Medical Device Patent Disputes India.
I. Legal Framework Governing Medical Device Patents in India
Medical devices in India are protected under the Patents Act, 1970 (as amended). Unlike pharmaceuticals, medical devices often involve mechanical, electronic, and software-based inventions, which leads to distinct patentability challenges.
Key Legal Provisions:
Section 2(1)(j) – Definition of “invention”
Section 2(1)(ja) – Inventive step
Section 3(d) – Evergreening (mainly pharma, but sometimes raised in device cases)
Section 3(e) – Mere admixture
Section 3(f) – Mere arrangement or duplication of known devices
Section 3(k) – Computer programs per se (important for software-enabled devices)
Section 48 – Rights of patentees
Section 107 – Patent infringement defenses
Section 64 – Revocation of patents
II. Major Medical Device Patent Disputes in India (Detailed Case Laws)
1. Koninklijke Philips Electronics NV v. Rajesh Bansal & Others
(DVD Player / MPEG-2 Technology – Delhi High Court)
Facts:
Philips owned a Standard Essential Patent (SEP) related to MPEG-2 decoding technology, which is used in DVD players and certain medical imaging equipment. The defendants manufactured DVD players without obtaining a license.
Legal Issues:
Whether Philips’ patent was valid and infringed
Whether the patent was essential to the standard
Whether licensing terms were FRAND-compliant
Whether Indian manufacturers could avoid liability due to cost concerns
Arguments:
Philips:
Patent was essential to MPEG-2 standard
Use of technology without license constituted infringement
Defendants:
Patent lacked inventive step
Royalty demanded was excessive
Patent was not truly “essential”
Court’s Reasoning:
Recognized the concept of Standard Essential Patents under Indian patent law
Held that use of standardized technology without a license is infringement
Observed that commercial inconvenience does not negate patent rights
Upheld Philips’ patent validity
Impact:
First major Indian ruling recognizing SEP enforcement
Important for medical imaging devices, diagnostic equipment, and other standardized technologies
Strengthened patent protection for device manufacturers
2. Allergan Inc. v. Controller of Patents
(Ophthalmic Medical Device – Patent Office & IPAB)
Facts:
Allergan sought patent protection for a sustained-release ocular implant used in treating eye disorders. The Controller rejected the patent application.
Legal Issues:
Whether the device was merely a known arrangement of known elements (Section 3(f))
Whether there was sufficient inventive step
Whether therapeutic benefit alone establishes patentability
Arguments:
Allergan:
Device offered controlled drug release, improving patient compliance
Structural configuration was novel
Patent Office:
Implant combined known polymer and drug
No technical advancement beyond known devices
Decision:
Rejection upheld
Tribunal held that functional improvement without structural novelty is insufficient
Emphasized technical advancement, not just medical benefit
Impact:
Important precedent for implantable medical devices
Clarified that incremental improvements must show engineering novelty
3. B. Braun Melsungen AG v. Controller of Patents & Designs
(Surgical Sutures & Infusion Devices)
Facts:
B. Braun applied for patents relating to medical infusion systems and surgical devices. The Patent Office rejected the application citing lack of inventive step.
Legal Issues:
Whether rearrangement of components in a medical device constitutes invention
Interpretation of Section 2(1)(ja) (inventive step)
Arguments:
Applicant:
Claimed improved safety and reduced infection risk
Patent Office:
Improvements were obvious to a person skilled in the art
Decision:
Rejection upheld
Court stressed:
“Improvement in performance alone does not establish inventive step unless technical ingenuity is demonstrated.”
Impact:
High threshold for patenting incremental medical device innovations
Frequently cited in device patent examinations
4. Edwards Lifesciences Corporation v. Meril Life Sciences Pvt. Ltd.
(Heart Valve Technology – Delhi High Court)
Facts:
Edwards sued Meril for infringement of patents relating to Transcatheter Heart Valve Replacement (THVR) technology.
Legal Issues:
Whether Meril’s valve infringed Edwards’ patent
Whether Edwards’ patents were invalid due to prior art
Balance between public health and patent rights
Arguments:
Edwards:
Core valve design and deployment mechanism copied
Meril:
Claimed independent development
Invoked public interest and affordability
Court’s Reasoning:
Conducted claim-to-claim comparison
Held that public interest cannot override patent rights unless compulsory license conditions are met
Granted injunction in favor of Edwards
Impact:
One of the most significant medical device infringement cases in India
Reinforced that life-saving nature of devices does not dilute patent protection
5. Roche Diagnostics GmbH v. SD Biosensor India Pvt. Ltd.
(Diagnostic Medical Devices – COVID-era relevance)
Facts:
Roche owned patents relating to in-vitro diagnostic testing systems. SD Biosensor challenged validity during enforcement proceedings.
Legal Issues:
Whether diagnostic devices fall under exclusions
Whether method claims were patentable
Patent infringement during public health emergencies
Court’s Observations:
Diagnostic devices are patentable, but diagnostic methods practiced on the human body are excluded
Emphasized device vs method distinction
Refused blanket invalidation merely due to emergency context
Impact:
Clarified scope of patent protection for diagnostic kits and testing equipment
Important for biomedical device startups
6. Stryker Corporation v. Zimmer India Pvt. Ltd.
(Orthopedic Implants – Delhi High Court)
Facts:
Dispute over knee replacement implant designs.
Legal Issues:
Whether design and utility patents overlapped
Whether minor design alterations avoid infringement
Decision:
Court held that functional similarity with immaterial variations constitutes infringement
Applied Doctrine of Equivalents
Impact:
Strong precedent for orthopedic implant patent enforcement
Prevented easy design-arounds in medical devices
III. Key Legal Principles Emerging from Indian Medical Device Patent Disputes
High Inventive Step Threshold
Incremental changes must demonstrate engineering innovation, not just clinical benefit.
Public Interest Is Not an Automatic Defense
Courts consistently hold that affordability alone does not negate patent rights.
Device vs Method Distinction
Devices are patentable; diagnostic or therapeutic methods on the human body are excluded.
SEP Enforcement Is Recognized
Important for digitally enabled medical devices.
Doctrine of Equivalents Applies
Minor modifications will not escape infringement.
IV. Conclusion
India’s approach to medical device patent disputes reflects a balanced but stringent regime:
Strong enforcement against infringement
Strict scrutiny during patent grant
Emphasis on genuine technological advancement
Alignment with public health without undermining innovation incentives
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