Indian Patent Office rejects BPaL TB regimen patent under Patents Act
The Indian Patent Office has rejected the TB Alliance's patent application for BPaL, a drug-resistant tuberculosis regimen. BPaL joins bedaquiline, pretomanid and linezolid in a six-month course taken by mouth. Patients' groups had opposed the claim before grant. The office accepted every ground they raised, including the Patents Act, 1970 bar on new uses of known substances.
Syllabus: Prelims · Current Affairs & IR; GS2 · Health, Education & Human Resources; GS3 · IT, Space, Biotech & IPR
Why this matters for UPSC
GS3 intellectual property rights and GS2 health. Prelims can ask what Sections 3(d), 3(e) and 3(i) of the Patents Act, 1970 exclude; Mains, about patents and access to TB medicines.
Why it matters
A patient with drug-resistant TB in India has long faced more than a year of tablets and painful injections. A six-month course taken by mouth lets such a patient return to work sooner and puts less strain on the family. With the patent on the combination refused in India, one legal barrier to cheaper supply for the public programme is gone. The ruling also shows how patients' groups can use the patent system itself to question weak claims. The larger question is how a country rewards drug developers while keeping essential medicines within reach of the poor.
Prelims pointers
- Section 3(i) of the Patents Act, 1970 excludes medicinal, surgical, curative, prophylactic, diagnostic and therapeutic treatment processes for humans, and similar processes for animals.
- Under Section 53(1), a patent's term is twenty years from the date of filing of the application.
- Section 84(1) allows a compulsory licence three years after grant if public needs are unmet, the price is not reasonably affordable, or the invention is not worked in India.
- Section 10(4) requires a complete specification to disclose the best method of performing the invention known to the applicant and to end with claims.
- Section 25(1)(k) lets an opponent show the invention was anticipated by oral or other knowledge within a local or indigenous community in India or elsewhere.
- The Controller General of Patents, Designs and Trade Marks is appointed under Section 3 of the Trade Marks Act, 1999 and is the Controller of Patents (Section 73(1)).
Practise a UPSC-style question
With reference to Section 3 of the Patents Act, 1970, consider the following statements:
1. Under clause (d), combinations of a known substance count as the same substance unless they differ significantly in efficacy.
2. Under clause (e), a substance made by mere admixture that only aggregates its components' properties is not an invention.
3. Under clause (i), processes for treating human beings are excluded, but processes for treating animals remain patentable.
Which of the statements given above is/are correct?
- (a) 1 and 2 only
- (b) 2 and 3 only
- (c) 1 and 3 only
- (d) 1, 2 and 3
Show the answer
Answer: (a) 1 and 2 only
Answer: (a) 1 and 2 only. Clauses (d) and (e) are stated correctly; clause (i) covers animals too.
Statement 1: correct. The Explanation to Section 3(d) treats salts, esters, polymorphs, combinations and other derivatives as the same substance unless efficacy differs significantly.
Statement 2: correct. Section 3(e) excludes a substance from mere admixture that only aggregates the properties of its components, and the process for producing it.
Statement 3: incorrect. Section 3(i) also excludes any process for similar treatment of animals to free them of disease or raise their economic value.
Eliminate: Statement 3 is wrong because clause (i) names animals as well. Out: (b), (c), (d).
Trap: Half-true statement. Statement 3 starts with the true exclusion for human treatment and then adds a false carve-out for animals.
Remember: Section 3(i) shuts out medical-treatment processes for humans and animals alike.
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