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INTRODUCTIONOver the past three decades, the Indian pharmaceutical industry has experienced consistent expansion. It is a developing high-tech business. There are currently a number of private Indian enterprises operating in this sector, and they have successfully captured a sizeable portion of the domestic pharmaceutical market as a result of favourable public policies and little overseas rivalry, among other things. However, the liberalisation of the Indian economy is reshaping as Indian enterprises emerge from domestic markets and are ready for foreign competition. India is a prime example of the Indian pharmaceutical industry, which is being compelled to reevaluate its long-term plans and business models as India opens its markets to international trade.
Considerations like intellectual property are becoming more important as the necessity to protect valuable assets in research and development has grown. India is making attempts to address issues with the inadequate enforceability of current intellectual property laws, and the Indian government is attempting to establish a patent system that promotes technological advancement and conforms with its international obligations.
Given that India and its pharmaceutical businesses are substantial producers of affordable pharmaceutical products in the form of generic medications, pharmaceutical patenting in India is particularly important in light of the present public health concerns. Since the turn of the millennium, the issue of access to medications has assumed a worldwide scope due to India's participation in the Doha Declaration on the TRIPs and Public Health Agreement, 2001.
However, due to inadequate public health spending and a lack of public health institutions, India's economy grew at a relatively slow pace. India's worst sufferers are its weak, despondent, and inexperienced citizens, who make up a sizable portion of the population. The protection of the health of the countless millions of weak individuals in our nation has now become one of the major issues. The significance of Indian patent law in relation to the TRIPS Treaty and how these two legal frameworks affect the general public's health cannot be overstated.[1]
PATENT REGIMEPatents are granted in order to safeguard the inventions. The government grants the creator an exclusive right to use their innovation through the issuance of a patent. Any person designated by the inventor may submit a patent application. It is the right to prohibit others from engaging in unlawful production, usage, offering for sale, purchase, or import. The patent is a negative right that grants the patentee (patent proprietor) the authority to forbid or halt the use of the invention by third parties without their permission. It does not grant the right to create, use, or sell the invention. The invention's right to be manufactured, used, or sold by others is protected by the patent.
A patent is an arrangement in which the government, once the applicant or inventor has provided full disclosure, gives the right for the invention to be protected for a set amount of time. Therefore, patenting offers a clever method of safeguarding inventions without sacrificing anonymity.
A technical answer to the technical issue is provided via a patent. Patents are only issued for inventions that satisfy the so-called patentability standards. A patent may be held for a maximum of 20 years from the day it was issued. Patents are sovereign rights, but they are only enforceable in the country in which they were issued.
Therefore, any legal action against the infringement or violation of patent rights will only be requested in that nation. To obtain patent protection in many countries, patent rights must be applied for in each nation. A single patent applicant may submit an international patent application in numerous different nations via the Patent Cooperation Treaty (PCT) method. However, following the filing of the PCT application, the decision to award a patent must remain in the sole discretion of each patent office.[2]
DEVELOPMENT OF PATENT LAW IN INDIAThe major piece of legislation in India governing the patenting process is the Patents Act, 1970. No product patents may be issued initially under this rule; but, process patents for inventions relevant to foods, medications, and chemical goods may. However, India has allowed product patenting since 2005. In fact, the World Trade Organization (WTO) was a member when the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement was signed in 1995. (WTO). TRIPS suggested that each of its member states adhere to the minimal standards for IP laws. Making India a signatory to the TRIPS Treaty fulfilled India's contractual obligation to amend its patent legislation in order to adhere to the conditions of the agreement.
Before the nation began to give product patents, the first modification in this sequence was to grant pipeline protection in the form of the Patents (Amendment) Act of 1999. It outlined the prerequisites for the registration of product patent applications in the fields of pharmaceuticals and agrochemicals as mailbox applications beginning on January 1, 1995, and granted them exclusive marketing rights (EMRs).
The Patents (Amendment) Act of 2002 further amended the TRIPS Act of 1970 to conform to the second set of TRIPS obligations. Through this change clause, the 20-year standard patent period for all types of innovations had been established.
The provisions for removing the presumption of proof in the event of a formal patent infringement were introduced to the Statute as well as other amendments to the main act, including the phrase "innovation," as part of this revision that was also made under the TRIPS agreement. The Patents (Amendment) Act, 2005, the third set of modifications to patent law, was enacted. Through this amendment, India's system of product patents was put into place. Provisions regarding pre-grant and post-grant objections have been altered under certain circumstances, including the mere discovery of new properties or uses for substances already known, and a provision has been made for the grant of an export licence on a mandatory licence for pharmaceuticals with patents under certain circumstances.[3]
CRITERIA OF PATENTINGPatents must be granted for inventions that satisfy the so-called patentability standards. A patentable invention is defined as "a new product or technology that requires an innovative phase and can industrialise" in the Indian Patent Act. The following basic requirements must be met for any innovation to qualify for patent protection.
(a) Newness: The invention's subject matter cannot be revealed until the date of patent filing. Innovation is regarded as novel if it is not recorded or used in any nation or region of the world.
