By - King Stubb & Kasiva on March 27, 2023
India's pharmaceutical industry has grown significantly in recent decades, now ranking third in the world in terms of volume and fourteenth in terms of value. With a total turnover of Rs. 2,89,998 crores in the 2019-2020 financial year, the industry is a major contributor to the country's foreign trade and presents profitable opportunities for investment. Additionally, India boasts a high number of facilities that comply with Good Manufacturing Practices (GMP) standards specified by the World Health Organization (WHO) and the United States Food and Drug Administration (USFDA), making it a leader in producing affordable generic drugs.
Patent Laws and Regulations in Indian Pharma Industry are defined through the Indian Patents Act, 1970 (IPA,1970). After passage of IPA,1970, pharmaceutical companies in India are now permitted to patent the processes used in making their drugs.
The pharmaceutical industry benefits from a patent in following ways:
Under The Patents Act, an invention that is new, non-obvious, and has utility may be patented for a minimum of 20 years. However, in the Indian pharmaceutical industry, patents are only issued for the processes used to make substances intended for use as food, drugs, or medicines, and not for the substances themselves. This means that current Patent Laws and Regulations in the Indian Pharma Industry do not provide sufficient patent protection for pharmaceutical products, and molecules that are by-products of chemical reactions are not patentable.
Pharmaceutical patents are divided into following categories:
The process of applying for a patent, in accordance with the Patent Laws and Regulations in Indian Pharma Industry consists of the following steps: -
An Overview of Indian Patent Act shows that the Act defines patent rights but does not define patent infringement. Anything that infringes on such patent rights may be seen to be a violation of those rights. So, throughout the active period of a patent, any illegal manufacture, using, offering for sale, selling, or importing into India a patented invention may be regarded as patent right infringement.
The Honourable Delhi High court issued an injunction against Glenmark in the Merck v. Glenmark case for producing the generic medication Sitagliptin using a proprietary Merck Sharp product. The Delhi High Court affirmed that Merck's patent rights on its patented medication sitagliptin were prima facie violated in this case, and that the patent owners also suffered irreparable harm. As a result, the balance of convenience favours Merck, the patent holder, and the Delhi High court issued an order prohibiting Glenmark from producing and marketing Zita and Zitamet. Merck's patent rights were thus safeguarded and upheld.
Patent Laws are a boon for the Pharmaceutical Industry in India. These laws have a positive impact on the industry in the following ways: -
Pharmaceutical industries often acquire patents for ideas that aren't novel. They repackage outdated research or make minimal adjustments to their already successful items to maintain their patents indefinitely.
Strategic patenting may also hinder innovation by diminishing the incentives for innovators to do so and limiting generics' capacity to create alternative generic goods. High medicine costs are another factor that may do so.
The development of patent laws has had a significant influence on pharmaceutical investment both domestically and internationally. Increased FDI in the Indian pharmaceutical industry appears to be driven by the effects of the 2005 amendment to the patent legislation. From $12 million in 1994 to $342 million in 2004, $116 million in 2005, and $216 million in 2006, annual FDI inflows into India's drug and pharmaceutical sector have increased substantially. Greenfield projects, strategic partnerships between foreign and domestic businesses, and mergers and acquisitions are just a few examples of the different shapes that FDI in India may take.
Determining the extent of the rights granted by the patent, which must be discovered via the construction of the claims, is the first stage in the evaluation of patent infringement litigation. The High Court of Delhi ruled in Merck Sharpe Dohme v. Glenmark Pharmaceuticals that the nature of the stated claims depends on –
To initiate a Patent Litigation in the Indian Pharma Industry, a person may initiate a lawsuit under the Patents Act of 1970 for threats of infringement and request for the following reliefs:
Section 64 of the Patents Act of 1970 lists the reasons due to which a patent may be revoked:
The Indian government through amendments made in 2005, incorporated Section 3(d) to the Patents Act, 1970, which creates a high barrier for secondary patents and addresses concerns that, additional patents on substances already in use would be used to prolong market exclusivity and postpone generic competition.
Patent disputes and Patent Litigation in the Indian Pharma Industry are due to patent infringement. Patent infringement is not defined in the Patents Act and there’s only a derived meaning that states that violating patent-related rights amounts to infringement. Additionally, even though the amendments introduced in 2005 have made way for provisions concerning patenting of pharmaceutical products and processes, the provisions are yet unclear.
