter XVI (Section 82-98) of the amended
Indian Patent Act, 1970 is devoted to
Compulsory Licensing. Section 84 of Indian
Patent Act provides for grant of CL.

The grounds on which a compulsory licence


can be granted under the Act can be sub‐
divided into the following 2 categories

(NEXT SLIDE)
• Abuse of patent rights [ Sec. 84 (1) ]

• If the reasonable requirements of the public with respect


to the patented invention have not been satisfied.
• If the patented invention is not available to the public at an
affordable price.
• If the patented invention is not worked in the territory of
India.

• 2) Public Interest [ Sec. 92 (A) ]

• For export in certain exceptional circumstances


• In case of national emergency
• To countries having insufficient or no manufacturing
Bayer Vs. Natco: Case
 Bayer v/s Natco was the first case of compulsory licensing
being obtained in India in pharmaceutical field of discipline.

BAYER NATCO
CORPORATIO PHARMA LTD.
N
•International manufacturing •Indian generic pharmaceutical
firm company
•Invented a drug –
SORAFENIB •Requested Bayer for voluntary
(used in t/t of liver & license
)kidney cancer

•Brand name – NEXAVAR •Bayer denied the request

•Natco filed an application for


•Obtained a patent on
CL
Nexavar
•Nexavar Cost : Rs 2.88 • Want to manufacture the low-price drug
Case Overview:
On 9th March, 2012 the Controller General of India passed an order of
compulsory license against Bayer’s patented drug Nexavar, which is
India’s first compulsory license.

The compulsory license was granted in accordance with the grounds


described under section 84 of the Indian Patent Act

The compulsory license enables Natco to sell the drug at a price not
exceeding Rs 8,880 for a pack of 120 tablets (one month's therapy)
as against Rs 2.88 lakh being the cost of Nexavar sold by Bayer.

The order also makes it obligatory for Natco to supply the drug free
of
cost to at least 600 needy patients per year.

Natco will have to pay 6% royalty on sales to Bayer for the drug on a
quarterly basis.
Global Perspective:
Mainly developing countries are giving
importance to compulsory license because
of unavailability and unaffordability of
medicines while developed countries like
– U.S and Europe are opposing it
because of decline in innovation.
Impact of Compulsory
Licensing:
 Innovation
 The increasing cases of compulsory licensing around the globe would decline
the innovation because it will hamper the desire of the pharmaceutical
companies of the developing countries to go into the research and they may
become dependent on the generic medicines.
 Furthermore, research based pharmaceutical companies will not launch
patent molecule .

 Competition and Cost


 Compulsory licensing ultimately will lead to increases in the competition
because more and more generic companies come into the role to capture the
high market share.

 Patients
 This phenomenon of compulsory licensing extensively helpful
for the financially challenged patients of developing countries by easy
access to the medicines at lower prices for maintaining good health.
CONCLUSION:

•So, it can be concluded that compulsory


licensing now became the new hope for
the financially challenged patients while
challenge for the innovators and at last
we can say that it turns into the most
concerned Intellectual property matter
around the globe at this present
scenario.
THANK YOU

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