(b)Inventive step: Refers to a function of invention that, when compared to prior knowledge, has economic significance, or both, necessitates technological improvement, but does not immediately reveal the innovation.
(c)Industrial applicability: This criterion suggests that it may be feasible to produce a novel invention or technological advancement. For instance, a cutting-edge and novel technique to remove tumour cells from a patient's body cannot be industrially copyrighted.
TRANSFER OF THE PATENT RIGHTBeing a type of property, the patent may be licenced or given by the patentee to any third party. According to the Indian Patent Act, the grant or licence of a patent must be in writing, and all terms and conditions defining the rights and obligations of the parties must be specified.[4]
(a) Patent assignment
In general, the transfer of ownership of one's property refers to the interest and rights in the property that go to someone else. The term "transfer by this patent proprietor" refers to the assignment by this patent proprietor of all or a portion of its right, title, and interest in the patent or patent application.
(b) Patent licencing
A patent holder may, by way of licencing, allow others to make, use, or exercise an invention that would not otherwise be allowed. A set of rights that are time-, place-, or application-limited are transferred through patent licencing. A patent licence might be either voluntary or required.
(c)Voluntary licence
If the patent holder gives someone written permission to create, use, or exercise the patented invention, this is referred to as a voluntary licence. The Indian Patent Office and the Central Government play no part in such a licence.
(d) Mandatory licence pursuant to Section 84: Under certain circumstances, the patent controller may give a mandatory licence to a third party.
The obligatory licence under the patent system is an unintentional contract that the government imposes and upholds between a willing buyer and an unwilling seller. Under a compulsory licence, the government permits anybody else to use a patented technique or product without the owner's permission. According to Section 84 of the Patents Act of 1970, a compulsory licence may be granted for the reasons listed below:
(i) The patented invention has not received sufficient public demands;
(ii) No patent-protected invention has been made accessible to the general public for a reasonable price; or
(iii) No patent-protected invention has ever been operational on Indian soil.
A compulsory licence, however, cannot be issued until three years have passed since the patent was obtained. The first obligatory patent licence in India was granted in the case of Natco Pharma Ltd., India v. Bayer Corporation, USA, according to a decision made by Mr. P. H. Kurian, the country's patent controller at the time. Natco Pharma Ltd. was given a compulsive licence under M/patent S's number 215758. Corporation Bayer. This patent covers the Sorafenib Tosylate medication that Bayer sells under the trade name Nexavar. Hepatocellular Carcinoma-HCC and Renal Cell Carcinoma-RCC (kidney cancer) are both indicated uses for Nexavar (cancer of the liver).
Once this mandatory licence was obtained, Natco was free to create and market a generic Nexavar version in RCC and HCC. Natco will be compelled to give Bayer a 6 percent royalty on net sales at the end of each quarter. Moreover, it is not allowed to charge more than Rs 8800 for a monthly supply of 120 medication tablets. As a requirement of the compulsory licence agreement, Natco also agreed to provide 600 patients in need with free medication supply once a year.
Section 92A of the Patents Law, 1970 states that if a country has granted or permitted the importation of a patented pharmaceutical, of patented pharmaceutical goods, may be given to any country with insufficient or no pharmaceutical capacity for the concerned product to address public health issues. This section explains the obligation for manufacture and export. Only a compulsory licence, according to the terms and restrictions indicated, may be granted by the controller in response to a request for the manufacture and export of the relevant pharmaceutical product to that nation.
The Doha Declaration's paragraph 6 on TRIPS and public health was decided by the TRIPS Council, and this clause addresses the public health concerns of those nations with limited or no pharmaceutical manufacturing capability to execute that decision.
According to this rule, the mandatory licence may only be used for:
(a) production and export of the patented pharmaceutical product,
(b) To any nation with insufficient or no capacity to produce drugs, and
(c) The item that responds to the issues with regard to public health.
The patent law of India is a model statute that tries to strike a balance between the interests of ordinary people and inventors. After the creation of the product patent regime, a wide variety of pharmaceutical items can be patented in India. A compulsory licence provides the opportunity to market the patented goods under specific circumstances.[5]
PATENT LAWS IN INDIA AND PUBLIC HEALTHAccording to Section 3(d): The Act's Section 3 addresses non-patentable items. According to Section 3(d), a new variety of a known substance is merely to be discovered, which, absent the production of a known process or the use of at least one new reactant, does not increase the known effectiveness of the substance, merely discover any new property or use in a known substance, or merely use a known process, machine, or apparatus. Nevertheless, this portion is crucial to safeguarding the millions of people who live in our nation's health. The 1970 Patents Act includes this clause as a crucial public health safeguard. This part is in conflict with the issue and the evergreening defence.
According to Section 47: This section, among other things, states that in the event that a medicine or drug has a patent, the medicine or drug may be imported into the state for the sole purpose of own use or distribution by or on behalf of the government, or to any other pharmacy, hospital, or medical institution set up by the Central Government. The government's desire to safeguard the public's health makes this provision extremely advantageous. In a developing nation like India, where the security of public health has been one of the most serious issues, this area of government might provide the government with a great deal of comfort.
