INTELLECTUAL PROPERTY LAW IN THE PHARMACEUTICAL INDUSTRY: AN INDIAN PERSPECTIVE

In terms of profitability and impact on our country's GDP, the Indian pharmaceutical sector has grown dramatically over the last decade. The pharmaceutical and biotechnology industry in India is predicted to be worth USD 41 billion in 2021, rising to USD 65 billion by 2024 and reaching USD 120-130 billion before 2030. Given the pharmaceutical industry's brighter tomorrow, the government of India is working hard to promote it by creating and implementing rules that are in line with international standards. Because of the market's development and economic growth by industry participants, intellectual property rights preservation has become critical for businesses.



This article discusses the extent and range of pharmaceutical patent and trademark protection within Indian law.

Registration of a trademark considerably preserves pharmaceuticals from multiple pharmaceutical businesses and aids in retaining a drug's brand image in the market. When compared to any other segment in India, the pharmaceutical business accounts for a large proportion of trademark applications.



Pharmaceutical trademark protection is more difficult than other types of trademark protection. Section 9(a) of the Trademark Act of 1999 prohibits the acquisition of trademarks that are generic or lack distinctiveness, i.e., are incapable of distinguishing one supplier's service or product from those of another, and are of such a type as to mislead or confuse the public.However, when a trademark has developed a positive connotation or a unique character as a result of its extensive use and knowledge when it comes

In the particular instance of pharmaceutical trademark rights, the new brand or drug title is usually derived based just on the diagnosis conducted by the drug, the salt contents of the therapeutic agent, or any other relevant clinical term, and thus lacks an intrinsic unique personality. However, "distinctiveness" is a requirement for a mark to meet the criteria as a trademark.



Furthermore, according to Section 11 of the Trade Marks Act of 1999, a trademark should not be confusingly similar to a prior property. When purchasing generic drugs or drugs, customers will be able to easily distinguish between pharmaceutical goods or medications, aspects of brand name or drug title, and trade dress in order to avoid or reduce mistakes. As a result, the procedure of protecting a brand name or medical name becomes difficult, and proof of the figurative meaning or obtained distinct style is the criterion used to determine distinctiveness.



Another notable thing in this reference is Section 13 of the Trade Marks Act, 1999, which states that a "trademark must not be any name of chemical elements, compounds, or International Non-proprietary Names (INNs) declared by the World Health Organization and notified by the Registrar of Trademarks in 2012, or that is deceptively similar to the INNs." Because the mentioned INNs are conventional names for pharmaceutically active compounds, neither pharmaceutical corporation may claim monopolistic power over them, and they can thus be used by anybody.



As a result, in order to evade trademark resistance or objections to the preservation of the major brand or medicine name, the trademark ought to be free of:

  1. Generic words or terminology: For pharmaceutical goods, common daily names like "pharma" or "anti" must be omitted. These marks are unlikely to be protected because they merely show the product component and not the origin of the product, thus misleading customers.

  2. Descriptive words or terms: words or phrases that explicitly describe or transmit messages about the attributes or performance of pharmaceutical drugs, such as REMOVEPAIN for a pain reliever.

  3. Indicative words or phrases: words or terminology that indicate characteristics or traits of pharmaceutical services and goods without really articulating them, such as "GRROW" for a children's natural remedy.



Pharmaceutical businesses are currently developing new and creative methods to help differentiate their products from their competition in the industry. As a result, pharmaceutical firms are turning to non-traditional methods to safeguard their treatments' trademarks in contrast to merely the branded product or drug title. This aims to limit customer deceit and ambiguity while simultaneously emphasising the trademark's distinctiveness.



In the judgement of Cadila Health Care Ltd. v. Cadila Pharmaceuticals Ltd., the Supreme Court of India established specific elements for assessing misleading resemblance between pharmaceutical trademarks, which include:

  1. The essence of the marks, i.e., if the marks are word marks, label marks, or composite marks;

  2. The extent of likeness between the marks, i.e., resemblance of idea or sound,

  3. The product's features

  4. The type of purchasers, their intellectual ability, and the degree of care they are likely to show in purchasing and/or using the goods;

  5. The method of purchasing the stuff or ordering stuff for the product lines

  6. Are there any additional facts that may be significant in determining the degree of differentiation between the contending marks?



The pharmaceutical industry has always been an experienced and understanding one and requires significant expenditures. When compared to other areas or businesses, the development time for pharmaceutical items to achieve beneficial results is significantly longer. As a result, it is critical for the pharmaceutical industry to acquire patent rights in order to protect their inventions. Patents, for example, motivate inventors to innovate by protecting the capital made in product development and creating an inducement for innovation. However, due to legislative issues, the gene patenting of pharmaceutical innovations has long been a source of contention, notably in India. Aside from the global patentability criteria of originality, inventive step, and industrial application, pharmaceutical and related discoveries must pass the litmus test outlined in Section 3 of the Patents Act of 1970, specifically Sections 3 (d), (e), and (f) (i).



It is critical to remember that the primary goal of Section 3(d) of the Patents Act of 1970 is to limit the ever-greening of pharmaceutical patents and to include discoveries, particularly those involving drugs or chemical compounds, within the scope of patenting. This section states that an invention asserting a unique form of a specific compound or two consecutive uses of a specific compound with a foundational medicinal task is handled as the same material and is not patentable unless such innovation substantially illustrates enhanced treatment effectiveness with respect to that specific compound.



In its decision in Novartis AG vs. Union of India (UOI) and Ors, the Hon'ble Supreme Court of India emphasised the true intent of the law of Section 3 (d) of the Patents Act, 1970 and stated that "Section 3 (d) is intended to deal specifically with chemical substances, and particularly pharmaceutical products." The amended section 3(d) clearly establishes a second tier of qualifying standards for chemical substances or pharmaceutical products to allow for true and genuine inventions while discouraging any attempt at repetitive patenting or patent term extension on spurious grounds."



In the pharmaceutical industry, technique of therapy assertions are frequently made under the pretence of formulation assertions. However, it is vital to highlight that any claim relating to therapy is not patentable in India. A patent can, however, be secured for medical, pharmaceutical, or diagnostic devices or equipment.

Indian courts also give explanations for securing intellectual property rights enforcement in order to enhance preservation in all industries, including the pharmaceutical business.



This article is written by Anushka Dwivedi of Amity University, Noida.

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