New Use Patentability India.
1. Overview: “New Use” Patentability in India
Definition:
A “new use” invention refers to an existing substance or compound being discovered for a new therapeutic or industrial use, even if the compound itself is already known.
Example:
A drug already known to treat disease A is now discovered to treat disease B.
Legal Framework in India:
Governed under The Patents Act, 1970, especially:
Section 3(d) – Prohibits patenting of new forms of known substances unless they show enhanced efficacy.
Section 2(1)(j) – Definition of “invention”.
Section 3(e) – Prohibits patenting of minor modifications of known substances unless they demonstrate significant technical advantage.
Key Principles:
Known Substance + New Use = Patentable?
Yes, if the new use is not obvious, and shows enhanced efficacy or a new technical application.
Known Substance + Mere Discovery of Use = Patentable?
Courts are stricter. Mere accidental discovery of a new use without technical innovation may not be patentable.
India is stricter than the US, where “new use” patents are broadly allowed.
2. Case Law Analysis
Here are detailed explanations of important Indian cases on New Use patentability:
(i) Novartis AG v. Union of India (2013) – Glivec Case
Facts:
Novartis filed a patent for the β-crystalline form of imatinib mesylate (Glivec), a known drug.
India had Section 3(d) in place to prevent “evergreening” (minor modifications of known substances).
Ruling & Doctrine Application:
Supreme Court denied patent.
Court held that:
Mere new form of a known substance is not patentable unless it shows enhanced therapeutic efficacy.
Discovery of a new use alone is insufficient for patent protection in India.
Significance:
Landmark case establishing India’s stringent standards against evergreening.
Reiterates that “new use” must demonstrate enhanced efficacy, not just a new application.
(ii) F. Hoffmann-La Roche Ltd. v. Cipla Ltd. (2008)
Facts:
Roche patented Erlotinib (anti-cancer drug).
Cipla produced a generic version for a new therapeutic use.
Ruling & Doctrine Application:
Delhi High Court emphasized that new use of known compounds may be patentable, but only if:
It is non-obvious, and
It provides technical advantage or therapeutic benefit.
Mere discovery of new use without demonstrating efficacy does not meet patentability threshold.
Significance:
Reinforced the “enhanced efficacy” requirement under Section 3(d).
(iii) Bayer Corporation v. Union of India (2014)
Facts:
Bayer held a patent for Sorafenib for cancer treatment.
Indian generic companies sought to produce it for new therapeutic applications.
Ruling & Doctrine Application:
Court held that a new therapeutic use of a known compound can qualify as an invention if:
It shows enhanced efficacy or
Provides a new, inventive application.
Mere off-label use does not qualify.
Significance:
Clarified that India allows new use patents, but the bar is high.
Novel use must be scientifically and technically supported.
(iv) Lee Pharma Ltd. v. Cipla Ltd. (2002)
Facts:
Lee Pharma discovered a new pharmaceutical use for an existing compound.
Cipla argued that this new use was non-patentable as the compound itself was known.
Ruling & Doctrine Application:
Delhi High Court held that:
New use of a known compound can be patentable under Section 2(1)(j),
Provided it demonstrates technical advancement or unexpected efficacy.
Mere discovery of a potential therapeutic use without experimental proof is insufficient.
Significance:
First major decision indicating conditional patentability for new uses.
(v) Ferring BV v. Lupin Ltd. (2017)
Facts:
Ferring BV patented a known hormone for a new fertility treatment.
Lupin filed opposition claiming it was a known substance with known properties.
Ruling & Doctrine Application:
IPAB (Intellectual Property Appellate Board) held that:
A new use of a known substance is patentable if it involves:
Technical innovation, or
Unexpected therapeutic or industrial effect.
Mere speculative use without supporting evidence is rejected.
Significance:
Reinforces that data and evidence are critical for new use patents in India.
(vi) Pfizer Inc. v. Cipla Ltd. (2009)
Facts:
Pfizer patented Sildenafil (Viagra) for erectile dysfunction.
Cipla tried to produce it for pulmonary hypertension (a new use).
Ruling & Doctrine Application:
Court allowed new use patent if:
It is not obvious,
Demonstrates therapeutic advantage,
Requires specific technical evidence.
Mere off-label use is not sufficient.
Significance:
Emphasizes the high standard of proof for new use patentability in India.
3. Key Takeaways from Indian Case Law on New Use Patents
New use of a known substance is patentable in India only if it demonstrates technical or therapeutic advantage.
Mere discovery of a different application without proof of efficacy is not patentable (Novartis case).
Experimental data and technical evidence are crucial to support claims of new use.
Section 3(d) prevents evergreening, i.e., incremental discoveries for the same substance without efficacy improvement are denied patent protection.
Courts distinguish between:
Obvious use (not patentable) vs
Non-obvious, inventive, and efficacious use (patentable).
4. Summary Table of Important Cases
| Case | Compound/Drug | New Use | Outcome | Key Principle |
|---|---|---|---|---|
| Novartis AG v. Union of India | Imatinib mesylate | Cancer | Patent rejected | New form must show enhanced efficacy |
| F. Hoffmann-La Roche v. Cipla | Erlotinib | Cancer | Allowed if proven efficacy | New use must be non-obvious |
| Bayer Corp v. Union of India | Sorafenib | Cancer | Allowed with proof | New use patentable with technical advantage |
| Lee Pharma v. Cipla | Pharmaceutical compound | Therapeutic | Conditionally allowed | Experimental proof required |
| Ferring BV v. Lupin | Hormone | Fertility | Allowed | Unexpected therapeutic effect required |
| Pfizer v. Cipla | Sildenafil | Pulmonary hypertension | Allowed | Off-label use insufficient |
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