Indian Pharmaceutical Industry is considered highly progressive in the field of drug manufacturing and technology. Today India has a global presence in the field of generic drugs and hence protects the new drug combinations and their process by means of intellectual property rights (IPR).
Patenting innovation has played a pivotal role in the economic growth of India. Economists have long established a connection between research and development (R&D) expenditures and innovation, as measured by patenting activity. However, patenting in the pharmaceutical industry is quite unlike other industries because the patent is the product itself (a new drug) which is the result of the cost involved in R&D and extensive clinical testing. Factors such as the protection of intellectual property (e.g. patents) are increasing in significance due to the growing recognition of the need to ensure the protection of valuable investments in research and development (R&D). Various efforts have been taken by India to check problems of weak enforceability of existing intellectual property legislations, and the Indian government is regularly implementing new amendments in Indian patent laws to establish a good patent system that is beneficial to technological advances and in keeping with its global commitments. Understanding different types of patents are equally important for the innovators and their generic counterparts.
Types of Pharmaceutical patents
There are several types of patents that are relevant to the pharmaceutical industry.
Drug product patent: This patent claims the active pharmaceutical substance or its intermediate as a new chemical entity. Product patent gives a higher level of protection to the inventor as no other manufacturer can provide the same product through the same or any other process. In pharmaceutical patents term ‘composition of matter’ also denotes a product claim.
Product by process patent: This type of patent claims a chemical or other process used to manufacture the drug whenever the drug is made by the patented process and also confers protection against the importation of a product. However, the drug can be made and sold if another company can devise a commercially viable process not covered in the patent.
Process patent: This patent claims the chemical or other process used to manufacture the drug. The chemical product itself is not covered. There is a high possibility for competitors to redesign the original invention by discovering a new process with less strain and investment.
Formulation patent: This patent claims the pharmaceutical dosage form on the drug, commonly also known as a composition but not to be confused with ‘composition of matter (see previously). There may also be formulation process patents covering the manufacturing processes used to make the formulation.
Patents on different crystal forms: Many compounds exist in different crystal forms or polymorphic forms. These different crystals may have different pharmaceutical properties such as solubility and bioavailability. Patents on crystal forms (polymorphs) are becoming increasingly popular as another method to block or delay generic entry.
Method of use: This covers the use of the drug to treat a disease. This type of patent claim is generally not allowed in India but in a few cases, it may be allowed. Remember that not all types of claims are allowed in India.
Technology Patents: These patents are based on the techniques used to solve specific technology-related problems like stabilization, taste masking, increase in solubility, purification, etc.
Patent, in the pharmaceutical area, refers to the legal protection for the inventors’ inventions, including new and useful medicines or drugs discovered by research-based pharmaceutical firms. The patent rights on drugs mean that only the patentee can manufacture, use, and sell the patented drug. The patent can also provide solutions for technical issues, but to obtain those benefits by getting the invention patented, the inventors should ensure that their ideas satisfy the criteria of patentability.
Criteria for patentability in India:
The patent offers a technical solution to a technical problem. The patent is granted only to those inventions which satisfy certain conditions known as criteria of patentability. The basic criteria for patentability in India are as follows:
- Absolute novelty – The invention should be new and not disclosed to the public anywhere in the world in any form or through any medium.
- Inventive step/non-obviousness – The invention should not be obvious to a person skilled in the art in the relevant area of technology and should involve an inventive feature that is distinctive in nature from the previous inventions made in the same field.
- Industrial application –The new product or process should be capable of being made or used in an industry and it should have economic significance.
- The invention should not fall under Sections 3 and 4 of the Indian Patents Act.
The Indian patent law is excellent patent legislation that is aimed at balancing the interests of the common man and the inventors. It is very important for pharmaceutical companies to obtain patent protection for their products in order to recover their investments. It is widely accepted that patents are a fundamental incentive for innovative activities in the pharmaceutical industry, hence it needs to be protected. Indian Patent Law is generally supporting national technological and industrial strategies.
- ‘Draft Manual of Patent Office Practice and Procedure’ is available at http :// www.ipindia.nic.in /writereaddata/Portal/News/505_1_Draft_MANUAL_OF_PATENT_OFFICE_PRACTICE_AND_PROCEDURE_01-03-2019.pdf
- The Patents Act, 1970 available at http:// www.ipindia.nic.in /writereaddata /Portal/IPOAct / 1_31_1_patent-act-1970-11march2015.pdf
- ‘Patenting of Pharmaceuticals: An Indian Perspective’; Int. J. Drug Dev. & Res., 4(3), 27-34, 2012
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- ‘Patenting and R&D in Indian Pharmaceutical Industry’; J. of Intellectual Property Rights, 18, 105-110, 2013.
- ‘Patenting trends in Indian pharmaceutical industry’; Annals of Library and Information Studies, 64, 260-267, 2017.