The Indian Patent Office on 9th March 2012, issued the first-ever compulsory licence (CL) to an Indian generic drug manufacturer, Natco Pharma, to manufacture an affordable generic version of Sorafenib tosylate (Nexavar), the anti-cancer drug for which Bayer had obtained a Patent in India in 2008.
Section 83 of the Indian Patents Act
This act says about General principles applicable to working of patented inventions according to which:-
"Without prejudice to the other provisions contained in this Act, in exercising the powers conferred by this Chapter, regard shall be had to the following general considerations, namely:-
(a) That Patents are granted to encourage inventions and to secure that the inventions are worked in India on a commercial scale and to the fullest extent that is reasonably practicable without undue delay;
(b) That they are not granted merely to enable patentees to enjoy a monopoly for the importation of the patented article;
(c) That the protection and enforcement of patent rights contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations;
(d) That Patents granted do not impede protection of public health and nutrition and should act as an instrument to promote public interest specially in sectors of vital importance for socio-economic and technological development of India;
(e) That Patents granted do not in any way prohibit Central Government in taking measures to protect public health;
(f) That the Patent right is not abused by the patentee or person deriving title or interest on Patent from the patentee, and the patentee or a person deriving title or interest on Patent from the patentee does not resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology; and
(g) That Patents are granted to make the benefit of the patented invention available at reasonably affordable prices to the public." Therefore, we can conclude the above mentioned section simply by stating that sole motto of Patent is to benefit people by making it available to public in affordable prices, encouraging inventions and not only to enjoy a monopoly for the importation of the invention.
Section 146 of the Indian Patents Act
Submission of working statements complies with the Section 146 of the Indian Patent act which says about the Power of Controller to call for information from patentees.
"(1) The Controller may, at any time during the continuance of the Patent, by notice in writing, require a patentee or a licensee, exclusive or otherwise, to furnish to him within two months from the date of such notice or within such further time as the Controller may allow, such information or such periodical statements as to the extent to which the patented invention has been commercially worked in India as may be specified in the notice.
(2) Without prejudice to the provisions of sub-section (1), every patentee and every licensee (whether exclusive or otherwise) shall furnish in such manner and form and at such intervals (not being less than six months) as may be prescribed statements as to the extent to which the patented invention has been worked on a commercial scale in India.
(3) The Controller may publish the information received by him under sub-section (1) or sub-section (2) in such manner as may be prescribed."
As mentioned above in subsection (2) of Section 146, every patentee and every licensee has to provide the information on the extent to which the patented invention has been worked on a commercial scale in India. The working statement as said must be furnished towards the controller in Prescribed intervals as under rule 131 of the Patents rule, 2003, which says:-
"Form and manner in which statements required under section 146(2) are to be furnished.
(1) The statements which shall be furnished by every patentee and every licensee under sub-section (2) of section 146 in Form 27 which shall be duly verified by the patentee or the licensee or his authorized agent.
(2) The statements referred to in sub-rule (1) shall be furnished in respect of every calendar year within three months of the end of each year.
(3) The Controller may publish the information received by him under sub-section (2) of section 146."
Therefore as mentioned in rule 131 these statements can be supplied every financial calendar year, within three months of the end of each year.
Section 122 of Indian Patent Act as mentioned in Penalty in chapter XX
Refusal or failure to supply information.
(1) If any person refuses or fails to furnish -
(a) To the Central Government any information which he is required to furnish under subsection (5) of section 100.
(b) To the Controller any information or statement which he is required to furnish by or under section 146, he shall be punishable with a fine which may extend to ten lakh rupees.
(2) If any person, being required to furnish any such information as is referred to in sub-section (1), furnishes information or statement which is false, and which he either knows or has reason to believe to be false or does not believe to be true, he shall be punishable with imprisonment which may extend to six months, or with a fine, or with both."
As mentioned in subsection 1(B) and section (2) failure to submit the working statement may lead to fine which may extend up to ten lakh rupees, and submission of false working statement may lead to imprisonment of up to six months or with a fine, or with both.
Further the non-working of Patents may open the way towards compulsory licensing provisions as mentioned under the act in section 84(1) (C) which says that at any time after the expiration of three years from the date of the grant of a Patent, any person interested may make an application to the Controller for the grant of compulsory license on Patent on grounds that the patented Invention is not worked in the territory of India.
Disclaimer: The sole purpose of this article is for information only; and not to be construed for any legal advice. The article was drafted, based on the information considered upto 21st November, 2012.