According to Section 66: Under this section, the Central Government may, after giving the patent a chance to be heard, make a declaration in the Official Gazette to that effect, and the patent is then considered revoked. This is the case if the Central Government believes that the patent or the way it operates is not good for the state or generally harmful for the population. Therefore, if a patent or patent procedures were harmful to the public, this clause gave the Central Government the authority to revoke any patents mentioned in this part. It is possible to broaden the public interest while yet protecting public health.
According to Section 8 : Any interested party may submit an application to the Controller for the issuance of a compulsory licence on a patent at any time following the lapse of three years from the date the patent was granted for any cause, namely:
(a) That the patented innovation has failed to satisfy or meet the reasonable expectations of the public.
(b) That the patented innovation is not accessible to the general public at an affordable price or that it is not accessible to the general public at a fair price.
(c) The patented innovation is not used within the borders of India.
According to Section 85: For instance, after two years from the date of an order granting a first compulsory patent, the central government and any interested party may apply to the Controller for an order of revocation of a patent because the patented invention was not worked in the territory. If the Controller is satisfied with such arguments, he or she may order the revocation of the patent. As a result, the measure may also act as a check and balance to safeguard the nation's public health, and this section contains the government's tools for doing so.
According to Section 92: The Central Government may make a declaration in this regard through a notification in the official gazette if it determines that it is appropriate to issue compulsory licences to operate in respect of any patent in force at any time after sealing the invention, either in cases of extreme urgency or in cases of public, noncommercial usage. Again, if the Controller determines that there is a need for — after considering the application mentioned in subparagraph I of subsection (1)
(i) a national emergency's specifics; or
(ii) a scenario that is urgently needed;
(iii) Publicly accessible non-commercial use that may arise or that may be necessary, such as public health emergencies related to the acquired immune deficiency syndrome, human immunodeficiency viruses, tuberculosis, malaria, or other epidemics, is covered by the application for licences under this section. A compulsory licence may be issued in the case of a national emergency, an extreme emergency, and public noncommercial use. The public health crisis is one reason it might possibly be issued.
According to Section 92A: This section allows for a mandatory licence to be issued for the manufacture and export of a product to any nation that lacks the pharmaceutical sector manufacturing capacity to address the product's public health concerns, so long as the nation is notifiable or otherwise permitted to import goods. The Controller shall award a compulsory licence for the manufacturing and export of the relevant pharmaceutical product into that country upon receipt of an application in the manner directed, solely in accordance with any conditions stated and published by the Controller. This section is crucial for maintaining public health in our nation, and in the proper circumstances, the Controller must issue the compulsory licences outlined in this section to preserve public health.
According to Section 102: If the Central Government is convinced that an invention that is the subject of a patent application or patent must also be obtained by the applicant or the patent proprietor for a public purpose, this section requires the Central Government to publish a notification to this effect in the Official Gazette and, by that notice, to the invention or patent and, thus, all rights relating to the Invention or Patent. When a patent is utilised for a public purpose, the claimant or patent owner must provide the central government the authority to accept the patent, and in that case, the central government may transfer the owner's entire set of rights. Public intent, which includes "public health," is a very nebulous concept in this context.
According to Provision 107 A: This section has made it legal for anybody who has been duly authorised by the law to manufacture, sell, or distribute the product to import patented goods; doing so will not be viewed as a violation of the patents' rights. If necessary, this section may assist in importing proprietary medications at reasonable costs to safeguard the public's health.[6]
CONCLUSIONIn developing nations like India, the setting for a flagrant violation of fundamental rights has been the way that health care is organised. The fairness principle is broken when the vast majority of the population lacks access to a minimal level of medical care. The pharmaceutical sector's compliance with the TRIPS Agreement will have a significant impact on how public health will develop in India. The term "local patent activity" refers to the application of a patented process or product in the local market. The inventive phase can lead to innovativeness, leading to technical advancement and industrial and economic prosperity, which can only be achieved through the local application of patented inventions.
The financial interests of major pharma industry actors continue to pose a constant threat to India's access to affordable, life-saving medications. Innovation and patenting are two sides of the same coin. Particularly in the sphere of medicine, innovations should be made for the benefit of humanity, and patents shouldn't just be obtained for financial gain.
~Authored by Kajol Kamat
References:
[1] Patents and the right to healthcare in India; Retrieved from https://blog.ipleaders.in/patent-right-healthcare-india/
[2] Patents and the right to healthcare in India; Retrieved from https://blog.ipleaders.in/patent-right-healthcare-india/
[3] Retrieved from https://www.ijddr.in/drug-development/patenting-of-pharmaceuticals-an-indian-perspective.pdf
[4] Retrieved from http://ili.ac.in/pdf/paper5.pdf
[5] Retrieved from http://ijlljs.in/wp-content/uploads/2017/08/2._FINAL__PATENT_LAW_TRIPS___PUBLIC_HEALTH-_A_REVIEW_FROM_INDIAN_PERSPECTIVE.pdf
[6]Patents and the right to healthcare in India; Retrieved from https://blog.ipleaders.in/patent-right-healthcare-india/