Compulsory Licensing: Regulatory perspective on how it can be filed and how they can be used for public health, especially essential anti-cancer molecules. A tool to scale down the cost of essential life saving medicines

1. Compulsory Licensing
(IPR)
By-
Cyril Jose

2. WTO defines ''Compusory Licensing as a process wherein government
allows someone else to produce the patented product or process
without the consent of the patent owner''

3. Contained in Chapter XVI of the Patents Act 1970, under the sections
82 to 94
Conditions vary between each patent syst
Granted
After expiration of three years of filing of patent
By the Controller for grant of compulsory license
Conditions for granting of CL
Reasonable requirements of the public have not been satisfied.
Not available to the public at a reasonably affordable price.
Not worked in the territory of India.

4. Considerations for granting of CL
(i) the nature of invention, the time which has elapsed since the sealing
of the patent and the measures already taken by the patentee or any
licensee to make full use of the invention
(ii) the ability of the applicant to work the invention to the
public advantage.
(iii) the capacity of the applicant to undertake the risk in providing
capital and working out the invention, if the application were granted.
(iv) as to whether the applicant has made efforts to obtain a licence
from the patentee on reasonable terms and conditions and such efforts
have not been successful within a reasonable period(six months).
Revocation of Patents
After expiration of two years from the date of the order granting the first
compulsory licence, the central government or any person interested
may apply to the Controller for an order revoking the patent.

5. Procedure after filing Compulsory license
Prima Facie case being filed by the Controller
Forwards copies of the application to the patent holder
The same is then published in the official journal
Notice of opposition need to be filed by the patentee within a prescribed period
deemed fit by the Controller
The Controller shall notify the applicant in case of a opposition being filed
Both the applicant and the opponent gets an opportunity to be heard before
deciding the case.

6. Power of Controller to adjourn applications for
compulsory license
 If the controller is satisfied that the time elapsed since the sealing
of the patent has been insufficient to enable the invention to be worked
on a commercial scale.
 A period of 12 months are usually granted to the patentee to work
out the invention in the territory of India.
 Within one year the controller has to reveal his stand for the
application.

7. Power of Controller in granting of CL
When an appilcation for compulsory license is made by a patent holder-
Order the existing licence to be cancelled, or may, if he thinks fit, instead of making
an order for the grant of a licence to the applicant, order the existing licence to be
amended
Where two or more patents are held by the same patentee-
If the Controller is satisfied that the applicant cannot efficiently or satisfactorily work
the licence granted to him under those patents without infringing the other patents he
may, by order, direct the grant of a licence in respect of the other patents also to
enable the licensee to work the patent or patents in regard to which a licence is
granted.
Where the terms and conditions of a licence have been settled by the
Controller,
The licensee may, at any time after working out the invention on a commercial scale
for a period of not less than 12 months, apply to the Controller for the revision of the
terms and conditions on the ground that the terms and conditions settled have proved
to be more onerous than originally expected and the licensee is unable to work the
invention except at a loss, provided that no such application shall be entertained a
second time.

8. Terms and Conditions of Compulsory Licenses
 The royalty and other remuneration entitled to the patent should be
reasonable
 The patented invention is worked to the fullest extent by the
applicant with reasonable profit to him
 The patented articles should be made available to the public at
reasonably affordable prices
 The licence granted is a non-exclusive licence
 The right of the licensee is non-assignable
 The licence is granted with a predominant purpose of supply in the
Indian market and that the licensee may also export the patented
product ''if need be''

9. Termination of Compulsory Licence
The operation of compulsory Licence may be terminated by the Controller if and
when the circumstances that gave rise to the grant thereof no longer exist and
such circumstances are unlikely to recur
Any order for the grant of a licence under this Chapter shall operate as if it were a
deed granting a licence executed by the patentee and all other necessary parties
embodying the terms and conditions, if any, settled by the Controller.
Facts-
Only 3 Compulsory Licensing has been filed till date in India.

10. India grants first compulsory licence to Generic manufacturer NATCO for
sorafenib tosylate over Bayer AG’s “Nexavar”
According to the Indian Patent Office's decision, the German drug-maker BAYER
did not begin importing the drug to India in 2008 and only small quantities were
available during the following two years.
"The drug is exorbitantly priced and out of reach of most of the people," the patent
authority wrote in its 62-page decision.
In its compulsory license request, Indian generic manufacturer Natco proposed
selling sorafenib tosylate at Rs. 8,800 per patient per month - approximately US
$175 - resulting in a 97 percent price cut compared to Nexavar.
The Indian Patent Office also said that Natco must pay royalties to Bayer on a
quarterly basis at the rate of 6 percent of the net sales of the medicine, in
accordance with remuneration guidelines set forth by the United Nations
Development Programme.

12. Reference-
http://ipindia.nic.in/IPActs_Rules/updated_Version/sections/ps84.html
Case studies-
http://www.prepsure.com/news/india-placed-at-the-bottom-in-
international-best-practices-usa-chamber-of-commerce/
http://www.firstpost.com/living/world-cancer-day-compulsory-licensing-
of-key-drugs-only-way-for-india-to-fight-this-grave-threat-
2612574.html
http://www.ictsd.org/bridges-news/bridges/news/india-grants-first-
compulsory-license-to-generic-drug-producer