Patent Registration Procedures.
Patent Registration Procedures in India
The patent system in India is governed by the Patents Act, 1970, as amended, and the procedures are mainly administered by the Office of the Controller General of Patents, Designs and Trademarks (CGPDTM). Here’s a detailed stepwise explanation:
Step 1: Determine Patentability
Before applying, the inventor should determine if the invention is patentable.
Criteria for Patentability (Section 2(1)(j), 3, 4 of Patents Act, 1970):
Novelty – The invention must be new. It should not be part of prior art.
Inventive Step (Non-obviousness) – It should not be obvious to a person skilled in the art.
Industrial Applicability – The invention should be capable of being used in some industry.
Exclusions – Scientific discoveries, abstract theories, business methods, methods of treatment, plants & animals (Section 3), etc., are not patentable.
Tip: Conduct a prior art search in Indian and international databases to check novelty.
Step 2: Filing a Patent Application
There are two types of applications in India:
Provisional Application (Sec 7)
Filed when the invention is at the conceptual stage.
Secures the priority date.
Must be followed by a complete specification within 12 months.
Complete Application (Sec 7(2))
Contains full details of the invention.
Includes claims defining the scope of protection.
Documents Required:
Form 1: Application for patent
Form 2: Provisional/Complete specification
Form 3: Statement & undertaking regarding foreign applications
Form 5: Declaration as to inventorship
Drawings (if applicable)
Prescribed fees
Step 3: Publication of Application
After 18 months from the priority date, the application is automatically published (Sec 11A).
Early publication can be requested (Form 9) for faster processing.
Step 4: Request for Examination
Must be filed within 48 months from priority date (Sec 11B).
Examination ensures the application meets patentability requirements.
Examination Report is issued citing objections if any.
Step 5: Response to Examination Report
Applicant responds to objections within 6 months (extendable to 3 months).
After satisfactory response, the application proceeds further.
Step 6: Grant of Patent
After examination and compliance, the Controller grants the patent (Sec 21).
Patent is published in the Patent Journal.
Step 7: Post-Grant
Patent is valid for 20 years from the filing date (Sec 53).
Annual renewal fees must be paid.
Rights: The patentee can exclude others from making, using, selling the invention.
Step 8: Opposition (Pre-Grant & Post-Grant)
Pre-grant opposition (Sec 25(1))
Any person can oppose after publication but before grant.
Post-grant opposition (Sec 25(2))
Any person can oppose within one year of grant.
Grounds for opposition:
Not new, obvious, or not an invention
Wrongful ownership
Non-disclosure of prior art
Key Case Laws in Patent Registration
Here’s a detailed discussion of 5+ landmark cases:
1. Novartis AG v. Union of India (2013)
Facts: Novartis applied for a patent for Glivec, a cancer drug. The application was rejected by Indian Patent Office under Section 3(d) for lack of enhanced efficacy over prior art.
Issue: Whether incremental improvements of existing drugs are patentable.
Held: Supreme Court held that mere modification without significant efficacy is not patentable under Section 3(d).
Significance: Strengthened India’s stance against “evergreening” of pharmaceutical patents.
2. Monsanto Technology LLC v. Nuziveedu Seeds Ltd. (2018)
Facts: Monsanto held patents on genetically modified cotton seeds in India.
Issue: Whether Monsanto’s patents could restrict farmers from saving seeds.
Held: Patents on genetically modified seeds were upheld, but farmers’ traditional practices were recognized to some extent.
Significance: Balanced IPR protection vs farmers’ rights in agriculture.
3. Bayer Corporation v. Union of India (2014)
Facts: Bayer patented an anti-cancer drug. Generic companies challenged its patent.
Held: Indian courts emphasized Section 3(d) and requirement of enhanced therapeutic efficacy.
Significance: Reinforced India’s strict standard for pharmaceutical patents.
4. F. Hoffmann-La Roche Ltd. v. Cipla Ltd. (2008)
Facts: Dispute over Roche’s drug “Nexavar”.
Issue: Cipla sought compulsory license citing affordability and public health.
Held: Compulsory licensing allowed if drug is unaffordable or insufficiently available.
Significance: Demonstrated patent law balancing IPR and public health.
5. Novartis AG v. Union of India – Patentability of Incremental Innovation
Facts: Same as above but highlights incremental innovation issue.
Held: Only significant improvement over prior art is patentable.
Significance: Indian patent law protects genuine innovation, not minor tweaks.
6. Pfizer Inc. v. Cipla Ltd.
Facts: Pfizer’s patent for HIV drug challenged by Cipla for generic production.
Held: Patent upheld but negotiations emphasized affordable medicine for public health.
Significance: Illustrates tension between IPR and public access.
7. Novartis v. Union of India – Section 3(d) Interpretation
Supreme Court clarified:
Efficacy = therapeutic efficacy for drugs
Minor chemical modifications not sufficient
Encourages true innovation in pharmaceuticals
Key Takeaways from Case Laws
India applies a strict standard of patentability (Sec 3(d)) for pharmaceuticals.
Public interest and access to essential medicines is prioritized.
Compulsory licensing is allowed in case of non-availability or high cost.
Farmers’ rights are considered in biotech patents.
Incremental innovation alone is not enough; substantial improvement is required.
RELATED Blog
comments