Patent Laws And Regulations In The Indian Pharma Industry

Overview of the Indian pharma industry

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.[1]

The pharmaceutical industry benefits from a patent in following ways:

• Patents are a crucial instrument for the advancement of innovative approaches and technology.
• Patents enable the development of novel pharmaceuticals and incentivize pharmaceutical companies to innovate.
• Major pharmaceutical companies can use patents to enter into licencing agreements to recover their R&D expenditures.
• Patents contribute to market monopolisation.

Understanding The Patent Laws And Regulations In The Indian Pharma Industry

Criteria for patentability in the Indian pharma industry

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.

Types of patents available in the Indian pharma industry

Pharmaceutical patents are divided into following categories:

• Markush Claims/Drug Compound Patents: Allows for multiple "functionally equivalent" chemical entities in one or more drug compounds, providing the highest level of patent security.
• Formulation/Composition Patents: Covers a specific technology to produce a quantity or formulation of the drug's primary constituents.
• Synergistic Combination Patents: Combines two or more medications to increase the impact of one, such as creating a patented medicine by combining drugs X and Y.
• Technology Patents: Focus on the manufacturing process and technology used to create the medication.
• Polymorph Patents: Cover different physical forms or crystal structures of a recognized substance created to improve stability and lower impurities.
• Biotechnology Patents: Use biological components or living creatures in creating pharmaceutical medications, covering a wide range of medicinal, immunological, and diagnostic products.
• Process Patents: Protect unique and novel ways to make drugs, such as synthetizing a chemical to create a medication.

Patent application process in the Indian pharma industry

The process of applying for a patent, in accordance with the Patent Laws and Regulations in Indian Pharma Industry consists of the following steps: -

• Patent Search: Check if the innovation hasn't been created before.
• Selecting Appropriate Patent Office: Submit to the office in your jurisdiction.
• Drafting of the Patent Application: Submit prescribed forms and declarations.
• Provisional/Complete Specification: File for provisional if invention not completed.
• Patent Application Filing: Submit the application with forms and fees.
• Publication of the Application: The application is published within 18 months.
• Pre-grant Opposition: Objections can be filed within six months of publication.
• Filing Request for Examination of Application: Request an examination within 48 months of filing.
• First Examination Report: Examiner creates a report within three months.
• Handling Objections: Address objections within six months (extendable by three).
• Grant of Patent Certificate: A certificate is granted when criteria are met.
• Post-grant Opposition: Anyone can submit an objection within a year of publication.

Patent infringement in the Indian pharma industry

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.

Impact Of Patent Laws On The Indian Pharma Industry

Positive and negative effects of patent laws on the Indian pharma industry

Patent Laws are a boon for the Pharmaceutical Industry in India. These laws have a positive impact on the industry in the following ways: -

• Aids in safeguarding from potential infringement.
• In the case of patented medications, it offers a powerful enforcement mechanism for combating infringement.
• Protection of Innovation.
• Incremental economic development and company-level competition.
• Protection against potential infringement on medication research and discovery.

Negative Impact:

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.

Implications of patent laws on foreign investment in the Indian pharma industry

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[2], 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.

Patent Litigation In The Indian Pharma Industry

Overview of patent litigation in India

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 –

• The nature of the claims.
• Enabling disclosures provided in the patent specification by the patentee.

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:

• A statement that the threats are unjustified.
• An order prohibiting the threats from being made again.
• Compensation for any damages incurred.

Section 64 of the Patents Act of 1970 lists the reasons due to which a patent may be revoked:

• The specification of another patent filed in India makes reference to the innovation.
• The applicant for the patent had no right to do so.
• The claim does not refer to an invention as its subject.
• Due to past usage, prior publishing, or prior awareness by the general public in India, the invention is apparent or does not need an inventive step.
• There is an insufficient description of the innovation.
• The claim's scope is unclear etc.

Common patent disputes in the Indian pharma industry

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.

Recent patent litigation cases in the Indian pharma industry

• Glenmark Pharmaceuticals Ltd. &Anr. v. Symed Labs Limited[3]

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 v. Union of India (2013) 6 SCC [4]

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.

Conclusion

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.

FAQs

[1]https://pharmaceuticals.gov.in/sites/default/files/english%20Annual%20Report%202020-21.pdf

[2]https://www.usitc.gov/publications/332/journals/pharm_fdi_indian_patent_law.pdf

[3] 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

[4] 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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