INTRODUCTION
In recent decades, the Indian pharmaceutical industry has developed considerably, both in terms of market share and contribution to our country’s GDP. India’s domestic pharmaceutical business is valued at around USD 41 billion, with a predicted growth to USD 65 billion by 2024 and USD 120-130 billion by 2030. Given the pharmaceutical industry’s promising future, Market participants in this field are planning to produce a lot of inventions, and the government is also working to put rules and regulations in the medical industry up to global standards, thus the notion of intellectual property rights comes into play. But what do writers mean by IPR (also known as intellectual property rights)? Intellectual property refers to any original work of the human brain, such as artistic, literary, or scientific creations. These rights are enforced to protect individuals’ ideas for a specified length of time. These aspects are crucial since the inventors’ knowledge, as well as their labour and money, must be protected[1]. Therefore, in this piece, the author will be putting forward different components of IPR in relation to the medical industry and most importantly the scenario of covid 19 vaccines with IPR. Moreover, in addition to it, the author will also specify some really interesting case laws and finally end with the advantages and disadvantages of IPR for the pharmaceutical industry.
TRADEMARK LAWS AND THE PHARMACEUTICAL INDUSTRY
Trademarks are legally protected names, logos, or phrases that companies use to identify and distinguish their products or services from those of other companies. In the medical industry, trademarks can be used to identify and protect the names of pharmaceutical items, medical equipment, or other health-related products or services. Companies in the medical industry regularly invest significant amounts in creating and advertising their trademarks in order to increase brand awareness and consumer loyalty[2]. It is vital for companies in this industry to protect their trademarks against infringement and illegal use by others. Furthermore, to avoid trademark resistance or objections to the brand name or medical name being protected, the trademark should be free of:
- Generic words: Common daily terms such as “pharma” or “anti” should be avoided when naming pharmaceutical things. These marks are unlikely to be protected because they just represent the component rather than the source of the products, thus deceiving buyers.
- Descriptive words: Words or keywords that expressly identify or convey information about a pharmaceutical drug’s qualities or quality, for as REMOVEPAIN for a muscle relaxant.
- Suggestive words: Words or phrases that convey characteristics or characteristics of pharmaceutical products and services without explicitly stating them
COVID 19 AND INTELLECTUAL PROPERTY RIGHTS
Patent, trademark, copyright, and industrial design restrictions are relaxed by an intellectual property rights waiver. A vaccine company is prohibited from exporting considerable quantities of its vaccines to another nation under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, and the majority of vaccine manufacturing must be retained in the home country. Only a few countries manufacture vaccines, making it difficult for vaccine manufacturers to export large quantities of vaccinations to other countries during times of crisis. With the IPR waiver, vaccine producers are permitted to divulge their trade secrets to regulatory agencies in other nations[3], enabling local production there and enhancing vaccine equity, accessibility, and affordability across countries[4]. Moreover, while considering these issues two points come to mind and are as follows:
- How ethical are ownership rights and patents?
When wealthy governments restrict underprivileged nations’ access to vaccines, they breach the ethical standards of nonmaleficence and fairness. In times of disaster and misfortune, the fundamental human rights to life and liberty should take precedence over ownership and property rights. These expenses are not accounted for when providing ownership rights to the firm.
Following COVID-19, a group of firms established The Open COVID Pledge[5], which establishes a “non-exclusive and royalty-free licence” and an open framework in which patent holders can voluntarily agree not to enforce their rights to the product’s manufacturing, usage, sale, replication, and import. However, because of its voluntary nature, it cannot be regarded as a long-term solution.
- Is there any other possible solution?
Although patents may limit vaccine availability in poor nations, other variables such as knowledge transfer or support for pharmaceutical businesses by wealthier countries can significantly improve vaccine manufacture and distribution while minimising the negative impacts of patent waivers[6].
Domestic patent rules and international treaties must promote innovation while preventing technology access to downstream innovations and vaccination accessibility[7]. These should not be considered as distinct government initiatives, but rather as complimentary, with adoption shifting depending on the country’s status of public health.
CASE LAWS
- Cipla Limited v/s M.K. Pharmaceuticals[8]:
Plaintiff sold “NORFLOXACIN” pills in oval, orange blister packaging as “NORFLOX-400.” Despite the fact that the defendant utilised a similar name—”NORFLOX-400″—for which the plaintiff was not litigating, the plaintiff alleged that the defendant mimicked the form, colour, and blister packaging of pills, causing confusion. There is no such thing as a colour monopoly, as is commonly claimed because no one orders medicine based on its colour, shape, or packaging. Tablets are typically round or oval in form, with blister packaging. As a result, there was no injunction imposed. As a result of this decision, it has been ruled that the drug’s name, rather than its colour, shape, or packaging, identifies it, even when deliberate duplication is utilised.
