Rule 46 of the Patents Rules, 2003
Omitted provision
An omitted rule from the chapter that ended in 2005, when India began granting product patents for medicines and agricultural chemicals.
Official legal text
This provision has been omitted, but its number remains. Statutes here are amended by omission rather than renumbering, which keeps every other number stable. Anyone reading a file, an order or a commentary from the period when it applied will meet this number and need to know what it covered.
The authority is the enacted text, not this page. Where our wording and the official provision, or an applicable Gazette notification, do not match, the official material prevails.
What this rule requires, step by step
The turning point for this chapter was the start of 2005. Until then, Indian law allowed patents in the pharmaceutical and agrochemical fields only for processes, not for the products themselves. The Patents (Amendment) Act, 2005 changed that, and with product patents available there was no longer any reason to keep a substitute right that let a company sell an article exclusively while its application waited. The chapter went, and this rule went with it.
The change also brought new safeguards into the permanent law rather than leaving them behind. The 2005 amendment strengthened the exclusions from patentability for new forms of known substances, expanded the grounds available in opposition, and provided protection for enterprises that had already invested in making a product covered by a held application before the new regime began. Reading the omitted chapter today is useful mainly for understanding that context: it marks the end of one system and the start of the one that Indian applicants and opponents work with now.
Why this rule matters
Generic manufacturers, originator companies and anyone studying the 2005 reform of Indian patent law.
Only in historical or comparative work about the change of regime.
Nothing today. The permanent regime introduced in 2005 governs instead.
Missing the safeguards the 2005 amendment introduced alongside product patents, which are still the most litigated provisions in Indian pharmaceutical patent practice.
How it works in practice
A company that changed its strategy in 2005
A mid-sized Indore pharmaceutical company had built its business on making medicines by its own routes, relying on the fact that Indian law protected processes but not products. In late 2004 its managing director asked the legal team what would change. The answer reshaped the company. From the beginning of 2005 a competitor could hold a patent on the molecule itself, so an alternative manufacturing route would no longer be a way around it. On the other hand, the amendment also tightened what could be patented as a new form of a known substance and widened the grounds for opposing a patent both before and after grant. The company stopped investing in process workarounds for molecules under held applications and built a small team to study published applications and file pre-grant oppositions where the claims looked weak. Twenty years later that team is still the most valuable department in the business.
Simplified illustration only. Actual legal outcomes depend on the facts.
Key points to remember
- Product patents for medicines and agricultural chemicals became available in India from the start of 2005.
- The transitional selling right and its rules were omitted at the same time.
- The 2005 amendment introduced safeguards, including stricter tests for new forms of known substances and wider opposition rights.
Connected provisions
This page explains a rule of the Patents Rules, 2003. A rule does not stand on its own; it works out a duty or a power that the Patents Act, 1970 has already created. The parent sections are listed separately so you can read the source of that authority.
Forms, deadlines and fees
Where a fee is payable under this provision, the figure comes from the First Schedule. Categories of applicant are charged at different rates, and electronic filing is treated differently from paper filing, so an accurate number can only come from the Schedule in force on the day you file. How Indian patent fees work.
Related judgments
Case law is added slowly and deliberately. A summary is drafted, checked against the reported judgment and then reviewed before publication, because a wrong case note can mislead a reader badly. No summary for this provision has reached publication yet. How case notes are prepared.
Questions people ask about Rule 46
From which date were product patents on medicines allowed in India?
From the start of 2005, when the Patents (Amendment) Act 2005 came into effect. Before that, Indian law allowed patents on processes of manufacture in the pharmaceutical and agrochemical fields but not on the products themselves. Applications filed for such products from 1995 onwards were held and then examined after the amendment. The transitional selling right that had covered the gap was abolished at the same time, along with the rules that supported it.
What else did the 2005 amendment change?
Besides introducing product patents, it tightened the exclusion for new forms of known substances that do not show enhanced efficacy, restructured the opposition system so that a patent can be challenged both before grant and after it, and provided protection for enterprises that had already made significant investment in producing an article covered by a held application. Those provisions, rather than the abolished transitional chapter, are what shape Indian pharmaceutical patent disputes today.
Assessing a pharmaceutical patent position in India?
MYCrave Consultancy advises on patentability, oppositions and freedom to operate under the post-2005 Indian regime.
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