Medical Patents and Impact on Availability and Affordability of Essential Medicines in India

Medical Patents and Impact on Availability and Affordability of Essential Medicines in India

Kishore Dulam (IMT Ghaziabad, India)
Copyright: © 2017 |Pages: 17
DOI: 10.4018/978-1-5225-2414-4.ch003
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This paper discusses the Pharmaceutical patents in India and its effects. The definition of patents and its aspects, registration patent bodies, and the time period aspects are studied. The need of patents in the pharmaceutical industry is discussed in detail with cases. Regulatory bodies and their relevance as the majority of revenue for Indian pharmaceutical companies are studied. The intent of the government is to control the prices of a few drugs and to make basic drugs affordable to the common public.
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When expanding businesses, industries are forced to evolve their business models according to recent changes in the operating market. In January 2005, India implemented a patent law that reinstated product patents. The legislation started on the timeline set by the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. It mandated the patent protection on both products and processes for a period of 20 years. Under this new law, India is forced to recognize not only new patents, but also all patents filed after 1 January 1995. Companies in India achieved their status in the market by infringement of these patents. They are expected to lose $650 million of the local generics market to the original patent-holders. This change has a significant impact on Indian pharmacy companies.

Requirement for Getting a Patent

To become patentable, an invention should meet the subsequent criteria

  • It should be novel.

  • It should have an ingenious step or it should be non-obvious

  • It should be capable of commercial application.

The basic obligation of a patent is that the invention altogether branches technology. Not whether the product or processes are patentable meets the 3 tests: being a novelty, an inventive step, and being capable of commercial application. Additionally, to the overall security exemption that applies to the whole TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement, specific exclusions are permissible from the scope of the patentability of inventions; the hindrance of whose business exploitation is critical to guard public order or morality, human, animal, plants or health; or to avoid serious prejudice to the setting. Further, members can also exclude the patentability of diagnostic, therapeutic, and surgical ways of the treatment of humans, plants, and animals aside from micro-organisms and basic biological processes for the assembly of plants and animals.

The visits agreement provides a minimum term of protection of twenty years beginning from the date of filing. However, in the case of applications filed under PCT the term of 20 years begins from the International filing date. The government of India had already enforced the requirements in Articles 70.8 and 70.9 of the TRIP Agreement.

Ministry administering the IPR:

  • Department Industrial Policy and Promotion

  • Ministry of Commerce & industry

The main workplace is in Kolkata and 4 branches of the Patent Offices are in Kolkata, Mumbai, Delhi, and Chennai. Mumbai supervises jurisdiction of Maharashtra, Gujrat, Madhya Pradesh and Goa, Daman and Diu, Dadra, and Nagar Haveli. In Chennai’s jurisdiction, the States of Andhra Pradesh, Kerala, Tamil Nadu, Mysore and Pondicherry, Laccadive, Minicoy and the Aminidivi Islands are included. The New Delhi branch looks over the jurisdiction of Haryana, Himachal Pradesh, Jammu, Kashmir, Punjab, Rajasthan, Chandigarh, and Delhi City. The remainder of the Republic of India comes under the jurisdiction of Delhi.

Patent protection is a territorial right and thus it’s effective solely inside the territory of the Republic of India. However, filing an application in the Republic of India allows anybody to file a corresponding application for the same invention in convention countries, during or before the end of the twelve month filing period in the Republic of India. Therefore, separate patents ought to be obtained in every country wherever the applicant needs the protection of his or her invention in those countries. No patent is valid worldwide.

An application can be filed by either the true and initial discoverer or his or her recipient, alone, or conjointly with the other person. Also, the personal representative of an associate decedent can create a patent application.

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