The Delhi High Court in Glenmark Pharmaceuticals Ltd. case [FAO (OS) No. 60 of 2015] has renewed attention on process patent infringement in the pharmaceutical industry. The ruling of the single judge of the Delhi High Courtwas overturned by the division bench of the Delhi High Court.
In accordance with Section 48 of the Act, the patentee has the only authority to prohibit other parties from using the patented method without authorization and from using, proposing for sale, selling, or importing the product made directly through the patented process in India. This is in contrast to a product patentee's rights, which give the patentee the authority to forbid others from creating/utilising/offering for sale/selling/importing the patented product into India.
Section 104 A of the Act is pertinent to process patent infringement. According to this clause, if the patentee can demonstrate that the product made using the patented process and the product made by the defendant are identical, the burden of proof in the infringement lawsuit shifts to the defendant, who must show that the process used to make their product is different from the one described in the patent.Under this provision, the defendant is responsible for proving that they did not use the patented process, provided that the product they produced is identical to the one produced by the patented process.
The Symed v. Glenmark case, it should be emphasised, is the first instance of a process patent dispute in India that illustrates the challenges and uncertainties involved in proving that the products are similar.
Novartis submitted an application to patent "Gleevec," one of their medications, by claiming that it fell within the definition of "innovation" in Section 3 of the Patents Act of 1970. After a 7-year fight, the Supreme Court denied their application and stated that, since the discovery of an already-existing medicine does not qualify as an innovation, no new drug was created. The Indian Patent Act now includes a new improved therapeutic effectiveness test for pharmaceutical patent grants, which was upheld by the Supreme Court in this case. Novartis's medicine did not pass this test since it was an incremental improvement to an already-approved treatment.
This evidence was presented in addition to demonstrating the traditional tests of novelty, inventive step, and application. The ruling became significant because the court saw past the technicalities and recognized that these companies were attempting to "evergreen" their patents so that they could not be purchased for a bargain price.
The Indian Patent Act 1970, amended in 1999, 2002, and 2005 to align with WIPO and TRIP standards, governs the patent system. Recent court cases highlight equitable, inventive patent protection. Opinions differ on the impact of the legislative framework on long-term research and development, but patenting innovation is crucial to claim exclusive rights. The patent must meet the standards for innovation and patentability and be acquired following the proper process. Infringement suits must be filed against anyone claiming rights to a rightfully patented drug/medicine.
Patent laws have both positive and negative impact on the industry in the following ways: -
1. It aids in safeguarding any company from potential infringement.
2. In the case of patented medications, it offers a powerful enforcement mechanism for combating infringement.
3. Protection of Innovation.
4. Incremental economic development and company-level competition.
5. Protection against potential infringement on medication research and discovery.
However, Pharmaceutical industries often acquire patents for ideas that aren'tnovel. They repackage outdated research or make minimal adjustments to their already successful items to maintain their patents indefinitely. Strategic patenting may also hinder innovation by diminishing the incentives for innovators to do so and limiting generics' capacity to create alternative generic goods. High medicine costs are another factor that may do so.
Each discovery of a pharmaceutical product or technique that satisfies predefined requirements is entitled to a patent for a minimum of 20 years.
The process of obtaining a patent in the Indian pharma industry is as follows: -
1. Patent Search
2. Selecting Appropriate Patent Office.
3. Drafting of the Patent Application
4. Provisional/Complete Specification
5. Patent Application Filing
6. Publication of the Application
7. Pre-grant Opposition
8. Filing Request for Examination of Application
9. First Examination Report
10. Handling Objections
11. Grant of Patent Certificate
12. Post-grant Opposition.
 Case Name: Symed Labs Ltd. v. Glenmark Pharmaceuticals Ltd.
Citation: 2015 SCC online Del 6745 or (2015) 61 PTC 485
Document Link: http://www.scconline.com.eu1.proxy.openathens.net/DocumentLink/53TbOnjT
 Case Name: Novartis AG v. Union of India
Citation: (2013) 6 SCC 1
Document Link: http://www.scconline.com.eu1.proxy.openathens.net/DocumentLink/GSw0hHTj
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