By Manjunatha N G
Patent refers to “a government authority to an individual or organization conferring a right or title, especially the sole right to make or use or sell some invention. It is a monopoly or elite right granted by State in errand of an inventor in reverence of an invention. It refers to a grant of some privilege, property orauthority made by the government orthe sovereign of the country to one or more individuals. The instrument by which such grant is made is known as ‘patent’. A patent is granted only to those inventions that are novel, having an inventive step and industrial applicability. It may also be described as an official document which gives the patentee right of ownership of an invention. The elementary objective in the rear of the Patent Law is to persuade scientific research, new technology and industrial progress. Patent under the Act, is granted by the controller to the inventor for a period of 20 years. It is the exclusive right to make use, exercise and vend his invention. To be patentable the invention must be new product or process, useful and capable of industrial application. It was held in Biswanath Prasad Radhey Shyam v. Hindustan Metal Industries that the fundamental principle of patent law is that a patent is granted only for an invention and it must be new and useful.
Historical Background of Patent Law in India
The origin of the term of Patent can be attributed to the term “Letters Patent” which were issued under great seal of the king of England addressed by the crown to the subjects conferring certain rights and privileges on one or more persons. These were in respect of inventions and were, referred to as the grants made by the crown to a subject enabling the gruantee to prevent all persons other than him and those whom he authorizes for making, or using or vending that which is the subject-matter of “Letter Patent”.
In other words, “Letters Patent” were grant of a form of trade monopolies. It was a document granting some right or privilege, issued under Governmental seal and open to public inspection. Introduction of Patent Law in India took place in 1856 whereby certain exclusive privileges to the inventors of new inventions were granted for a period of 14 years. However the formal Patent fortification in India was introduced by way of Patent Act, 1911. Subsequently, various acts appeared on the facade of the patent law pattern.
At the moment, the provisions with respect to Patents in India are governed by The Patents Act 1970 as amended by The Patents (Amendments) Act, 2005 and The Patents Rules, 2003 as amended by The Patents (Amendments) Rules, 2005. Both Act and the Rules are an outcome of various amendments made in the Patent Act 1970 and Patent Rules 2003 done mainly to meet the requirements of TRIPS so as to tune up the Indian patents regime with International standards and meet India’s obligations under International agreements. The Patents (Amendment) Act, 2005 was India’s last step towards achieving complete TRIPS compliance and this Act has had a fairly long innings. It began as the
Patents (Amendment Bill), 2003 under the BJP government. The Bill lapsed owing to a change in government at the Centre and the consequent dissolution of the Lok Sabha. The new Congress-led coalition government endorsed the Bill – however, since they were unsure of whether it would go through Parliament in time to meet the TRIPS deadline of January 1, 2005, they had it passed as a Presidential Ordinance. After receiving Presidential assent and being published in the official gazette, it finally came into force with retrospective effect from January 1, 2005. The introduction of product patents for pharmaceutical inventions and the consequent threat to an internationally renowned generic trade and commerce that has thus far ensured the supply of affordable drugs spurred widespread protests, both nationally and internationally.
The elementary objective in the rear of the Patent Law is to persuade scientific research, new technology and industrial progress. Patent under the Act, is granted by the controller to the inventor for a period of 20 years. It is the exclusive right to make use, exercise and vend his invention. To be patentable the invention must be new product or process, useful and capable of industrial application
The outcome is an Act that endeavors to balance the competing interests of a variety of stakeholders, including domestic generic medicine producers, the domestic research and development community, foreign multinational pharmaceutical companies, civil society groups concerned with access to medicines and intellectual property lawyers. Although this delicate balancing deserves some applause, the unfortunate fall-out has been the hasty introduction of provisions that go against the grain of time tested patent law doctrine and are likely to afford excellent fodder for litigation.
New Patent Regime in India
The Indian Patent System owed its origin to British rule in India and the important patent related enactments include Act VI of 1856 on Protection of Inventions based on British Patent Law of 1852 which provided exclusive privileges to inventors for 14 years;
The Patent and Designs Act, 1911 introduced during the colonial rule was reviewed and enacted The Indian Patents Act, 1970 which provided for process patents and acted as an essential tool in laying a strong foundation for growth and development of pharmaceutical industry in independent India. The important provisions contained in this Act were, permitting process patents of chemicals which included pharmaceuticals; reducing the term of patent for process patents in pharmaceuticals to 7 years from date of application of patent and 5 years from date of grant of patents, whereas for all other matters the patent was for a fixed period of 14 years; and introduction of provision relating to expeditious licensing mechanism.
