[Ip-health] India CL Submissions due today
sflynn at wcl.american.edu
Thu Sep 30 07:33:24 PDT 2010
Please note that submissions to India on its compulsory licensing
policies are due today.
Some helpful resources from PIJIP Asst Dir. Mike Palmedo:
The 25 page paper the government released when it announced its request
Here are the email addresses to send the comments to:
v.bhaskar at nic.in
chandni.raina at nic.in
sk.lal at nic.in
Here is the list of submissions received so far. Includes PhRMA and
Oxfam. Pfizer's has been removed:
Here are the 13 specific questions the government is seeking information
1. Are guidelines necessary or required for the issue of
compulsory licences? Can it be argued that it is inadvisable to fetter
the discretionary power of government relating to the circumstances in
which compulsory licences should be issued, and thus such guidelines
should not be applied to Category I CLs but be restricted to Category
II CLs? Even the latter are issued through the exercise of quasi
judicial powers by the Controller. Will the issue of guidelines to
trammel her subjective satisfaction be desirable? Should therefore such
guidelines be restricted to the royalty payment to be awarded while
issuing a CL?
2. Do the requirements for issue of a notification by the
Central Government (national emergency; extreme urgency; public non
commercial use) under Section 92 require amplification through issue of
guidelines? Further are these grounds sufficient to meet all the
circumstances and exigencies that may necessitate issue of a compulsory
licence? Does the term public non commercial use necessarily imply free
distribution? Should such distribution be confined to government
channels? Should drugs for treating diseases like cancer or diabetes
should also fall within the ambit of CLs? Should such notifications be
confined to public health emergencies? Are there other valid
circumstances when such provisions can be invoked?
3. How should recourse to issue of a compulsory licence
under section 92 and recourse to use by the Central Government of an
invention under Section 100 be differentiated in the matter of use?
Under what circumstances should each be invoked?
4. Can products manufactured under a Category I licence be
effectively distributed solely through government channels? Does issue
of Category I CL envisage sale of the compulsory licensed goods
outside the ambit of government and in the market?
5. The Competition Act 2002 does not explicitly provide for
issue of Compulsory Licences as a remedy for anti competitive practices.
However, Section 27(g) empowers the Competition Commission to pass 'such
other order or issue such other directions as it may deem fit'. Further
Section 90(ix) of the Patents Act recognizes that CLs can be granted to
remedy a practice determined, after judicial or administrative process
to be anti competitive. Should CLs be issued on the basis of anti
competition law - if it is determined that companies have abused their
dominant position in the market or engaged in unfair competition?
6. Should working of a patent in the territory of India be
interpreted to mean that it should be manufactured within the territory
of India? Under what circumstances should the provisions of Section
84(7) (e) regarding working of the patent being prevented or hindered by
importation from abroad be applied?
7. How should the essential elements of a Category II CL
outlined in Para 54 and 55 above be proved by the applicant to the
satisfaction of the Controller?
8. What should be the basis for royalty payments to
compensate for CLs? Should a uniform stance be taken for Category I
CLs; Category II CLs and Central Government use of inventions? Or should
a differential approach be adopted?
9. Should payments to the patent holder include a component
of solatium as indicated in Para 62? How should such a solatium be
arrived at? Should the aggregate royalty and solatium be fixed at say
10% of the generic price?
10. How can the operational constraints in the implementation
of the August 30 decision be resolved during the course of issue of CLs
under Section 92A?
11. While originally applying for a patent, the applicant is
required to disclose complete specifications of the invention, as well
as the best method for working it. However, there may be an incentive
for the patentee to limit the description in the patent resulting in
critical portions of the technology remaining undisclosed. This may
cause delay in working of the CL. should such a problem of
insufficiency of information in the Patent application arise in relation
to the issue of a CL, how should it be addressed?
12. Should the Controller be obligated to examine and take a
final view on all CL applications within a specified time period? What
should be this time period? Should this time period be the same for
Category I and Category II CL applications?
13. Should publicly funded Indian research organizations
stipulate while selling/ transferring patents to Indian private sector
companies that the ownership of patents will revert to these
organizations in case the ownership of those companies passes on to
Program on Information Justice and Intellectual Property
American University Washington College of Law
4801 Massachusetts Ave., NW
Washington, DC 20016
T - 202-2274-4442 | F - 202-274-4495
mpalmedo at wcl.american.edu
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