- Kaviraj Pandit Durga Dutt Sharma v/s Navaratna Pharmaceutical Laboratories[9]
The respondent offered Ayurvedic pharmaceutical items under the brand name ‘NAVRATNAKALPA,’ whereas the appellant sold medical products under the registered trademarks ‘NAVARATNA’ and ‘NAVARATNA pharmaceutical labs. The appellant filed an appeal against the District Court’s ruling as well as an initial petition in Travancore Cochin High Court. He contended that the plaintiff did not have a monopoly on the word “Navaratna,” because it is a popular phrase used across the Ayurvedic school of medicine and is frequently used by Ayurvedic practitioners to designate drugs containing the nine precious stones.
- Astra-IDL Limited v/s TTK Pharma Limited[10]:
Since the defendant’s use of the trade mark “BETALONG,” which is confusingly similar to the plaintiff’s mark “BETALOC,” the plaintiff sought a permanent injunction against the defendant. The defendant claims that he registered the trademark “BATALONG” and issued a drug to cure angina pectoris and hypertension. The defendant contends that the product is often marketed and has earned a strong reputation and goodwill. Because this is a schedule “H” drug, it can only be sold by pharmacists who have the required licences. According to the defendant, the word “BETA” is often used in this field.
It was determined that the defendant was profiting from the plaintiff’s reputation, and the defendant’s claim of prescription necessity was also dismissed.
DISADVANTAGES
The following are some of the downsides of intellectual property:
- Extra costs: Obtaining protection for the first time can be expensive, particularly if the product is complicated and integrates techniques, designs, and procedures, and the consultation price of technological layers is on the higher side.
- Lack of legislation: Although technology law and intellectual property rights (IPR) are widespread in today’s world, there is a lack of concise laws, rules, and regulations on the issue, resulting in difficult circumstances.
- Piracy: Even with IP protection, it may be impossible to prevent someone from replicating the inventory work. People tend to mimic or reproduce something since the consequences are not severe.
ADVANTAGES
- Protect unauthorizes use: One may employ intellectual property protection to prevent unauthorised usage of your intellectual property and works. Moreover, IPR protection offers your company a competitive advantage over competitors.
- Increases goodwill: IPR increases the value of your organisation and provides options for cooperation and revenue generation, such as entering into licencing agreements to exploit/work the invention/work.
- Customer satisfaction: IPR promotes your brand and increases its value. Consumers, for example, begin recognising your items with a distinctive logo or registered brand.
CONCLUSION
To summarise, intellectual property in the pharmaceutical sector serves more than only maximising revenues and maintaining market competitiveness. Intellectual property rights protection aids in the creation and accessibility of new, innovative goods, as well as the building of a robust and effective public health infrastructure. The discovery of new drugs is expensive, and without funds to support research, new treatments would take longer to enter the market. It requires money to develop items and ensure their safety for both humans and animals. Intellectual property facilitates the development of novel ideas into potential new medications. One advantage of intellectual property in this industry is that trademark and patent systems allow authorities to check the quality of drug items on the market. These safeguards enable authorities to take preventative efforts to halt the sale of counterfeit drugs. Governments would find it difficult to guarantee the security of pharmaceuticals crossing their borders without such protections[11]. Intellectual property also has the benefit of encouraging innovative businesses to enter the market, hastening the development of novel products but one should never forget it too comes with disadvantages and one needs to balance it out[12].
Author(s) Name: Tarang Arora (Maharashtra National Law University, Nagpur)
References:
[1] Yukta Singh, ‘Emerging Trends in the IPR Regime’ (2020) 3 Int’l JL Mgmt & Human 1864
[2] F. M. Scherer, ‘The Pharmaceutical Industry and World Intellectual Property Standards’ (2000) 53 Vand L Rev 2245
[3] Ritika Sharma, ‘Pharmaceutical Patents and Their Impact on Indian Pharmaceutical Industry’ (2019) 2 Int’l JL Mgmt & Human 400
[4]Saptarshi Ghosh, ‘An Examination of the Compulsory Licensing Provision under TRIPS in Relation to Access to Cheap Generic Medicines within a Human Rights Framework’ (2006) 2 J Islamic St Prac Int’l L 46
[5] Stacey B. Lee, ‘Pharmaceutical and Intellectual Property’ (2013) 34 J Legal Med 149
[6] Gerald Dworkin, ‘Patents relating to Methods of Medical Treatment’ (2001) 6 Int’l Intell Prop L & Pol’y 12-1
[7] Cindy Bors , Andrew Christie, Daniel Gervais & Ellen Wright Clayton, ‘Improving Access to Medicines in LowIncome Countries: A Review of Mechanisms’ (2015) 18 J World Intell Prop 1
[8] Cipla Limited v M.K. Pharmaceuticals MIPR (2007) (3) 170
[9]Kaviraj Pandit Durga Dutt Sharma v Navaratna Pharmaceutical Laboratories (1965) AIR SC 980
[10] Astra-Idl Limited v Ttk Pharma Limited (1992) Bom 35
[11] Daya Shanker, ‘India, the Pharmaceutical Industry and the Validity of TRIPS’ (2002) 5 J World Intell Prop 315
[12] Timothy Bazzle, ‘Pharmacy of the Developing World: Reconciling Intellectual Property Rights in India with the Right to Health: TRIPS, India’s Patent System and Essential Medicines’ (2011) 42 Geo J Int’l L 785
