Novelty And Inventive Step Analysis.
1. Novelty (Section 2(1)(j) & 29 of the Indian Patents Act, 1970)
Definition:
A claimed invention must be new, meaning it does not form part of the prior art. Prior art includes everything published anywhere in the world before the filing date (or priority date) of the patent application.
Key Points:
If a single prior disclosure anticipates the invention, it lacks novelty.
Even partial disclosure can destroy novelty if it makes the invention obvious in combination with common knowledge.
The invention must be disclosed in a single prior art reference, not pieced together from multiple sources.
Important Case Laws on Novelty:
Case 1: Novartis AG v. Union of India (2013)
Facts: Novartis sought a patent for the beta-crystalline form of Imatinib (used for cancer). The Indian Patent Office rejected it, citing Section 3(d), which limits patentability of new forms of known substances unless they show enhanced efficacy.
Principle: Mere new forms (salts, polymorphs) of known drugs are not novel if they don’t show significant improvement.
Outcome: Supreme Court upheld rejection.
Lesson: Novelty isn’t just about a physical difference; functional improvement may be necessary.
Case 2: Monsanto Co. v. Stauffer Chemical Co.
Facts: Monsanto claimed a patent for a new herbicide. Stauffer argued prior publications disclosed the same composition.
Principle: If a prior single document discloses all elements of the claimed invention, the invention lacks novelty.
Outcome: Patent denied.
Lesson: Exact disclosure in prior art is sufficient to destroy novelty.
Case 3: Lederle Laboratories v. Pfizer
Facts: Lederle claimed a new method of using a known compound. Pfizer challenged novelty citing earlier publications describing the compound.
Principle: Novelty is lost if the prior art anticipates the claimed invention.
Outcome: Court emphasized “anticipation” must be clear and direct.
Lesson: Novelty is strict; even if not practically used before, prior disclosure destroys it.
Case 4: F. Hoffmann-La Roche Ltd. v. Cipla Ltd. (India)
Facts: Roche patented a particular drug, and Cipla produced a generic version. Cipla argued the drug was already disclosed in prior art.
Principle: Prior public disclosure anywhere in the world negates novelty.
Outcome: Indian courts rejected Roche’s patent claim on novelty grounds for certain formulations.
Lesson: Novelty includes global prior publications, not just domestic.
2. Inventive Step / Non-Obviousness (Section 2(1)(ja) & 2(1)(j) & 29 of Patents Act, 1970)
Definition:
An invention involves an inventive step if it is not obvious to a person skilled in the art at the time of the patent application, considering the prior art.
Key Points:
Objective: Prevent patents on trivial or routine improvements.
Test: Would a skilled person, with prior art knowledge, arrive at the invention without inventive ingenuity?
In India, this is assessed in light of Section 3(d) and global standards (e.g., TRIPS).
Important Case Laws on Inventive Step:
Case 5: Bishwanath Prasad Radhey Shyam v. Hindustan Metal Industries (AIR 1971 SC 206)
Facts: A patent was claimed for a process of preparing lead acetate. It was challenged for being obvious.
Principle: If a skilled person could modify existing techniques without any inventive effort, it lacks inventive step.
Outcome: Patent invalidated.
Lesson: Simple variations of known methods do not qualify as inventive.
Case 6: Novartis AG v. Union of India (2013)
Relevance to inventive step: Beyond novelty, the court ruled that mere new forms of known drugs are obvious unless they provide enhanced efficacy.
Outcome: Patent rejected.
Lesson: Novelty without inventive step is insufficient; inventive step requires significant technical advance.
Case 7: Pfizer v. Cipla (India)
Facts: Pfizer’s patented drug was challenged by Cipla on grounds of obviousness.
Principle: If a skilled chemist could combine prior art to arrive at the claimed invention without ingenuity, it lacks inventive step.
Outcome: Courts scrutinized inventive contribution, rejecting claims that were routine chemical modifications.
Lesson: Incremental changes do not meet inventive step standards.
Case 8: Merck & Co. v. Glenmark Pharmaceuticals (India)
Facts: Merck patented a compound for cholesterol lowering. Glenmark argued the compound was obvious from known structures.
Principle: Courts assessed whether the modification would be obvious to someone skilled in medicinal chemistry.
Outcome: Patent was restricted; some claims invalidated for lack of inventive step.
Lesson: Non-obviousness is judged from the perspective of a skilled person, not a layman.
3. Summary Table: Novelty vs. Inventive Step
| Feature | Novelty | Inventive Step (Non-Obviousness) |
|---|---|---|
| Definition | Must be new, not disclosed anywhere | Must be non-obvious to skilled person |
| Test | Is it disclosed in prior art? | Would it be obvious from prior art? |
| Case Law Focus | Novartis AG, Monsanto, Lederle | Bishwanath Prasad, Novartis, Pfizer |
| Key Point | Exact anticipation destroys patentability | Obvious improvements fail inventive step |
✅ Conclusion:
Novelty ensures the invention is truly new.
Inventive step ensures it contributes a non-trivial advance.
Both are essential for patentability.
Courts rely heavily on prior art, expert opinion, and the perspective of a skilled person in the art.
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