Milmet Oftho Industries v.
Allergen Inc. (2004): A
Landmark Case in Indian
Patent Law
The case of Milmet Oftho Industries v. Allergen Inc., decided by the
Supreme Court of India in 2004, is a pivotal moment in Indian
patent law. This case delves into the critical issue of "working" a
patent and its implications for the pharmaceutical industry, access
to medicines, and the balance between patent holder rights and
public interest.
Understanding the Key Players: Milmet and
Allergan
Milmet Oftho Industries Allergan Inc.
An Indian pharmaceutical company specializing in the A multinational pharmaceutical corporation known for
production of generic drugs. Milmet held approximately its innovative drugs. In 2004, Allergan reported global
5% of the Indian ophthalmic drug market and played a revenue of $4.82 billion, reflecting its significant
crucial role in providing affordable healthcare solutions presence in the global pharmaceutical market.
to the Indian population.
The Core of the Dispute: Composition of
Matter Patent
Allergan's Patent Milmet's Challenge Patent Specifics
Allergan held Indian Patent No. Milmet aimed to introduce a The core patent claim revolved
194223, concerning a specific generic version of the same drug around a complex chemical
composition of matter used in a in the Indian market, challenging compound: "(11aR)-N-[2-(5,6-
drug for treating glaucoma. This Allergan's patent rights and dihydro-1H-azepin-4-yl)ethyl]-7-
patent was originally filed in the setting the stage for a significant [(R)-hydroxy-phenylacetyl]-4,9-
U.S. in 1991, before being filed in legal battle. dioxa-6-aza-undecahydro-1H-
India. benz[f]indene-5-carboxamide, or a
pharmaceutically acceptable salt
thereof."
The Critical Legal Question: What Constitutes
"Working" a Patent?
Core Issue Global Approval vs. Local Indian Law Requirement
Activity
The central legal issue was whether Indian law requires active
Allergan had indeed "worked" the A key point of contention was commercial activity to be considered
patent in India, as required by Indian whether obtaining marketing as "working" a patent in India. This
law, to be granted an injunction approval in numerous countries (over helps encourage local production and
against infringement by Milmet. 80, including the US and Europe) was ensures medicines reach the public.
equivalent to "working" the patent
within India.
The Court's Verdict: Local Activity is Key
Supreme Court Ruling 1
The Supreme Court of India unequivocally stated that securing
marketing approval outside of India does not equate to "working"
the patent within India. 2 Commercial Activity Required
The court emphasized that "working" a patent necessitates
substantial commercial activity within the country, such as local
Affordable Access 3 manufacturing or marketing efforts.
The court highlighted the importance of ensuring that patented
products are accessible to the Indian public at reasonable prices,
aligning with the public interest. 4 Section 83(b) of the Patents Act
The ruling cited Section 83(b) of the Patents Act, 1970, stressing
the need for patents to encourage inventions and ensure they are
worked on a commercial scale within India.
Reshaping Patent Law: Implications of the Ruling
1 Enforceability 2 Discouraging Patent 3 Local Manufacturing
Hoarding
The verdict reinforced that The ruling encouraged local
patents must be actively It discouraged patent holders manufacturing and enhanced
"worked" in India to be from merely obtaining patents the availability of essential
enforceable, setting a clear without the genuine intention drugs within the Indian
precedent for future cases. to manufacture or market the market, boosting the domestic
product within India. pharmaceutical industry.
REASON WITH DECISION
Deceptive Similarity and
1 First in the Market Principle
Public Interest
2
Global Presence vs. Local Use
4 Protection of Domestic
3 Enterprises
Key Takeaways: Balancing
Innovation and Public
Interest
The Milmet Oftho Industries v. Allergen Inc. case remains a
cornerstone in Indian patent law, underscoring the necessity of
actively "working" patents within India to ensure their
enforceability. This landmark decision has profoundly impacted the
pharmaceutical industry, enhancing access to affordable medicines
and fostering local manufacturing.
The Supreme Court adeptly balanced the rights of patent holders
with the overarching public interest in accessible and affordable
healthcare, setting a precedent that continues to shape patent law
and policy in India.
THANK YOU
