This document discusses compulsory licensing of patents in India. It begins by defining compulsory licensing as allowing a third party to use a patented invention without the patent owner's consent, through a court or patent office. It then explains that compulsory licensing balances patent rights with ensuring patents are reasonably used. The document reviews compulsory licensing under TRIPS and Indian patent law, including allowed grounds and cases in India. It notes India retains sovereign right to issue compulsory licenses and will not privately assure against doing so.

1. 'Limitation to Patent Rights –
Compulsory Licensing'
Pankaj Kumar
Assistant Professor and IP Consultant

2. Indian patent regime and Safeguards
in Public Interest
• Patentability Criteria:
Section 3(d) (Novartis Dispute)
• Strong Opposition Mechanism
• CL for generics
• Parallel imports
• Government use

3. Compulsory License
use of the patented invention may be
authorized to a third party either by the
competent court or by a Patent Office
(depending on the law of the country)
without the consent of the patent owner
through a regime called compulsory
licensing

4. Why compulsory license?
• An intervention mechanism,
• through which, the Government balances the
rights of the patent holder with its obligations
to ensure proper and reasonable working of
patents.

5. Compulsory License and Paris Convention and the
TRIPS Agreement
• … prevents the abuses which might result from the exclusive rights
conferred by a patent.
• The agreement allows CL as part of the agreement’s overall attempt to
strike a balance between promoting access to existing drugs and
promoting research and development into new drugs.
• The term “compulsory licensing” does not appear in the TRIPS
Agreement. Instead, the phrase “other use without authorization of
the right holder” appears in the title of Article 31. Compulsory
licensing is only part of this since “other use” includes use by
governments for their own purposes.
• This regime may also be applied in case of non-use of the
patented invention within a prescribed period (generally four years
from the filing date of application for patent, or three years from the
issue of patent).

6. What are the grounds for using
Compulsory License as per TRIPS?
TRIPS Agreement does not specifically list the
reasons that might be used to justify compulsory
licensing.
In Article 31,it does mention –
• National emergencies,
• Other circumstances of extreme urgency and
• Anti-competitive practices

7. Compulsory License provisions in India
• S.84 Compulsory licenses
• S. 86 Power of Controller to adjourn applications for CL, etc., in certain cases
• S. 87 Procedure for dealing with applications u/s 84 and 85
• S. 88 Power of Controller in granting CL
• S. 89General purposes for granting CL
• S. 90 T&C of CL
• S. 92 Spl provision for CL on notifications by central Govt.
• S. 92A CL for export of patented pharmaceutical products in certain exceptional
circumstances
• S. 94 Termination of CL

8. Compulsory licenses: Grounds (S.84)

9. Compulsory License Cases in India
• Out of 3 applications for grant of Compulsory
License so far, only in first case the license was
granted

10. 1st Compulsory License case in India
Natco Pharma Ltd v Bayer
• Bayer patented drug Nexavar (SorafenibTosylate) is to treat advanced stage of
kidney and liver cancer
• The cost of therapy is INR 2,80,428/- per month
• Bayer's admission that only 2% of kidney and liver cancer patients were able
to access the drug and that the drug was imported and not manufactured
within India
• CG - public requirements failed
• IPAB - "It is only because of public interest, we are not interfering in this
appeal on this ground".
• HC - no reason to interfere with the findings of the authorities under the Act.
• SC - upheld the decision of Controller and upheld the grounds for which
Compulsory license was issued.

11. 2nd Compulsory License case in India
BDR Pharmaceuticals v Bristol-Myers Squibb
• Dasatinib, an anti-cancer drug
• Controller ruled in the favor of patentee
• AP has not made efforts to obtain a license
from the patentee as evident by the
applicant's conduct by not taking any action
on the queries by the patentee.

12. 3rd Compulsory License case in India
Lee Pharma v AstraZeneca
• Drug Saxagliptin
• CG rejected application majorly on the
grounds that applicant was unable to
substantiate that the public requirement was
not being met and the drug was unaffordable
to the public.

13. Shift in government policy on grant of CL
• Recently it was in the air that the Indian
Government offering private assurance to US
Trade Representative that it will not invoke
compulsory licenses anymore (save for public
noncommercial use). The news started to be
covered in legal and mainstream media with
indication that there is a shift in government
policy on grant of compulsory license.

14. News "private assurance"
• press statement published by NDTV website
(on 12th April) where both BDR Pharma and
Lee Pharma blamed lack of government
support for cheap generics and pressure from
Big Pharma for not pursuing Compulsory
License application anymore

15. Clarification of Govt (DIPP) –
"There have been recent media reports that the Government of India
has privately assured that it will not issue any more compulsory
license. It is hereby clarified that such reports are factually
incorrect. In this regard, it may be noted that India has a well
established TRIPS compliant legislative, administrative and judicial
framework to safeguard IPRs. Under the Doha Declaration on the
TRIPS Agreement Public Health, each member has the right to
grant compulsory licenses and the freedom to determine the
grounds upon which such licenses are granted.
Even as the Government of India is conscious of the need to spur
innovation and protect individual rights, it retains the sovereign
right to utilize the flexibilities provided in the international IPR
regime. It may be noted that till date, there has been only one case
of compulsory license in India and that too after a well-thought out
and laid down process, which was subsequently upheld right up to
the highest Court of the land."

16. National IP Policy & CL
• Finance Minister Arun Jaitley said India will
retain the right to issue so-called compulsory
licenses to its drug firms, under "emergency"
conditions.

17. Thank you!