During the period 1995 to 2005, India carried out 3 amendments to its patent laws and transitioned from process patent regime to product patent regime and became TRIPS Compliant. The 1st amendment of The Patents Act, 1970 was carried out in 1999 whereby “Mail-box” provisions were introduced to provide a means by which product patent applications could be filed with effective from January 1, 1995. The 2nd amendment in 2002 provided for incorporation of all substantive provisions except for providing patents to products. The important provisions incorporated include: redefining patentable subject matter; extension of patent term to 20 years; and amending compulsory licensing system. The 3rd amendment in 2005 provided for product patents which marked the beginning of new patents regime in India.
The TRIPS consistent Indian patent law addressed three important issues relating to patent of products is adoption of definition of “pharmaceutical substance”; exclusion of “mere discovery of anew form of known substance” and “new use for a known substance”; and protecting the interests of those who are already producing the products which may be granted patent protection in the new regime. The Act introduced new definition of the term ‘new invention’; restrictions in the scope of patentability; provisions relating to Bolar Exemption; and the provisions on parallel imports.” Also India had provided a means for filing patent applications for pharmaceutical and agricultural chemical products which is consistent with TRIPS agreement.
Now, it is made explicit in the amended Act that patents would not be available on the following grounds, the mere discovery of a known substance which does not result in the enhancement of the known efficacy of that substance, the mere discovery of any new property or new use for a known substance, and the mere use of a known process, machine or apparatus, unless such known process results in a new product or employs at least one new reactant.”
Also the patent (amendment) act, 2005 introduced two “private” grounds for obtaining compulsory licenses, they are as follows: The first one, a truly unique provision aimed at aiding generic manufacturers, provides that in the case of those mailbox applications that result in the grant of a patent, an automatic compulsory license would issue to those generic companies that had made a ‘significant investment’ and were ‘producing and marketing’ a drug covered by the mailbox application prior to 2005. It was held in Raj Prakash v. Mangat
Ram that whether a patent sets out an invention is to be determined by a true and fair construction of the specifications. However, because neither CIPLA nor any of the other Indian generic manufacturers produced any Tamiflu prior to 2005, they cannot invoke this ground. The second ground added by the 2005 amendments provides for compulsory licenses to enable export to countries with inadequate manufacturing capabilities and incorporates what is commonly referred to as the Paragraph 6 Decision. Section 92A reads as below:
“Compulsory license shall be available for manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems, provided compulsory license has been granted by such country or such country has, by notification or otherwise, allowed importation of the patented pharmaceutical products from India.”
Section 3(d) of the Patents Act, 1970 excluded a “new use for a known substance” from the ambit of ‘invention’. The 2005 Act has expanded on this exception by providing that “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance” would not be patentable. It is interesting to note in this connection that this provision in the 2005 Act, which finds no parallel in any other patent legislation in the world, has been copied from a European Directive dealing with drug safety regulation. Article 10(2) (b) of Directive 2004/27/EC defines a ‘generic medicinal product’. Bioavailability studies need not be required of the applicant if he can demonstrate that the generic medicinal product meets the relevant criteria as defined in the appropriate detailed guidelines.
Also, the 2005 Act has launched a post-grant opposition mechanism for the first time. Within a year of the patent being granted, a ‘person interested’ can challenge the issued patent on grounds that are identical to the grounds available at the pre-grant opposition stage. This combination of a pre-grant opposition mechanism, a post-grant opposition mechanism and a revocation mechanism makes the regime a very effective one for filtering out frivolous claims.
The earlier Section 107A (b) provided that it was not an infringement to import a patented product provided such import was from an exporter who was “duly authorized by the patentee to sell or distribute the product”. In Crossley v. Coates, in the case of an infringement it was held that “patent granted will be invalid on the grounds of prior use. The provision therefore is extremely broad in scope and may contravene TRIPS. Article 6 of TRIPS states that, “nothing in this Agreement shall be used to address the issue of the exhaustion of intellectual property rights”.
Conclusion
From the above discussion it can be concluded that The Patents Act in its concluding form is the upshot of widespread politicking, lobbying and of course, compromise. With competing anxiety from multinationals, civil society, a communist coalition partner and an opposition party that performed the most stunning volte face, the government performed the finest tightrope walk ever witnessed in the annals of Indian intellectual property law making. In other words, the problem of ‘access’ moves beyond the realm of the purely ‘legal’ into the realms of ‘economics’ and ‘politics’.
This dexterous stage management around competing interests undoubtedly deserves extol. However, the net consequence of such a compromise and a hasty legislative process is a lack of transparency in the law. The price for these deficiencies will, no doubt, manifest itself in the years to come – in sharp contrast to the way that a carefully deliberated policy in 1970 resulted years later in a generic industry that became the pride of the nation. However, there are provisions in the patent regime and other related regimes that could be interpreted in a manner as to help keep the costs down. Whether these provisions would be so interpreted to further public health concerns remains to be seen.