|
July 8, 2008
Patentee to be
heard in proceedings for compulsory licensing for export
Section 92-A of the Patents Act, 1970 dealing with compulsory
license for export to underdeveloped countries, was again under
scanner on July 4, 2008 at the Patent Office. The Patent Office
rejected Natco Pharma Limited ("Natco")'s petition opposing the Patent Office’s
move to seek Pfizer’s say on Natco’s application for compulsory
license.
Natco, a Hyderabad based pharmaceutical company has applied for
the grant of a compulsory license to manufacture and export
generic version of Pfizer’s patented cancer medicine ‘Sunitnib
Malate’, sold with a brand name ‘Sutent’’, to Nepal. While considering Natco’s application, the Patent
Office, gave an opportunity to the patentee (Pfizer) of being
heard. Natco contended that Section 92-A of the Patents Act or
the Rules do not prescribe that an opportunity of hearing shall
be given to the patentee. The Patent Office was of the opinion
that hearing the patentee would not only serve as an aid in
deciding upon the application but would also prevent any abuse
of the provisions of Section 92-A.
Background
Section 92-A was introduced by the 2005 Amendment to the Patents
Act, 1970, when the product patent regime was introduced. This
is the only provision of the Compulsory Licensing chapter that
specifically deals with pharma patents and enunciates that a
compulsory license can be issued for the manufacture and export
of patented ‘pharmaceutical products’ to any other country
having insufficient or no manufacturing capacity in the pharma
sector for the concerned product. This provision has been
inserted with a view to address the health problems of poor and
economically weaker countries, which lack the capability of
manufacturing such pharmaceutical products. Another important
condition attached to such a grant of compulsory license is that
the importing country should have issued a notification or
otherwise should have allowed importation of such pharmaceutical
products.
Section 92-A is based on Paragraph 6 of the ‘Declaration on
TRIPS Agreement and Public Health’ and Article 31bis of the
TRIPS Agreement. The issues relating to Public Health have been
of material consideration and have been discussed strongly under
the TRIPS Agreement at various levels of the WTO. The
Ministerial Council had adopted the ‘Declaration on TRIPS
Agreement and Public Health’ on November 20, 2001. Paragraph six
of the Declaration stated, “We recognize that WTO members with
insufficient or no manufacturing capacities in the
pharmaceutical sector could face difficulties in making
effective use of compulsory licensing under the TRIPS Agreement.
We instruct the Council for TRIPS to find an expeditious
solution to this problem and to report to the General Council
before the end of 2002.” Subsequently, the General Council
adopted the Protocol amending the TRIPS Agreement on December 6,
2005 and submitted the same for the acceptance of the members.
The said amendment to the TRIPS Agreement introduced Article
31bis. This Article of the TRIPS Agreement lays down the
obligations of a member nation with respect to grant of
compulsory license for the purposes of export of patent
pharmaceutical products to an eligible importing member. An
eligible importing member has been defined in the Article to
include any least developed country and any other member that
has made a notification to the TRIPS Council in this regard.
Natco is the first and so far the only generic drug maker that
seeks to apply for a compulsory license under Section 92-A.
Patent office applies principles of natural justice
Rule 96 of the Patent Rules, 2003 (as amended in 2005)
prescribes that an application made under Section 92-A has to be
made in Form 17 to the Controller of Patents and the applicant
needs to disclose his interest in seeking the license, and the
terms and conditions of the license that he is willing to
accept. Further, Rule 97 provides that the Controller shall
notify the applicant if upon consideration of the evidence the
Controller is satisfied that a prima facie case has not been
made out. In case if the applicant requests to be heard within a
period of one month, the Controller shall give the applicant an
opportunity of being heard. The Controller then determines
whether the license should be granted or whether the application
should be refused.
A bare perusal of the said Section and other relevant provisions
of the Act, and the Rules framed under it do not explicitly
envisage any such opportunity to the patentee in matters of
compulsory licensing under Section 92-A. At the same time, such
an opportunity to the patentee has not been explicitly excluded.
The Act or the Rules do not provide as to whether or not, the
opponent i.e. the patentee against whom a compulsory license has
been sought, will be entitled to present his case or whether a
license under Section 92-A can be issued based solely upon the
applicant’s contentions and representations.
Under Section 87 of the Act, a patentee is allowed to oppose the
application for a compulsory license made under Sections 84 and
85 (which are for domestic sales), however, a similar provision
in respect of Section 92-A is absent from the Act. Similarly,
the said Section does not speak of royalties but leaves it to
the Controller to decide upon the terms and conditions of the
grant of license.
The Controller of Patents has filled in an important and
debatable lacuna in the proceedings under Section 92-A, as while
deciding upon the Natco application it provided an opportunity
to the patentee to put forward its contentions.
The decision of the Controller to grant an opportunity to the
patentee (Pfizer) clearly demonstrates an inclination on the
part of the Controller and the Patent Office to uphold the
interests of patentees and to ensure that Section 92-A is not
abused. In the absence of any explicit provision to hear the
patentee under Section 92-A, the Patent Office has taken a
commendable step. It is one of the fundamental tenets of the
principles of natural justice that a party whose interests are
being affected should be given an opportunity of being heard.
Thus the Patent Office’s move of considering a patentee’s
contentions upholds one of the basic principles of law. It
should be borne in mind that protection of vested and public
interests are just two facets of Patent Law and it is essential
to strike an optimum balance between the two.
Sources:
|
